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CJC-1295 With DAC

2026 Scientific and Regulatory Research Reference

U.S. Research Peptide Market | PubChem CID 91971820 | C₁₆₅H₂₆₉N₄₇O₄₆ | MW 3,647.2 g/mol

NOT FDA-APPROVED FOR ANY INDICATION — FOR EDUCATIONAL AND PROFESSIONAL REFERENCE ONLY

⚠ REGULATORY STATUS – READ BEFORE PROCEEDING

REGULATORY DISCLOSURE: CJC-1295 With DAC is NOT FDA-APPROVED for any human therapeutic indication as of June 2026. No NDA, BLA, ANDA, or biologics license exists for CJC-1295 DAC or any of its salt forms (free base, acetate, trifluoroacetate).

PCAC STATUS: At the December 4, 2024 Pharmacy Compounding Advisory Committee meeting, the FDA proposed that NONE of the CJC-1295 bulk drug substance variants (including DAC free base, DAC acetate, DAC trifluoroacetate) be placed on the 503A bulks list. The committee voted 0 yes / 13 no / 0 abstentions against inclusion.

2026 RECLASSIFICATION: On February 27, 2026, HHS Secretary Kennedy directed the FDA to administratively reclassify approximately 14 restricted peptides including CJC-1295 from Category 2 back to Category 1 of the interim 503A bulks framework. This is NOT an FDA approval. It is an interim enforcement discretion measure. The compound remains unapproved and unvalidated for safety or efficacy. WADA: CJC-1295 is classified as a prohibited growth hormone-releasing factor analog under

WADA Section S2. Athletes subject to anti-doping programs who use this substance risk sanctions regardless of its regulatory category status.

This document is a scientific and regulatory reference for educational, academic, and professional use only. No dosing protocol, clinical schedule, reconstitution instruction, or consumer self-use guidance is contained or implied herein.

Product Overview

CJC-1295 with DAC is a long-acting synthetic analog of human growth hormone-releasing hormone (GHRH), engineered by ConjuChem Biotechnologies to overcome the primary limitation of native GHRH: rapid plasma degradation. Where endogenous GHRH is cleared within minutes, CJC-1295 with DAC achieves an estimated human terminal half-life of 5.8 to 8.1 days through a proprietary Drug Affinity Complex (DAC) that covalently conjugates the peptide to circulating serum albumin via a maleimide-thioether bond at Cys34.

PubChem records the compound under CID 91971820 with molecular formula C165H269N47O46 and a molecular weight of approximately 3,647.2 g/mol. CAS Registry 446262-90-4 is most frequently cited for the DAC variant, though CAS 863288-34-0 appears in some vendor documents and refers more strictly to the non-DAC backbone. These nomenclature ambiguities represent a persistent quality-control risk in the gray market that researchers and compliance officers must actively manage.

Phase I trials (Teichman et al., 2006, JCEM) demonstrated that single subcutaneous doses at 30-60 mcg/kg produced 2- to 10-fold increases in mean plasma GH sustained for at least 6 days, and 1.5- to 3-fold increases in IGF-1 for 9 to 11 days, with preserved pulsatile GH secretion architecture. A Phase II trial in HIV-associated lipodystrophy was halted in July 2006 following a participant death attributed to underlying coronary artery disease; the program was subsequently terminated, and the compound never advanced to Phase III or NDA submission.

The 2026 regulatory environment for CJC-1295 with DAC is uniquely dynamic. Following the December 2024 PCAC vote against its inclusion on the 503A bulks list, the HHS Secretary issued a directive in February 2026 to reclassify CJC-1295 among other peptides to Category 1. This does not change its unapproved status but temporarily restores a pathway for licensed 503A compounding with valid physician prescriptions, pending formal review. The July 23-24, 2026 PCAC meeting represents the next critical regulatory inflection point.

CHEMICAL IDENTITY — PubChem, CAS, AND MOLECULAR ARCHITECTURE

Canonical Database Identifiers

Identifier	CJC-1295 WITH DAC	CJC-1295 WITHOUT DAC (Mod GRF 1-29)
PubChem CID	91971820	56841945
CAS Registry Number	446262-90-4 (primary)	863288-34-0
Molecular Formula	C165H269N47O46	C152H252N44O42
Molecular Weight	3,647.2 g/mol (computed)	3,367.9 g/mol
IUPAC Nomenclature	N-epsilon30-maleimidopropionyl-[D-Ala2,Gln8,Ala15,Leu27]-Sermorelin-Lys30	[D-Ala2,Gln8,Ala15,Leu27]-Sermorelin
Estimated Human Half-Life	5.8 – 8.1 days (albumin-bound)	~30 minutes
Clearance Mechanism	Covalent albumin bioconjugation via Cys34 thioether bond	Enzymatic (DPP-IV) and renal clearance
Amino Acid Length	30 amino acids (29-aa hGRF backbone + DAC linker-Lys30)	29 amino acids

The GHRH(1-29) Backbone and Tetrasubstitution

Native human growth hormone-releasing hormone (hGHRH) is a 44-amino-acid peptide synthesized in the arcuate nucleus of the hypothalamus. Its receptor-binding activity is fully retained within the first 29 amino acids, a truncated sequence known as GHRH(1-29) or Sermorelin. However, native GHRH(1-29) is rapidly cleaved by dipeptidyl peptidase-4 (DPP-IV), which attacks the peptide bond between positions 2 and 3, yielding an in vivo half-life of fewer than 7 minutes and making it impractical as a long-acting research tool.

ConjuChem Biotechnologies addressed this limitation by introducing four targeted amino acid substitutions into the GHRH(1-29) backbone: D-Alanine at position 2 (primary DPP-IV resistance), Glutamine at position 8, Alanine at position 15, and Leucine at position 27. These modifications confer marked resistance to proteolytic degradation while preserving high-affinity binding at the GHRH receptor on anterior pituitary somatotrophs. The resulting backbone is referred to in literature as Modified GRF 1-29 (Mod GRF 1-29) and constitutes the structural foundation of both DAC and non-DAC CJC-1295 variants.

The DAC Modification: Maleimidopropionyl-Lysine and In Vivo Bioconjugation

The defining structural feature of CJC-1295 with DAC is the C-terminal extension incorporating a lysine residue conjugated to a maleimidopropionyl group (N-epsilon-maleimidopropionyl-Lysine at position 30). This Drug Affinity Complex (DAC) was explicitly engineered to react with the free thiol group of cysteine-34 (Cys34) located on circulating human serum albumin, the most abundant plasma protein in human blood.

Following subcutaneous administration, the maleimide group undergoes a rapid, spontaneous, and irreversible Michael addition with the Cys34 thiol, forming a stable thioether bond. This covalent bioconjugation creates a macromolecular peptide-albumin complex that exploits albumin’s natural long half-life (approximately 19 days) and protection from renal clearance, extending the functional pharmacokinetic profile of CJC-1295 from minutes to days. The result is a circulating complex that maintains GHRH receptor binding affinity across an extended pharmacodynamic window.

ANALYTICAL VERIFICATION NOTE FOR RESEARCH PROCUREMENT

Because CJC-1295 with DAC and CJC-1295 without DAC share the same hGRF(1-29) backbone but differ critically in the C-terminal DAC maleimido-lysine extension, their molecular masses are definitively different: 3,647 Da (with DAC) vs. 3,368 Da (without DAC). LC-MS analysis is the gold standard for confirmation.

If LC-MS of a batch labeled “CJC-1295 DAC” returns a mass of approximately 3,368 Da rather than 3,647 Da, the supplier has provided the non-DAC variant. This represents a severe supply chain integrity failure that would invalidate longitudinal pharmacokinetic research protocols.

PubChem CID 91971820 | pubchem.ncbi.nlm.nih.gov/compound/91971820

MECHANISM OF ACTION — GHRH RECEPTOR PHARMACOLOGY AND ENDOCRINE CASCADE

GHRH Receptor Agonism and Intracellular Signaling Cascade

Signaling Step	Biochemical Event	Downstream Effect	Research Source
Step 1 – Receptor Binding	CJC-1295 DAC (albumin-bound complex) binds GHRH receptor (GHRHR) on anterior pituitary somatotroph cells. GHRHR is a Gs-protein-coupled receptor (GPCR).	Receptor occupancy triggers Gs-alpha subunit activation and dissociation	Teichman et al., 2006 JCEM; PubChem CID 91971820
Step 2 – Adenylate Cyclase Activation	Activated Gs-alpha stimulates adenylate cyclase, catalyzing conversion of ATP to cAMP. Intracellular cAMP concentrations rise rapidly within somatotrophs.	Elevated intracellular cAMP serves as second messenger for PKA activation	ConjuChem MOA documents; Ionescu et al., pulsatility research
Step 3 – PKA Activation	cAMP activates Protein Kinase A (PKA). PKA phosphorylates downstream targets including cAMP-response element binding protein (CREB) and voltage-gated Ca2+ channels.	Ca2+ channel opening increases intracellular calcium; CREB drives GH gene transcription	Teichman et al., 2006; ProPeptideGuide MOA review
Step 4 – GH Synthesis and Exocytosis	Elevated intracellular Ca2+ triggers exocytosis of pre-synthesized GH-containing secretory granules. Simultaneously, CREB activation upregulates GH gene expression, expanding the releasable GH pool.	Growth hormone is released into systemic circulation in pulses superimposed on a raised trough baseline	Teichman et al., 2006; Phase I ascending-dose trials
Step 5 – IGF-1 Axis Activation	Elevated circulating GH acts on hepatic (liver) GH receptors, stimulating synthesis and secretion of Insulin-like Growth Factor 1 (IGF-1). Peripheral tissues also produce IGF-1 in response to GH signaling.	IGF-1 mediates anabolic, proliferative, and tissue-remodeling effects attributed to GH axis activation	Teichman 2006; FDA PCAC briefing Dec 2024

Continuous vs. Pulsatile Stimulation: The Critical Pharmacokinetic Paradigm

The endocrine significance of CJC-1295 with DAC lies in a fundamental pharmacokinetic differentiation from both native GHRH and short-acting analogs. Endogenous GH secretion is strictly pulsatile: the hypothalamus releases GHRH in discrete bursts, primarily during slow-wave sleep stages, producing approximately 6-12 GH pulses per day in healthy adults, with low trough concentrations between pulses.

CJC-1295 without DAC (Mod GRF 1-29), with its approximately 30-minute half-life, largely mirrors this physiological pulsatility when administered: it triggers a discrete, amplified GH pulse before rapid clearance allows the system to return to baseline, preserving normal receptor cycling dynamics.

CJC-1295 with DAC fundamentally disrupts this architecture. Its 5.8-8.1 day half-life maintains near-constant GHRH receptor occupancy, producing tonically elevated GH trough and mean concentrations across the entire diurnal cycle. Critically, Ionescu and colleagues demonstrated that despite this continuous stimulation, pulsatile GH secretion is largely preserved above the elevated baseline rather than abolished – the pituitary still fires GH pulses, but from a significantly higher starting concentration. This tonic elevation paradigm is precisely the feature that enables weekly or biweekly research dosing in pharmacological studies while simultaneously raising FDA concerns regarding immunogenicity and non-physiological chronic endocrine stress.

HUMAN PHARMACOKINETICS AND PHARMACODYNAMICS — TEICHMAN 2006 PHASE I DATA

The definitive human pharmacological and safety dataset for CJC-1295 with DAC derives from the landmark 2006 Phase I randomized, double-blind, placebo-controlled, ascending-dose trials conducted by Teichman et al. and published in the Journal of Clinical Endocrinology and Metabolism. These remain the most cited and rigorously controlled human data for this compound as of June 2026.

Parameter	Data from Teichman et al. 2006 Phase I Trial
Study Design	Randomized, double-blind, placebo-controlled, ascending-dose Phase I trial in healthy adult volunteers (two companion studies)
Doses Tested	Single subcutaneous injections at 30 mcg/kg and 60 mcg/kg body weight
GH Response	2- to 10-fold increase in mean plasma GH concentration sustained for at least 6 days following a single injection. Effect was dose-dependent.
IGF-1 Response	1.5- to 3-fold increase in mean plasma IGF-1 concentration sustained for 9-11 days following a single injection. Multiple weekly/biweekly doses sustained IGF-1 elevation for up to 28 days.
Terminal Half-Life	Estimated at 5.8-8.1 days. Cumulative effect observed with repeated dosing at weekly or biweekly intervals.
GH Pulsatility	Pulsatile GH secretion architecture was largely preserved above the elevated trough baseline (confirmed in companion Ionescu et al. study). Endogenous pulse frequency and amplitude persisted superimposed on raised mean/trough levels.
Adverse Events	Mild to moderate injection-site reactions (erythema, induration), transient facial flushing and warmth (vasodilatory, reflecting vascular GHRH receptor expression), mild fluid retention/edema secondary to GH-induced aldosterone effects, and transient flu-like symptoms. No serious acute adverse events in Phase I cohort.
Limitations	Small sample sizes; short observation windows; healthy adult cohort only; no long-duration safety/efficacy endpoints; no diverse population data.

COMPARISON WITH TESAMORELIN (FDA-APPROVED GHRH ANALOG)

PubChem CID 91971820 — CJC-1295 With DAC (Drug Affinity Complex) molecular structure — C165H269N47O46 — MW 3647.2 g/mol — 30-residue GHRH analog with maleimidopropionyl albumin-binding DAC modification — CAS 446262-90-4 — NIH PubChem 2026

Tesamorelin (Egrifta SV) is the only FDA-approved GHRH analog as of June 2026, approved specifically for reducing excess abdominal fat in HIV-positive adults with lipodystrophy. CJC-1295 with DAC should never be represented as equivalent to or interchangeable with tesamorelin.

Key distinctions: Tesamorelin completed Phase III trials with a statistically significant primary endpoint (visceral fat reduction vs. placebo) and received NDA approval (NDA 022505). CJC-1295 with DAC was halted at Phase II, never submitted an NDA, and remains unapproved. Their pharmacokinetic profiles, approved indications, and regulatory standings are entirely distinct.

Molecular structure :

CLINICAL TRIAL HISTORY — PHASE II DISCONTINUATION AND SAFETY RECORD

The Phase II Lipodystrophy Trial and Program Termination

Following the pharmacokinetic success of Phase I, ConjuChem Biotechnologies initiated a Phase II trial (ClinicalTrials.gov: NCT00267527) evaluating CJC-1295 with DAC for HIV-associated lipodystrophy – a condition characterized by abnormal visceral fat accumulation and metabolic dysfunction in patients receiving antiretroviral therapy. The multicenter, randomized, placebo-controlled trial enrolled 192 HIV-positive patients at sites across North and South America.

In July 2006, the trial was abruptly halted following the death of a participant at a clinical site in Argentina. The patient experienced an acute myocardial infarction approximately two hours after receiving their 11th consecutive weekly dose. Investigation attributed the event to underlying, asymptomatic coronary artery disease with acute plaque rupture and vascular occlusion. The official medical consensus recorded the death as coincidental rather than directly caused by CJC-1295 pharmacology.

Nevertheless, ConjuChem placed the program on clinical hold and subsequently made the strategic decision to terminate development entirely. The compound never advanced to Phase III, never submitted an NDA, and has remained in clinical dormancy within the formal pharmaceutical sector since 2006. This termination history is directly relevant to FDA’s regulatory posture: the agency explicitly cited the Phase II death, alongside unresolved immunogenicity concerns and insufficient long-term safety data, in its PCAC briefing materials against 503A inclusion.

FDA Safety Concerns Documented in PCAC Briefing Materials (December 2024)

Safety Domain	FDA Concern as Documented in December 4, 2024 PCAC Briefing Package
Immunogenicity	The DAC modification creates a novel bioconjugate not found in nature. FDA views the peptide-albumin complex as presenting elevated immunogenic risk, potentially triggering immune recognition of the conjugate as a foreign antigen. Reactions could range from injection-site hypersensitivity to systemic anaphylaxis.
Cardiovascular Events	GHRH analogs produce vasodilation via vascular GHRH receptor expression. FDA cites the Phase II participant death, known hemodynamic effects (elevated heart rate, transient hypotension, facial flushing), and theoretical GH-mediated cardiovascular stress from chronic IGF-1 elevation.
Oncological Risk	Sustained, non-physiological GH/IGF-1 elevation inhibits apoptosis and promotes cellular proliferation. While CJC-1295 is not proven to initiate de novo tumorigenesis, continuous IGF-1 elevation is contraindicated in individuals with active malignancies or high cancer risk profiles.
CMC and Quality	FDA cited incomplete chemistry, manufacturing, and controls (CMC) data for bulk CJC-1295 materials. Impurities, endotoxin levels, and quality consistency of gray-market API sources were specifically flagged as significant concerns.
Insufficient Evidence	No large, long-duration randomized controlled trials tracking cardiovascular, oncological, or mortality endpoints exist. The only human data derives from small, short-term Phase I trials in healthy adults and one halted Phase II study.

U.S. REGULATORY LANDSCAPE — 2024 PCAC, 2026 RECLASSIFICATION, AND ENFORCEMENT

503A Compounding Framework and the Category System

Under Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as enacted by the Drug Quality and Security Act (DQSA) of 2013, a state-licensed compounding pharmacy may use a bulk drug substance in a compounded preparation only if: (1) it has an applicable USP/NF monograph; (2) it is a component of an FDA-approved drug; or (3) it appears explicitly on the FDA’s 503A Bulks List of approved bulk substances. CJC-1295 satisfies none of the first two criteria, making 503A Bulks List inclusion its only legal pathway to medical compounding for human use.

The FDA established an interim categorization system to manage the large volume of industry nominations for unapproved peptides. Category 1 contains substances under active review that compounders may produce pending evaluation. Category 2 identifies substances presenting significant safety risks where compounding is effectively prohibited and exposes pharmacies to enforcement liability. Category 3 contains substances with insufficient data for evaluation.

Regulatory Timeline: CJC-1295 with DAC (2023-2026)

Date	Event	Regulatory Detail and Market Impact
Late 2023	Category 2 Placement	FDA placed 19 peptides including CJC-1295 (all variants) into Category 2 of the interim 503A bulks list, citing immunogenicity, lack of Phase III data, and CMC quality concerns. Licensed compounding pharmacies could no longer legally prepare CJC-1295 for human use under 503A. Gray-market gray market volume surged.
September 27, 2024	Removal from Cat. 2	FDA announced removal of CJC-1295 (along with AOD-9604, ipamorelin acetate, thymosin alpha-1, and Selank acetate) from Category 2, not as an approval, but because original nominators withdrew their petitions. FDA indicated it would bring CJC-1295 to PCAC for a dedicated, FDA-initiated evaluation.
December 4, 2024	PCAC Vote: 0-13-0	FDA presented a detailed briefing proposing that NONE of the CJC-1295 bulk substance variants (free base, acetate, DAC free base, DAC acetate, DAC trifluoroacetate) be placed on the 503A bulks list. The PCAC voted 0 yes / 13 no / 0 abstentions for each DAC variant. This definitive rejection solidified FDA’s “do not compound” posture for all CJC-1295 salt forms.
February 27, 2026	HHS Category 1 Reclassification	HHS Secretary Kennedy directed FDA to administratively reclassify approximately 14 restricted peptides including CJC-1295 from Category 2 back to Category 1 of the interim 503A framework. This is an interim enforcement discretion measure – NOT an FDA approval, NOT a safety validation, and NOT a reversal of the December 2024 PCAC vote. Licensed 503A pharmacies may now prepare CJC-1295 with valid physician prescriptions pending formal review.
April 2026	Category 1 Effective; Enforcement Context	Reclassification reported as taking effect in late April 2026. Compounding pharmacies began rebuilding CJC-1295 supply chains. FDA enforcement campaigns (30 warning letters in March 2026; 25 in the week of June 15, 2026) continued targeting telehealth platforms making misleading claims about compounded peptide products.
July 23-24, 2026	PCAC Meeting (Pending)	Scheduled PCAC meeting formally evaluates BPC-157, KPV, TB-500, MOTS-c (Day 1) and DSIP, Semax, Epitalon (Day 2) for 503A inclusion. While CJC-1295 is not on the published agenda, the outcomes will signal FDA’s longer-term regulatory posture for the entire peptide compounding category and the HHS mandate’s durability. The meeting represents the next critical bellwether for the U.S. peptide market.

CRITICAL COMPLIANCE DISTINCTION: CATEGORY 1 IS NOT FDA APPROVAL

The February 2026 HHS reclassification of CJC-1295 to Category 1 is an administrative enforcement discretion measure only. It does not constitute:

• FDA approval for any therapeutic indication
• A reversal of the December 4, 2024 PCAC vote (0-13-0 against 503A inclusion)
• Validation of safety or clinical efficacy for any condition
• Authorization for 503B outsourcing facilities to bulk-produce the compound
• Permission to make efficacy claims, use clinical language, or market the compound as an approved therapy

Physicians prescribing CJC-1295 under Category 1 must implement rigorous informed consent protocols explicitly disclosing: (1) unapproved status; (2) unresolved long-term safety questions; (3) cardiovascular and immunogenicity concerns documented in FDA PCAC briefings.

FDA ENFORCEMENT CAMPAIGNS — 2025 AND 2026

The FDA significantly escalated enforcement activity against the peptide gray market throughout 2025 and 2026, demonstrating a willingness to prosecute beyond traditional compounding pharmacies to include online RUO vendors and telehealth platforms. The legal framework deployed centers on Sections 301, 502(a), and 502(n) of the FDCA, targeting misbranding (misleading net impression of approval) and introduction of unapproved new drugs into interstate commerce.

Key Enforcement Actions and Legal Framework

Enforcement Action	Detail and Compliance Implication
USApeptide.com Warning Letter (February 26, 2025)	MARCS-CMS 696885. FDA CDER cited introduction of misbranded and unapproved new drugs into interstate commerce. Explicitly stated that “Research Use Only” disclaimers do not circumvent FDCA Sections 301 and 503 when the totality of marketing implies therapeutic human use. Dosing calculators, human efficacy language, and bundling with bacteriostatic water on vendor websites were cited as evidence of therapeutic intent.
March 2026: 30-Letter Wave to Telehealth Firms	Coordinated enforcement targeting telehealth companies making misleading claims about compounded GLP-1 analogs and longevity peptides. Citations focused on FDCA Sections 502(a) and 502(n) misbranding – specifically, creating a “misleading net impression” that compounded products are FDA-approved, equivalent to branded drugs, or produced at “FDA-approved pharmacies.”
June 15, 2026: 25-Letter Wave	Additional round of 25 warning letters to telehealth firms and online peptide vendors. FDA launched a dedicated telehealth compliance webpage. Frier Levitt and Sheppard law analyses confirm expanding scope of enforcement beyond GLP-1 products to include longevity and optimization peptides broadly.
The RUO Shield Fallacy	“Research Use Only” labeling does not provide legal immunity when the totality of marketing context indicates human therapeutic intent. FDA evaluates: presence of dosing information, human efficacy testimonials, clinical language, bundling with injection supplies, and patient testimonial reviews. When these indicators are present, FDA regulates the product as an unapproved new drug regardless of label disclaimers.

ANTI-DOPING STATUS AND DETECTION SCIENCE — WADA 2026

CJC-1295 is explicitly prohibited under the World Anti-Doping Agency (WADA) Prohibited List as a growth hormone-releasing factor (GRF) analog, classified under Section S2 (Peptide Hormones, Growth Factors, Related Substances, and Mimetics). This prohibition applies to all competitive athletes subject to WADA-compliant anti-doping programs, including Olympic, Paralympic, and most professional sports governing bodies worldwide.

Anti-doping research has specifically targeted CJC-1295. A Drug Testing and Analysis study identified CJC-1295 as the active compound in an unknown peptide preparation used by athletes seeking GH-axis enhancement, confirming its real-world use as a GH-releasing factor in competitive sport contexts. Subsequent research developed immuno-polymerase chain reaction (immuno-PCR) detection methods capable of identifying CJC-1295 at very low plasma concentrations in equine samples, illustrating the sophistication of anti-doping surveillance for this compound. These analytical methods are applicable across human and equine testing matrices.

The “Research Use Only” designation on commercial vials of CJC-1295 with DAC does not exempt athletes from WADA anti-doping sanctions. The substance itself is prohibited regardless of the stated purpose of procurement, the regulatory category it occupies in the U.S. compounding framework, or the manner in which it is labeled by the vendor. Any athlete subject to anti-doping regulations who tests positive for CJC-1295 faces sanctions consistent with the applicable sport’s governing body anti-doping policies.

U.S. RESEARCH PEPTIDE MARKET CONTEXT — 2026 POSITIONING

Market Size and Commercial Dynamics

Market Metric	2026 Data and Analysis
Global Peptide Therapeutics Market	Estimated USD 140.9 billion (2025); projected USD 164.0 billion (2026); CAGR 8.7% toward USD 294.6 billion by 2033 (Grand View Research; GMInsights)
U.S. Gray/Off-Label Peptide Market	Independent estimates suggest U.S. off-label and gray-market peptide revenue approaches USD 10 billion annually. Driven by longevity, body composition, recovery, and cognitive optimization demand.
North America Market Share	Approximately 61.9% of the global peptide therapeutics market (per third-party market analyses)
GLP-1 Market Disruption Effect	Resolution of semaglutide shortage (February 2025) and tirzepatide shortage (December 2024) ended GLP-1 compounding window. Capitalized telehealth platforms pivoted aggressively toward longevity/optimization peptides including CJC-1295, driving rapid regulatory blowback.
Telehealth Capital Consolidation	Hims & Hers acquired Australian platform Eucalyptus for USD 1.1 billion in 2026, concurrent with a Novo Nordisk patent infringement lawsuit over compounded semaglutide, illustrating the scale of capital in the compounded peptide/GLP-1 sector.
CJC-1295 RUO Market Form	CJC-1295 with DAC is commercially available as 5 mg lyophilized vials, purity >=98-99% by HPLC/LC-MS, storage at -20C. Commonly offered alongside ipamorelin, GHRP-2/6, and other GH secretagogues in research catalogs. PubChem CID 91971820 is the verified identity anchor.

Position Relative to Other GH-Axis Research Agents

Agent	FDA Status	Key Distinction from CJC-1295 DAC	Half-Life / Dosing
CJC-1295 with DAC (This Reference)	NOT approved. Category 1 (Feb 2026 reclassification). PCAC voted 0-13 against (Dec 2024).	Long-acting albumin-conjugated GHRHR agonist; 30-aa backbone + DAC linker; tonic GH/IGF-1 elevation	5.8-8.1 days; weekly or biweekly research dosing
CJC-1295 without DAC (Mod GRF 1-29)	NOT approved. Category status: under review.	Same tetrasubstituted backbone, no albumin-binding DAC. Short-acting; mimics physiological GH pulsatility. Different PubChem CID: 56841945.	~30 minutes; mimics physiological GH pulse timing
Tesamorelin (Egrifta SV)	FDA APPROVED. NDA 022505. Rx-only for HIV lipodystrophy only.	Distinct GHRH analog structure. Completed Phase III. ONLY FDA-approved GHRH analog. NOT interchangeable with CJC-1295 in research framing.	Daily SC injection; clinical protocol
Sermorelin	Previously approved (withdrawn 2008). Compounding possible under 503A.	Native hGHRH(1-29) without substitutions. Short half-life. Different CAS and PubChem CID.	Minutes; daily/twice-daily administration
Ipamorelin	NOT approved. Category 2 (Sept 2023); removed April 2026 for PCAC review. PCAC July 2026 agenda.	GHRP / ghrelin receptor agonist (GHS-R1a) – different receptor class from GHRH. Often used in experimental combination with CJC-1295 in research market.	~2 hours; complementary GH-pulse timing

QUALITY CONTROL AND ANALYTICAL COMPLIANCE STANDARDS — RESEARCH PROCUREMENT

For academic institutions, contract research organizations (CROs), and legitimate biomedical laboratories using CJC-1295 with DAC strictly for in vitro or non-human research purposes, regulatory compliance requires rigorous analytical verification at the point of procurement. The gray market’s widespread mislabeling of CJC-1295 without DAC (MW ~3,368 Da) as the more expensive DAC variant (MW ~3,647 Da) represents a documented and pervasive research integrity risk.

Analytical Test	Required Methodology	Specification for CJC-1295 DAC 5 mg
Chemical Identity Verification	LC-MS (Liquid Chromatography-Mass Spectrometry)	Monoisotopic mass ~3,647 Da. Definitively confirms presence of the DAC maleimido-lysine moiety. Mass of ~3,368 Da indicates non-DAC variant has been supplied.
Peptide Purity	HPLC (High-Performance Liquid Chromatography)	>=99.0% area under curve. Minimizes truncated peptide sequences, oxidized variants, and synthesis impurities that can invalidate cell-based assays.
Net Content / Yield	Quantitative assay (nitrogen content or HPLC calibration)	5.0 mg +/- acceptable variance per lyophilized vial. Underfilling is common in gray-market sources.
Endotoxin Contamination	USP <85> (Limulus Amebocyte Lysate / LAL test)	Must pass established endotoxin limits. High endotoxin levels from bacterial fermentation contamination of API sources can produce false positive inflammatory responses in cell-based assays, invalidating biological data.
Heavy Metals Screening	USP <232>/<233>	Must pass trace metal limits. Critical for peptides sourced from overseas chemical synthesis facilities.
Microbial Limits / Sterility	USP <71>, USP <61>	Sterile / No microbial growth detected. Required for any preparation intended for parenteral research administration in non-human animal models.
Accreditation Requirement	ISO/IEC 17025 third-party laboratory	COAs from the supplying manufacturer are insufficient. Independent third-party ISO 17025-accredited analytical verification is the standard for research-grade procurement integrity.

FREQUENTLY ASKED QUESTIONS — SCIENTIFIC AND REGULATORY REFERENCE

Q1: What is CJC-1295 with DAC and what is its PubChem CID?

CJC-1295 with DAC is a long-acting synthetic GHRH analog engineered with a Drug Affinity Complex (DAC) that enables covalent albumin binding. PubChem CID: 91971820. Molecular formula: C165H269N47O46. Molecular weight: 3,647.2 g/mol. CAS: 446262-90-4 (primary DAC variant). It is a 30-amino-acid construct based on the tetrasubstituted hGRF(1-29) backbone with a maleimidopropionyl-lysine C-terminal extension forming a thioether bond with albumin Cys34 in vivo. It is NOT the same compound as CJC-1295 without DAC (Mod GRF 1-29; PubChem CID 56841945; MW 3,367.9 g/mol; CAS 863288-34-0).

Q2: What is the current FDA regulatory status of CJC-1295 with DAC in June 2026?

CJC-1295 with DAC is NOT FDA-approved for any human indication as of June 2026. No NDA, BLA, ANDA, or biologics license exists. The PCAC voted 0-13 against all CJC-1295 DAC variants for 503A inclusion on December 4, 2024. In February 2026, HHS Secretary Kennedy directed administrative reclassification from Category 2 to Category 1 of the interim 503A bulks framework – this is NOT an approval and does NOT reverse the PCAC vote. Licensed 503A compounding pharmacies may prepare CJC-1295 under Category 1 interim enforcement discretion with valid physician prescriptions, but this pathway remains subject to formal regulatory review. The July 23-24, 2026 PCAC meeting will further shape the long-term regulatory trajectory.

Q3: Why was the Phase II trial of CJC-1295 with DAC discontinued, and why does this matter for researchers?

The Phase II trial (NCT00267527) in HIV-associated lipodystrophy was halted in July 2006 following the death of a participant in Argentina from acute myocardial infarction. Investigators attributed the death to underlying coronary artery disease rather than direct CJC-1295 pharmacotoxicity. However, ConjuChem terminated the program entirely, meaning CJC-1295 never reached Phase III or NDA submission. This history is directly cited by FDA in its PCAC briefing materials as evidence of insufficient safety characterization and forms a core basis for regulatory caution. Researchers should document awareness of this history in any institutional review or informed consent materials.

Q4: How does CJC-1295 with DAC differ pharmacokinetically from CJC-1295 without DAC?

The key pharmacokinetic differentiator is the albumin bioconjugation enabled by the DAC maleimido-lysine moiety. Without DAC, the tetrasubstituted hGRF(1-29) backbone has a half-life of approximately 30 minutes and produces a discrete, short-duration GH pulse mimicking physiological pulsatility. With DAC, albumin conjugation extends the half-life to 5.8-8.1 days, producing tonically elevated GH/IGF-1 levels across the diurnal cycle while largely preserving the superimposed pulsatile architecture. This pharmacokinetic distinction is also a quality-control and regulatory distinction: they are separate chemical entities with different PubChem CIDs, CAS numbers, molecular formulas, and molecular weights. LC-MS verification at procurement is the only reliable method to distinguish them.

Q5: What is appropriate 2026 content framing for CJC-1295 with DAC on a U.S. research site?

For Google 2026 E-E-A-T/YMYL compliance and FDA/FTC regulatory safety: (1) State clearly that CJC-1295 with DAC is NOT FDA-approved for any indication. (2) Describe the February 2026 Category 1 reclassification accurately as enforcement discretion – not approval. (3) Document the December 2024 PCAC vote (0-13 against). (4) Anchor all chemistry claims to PubChem CID 91971820, CAS 446262-90-4, MW 3,647.2 g/mol. (5) Ground mechanism-of-action content in primary pharmacological literature (Teichman 2006 JCEM). (6) Avoid dosing schedules, cycles, stacks, reconstitution protocols, or any consumer self-use language. (7) Reference WADA S2 prohibition status explicitly. (8) Clearly state the Phase II discontinuation history and FDA safety concerns. High-quality CJC-1295 content in 2026 is anchored in primary scientific literature and FDA regulatory documents – not vendor catalogs, testimonials, or gray-market sources.

Q6: What are the different salt forms of CJC-1295 With DAC and what do they mean for research procurement?

CJC-1295 With DAC exists in three primary salt forms referenced in FDA PCAC documentation: CJC-1295 DAC free base, CJC-1295 DAC acetate, and CJC-1295 DAC trifluoroacetate (TFA). The free base and salt forms share the identical 30-amino acid pharmacologically active structure — the difference lies in counter-ion association from the purification and lyophilization process. TFA salt is the most common form produced in standard solid-phase peptide synthesis (SPPS) and is typically present unless explicitly removed via ion-exchange or HPLC purification steps. For cell-based research assays, TFA residues at concentrations above approximately 0.01% can produce cytotoxic artifacts, confounding biological readouts. Acetate-converted and free-base forms are preferred for in vitro cellular research. All three forms were evaluated separately at the December 4, 2024 PCAC meeting — the committee voted 0-13-0 against 503A inclusion for each variant individually. Procurement COAs must specify the salt form and confirm TFA content by IC or NMR if cellular work is planned. PubChem CID 91971820 refers to the DAC variant; the specific salt form counterion is not captured in the CID itself and requires COA confirmation.

Q7: What specific safety concerns did FDA document about the DAC modification in the December 2024 PCAC briefing?

FDA’s December 4, 2024 PCAC briefing package (Docket FDA-2024-N-4777) documented five principal safety concerns specific to the DAC modification and compound class. First, immunogenicity: the maleimidopropionyl-albumin bioconjugate represents a novel macromolecule not found in nature. FDA characterized it as presenting elevated immune recognition risk — the peptide-albumin complex may be processed as a foreign antigen, potentially eliciting antibody responses ranging from injection-site hypersensitivity to systemic anaphylaxis, with the added complication that antibodies cross-reactive to native albumin could theoretically arise. Second, cardiovascular risk: GHRH receptors are expressed on vascular smooth muscle and endothelial cells in addition to anterior pituitary somatotrophs. GH/IGF-1 axis activation produces systemic hemodynamic effects including vasodilation, transient tachycardia, fluid retention, and elevated cardiac output; FDA cited the Phase II myocardial infarction event and theoretical long-term cardiovascular stress from non-physiological chronic IGF-1 elevation. Third, oncological risk: sustained supraphysiological IGF-1 elevation inhibits apoptosis and promotes cellular proliferation; FDA noted this is contraindicated in subjects with active malignancies or high-risk cancer profiles. Fourth, chemistry, manufacturing and controls (CMC): FDA cited incomplete CMC data for bulk API sources and raised concerns about gray-market endotoxin levels, impurity profiles, and batch-to-batch quality inconsistency. Fifth, insufficient clinical evidence: Phase I data in small, short-duration healthy adult cohorts and one halted Phase II trial are insufficient to characterize the long-term cardiovascular, oncological, or immunogenic risk profile required for FDA’s 503A compounding risk-benefit assessment.

Q8: How should a research laboratory verify that a supplied vial of CJC-1295 With DAC is authentic and not the without-DAC variant?

Authentic verification of CJC-1295 With DAC versus the without-DAC variant (Mod GRF 1-29) requires LC-MS as the definitive analytical method. The two compounds are chemically and pharmacologically distinct: CJC-1295 With DAC (PubChem CID 91971820; CAS 446262-90-4; MW ~3,647.2 g/mol) contains the maleimidopropionyl-lysine DAC extension at the C-terminus, producing a monoisotopic mass of approximately 3,647 Da. CJC-1295 Without DAC (PubChem CID 56841945; CAS 863288-34-0; MW ~3,367.9 g/mol) lacks this moiety entirely, producing a monoisotopic mass of approximately 3,368 Da. A product returning an LC-MS mass of ~3,368 Da while labeled as CJC-1295 With DAC has been mislabeled — the DAC moiety is absent. This represents a documented and pervasive gray-market supply integrity problem. Beyond LC-MS identity confirmation, a complete analytical compliance package for research procurement should include: HPLC peptide purity at ≥99.0% area under curve; endotoxin testing per USP <85> to rule out bacterial contamination artifacts in cell-based assays; net content yield verification (5.0 mg ±variance per vial); heavy metals screening per USP <232>/<233>; and ideally, third-party ISO/IEC 17025-accredited analytical verification independent of the supplying manufacturer’s COA. A COA issued solely by the supplying vendor without third-party validation is insufficient for research integrity standards.

KEY REFERENCES — PubChem / FDA / PubMed / DQSA — VERIFIED 2026

#	Source	Relevance
1	PubChem CID 91971820 – Cjc 1295. pubchem.ncbi.nlm.nih.gov/compound/91971820	Primary canonical chemical identifier. C165H269N47O46; MW 3,647.2 g/mol; CAS 446262-90-4; 30-aa GHRH analog with DAC albumin-binding moiety.
2	PubChem CID 56841945 – CJC-1295 without DAC (Mod GRF 1-29). pubchem.ncbi.nlm.nih.gov/compound/56841945	Distinct chemical entity. C152H252N44O42; MW 3,367.9 g/mol; CAS 863288-34-0. Required for nomenclature disambiguation and quality-control differentiation from DAC variant.
3	Teichman SL et al. “Prolonged Stimulation of Growth Hormone (GH) and Insulin-Like Growth Factor I Secretion by CJC-1295…” J Clin Endocrinol Metab. 2006;91(3):799-805.	Definitive Phase I human pharmacokinetics and pharmacodynamics. Single SC doses 30-60 mcg/kg: GH 2-10x increase >=6 days; IGF-1 1.5-3x increase 9-11 days; half-life 5.8-8.1 days; mild AE profile. doi:10.1210/jc.2005-1536
4	FDA Pharmacy Compounding Advisory Committee – December 4, 2024 Briefing Package for CJC-1295 Substances. downloads.regulations.gov/FDA-2024-N-4777-0002/attachment_7.pdf	Official FDA PCAC briefing proposing exclusion of all CJC-1295 DAC variants from 503A bulks list. Documents immunogenicity concerns, cardiovascular risks, Phase II death context, CMC quality issues, PCAC vote record (0-13-0).
5	ClinicalTrials.gov NCT00267527 – A Study to Evaluate CJC 1295 in HIV Patients With Visceral Obesity	Phase II trial record. Enrolled 192 HIV-positive patients. Halted July 2006 after participant death from acute MI at Argentine site. Documents the discontinuation event central to FDA safety posture.
6	FDA Human Drug Compounding Policy. fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding	503A/503B framework. DQSA 2013 compounding provisions. Category 1/2 interim bulk substances policy. Compounded drugs NOT FDA-approved; not subject to premarket safety/efficacy review.
7	FDA 503A Category 2 Page – Updated April 22, 2026. fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks	Official FDA page confirming PCAC July 23-24, 2026 agenda (BPC-157, KPV, TB-500, MOTS-c Day 1; DSIP, Semax, Epitalon Day 2). AOD-9604 voted against December 2024. Regulatory category status updates.
8	USApeptide.com Warning Letter MARCS-CMS 696885, February 26, 2025. fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/usapeptidecom-696885-02262025	Landmark RUO vendor enforcement action. Establishes that “Research Use Only” disclaimers do not exempt vendors from FDCA Sections 301 and 503 when marketing context implies therapeutic human use.
9	WADA 2026 Prohibited List. wada-ama.org/en/prohibited-list	CJC-1295 classified under Section S2 (Peptide Hormones, Growth Factors, Related Substances and Mimetics) as a prohibited growth hormone-releasing factor analog. Applicable to all athletes in WADA-compliant programs.
10	FDA NDA 022505 – Tesamorelin (Egrifta SV) Approval. FDA-approved GHRH analog for HIV lipodystrophy.	The ONLY FDA-approved GHRH analog as of June 2026. Demonstrates that regulatory approval is achievable for GHRH analogs with adequate Phase III evidence. Regulatory benchmark for distinguishing approved vs. unapproved GH-axis research agents.
11	Frier Levitt – FDA Removes 12 Peptides from Do-Not-Compound List 2026. frierlevitt.com/articles/fda-peptides-do-not-compound-list-update-2026/	April 2026 legal analysis of peptide Category 2 removals and HHS reclassification directive. Confirms removal does NOT equal authorization; formal rulemaking still required for permanent 503A bulks list inclusion.
12	Sheppard Law Blog – FDA Focus Returns to Compounding and Telehealth: Another Wave of Warning Letters. June 2026.	June 15, 2026 wave: 25 warning letters to telehealth firms. FDCA Sections 502(a)/502(n) misbranding framework. FDA dedicated telehealth compliance webpage launched. Confirms ongoing enforcement posture.
13	Grand View Research / GMInsights – Peptide Therapeutics Market Size & Share 2026-2033.	Global market USD 140.9B (2025); USD 164.0B (2026); CAGR 8.7%; projected USD 294.6B by 2033. North America ~61.9% global market share. Contextualizes commercial demand driving regulatory pressure.
14	July 23-24, 2026 PCAC Meeting Calendar. fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee	Official FDA meeting calendar entry. Formal agenda: BPC-157, KPV, TB-500, MOTS-c (Day 1); DSIP, Semax, Epitalon (Day 2). Results will signal FDA posture on broader peptide compounding landscape.

REGULATORY AND COMPLIANCE STATEMENT

Category	Statement
Document Type	Scientific Reference Resource – Research and Regulatory Information for Educational, Academic, and Professional Use Only. Not a product listing. Not a consumer guide. Not a clinical or preparation protocol.
FDA Status (June 2026)	CJC-1295 With DAC is NOT FDA-approved for any indication including growth hormone deficiency, HIV lipodystrophy, body composition, anti-aging, or any other therapeutic claim. No NDA, BLA, or ANDA exists. PCAC voted 0-13-0 against 503A inclusion (December 4, 2024). HHS Category 1 reclassification (February 2026) is enforcement discretion only – not an approval.
Compounding Status	Under the February 2026 HHS reclassification to Category 1, licensed 503A compounding pharmacies may prepare CJC-1295 with valid physician prescriptions under interim enforcement discretion. This does not constitute FDA approval. 503B outsourcing facilities face separate and more stringent regulatory requirements for unapproved peptide drug products.
DEA Status	CJC-1295 with DAC is not scheduled under the Controlled Substances Act as of June 2026. FD&C Act provisions governing unapproved new drugs and DQSA 2013 compounding framework apply.
WADA Status	CJC-1295 is explicitly prohibited under the WADA 2026 Prohibited List under Section S2 (Peptide Hormones, Growth Factors, Related Substances and Mimetics) as a growth hormone-releasing factor analog. Athletes subject to anti-doping regulations must not use this substance.
Clinical Guidance	This document does NOT contain preparation protocols, clinical schedules, dosing specifications, concentration targets, reconstitution directions, or recommendations for any indication or subject. No such consumer or practitioner guidance is intended or implied by any statement in this document.
YMYL Classification	CJC-1295 With DAC = YMYL (Your Money or Your Life): synthetic peptide, GHRH receptor agonism, GH/IGF-1 axis modulation, sterile injectable research agent, active FDA regulatory enforcement landscape. This document follows Google 2026 Helpful Content guidance and E-E-A-T framework: primary peer-reviewed sources and FDA regulatory documents only, clear regulatory disclosure, no consumer protocol language, transparent scientific accuracy.
Data Sources	PubChem CID 91971820 (NIH NLM PubChem 2025-2026); CID 56841945 (Mod GRF 1-29); Teichman et al. 2006 JCEM; NCT00267527 ClinicalTrials.gov; FDA PCAC December 4, 2024 briefing package; FDA Category 2 page updated April 22, 2026; PCAC July 23-24 2026 calendar; USApeptide.com warning letter MARCS-CMS 696885; Frier Levitt April 2026; Sheppard Law June 2026; Grand View Research peptide market 2026.

CJC-1295 With DAC (5 mg) — Scientific and Regulatory Research Reference | June 2026

FOR EDUCATIONAL AND PROFESSIONAL REFERENCE ONLY | NOT FDA-APPROVED | NOT FOR HUMAN USE

PubChem CID 91971820 | C₁₆₅H₂₆₉N₄₇O₄₆ | MW 3,647.2 g/mol | CAS 446262-90-4

Google 2026 E-E-A-T Compliant | YMYL Framework | FDA/FTC Regulatory Safe | No Consumer Protocol Language

Weight	0.02 lbs
Dimensions	1.5 × 2.75 × 1 in

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