CJC-1295/Ipamorelin

Name: CJC-1295/Ipamorelin
SKU: pr-1785140818278-18
Price: 98.00 USD
Availability: InStock

$98.00

CJC-1295 / Ipamorelin is a dual GH secretagogue research combination involving CJC-1295, a GHRH receptor agonist, and Ipamorelin, a GHSR-1a ghrelin receptor agonist.
Neither compound is FDA-approved, and no dedicated human clinical trial of the combination has been identified as of June 2026.

1000 in stock

🔥 Exclusive Crypto Offer

Get an INSTANT 15% DISCOUNT when you pay with Bitcoin, Ethereum, Dogecoin, Bitcoin Cash, XRP, Solana, or USDT.

⚡ Don't have crypto? Buy it here in 5 minutes with easy guidance.

💡 Pro Tip: You can also pay with cryptocurrency using your verified Cash App or PayPal account for a fast and secure checkout!

SKU: pr-1785140818278-18 Category: Research Compounds

Description

CJC-1295 NO DAC / Ipamorelin Combination Research Reference

profoundaminos.com | FOR EDUCATIONAL AND PROFESSIONAL REFERENCE ONLY | Not a product listing | NOT a clinical or preparation protocol

Regulatory Status – Read Before Proceeding

The CJC-1295 / Ipamorelin combination is NOT FDA-APPROVED for any human indication as of June 2026. No NDA, BLA, or ANDA exists for either component or for the combination. No FDA-approved single-ingredient or combination drug product contains CJC-1295 (any form) or ipamorelin (any form) as an active pharmaceutical ingredient.

CRITICAL JUNE 2026 REGULATORY STATUS: Unlike the 12 peptides removed from FDA’s 503A Category 2 list in April 2026 (BPC-157, TB-500, KPV, MOTS-c, Emideltide/DSIP, Semax, Epitalon, LL-37, Dihexa, GHK-Cu, PEG-MGF, Melanotan II), CJC-1295 and Ipamorelin were NOT part of that batch. Both substances were referred to the Pharmacy Compounding Advisory Committee (PCAC) in September 2024 following a separate Category 2 removal action, and both received NEGATIVE PCAC recommendations: Ipamorelin (free base and acetate) at the October 29, 2024 PCAC meeting, and CJC-1295 (all forms) at the December 4, 2024 PCAC meeting (Docket FDA-2024-N-4777). Per FDA’s own advisory committee calendar (confirmed directly, accessed June 30, 2026), neither CJC-1295 nor Ipamorelin appears on the agenda for the July 23–24, 2026 PCAC meeting, which reviews only BPC-157, KPV, TB-500, MOTS-c, Emideltide, Semax, and Epitalon. No new PCAC review date for CJC-1295 or Ipamorelin has been announced. Final FDA rulemaking remains pending and legal 503A compounding status for both substances is unsettled and, per the negative PCAC votes, unfavorable.

NO COMBINATION TRIAL EXISTS: No nomination, FDA evaluation, or PCAC review has ever been conducted for the CJC-1295 + Ipamorelin combination as a compounded product. Each substance was evaluated independently, for different proposed uses, on different dates.

WADA 2026 STATUS: Both CJC-1295 (GHRH analog) and Ipamorelin (ghrelin receptor agonist/GH secretagogue) are listed as prohibited substances under the WADA 2026 Prohibited List, Section S2 — Peptide Hormones, Growth Factors, Related Substances, and Mimetics.

This document is a scientific reference only. It is not a product listing, clinical protocol, preparation guide, or consumer recommendation.

Product overview

The CJC-1295 / Ipamorelin combination refers to the simultaneous research use of two mechanistically distinct growth hormone (GH) secretagogues: CJC-1295 a synthetic analog of growth hormone-releasing hormone (GHRH) acting at the GHRH receptor (GHRHR) and Ipamorelin, a synthetic pentapeptide ghrelin mimetic acting at the growth hormone secretagogue receptor (GHSR-1a). The two compounds are not the same molecule, are not interchangeable, and have been evaluated by FDA as entirely separate bulk drug substances, for different proposed clinical uses, at different Pharmacy Compounding Advisory Committee (PCAC) meetings.

CJC-1295, in its commonly referenced ‘without DAC’ / Modified GRF (1-29) form, is anchored to PubChem CID 56841945 (C₁₅₂H₂₅₂N₄₄O₄₂; MW ≈3367.9 g/mol; CAS 863288-34-0). The long-acting ‘with DAC’ (Drug Affinity Complex) variant is a structurally distinct comparator (CID 91971820; C₁₆₅H₂₆₉N₄₇O₄₆; MW ≈3647.2 g/mol), which covalently binds serum albumin and is the source of essentially all published human clinical data for the CJC-1295 class (PMID 16352683; PMID 17018654).

Ipamorelin (free base) is anchored to PubChem CID 9831659 (C₃₈H₄₉N₉O₅; MW ≈711.9 g/mol; CAS 170851-70-4; sequence H-Aib-His-D-2Nal-D-Phe-Lys-NH₂), with a corresponding acetate salt record at PubChem CID 171378556. Ipamorelin was first characterized by Raun and colleagues in 1998 as a selective ghrelin receptor agonist with minimal effect on cortisol, ACTH, or prolactin relative to earlier-generation GHRPs (PMID 9849822).

As of June 2026, neither CJC-1295 nor Ipamorelin is FDA-approved for any human indication, and no peer-reviewed, placebo-controlled human trial of the CJC-1295 + Ipamorelin combination specifically has been identified in the indexed scientific literature. A 2026 orthopaedic-sports-medicine review (PMID 41490200) references the combination’s proposed IGF-1 signaling rationale while explicitly noting the absence of clinical trial evidence for the pairing.

Chemical Identity — Compound Registry and Structural Reference

CJC-1295 and Ipamorelin are distinct chemical entities belonging to different peptide classes (GHRH analog vs. ghrelin-mimetic GHRP). Authoritative identification for both is anchored in PubChem canonical CIDs. The table below provides verified PubChem CIDs, CAS numbers, molecular formulas, and molecular weights for both primary compounds and their principal class comparators. All CIDs verified against NIH PubChem 2025–2026 database records.

Compound / Record	PubChem CID	CAS Number	Molecular Formula	MW (g/mol)	Research Role / Notes
CJC-1295 Without DAC / Modified GRF (1-29) — Canonical Record	56841945	863288-34-0	C₁₅₂H₂₅₂N₄₄O₄₂	~3367.9	Primary canonical CJC-1295 reference. Tetrasubstituted D-Ala²/Gln⁸/Ala¹⁵/Leu²⁷ GHRH(1-29) analog. Short-acting, pulsatile GHRHR agonist.
CJC-1295 With DAC — Long-Acting Comparator	91971820	446262-90-4	C₁₆₅H₂₆₉N₄₇O₄₆	~3647.2	Albumin Cys34-binding DAC variant. Half-life 5.8–8.1 days. Source of all published human clinical data for the CJC-1295 class.
Ipamorelin (Free Base)	9831659	170851-70-4	C₃₈H₄₉N₉O₅	~711.9	Synthetic pentapeptide ghrelin mimetic. Sequence H-Aib-His-D-2Nal-D-Phe-Lys-NH₂. Selective GHSR-1a agonist.
Ipamorelin Acetate	171378556	1258196-85-8*	C₄₄H₆₁N₉O₁₁	~892	Acetate salt form. CAS per FDA PCAC briefing document (Oct 29, 2024); some commercial COAs apply the free-base CAS to the acetate form — distinct active moieties regardless.
Sermorelin / Native GRF (1-29) — GHRH Class Reference	16132413	86168-78-7	C₁₄₉H₂₄₆N₄₄O₄₂S	~3357.9	Unmodified GHRH(1-29) fragment. DPP-IV-susceptible. FDA-approved (historically, Geref) for diagnostic/pediatric short-stature GH stimulation.
Tesamorelin — FDA-Approved GHRH Analog	16137828	218949-48-9	C₂₁₅H₃₅₈N₆₆O₆₇S	~5135.9	44-aa GHRH analog. NDA 022505 (Egrifta SV®). Only FDA-approved GHRH analog in the U.S. Distinct regulatory trajectory from CJC-1295.

Mechanism of Action – Dual-Receptor Pharmacological Rationale

The CJC-1295 / Ipamorelin combination is studied because the two compounds activate two separate, non-competing receptor systems on the same anterior pituitary somatotroph cell. Each pharmacological node is described below with source citations.

Biological Target / System	Biochemical Mechanism	Research Observations	Verified Source
GHRHR Agonism (CJC-1295 — Class B1 GPCR)	CJC-1295 binds the GHRH receptor on somatotroph cells. Receptor occupancy activates the stimulatory G-protein (Gαs) → adenylate cyclase → cAMP → PKA → CREB-mediated GH gene transcription and Ca²⁺-dependent GH exocytosis.	Receptor selectivity and DPP-IV resistance established in albumin-bioconjugate discovery work. Confirmed in anterior-pituitary somatotroph and in vivo models.	PMID 15817669 (Jetté et al., Endocrinology 2005); PMID 16352683 (Teichman et al., JCEM 2006)
GHSR-1a Agonism (Ipamorelin — Class A GPCR)	Ipamorelin binds the ghrelin receptor (GHSR-1a) on somatotrophs and hypothalamic GHRH-positive neurons. Activates Gαq/phospholipase C → IP₃/DAG → intracellular Ca²⁺ release, triggering acute GH exocytosis and directly antagonizing hypothalamic somatostatin tone.	Established as the first selective GH secretagogue with minimal cortisol/ACTH/prolactin co-release versus earlier GHRPs (GHRP-6, hexarelin).	PMID 9849822 (Raun et al., Eur J Endocrinol 1998)
Proposed Convergent / Synergistic Signaling	Because GHRHR (Gαs/cAMP) and GHSR-1a (Gαq/PLC) are separate signal-transduction arms converging on the same somatotroph, simultaneous activation is mechanistically plausible as additive or synergistic GH pulse amplification — CJC-1295 sustaining transcriptional/synthetic capacity, Ipamorelin triggering acute exocytotic release.	Mechanistic synergy for GHRH-analog + GHS pairings is described in the general dual-receptor pharmacology literature and referenced explicitly for CJC-1295 + Ipamorelin in a 2026 orthopaedic sports-medicine review, which simultaneously states that clinical trial evidence for the combination itself is lacking.	PMID 41490200 (Rahman, Lee, Seeds, J Am Acad Orthop Surg Glob Res Rev 2026); general GHRH/GHS dual-receptor literature
GH Pulsatility — Preservation of Physiological Architecture	Both compounds operate within the endogenous hypothalamic GHRH/somatostatin oscillatory system rather than replacing it, in contrast to exogenous recombinant GH, which suppresses endogenous pulsatility via negative feedback.	In the CJC-1295 DAC comparator study, overnight sampling confirmed trough GH +7.5-fold (p<0.0001), mean GH +46% (p<0.01), with pulse frequency/amplitude statistically unaltered. No equivalent overnight pulsatility study has been published for the combination.	PMID 17018654 (Ionescu & Frohman, JCEM 2006)
Downstream GH/IGF-1 Axis (JAK2/STAT5b)	GH released via either pathway acts on hepatocyte GH receptors → JAK2/STAT5b → IGF-1 gene transcription. Circulating IGF-1 provides negative feedback on both pituitary GH release and hypothalamic GHRH tone.	IGF-1 elevation (1.5–3-fold for 9–11 days) established for CJC-1295 DAC. Ipamorelin’s GH-release pharmacodynamics were characterized via IV dosing in healthy volunteers (peak GH ~0.67 h post-dose, terminal half-life ~2 h); the study did not evaluate IGF-1 endpoints or co-administration with a GHRH analog.	PMID 16352683; PMID 10496658 (Gobburu et al., Pharm Res 1999)

Critical Evidence Gap – The Combination Specifically

No randomized, placebo-controlled human trial of CJC-1295 administered concurrently with Ipamorelin has been identified in PubMed, Embase, or ClinicalTrials.gov as of June 2026. FDA’s own October 29, 2024 PCAC briefing document for ipamorelin-related bulk drug substances references the ‘trending’ commercial pairing of ipamorelin with CJC-1295 as reported by subject-matter experts consulted for the M-CERSI report but explicitly notes that this report did not evaluate clinical outcomes for the combination. Each compound’s clinical evidence base derives exclusively from single-agent trials: CJC-1295 from the DAC-bearing long-acting variant in healthy adults (PMID 16352683; PMID 17018654), and Ipamorelin from a negative Phase 2 postoperative-ileus trial and a single IV pharmacokinetic study in healthy volunteers (PMID 25331030; PMID 10496658). Any claimed synergistic GH-output multiplier for the combination is extrapolated from separate single-agent pharmacology, not demonstrated by direct human combination-arm data.

2025–2026 Indexed Scientific Literature – CJC-1295 / Ipamorelin Regulatory and Safety Context

PMID / Authors / Journal	Year	Study Type	Key Findings Relevant to CJC-1295 / Ipamorelin
PMID 41490200 — Rahman OF, Lee SJ, Seeds WA. J Am Acad Orthop Surg Glob Res Rev	2026	Review	CJC-1295 + Ipamorelin listed as GH secretagogues proposed to activate IGF-1 signaling (PI3K/Akt, mTOR, MAPK) in skeletal-muscle biology. Lack of clinical trial evidence for the combination noted explicitly.
PMID 41966639 — Mendias CL, Awan TM. Sports Med	2026	Evidence Review	CJC-1295 classified unapproved; gray-market distribution documented; sparse human safety data; placebo effect identified as a likely mediator of perceived efficacy in uncontrolled settings.
PMID 41880199 — Coutinho LFD et al. J Sports Med Phys Fitness	2026	Review	CJC-1295 explicitly listed among GHRH analogs used in sport/bodybuilding contexts; cardiovascular and gray-market quality-control risk themes identified.
PMID 25331030 — Beck DE, Sweeney WB, McCarter MD et al. Int J Colorectal Dis	2014	Phase 2 RCT	117 subjects post-abdominal surgery, IV ipamorelin 0.03 mg/kg BID vs placebo. Primary endpoint not statistically significant. Higher rates of hypokalemia and hyperglycemia in the ipamorelin arm. Two fatal serious adverse events occurred in ipamorelin-treated subjects.
PMID 10496658 — Gobburu JV, Agersø H, Jusko WJ, Ynddal L. Pharm Res	1999	PK/PD Study	Randomized, placebo-controlled IV dose-escalation in 48 healthy male subjects. Ipamorelin terminal half-life ≈2 hours; peak GH response ≈0.67 h post-dose; linear two-compartment PK model. No co-administration with a GHRH analog evaluated.
PMID 9849822 — Raun K, Hansen BS, Johansen NL et al. Eur J Endocrinol	1998	Foundational Preclinical	First description of ipamorelin as a selective GHSR-1a agonist; in vitro GH-secretagogue potency ≈1.3 nM; minimal cortisol/ACTH/prolactin co-release versus earlier GHRPs.
PMID 10373343 — Johansen PB, Nowak J, Skjærbæk C et al. Growth Horm IGF Res	1999	Preclinical	Ipamorelin induces longitudinal bone growth and increased bone mineral content in adult female rats.
PMID 19289567 — Venkova K, Mann W, Nelson R, Greenwood-Van Meerveld B. J Pharmacol Exp Ther	2009	Preclinical (Rodent POI Model)	Repetitive IV ipamorelin dosing accelerated colonic transit and increased fecal output, food intake, and body-weight gain in a rodent postoperative-ileus model.
PMID 32801950 — Attenuation of Visceral and Somatic Nociception by Ghrelin Mimetics	2020	Preclinical	Ghrelin-receptor-mediated mechanisms reduce colonic hypersensitivity and somatic mechanical allodynia in rat models; effect statistically significant at 1.0 mg/kg ipamorelin IV dose.
PMID 39043357 — Lu Z, Ngan MP, Liu JYH et al. Physiol Behav	2024	Preclinical (Ferret Model)	Ipamorelin and the related ghrelin mimetic anamorelin attenuated cisplatin-induced weight loss in ferrets without effect on acute emesis when given peripherally.
PMID 16352683 — Teichman SL, Neale A, Lawrence B et al. J Clin Endocrinol Metab	2006	Phase 1, RCT	CJC-1295 DAC: GH elevated 2–10-fold for ≥6 days; IGF-1 elevated 1.5–3-fold for 9–11 days; half-life 5.8–8.1 days; no serious adverse reactions at 30–60 mcg/kg.
PMID 17018654 — Ionescu M, Frohman LA. J Clin Endocrinol Metab	2006	Mechanistic Human Study	CJC-1295 DAC preserves GH pulsatility; trough GH +7.5-fold (p<0.0001); mean GH +46% (p<0.01); IGF-1 +45% (p<0.001).
PMID 15817669 — Jetté L, Léger R, Thibaudeau K et al. Endocrinology	2005	Foundational Discovery	Albumin Cys34 covalent binding via DAC thiol-Michael addition; 4-fold GH AUC increase vs native hGRF(1-29). Identification of CJC-1295.

FDA and Regulatory Landscape – 2026 Comprehensive Update

Comprehensive Regulatory Timeline — CJC-1295 and Ipamorelin, United States, 2023–2026

Date	Regulatory Event	Compliance Implications
Sep 2023	FDA places CJC-1295 (all forms) and ipamorelin acetate on Category 2 of the 503A interim bulk drug substances policy, citing immunogenicity risk, API characterization complexity, and insufficient clinical evidence.	503A compounding pharmacies PROHIBITED from compounding either substance for human use. No legal prescription pathway.
Sep 2024	FDA removes CJC-1295, Ipamorelin acetate, AOD-9604, and Thymosin Alpha-1 from Category 2 (nominations withdrawn) and refers all four to PCAC for formal four-factor review.	Category 2 prohibition lifted. PCAC review initiated for both substances separately. No automatic reauthorization.
Oct 29, 2024	PCAC Meeting: reviews Ipamorelin (free base) and Ipamorelin acetate — evaluated for growth hormone deficiency and postoperative ileus, alongside ibutamoren mesylate, L-theanine, and kisspeptin-10.	Committee voted AGAINST 503A inclusion: Ipamorelin free base 0 yes/12 no; Ipamorelin acetate 0 yes/12 no/1 abstain. FDA’s briefing cited unresolved characterization, lack of demonstrated effectiveness, and the Beck 2014 fatal-SAE signal.
Dec 4, 2024	PCAC Meeting (Docket FDA-2024-N-4777): reviews CJC-1295 acetate, CJC-1295 DAC forms, and Thymosin Alpha-1.	Committee voted AGAINST CJC-1295 inclusion on the 503A Bulk Drug Substances List across all reviewed forms.
Feb 27, 2026	HHS Secretary Kennedy announces, on a podcast appearance, that approximately 14 of 19 Category 2 peptides reported by multiple outlets to include CJC-1295 and Ipamorelin would be considered for reclassification toward Category 1.	Policy intent announced publicly. No Federal Register action taken specific to CJC-1295 or Ipamorelin. Not legally binding.
Apr 15–22, 2026	FDA formally removes 12 peptides from Category 2 — BPC-157, TB-500, KPV, MOTS-c, Emideltide (DSIP), Semax, Epitalon, LL-37, Dihexa, GHK-Cu, PEG-MGF, Melanotan II. CJC-1295 and Ipamorelin are NOT in this batch.	CJC-1295 and Ipamorelin remain in a formal REGULATORY GAP distinct from the April 2026 cohort: both already received negative PCAC recommendations in 2024, and neither was included in the April 2026 administrative action. No Category 1 placement for either substance.
Jun 30, 2026 (Today)	Current status, confirmed directly against FDA’s official advisory-committee calendar: CJC-1295 and Ipamorelin are off Category 2 (since Sep 2024); neither is on Category 1; both received negative PCAC votes (Oct/Dec 2024); no final FDA rulemaking; RFK Jr. reclassification intent announced but not enacted for these two substances.	REGULATORY GAP PERSISTS for both compounds, with an unfavorable advisory-committee record specific to each. Independent legal counsel required before any compounding-related activity. Not FDA-approved.
Jul 23–24, 2026 (This Week)	Scheduled PCAC meeting at FDA White Oak Campus reviews seven different bulk drug substances only: BPC-157, KPV, TB-500, MOTs-c (Day 1); Emideltide, Semax, Epitalon (Day 2). Confirmed directly from FDA’s official meeting page (content current as of 06/29/2026).	CJC-1295 and Ipamorelin are NOT on the July 2026 PCAC agenda. No re-review date has been announced for either substance. Content asserting an imminent or pending reclassification review for CJC-1295/Ipamorelin specifically would be factually inaccurate as of this publication date.

FDA Drug Approval and Enforcement Context

No FDA-approved drug product containing CJC-1295 or Ipamorelin (any form) exists in the United States. The only FDA-approved GHRH analog is tesamorelin (NDA 022505, Egrifta SV®) for HIV-associated lipodystrophy; the only FDA-approved oral GH secretagogue for diagnostic use is macimorelin (Macrilen, NDA 205598). Alvimopan (Entereg, NDA 021775) is the only FDA-approved drug specifically for accelerating GI recovery following bowel resection — the indication for which ipamorelin’s Phase 2 program (Beck et al. 2014) failed its primary endpoint.

FDA executed three major telehealth/compounding warning-letter campaigns in 2025–2026 (approximately 80 letters September 2025, 30 letters March 2026, and 25 letters the week of June 15, 2026), applying FDCA Sections 502(a) and 502(n) misbranding theory to marketing communications creating a misleading net impression of FDA approval or equivalence. This enforcement framework applies equally to any compounded or research-labeled product containing CJC-1295 and/or Ipamorelin.

CJC-1295 Without DAC chemical structure — PubChem CID 56841945 — synthetic
GHRH receptor analog — molecular formula C152H252N44O42 — CAS 863288-34-0 — Profound Aminos research
reference 2026

Ipamorelin chemical structure — PubChem CID 9831659 — synthetic pentapeptide ghrelin
receptor agonist GHSR-1a — molecular formula C38H49N9O5 — CAS 170851-70-4 — Profound Aminos research
reference 2026

Research-Documented Compounding History and Safety-Signal Comparison – 2026

The following side-by-side comparison draws exclusively from FDA’s own PCAC briefing documents and FAERS-derived safety review for each substance, plus the controlled human trial data already cited above. It is included to show where the two compounds’ evidence bases genuinely converge and diverge — information directly useful for accurate, defensible research content.

Evidence Category	CJC-1295	Ipamorelin
First Human/Foundational Characterization	2005–2006: albumin-bioconjugate discovery (PMID 15817669) and Phase 1 healthy-adult trials (PMID 16352683; PMID 17018654)	1998: first described as a selective GHSR-1a agonist (PMID 9849822); human PK/PD characterized the same year (PMID 10496658)
FDA Outsourcing Facility (503B) Compounding History	Not identified with comparable specificity in reviewed FDA materials	FDA-confirmed: outsourcing facilities reported compounding single-API (0.6mg/mL, 1.5mg/mL) and multi-API injections (e.g., with sermorelin) from 2H2017 through 1H2020. No OF compounding reports for ipamorelin identified after 2020.
Real-World Dispensing Data Presented to PCAC	Proponents presented 449,184 compounding-pharmacy dispenses with zero serious FAERS/CAERS adverse events at the Dec 4, 2024 PCAC meeting	FDA’s own FAERS search (through Sep 30, 2023) retrieved 2 non-serious AE reports — increased lacrimation/headache (nasal spray, single-ingredient) and arthralgia (combined with sermorelin)
Controlled Human Trial Adverse Events	Teichman et al. (PMID 16352683): no serious adverse reactions reported at 30–60 mcg/kg doses in healthy adults	Beck et al. (PMID 25331030): hypokalemia 12.5% vs 3.4% placebo; hyperglycemia 14.3% vs 8.6% placebo; 2 fatal SAEs in the ipamorelin treatment arm following anastomotic-leak complications
PCAC Review Date and Outcome	Dec 4, 2024 — voted against 503A inclusion across all reviewed CJC-1295 forms (Docket FDA-2024-N-4777)	Oct 29, 2024 — free base 0 yes/12 no; acetate 0 yes/12 no/1 abstain
WADA Anti-Doping Detection Maturity	Validated urine (LOD ≤0.5 ng/mL, PMID 41138283) and blood (PMID 35298973) detection methods; 19 in vitro metabolites characterized for screening (PMID 34665524)	Detected in confiscated doping-control vials in Germany, Belgium, Australia, and the United States per FDA’s own briefing document; no specific validated-LOD assay identified in reviewed FDA materials

Frequently Asked Questions — Scientific and Regulatory Reference

Q1: Are CJC-1295 and Ipamorelin the same compound, or two different substances combined?

Two entirely different substances. CJC-1295 (PubChem CID 56841945, C₁₅₂H₂₅₂N₄₄O₄₂) is a 29-amino-acid GHRH receptor agonist. Ipamorelin (PubChem CID 9831659, C₃₈H₄₉N₉O₅) is an unrelated 5-amino-acid ghrelin-receptor (GHSR-1a) agonist. They are frequently sold and researched together as a stack or pre-blended vial because they act on different receptors, but FDA has always evaluated them as separate bulk drug substances, with separate nominations, separate PCAC review dates, and separate negative votes.

Q2: What is the current FDA regulatory status of CJC-1295 and Ipamorelin as of June 2026?

Neither compound is FDA-approved for any human indication. Both were placed on FDA’s Category 2 do-not-compound list in September 2023, removed from Category 2 in September 2024 following nomination withdrawal, and then formally reviewed by PCAC — Ipamorelin on October 29, 2024 (voted against, 0 yes/12 no for free base) and CJC-1295 on December 4, 2024 (voted against across all forms, Docket FDA-2024-N-4777). Neither substance is part of the 12 peptides FDA removed from Category 2 in April 2026, and neither appears on the agenda for the July 23–24, 2026 PCAC meeting.

Q3: Has the CJC-1295 + Ipamorelin combination itself ever been clinically tested in humans?

No randomized, placebo-controlled human trial of the combination has been identified in PubMed, Embase, or ClinicalTrials.gov as of June 2026. All published human clinical data exist for the individual components administered alone: CJC-1295 DAC (PMID 16352683; PMID 17018654) and Ipamorelin via IV infusion (PMID 10496658; PMID 25331030). FDA’s own October 2024 ipamorelin briefing document references the commercial pairing as a trending combination reported by subject-matter experts, while explicitly noting that no clinical outcome data accompanied that observation.

Q4: Why did FDA’s Pharmacy Compounding Advisory Committee vote against including Ipamorelin on the 503A Bulks List?

FDA evaluated ipamorelin for growth hormone deficiency and postoperative ileus and found insufficient effectiveness data for both. The only identified human efficacy trial Beck et al. 2014, a Phase 2 study in 117 post-abdominal-surgery patients did not meet its primary endpoint. The ipamorelin arm also showed higher rates of hypokalemia and hyperglycemia than placebo, and two subjects receiving ipamorelin experienced fatal serious adverse events following anastomotic-leak complications. Development of ipamorelin for postoperative ileus was subsequently discontinued.

Q5: Why did FDA’s Pharmacy Compounding Advisory Committee vote against including CJC-1295 on the 503A Bulks List?

FDA’s December 4, 2024 evaluation found that peer-reviewed human clinical data exist only for the DAC-bearing long-acting variant, with no dedicated human pharmacokinetic or pharmacodynamic trials identified for CJC-1295 without DAC specifically. Concerns cited included peptide characterization and impurity-profile gaps, immunogenicity risk associated with subcutaneous administration, and the absence of a completed Phase 2/3 efficacy program.

Q6: How do CJC-1295 and Ipamorelin mechanistically differ, and why are they studied together?

CJC-1295 activates GHRHR (a Class B1 GPCR) via Gαs/cAMP/PKA/CREB signaling, increasing GH gene transcription and sustaining somatotroph synthetic capacity. Ipamorelin activates GHSR-1a (a Class A GPCR) via Gαq/phospholipase C/IP₃, triggering acute calcium-dependent GH exocytosis and antagonizing hypothalamic somatostatin. Because the two receptors converge on the same somatotroph cell through non-competing pathways, simultaneous activation is mechanistically plausible as additive GH-pulse amplification — a rationale described in the literature (PMID 41490200) but not yet confirmed by a dedicated human combination trial.

Q7: What is the WADA 2026 anti-doping status of CJC-1295 and Ipamorelin?

Both substances are prohibited under the WADA 2026 Prohibited List, Section S2 — Peptide Hormones, Growth Factors, Related Substances, and Mimetics — applicable in and out of competition. CJC-1295 is classified as a GHRH analog/growth hormone-releasing factor; Ipamorelin is classified as a growth hormone secretagogue. Validated analytical detection methods exist for CJC-1295 in both urine and blood matrices (PMID 41138283; PMID 34665524). Ipamorelin has been identified in confiscated doping-control samples in multiple countries per FDA’s own October 2024 briefing document.

Q8: What is appropriate 2026 content framing for a CJC-1295 / Ipamorelin combination page on a U.S. research platform?

For Google 2026 E-E-A-T/YMYL compliance and FDA/FTC alignment, content must: (1) state clearly that neither compound is FDA-approved for any indication and that no FDA-approved combination product exists; (2) identify both compounds by canonical PubChem CID, molecular formula, and CAS number rather than treating CJC-1295/Ipamorelin as a single registered substance; (3) accurately represent the separate, negative PCAC outcomes for each compound; (4) disclose that no human RCT of the combination exists; (5) avoid preparation protocols, dosing schedules, or body-composition/anti-aging outcome claims; (6) ground every mechanism-of-action claim in PMID-anchored primary literature; (7) state WADA S2 prohibited status explicitly.

Regulatory and Compliance Statement – Scientific Reference Document

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 and Ipamorelin (all forms, individually or combined) are NOT FDA-APPROVED for any human indication as of June 2026. No NDA, BLA, or ANDA exists for either substance or for the combination. No FDA-approved drug product contains either compound.
503A/503B Compounding Status — Jun 30, 2026	REGULATORY GAP, unfavorable for both compounds. Both removed from Category 2 (Sep 2024); both received negative PCAC recommendations (Ipamorelin Oct 29, 2024; CJC-1295 Dec 4, 2024); neither was part of the April 2026 Category 2 removal batch; neither is on the July 23–24, 2026 PCAC agenda (confirmed directly against FDA’s official meeting calendar). Legal compounding status for both substances is unsettled and, per the negative advisory votes, currently unfavorable. Independent legal counsel required before initiating any compounding-related activity.
WADA / Anti-Doping Status	CJC-1295 and Ipamorelin are both prohibited under WADA 2026 Prohibited List Section S2: Peptide Hormones, Growth Factors, Related Substances, and Mimetics.
Clinical Evidence Status	Published human clinical trials exist only for each compound individually (CJC-1295 DAC: PMID 16352683, PMID 17018654; Ipamorelin: PMID 10496658, PMID 25331030). No peer-reviewed human trial of the CJC-1295 + Ipamorelin combination has been identified in indexed literature as of June 2026.
Research Use Framing	CJC-1295 and Ipamorelin, when sold as research-grade compounds (individually or as a pre-blended vial), are sold for in vitro and preclinical laboratory research use only. Research use only labeling does not confer FDA compliance if marketing implies human-use intent.
YMYL Classification	YMYL (Your Money or Your Life): investigational pharmacological research compounds; somatotropic axis modulation; active FDA enforcement and advisory-committee landscape; WADA anti-doping classification. 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.

Key References — PubChem / FDA / PubMed / WADA — Verified June 2026

PubChem CID 56841945 — CJC-1295 Without DAC / Modified GRF 1-29 (canonical). pubchem.ncbi.nlm.nih.gov/compound/56841945 — C₁₅₂H₂₅₂N₄₄O₄₂; CAS 863288-34-0; MW ~3367.9 g/mol.
PubChem CID 91971820 — CJC-1295 With DAC (long-acting comparator). pubchem.ncbi.nlm.nih.gov/compound/91971820 — C₁₆₅H₂₆₉N₄₇O₄₆; albumin-binding; half-life 5.8–8.1 days.
PubChem CID 9831659 — Ipamorelin (free base). pubchem.ncbi.nlm.nih.gov/compound/Ipamorelin — C₃₈H₄₉N₉O₅; CAS 170851-70-4; MW ~711.9 g/mol.
PubChem CID 171378556 — Ipamorelin Acetate. pubchem.ncbi.nlm.nih.gov/compound/Ipamorelin-acetate — C₄₄H₆₁N₉O₁₁; MW ~892 g/mol.
PubChem CID 16132413 — Sermorelin / native GRF(1-29). pubchem.ncbi.nlm.nih.gov/compound/16132413 — CAS 86168-78-7. GHRH class reference.
PubChem CID 16137828 — Tesamorelin. pubchem.ncbi.nlm.nih.gov/compound/16137828 — FDA-approved NDA 022505 (Egrifta SV®), HIV-associated lipodystrophy.
PMID 16352683 — Teichman SL, Neale A, Lawrence B et al. J Clin Endocrinol Metab. 2006 Mar;91(3):799-805. pubmed.ncbi.nlm.nih.gov/16352683/ DOI: 10.1210/jc.2005-1536.
PMID 17018654 — Ionescu M, Frohman LA. J Clin Endocrinol Metab. 2006 Dec;91(12):4792-7. pubmed.ncbi.nlm.nih.gov/17018654/ DOI: 10.1210/jc.2006-1702.
PMID 15817669 — Jetté L, Léger R, Thibaudeau K et al. Endocrinology. 2005 Jul;146(7):3052-8. pubmed.ncbi.nlm.nih.gov/15817669/ DOI: 10.1210/en.2004-1286.
PMID 9849822 — Raun K, Hansen BS, Johansen NL et al. Eur J Endocrinol. 1998 Nov;139(5):552-61. pubmed.ncbi.nlm.nih.gov/9849822/.
PMID 10496658 — Gobburu JV, Agersø H, Jusko WJ, Ynddal L. Pharm Res. 1999 Sep;16(9):1412-6. pubmed.ncbi.nlm.nih.gov/10496658/.
PMID 25331030 — Beck DE, Sweeney WB, McCarter MD; Ipamorelin Investigative Group. Int J Colorectal Dis. 2014 Dec;29(12):1527-34. pubmed.ncbi.nlm.nih.gov/25331030/.
PMID 10373343 — Johansen PB, Nowak J, Skjærbæk C et al. Growth Horm IGF Res. 1999 Apr;9(2):106-13. pubmed.ncbi.nlm.nih.gov/10373343/.
PMID 19289567 — Venkova K, Mann W, Nelson R, Greenwood-Van Meerveld B. J Pharmacol Exp Ther. 2009 Jun;329(3):1110-6. pubmed.ncbi.nlm.nih.gov/19289567/.
PMID 32801950 — Attenuation of Visceral and Somatic Nociception by Ghrelin Mimetics. pubmed.ncbi.nlm.nih.gov/32801950/.
PMID 39043357 — Lu Z, Ngan MP, Liu JYH et al. Physiol Behav. 2024 Jul 21;284:114644. pubmed.ncbi.nlm.nih.gov/39043357/ DOI: 10.1016/j.physbeh.2024.114644.
PMID 41490200 — Rahman OF, Lee SJ, Seeds WA. J Am Acad Orthop Surg Glob Res Rev. 2026 Jan 2;10(1). pubmed.ncbi.nlm.nih.gov/41490200/ DOI: 10.5435/JAAOSGlobal-D-25-00236.
PMID 41966639 — Mendias CL, Awan TM. Sports Med. 2026 Apr 12. pubmed.ncbi.nlm.nih.gov/41966639/ DOI: 10.1007/s40279-026-02437-0.
PMID 41880199 — Coutinho LFD et al. J Sports Med Phys Fitness. 2026;66(7):880-885. pubmed.ncbi.nlm.nih.gov/41880199/ DOI: 10.23736/S0022-4707.26.17773-1.
FDA PCAC Briefing Document — Ipamorelin-Related Bulk Drug Substances, October 29, 2024 meeting. fda.gov/media/182088/download.
FDA PCAC Vote Results — October 29, 2024 meeting transcript/record. fda.gov/media/185412/download. Ipamorelin (free base) 0 yes/12 no; Ipamorelin acetate 0 yes/12 no/1 abstain.
FDA PCAC Briefing Document — CJC-1295-Related Bulk Drug Substances, December 4, 2024 meeting (Docket FDA-2024-N-4777). fda.gov/media/183819/download.
FDA Advisory Committee Calendar — July 23-24, 2026 Meeting of the Pharmacy Compounding Advisory Committee. fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026.
FDA 503A Bulk Drug Substances framework and significant-safety-risk compounding pages. fda.gov/drugs/human-drug-compounding/.
ClinicalTrials.gov NCT00267527 — CJC-1295 Phase 2 HIV Lipodystrophy Trial. clinicaltrials.gov/study/NCT00267527.
WADA Prohibited List 2026 — Section S2: Peptide Hormones, Growth Factors, Related Substances, and Mimetics. wada-ama.org/en/prohibited-list.

CJC-1295 and Ipamorelin (individually or in combination) are NOT FDA-approved for any human indication. This document is not a product listing. No consumer or self-directed use is implied or recommended.

Weight	0.02 lbs
Dimensions	1.5 × 2.75 × 1 in

Reviews

There are no reviews yet.

Only logged in customers who have purchased this product may leave a review.

DISCLAIMER:

Products sold on our website are meant for scientific research purposes only, designed for in vitro testing and lab experimentation exclusively. These products are not intended to be used as foods, drugs or cosmetics, any sort of bodily introduction of the products into humans or animals is strictly prohibited. They must also not be misbranded, misused, or mislabeled, or used for anything other than research and scientific investigation.
All the products you see on the website are being sold in a lyophilized powder state (freeze-dried), in a sealed sterile vial; and should be reconstituted.
The product’s label clearly states the amount of product a vial contains; some products are offered in different variations.
The products we are selling come in a sealed vial but require additional lab equipment for proper testing.
Though we make sure packaging, label, seals and writing does not differ from the product photos you see on our website, there is a chance for a minimal deviation.