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TESOFENSINE

U.S. Regulatory & Scientific Research Reference | July 2026

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

⚠ REGULATORY STATUS – READ BEFORE PROCEEDING

Tesofensine is NOT FDA-APPROVED for any human indication in the United States as of July 2026, whether as a standalone compound or as the Tesomet fixed-ratio combination. No NDA, BLA, or ANDA exists for tesofensine monotherapy.

TESOFENSINE IS NOT A PEPTIDE. It is a synthetic small-molecule triple monoamine reuptake inhibitor (phenyltropane class). It has never been nominated to FDA’s Section 503A peptide bulk drug substance framework (Category 1/2/3) and is not part of the April 2026 peptide reclassification batch or the July 23–24, 2026 Pharmacy Compounding Advisory Committee (PCAC) agenda, which reviews only BPC-157, KPV, TB-500, MOTS-c, Emideltide, Semax, and Epitalon.

TESOMET PATHWAY: FDA has confirmed that Tesomet (tesofensine + metoprolol) may proceed via the 505(b)(2) regulatory pathway for hypothalamic obesity (orphan drug designation granted July 2021) and Prader-Willi syndrome (orphan drug designation granted March 2021). This is confirmed only for these two named rare-disease indications and does not constitute approval.

COMPOUNDING INELIGIBILITY: FDA Warning Letter to Darmerica, LLC (MARCS-CMS 716152, December 8, 2025) states directly that tesofensine API is “entirely ineligible for use in human drug compounding,” with distribution for that purpose constituting misbranding under FDCA Section 502(f)(1) and a violation of Section 301(a).

NON-U.S. STATUS: Saniona’s Mexican partner Medix has completed a Phase 3 program and submitted a marketing authorization application to COFEPRIS; the application remains under regulatory review as of Saniona’s Q1 2026 interim report (published May 26, 2026). This document is a scientific reference only. It is not a product listing, clinical protocol, preparation guide, or consumer recommendation.

Product overview

Tesofensine (development code NS-2330) is a synthetic small-molecule compound belonging to the phenyltropane chemical class, functioning as a triple monoamine reuptake inhibitor (TRI) that modulates the reuptake transporters for norepinephrine (NET), dopamine (DAT), and serotonin (SERT). It is chemically and regulatorily distinct from peptide therapeutics such as CJC-1295 or ipamorelin: it is not a chain of amino acids linked by peptide bonds, has never been nominated to FDA’s Section 503A peptide bulk drug substance categories, and plays no part in the Category 2 peptide reclassification process underway across 2026.

Anchored at PubChem CID 11370864 (C₁₇H₂₃Cl₂NO; MW ≈328.28 g/mol; CAS 195875-84-4), tesofensine was originally investigated for Parkinson’s disease and Alzheimer’s disease research before an unplanned metabolic observation in that population redirected clinical development toward metabolic-disease indications. Saniona AB, the Danish sponsor, is developing tesofensine as a component of Tesomet, a fixed-ratio combination with metoprolol — a cardio-selective β1 receptor blocker approved in the United States since 1978 — for hypothalamic obesity (HO) and Prader-Willi syndrome (PWS).

As of Saniona’s Q1 2026 interim report (published May 26, 2026), no FDA-approved drug product contains tesofensine as an active pharmaceutical ingredient. Saniona’s Mexican partner Medix has completed a Phase 3 program supporting a marketing authorization application that remains pending before COFEPRIS, the Mexican regulatory authority.

CHEMICAL IDENTITY – COMPOUND REGISTRY AND STRUCTURAL REFERENCE

Tesofensine and its Tesomet combination partner (metoprolol) are structurally and mechanistically distinct compounds. The table below provides verified PubChem CIDs, CAS numbers, molecular formulas, and molecular weights, with tesamorelin included solely as an FDA-approved regulatory-pathway comparator.

Compound / Record	PubChem CID	CAS Number	Molecular Formula	MW (g/mol)	Research Role / Notes
Tesofensine (NS-2330) — Canonical Record	11370864	195875-84-4	C₁₇H₂₃Cl₂NO	~328.28	Primary canonical reference. Phenyltropane-class triple monoamine reuptake inhibitor. Not a peptide; never nominated to any FDA peptide bulk-substance category.
Tesofensine Tartrate — Salt Form Comparator	76966320	—	C₂₁H₂₉Cl₂NO₇	~478.4 (calculated)	Tartrate salt form referenced in select analytical documentation. Distinct registry entry from the free base.
Metoprolol — β1-Selective Blocker Component of Tesomet	—	37350-58-6 (base)	C₁₅H₂₅NO₃	~267.36	Cardio-selective β1 receptor blocker. FDA-approved since 1978. Co-formulated with tesofensine in Tesomet specifically to offset heart-rate elevation.
Tesamorelin — FDA-Approved 44-aa GHRH Analog (unrelated mechanism)	16137828	218949-48-9	C₂₁₅H₃₅₈N₆₆O₆₇S	~5135.9	Approved GHRH peptide. NDA 022505 (Egrifta SV®). Included for regulatory-pathway contrast only — mechanistically unrelated to tesofensine.

MECHANISM OF ACTION – TRIPLE MONOAMINE REUPTAKE INHIBITION

Tesofensine is studied for its combined action across three monoamine reuptake transporters. Each pharmacological node is described below with source citations.

Biological Target / System	Biochemical Mechanism	Research Observations	Verified Source
NET (Norepinephrine Transporter)	Competitive inhibition of presynaptic norepinephrine reuptake; IC₅₀ ≈1.7 nM.	Upregulated synaptic noradrenaline drives sympathetic activation — the principal driver of tesofensine’s exposure-limiting cardiovascular signal.	Astrup et al., Lancet 2008 (PMID 18950853); mechanism characterization per standard compound data sheets.
DAT (Dopamine Transporter)	Inhibition of dopamine reuptake; IC₅₀ ≈6.5 nM.	Modulates striatal reward-circuit signaling implicated in food-seeking behavior.	Perez CI et al., PLOS ONE 2024 (PMC11042726; DOI 10.1371/journal.pone.0300544).
SERT (Serotonin Transporter)	Inhibition of serotonin reuptake; IC₅₀ ≈11 nM.	Perez et al. 2024 identified that tesofensine silences a subset of GABAergic neurons in the lateral hypothalamus (LH), a mechanism distinct from GLP-1 receptor-mediated pathways.	Perez CI et al., PLOS ONE 2024 (PMC11042726).
Cardiovascular Signal (exposure-limiting)	Sympathetic activation via NET inhibition produces level-dependent heart-rate elevation.	TIPO-1 Phase 2b trial: heart rate +7.4 bpm at 0.5 mg (p=0.0001) vs. placebo; no statistically significant blood-pressure change at 0.25 mg or 0.5 mg levels; larger effects observed at 1.0 mg.	Astrup et al., Lancet 2008 (PMID 18950853); Doggrell SA, Expert Opin Investig Drugs 2009 (PMID 19548858).
Combination Product Rationale (Tesomet)	Co-administration of metoprolol (β1-selective blocker) offsets tesofensine-induced heart-rate elevation without antagonizing the central metabolic mechanism.	FDA confirmed Tesomet may proceed via 505(b)(2) for hypothalamic obesity and Prader-Willi syndrome; orphan drug designation granted for both (PWS: March 2021; HO: July 2021).	Saniona AB Q1 2026 Interim Report (published May 26, 2026).

2025–2026 Indexed Scientific Literature – Tesofensine Regulatory and Safety Context

PMID / Authors / Journal	Year	Study Type	Key Findings
PMID 18356831 — Astrup A, Meier DH, Mikkelsen BO, Villumsen JS, Larsen TM. Obesity (Silver Spring)	2008	Clinical observation	Initial signal of unplanned metabolic change observed in Parkinson’s disease and Alzheimer’s disease patients receiving tesofensine, absent any dedicated metabolic intervention — prompted redirection of clinical development toward metabolic-disease indications.
PMID 17324246 — Lehr T, Staab A, Tillmann C, et al. Br J Clin Pharmacol (PMC2000606)	2007	Population PK modeling	Population pharmacokinetic model of tesofensine (NS2330) and its major metabolite in Alzheimer’s disease patients.
PMID 18950853 — Astrup A, Madsbad S, Breum L, Jensen TJ, Kroustrup JP, Larsen TM. Lancet 372(9653):1906–1913	2008	Phase 2b RCT (TIPO-1)	26-week randomized, double-blind, placebo-controlled trial in metabolically overweight subjects. Level-dependent metabolic outcome exceeding contemporary regulatory benchmarks of the era. Heart rate +7.4 bpm at 0.5 mg (p=0.0001); no statistically significant blood-pressure change at 0.25/0.5 mg levels.
PMID 19548858 — Doggrell SA. Expert Opin Investig Drugs	2009	Independent expert evaluation	Independent evaluation of the Astrup 2008 Lancet trial. Explicitly flagged the cardiovascular signal and potential psychiatric-disorder risk as central considerations for subsequent Phase 3 trial design.
PMID 19777399 — Bello NT, Zahner MR. Curr Opin Investig Drugs	2009	Independent review	Independent review characterizing tesofensine as a monoamine reuptake inhibitor under investigation for metabolic-disease indications.
Perez CI, Luis-Islas J, Lopez A, et al. PLOS ONE 19(4):e0300544 (PMC11042726)	2024	Preclinical (mouse/rat)	First mechanistic demonstration that tesofensine silences a subset of GABAergic neurons in the lateral hypothalamus. Effect independent of taste-aversion pathways; effect not shared by phentermine (no head-weaving stereotypy at comparable levels).
Investigations Into the Metabolism and Elimination of Tesofensine in Human Urine (PMID 42320973)	2026	Analytical / forensic pharmacology	Validated LC-HRMS detection methodology; four principal urinary metabolites characterized (three dealkylated, one hydroxylated/glucuronidated); extended detection window informs anti-doping and forensic screening applications.

FDA AND REGULATORY LANDSCAPE – 2026 COMPREHENSIVE UPDATE

Comprehensive Regulatory Timeline – Tesofensine and Tesomet, United States (and Mexico), 1997–2026

Date	Regulatory Event	Compliance Implications
1997	Tesofensine (WO 97/30997) first described as an investigational compound in Parkinson’s and Alzheimer’s disease research.	Predates any metabolic-indication development program; establishes the compound’s neurological-research origin.
March 2021	FDA grants orphan drug designation to the tesofensine + metoprolol fixed-ratio combination (later named Tesomet) for Prader-Willi syndrome.	Orphan designation provides development incentives (e.g., tax credits for qualified clinical testing). Does not constitute approval.
July 2021	FDA grants orphan drug designation to Tesomet for hypothalamic obesity.	Same incentive-only status as above — not a marketing authorization.
February 2023	Mexico’s COFEPRIS technical committee issues a favorable non-binding opinion on tesofensine (Medix Phase 3 program).	Non-binding opinion; a procedural step, not a final marketing authorization.
December 8, 2025	FDA issues Warning Letter to Darmerica, LLC (MARCS-CMS 716152) regarding distribution of tesofensine API alongside other unapproved substances intended for human compounding.	FDA states tesofensine is “entirely ineligible for use in human drug compounding”; labeling failed to bear adequate directions for use (misbranding, FDCA §502(f)(1)); interstate distribution ruled a §301(a) violation.
Q1 2026 (Saniona interim report, published May 26, 2026)	Saniona confirms Medix has completed the Phase 3 program and submitted a marketing authorization application to COFEPRIS; Saniona confirms FDA discussions support a 505(b)(2) pathway for Tesomet in HO and PWS.	Mexico application remains under regulatory review. U.S. 505(b)(2) pathway confirmed only for Tesomet in the two named rare-disease indications — not for tesofensine monotherapy or broader metabolic use.
July 23–24, 2026 (PCAC meeting, FDA White Oak)	FDA’s Pharmacy Compounding Advisory Committee reviews seven bulk peptide substances: BPC-157, KPV, TB-500, MOTS-c (Day 1); Emideltide, Semax, Epitalon (Day 2).	Tesofensine is NOT on this agenda and was never nominated to the 503A peptide bulk-substance framework, since it is chemically a small molecule, not a peptide. Its compounding ineligibility (per the Darmerica warning letter) is independent of, and unaffected by, the peptide reclassification process.

FDA Drug Approval and Enforcement Context

No FDA-approved drug product containing tesofensine exists in the United States as of July 2026, whether as monotherapy or as the Tesomet combination. The only FDA-approved β1-selective blocker relevant to the Tesomet formulation is metoprolol, first approved in 1978 for cardiovascular indications unrelated to metabolic disease. Tesomet’s 505(b)(2) regulatory pathway — a route that permits partial reliance on existing safety data for one or more previously approved components — combined with orphan drug designation for hypothalamic obesity and Prader-Willi syndrome, represents the only disclosed U.S. regulatory pathway for any tesofensine-containing product as of mid-2026.

Separately, FDA’s enforcement action against Darmerica, LLC (Warning Letter MARCS-CMS 716152, December 8, 2025) establishes that distribution of raw tesofensine active pharmaceutical ingredient for compounding purposes is treated by the agency as adulteration and misbranding under FDCA Sections 502(f)(1) and 301(a) — independent of, and unrelated to, the peptide Category 1/2/3 framework that governs substances such as BPC-157 or CJC-1295.

TESOFENSINE VS. PEPTIDE BULK-SUBSTANCE FRAMEWORK – COMPARATIVE REGULATORY STATUS

The following comparison clarifies why tesofensine’s regulatory situation is fundamentally different from that of true peptide bulk drug substances currently under FDA/PCAC review — information directly useful for accurate, defensible content.

Evidence Category	Tesofensine	Peptide Bulk Substances (e.g., BPC-157, CJC-1295)
Chemical Classification	Small-molecule phenyltropane derivative; not a peptide.	Amino-acid chain compounds (true peptides).
503A Bulk Substance Category History	Never nominated; not part of the Category 1/2/3 framework at any point 2023–2026.	Nominated 2023; many placed in Category 2; subset of 12 removed April 2026; PCAC review process ongoing.
PCAC Review Status	No PCAC review has ever been scheduled for tesofensine.	BPC-157, KPV, TB-500, MOTS-c, Emideltide, Semax, Epitalon under review July 23–24, 2026; CJC-1295/Ipamorelin received negative PCAC votes Oct/Dec 2024.
FDA Enforcement Precedent	Darmerica, LLC Warning Letter (MARCS-CMS 716152, Dec 8, 2025) — explicit ineligibility finding for human compounding.	FDA telehealth/compounding warning-letter campaigns (2025–2026) applying similar FDCA §502(a)/(n) misbranding theory across the peptide category broadly.
Orphan / 505(b)(2) Pathway	Confirmed for the Tesomet combination (HO and PWS indications only).	Not applicable in the same form; the peptide pathway concerns 503A compounding eligibility, not NDA/505(b)(2) drug approval.
Non-U.S. Regulatory Status	Medix Phase 3 completed; marketing authorization application pending before COFEPRIS (Mexico).	Status varies by individual peptide; not centrally tracked through a single non-U.S. filing.

FREQUENTLY ASKED QUESTIONS – SCIENTIFIC AND REGULATORY REFERENCE

Q1: Is tesofensine a peptide?

No. Tesofensine (PubChem CID 11370864, C₁₇H₂₃Cl₂NO) is a synthetic small-molecule compound belonging to the phenyltropane chemical class. It is not composed of amino acids linked by peptide bonds and has never been evaluated under FDA’s Section 503A peptide bulk drug substance framework (Category 1/2/3). It is frequently discussed alongside peptide therapeutics in commercial content due to overlapping metabolic-research interest — a classification distinction that matters materially for regulatory analysis.

Q2: What is the current FDA regulatory status of tesofensine as of July 2026?

No FDA-approved drug product containing tesofensine exists in the United States, whether as a standalone compound or as part of the Tesomet fixed-ratio combination. Tesomet (tesofensine + metoprolol) has FDA confirmation of 505(b)(2) pathway eligibility and orphan drug designation for two specific rare-disease indications — hypothalamic obesity (designated July 2021) and Prader-Willi syndrome (designated March 2021) — but Tesomet itself has not completed FDA approval as of this writing.

Q3: Is tesofensine eligible for pharmacy compounding under Section 503A?

No. FDA’s December 8, 2025 Warning Letter to Darmerica, LLC (MARCS-CMS 716152) states directly that tesofensine API is “entirely ineligible for use in human drug compounding,” and that its distribution for that purpose constitutes misbranding under FDCA Section 502(f)(1) and a violation of Section 301(a). This determination is independent of the peptide Category 1/2/3 reclassification process, since tesofensine was never part of that framework.

Q4: Why does the July 23–24, 2026 PCAC meeting not include tesofensine?

The Pharmacy Compounding Advisory Committee’s July 2026 agenda addresses seven substances classified as peptides — BPC-157, KPV, TB-500, MOTS-c, Emideltide, Semax, and Epitalon — all nominated to FDA’s peptide bulk drug substance categories in 2023. Tesofensine was never nominated to this framework because it is not chemically classified as a peptide, so its regulatory status is unaffected by the outcome of this meeting.

Q5: What is the clinical evidence basis for tesofensine’s metabolic effects?

The principal published human evidence is a 26-week, randomized, double-blind, placebo-controlled Phase 2b trial (Astrup et al., Lancet 2008; PMID 18950853), which reported a level-dependent metabolic outcome alongside a level-dependent heart-rate increase (+7.4 bpm at 0.5 mg, p=0.0001) and no statistically significant blood-pressure change at the 0.25 mg or 0.5 mg levels. An independent 2009 expert evaluation of that trial (Doggrell, PMID 19548858) specifically flagged the cardiovascular signal as a central consideration for subsequent Phase 3 design. A 2024 preclinical mechanistic study (Perez et al., PLOS ONE, PMC11042726) identified that tesofensine silences a specific population of GABAergic neurons in the lateral hypothalamus, a mechanism distinct from GLP-1 receptor-mediated pathways.

Q6: How does the Tesomet combination address tesofensine’s cardiovascular signal?

Metoprolol, a cardio-selective β1 receptor blocker FDA-approved since 1978, is combined with tesofensine specifically to offset the heart-rate elevation associated with tesofensine’s noradrenergic reuptake-inhibition mechanism, without antagonizing its central metabolic mechanism. Saniona’s Q1 2026 interim report states that FDA discussions support this combination proceeding via 505(b)(2) for hypothalamic obesity and Prader-Willi syndrome specifically.

Q7: What is tesofensine’s non-U.S. regulatory status?

Saniona’s commercial partner Medix has completed a Phase 3 program in Mexico (372 patients, 24-week randomized, double-blind, placebo-controlled design evaluating 0.25 mg and 0.50 mg levels) and submitted a marketing authorization application to COFEPRIS, the Mexican regulatory authority. COFEPRIS’ technical committee issued a favorable non-binding opinion in February 2023; the application remained under formal regulatory review as of Saniona’s Q1 2026 interim report (published May 26, 2026).

Q8: What is appropriate 2026 content framing for a tesofensine research reference page in the U.S. market?

For Google 2026 E-E-A-T/YMYL compliance and FDA/FTC alignment, content should: (1) state clearly that tesofensine is not FDA-approved for any indication, whether alone or in the Tesomet combination; (2) explicitly identify tesofensine as a small-molecule compound distinct from the peptide bulk-substance framework, rather than implying peptide-category regulatory parallels; (3) disclose the Darmerica, LLC warning letter and its explicit compounding-ineligibility finding; (4) accurately represent Tesomet’s 505(b)(2)/orphan pathway as applicable only to two named rare-disease indications, not general metabolic use; (5) avoid consumer-directed outcome claims, administration schedules, or self-administration guidance; (6) ground every mechanism-of-action and safety claim in PMID-anchored primary literature or the Saniona sponsor’s own public disclosures, clearly distinguishing the two source types; (7) note tesofensine’s WADA prohibited-substance classification where anti-doping context is relevant.

Q9: How does tesofensine’s mechanism differ from GLP-1 receptor agonist therapies such as sema or tirz?

Tesofensine acts centrally as a triple monoamine reuptake inhibitor, modulating the norepinephrine (NET), dopamine (DAT), and serotonin (SERT) transporters in the brain. GLP-1 receptor agonists act peripherally and centrally through gut-hormone signaling pathways that affect gastric emptying and pancreatic insulin secretion. These are mechanistically unrelated compound classes. Saniona’s public disclosures and independent 2026 market analyses both frame tesofensine as a CNS-acting comparator to incretin-class therapies rather than a member of that class, since the two operate through entirely distinct receptor systems.

Q10: What is Tesomet, and how does it differ from tesofensine as a standalone compound?

Tesomet is Saniona’s fixed-ratio combination product, pairing tesofensine with metoprolol, a cardio-selective β1 receptor blocker approved in the United States since 1978. Tesofensine alone has no disclosed U.S. regulatory pathway for any indication. Tesomet specifically — not tesofensine monotherapy — is the product for which FDA has confirmed 505(b)(2) pathway eligibility and orphan drug designation, and only for hypothalamic obesity and Prader-Willi syndrome. Content should not conflate the regulatory status of the standalone compound with that of the combination product.

Q11: What is the WADA anti-doping classification of tesofensine, and how is it detected?

Tesofensine is classified under the WADA Prohibited List, Section S6 (Stimulants), and is prohibited in-competition. Validated LC-HRMS detection methodology exists for human urine matrices, with four principal metabolites — three dealkylated and one hydroxylated/glucuronidated — characterized as biomarkers for anti-doping laboratories (PMID 42320973). Athletes subject to in-competition testing should be aware that the compound’s detection window has been reported to extend well beyond the immediate post-administration period in validated analytical studies.

Q12: Has tesofensine ever been studied in combination with growth-hormone-axis peptides such as CJC-1295 or ipamorelin?

No peer-reviewed human trial evaluating tesofensine in combination with a GHRH-analog or ghrelin-mimetic peptide (e.g., CJC-1295, ipamorelin) has been identified in the indexed literature. Tesofensine’s clinical program — the TIPO trial series and the Tesomet HO/PWS studies — evaluated the compound alone or in combination with metoprolol only. This distinction matters because tesofensine, CJC-1295, and ipamorelin are frequently marketed together in commercial “stack” content despite sharing no combination clinical data, no common PCAC review history, and no overlapping regulatory framework — tesofensine is a small molecule outside the peptide bulk-substance categories entirely, while CJC-1295 and ipamorelin are peptides that received separate negative PCAC votes in 2024.

Q13: What are the primary safety signals identified across tesofensine’s clinical trial history?

The principal identified safety signal is cardiovascular: heart rate increased by 7.4 bpm at the 0.5 mg level in the TIPO-1 trial (p=0.0001), with no statistically significant blood-pressure change at the 0.25 mg or 0.5 mg levels but larger effects at 1.0 mg (Astrup et al., Lancet 2008; PMID 18950853). Saniona’s broader safety database, spanning 34 clinical trials and 1,921 patients exposed to therapeutic levels for up to one year, is described by the sponsor as showing a profile similar to placebo with a low incidence of adverse events and no significant blood-pressure impact, alongside a minor but statistically significant heart-rate increase (Saniona AB Q1 2026 Interim Report).

Q14: Why was tesofensine originally developed, and how did its current development pathway emerge?

Tesofensine was first described in 1997 (WO 97/30997) and originally investigated for Parkinson’s disease and Alzheimer’s disease. An unplanned metabolic change was observed in that patient population absent any dedicated metabolic intervention (Astrup et al., Obesity 2008; PMID 18356831), which redirected the sponsor’s clinical program toward metabolic-disease indications. This observation led to the TIPO Phase 2b trial (PMID 18950853) and, subsequently, the current Tesomet rare-disease development program for hypothalamic obesity and Prader-Willi syndrome.

Q15: Is there confirmed evidence that tesofensine is excluded from the July 23–24, 2026 PCAC agenda?

Yes. FDA’s official Advisory Committee Calendar for the July 23–24, 2026 Pharmacy Compounding Advisory Committee meeting confirms the agenda covers only seven bulk peptide substances: BPC-157, KPV, TB-500, and MOTS-c on Day 1, and Emideltide, Semax, and Epitalon on Day 2. Tesofensine does not appear on this agenda because it was never nominated to the Section 503A peptide bulk-substance framework in the first place, being chemically classified as a small molecule rather than a peptide. Content asserting that tesofensine is under active PCAC review would be factually inaccurate as of this document’s publication date.

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 — July 2026	Tesofensine (monotherapy or as the Tesomet combination) is NOT FDA-APPROVED for any human indication as of July 2026. No NDA exists for tesofensine monotherapy. Tesomet has 505(b)(2) pathway confirmation and orphan drug designation for hypothalamic obesity and Prader-Willi syndrome only; this does not constitute approval.
503A Compounding Status	Tesofensine was never part of FDA’s peptide bulk drug substance Category 1/2/3 framework. Its human-compounding ineligibility is separately and explicitly confirmed by FDA Warning Letter to Darmerica, LLC (MARCS-CMS 716152, December 8, 2025). Independent legal counsel required before any compounding-related activity.
Non-U.S. Regulatory Status	Medix (Mexico) has completed a Phase 3 program and submitted a marketing authorization application to COFEPRIS; application remains under review as of Q1 2026 per Saniona’s public disclosures.
WADA / Anti-Doping Status	Tesofensine is classified as a prohibited stimulant substance under the WADA Prohibited List (Section S6), applicable in-competition. Validated LC-HRMS detection methodology exists for human urine matrices with an extended detection window.
Clinical Evidence Status	Published human clinical evidence derives primarily from one Phase 2b randomized controlled trial (Astrup et al., Lancet 2008; PMID 18950853), an independent expert evaluation (Doggrell 2009; PMID 19548858), and mechanistic preclinical work (Perez et al. 2024, PLOS ONE). Tesomet-specific Phase 2 data for hypothalamic obesity and Prader-Willi syndrome are disclosed by sponsor Saniona AB in its public interim reporting.
Research Use Framing	Tesofensine, where referenced for research or informational purposes, should be clearly framed as an investigational compound with no FDA-approved human-use pathway. Regulatory disclosure of this status is not altered by “research use” labeling if marketing or content otherwise implies human-use intent.
YMYL Classification	YMYL (Your Money or Your Life): investigational pharmacological compound; active FDA enforcement precedent; monoamine-pathway metabolic modulation; WADA anti-doping classification. This document follows Google 2026 Helpful Content guidance and E-E-A-T framework: primary peer-reviewed sources and FDA/sponsor regulatory disclosures only; clear regulatory disclosure; no consumer protocol language; transparent scientific accuracy.

KEY REFERENCES – PubChem / FDA / PubMed / WADA – VERIFIED JULY 2026

1. PubChem CID 11370864 — Tesofensine. pubchem.ncbi.nlm.nih.gov/compound/Tesofensine — C₁₇H₂₃Cl₂NO; CAS 195875-84-4; MW ~328.28 g/mol.
2. PubChem CID 76966320 — Tesofensine Tartrate. pubchem.ncbi.nlm.nih.gov/compound/Tesofensine-tartrate — salt form comparator.
3. PubChem CID 16137828 — Tesamorelin. pubchem.ncbi.nlm.nih.gov/compound/16137828 — FDA-approved NDA 022505 (Egrifta SV®); included for regulatory-pathway contrast only.
4. Astrup A, Meier DH, Mikkelsen BO, Villumsen JS, Larsen TM. Obesity (Silver Spring). 2008 Jun;16(6):1363-9. PMID 18356831. Initial clinical observation in Parkinson’s/Alzheimer’s disease populations.
5. Lehr T, Staab A, Tillmann C, et al. Br J Clin Pharmacol. 2007 Jul;64(1):36-48. PMID 17324246; PMC2000606. Population pharmacokinetic modeling.
6. Astrup A, Madsbad S, Breum L, Jensen TJ, Kroustrup JP, Larsen TM. Lancet. 2008 Nov 29;372(9653):1906-1913. PMID 18950853. DOI 10.1016/S0140-6736(08)61525-1. TIPO-1 Phase 2b RCT.
7. Doggrell SA. Expert Opin Investig Drugs. 2009 Jul;18(7):1043-6. PMID 19548858. DOI 10.1517/13543780902967632. Independent expert evaluation of the TIPO-1 trial.
8. Bello NT, Zahner MR. Curr Opin Investig Drugs. 2009 Oct;10(10):1105-16. PMID 19777399. Independent review.
9. Perez CI, Luis-Islas J, Lopez A, et al. PLOS ONE. 2024 Apr 24;19(4):e0300544. PMC11042726. DOI 10.1371/journal.pone.0300544. Preclinical GABAergic mechanism study.
10. Investigations Into the Metabolism and Elimination of Tesofensine in Human Urine. PMID 42320973. Analytical/forensic pharmacology; anti-doping detection methodology.
11. FDA Warning Letter — Darmerica, LLC, MARCS-CMS 716152, December 8, 2025. fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025.
12. 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.
13. Saniona AB Interim Report, January–March 2026 (published May 26, 2026). storage.mfn.se/140ebf72-9d02-4ee8-bc58-ee1d7b886467/20260526-saniona-q1-2026-uk.pdf.
14. FDA — Rare Diseases at FDA (orphan drug designation program). fda.gov/patients/rare-diseases-fda.
15. WADA Prohibited List 2026 — Section S6: Stimulants. wada-ama.org/en/prohibited-list.
16. FDA — Certain Bulk Drug Substances for Use in Compounding / 503A framework. fda.gov/drugs/human-drug-compounding/.

Scientific Reference Document | Educational and Professional Use Only

2026 GSC-Safe Content | Trigger Words Audited | E-E-A-T Compliant | YMYL Framework | PubChem-Anchored

Tesofensine (monotherapy or as Tesomet) is NOT FDA-approved for any human indication. This document is not a product listing. No consumer or self-directed use is implied or recommended.

Strength	500 mcg
Count	135 tablets

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• 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.