Evidence review: Open Peptide Project (verified against primary PubMed, ClinicalTrials.gov & FDA records) · Last checked 2026-10-27. ← Back to Evidence Library · Trial & Regulatory Tracker →

Taldefgrobep alfa (BHV-2000, BMS-986089, RG6206): what the evidence says

Name: Taldefgrobep alfa (BHV-2000, BMS-986089, RG6206)
Published: 2026-10-27

At a glance

What it is: an engineered protein (an adnectin fused to an antibody Fc fragment) that binds myostatin and blocks its signaling. It is a protein, larger than a typical peptide. ^R1

What the evidence says: Human in healthy adults it raised thigh muscle volume, but in boys with Duchenne muscular dystrophy a phase 2/3 trial failed its futility test and the program was stopped in 2019. ^R1 A phase 3 SMA trial (RESILIENT, n = 269) finished ^R2; UNVERIFIED reports that it missed its primary endpoint (no peer-reviewed result found).

Biggest risks: in DMD trials no safety concerns were reported. ^R1 Long-term safety unknown.

Rating


Human Human evidence	Limited: DMD trials negative; SMA phase 3 unpublished ^{R1, R2}
Animal Animal / lab evidence	Mice and other species ^R1
Regulatory	Investigational · not FDA-approved · not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page ^{R3, R4, R5} · banned by WADA S4.3 ^R6
Established human dose	No

Evidence verdict: Duchenne (DMD): failed (futility) · SMA: Limited (phase 3 reported negative, unverified) · Obesity: Unknown

This page reports what studies used. It is not dosing advice.

Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source

About the evidence: positive effects on muscle size did not translate into better function in DMD. The SMA design paper and a review describe the rationale, not results. ^{R7, R8}

What is it?

Related pages: apitegromab, ace-031, follistatin, bimagrumab.

Does it work?

Human Healthy adults: more thigh muscle volume. ^R1
Human DMD phase 2/3: no functional benefit; stopped for futility. ^{R1, R9}
Unknown SMA phase 3 RESILIENT: no peer-reviewed results. ^{R2, R7}

Is it safe?

Human DMD: no patient withdrew for treatment-related adverse events. ^R1

Pipeline status (investigational)

Sponsor: Biohaven. ^R2
Trials: NCT05337553 RESILIENT SMA (primary completion Sep 2024) ^R2; NCT07281495 obesity phase 2, estimated primary completion Sep 2026. ^R10
Expected readouts: obesity phase 2 UNVERIFIED timing.

Gray-market vials: extra risks

A gray-market vial has no quality control and no guarantee of identity, strength or sterility. We test retail vials blind under the Open Peptide Standard; see /tests/. A passing test covers one batch on one date and does not mean the compound is safe.

Is it legal?

US: not FDA-approved; no Drugs@FDA application found (openFDA searched Oct 27, 2026).
Compounding: not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page. ^{R3, R4, R5}
Sport: WADA 2026 S4.3 (agents preventing activin receptor IIB activation) bans myostatin inhibitors at all times ^R6.

Study details

These are amounts researchers used, not recommendations.

Study	People / model	Route	Amount used	Follow-up	Reported	Citation
DMD phase 1b/2/3 program (Muntoni 2024)	Healthy adults; ambulatory boys with DMD	SC	Per study	Per study	Muscle volume up; no functional benefit	PMID 38190001

Full reference list (PubMed, CT.gov, FDA and WADA checked Oct 27, 2026)

^R1 Muntoni F, et al. Neurol Ther. 2024. PMID 38190001
^R2 ClinicalTrials.gov NCT05337553, RESILIENT phase 3 SMA, Biohaven (CT.gov API v2, checked Oct 27, 2026). https://clinicaltrials.gov/study/NCT05337553
^R3 FDA, 503A bulk drug substances categories list (updated May 14, 2026). https://www.fda.gov/media/94155/download
^R4 FDA, 503B bulk drug substances categories list (updated Mar 21, 2025). https://www.fda.gov/media/94164/download
^R5 FDA, Certain bulk drug substances for use in compounding that may present significant safety risks (content current Apr 22, 2026). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
^R6 WADA. The 2026 Prohibited List, S4.3 Agents preventing activin receptor IIB activation. https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf
^R7 Servais L, et al. Int J Mol Sci. 2024. PMID 39408601
^R8 Finkel RS, et al. Expert Rev Neurother. 2026. PMID 41566720
^R9 ClinicalTrials.gov NCT02515669, phase 1b/2 DMD, terminated (CT.gov API v2, checked Oct 27, 2026). https://clinicaltrials.gov/study/NCT02515669
^R10 ClinicalTrials.gov NCT07281495, phase 2 obesity, Biohaven, active (CT.gov API v2, checked Oct 27, 2026). https://clinicaltrials.gov/study/NCT07281495

Disclaimer

This page is for education and harm reduction, not medical advice or a recommendation to use Taldefgrobep alfa (BHV-2000, BMS-986089, RG6206). This is an investigational drug. It is available only inside registered clinical trials; products sold online under this name are unregulated. Report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).