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Evidence: LowProtein, not a peptide Clinical Trials Pipeline & In-Development

Taldefgrobep alfa

also known as: BMS-986089, BHV-2000

Biohaven's anti-myostatin adnectin-Fc fusion: its Duchenne programme ended in 2019 after a futility analysis, and its phase 3 RESILIENT trial in SMA missed its primary endpoint in November 2024.

A recombinant anti-myostatin adnectin fused to a human Fc domain, originally BMS-986089, now developed by Biohaven as BHV-2000; the RESILIENT Phase 3 trial in spinal muscular atrophy missed its primary endpoint in December 2024, and subsequent development is focused on obesity and sarcopenia indications where the muscle-sparing profile is more commercially relevant.

Mechanism of action

The adnectin domain binds myostatin (GDF-8) with high affinity and blocks engagement with ActRIIB receptors; the Fc fusion extends circulating half-life and supports subcutaneous dosing. Adnectins are single-domain engineered proteins derived from the tenth fibronectin type III domain — a non-antibody binding scaffold.

Primary uses

  • Spinal muscular atrophy (Phase 3 — missed primary endpoint)
  • Obesity (Phase 2 muscle-sparing combination)
  • Sarcopenia (investigational)

Typical dosing

not publicly disclosed mg weekly (trial protocols) (subcutaneous)

RESILIENT Phase 3 used weekly SC administration.

Regulatory status

Not approved. Biohaven reported in December 2024 that RESILIENT, the Phase 3 trial in spinal muscular atrophy, missed its primary endpoint on the Motor Function Measure-32. Development continues in obesity (as a muscle-sparing GLP-1 adjunct) and other muscle-wasting conditions.

Status as of this entry's last review, October 4, 2026. Approvals, compounding rules and sport rules change; the regulatory tracker is checked more often.

What the studies show

Taldefgrobep alfa is an anti-myostatin adnectin fused to an antibody tail. In its phase 3 RESILIENT trial in spinal muscular atrophy (NCT05337553), Biohaven reported on November 25, 2024 that it missed its primary endpoint, a change in the MFM-32 motor score at 48 weeks, though the company described clinically meaningful changes; the papers below review its earlier trials.

Review · 2024

The Duchenne programme

Across a phase 1 study in healthy adults and two placebo-controlled trials in boys with Duchenne, it suppressed free myostatin and raised thigh muscle volume in adults, but the phase 2/3 trial failed its futility analysis on the North Star score and the Duchenne programme was ended in 2019.

PMID 38190001

Review · 2024

The RESILIENT trial design

Describes the rationale for adding myostatin blockade to SMN-raising drugs in spinal muscular atrophy and introduces RESILIENT, a phase 3 placebo-controlled trial (NCT05337553); written before its results.

PMID 39408601

References

  1. [manufacturer] Biohaven. Letter to the SMA community on RESILIENT results (released November 25, 2024: primary endpoint not met; open-label extension continuing), December 18, 2024. Read October 4, 2026.
  2. [clinicaltrials] ClinicalTrials.gov NCT05337553: RESILIENT, phase 3 randomised placebo-controlled trial of taldefgrobep alfa with SMN upregulators in spinal muscular atrophy, ages 4-21, 48-week double-blind phase. Read October 4, 2026.
  3. [pubmed] Muntoni F, et al. "The Clinical Development of Taldefgrobep Alfa: An Anti-Myostatin Adnectin for the Treatment of Duchenne Muscular Dystrophy." Neurol Ther, 2024;13(1):183-219. PMID: 38190001.
  4. [pubmed] Servais L, et al. "Taldefgrobep Alfa and the Phase 3 RESILIENT Trial in Spinal Muscular Atrophy." Int J Mol Sci, 2024;25(19). PMID: 39408601.

Related peptides

Bimagrumab

The activin receptor antibody that adds muscle and removes fat: failed in a muscle disease, now paired with semaglutide for obesity.

Trevogrumab

⚠ Monoclonal antibody — not a classical peptide. A Regeneron anti-myostatin fully human IgG (~150 kDa) being tested as a muscle-sparing adjunct to GLP-1 therapy — CONVERGE combination program with semaglutide in obesity; earlier sarcopenia programs were deprioritized in favor of the obesity opportunity. Included here because it's widely discussed alongside peptides in muscle-sparing conversations.

Apitegromab

⚠ Monoclonal antibody, not a peptide. Scholar Rock's antibody against the proforms of myostatin, FDA-approved on September 11, 2026 as Isembyld for spinal muscular atrophy in patients 2 and older already on an SMN2-targeted treatment.

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Disclaimer

This entry is for educational purposes only and does not constitute medical advice. Dosing information reflects published regulatory or research data and is not a recommendation. Many compounds described here are not approved for human use in the United States. Consult a licensed medical professional before considering any peptide therapy.