Clinical Trials Pipeline & In-Development

Taldefgrobep alfa

also known as: BMS-986089, BHV-2000

A Biohaven (ex-BMS) myostatin-binding adnectin-Fc fusion — RESILIENT Phase 3 trial in spinal muscular atrophy missed its primary endpoint (December 2024); further development pivoted toward obesity and sarcopenia indications.

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.

References

  1. [manufacturer] Biohaven Pharmaceuticals. "RESILIENT Phase 3 topline results for taldefgrobep alfa in spinal muscular atrophy," corporate press release, December 2024.
  2. [clinical-trial] ClinicalTrials.gov identifier for the RESILIENT Phase 3 trial in SMA.

Related peptides

Bimagrumab

⚠ Monoclonal antibody — not a classical peptide. A first-in-class muscle-sparing antibody (fully human IgG1, ~150 kDa) against activin type II receptors. Combined with semaglutide in the BELIEVE Phase 2b trial (Nature Medicine, March 2026), it produced greater fat loss than semaglutide alone while preserving lean mass. Not approved; Lilly developer. Included here because it's widely discussed alongside peptides in the muscle-sparing and myostatin conversations.

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 classical peptide. A Scholar Rock fully human IgG (~150 kDa) selective for pro-/latent myostatin (sparing mature myostatin in other tissues) — SAPPHIRE Phase 3 in spinal muscular atrophy read out positive in October 2024; BLA submission in 2025. Platform validation for myostatin biology beyond the muscle-sparing-in-obesity use case.
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.