Taldefgrobep Alfa

Muscle Growth & Body Composition

Also known as: BMS-986089, Taldefgrobep, Anti-Myostatin Adnectin

Myostatin / Activin InhibitorsResearch phase: Phase 2/3Regulatory: Not FDA-approved. Under clinical development (Bristol-Myers Squibb). Rare Pediatric Disease and Fast Track Designation.

Mechanism

Taldefgrobep alfa is an anti-myostatin adnectin (engineered protein based on fibronectin scaffolds rather than antibodies) developed for Duchenne muscular dystrophy. It has a smaller molecular size than antibodies, potentially allowing better tissue penetration. Phase 2/3 trials in DMD are ongoing, making it one of the most advanced myostatin inhibitor programs.

Technical detail

Taldefgrobep alfa (BMS-986089) is an engineered adnectin (fibronectin type III domain-based scaffold protein) that binds and neutralizes myostatin with high affinity. Unlike monoclonal antibodies (~150 kDa), its smaller size (~10 kDa) may enable better tissue distribution and muscle penetration. Phase 1 data in healthy volunteers showed dose-dependent increases in thigh muscle volume (3.5% at highest dose). The RESILIENT trial (Phase 2/3) in non-ambulatory DMD patients is evaluating effects on upper limb function. It has received Rare Pediatric Disease Designation and Fast Track Designation from FDA.