Home / Health / Ipsen Drug Fails FOP Trial
Ipsen Drug Fails FOP Trial
22 Dec, 2025
Summary
- Fidrisertib trial for FOP fails primary endpoint, showing no benefit over placebo.
- Ipsen terminates the FALKON Phase II trial early due to lack of efficacy.
- FOP is an ultra-rare genetic condition with limited treatment options.
Ipsen's fidrisertib, an ALK2 kinase inhibitor, has failed to meet its primary endpoint in a Phase II trial for fibrodysplasia ossificans progressiva (FOP). The FALKON study, which evaluated the drug's ability to reduce new heterotopic ossification (HO), showed no meaningful benefit above placebo.
Despite the disappointing efficacy results, no safety concerns were identified during the trial. Ipsen has announced the early termination of the FALKON study, which had enrolled 113 patients globally. Dr. Christelle Huguet expressed disappointment but highlighted the potential contribution of the data to FOP research.
FOP is an ultra-rare genetic disorder causing irreversible bone formation in soft tissues. Current treatments are limited, primarily involving corticosteroids for inflammation and pain management. Ipsen previously gained FDA approval in 2023 for its FOP therapy Sohonos (palovarotene).
