As of 6th May 2026, Incyte have officalliy licensed zilurgisertib to Mirum Pharmaceuticals. A New Drug Application (NDA) for zilurgisertib has been submitted to and accepted for Priority Review by the FDA.
Zilurgisertib is an oral investigational medication developed by Incyte to treat FOP. It acts as a potent and selective inhibitor of ALK2 (or ACVR1), the specific protein that becomes overactive due to the genetic mutation in FOP.
The drug is currently being evaluated in the PROGRESS Phase 2 clinical trial, which is studying its safety and effectiveness in adults and children (ages 6 and older). Currently, zilurgisertib remains an active area of research.
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