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SEP 25 2026
APPROVED · 4 DAYS AGO

Mirum Pharmaceuticals and Incyte — Atebrioz (zilurgisertib)

for to reduce the volume of total new heterotopic ossification in adults and pediatric patients 12 years and older with fibrodysplasia ossificans progressiva (FOP)

NDA · Priority Review · Fast Track · Orphan

FDA approved Atebrioz (zilurgisertib) on September 25, 2026, the third FDA-approved treatment for FOP, to reduce the volume of total new heterotopic ossification in patients 12 and older. In a randomized, placebo-controlled trial of 63 patients (NCT05090891), new heterotopic ossification fell by an average 3.2 cm³ at week 24 on Atebrioz versus a 24.6 cm³ increase on placebo.

Pivotal trial

Progress Phase 2 recruiting NCT05090891

This Phase 2, Randomized, Double-Blind, Placebo-Controlled Study is intended to evaluate the Efficacy, Safety, and Tolerability and PK of INCB000928 administered to participants with a clinical diagnosis of fibrodysplasia ossificans progressiva (FOP).

Source: ClinicalTrials.gov

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