FDA approves new treatment for FOP
Total new heterotopic ossification volume decreased with treatment and increased with placebo at week 24.
By
Kathryn Wighton
September 28, 2026
Clinical Scorecard: FDA approves new treatment for FOP
At a Glance
Category Detail
Condition Fibrodysplasia ossificans progressiva Key Mechanisms Mutation in activin A receptor-type 1 affecting bone growth regulation Target Population Adult and pediatric patients aged 12 years and older Care Setting Clinical trial and outpatient management
Key Highlights
Zilurgisertib (Atebrioz) approved to reduce heterotopic ossification volume Randomized, double-blind, placebo-controlled trial involved 63 patients Mean total new heterotopic ossification volume declined by 3.2 cm³ in treatment group Most common adverse effects include headache, joint pain, and nausea Effective contraception recommended for patients of reproductive potential Guideline-Based Recommendations
Diagnosis
Diagnosis based on clinical evaluation and imaging studies Management
Zilurgisertib administered orally at 100 mg once daily Monitoring & Follow-up
Monitor for adverse effects and efficacy through imaging Risks
Potential fetal harm; discontinue if pregnancy occurs Patient & Prescribing Data
Patients with fibrodysplasia ossificans progressiva aged 12 years and older
Zilurgisertib may be taken with or without food
Clinical Best Practices
Assess for contraindicated medications before prescribing zilurgisertib Provide counseling on the importance of effective contraception Related Resources & Content
