For fibrodysplasia ossificans progressiva (FOP). NDA 221198, held by Mirum. Zilurgisertib Fumarate.
As of Nov 13, 2026, NDA 221198 (Atebrioz), held by Mirum, was first approved by FDA on Sep 25, 2026, with 0 approved supplements and 0 published complete response letters.
1. INDICATIONS AND USAGE ATEBRIOZ is indicated to reduce the volume of total new heterotopic ossification (HO) in adults and pediatric patients aged 12 years and older with fibrodysplasia ossificans progressiva (FOP). ATEBRIOZ is an activin receptor-like kinase-2 (ALK2) inhibitor
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 25, 2026 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| AtebriozEQ 25MG BASE · tablet;oral | Zilurgisertib Fumarate | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
