Atebrioz™ is the third treatment approved for people living with FOP in the United States
Today, September 25, is an incredible day for the FOP community! We want to start by thanking FOP community members from around the world who participated in the zilurgisertib trial.
Mirum Pharmaceuticals and Incyte have announced the U.S. Food & Drug Administration's (FDA) approval of zilurgisertib tablets for the treatment of fibrodysplasia ossificans progressiva (FOP) in the United States.
Novartis originally developed zilurgisertib and then licensed it to Incyte, which conducted the Phase 2 trial in adults and children ages 12 and up. In May 2026, Mirum announced it licensed zilurgisertib from Incyte.
Zilurgisertib is the first FOP drug approved after completing only a Phase 2 clinical trial.
Read Mirum's press release and see the U.S. Prescribing Information and Medication Guide.
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The brand name of the drug is Atebrioz™
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Once-daily oral ALK2 inhibitor approved to reduce the volume of total new heterotopic ossification in patients aged 12 years and older with FOP.
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Mirum will soon release websites to help people with FOP and their local healthcare providers learn more about Atebrioz.
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Atebrioz is expected to be available in the United States in October through Mirum Access Plus (MAP), with eligible patients paying as little as $0 per month.
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Atebrioz is only available for treatment of FOP for individuals in the United States.
- The European Medicines Agency (EMA) in the European Union is also reviewing zilurgisertib.
Letter from Mirum's CEO
We're pleased to share this letter from Chris Peetz, CEO, Mirum Pharmaceuticals.
THANK YOU
Zilurgisertib (now known as Atebrioz) was tested in the PROGRESS Phase 2 clinical trial. We are deeply grateful to the 63 people with FOP who participated.
We're also grateful to the Principal Investigators, Study Coordinators, and all of the staff at the trial sites who took such good care of our families.
We want to thank Novartis, Incyte, and Mirum for their commitment and dedication to the FOP community.
Publications & Presentations
The links below include press releases, a poster, and a plain language summary of the PROGRESS trial results. We expect a publication in a peer-reviewed journal.
Presentations from the 2026 7th FOP Drug Development Forum
Plain Language Summary of the PROGRESS Cohort 1 Results
June 14, 2026 press release announcing Phase 2 results from the PROGRESS trial
Incyte shared this poster and plain-language summary of their results, which show an 81% reduction in the proportion of patients with new lesions at Week 24 (compared to placebo), at ENDO 2026, the leading global meeting on endocrinology research and clinical care hosted by the Endocrine Society.
Where is Atebrioz Approved?
It is important to note that the FDA’s approval of Atebrioz is only for people aged 12 and older with FOP living in the United States. On August 5, 2026, Mirum announced during an Investor Call that the EMA in the European Union accepted zilurgisertib for review. We await the EMA's decision.
In What Other Countries is Mirum Seeking Approval of Zilurgisertib?
Zilurgisertib previously received Fast Track designation and Orphan Drug Designation from the FDA, as well as Orphan Designation by the European Medicines Agency in the European Union.
We communicate regularly with Mirum about developments with zilurgisertib and will share announcements with the FOP community when they are publicly available.
Is Zilurgisertib in a Trial for Children Younger than 12?
The PROGRESS Phase 2 trial includes an active Cohort 2 for children ages 6 to < 12 years of age that is fully enrolled. Cohort 3 for children ages 2 to < 12 years is recruiting. You can learn more at ifopa.org/progress
If you would like to receive updates on clinical trials and drug reviews, please sign up for IFOPA’s Clinical Trial Alerts at ifopa.org/clinical-trial-alerts
About Zilurgisertib
People with FOP harbor mutations in the ALK2 protein (also known as ACVR1) that drives excessive bone morphogenetic protein (BMP) signaling, which regulates cartilage and bone development.
Zilurgisertib (INCB000928) is an oral investigational drug designed to target and block this disease-causing mutant FOP protein hyperactivity. In preclinical studies, zilurgisertib demonstrated potency for the target kinase, selectivity, safety and strong suppression of heterotopic ossification (HO) in animal models.
