Fibrodysplasia ossificans progressiva Advocacy Hub | UniteRare

for the reduction in volume of new heterotopic ossification in adults and pediatric patients aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (FOP)

FDAcompleted

Nov 2022A Study to Assess Safety, Tolerability and Efficacy of Garetosmab Versus Placebo Administered Intravenously (IV) in Adult Participants With Fibrodysplasia Ossificans Progressiva (FOP)

Regeneron Pharmaceuticals — PHASE3

TrialACTIVE NOT RECRUITING

May 2022To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva

Incyte Corporation — PHASE2

TrialRECRUITING

Dec 2021A Study to Assess the Effectiveness and Safety of 2 Dosage Regimens of Oral Fidrisertib (IPN60130) for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP).

Clementia Pharmaceuticals Inc. — PHASE2

TrialACTIVE NOT RECRUITING

Aug 2020Saracatinib Trial TO Prevent FOP

Amsterdam UMC, location VUmc — PHASE2

TrialRECRUITING

Data from FDA regulatory filings and ClinicalTrials.gov. Updated periodically.

Financial Assistance

1 program

FINANCIAL LANDSCAPE SUMMARY

Total programs

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Copay cards

Copay Assistance1

SOHONOS

Ipsen

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Approved Treatments

1 FDA-approved

Sohonos

(PALOVAROTENE)Orphan drug

Ipsen Biopharmaceuticals, Inc.

Retinoid [EPC]

12.1 Mechanism of Action In patients with FOP, abnormal bone formation, including heterotopic ossification (HO), is driven by a gain-of-function mutat...

Approved Aug 2023FDA label ↗

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Clinical Trial Landscape

7 active trials

1Phase 3

3Phase 2

2Unknown

1PHASE2, PHASE3

7Total recruiting

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Recent News & Research

1 article

ClinicalTrials.govJan 28, 2026

New recruiting trial: MIHRA - Patient-Rooted Insights for Shaping Myositis Science (PRISMS)

Myositis diseases are each rare diseases. As in other rare diseases, people living with myositis diseases face physical and psychosocial challenges that may not be recognized in current research prior...

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