Fibrodysplasia Ossificans Progressiva (FOP)

2
Pipeline Programs
2
Companies
2
Clinical Trials
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
0
0
1
1
Early DiscoveryClinical DevelopmentMarket

On Market (1)

Approved therapies currently available

Ipsen
SOHONOSApproved
palovarotene
Ipsen
Retinoid [EPC]oral2023

Competitive Landscape

2 companies ranked by most advanced pipeline stage

Ipsen
IpsenChina - Tianjin
1 program
1
1
PalovarotenePhase 31 trial
Active Trials
NCT05027802Completed61Est. Nov 2024
Regeneron
RegeneronTARRYTOWN, NY
1 program
Non-InterventionalN/A1 trial
Active Trials
NCT06064656Completed131Est. Sep 2023

Trial Timeline

Clinical trial activity over time

2022
2023
2024
2025
2026
IpsenPalovarotene
RegeneronNon-Interventional

Clinical Trials (2)

Total enrollment: 192 patients across 2 trials

NCT05027802IpsenPalovarotene

A Rollover Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged ≥14 Years With Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed the Relevant Parent Studies.

Start: Mar 2022Est. completion: Nov 202461 patients
Phase 3Completed
NCT06064656RegeneronNon-Interventional

A Non-Interventional Study of Clinical Characteristics and Mortality of US Patients With Fibrodysplasia Ossificans Progressiva (FOP)

Start: Jun 2023Est. completion: Sep 2023131 patients
N/ACompleted

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

1 late-stage (Phase 3) programs — potential near-term approvals
2 companies competing in this space