7 completed, 2 terminated. 4 Phase 1, 3 Phase 2, 2 Phase 3.
By phase and status
Follow this drug Literature Review of Palovarotene trials Research Report on Palovarotene
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix .
Trial Phase Status Sponsor Enrollment Start Updated
A Study of the Blood Levels of Palovarotene in Participants With Abnormal Liver Function Compared to Healthy Adult Participants After Intake of a Single Dose Palovarotene - Hepatic Impairment, Healthy Phase 1 Completed Ipsen 31 2025-03-14 2026-04-30 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. Palovarotene - Fibrodysplasia Ossificans Progressiva (FOP) Phase 3 Completed Ipsen 61 2022-03-14 2025-06-22 Study Evaluating the Effect of Food on the Pharmacokinetics of Palovarotene and the Effect of Palovarotene on the Pharmacokinetics of the CYP3A4 Substrate Midazolam in Two Cohorts of Healthy Adult Subjects Palovarotene, midazolam - Fibrodysplasia Ossificans Progressiva Phase 1 Completed Clementia Pharmaceuticals Inc. 48 2019-01-03 2021-04-02 Study to Assess Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Palovarotene Ophthalmic Solution in Healthy Adult Subjects Palovarotene, Vehicle - Dry Eye Disease Phase 1 Completed Clementia Pharmaceuticals Inc. 48 2018-08-30 2021-02-21 An Efficacy and Safety Study of Palovarotene for the Treatment of MO Palovarotene 2.5 mg, Palovarotene 5.0 mg, Placebo - Exostoses, Multiple Hereditary Phase 2 Terminated Clementia Pharmaceuticals Inc. 193 2018-03-22 2022-08-01 An Efficacy and Safety Study of Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva. Palovarotene - Fibrodysplasia Ossificans Progressiva Phase 3 Completed Clementia Pharmaceuticals Inc. 107 2017-11-30 2023-11-29 In-Home Evaluation of Episodic Administration of Palovarotene in Fibrodysplasia Ossificans Progressiva (FOP) Subjects Palovarotene - Fibrodysplasia Ossificans Progressiva Phase 2 Terminated Clementia Pharmaceuticals Inc. 6 2015-12-07 2020-10-19 Study to Compare the Pharmacokinetics, Safety, and Tolerability Following Administration of Palovarotene in Healthy Japanese and Non-Asian Subjects palovarotene low-dose, palovarotene high-dose - FOP Phase 1 Completed Clementia Pharmaceuticals Inc. 18 2015-09-01 2021-04-02 An Efficacy and Safety Study of Palovarotene to Treat Preosseous Flare-ups in FOP Subjects Palovarotene, Placebo - Fibrodysplasia Ossificans Progressiva Phase 2 Completed Clementia Pharmaceuticals Inc. 40 2014-07-14 2021-02-16
Conditions studied Myositis Ossificans (5) · Ossification, Heterotopic (3) · Dry Eye Syndromes (1) · Exostoses, Multiple Hereditary (1) · Osteochondroma (1)
Sponsors Clementia Pharmaceuticals Inc. (7) · Ipsen (2)
Countries United States (7) · Canada (4) · France (4) · United Kingdom (4) · Australia (3) · Italy (3) · Spain (3) · Argentina (2) · Brazil (2) · Japan (2) · Sweden (2) · Belgium (1) · Netherlands (1) · Portugal (1) · Turkey (Türkiye) (1)
Results publications PMID 37156007 , PMID 35854638 , PMID 36526263 , PMID 36583535 , PMID 37804430 , PMID 37957586 , PMID 41188357
NIH funding 2017 (2), 2014 (1)