SOHONOS

Growth

palovarotene

NDAORALCAPSULEPriority Review
Approved
Aug 2023
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
11

Mechanism of Action

FOP, abnormal bone formation, including heterotopic ossification (HO), is driven by a gain-of-function mutation in the bone morphogenetic protein (BMP) type I receptor ALK2 (ACVR1). Palovarotene is an orally bioavailable retinoic acid receptor agonist, with particular selectivity at the gamma…

Pharmacologic Class:

Retinoid

Clinical Trials (5)

NCT06908954Phase 1Completed

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

Started Mar 2025
31 enrolled
Hepatic ImpairmentHealthy
NCT06089616N/ARecruiting

A Study to Document and to Further Describe Long-term Safety and Effectiveness of Palovarotene in Participants With Fibrodysplasia Ossificans Progressiva (FOP)

Started Dec 2024
100 enrolled
Fibrodysplasia Ossificans Progressiva
NCT05027802Phase 3Completed

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.

Started Mar 2022
61 enrolled
Fibrodysplasia Ossificans Progressiva (FOP)
NCT04829773Phase 1Completed

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

Started Jan 2019
48 enrolled
Fibrodysplasia Ossificans Progressiva
NCT04762355Phase 1Completed

Study to Assess Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Palovarotene Ophthalmic Solution in Healthy Adult Subjects

Started Aug 2018
48 enrolled
Dry Eye Disease

Loss of Exclusivity

LOE Date
Jun 8, 2037
137 months away
Patent Expiry
Jun 8, 2037
Exclusivity Expiry
Aug 16, 2030

Patent Records (5)

Patent #ExpiryTypeUse Code
10292954
Aug 31, 2031
U-3676
12023312
Aug 31, 2031
U-3966
9314439
Aug 31, 2031
U-3676
9789074
Aug 31, 2031
U-3676
12138245
Jun 8, 2037
U-4031