Sohonos

(Palovarotene)

Small molecule

Ipsen

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Clinical

Trials by Indication[1]

Fibrodysplasia Ossificans Progressiva4 trials

An Open-Label Extension Study of Palovarotene Treatment in Fibrodysplasia Ossificans Progressiva (FOP)

Completed·CClementia Pharmaceuticals Inc.·Phase 2·NCT02279095·58 enrolled

An Efficacy and Safety Study of Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva.

Completed·CClementia Pharmaceuticals Inc.·Phase 3·NCT03312634·107 enrolled

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.

Completed· Ipsen logo

Ipsen·Phase 3·NCT05027802·61 enrolled

Show 1 more trial

In-Home Evaluation of Episodic Administration of Palovarotene in Fibrodysplasia Ossificans Progressiva (FOP) Subjects

Terminated·CClementia Pharmaceuticals Inc.·Phase 2·NCT02521792·6 enrolled

Efficacy and Safety2 trials

An Efficacy and Safety Study of Palovarotene for the Treatment of MO

Terminated·CClementia Pharmaceuticals Inc.·Phase 2·NCT03442985·193 enrolled

An Efficacy and Safety Study of Palovarotene to Treat Preosseous Flare-ups in FOP Subjects

Completed·CClementia Pharmaceuticals Inc.·Phase 2·NCT02190747·40 enrolled

Adult Subject2 trials

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

Completed·CClementia Pharmaceuticals Inc.·Phase 1·NCT04829773·48 enrolled

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

Completed·CClementia Pharmaceuticals Inc.·Phase 1·NCT04762355·48 enrolled

Tics1 trial

Study to Compare the Pharmacokinetics, Safety, and Tolerability Following Administration of Palovarotene in Healthy Japanese and Non-Asian Subjects

Completed·CClementia Pharmaceuticals Inc.·Phase 1·NCT04829786·18 enrolled

Single Dose1 trial

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

Completed· Ipsen logo

Ipsen·Phase 1·NCT06908954·31 enrolled

Regulatory

FDA Approval Timeline[3]

Aug 16, 2023

SOHONOS

NDA NDA215559

Sources

References

[1]
ClinicalTrials.gov — 10 trial records for Palovarotene. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Palovarotene compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA215559). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Sohonos. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Ipsen company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: Ipsen

Patent Landscape[4]

Patent Cliff

Aug 31, 2031

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12023312Aug 31, 2031

10292954Aug 31, 2031

9789074Aug 31, 2031

9314439Aug 31, 2031

11622959Jun 8, 2037

4 more patents

12201614Jun 8, 2037

10864194Jun 8, 2037

12458626Jun 8, 2037

12138245Jun 8, 2037