NDAORALCAPSULEPriority Review
Approved
Aug 2023
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
11
Data completeness
5/8 — Partial
Priority Review
SOHONOS (palovarotene) by Ipsen. Approved for retinoid [epc]. First approved in 2023.
Drug data last refreshed 13h ago · AI intelligence enriched 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SOHONOS (palovarotene) is an oral retinoid capsule approved by the FDA in August 2023 for rare genetic skeletal disorders characterized by abnormal bone formation. It represents a novel therapeutic approach targeting retinoid signaling pathways to modulate heterotopic ossification and related conditions. The drug addresses a significant unmet medical need in ultra-rare patient populations with limited treatment options.
Peak10.7 years to LOE
As a newly launched specialty product in peak phase with minimal competitive pressure, the brand team is likely expanding to build awareness and access in a niche rare disease market.
Mechanism of Action
Pharmacologic Class:
Retinoid
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (11)
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
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
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)
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
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
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.