SOHONOS (palovarotene)
Sohonos is a retinoid medication used for patients living with fibrodysplasia ossificans progressiva (FOP). It helps adults and children—specifically females aged 8 and older and males aged 10 and older—by reducing the volume of new, abnormal bone formation. This therapy is prescribed to manage the development of heterotopic ossification, which is the hallmark of this progressive condition.
How SOHONOS Works
This medication works by binding to the gamma subtype of the retinoic acid receptor to decrease overactive signaling caused by a specific genetic mutation. By inhibiting this pathway, the drug reduces the differentiation of cells into bone-forming cells, which results in less endochondral bone formation.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2023-08-16
- Patent Cliff
- 2037
- Routes
- ORAL
- Dosage Forms
- CAPSULE
SOHONOS Approval History
What SOHONOS Treats
1 indicationsSOHONOS is approved for 1 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Fibrodysplasia Ossificans Progressiva
SOHONOS Boxed Warning
EMBRYO-FETAL TOXICITY and PREMATURE EPIPHYSEAL CLOSURE IN GROWING PEDIATRIC PATIENTS WARNING: EMBRYO-FETAL TOXICITY and PREMATURE EPIPHYSEAL CLOSURE IN GROWING PEDIATRIC PATIENTS See full prescribing information for complete boxed warning. SOHONOS is contraindicated in pregnancy ( 5.1 , 8.1 ) Because of the risk of teratogenicity and to minimize fetal exposure, SOHONOS is to be administered only if conditions for pregnancy prevention are met ( 5.1 , 8.1 ) SOHONOS causes premature epiphyseal clos...
WARNING: EMBRYO-FETAL TOXICITY and PREMATURE EPIPHYSEAL CLOSURE IN GROWING PEDIATRIC PATIENTS WARNING: EMBRYO-FETAL TOXICITY and PREMATURE EPIPHYSEAL CLOSURE IN GROWING PEDIATRIC PATIENTS See full prescribing information for complete boxed warning. SOHONOS is contraindicated in pregnancy ( 5.1 , 8.1 ) Because of the risk of teratogenicity and to minimize fetal exposure, SOHONOS is to be administered only if conditions for pregnancy prevention are met ( 5.1 , 8.1 ) SOHONOS causes premature epiphyseal closure in growing pediatric patients with FOP, close monitoring is recommended ( 5.2 , 8.4 ) Embryo-Fetal Toxicity SOHONOS is contraindicated in pregnancy. SOHONOS may cause fetal harm. Because of the risk of teratogenicity and to minimize fetal exposure, SOHONOS is to be administered only if conditions for pregnancy prevention are met [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ]. Premature Epiphyseal Closure Premature epiphyseal closure occurs in growing pediatric patients treated with SOHONOS, close monitoring is recommended [see Warnings and Precautions (5.2) and Use in Specific Populations (8.4) ] .
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06908954 | CLIN-60120-458 | Ph 1 | completed | 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 |
| NCT05027802 PIVOINE results posted | CLIN-60120-452 2021-002244-70 | Ph 3 | completed | 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. |
| NCT03312634 MOVE results posted | PVO-1A-301 2017-002541-29 | Ph 3 | completed | An Efficacy and Safety Study of Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva. |
| NCT04829773 | PVO-1A-102 | Ph 1 | completed | 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 |
| NCT04762355 | PVO-3A-101 | Ph 1 | completed | Study to Assess Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Palovarotene Ophthalmic Solution in Healthy Adult Subjects |
| NCT02190747 results posted | PVO-1A-201 2014-001453-17 | Ph 2 | completed | An Efficacy and Safety Study of Palovarotene to Treat Preosseous Flare-ups in FOP Subjects |
| NCT02521792 results posted | PVO-1A-203 | Ph 2 | terminated | In-Home Evaluation of Episodic Administration of Palovarotene in Fibrodysplasia Ossificans Progressiva (FOP) Subjects |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SOHONOS FDA Label Details
Indications & Usage
FDA Label (PDF)SOHONOS is indicated for the treatment of Fibrodysplasia Ossificans Progressiva.
WARNING: EMBRYO-FETAL TOXICITY and PREMATURE EPIPHYSEAL CLOSURE IN GROWING PEDIATRIC PATIENTS WARNING: EMBRYO-FETAL TOXICITY and PREMATURE EPIPHYSEAL CLOSURE IN GROWING PEDIATRIC PATIENTS See full prescribing information for complete boxed warning. SOHONOS is contraindicated in pregnancy ( 5.1 , 8.1...
SOHONOS Patents & Exclusivity
Patents (9 active)
Exclusivity
Pro Intelligence Preview
Deep insights for SOHONOS
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2037
- • 225 active patents
Trial Analysis
- • 9 total trials
- • Stage: Declining
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment