Substance / Medication

Palovarotene

Overview

Active Ingredient
palovarotene
RxNorm CUI
2663954

Indications

SOHONOS is indicated for the reduction in volume of new heterotopic ossification in adults and pediatric patients aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (FOP).

Labeler: Ipsen Biopharmaceuticals, Inc.Updated: 2025-03-18T00:00:00.000ZFull label on DailyMed

Contraindications

When this intervention should not be used

SOHONOS is contraindicated in the following patients: Warnings and Precautions (5.1) Use in Specific Populations (8.1) [seeand] During Pregnancy. Description (11) [see]. A history of allergy or hypersensitivity to retinoids, or to any component of SOHONOS. Anaphylaxis and other allergic reactions ha

Indications & Related Conditions

Conditions associated via SNOMED clinical relationships

Administration & Protocol

Dosing, route, and treatment protocol

Detailed dosage and administration information is available in the full FDA drug label.

View full prescribing information on DailyMed

Monitoring & Follow-Up

Biomarkers relevant to this intervention via related conditions

No monitoring biomarkers have been mapped yet. Biomarker-intervention linkages are derived through related conditions and will expand as the knowledge graph grows.

Research Evidence

Published studies and systematic reviews

Sort:
A Randomised Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics of Palovarotene Ophthalmic Solution.
Foster William J, Strahs Andrew L, Small Kent W et al. · Drugs R D · 2023
PMID: 36542308RCTFull text (PMC)
A Pharmacokinetic, Safety, and Tolerability Trial of Palovarotene in Healthy Japanese and Non-Japanese Participants.
Dube Louise, Haga Nobuhiko, Grogan Donna et al. · Eur J Drug Metab Pharmacokinet · 2023
PMID: 36802022RCTFull text (PMC)
Palovarotene for Fibrodysplasia Ossificans Progressiva (FOP): Results of a Randomized, Placebo-Controlled, Double-Blind Phase 2 Trial.
Pignolo Robert J, Baujat Geneviève, Hsiao Edward C et al. · J Bone Miner Res · 2022
PMID: 35854638RCT
Palovarotene in fibrodysplasia ossificans progressiva: review and perspective.
Verheij Vincent A, Diecidue Robert J, Botman Esmée et al. · Expert Opin Pharmacother · 2025
PMID: 39834193Review
The first approved drug for abnormal bone formation: palovarotene challenges and way forward.
Khan Alizai Hassam Nasir, Pasha Aainah, Alizai Parsa Khan et al. · J Pak Med Assoc · 2025
PMID: 40698472Other
Study methodology and insights from the palovarotene clinical development program in fibrodysplasia ossificans progressiva.
Pignolo Robert J, Al Mukaddam Mona, Baujat Geneviève et al. · BMC Med Res Methodol · 2023
PMID: 37957586OtherFull text (PMC)
Palovarotene.
Am J Health Syst Pharm · 2023
PMID: 37796111Other

Research data from MEDLINE/PubMed

Benefits & Expected Outcomes

Benefits, expected outcomes, efficacy data, and NNT (Number Needed to Treat) are pending physician authorship and evidence review.

Risks & Side Effects

Adverse reaction and safety data for this drug is sourced from the FDA-approved label.

View adverse reactions & drug interactions on DailyMed

Related Symptoms

Symptoms associated with conditions this intervention addresses

No related symptoms have been mapped yet. Symptom linkages are derived through associated conditions.

Alternatives & Comparisons

Alternative treatments, comparison data, and clinical decision support are pending physician authorship.

Medical Disclaimer

This information is for educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider regarding any medical condition or treatment plan.

Do not start, stop, or change any treatment without consulting your healthcare provider.

Quick Facts

Type
Substance / Medication
Fully Specified Name
Palovarotene (substance)
SNOMED CT
1783991000168109
UMLS CUI
C2745017
RxNorm CUI
2663954
Labeler
Ipsen Biopharmaceuticals, Inc.

Clinical Data

This intervention maps to 1 entities in the Healos knowledge graph.

1
Conditions
0
Biomarkers
0
Specialists
0
Symptoms

Data is sourced from SNOMED CT, UMLS, and the Healos clinical knowledge graph. Content sections marked as pending require physician authorship. Consult a healthcare provider before starting any treatment.