Palovarotene

Orphan DrugFDA Approved

Description

Palovarotene is a retinoic acid receptor gamma (RARγ) selective agonist used to treat fibrodysplasia ossificans progressiva (FOP). It works by reducing new heterotopic ossification (HO) volume in patients with FOP.

Indications & Therapeutic Use

Fibrodysplasia Ossificans Progressiva

Global Availability (1 countries)

CountryAccess RouteRegulatory PathwayLead TimeStatus

Available Through

This drug is available for procurement through the following fulfilment partner.

Fulfilment Partner
Palovarotene
Generic NamePalovarotene
Brands1 brand available
Active IngredientPalovarotene
Drug ClassFibrodysplasia Ossificans Progressiva
ManufacturerIpsen
Dosage FormsCapsule
Medical CodeM04AA05
Orphan StatusYes — Orphan Drug
Cold ChainNot Required
Lead Time14 days
Reg. StatusFDA Approved
Clinical TrialNCT03997618
Countries1 countries
Authority Signals
Last Verified3/21/2026
Data ConfidenceHigh (AI + Pharmacist)
Source Citations2 Validated Nodes
Palovarotene | OrphanDrug