Last reviewed · How we verify
Filsuvez
At a glance
| Generic name | Filsuvez |
|---|---|
| Also known as | Birch bark extract |
| Sponsor | Amryt Pharma |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
- Epidermolysis bullosa
Common side effects
- Application site reaction
- Application site pruritus
- Administration site pain
- Administration site pruritus
Serious adverse events
- Squamous cell carcinoma of the skin
- Hypersensitivity reactions
Key clinical trials
- A Study to Learn About the Safety and Efficacy of the Drug Oleogel-S10 in Japanese Patients With Epidermolysis Bullosa (PHASE3)
- A Study to Assess the Incidence of Skin Cancers in Patients With Epidermolysis Bullosa Receiving Filsuvez
- Phase III Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Filsuvez CI brief — competitive landscape report
- Filsuvez updates RSS · CI watch RSS
- Amryt Pharma portfolio CI