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Tirbanibulin ointment 1%
Tirbanibulin ointment 1%, marketed by Almirall, S.A., holds a distinct position in the dermatology segment with its unique mechanism of action. The drug's key strength lies in its key composition patent, which is set to expire in 2028, providing a period of market exclusivity. The primary risk is the potential increase in competition once the patent expires, which could impact revenue.
At a glance
| Generic name | Tirbanibulin ointment 1% |
|---|---|
| Also known as | Klisyri (tirbanibulin ointment 1%) |
| Sponsor | Almirall, S.A. |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
Common side effects
Key clinical trials
- A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With Actinic Keratosis (PHASE3)
- Treating Basal and Squamous Cell Carcinomas With Fractional Laser and Tirbanibulin Ointment (PHASE1, PHASE2)
- KX01 Ointment Phase 1 Study in Patients With Plaque Type Psoriasis (PHASE1)
- Tirbanibulin for Pediatric Warts (PHASE4)
- A Study of Tirbanibulin Ointment and Diclofenac Sodium Gel for the Treatment of Adult Participants With Actinic Keratosis on the Face or Scalp (PHASE4)
- Patient and Clinician Reported Outcomes for Tirbanibulin Effectiveness and Safety in Actinic Keratosis
- Proof of Concept Study to Access Superficial Basal Cell Carcinoma in Adults (PHASE2)
- Tirbanibulin 1% Ointment for the Treatment of Actinic Keratosis on the Back of the Hands (PHASE4)
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:
- Tirbanibulin ointment 1% CI brief — competitive landscape report
- Tirbanibulin ointment 1% updates RSS · CI watch RSS
- Almirall, S.A. portfolio CI