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Klisyri (TIRBANIBULIN)
Klisyri works by disrupting the microtubule network, which is essential for cell division.
At a glance
| Generic name | TIRBANIBULIN |
|---|---|
| Sponsor | Almirall |
| Drug class | Microtubule Inhibitor [EPC] |
| Target | Tyrosine-protein kinase Lyn |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
| First approval | 2020 |
Mechanism of action
Tirbanibulin is microtubule inhibitor. The mechanism of action of KLISYRI for the topical treatment of actinic keratosis is unknown.
Approved indications
- Actinic keratosis
Common side effects
- Local skin reactions
- Application site pain
- Erythema
- Application site pruritus
- Flaking/Scaling
- Crusting
- Swelling
- Vesiculation/ Pustulation
- Erosion/ Ulceration
- Phototoxic skin reactions
- Photoallergic skin reactions
- Contact sensitization
Key clinical trials
- A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on AK on Face or Scalp (PHASE3)
- A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on Actinic Keratosis on Face or Scalp (AK004) (PHASE3)
- A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With Actinic Keratosis (PHASE3)
- Efficacy and Safety of Cryotherapy Followed by Tirbanibulin Ointment for Actinic Keratosis on the Scalp and Forehead (PHASE3)
- Treating Basal and Squamous Cell Carcinomas With Fractional Laser and Tirbanibulin Ointment (PHASE1,PHASE2)
- Investigation of the Efficacy and Tolerability of Topical Applied Tirbanibulin on Actinic Keratoses With Downward-directed Proliferation Patterns
- KX01 Ointment Phase 1 Study in Patients With Plaque Type Psoriasis (PHASE1)
- Tirbanibulin for Pediatric Warts (PHASE4)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Klisyri CI brief — competitive landscape report
- Klisyri updates RSS · CI watch RSS
- Almirall portfolio CI