KLISYRI (tirbanibulin)
Klisyri (tirbanibulin) is a topical microtubule inhibitor indicated for the field treatment of actinic keratosis on the face or scalp. It is supplied as a 1% ointment for direct application to the affected area.
How KLISYRI Works
Tirbanibulin is a microtubule inhibitor. While its exact mechanism of action for the topical treatment of actinic keratosis is unknown, it works by inhibiting tubulin polymerization and disrupting microtubule assembly.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2020-12-14
- Patent Cliff
- 2038
- Routes
- TOPICAL
- Dosage Forms
- OINTMENT
KLISYRI Approval History
What KLISYRI Treats
1 indicationsKLISYRI is approved for 1 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Actinic Keratosis
KLISYRI Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to KLISYRI
3 of 7FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06135415 TirbAKare | M-14867-33 2023-505487-11-00 | Ph 3 | completed | A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With Actinic Keratosis |
| NCT06026358 | Tirbanibulin: Back of Hands | Ph 4 | withdrawn | Tirbanibulin 1% Ointment for the Treatment of Actinic Keratosis on the Back of the Hands |
| NCT05900258 SunDamage | SunDamage | Ph 4 | completed | Tirbanibulin 1% Ointment for the Treatment of Chronically Sun-damaged Skin on the Face |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
KLISYRI FDA Label Details
Indications & Usage
FDA Label (PDF)KLISYRI is indicated for the treatment of Actinic Keratosis.
KLISYRI Patents & Exclusivity
Patents (6 active)
Exclusivity
Pro Intelligence Preview
Deep insights for KLISYRI
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2038
- • 6 active patents
Trial Analysis
- • 3 total trials
- • Stage: Mature
Competitive Landscape
- • 7 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment