NDATOPICALOINTMENT
Approved
Dec 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
7
Data completeness
6/8 — Strong
KLISYRI (tirbanibulin) by Almirall. Approved for microtubule inhibitor [epc]. First approved in 2020.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
KLISYRI (tirbanibulin) is a topical microtubule inhibitor ointment approved for actinic keratosis, a common precancerous skin lesion. It works by disrupting microtubule dynamics in keratinocytes, leading to cell death of actinic keratosis lesions. This is the first and only topical microtubule inhibitor indicated for this indication.
$0.003BPart D
Peak12.3 years to LOEEarly-stage peak revenue generation with modest Medicare claims volume suggests a niche market position requiring focused commercial execution and high-touch dermatology engagement.
Mechanism of Action
Pharmacologic Class:
Microtubule Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
Efficacy and Safety of Cryotherapy Followed by Tirbanibulin Ointment for Actinic Keratosis on the Scalp and Forehead
Started Nov 2025
59 enrolled
KeratosisActinic Keratoses
A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With Actinic Keratosis
Started Dec 2023
280 enrolled
Keratosis, Actinic
Tirbanibulin 1% Ointment for the Treatment of Actinic Keratosis on the Back of the Hands
Started Oct 2023
0Actinic Keratoses
A Study of Tirbanibulin on the Wellbeing of Participants With Actinic Keratoses
Started Jan 2023
334 enrolled
Actinic Keratosis
A Study of Tirbanibulin Ointment and Diclofenac Sodium Gel for the Treatment of Adult Participants With Actinic Keratosis on the Face or Scalp
Started Oct 2022
447 enrolled
Keratosis, Actinic
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.