Prescription medicine
Tirbanibulin Brand names: Klisyri
Tirbanibulin (Klisyri) is a prescription medicine with an FDA approval on record since 2020. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the tirbanibulin FDA label on DailyMed (effective June 24, 2026, Almirall, LLC); the NDA 213189 record on Drugs@FDA; every tirbanibulin label on DailyMed.
Highlights of the record
FDA label of June 24, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageKLISYRI is indicated for the topical field treatment of actinic keratosis on the face or scalp.
Forms and strengths
- 10 mg/g
Ointment.
On the market
- Earliest approval on file
- December 14, 2020 Klisyri, Almirall; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- September 7, 2038 Klisyri ointment; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 244 through July 30, 2026
What is tirbanibulin used for?
From the label: indications and usageKLISYRI is indicated for the topical field treatment of actinic keratosis on the face or scalp. KLISYRI is a microtubule inhibitor indicated for the topical treatment of actinic keratosis of the face or scalp.
FDA pharmacologic class: Microtubule Inhibitor.
Source: FDA drug label (Klisyri), Almirall, LLC, effective June 24, 2026 (SPL set 589c8de8-b773-4d47-b60c-48471806cccc), via openFDA; the full label on DailyMed
Is there a generic for tirbanibulin (Klisyri)?
No generic tirbanibulin is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 7 patents for Klisyri ointment: the compound patent runs to September 7, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2020 earliest approval on file
- 2038 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for tirbanibulin?
The FDA Adverse Event Reporting System holds 244 reports that list tirbanibulin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 9 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other microtubule inhibitors
- the pharmacologic class, with prices and generics
- Tirbanibulin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other