Regulatory PathRegulatory requirements compared

Active substance

Tirbanibulin

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
KLISYRI1%ointment · topicalALMIRALLPrescription14 Dec 2020

EMA European Union — centrally authorised medicines

Klisyri Almirall, S.A. · Authorised · authorised 16 Jul 2021 · ATC D06BX03

Therapeutic indication (EMA)

Klisyri is indicated for the field treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis (Olsen grade 1) of the face or scalp in adults.

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
NHS Drug TariffTirbanibulin 10mg/g ointment 250mg sachets£59.005 sachet1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

All safety entries for tirbanibulin →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.