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Molecule

Tirbanibulin

Microtubule Inhibitor
Available on requestDermatology
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Tirbanibulin is a microtubule inhibitor indicated for the topical field treatment of actinic keratosis on the face or scalp. It is available as ointment for topical use. MedsAcross supplies Tirbanibulin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Microtubule Inhibitor, Microtubule Inhibition
ATC classification
D06BX03 Tirbanibulin · Antibiotics and antivirals for the skin, subgroup D06B, subgroup D06BX
US FDA first approval
14 December 2020
EU status
Authorised
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Topical
Dosage forms
Ointment
Identifiers
UNII 4V9848RS5GCAS 897016-82-9DrugBank DB06137Q27888424

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

KLISYRI 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.

Source: US FDA prescribing information

How it works

Tirbanibulin is a microtubule inhibitor. The mechanism of action of KLISYRI for the topical treatment of actinic keratosis is unknown.

Source: US FDA prescribing information

Dosing overview

For topical use only, not for oral or ophthalmic use. Apply KLISYRI evenly to cover up to 100 cm 2 treatment field on the face or balding scalp once daily for 5 consecutive days using 1 unit-dose packet per application. Wash hands immediately with soap and water after application. Avoid washing and touching the treated area for approximately 8 hours after application of KLISYRI. Following this time, the area may be washed with a mild soap. Avoid transfer of KLISYRI to the periocular area. Avoid application near and around the mouth and lips. For topical use, not for oral or ophthalmic use. Apply KLISYRI to the treatment field on the face or scalp once daily for 5 consecutive days using 1 unit-dose packet per application.

Source: US FDA prescribing information

Warnings and precautions

Ophthalmic Adverse Reactions: May cause eye irritation upon ocular exposure. Avoid transfer of the drug into the eyes and to the periocular area. If accidental exposure occurs, flush eyes with water and seek medical care. Local Skin Reactions: Local skin reactions can occur including severe reactions (e.g., vesiculation/pustulation, erosion/ulceration) in the treated area. Avoid use until skin is healed from any previous drug or surgical treatment.

Source: US FDA prescribing information

Side effects

Most common adverse reactions (incidence ≥2%) are local skin reactions, application site pruritus, and application site pain.

Source: US FDA prescribing information

Storage

Store at 20°C-25°C (68°F-77°F), excursions permitted to 15°C-30°C (59°F-86°F). Do not refrigerate or freeze.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Tirbanibulin, sorted by availability.

MedicineManufacturerRegisterAvailability
Klisyri 1% ointmentTopicalAlmirallUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 14 December 2020Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Tirbanibulin available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Tirbanibulin and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Tirbanibulin have?

The catalogue lists 1 brand names for Tirbanibulin, including Klisyri.

Is Tirbanibulin approved by the US FDA?

Yes. The US FDA first approved Tirbanibulin on 14 December 2020, according to Drugs@FDA.

Is Tirbanibulin authorised in the European Union?

Yes. Tirbanibulin has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Tirbanibulin need cold chain shipping?

No listed presentation of Tirbanibulin is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Tirbanibulin in?

Tirbanibulin is classified under ATC code D06BX03 (Tirbanibulin).

References

  1. Klisyri prescribing information (Almirall). U.S. National Library of Medicine, DailyMed. Retrieved 24 June 2026
  2. Klisyri: European public assessment report (EPAR). European Medicines Agency. Retrieved 19 February 2026

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