Product image of Klisyri (Tirbanibulin) supplied by GNH India

Klisyri

Active Ingredient:
Tirbanibulin
Origin:
EU

Klisyri (Tirbanibulin)

Tirbanibulin, the active ingredient in Klisyri, is a kinase inhibitor presented as a 1% w/w topical gel for topical use. It is indicated for the treatment of actinic keratosis of the face and scalp in adult patients. The formulation is designed for once‑daily application to the affected skin areas, providing localized drug delivery with minimal systemic exposure.

GNH India supplies Klisyri as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, ensuring quality assurance and regulatory compliance across all markets.

Manufacturer / TM Owner

Almirall, S.A.

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Indications & Clinical Uses

Klisyri (tirbanibulin) is a topical anti‑neoplastic agent used to treat actinic keratosis, a precancerous skin lesion.

  • Actinic keratosis of the face: reduces lesion count and prevents progression to squamous cell carcinoma.
  • Actinic keratosis of the scalp: clears lesions and improves skin appearance.

How It Works

  • Tirbanibulin inhibits tubulin polymerization and blocks Src kinase signaling pathways in abnormal keratinocytes. This dual inhibition leads to cell‑cycle arrest at the G2/M phase and triggers apoptosis of dysplastic cells, resulting in the removal of precancerous lesions while sparing surrounding healthy tissue.

Side Effects

Klisyri may cause local skin reactions and, rarely, more severe adverse events.

Common Side Effects

  • Erythema: redness at the application site.
  • Crusting or scaling: formation of dry, flaky skin.
  • Itching or burning sensation: mild to moderate discomfort.
  • Swelling or edema: localized puffiness.

Serious or Rare Side Effects

  • Severe allergic reaction: signs include widespread rash, hives, or difficulty breathing.
  • Ulceration or infection of the treated area: persistent open sores or signs of bacterial infection.

Precautions & Warnings

Before using Klisyri, consider the following precautions:

  • Avoid application on compromised or inflamed skin: use only on intact lesions.
  • Do not apply to mucous membranes or ocular areas: risk of irritation.
  • Use as directed by a qualified prescriber: follow the prescribed treatment duration.
  • Monitor for excessive local reactions: discontinue and seek medical advice if severe.
  • Pregnancy and lactation: safety not established; avoid unless benefit outweighs risk.
  • Store at room temperature: keep in the original container, protect from moisture and direct sunlight.

Avoid Interactions

Klisyri has limited systemic interactions, but topical co‑applications may affect safety or efficacy.

Major Interactions (Avoid)

  • Concurrent use with other topical anti‑neoplastic agents (e.g., 5‑fluorouracil, imiquimod): may increase irritation.
  • Application over areas treated with systemic kinase inhibitors: potential additive pharmacologic effect.

Moderate Interactions (Monitor Closely)

  • Use with photosensitizing drugs (e.g., tetracyclines): may enhance sun sensitivity.
  • Co‑application of potent topical corticosteroids: could reduce tirbanibulin efficacy.
  • Over‑the‑counter skin irritants (e.g., harsh exfoliants): may exacerbate local reactions.

Frequently Asked Questions

Klisyri is a prescription topical gel that contains tirbanibulin. It is approved for the treatment of actinic keratosis on the face and scalp, helping to clear precancerous skin lesions and reduce the risk of progression to squamous cell carcinoma.

Tirbanibulin blocks tubulin polymerization and inhibits Src kinase signaling within abnormal keratinocytes. This dual action stops cell division and induces programmed cell death, leading to the removal of dysplastic skin cells that characterize actinic keratosis.

The dosing regimen for Klisyri is determined by the prescribing healthcare professional. Typically, the gel is applied once daily to the affected area for a prescribed number of days, but the exact amount and duration should follow the prescriber’s instructions.

Safety data for tirbanibulin in pregnancy and lactation are limited. It is classified as having an unknown pregnancy category, so it should be avoided unless the potential benefit justifies the potential risk to the fetus or infant.

To request Klisyri, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Klisyri’s tirbanibulin offers a distinct mechanism—kinase inhibition—compared with alternatives such as 5‑fluorouracil or imiquimod, which act as antimetabolites or immune modulators. Clinical data suggest comparable lesion clearance rates, with a short treatment course and a different side‑effect profile.

Klisyri should be stored at room temperature, below 25 °C, in its original packaging. Protect the gel from moisture and direct sunlight. Keep the container tightly closed when not in use to maintain product stability.

Klisyri is applied topically to the affected skin area. The prescriber will indicate the amount to use, usually a thin layer covering the lesion, and the frequency—commonly once daily—for the prescribed treatment period.

Serious risks include severe allergic reactions such as anaphylaxis, extensive ulceration of the treated skin, and secondary bacterial infection. Patients should seek immediate medical attention if they experience widespread rash, difficulty breathing, or signs of infection.

Klisyri is contraindicated in individuals with known hypersensitivity to tirbanibulin or any component of the formulation. It should also be avoided on broken, inflamed, or infected skin, and in pregnant or breastfeeding women unless the prescriber determines that the benefit outweighs the risk.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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