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Onakta (tirbanibulin)
Published
Product name
Onakta
Active ingredient
Tirbanibulin
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Onakta (tirbanibulin) was approved for the following therapeutic use:
Onakta is indicated for the topical field treatment of non-hyperkeratotic, nonhypertrophic actinic keratosis of the face or scalp in adults.
How this medicine works
Tirbanibulin disrupts microtubules by direct binding to tubulin, which induces cell cycle arrest and apoptotic death of proliferating cells and is associated with disruption of Src tyrosine kinase signalling.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Onakta was considered favourable for the therapeutic use approved.
Sponsor
ARTG details