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Ledaga
Published
Product name
Ledaga
Active ingredient
Chlormethine hydrochloride
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Ledaga (chlormethine hydrochloride) was approved for the following therapeutic use:
Ledaga is indicated for the topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-type CTCL) in adult patients.
How this medicine works
Chlormethine is a bifunctional alkylating agent that reacts with deoxyribonucleic acid to form cross-links, inducing the death of rapidly proliferating cells.
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 Ledaga was considered favourable for the therapeutic use approved.