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Sunlenca
Published
Product name
Sunlenca
Active ingredient
Lenacapavir sodium
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Sunlenca (lenacapavir sodium) was approved for the following therapeutic use:
Sunlenca, in combination with other antiretrovirals, is indicated for the treatment of adults with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.
How this medicine works
Lenacapavir is a multistage, selective inhibitor of human immunodeficiency virus-1 (HIV-1) capsid function that directly binds to the interface between capsid protein (CA) subunits. Lenacapavir inhibits HIV-1 replication by interfering with multiple, essential steps of the viral lifecycle, including capsid-mediated nuclear uptake of HIV-1 proviral DNA (by blocking nuclear import proteins binding to capsid), virus assembly (by interfering with Gag/Gag-Pol functioning, reducing production of CA subunits), and capsid core formation (by disrupting the rate of capsid subunit association, leading to virions with malformed capsids and reduced infectivity).
Lenacapavir has activity that is specific to human immunodeficiency virus (HIV-1 and HIV-2).
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 Sunlenca was considered favourable for the therapeutic use approved.
Sponsor