LENACAPAVIR: A NOVEL CAPSID INHIBITOR TRANSFORMING HIV MANAGEMENT
*Mohammad Mujtaba and Dr. Rahila Tarannum
Lenacapavir (GS 6207, brand Sunlenca/Yeztugo) is an anti-Retroviral drug developed by Gilead Sciences as one of very first class of HIV capsid inhibitor. Its discovery has been built upon decades of NIH (National Institute of health)-funded structural biology research showing the HIV capsid (p24) as a critical, druggable target. Structure-based design in the 2010s led to GS CA1 and later lenacapavir, which binds between capsid subunits and “molecularly glues” them together. Researchers found lenacapavir disrupts the capsid by binding CA proteins, preventing the virus from entering the nucleus or replicating. In 2019 the FDA granted Breakthrough Therapy designation. The pivotal Phase 2/3 CAPELLA trial in heavily treatment-experienced (HTE) patients with multi-drug-resistant HIV was launched (NCT04150068) and later supported global regulatory filings. By Aug 2022 the EMA granted marketing authorization (EU) for lenacapavir in multi-drug-resistant HIV, followed by US FDA approval (Sunlenca) in Dec 2022 and Canadian approval soon after. On June 18, 2025, the U.S. Food and Drug Administration (FDA) approved Yeztugo (lenacapavir) for use as PrEP to reduce the risk of sexually-acquired HIV-1 infection in adults and adolescents weighing ≥ 35 kg. The drug is given via subcutaneous injection every 6 months (twice-yearly), making it the first FDA-approved HIV prevention option with that dosing frequency.
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