Sunlenca lenacapavir

Drug Class

HIV-1 capsid inhibitor

Mechanism

Inhibits HIV-1 replication by binding directly to the capsid protein, thereby interfering with capsid-mediated nuclear import, virion assembly and release, and capsid disassembly.

Approved Indication

Treatment of HIV-1 infection, in combination with other antiretroviral(s), in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen.

What This Means For Patients

Sunlenca (lenacapavir) is a first-in-class, long-acting HIV capsid inhibitor approved by the FDA, EMA, and NMPA. Designed for patients with multidrug-resistant HIV, it requires dosing only twice a year after initial startup. Under special import rules, eligible patients can access this innovative therapy at designated clinics in the Boao Lecheng pilot zone.

Regulatory Approvals

• FDA — approved (2022) — label
• EMA — approved (2022) — source
• NMPA — approved (2025) — source

Pivotal Clinical Evidence

• CAPELLA — Segal-Maurer et al., N Engl J Med 2022 (NCT04150068) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215973s000lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/sunlenca
• https://www.nmpa.gov.cn/