Drug profile · INN
lenacapavir
SUNLENCA
lenacapavir (SUNLENCA) is a structural capsid protein inhibitor. Route of administration: subcutaneous. Current US regulatory status: approved.
Drug details — lenacapavir
- US status
- approved
- Class
- Antiinfectives for systemic use (J05)
- Route
- SUBCUTANEOUS
- Patents
- 0
- Programs
- 5
- Data quality
- 0.84
Quick answer
lenacapavir (SUNLENCA) is a structural capsid protein inhibitor. Route of administration: subcutaneous. Current US regulatory status: approved.
Key facts
Mechanism of action
Structural capsid protein inhibitor
Primary target: Structural capsid protein
Approval history
| Authority | Status | Date |
|---|---|---|
| FDA | approved | — |
| EMA | approved | — |
Recent coverage
Merck and Gilead report mixed outcomes in lung cancer and HIV studies
Merck Gilead report mixed outcomes in key lung cancer and HIV studies: a Phase 3 Trodelvy plus KEYTRUDA lung cancer trial was halted, while two Phase 3 HIV studies for islatravir/lenacapavir reported positive topline results. This plan focuses on the business and clinical implications for analysts and BD teams.
Lenacapavir posts 100% HIV prevention in PURPOSE 1
Gilead’s lenacapavir posted 100% efficacy in the Phase 3 PURPOSE 1 trial for HIV prevention in cisgender women. The result strengthens the case for Lenacapavir PrEP and raises the stakes for Gilead’s next regulatory and clinical catalysts.
Lenacapavir PrEP shows high HIV-prevention efficacy in Gilead’s Phase 3 trials
Gilead’s lenacapavir PrEP has emerged as a high-efficacy HIV prevention asset after Phase 3 results showed strong protection versus comparators. This plan focuses on what changed, why it matters for investors and BD teams, and the next catalysts to watch.
HIV Treatment Clinical Trials Africa: Long-Acting Injectables & AMA Pathways
This article delves into HIV treatment clinical trials in Africa, highlighting long-acting injectables and the AMA pathways for enhanced patient care.
Pipeline programs
Related & competitor drugs
Frequently asked questions
What is lenacapavir?
lenacapavir (SUNLENCA) is a structural capsid protein inhibitor. Route of administration: subcutaneous. Current US regulatory status: approved.
What is the brand name for lenacapavir?
SUNLENCA is a marketed brand name for lenacapavir. Check FDA Drugs@FDA for the current US label holder and prescribing information.
What is the US approval status of lenacapavir?
lenacapavir has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.