FDA — authorised 18 June 2025
- Application: NDA220018
- Marketing authorisation holder: GILEAD SCIENCES INC
- Local brand name: YEZTUGO
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
🇺🇸 Lenacapavir long-acting in United States
FDA authorised Lenacapavir long-acting on 18 June 2025
Marketing authorisations
FDA — authorised 18 June 2025
- Application: NDA220020
- Marketing authorisation holder: GILEAD SCIENCES INC
- Local brand name: YEZTUGO
- Indication: TABLET — ORAL
- Status: approved
Other Infectious Disease approved in United States
Frequently asked questions
Is Lenacapavir long-acting approved in United States?
Yes. FDA authorised it on 18 June 2025; FDA authorised it on 18 June 2025.
Who is the marketing authorisation holder for Lenacapavir long-acting in United States?
GILEAD SCIENCES INC holds the US marketing authorisation.