Lenacapavir: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Lenacapavir appears in the FDA drug-label database. Marketed as Yeztugo.
- Boxed warning
- The FDA label for Lenacapavir carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
YEZTUGO is indicated for pre‑exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating YEZTUGO [see Dosage and Administration (2.1) and Warnings and Precautions (5.1) ]. YEZTUGO, a human immunodeficiency virus type 1 (HIV-1) capsid inhibitor, is indicated for pre‑exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating YEZTUGO. ( 1 )
Phase breakdown
Conditions being studied
| Condition | Trials |
|---|---|
| HIV · Lenacapavir for HIV | 3 |
| HIV Infections | 1 |
| HIV Prevention | 1 |
| Human Immunodeficiency Virus | 1 |
Recruiting trials involving Lenacapavir
- Lenacapavir Intensification to Disrupt HIV Reservoirs in Virologically Suppressed People With HIV Receiving Antiretroviral Therapy
- Mobile Vehicle-Based Delivery of Lenacapavir Pre-Exposure Prophylaxis in Los Angeles County
- Study of Lenacapavir, Teropavimab, and Zinlirvimab Versus Cabotegravir and Rilpivirine in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy
Common questions
Is Lenacapavir FDA-approved?
Yes, marketed as Yeztugo. Its FDA label carries a boxed warning.
How many recruiting trials involve Lenacapavir?
3 recruiting trials across 4 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.