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Sunlenca (LENACAPAVIR)
Sunlenca works by binding to a specific site on the HIV-1 protease, preventing the virus from replicating.
At a glance
| Generic name | LENACAPAVIR |
|---|---|
| Sponsor | Gilead Sciences |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 2022 |
| Annual revenue | 1600 |
Mechanism of action
SUNLENCA is an HIV-1 antiretroviral agent [see Microbiology (12.4)].
Approved indications
- Multidrug resistant HIV-1 infection
Boxed warnings
- WARNING: RISK OF DRUG RESISTANCE WITH USE OF YEZTUGO FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED HIV-1 INFECTION Individuals must be tested for HIV-1 infection prior to initiating YEZTUGO, and with each subsequent injection of YEZTUGO, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of YEZTUGO by individuals with undiagnosed HIV-1 infection. Do not initiate YEZTUGO unless negative infection status is confirmed. Individuals who acquire HIV-1 while receiving YEZTUGO must transition to a complete HIV-1 treatment regimen [see Dosage and Administration (2.1) , Contraindications (4) , Warnings and Precautions (5.1 , 5.2) ]. WARNING: RISK OF DRUG RESISTANCE WITH USE OF YEZTUGO FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED HIV-1 INFECTION See full prescribing information for complete boxed warning. Individuals must be tested for HIV-1 infection prior to initiating YEZTUGO, and with each subsequent injection of YEZTUGO, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of YEZTUGO by individuals with undiagnosed HIV-1 infection. Do not initiate YEZTUGO unless negative infection status is confirmed. Individuals who acquire HIV-1 while receiving YEZTUGO must transition to a complete HIV-1 treatment regimen ( 2.1 , 4 , 5.1 , 5.2 ).
Common side effects
- Injection Site Reactions
- Nausea
- Swelling
- Pain
- Erythema
- Nodule
- Induration
- Proteinuria
- ALT (>=5 ULN)
- AST (>=5 ULN)
- Direct Bilirubin (>ULN)
- Glycosuria (>2+)
Key clinical trials
- Lenacapavir Intensification to Disrupt HIV Reservoirs in Virologically Suppressed People With HIV Receiving Antiretroviral Therapy (PHASE1)
- CABOTEGRAVIR/LENACAPAVIR DUAL LONG ACTING THERAPY (COHORT IMEA 074)
- Mobile Vehicle-Based Delivery of Lenacapavir PrEP in Los Angeles County
- ImPrEP LEN Brasil: Twice-Yearly Lenacapavir for HIV Prevention (NA)
- Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention
- Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With an Optimized Background Regimen (OBR) in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance (PHASE2,PHASE3)
- Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP) (PHASE3)
- HIV Outpatient Monitoring Evaluation Through Self-collection of Dried Blood Spots
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Sunlenca CI brief — competitive landscape report
- Sunlenca updates RSS · CI watch RSS
- Gilead Sciences portfolio CI