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Phase 3
Development Phase
3
Upcoming Catalysts
0
Historical Events
2
Regulatory Approvals
FDA PDUFA Date bictegravir 75 mg/lenacapavir 50 mg (priority review)
FDA PDUFA Date bictegravir 75 mg/lenacapavir 50 mg (priority review)
1 competitor in HIV Prevention
View Full LandscapeTarget Indication
HIV Prevention
Mechanism of Action
Capsid Inhibitor
Clinical Trial
NCT04925752Last updated: 12/3/2025
Latest Patent Expiry
Patents Listed
7
Exclusivity
Application
NDA 215973Yeytuo
Yeytuo tablet is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents with increased HIV 1 acquisition risk, weighing at least 35 kg for:• oral loading• oral bridging(see sections 4.2, 4.4 and 5.1)
View on EMASunlenca
Sunlenca injection, in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant HIV 1 infection for whom it is otherwise not possible to construct a suppressive anti viral regimen (see sections 4.2 and 5.1). Sunlenca tablet, in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant HIV 1 infection for whom it is otherwise not possible to construct a suppressive anti viral regimen, for oral loading prior to administration of long-acting lenacapavir injection (see sections 4.2 and 5.1).
View on EMA