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Fast TrackBreakthrough TherapyLearn about designations

Phase 3

Development Phase

2

Upcoming Catalysts

0

Historical Events

2

Regulatory Approvals

Upcoming Catalysts
What are catalysts?
Oct '26
GILDPDUFA
Phase 3

FDA PDUFA Date bictegravir 75 mg/lenacapavir 50 mg (priority review)

Lenacapavir
Oct 2026~
Source
00%
3w
GILDPDUFA
Phase 3

FDA PDUFA Date lenacapavir (standard)

Lenacapavir
Oct 20
SEC
00%
Competitive Landscape

1 competitor in HIV Prevention

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Drug Information

Target Indication

HIV Prevention

Mechanism of Action

Capsid Inhibitor

Clinical Trial

NCT04925752

Last updated: 12/3/2025

Patent & Exclusivity
No Patent Data

Application

NDA NDA215974
Regulatory Approvals
EMA8/25/2025

Yeytuo

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)

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EMA8/17/2022

Sunlenca

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).

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Drug Science
Mechanism of action & safety profile
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