Yeytuo (lenacapavir)
- Region
- 🇪🇺 EU
- Active substance
- lenacapavir
- Company
- Gilead Sciences Ireland Unlimited Company
- Status
- Authorised
- Therapeutic area
- HIV Infections; HIV-1
- CHMP opinion
- Thu 24 Jul 2025
- EU approval
- Mon 25 Aug 2025
- Application
- EMEA/H/C/006658
- ATC
- J05AX31
- Official record
- www.ema.europa.eu
Indication
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)
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇺🇸 Bixlenvo Approved · Gilead Sciences Inc
- 🇪🇺 Sunlenca Authorised · Gilead Sciences Ireland Unlimited Company
- 🇺🇸 Bixlenvo Sunlenca Starter Pack (Copackaged) Approved · Gilead Sciences Inc
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.