{"id":68302,"date":"2026-06-16T14:34:07","date_gmt":"2026-06-16T06:34:07","guid":{"rendered":"https:\/\/flcube.com\/?p=68302"},"modified":"2026-06-16T14:34:08","modified_gmt":"2026-06-16T06:34:08","slug":"gilead-sciences-submits-snda-for-once-weekly-oral-yeztugo-prep-potential-first-long-acting-oral-hiv-prevention-option","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=68302","title":{"rendered":"Gilead Sciences Submits sNDA for Once-Weekly Oral Yeztugo PrEP \u2013 Potential First Long-Acting Oral HIV Prevention Option"},"content":{"rendered":"\n

Gilead Sciences, Inc.<\/strong> (NASDAQ: GILD<\/a>) announced that the U.S. Food and Drug Administration (FDA)<\/strong> has accepted for review a supplemental New Drug Application (sNDA)<\/strong> for Yeztugo (lenacapavir) 300 mg tablets<\/strong> as a potential once-weekly (QW) oral formulation for pre-exposure prophylaxis (PrEP)<\/strong> to prevent HIV infection. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 2, 2027<\/strong>.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Agency<\/strong><\/td>FDA (United States)<\/td><\/tr>
Application Type<\/strong><\/td>Supplemental New Drug Application (sNDA)<\/td><\/tr>
Product<\/strong><\/td>Yeztugo (lenacapavir) 300 mg tablets \u2013 once-weekly oral<\/td><\/tr>
Indication<\/strong><\/td>Pre-exposure prophylaxis (PrEP) for HIV prevention<\/td><\/tr>
PDUFA Date<\/strong><\/td>February 2, 2027<\/td><\/tr>
Current Approval Status<\/strong><\/td>Approved for initial loading dosing and as bridge to every-six-month injection<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Clinical Evidence \u2013 PURPOSE Trials<\/h2>\n\n\n\n
Trial<\/th>Population<\/th>Key Findings<\/th><\/tr><\/thead>
PURPOSE 1<\/strong><\/td>Cisgender women at risk for HIV<\/td>Demonstrated robust efficacy and safety profile<\/td><\/tr>
PURPOSE 2<\/strong><\/td>Cisgender men and gender-diverse individuals who have sex with men<\/td>Confirmed high efficacy across diverse global population<\/td><\/tr>
Combined Results<\/strong><\/td>Global, diverse study population<\/td>Established lenacapavir’s well-characterized clinical profile for PrEP<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

The pivotal PURPOSE 1 and PURPOSE 2 clinical trials fully demonstrated that lenacapavir has a robust and well-established clinical profile for PrEP<\/strong>, showing high efficacy across a diverse global population<\/strong> including cisgender women, cisgender men, and gender-diverse individuals.<\/p>\n\n\n\n

Drug Profile & Innovation<\/h2>\n\n\n\n