Drugs / Descovy

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Descovy — 2016-04-21 europa.eu ↗
Approved US (FDA) DESCOVY — 2016-04-04 fda.gov ↗

Trials 4

201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT07210528 Jun 2025 → Mar 2026 overdue Alzheimer disease National University Hospital, Singapore Recruiting No outcome recorded
Phase 31 trial
Phase 3 NCT04051970 Nov 2019 → Jun 2022 HIV infectious disease ANRS, Emerging Infectious Diseases Terminated No outcome recorded Stop: Enrollment
Phase 42 trials
Phase 4 NCT05528653 Jul 2022 → Jul 2024 — Vivent Health Completed No outcome recorded
Phase 4 NCT04782180 Feb 2022 → Nov 2024 HIV infectious disease, substance-related disorder University of Miami Completed No outcome recorded
Comparator or background therapy3 trials
Phase 2/3 NCT04742491 Background Mar 2021 → Aug 2024 — HIV Prevention Trials Network Completed No outcome recorded
Phase 3 NCT05378399 Background Dec 2022 → Feb 2026 HIV infectious disease, substance-related disorder Brigham and Women's Hospital Completed No outcome recorded
Phase 3 NCT02486133 Comparator Jul 2015 → May 2018 HIV infectious disease Technical University of Munich Completed No outcome recorded

Press releases naming this drug 12 releases

DateIssuerRelease
2020-03-10 Gilead Sciences Gilead Presents 96-week DISCOVER Trial Data Demonstrating Favorable Renal and Bone Safety Profile of Descovy® for HIV PrEP in At-Risk Populations gilead.com ↗
2019-11-06 Gilead Sciences Gilead Presents 96-week Discover Trial Data Supporting Non-inferior Efficacy and Key Safety Differences of Descovy For PrEP™ Compared With Truvada For PrEP® gilead.com ↗
2019-10-03 Gilead Sciences U.S. Food and Drug Administration Approves Descovy® for HIV Pre-Exposure Prophylaxis (PrEP) gilead.com ↗
2019-08-07 Gilead Sciences Gilead Sciences Statement on U.S. Food and Drug Administration Advisory Committee’s Recommendation on Descovy for PrEP™ gilead.com ↗
2019-07-23 Gilead Sciences Gilead Presents New Findings on Profile of Descovy® for Potential Use as HIV Pre-exposure Prophylaxis Compared With Truvada® gilead.com ↗
2019-04-05 Gilead Sciences Gilead Submits Supplemental New Drug Application to U.S. Food and Drug Administration for Once-Daily Descovy® for HIV Pre-Exposure Prophylaxis gilead.com ↗
2019-03-06 Gilead Sciences Gilead Announces Data Demonstrating Non-Inferiority of Once-Daily Descovy® vs. Once-Daily Truvada® for Prevention of HIV Infection gilead.com ↗
2018-12-04 Gilead Sciences China National Medical Products Administration Approves Descovy® (Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 Infection gilead.com ↗
2016-10-24 Gilead Sciences Gilead Presents Results from Phase 3 Studies Evaluating Switching to Descovy® (FTC/TAF)-Based Regimens from Truvada® (FTC/TDF)-Based Regimens gilead.com ↗
2016-04-25 Gilead Sciences European Commission Grants Marketing Authorization for Gilead’s Fixed-Dose Combination Descovy® (Emtricitabine, Tenofovir Alafenamide) for Treatment of HIV gilead.com ↗
2016-04-04 Gilead Sciences U.S. Food and Drug Administration Approves Descovy® (Emtricitabine, Tenofovir Alafenamide), Gilead’s Third TAF-Based HIV Therapy gilead.com ↗
2016-02-26 Gilead Sciences European CHMP Adopts Positive Opinion for Gilead’s Fixed-Dose Combination Descovy® (Emtricitabine/Tenofovir Alafenamide) for the Treatment of HIV gilead.com ↗

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 7 sources stand behind the page.

FieldValueCited text
Known as Descovy “one daily tablet of Descovy (emtricitabine 200 mg and tenofovir alafenamide 25mg, FTC/TAF) or one daily tablet of Truvada (emtricitabine 200 mg and tenofovir disoproxil...” NCT04742491 ↗
6

“TDF/XTC Gé or Descovy®” NCT04051970 ↗

NCT02486133 ↗

NCT04782180 ↗

NCT07210528 ↗

NCT05378399 ↗

NCT05528653 ↗

Known as FTC/TAF “one daily tablet of Descovy (emtricitabine 200 mg and tenofovir alafenamide 25mg, FTC/TAF) or one daily tablet of Truvada (emtricitabine 200 mg and tenofovir disoproxil...” NCT04742491 ↗
Route Oral “daily Descovy tab by mouth” NCT04782180 ↗