Drugs / F/TAF
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | HIV infectious disease | 2015-05-28 | “The MAA for two doses of an investigational fixed-dose combination of emtricitabine and tenofovir alafenamide (200/10 mg and 200/25 mg) (F/TAF) was fully validated on May 28, 2015 .” gilead.com ↗ “Gilead’s Marketing Authorization Application (MAA) for two doses of F/TAF (200/10 mg and 200/25 mg) was fully validated and under evaluation by the European Medicines Agency .” gilead.com ↗ “A Marketing Authorization Application (MAA) in the European Union (EU) for F/TAF was fully validated on May 28, 2015 .” gilead.com ↗ “A Marketing Authorization Application (MAA) in the European Union for F/TAF was fully validated on May 28, 2015” gilead.com ↗ “(F/TAF) has been fully validated and is now under evaluation by the European Medicines Agency (EMA).” gilead.com ↗ |
| Filed | US (FDA) | — | HIV infectious disease | 2015-04-07 | “Gilead filed New Drug Applications to the U.S. Food and Drug Administration for E/C/F/TAF and F/TAF on November 5, 2014 , and April 7, 2015 , respectively.” gilead.com ↗ “Gilead has filed NDAs with the FDA for two other TAF-based HIV medicines: two doses of an investigational fixed-dose combination of F/TAF” gilead.com ↗ “Today’s filing is Gilead’s second F/TAF-based NDA submitted to the FDA for review.” gilead.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT04143594 | Nov 2019 → Oct 2021 | HIV infectious disease | Gilead Sciences | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 18
| Date | Issuer | Release |
|---|---|---|
| 2025-10-15 | Gilead Sciences | Results Gilead Presents New HIV Research Data at EACS 2025 – Driving Scientific Innovation in Treatment and Prevention gilead.com ↗
In the group of BICSTaR study participants with 5 years of real-world follow-up, Biktarvy continued to demonstrate sustained viral suppression, a favorable safety and tolerability profile, and a high barrier to resistance. |
| 2024-10-09 | Gilead Sciences | Results Gilead to Present Late-Breaking Data Highlighting Antiviral Portfolio, Innovative Research Pipeline and HIV Leadership at IDWeek 2024 gilead.com ↗
Investigational Obeldesivir Safety and Tolerability Data From BIRCH and OAKTREE Trials Support Continued Evaluation as a Potential Treatment Option for RSV |
| 2023-07-23 | Gilead Sciences | Results New Biktarvy® Data Presented at IAS 2023 Further Demonstrate Safety and Efficacy Profile in a Broad Range of People and Communities Affected by the Global HIV Epidemic gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced results from multiple studies reinforcing Biktarvy ® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) as a treatment option for a broad range of people with HIV. |
| 2020-07-08 | Gilead Sciences | Results Gilead Sciences Presents Survey Findings on PrEP Access and Utilization in the U.S. During COVID-19 Shelter-in-Place Orders gilead.com ↗
Baseline prevalence and longitudinal trends in HIV-associated sexual risk behaviors during the DISCOVER trial suggest that risk compensation, defined as an increase in risk behavior due to a reduction in perceived risk, did not occur among study participants. |
| 2020-03-10 | Gilead Sciences | Results 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 ↗
The longer-term efficacy and safety outcomes from the DISCOVER trial continue to demonstrate that Descovy is effective for HIV prevention with non-inferior efficacy to Truvada, and that Descovy has an improved bone and renal safety profile compared with Truvada. |
| 2019-11-06 | Gilead Sciences | Results Gilead’s Biktarvy Maintained High Efficacy With No Cases of Treatment-Emergent Resistance Through Three Years in Phase 3 HIV Clinical Trials gilead.com ↗
Across all treatment groups no participants developed treatment failure with treatment-emergent resistance. |
| 2019-10-04 | Gilead Sciences | Results Gilead Presents New Data From the Company’s HIV Clinical Development Program and Latest Findings on the Impact of HIV Pre-exposure Prophylaxis (PrEP) at IDWeek 2019 gilead.com ↗
showing significant improvements in key measures of bone and renal safety parameters |
| 2019-10-03 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves Descovy® for HIV Pre-Exposure Prophylaxis (PrEP) gilead.com ↗
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration ( FDA ) approved a pre-exposure prophylaxis (PrEP) indication for Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF). |
| 2019-07-23 | Gilead Sciences | Results Gilead Presents New Findings on Profile of Descovy® for Potential Use as HIV Pre-exposure Prophylaxis Compared With Truvada® gilead.com ↗
Pharmacokinetic data from separate PK studies demonstrate that after using drugs for 14-28 days, F/TAF users who stop drug still maintain TFV-DP concentrations above the EC90 for at least 60 percent longer than F/TDF users. |
| 2018-12-04 | Gilead Sciences | Regulatory China National Medical Products Administration Approves Descovy® (Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 Infection gilead.com ↗
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the China National Medical Products Administration (NMPA) has approved Descovy ® (emtricitabine 200 mg/tenofovir alafenamide 10 mg and emtricitabine 200 mg/tenofovir alafenamide 25 mg, F/TAF), a fixed-dose combination for the treatment of HIV. |
| 2016-04-25 | Gilead Sciences | Regulatory European Commission Grants Marketing Authorization for Gilead’s Fixed-Dose Combination Descovy® (Emtricitabine, Tenofovir Alafenamide) for Treatment of HIV gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission has granted marketing authorization for two doses of Descovy ® (emtricitabine and tenofovir alafenamide 200/10 mg and 200/25 mg; F/TAF), a fixed-dose combination for the treatment of HIV-1 infection. |
| 2016-04-04 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves Descovy® (Emtricitabine, Tenofovir Alafenamide), Gilead’s Third TAF-Based HIV Therapy gilead.com ↗
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration ( FDA ) has approved Descovy ® (emtricitabine 200 mg/tenofovir alafenamide 25 mg, F/TAF), a fixed-dose combination for the treatment of HIV. |
| 2016-03-01 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves Gilead’s Second TAF-Based Single Tablet Regimen Odefsey® (Emtricitabine, Rilpivirine, Tenofovir Alafenamide) for the Treatment of HIV-1 Infection gilead.com ↗
Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the U.S. Food and Drug Administration ( FDA ) has approved Odefsey ® (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg or R/F/TAF) for the treatment of HIV-1 infection in certain patients. |
| 2016-02-26 | Gilead Sciences | Regulatory European CHMP Adopts Positive Opinion for Gilead’s Fixed-Dose Combination Descovy® (Emtricitabine/Tenofovir Alafenamide) for the Treatment of HIV gilead.com ↗ |
| 2016-02-23 | Gilead Sciences | Results Gilead Announces Results From First Study to Evaluate Switching to F/TAF-Based Regimens from Truvada® (F/TDF)-Based Regimens gilead.com ↗
At Week 48, the F/TAF-based regimens were found to be statistically non-inferior to the F/TDF-based regimens, based on percentages of patients with HIV-1 RNA levels less than 50 copies/mL. |
| 2015-11-23 | Gilead Sciences | Regulatory European Commission Grants Marketing Authorization for Gilead’s Single Tablet Regimen Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide) for the Treatment of HIV-1 Infection gilead.com ↗
Genvoya is the first TAF-based regimen to receive marketing authorization in the European Union (EU). |
| 2015-10-22 | Gilead Sciences | Results Gilead Announces Phase 3 Results for Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide), an Investigational Once-Daily Single Tablet Regimen for HIV gilead.com ↗
Patients receiving Genvoya also had improved renal and bone laboratory parameters compared to those treated with Stribild. |
| 2015-04-07 | Gilead Sciences | Regulatory Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Emtricitabine/Tenofovir Alafenamide for HIV Treatment gilead.com ↗
Today’s filing is Gilead’s second F/TAF-based NDA submitted to the FDA for review. |
All press releases naming this drug 22 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | F/TAF | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04143594 ↗ |
| Route | Oral | “F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28” NCT04143594 ↗ |