Drugs / Emtricitabine/Tenofovir Disoproxil Fumarate
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | Truvada | HIV-1 pre-exposure prophylaxis | 2011-12-15 | “submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration ( FDA ) for the approval of once-daily Truvada” gilead.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT06101329 | Nov 2023 → Jul 2026 overdue | — | Gilead Sciences | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2024-07-24 | Gilead Sciences | Results Full Efficacy and Safety Results for Gilead Investigational Twice-Yearly Lenacapavir for HIV Prevention Presented at AIDS 2024 gilead.com ↗
Lenacapavir also demonstrated superior prevention of HIV infections when compared with once-daily oral Truvada (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF). |
| 2024-06-20 | Gilead Sciences | Results Gilead’s Twice-Yearly Lenacapavir Demonstrated 100% Efficacy and Superiority to Daily Truvada® for HIV Prevention gilead.com ↗
PURPOSE 1 met its key efficacy endpoints of superiority of twice-yearly lenacapavir to once-daily oral Truvada ® (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF) and background HIV incidence (bHIV). |
| 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. |
| 2013-11-02 | Gilead Sciences | Results Gilead Announces Phase 3 Results for an All-Oral, Sofosbuvir-Based Regimen for the Treatment of Hepatitis C in Patients Co-Infected With HIV gilead.com ↗
In the trial, 76 percent (n=87/114) of genotype 1 HCV treatment-naïve patients receiving 24 weeks of an all-oral, interferon-free regimen of sofosbuvir plus ribavirin (RBV) achieved a sustained virologic response 12 weeks after completing therapy (SVR12). |
| 2012-11-15 | Gilead Sciences | Results Gilead’s Complera® Non-Inferior to Atripla® Among Treatment-Naïve HIV Patients gilead.com ↗
Complera demonstrated a statistically significant difference in efficacy compared to Atripla among patients with low baseline viral load (≤ 100,000 copies/mL), and was non-inferior to Atripla among patients with high baseline viral load (> 100,000 copies/mL). |
| 2012-03-07 | Gilead Sciences | Results Gilead’s Quad Single Tablet Regimen for HIV Non-Inferior to Atripla® in Pivotal Phase 3 Study gilead.com ↗
These data show that the Quad is as effective as a current standard of care in HIV therapy. |
| 2011-12-23 | Gilead Sciences | Regulatory U.S. FDA Accepts New Drug Application for Gilead’s Once-Daily, Single-Tablet Quad HIV Regimen gilead.com ↗ |
| 2011-08-15 | Gilead Sciences | Results Gilead's Investigational Antiretroviral Quad Regimen Meets 48-Week Primary Objective in Pivotal Phase 3 Clinical Study 102 gilead.com ↗
The mean 48-week increase in CD4 cell count from baseline was 239 cells/mm 3 in the Quad arm compared to 206 cells/mm 3 in the Atripla arm (p=0.009). |
| 2008-04-24 | Gilead Sciences | Results Gilead Announces 72-Week Data From Two Pivotal Phase III Studies Evaluating Viread(R) for the Treatment of Chronic Hepatitis B gilead.com ↗
The 72-week data demonstrate that the majority of patients in each study who were originally randomized to receive Viread had a virologic response below 400 copies/mL through week 72 (91 percent and 79 percent, respectively). |
| 2006-12-15 | Gilead Sciences | Results 96-Week Data From Gilead's Study 934 Comparing Viread(R) and Emtriva(R) to Combivir(R) Both in Combination With Sustiva(R) Published in Journal of Acquired Immune Deficiency Syndrome gilead.com ↗
Gilead Sciences, Inc. (Nasdaq:GILD) today announced the publication of 96-week data from an ongoing clinical trial, Study 934, in the Journal of Acquired Immune Deficiency Syndrome (JAIDS). |
All press releases naming this drug 10 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 | Emtricitabine/Tenofovir Disoproxil Fumarate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06101329 ↗ |
| Route | Oral | “200/300mg fixed dose combination (FDC) tablets administered orally” NCT06101329 ↗ |