Drugs / DOR/3TC/TDF
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | HIV infectious disease | 2018-07-02 | “Food and Drug Administration (FDA) accepted for review New Drug Applications for DOR and DOR/3TC/TDF for the treatment of HIV-1 infection in treatment-naïve adults.” merck.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT04375800 | Feb 2021 → Nov 2028 expected | HIV infectious disease | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2021-10-27 | Merck Sharp & Dohme LLC | Results Merck Presents New Data from Ongoing Phase 2b Clinical Trial Evaluating Efficacy and Safety of Investigational Islatravir in Combination With Doravirine Through 144 Weeks for HIV-1 Treatment at EACS 2021 merck.com ↗
Phase 2b data through 144 weeks demonstrated that islatravir combined with doravirine continued to maintain viral suppression, as measured by the number of study participants achieving HIV-1 RNA levels <50 copies/mL, similar to DOR/3TC/TDF. |
| 2018-01-08 | Merck Sharp & Dohme LLC | Regulatory FDA Accepts New Drug Applications for Merck’s Doravirine, the Company’s Investigational Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), for Treatment of HIV-1 Infection merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review two New Drug Applications (NDAs) for doravirine, the company’s investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV-1 infection in adults. |
| 2017-07-25 | Merck Sharp & Dohme LLC | Results Merck’s Investigational NNRTI, Doravirine, Meets Primary Efficacy Endpoint of Non-Inferiority to Efavirenz, Both in Combination with Other Antiretroviral Agents, in Pivotal Phase 3 Trial for Treatment of HIV-1 Infection merck.com ↗
In addition, through 48 weeks, statistically significantly fewer patients taking DOR/3TC/TDF reported pre-specified categories of neuropsychiatric events (dizziness, sleep disorders and disturbances, and inability to think clearly or concentrate) than patients receiving the EFV/FTC/TDF regimen. |
All press releases naming this drug 3 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 | DOR/3TC/TDF | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04375800 ↗ |
| Route | Oral | “Administered orally” NCT04375800 ↗ |