Drugs / DOR/ISL
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | HIV-1 infection in adults virologically suppressed on antiretroviral therapy | 2025-07-10 | “today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for doravirine/islatravir (DOR/ISL)” merck.com ↗ “Earlier this year, the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for DOR/ISL” merck.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT04233879 | Feb 2020 → Nov 2022 | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | Met primary |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2026-04-30 | Merck Sharp & Dohme LLC | Regulatory Merck & Co., Inc., Rahway, N.J., USA Announces First-Quarter 2026 Financial Results; Highlights Significant Regulatory Approvals and Clinical Milestones msd.com ↗
In April, FDA approved once-daily IDVYNSO, an oral, two-drug, single-tablet regimen of doravirine/islatravir (DOR/ISL) for the treatment of certain adults with virologically suppressed HIV-1, based on Phase 3 MK-8591A-051 and MK-8591A-052 trials. |
| 2026-04-30 | Merck Sharp & Dohme LLC | Regulatory Merck & Co., Inc., Rahway, N.J., USA Announces First-Quarter 2026 Financial Results; Highlights Significant Regulatory Approvals and Clinical Milestones merck.com ↗
In April, FDA approved once-daily IDVYNSO, an oral, two-drug, single-tablet regimen of doravirine/islatravir (DOR/ISL) for the treatment of certain adults with virologically suppressed HIV-1, based on Phase 3 MK-8591A-051 and MK-8591A-052 trials. |
| 2026-02-25 | Merck Sharp & Dohme LLC | Results Merck Announces Late-Breaking Data from Three Phase 3 Trials Evaluating Doravirine/Islatravir (DOR/ISL), an Investigational, Once-Daily, Two-Drug Regimen for the Treatment of Adults Living with HIV-1 at CROI 2026 merck.com ↗
DOR/ISL is the first non-INSTI, two-drug regimen to demonstrate non-inferiority and a similar safety profile at Week 48 to BIC/FTC/TAF in adults living with HIV-1 who had not previously received antiretroviral treatment |
| 2025-11-19 | Merck Sharp & Dohme LLC | Results Merck Announces Positive Topline Results from the Pivotal Phase 3 Trial Evaluating Investigational, Once-Daily, Oral, Two-Drug, Single-Tablet Regimen of Doravirine/Islatravir (DOR/ISL) in Treatment-Naïve Adults with HIV-1 Infection merck.com ↗
The primary safety objective of the trial was also met, with the safety profile of DOR/ISL being comparable to BIC/FTC/TAF. |
| 2025-10-15 | Merck Sharp & Dohme LLC | Results Merck Announces New Data from Phase 3 Trials Evaluating the Investigational, Once-Daily, Oral, Two-Drug Regimen of Doravirine/Islatravir (DOR/ISL) in Adults with Virologically Suppressed HIV-1 Infection merck.com ↗
DOR/ISL data presented show minimal changes in weight and body composition and no clinically meaningful effect on fasting lipids and the homeostatic model assessment of insulin resistance (HOMA-IR) across clinical trials |
| 2025-07-10 | Merck Sharp & Dohme LLC | Regulatory U.S. FDA Accepts New Drug Application for Merck’s Doravirine/Islatravir, an Investigational, Once-Daily, Oral, Two-Drug Regimen for Treatment of Adults with Virologically Suppressed HIV-1 Infection merck.com ↗
The FDA has set a target action date of April 28, 2026, for the application under the Prescription Drug User Fee Act (PDUFA). |
| 2025-03-12 | Merck Sharp & Dohme LLC | Results Merck Announces Positive Data from Phase 3 Trials that Show the Investigational, Once-Daily, Oral, Two-Drug Regimen of Doravirine/Islatravir (DOR/ISL) Maintained HIV-1 Viral Suppression at Week 48 merck.com ↗
In both trials, DOR/ISL met the primary efficacy success criterion for non-inferiority to comparator antiretroviral therapies and primary safety objectives at Week 48. |
| 2025-02-04 | Merck Sharp & Dohme LLC | Results Merck Announces Fourth-Quarter and Full-Year 2024 Financial Results merck.com ↗
In addition, Merck announced topline results from two pivotal Phase 3 trials of the investigational, once-daily, oral, two-drug, single-tablet regimen of doravirine/islatravir (DOR/ISL) in adults with virologically suppressed HIV-1 infection |
| 2021-11-18 | Merck Sharp & Dohme LLC | Results Merck Provides Update on Phase 2 Clinical Trial of Once-Weekly Investigational Combination of MK-8507 and Islatravir for the Treatment of People Living with HIV-1 merck.com ↗
There was no increased incidence of AEs related to infections in participants receiving DOR/ISL relative to comparators through Week 48. |
| 2021-10-25 | Merck Sharp & Dohme LLC | Results Merck Announces Positive Top-Line Results from Pivotal Phase 3 Trials Evaluating Investigational, Once-Daily Oral Fixed Dose Combination of Doravirine/Islatravir for the Treatment of People with HIV-1 Infection merck.com ↗
The safety and tolerability profile of DOR/ISL during the trials to date are consistent with the previously reported Phase 2 studies. |
All press releases naming this drug 11 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/ISL | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04233879 ↗ |
| Route | Oral | “100 mg DOR/0.75 mg ISL FDC single tablet taken once daily by mouth.” NCT04233879 ↗ |