Drugs / MK-8591A
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | virologically suppressed HIV-1 infection | 2025-07-29 | “the FDA accepted a New Drug Application (NDA) for doravirine/islatravir” merck.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06719570 | Jan → Mar 2024 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2026-03-13 | MSD R&D (China) Co., Ltd. | Results Merck & Co., Inc., Rahway, NJ, USA、HIV-1感染症成人患者を対象とした1日1回投与のドラビリン／イスラトラビル（DOR/ISL）の2剤配合錠について、第3相試験の最新のデータ３件をCROI 2026で発表 msd.co.jp ↗
Merck & Co., Inc., Rahway, NJ, USA（米国とカナダ以外ではMSD）は本日、開発中の1日1回経口投与のドラビリン／イスラトラビル［DOR/ISL（100 mg/0.25 mg）、（MK-8591A）］2剤配合錠について、HIV-1感染症成人患者を対象とする3件のピボタル第3相試験の結果を発表しました。 |
| 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 success criterion for the primary efficacy hypothesis, as measured by the percentage of participants with HIV-1 RNA levels <50 copies/mL at Week 48, was met, with DOR/ISL demonstrating non-inferiority to once-daily oral bictegravir/emtricitabine/tenofovir alafenamide i [BIC/FTC/TAF (50 mg/200 mg/25 mg)]. |
| 2025-07-11 | MSD R&D (China) Co., Ltd. | Regulatory 1日1回経口投与のHIV-1感染症治療薬として、新規のヌクレオシド系逆転写酵素トランスロケーション阻害剤（NRTTI）イスラトラビルと非ヌクレオシド系逆転写酵素阻害剤（NNRTI）ドラビリンの2剤配合錠を承認申請 msd.co.jp ↗
MSD株式会社（本社：東京都千代田区、代表取締役社長：プラシャント・ニカム、以下 「MSD」）は、6月30日、1日1回経口投与のヒト免疫不全ウイルス1型（HIV-1）の治療薬として、逆転写酵素に対する新規のヌクレオシド系逆転写酵素トランスロケーション阻害剤（NRTTI）であるイスラトラビルと非ヌクレオシド系逆転写酵素阻害剤（NNRTI）であるドラビリンの2剤配合錠（ドラビリン/イスラトラビル）について、製造販売承認申請を行いましたのでお知らせいたします。 |
| 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 ↗
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, 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), an investigational, once-daily, oral, two-drug regimen for adults with HIV-1 infection that is virologically suppressed on antiretroviral therapy. |
| 2025-03-28 | MSD R&D (China) Co., Ltd. | Results Merck & Co., Inc., Rahway, NJ, USA、1日1回経口投与のドラビリン／イスラトラビル（DOR/ISL）の2剤配合錠の第3相試験の良好なデータを発表48週時においてHIV-1のウイルス学的抑制を維持 msd.co.jp ↗
いずれの試験でも、DOR/ISLは有効性の主要評価項目を達成し、対照群（MK-8591A-052試験：BIC/FTC/TAF、MK-8591A-051試験：bART）に対する非劣性を示しました。 |
| 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. |
| 2025-01-14 | MSD R&D (China) Co., Ltd. | Results Merck & Co., Inc., Rahway, NJ, USA、ウイルス学的抑制が得られているHIV-1感染症成人患者の治療薬として1日1回経口投与のドラビリン／イスラトラビル（DOR/ISL）2剤配合錠を評価するピボタル第3相試験のトップラインデータを発表 msd.co.jp ↗
DOR/ISLは、非盲検のMK-8591A-051試験でbARTに対する非劣性、二重盲検のMK-8591A-052試験でBIC/FTC/TAFに対する非劣性を示しました。 |
| 2024-12-19 | Merck Sharp & Dohme LLC | Results Merck Announces Topline Results from Pivotal Phase 3 Trials Evaluating Investigational, Once-Daily, Oral, Two-Drug, Single-Tablet Regimen of Doravirine/Islatravir (DOR/ISL) for the Treatment of Adults with Virologically Suppressed HIV-1 Infection merck.com ↗
The success criterion for the primary efficacy hypothesis, as measured by the percentage of participants with HIV-1 RNA levels ≥50 copies/mL at Week 48, was met in both trials. |
| 2021-12-13 | Merck Sharp & Dohme LLC | Regulatory Merck Announces Clinical Holds on Studies Evaluating Islatravir for the Treatment and Prevention of HIV-1 Infection merck.com ↗
Additionally, participants in studies of DOR/ISL who were started on treatment will continue to receive study medication (partial clinical hold). |
| 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 ↗
Decreases in total lymphocyte and CD4+ T-cell counts were observed in study participants randomized to receive ISL+MK-8507. |
| 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 ↗ |
All press releases naming this drug 12 releases
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | MK-8591A | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06719570 ↗ |