Drugs / Doravirine
Doravirine
also known as
DOR · MK-1439 · Pifeltro · Doravirina · Doravirine (PIFELTRO) · Doravirine component of delstrigo · Mk-1439a
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed HIV infectious disease 2 milestones | |||||
| Filed | US (FDA) | — | HIV infectious disease | 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 ↗ “the FDA accepted a New Drug Application (NDA) for doravirine/islatravir” merck.com ↗ |
| Filed | US (FDA) | — | HIV infectious disease | 2018-01-08 | “The FDA accepted for review two NDAs for doravirine, the company’s investigational non-nucleoside reverse transcriptase inhibitor, for the treatment of HIV-1 infection in adults.” merck.com ↗ “Food and Drug Administration (FDA) has accepted for review two New Drug Applications (NDAs) for doravirine” merck.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (2) | US (FDA) | PIFELTRO | — | 2019-09-19 – 2022-01-27 | fda.gov ↗ |
| Approved | EU (EMA) | Pifeltro | — | 2018-11-22 | europa.eu ↗ |
| Approved | US (FDA) | PIFELTRO | — | 2018-08-30 | fda.gov ↗ |
Trials 54
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04820933 | Mar 2024 → Oct 2025 | HIV infectious disease | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 110 trials · 1 met primary · 1 missed | ||||||
| Phase 1 | NCT07086079 | Sep → Dec 2025 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT04900974 | Jun 2022 → Mar 2025 | HIV infectious disease, pregnancy disorder | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 1 | NCT04283656 | Jan → Oct 2022 | HIV infectious disease | Thomas Jefferson University | Completed | Missed primary |
| Phase 1 | NCT03894124 | Jun → Jul 2019 | HIV infectious disease | Chelsea and Westminster NHS Foundation Trust | Completed | No outcome recorded |
| Phase 1 | NCT03886701 | Apr → May 2019 | HIV infectious disease, isoniazid toxicity, latent tuberculosis infection | Walter K. Kraft | Completed | No outcome recorded |
| Phase 1 | NCT02641067 | Jan → May 2016 | impaired renal function disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT02715700 | Sep 2015 → Jun 2016 | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT02549040 | Sep → Dec 2015 | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT02089659 | Mar → May 2014 | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT01466985 | Oct 2011 → Apr 2012 | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03332095 | Jul 2018 → Aug 2020 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 210 trials · 1 met primary | ||||||
| Phase 2 | NCT07862569 | Dec 2026 → Sep 2029 expected | HIV infectious disease | Merck Sharp & Dohme LLC | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06774872 | Apr 2025 → Jan 2027 expected | HIV infectious disease | Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida | Recruiting | No outcome recorded |
| Phase 2 | NCT06034938 | Feb 2024 → Apr 2026 overdue | HIV infectious disease | University Hospital, Caen | Recruiting | No outcome recorded |
| Phase 2 | NCT04375800 | Feb 2021 → Nov 2028 expected | HIV infectious disease | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 2 | NCT04295772 | Nov 2020 → Dec 2021 | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT04513626 | Sep 2020 → Oct 2025 overdue | HIV infectious disease | Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida | Recruiting | No outcome recorded |
| Phase 2 | NCT04097925 | Feb → Aug 2020 | HIV infectious disease | Fight AIDS and Infectious Diseases Foundation | Completed | No outcome recorded |
| Phase 2 | NCT02652260 | Mar 2016 → Aug 2018 | central nervous system disorder | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT02629822 | Jan 2016 → Nov 2018 | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT01632345 | Oct 2012 → Dec 2014 | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 316 trials · 8 met primary | ||||||
| Phase 3 | NCT07075146 | May 2025 → Jun 2026 overdue | HIV infectious disease, obesity disorder | José Antonio Mata Marín | Recruiting | No outcome recorded |
| Phase 3 | NCT06203132 | Jan 2025 → Nov 2026 expected | HIV infectious disease | ANRS, Emerging Infectious Diseases | Recruiting | No outcome recorded |
| Phase 3 | NCT05766501 | Mar 2023 → Oct 2025 overdue | HIV infectious disease | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05705349 | Mar 2023 → Oct 2025 overdue | HIV infectious disease | Merck Sharp & Dohme LLC | Active not recruiting | Met primary |
| Phase 3 | NCT05631093 | Feb 2023 → Oct 2024 overdue | HIV infectious disease | Merck Sharp & Dohme LLC | Active not recruiting | Met primary |
| Phase 3 | NCT05630755 | Feb 2023 → Oct 2024 overdue | HIV infectious disease | Merck Sharp & Dohme LLC | Active not recruiting | Met primary |
| Phase 3 | NCT04892654 | Aug 2022 → Nov 2026 expected | HIV infectious disease | Chelsea and Westminster NHS Foundation Trust | Recruiting | No outcome recorded |
| Phase 3 | NCT04776252 | Sep 2021 → May 2029 expected | HIV infectious disease | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04429152 | Feb 2021 → Sep 2023 | HIV infectious disease | Professor Francois Venter | Unknown | No outcome recorded |
| Phase 3 | NCT04433780 | Jan 2021 → Feb 2023 | HIV infectious disease | Professor Francois Venter | Completed | No outcome recorded |
| Phase 3 | NCT04079452 | Feb → Aug 2020 | HIV infectious disease | Fight AIDS and Infectious Diseases Foundation | Completed | No outcome recorded |
| Phase 3 | NCT04223778 | Feb 2020 → Sep 2021 | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT04223791 | Feb 2020 → Aug 2021 | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT02397096 | Jun 2015 → Feb 2018 | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT02403674 | Jun 2015 → Mar 2017 | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT02275780 | Dec 2014 → Sep 2016 | — | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 415 trials · 1 missed | ||||||
| Phase 4 | NCT07673965 | Oct 2026 → Aug 2027 expected | HIV infectious disease | University of Witwatersrand, South Africa | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07357584 | Sep 2026 → Apr 2028 expected | HIV infectious disease | Fundación Huésped | Recruiting | No outcome recorded |
| Phase 4 | NCT06602622 | Aug 2024 → Nov 2025 overdue | HIV wasting syndrome | Mexican Social Security Institute | Recruiting | No outcome recorded |
| Phase 4 | NCT05289986 | Nov 2023 → Nov 2024 | HIV infectious disease | Chelsea and Westminster NHS Foundation Trust | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT06037564 | Nov 2023 → Oct 2026 expected | HIV infectious disease | Insel Gruppe AG, University Hospital Bern | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT05630638 | Oct 2023 → Jul 2028 expected | HIV infectious disease | University of Liverpool | Recruiting | No outcome recorded |
| Phase 4 | NCT05648201 | Mar 2023 → Nov 2024 | HIV infectious disease | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT05506605 | Dec 2022 → Dec 2024 | HIV infectious disease | Fundacion Clinic per a la Recerca Biomédica | Unknown | No outcome recorded |
| Phase 4 | NCT04636437 | Jul 2021 → Oct 2024 | HIV infectious disease | Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections | Completed | Missed primary |
| Phase 4 | NCT04665375 | Apr 2021 → Mar 2024 | HIV infectious disease | University Health Network, Toronto | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT04689737 | Mar → Jun 2021 | — | Fight AIDS and Infectious Diseases Foundation | Completed | No outcome recorded |
| Phase 4 | NCT04903847 | Feb 2021 → Feb 2023 | HIV infectious disease, impaired renal function disease, lipodystrophy, obesity disorder +1 | Thomas Benfield | Unknown | No outcome recorded |
| Phase 4 | NCT04233372 | Aug 2020 → Jul 2022 | HIV infectious disease | Hospital Clinic of Barcelona | Completed | No outcome recorded |
| Phase 4 | NCT04334551 | Jun 2020 → Jul 2022 | HIV infectious disease | Clinique du Quartier Latin | Unknown | No outcome recorded |
| Phase 4 | NCT04538040 | Dec 2019 → Nov 2021 | HIV infectious disease | Quest Clinical Research | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT05477407 | Oct 2022 → Mar 2024 | HIV infectious disease | Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida | Completed | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| Phase 2 | NCT06338826 Background | Feb 2025 → Sep 2027 expected | HIV infectious disease | ANRS, Emerging Infectious Diseases | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT03272347 Background | Nov 2017 → Mar 2021 | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT06630299 Comparator | Oct 2024 → Apr 2026 overdue | HIV infectious disease | Gilead Sciences | Active not recruiting | Met primary |
| Phase 3 | NCT05457530 Comparator | Aug 2022 → May 2023 | HIV infectious disease, abdominal obesity-metabolic syndrome, obesity disorder | Prism Health North Texas | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT03631732 Comparator | Aug 2018 → Aug 2019 | HIV infectious disease | Gilead Sciences | Completed | Met primary |
News releases announcing trial results or a regulatory action · 24
| Date | Issuer | Release |
|---|---|---|
| 2026-07-15 | Merck Sharp & Dohme LLC | Results Merck to Present New Data on Daily, Weekly, and Monthly Options Across its HIV Treatment and Prevention Pipeline at AIDS 2026 merck.com ↗
Switching to doravirine/islatravir (100/0.25 mg) once-daily maintained viral suppression at Week 96 in the presence of baseline NNRTI resistance-associated mutations and/or M184I/V in proviral DNA (Abstract #OAB0105LB). |
| 2026-05-15 | MSD R&D (China) Co., Ltd. | Regulatory FDA、1日1回投与のIDVYNSO™（ドラビリン／イスラトラビル）を承認 msd.co.jp ↗
FDA、1日1回投与のIDVYNSO™（ドラビリン／イスラトラビル）を承認 |
| 2026-04-21 | Merck Sharp & Dohme LLC | Regulatory FDA Approves Merck’s Once-Daily IDVYNSO™ (doravirine/islatravir) merck.com ↗
IDVYNSO is approved for adults with virologically suppressed HIV-1 with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine |
| 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 |
| 2025-03-28 | 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 the double-blind trial MK-8591A-052 (Abstract #204A), results for the primary endpoint (HIV-1 RNA ≥50 copies/mL) showed that 1.5% of participants who switched to DOR/ISL had a viral load of ≥50 copies/mL at Week 48, compared to 0.6% on BIC/FTC/TAF (treatment difference 0.9%, 95% CI -1.9, 2.9). |
| 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。 |
| 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. |
| 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 ↗
At 48 weeks, both trials met their primary efficacy endpoint of percentage of participants with HIV-1 RNA levels ≥50 copies/mL, demonstrating that antiviral efficacy was comparable between DOR/ISL and ART (ILLUMINATE SWITCH A) and between DOR/ISL and BIC/FTC/TAF (ILLUMINATE SWITCH B). |
| 2020-10-08 | Merck Sharp & Dohme LLC | Results Merck Announces Week 96 Data from Phase 2b Study Evaluating Islatravir in Combination With Doravirine in Adults With HIV-1 Infection merck.com ↗
Week 96 findings demonstrated that the combination of islatravir and doravirine maintained virologic suppression (as measured by the number of study participants achieving HIV-1 RNA levels <50 copies/mL, similar to DELSTRIGO™ (doravirine/lamivudine/tenofovir disoproxil fumarate)), and the findings were consistent with Week 48 results. |
| 2020-07-06 | Merck Sharp & Dohme LLC | Results Merck Announces New Analyses Showing Additional Safety and Efficacy Data for Investigational Islatravir in Combination with Doravirine in Adults with HIV-1 Infection merck.com ↗
The first sub-analysis further characterized the tolerability and safety profile of islatravir in combination with doravirine (100 mg) through Week 48 across the three dose levels studied (0.25, 0.75, 2.25 mg). |
| 2019-09-20 | Merck Sharp & Dohme LLC | Regulatory Merck’s PIFELTRO™ (doravirine) and DELSTRIGO™ (doravirine/lamivudine/tenofovir disoproxil fumarate) Receive US FDA Approval for Use in Appropriate Adults Living with HIV-1 Who Are Virologically Suppressed merck.com ↗ |
| 2019-07-24 | Merck Sharp & Dohme LLC | Results Merck Announces Presentation of Phase 2b Results for Investigational HIV-1 Therapy Islatravir (MK-8591) at IAS 2019 merck.com ↗
At all dose levels, the combination of islatravir and doravirine maintained antiviral activity as measured by the number of study participants achieving HIV-1 RNA levels <50 copies/mL, similar to DELSTRIGO at Week 48 of the study. |
| 2019-07-10 | Merck Sharp & Dohme LLC | Results Merck Highlights Commitment to HIV Research with Presentations for Investigational Anti-HIV Agent MK-8591 at IAS 2019 merck.com ↗
MK-8591, at doses of 0.25 to 2.25 mg QD, in combination with doravirine establishes and maintains viral suppression through 48 weeks in treatment-naïve adults with HIV-1 infection. |
| 2019-01-22 | Merck Sharp & Dohme LLC | Regulatory U.S. FDA Accepts sNDAs for PIFELTRO™ (doravirine) and DELSTRIGO™ (doravirine/lamivudine/tenofovir disoproxil fumarate) 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 supplemental New Drug Applications (sNDAs) for PIFELTRO™ and DELSTRIGO™. |
| 2018-11-28 | Merck Sharp & Dohme LLC | Regulatory European Commission Approves Merck’s DELSTRIGO™ (doravirine / lamivudine / tenofovir disoproxil fumarate), a Once-Daily Fixed-Dose Combination Tablet as a Complete Regimen and PIFELTRO™ (doravirine), an NNRTI, Both for the Treatment of HIV-1 in… merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the European Commission has approved DELSTRIGO™ and PIFELTRO™ for the treatment of HIV-1 infection. |
| 2018-10-04 | Merck Sharp & Dohme LLC | Results Merck’s HIV Therapy DELSTRIGO™ (doravirine / lamivudine / tenofovir disoproxil fumarate) Meets Primary Efficacy Endpoint in Phase 3 DRIVE-SHIFT Study Evaluating Switch to DELSTRIGO from Other Antiretroviral Treatment Regimens merck.com ↗ |
| 2018-10-04 | Merck Sharp & Dohme LLC | Results Merck Announces Week 96 Data from Pivotal Phase 3 DRIVE-AHEAD Study Evaluating DELSTRIGO™ (doravirine / lamivudine / tenofovir disoproxil fumarate) for the Treatment of HIV-1 in Treatment-Naïve Patients merck.com ↗
The efficacy findings at Week 96 in DRIVE-AHEAD were consistent with the findings at Week 48 in which DELSTRIGO demonstrated non-inferior efficacy in comparison to a fixed-dose combination of efavirenz (EFV, 600 mg), emtricitabine (FTC, 200 mg) and TDF (300 mg). |
| 2018-09-20 | Merck Sharp & Dohme LLC | Regulatory Merck Receives Positive CHMP Opinion for DELSTRIGO™ (doravirine/lamivudine/tenofovir disoproxil fumarate) and PIFELTRO™ (doravirine) in the European Union for the Treatment of HIV-1 Infection merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending granting of marketing authorization for two HIV-1 medicines: DELSTRIGO™, a once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (3TC, 300 mg) and tenofovir disoproxil fumarate (TDF, 300 mg); and PIFELTRO™ (doravirine, 100 mg), a new non-nucleoside reverse transcriptase inhibitor (NNRTI) to be administered in combination with other antiretroviral medicines. |
| 2018-08-30 | Merck Sharp & Dohme LLC | Regulatory FDA Approves Merck’s DELSTRIGO™ (doravirine / lamivudine / tenofovir disoproxil fumarate), a Once-Daily Fixed-Dose Combination Tablet as a Complete Regimen and PIFELTRO™ (doravirine), an NNRTI, Both for the Treatment of HIV-1 in Appropriate Patients merck.com ↗
Today’s approvals of DELSTRIGO and PIFELTRO provide two new options for the treatment of HIV-1 in appropriate treatment-naïve adult patients. |
| 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. |
| 2014-11-03 | Merck Sharp & Dohme LLC | Results Merck Announces Data from 48-Week Phase 2b Study of Investigational HIV Therapy Doravirine (MK-1439) in Treatment-Naive Patients merck.com ↗
The results showed a significantly lower incidence of one or more of reported CNS AEs (all causality) among the doravirine-treated group compared to the efavirenz-treated group (22.2 % vs. 43.5 %, respectively; p<0.001). |
| 2014-03-05 | Merck Sharp & Dohme LLC | Results Merck’s Investigational HIV Therapy, Doravirine (MK-1439), Demonstrates Antiviral Activity in Phase 2B Study of Treatment-Naïve Adults merck.com ↗
Interim data demonstrating potent antiretroviral (ARV) activity for four doses (25, 50, 100 and 200 mg) of once-daily, oral doravirine in combination with tenofovir/emtricitabine in treatment-naïve, HIV-1 infected adults after 24 weeks of treatment were presented during a late-breaker oral session. |
All press releases naming this drug 40 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 65 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Doravirine | “Objective:To evaluate the effectiveness, safety, and tolerability of Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) compared with...” NCT07075146 ↗58“This is a phase 2 study of the pharmacokinetics, safety, and efficacy of oral doravirine/islatravir (100 mg/0.25 mg) \[MK-8591A\] in pediatric participants with human...” NCT07862569 ↗ “Doravirine / lamivudine / tenofovir disoproxil fumarate (Delstrigo®) 100 mg doravirine, 300 mg lamivudine,300 mg tenofovir disoproxil fumarate equivalent to 245 mg de tenofovir...” NCT04233372 ↗ “Doravirine 100 mg (Pifeltro®) will be administered once daily in combination with co-formulated dolutegravir/lamivudine 50/300 mg (Dovato®) for a duration of 48 weeks.” NCT06037564 ↗ “received either doravirine (100 mg) and islatravir (0·25 mg) or bictegravir (50 mg), emtricitabine (200 mg), and tenofovir alafenamide (25 mg) orally once daily.” PMID 41763226 ↗ Feb 2026 “Delstrigo (300 mg of tenofovir disoproxil fumarate equivalent to 245 mg of tenofovir disoproxil, 300 mg of lamivudine and 100 mg of doravirine” NCT05289986 ↗ “The goal of this study is to learn what happens to doravirine (DOR) and islatravir (ISL) in a healthy lactating female's body over time.” NCT07086079 ↗ “Single tablet combination of 100 mg doravirine (DOR) with 0.25 mg Islatravir (ISL) in tablet form, taken orally, once daily.” NCT05631093 ↗ “Doravirine/Islatravir (DOR/ISL) in Pediatric Participants With Human Immunodeficiency Virus Type 1 (HIV-1)” NCT04295772 ↗ “100mg of doravirine (DOR), 300mg of lamivudine (3TC), and 300mg of tenofovir disoproxil fumarate (TDF)” NCT04665375 ↗ “FDC tablet of 100 mg doravirine, 0.75 mg islatravir taken orally, once daily for up to 192 weeks” NCT04776252 ↗ |
| Known as | DOR | “BACKGROUND: New regimens may provide better tolerability, convenience, and safety for nonoccupational human immunodeficiency virus (HIV) postexposure prophylaxis (PEP). For...” PMID 37539061 ↗ Jul 202316“Objective:To evaluate the effectiveness, safety, and tolerability of Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) compared with...” NCT07075146 ↗ “This randomized, three-period crossover, open-label, phase I trial assessed the effects of doravirine (DOR) and tenofovir disoproxil fumarate (TDF) on the pharmacokinetics...” PMID 38421210 ↗ Mar 2024 “Doravirine (DOR) is a new second generation Non-Nucleosidic Reverse Transcriptase Inhibitor (NNRTI) highly effective both in naïve and experienced patients in combination with...” NCT05477407 ↗ “This is a pilot study investigating the efficacy of Doravirine (DOR) in combination with Lamivudine (3TC) and Tenofovir Disoproxil Fumarate (TDF) administered over 48 weeks” NCT04429152 ↗ “The goal of this study is to learn what happens to doravirine (DOR) and islatravir (ISL) in a healthy lactating female's body over time.” NCT07086079 ↗ “Single tablet combination of 100 mg doravirine (DOR) with 0.25 mg Islatravir (ISL) in tablet form, taken orally, once daily.” NCT05631093 ↗ “Doravirine (DOR) in combination with Lamivudine (3TC) and Tenofovir Disoproxil Fumarate (TDF) administered over 48 weeks” NCT04433780 ↗ “100mg of doravirine (DOR), 300mg of lamivudine (3TC), and 300mg of tenofovir disoproxil fumarate (TDF)” NCT04665375 ↗ “FDC tablet of 100 mg doravirine (DOR)/0.25 mg islatravir (ISL) taken once daily” NCT05766501 ↗ “100 mg of doravirine (DOR), 300 mg of lamivudine (3TC), and 300 mg of TDF” NCT05457530 ↗ |
| Known as | Doravirina | ChEMBL registry synonym — accepted as the source's own label CHEMBL2364608 ↗ |
| Known as | Doravirine (PIFELTRO) | “Doravirine (PIFELTRO™)” NCT02397096 ↗ |
| Known as | Doravirine component of delstrigo | ChEMBL registry synonym — accepted as the source's own label CHEMBL2364608 ↗ |
| Known as | MK-1439 | “FDC tablet containing MK-1439 (doravirine) 100 mg / lamivudine 300 mg / tenofovir disoproxil fumarate 300 mg taken by mouth.” NCT02629822 ↗4“Safety and Efficacy of Doravirine (MK-1439) in Participants With Human Immunodeficiency Virus 1 (HIV-1) (MK-1439-018)” NCT02275780 ↗ “Single tablet containing MK-1439 (doravirine) 100 mg, lamivudine 300 mg, and tenofovir disoproxil fumarate 300 mg” NCT02397096 ↗ “Effects of Doravirine (MK-1439) on Methadone Pharmacokinetics in Methadone-Maintained Participants (MK-1439-045)” NCT02715700 ↗ “Doravirine (MK-1439) 100 mg administered orally once daily” NCT04097925 ↗ |
| Known as | Mk-1439a | ChEMBL registry synonym — accepted as the source's own label CHEMBL2364608 ↗ |
| Known as | Pifeltro | “Doravirine 100 mg (Pifeltro®) will be administered once daily in combination with co-formulated dolutegravir/lamivudine 50/300 mg (Dovato®) for a duration of 48 weeks.” NCT06037564 ↗4“Participants randomised in the "arm 1" will receive the DORAVIRINE/LAMIVUDINE combination: doravirine (PIFELTRO®) 100 mg 1 pill a day + lamivudine 300 mg 1 pill a day” NCT06774872 ↗ “Switch from etravirine to Doravirine (Pifeltro) 100 mg each day” NCT05506605 ↗ “PIFELTRO (doravirine) 100 mg tablet one daily for 3 months” NCT04820933 ↗ “DORAVIRINE 100 MG [Pifeltro]” NCT04513626 ↗ |
| Action | Inhibit | “Doravirine is a novel, potent, nonnucleoside reverse-transcriptase inhibitor” PMID 28026013 ↗ Dec 2016 |
| Modality | Small molecule | “Doravirine is a novel, non-nucleoside reverse transcriptase inhibitor” PMID 31740348 ↗ Nov 2019 |
| Route | Oral | “Doravirine tablets, orally, once daily for 7 days at a dose of 25 mg in Panel A and 200 mg in Panel B; dose in Panel C to be determined (≤200 mg).” NCT01466985 ↗ |