Doravirine
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | 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 · a red edge is where a trial was stopped
| 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 | ||||||
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| 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 29 trials | ||||||
| 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 | No outcome recorded |
| Phase 317 trials | ||||||
| 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 | NCT05924438 | Nov 2023 → Jun 2026 overdue | HIV infectious disease | Professor Francois Venter | Active not 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 | No outcome recorded |
| Phase 3 | NCT05631093 | Feb 2023 → Oct 2024 overdue | HIV infectious disease | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05630755 | Feb 2023 → Oct 2024 overdue | HIV infectious disease | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| 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 | NCT04223778 | Feb 2020 → Sep 2021 | HIV infectious disease | Merck Sharp & Dohme LLC | 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 | NCT04223791 | Feb 2020 → Aug 2021 | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT02397096 | Jun 2015 → Feb 2018 | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT02403674 | Jun 2015 → Mar 2017 | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT02275780 | Dec 2014 → Sep 2016 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 415 trials | ||||||
| Phase 4 | NCT07673965 | Aug 2026 → Aug 2027 expected | HIV infectious disease | University of Witwatersrand, South Africa | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07357584 | Jul 2026 → Jan 2028 expected | HIV infectious disease | Fundación Huésped | Not yet 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 |
| 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 | No outcome recorded |
| Phase 4 | NCT04665375 | Apr 2021 → Mar 2024 | HIV infectious disease | University Health Network, Toronto | Terminated | No outcome recorded |
| 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 |
Also used as a comparator or background therapy in 5 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 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 33 trials | ||||||
| Phase 3 | NCT06630299 Comparator | Oct 2024 → Apr 2026 overdue | HIV infectious disease | Gilead Sciences | Active not recruiting | No outcome recorded |
| 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 |
| Phase 3 | NCT03631732 Comparator | Aug 2018 → Aug 2019 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
Evidence & citations 12 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 ↗57“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 ↗ “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 ↗ “NNRTI = efavirenz, rilpivirine, etravirine, doravirine” NCT06338826 ↗ “doravirine (100 mg) and islatravir (0·75 mg)” NCT04223791 ↗ “Group 1: Doravirine/Islatravir (DOR/ISL)” NCT04223778 ↗ “doravirine (DOR)/TDF/3TC” NCT06630299 ↗ “Doravirine/Islatravir” NCT05630755 ↗ “doravirine (DOR)” NCT03631732 ↗ |
| Known as | Delstrigo | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05924438 ↗ |
| 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 ↗ “Doravirine (DOR)/Lamivudine (3TC)/Tenofovir Disproxyl Fumarate (TDF)” NCT06034938 ↗ “Doravirine (DOR) is a nonnucleoside reverse-transcriptase inhibitor.” PMID 33336698 ↗ Jul 2021 “Group 1: Doravirine/Islatravir (DOR/ISL)” NCT04223778 ↗ “Doravirine (DOR)” NCT03332095 ↗ “Doravirine (DOR)” NCT03886701 ↗ “doravirine (DOR)” NCT03631732 ↗ |
| 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 ↗ |