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doravirine

Trade name: pifeltro

Small moleculeapproved

Approved

Aug 30, 2018

Doravirine (MK-1439) is a nonnucleoside inhibitor of HIV reverse transcriptase (NNRTI). It displays excellent activities against not only WT viruses but also a broader panel of NNRTI-resistant viruses. Doravirine is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults who have never taken HIV medicines before. Doravirine is always used in combination with other HIV medicines. — NCATS

Clinical trial activity

58 trials · 41 clinical orgs · 1 marketing orgs

Phase 1
13
Phase 2
31
Phase 3
20
Phase 4
14

Earliest trial started Oct 1, 2011 (NCT01466985)

Timeline

2010s

  1. Jan 1, 2011

    Merck — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2012

    Merck — Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2014

    Merck — Earliest Phase 3 Sponsor(trial)

  4. Aug 30, 2018

    Merck — Earliest FDA Approval

  5. Aug 30, 2018

    Merck — NDA Secondary Org

  6. Aug 30, 2018

    Merck — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

  • delstrigo

    with tenofovir, lamivudine

    Also known as doravirine/lamivudine/tenofovir disoproxil fumarate 100 mg-300 mg-300 mg oral tablet [delstrigo]

Approval history

  • approvedAug 30, 2018

Chemistry & pharmacology

Loading structure…

SMILES

CN1C(=O)NN=C1CN2C=CC(=C(OC3=CC(Cl)=CC(=C3)C#N)C2=O)C(F)(F)F
Mol. weight
425.749 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • doravirine
  • doravirine
  • doravirine
  • doravirine
  • doravirine
  • doravirine
  • mk-1439
  • mk-1439
  • mk-1439
  • mk-1439

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07086079Phase 1Sep 26, 2025Merck
NCT07075146Phase 3May 5, 2025Instituto Mexicano del Seguro Social
NCT06774872Phase 2Apr 30, 2025Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida, Government of France, Sorbonne University
NCT06203132Phase 3Nov 30, 2024Assistance Publique - Hôpitaux de Paris, European and Developing Countries Clinical Trials Partnership (EDCTP), Government of France, Merck
NCT06602622Phase 4Aug 14, 2024Instituto Mexicano del Seguro Social
NCT06719570Phase 1Jan 23, 2024Merck
NCT06034938Phase 2Dec 1, 2023Merck, University of Caen-Normandie
NCT06037564Phase 4Nov 13, 2023University of Bern, University of Lausanne
NCT05924438Phase 3Nov 8, 2023Africa Health Research Institute, Merck, University of the Witwatersrand
NCT05766501Phase 3Mar 17, 2023Merck
NCT05705349Phase 3Mar 8, 2023Merck
NCT05630755Phase 3Feb 28, 2023Merck
NCT05631093Phase 3Feb 20, 2023Merck
NCT05648201Phase 4Jan 2, 2023Merck, Radboud University, ZonMw: The Netherlands Organisation for Health Research and Development
NCT05630638Phase 4Jan 1, 2023Desmond Tutu Health Foundation, University of Liverpool
NCT05506605Phase 4Oct 30, 2022University of Barcelona
NCT05477407N/ASep 15, 2022Assistance Publique - Hôpitaux de Paris, Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
NCT05457530Phase 3Aug 31, 2022Merck, Prism Health North Texas
NCT04820933Early Phase 1 (Phase 1)Jul 1, 2022Merck, The University of Texas, Dallas
NCT05289986Phase 4Jun 30, 2022Merck, University of London
Showing 20 of 58 trials
Page 1 / 3

Organizations

Research & Development (41)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
MerckFor profit392542011
University of BarcelonaAcademic/Hospital4332019
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le SidaAcademic/Hospital3322020
National Institute of Allergy and Infectious Diseases (NIAID)Government3222018
University of LondonAcademic/Hospital3332019
University of the WitwatersrandAcademic/Hospital3312020
Assistance Publique - Hôpitaux de ParisAcademic/Hospital2022022
Chelsea and Westminster Hospital NHS Foundation TrustAcademic/Hospital2022019
Fundacio Lluita Contra la SIDAAcademic/Hospital2122019
Gilead SciencesFor profit2012019
Government of FranceGovernment2122024
Instituto Mexicano del Seguro SocialGovernment2222024
Sorbonne UniversityAcademic/Hospital2012020
Thomas Jefferson UniversityAcademic/Hospital2212019
University of LiverpoolAcademic/Hospital2122019
Africa Health Research InstituteAcademic/Hospital1012023
AIDS Clinical Trials GroupAcademic/Hospital1112020
Boston UniversityAcademic/Hospital1012020
Center of Research and Disruption of Infectious DiseasesAcademic/Hospital1012021
Clinique du Quartier LatinAcademic/Hospital1112020
41 organizations
Page 1 / 3

Marketing (3)

OrganizationOrg typeRelationshipDate
MerckFor profitNDA2Aug 30, 2018
MerckFor profitNDAAug 30, 2018
MerckFor profitSYNApr 20, 2026