Product Description
Doravirine (brand name: Pifeltro) is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults who meet certain requirements, as determined by a health care provider. Doravirine is always used in combination with other HIV medicines. (Sourced from: https://clinicalinfo.hiv.gov/en/drugs/doravirine/patient)
Mechanisms of Action: NNRT Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Bosnia | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Ecuador | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Japan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Mexico | Netherlands | Norway | Peru | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States
Approved Indications: None
Known Adverse Events: None
Company: Merck
Company Location: Eastern America
Company Founding Year: 1668
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Brazil, Cameroon, Canada, Chile, Colombia, Finland, France, Germany, Israel, Italy, Japan, Malaysia, Mexico, Mozambique, Netherlands, New Zealand, Peru, Poland, Portugal, Puerto Rico, Russia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 27
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Merck presented P3 HIV Infections results on 2026-02-25 for Doravirine
- Clinical Outcomes Reported - Merck presented P3 HIV Infections results on 2025-11-19 for Doravirine
- Clinical Outcomes Reported - Merck presented P3 HIV Infections results on 2025-10-15 for Doravirine
Highest Development Phases
Phase 3: Communicable Diseases|HIV Infections
Phase 2: Acquired Immunodeficiency Syndrome
Phase 1: Healthy Volunteers|Lipid Metabolism Disorders|Pregnancy Outcomes
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT04900974 |
NCT04900974 | P1 |
Completed |
HIV Infections|Pregnancy Outcomes |
2025-03-27 |
24% |
2025-05-28 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT06034938 |
DOR | P2 |
Recruiting |
Acquired Immunodeficiency Syndrome |
2026-04-01 |
12% |
2025-08-27 |
Primary Endpoints |
NCT06203132 |
ELDORADO | P3 |
Recruiting |
HIV Infections|Communicable Diseases |
2026-11-01 |
28% |
2025-03-28 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT05924438 |
Opti-DOR | P3 |
Active, not recruiting |
HIV Infections |
2026-06-30 |
27% |
2025-04-03 |
Primary Endpoints |
NCT04820933 |
MISP# 60720 ; STU-2023-0724 | P1 |
Completed |
Lipid Metabolism Disorders |
2025-10-01 |
50% |
2026-01-31 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
2023-508626-10-00 |
ANRS0392s ELDORADO | P3 |
Recruiting |
HIV Infections |
2027-09-01 |
2025-05-02 |
Treatments |
|
jRCT2031220720 |
jRCT2031220720 | P3 |
Recruiting |
HIV Infections |
2026-08-03 |
36% |
||
2022-502099-22-00 |
MK-8591A-053 | P3 |
Withdrawn |
HIV Infections |
2026-08-01 |
36% |
2025-05-02 |
Treatments |
jRCT2051230002 |
jRCT2051230002 | P3 |
Recruiting |
HIV Infections |
2026-01-14 |
30% |
||
jRCT2031220698 |
jRCT2031220698 | P3 |
Recruiting |
HIV Infections |
2025-10-17 |
20% |
||
NCT05766501 |
MK-8591A-054 | P3 |
Active, not recruiting |
HIV Infections |
2025-10-16 |
30% |
2025-12-18 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Treatments |
2024-512215-53-00 |
MK-8591A-033 | P3 |
Active, not recruiting |
HIV Infections |
2025-10-07 |
59% |
2025-05-02 |
Treatments |
2019-000587-23 |
DOR/ISL Blinded Label Switch | P3 |
Completed |
HIV Infections |
2025-02-27 |
35% |
2025-07-06 |
Treatments |
NCT05630755 |
MK-8591A-052 | P3 |
Active, not recruiting |
HIV Infections |
2024-10-25 |
52% |
2024-11-08 |
Primary Completion Date|Primary Endpoints|Treatments |
2019-000586-20 |
DOR/ISL Open-Label Switch | P3 |
Completed |
HIV Infections |
2024-08-26 |
37% |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
jRCT2031210528 |
jRCT2031210528 | P3 |
Recruiting |
HIV Infections |
2024-07-24 |
59% |
||
2019-000590-23 |
Randomized, double blind, safety, efficacy Doravirine/Islatravir in Tx naïve | P3 |
Active, not recruiting |
HIV Infections |
2024-01-28 |
32% |
2025-05-06 |
Treatments |
jRCT2051230003 |
jRCT2051230003 | P3 |
Recruiting |
HIV Infections |
2023-09-26 |
52% |
||
2014-003382-17 |
MK-1439A versus ATRIPLA in treatment-naïve HIV-1 infected subjects | P3 |
Completed |
HIV Infections |
2023-09-07 |
32% |
2025-07-09 |
Treatments |
2014-001127-69 |
2014-001127-69 | P3 |
Completed |
HIV Infections |
2023-03-06 |
49% |
2025-05-06 |
Primary Completion Date |
2019-000588-26 |
DOR/ISL in heavily treatment-experienced participants | P3 |
Active, not recruiting |
HIV Infections |
2022-03-02 |
35% |
2022-03-13 |
Treatments |
NCT06719570 |
MK-8591A-055 | P1 |
Completed |
Healthy Volunteers |
2024-03-15 |
2024-12-07 |
||
NCT04375800 |
MK-1439-066 | P2 |
Recruiting |
HIV Infections|Acquired Immunodeficiency Syndrome |
2028-11-12 |
12% |
2026-02-19 |
Primary Completion Date|Primary Endpoints|Treatments |
2017-001518-27 |
2017-001518-27 | P2 |
Completed |
HIV Infections |
2023-04-13 |
2025-07-09 |
Treatments |
|
2022-502099-22-01 |
MK-8591A-053 | P3 |
Active, not recruiting |
HIV Infections |
2029-08-06 |
2025-05-02 |
Treatments |