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: None *
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: HIV Infections | HIV Infections
Known Adverse Events: Abdominal Pain | Dizziness | Headache | Pain Unspecified | Diarrhea
Company: Merck
Company Location: KENILWORTH NJ 07033
Company CEO: Robert M. Davis
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Brazil, Cambodia, Cameroon, Canada, Chile, Colombia, Finland, France, Germany, Israel, Italy, Ivory Coast, Japan, Korea, 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: 32
Highest Development Phases
Phase 3: Communicable Diseases|HIV Infections
Phase 2: Acquired Immunodeficiency Syndrome
Phase 1: Healthy Volunteers|Lipid Metabolism Disorders|Pregnancy Outcomes
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| MK-1439-066 | P2 |
Recruiting |
HIV Infections|Acquired Immunodeficiency Syndrome |
2028-03-04 |
25% |
| ANRS0392s ELDORADO | P3 |
Not yet recruiting |
HIV Infections |
2027-09-01 |
|
| jRCT2031220720 | P3 |
Recruiting |
HIV Infections |
2026-08-03 |
|
| MK-8591A-053 | P3 |
Recruiting |
HIV Infections |
2026-08-01 |