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, 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:
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-8591A-053 | P3 |
Unknown Status |
HIV Infections |
2029-08-06 |
|
| MK-1439-066 | P2 |
Recruiting |
Acquired Immunodeficiency Syndrome|HIV Infections |
2028-03-04 |
|
| ANRS0392s ELDORADO | P3 |
Unknown Status |
HIV Infections |
2027-09-01 |
|
| ELDORADO | P3 |
Not yet recruiting |
HIV Infections|Communicable Diseases |
2026-11-01 |