Product Description
Dolutegravir is used together with other medicines for the treatment of the infection caused by human immunodeficiency virus (HIV) in patients who have not received anti-HIV medicines in the past or to replace their current anti-HIV medicines. HIV is the virus that causes acquired immune deficiency syndrome (AIDS). Dolutegravir tablets are also used together with rilpivirine in adults to replace their current anti-HIV medicines when their healthcare provider determines that they meet certain requirements. (Sourced from: https://www.mayoclinic.org/drugs-supplements/dolutegravir-oral-route/description/drg-20061287)
Mechanisms of Action: HIV Integrase Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Bosnia | Brazil | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | New Zealand | Norway | Peru | Philippines | 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 | Uruguay | Vietnam
Approved Indications: HIV Infections | HIV Infections | HIV Infections
Known Adverse Events: Headache | Insomnia | Diarrhea
Company: ViiV Healthcare
Company Location:
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Belgium, Botswana, Brazil, Burkina Faso, Cameroon, Canada, Chile, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Ivory Coast, Japan, Jordan, Kenya, Mexico, Netherlands, Poland, Portugal, Puerto Rico, South Africa, Spain, Sweden, Switzerland, Tanzania, Thailand, Uganda, United Kingdom, United States, Zimbabwe
Active Clinical Trial Count: 26
Highest Development Phases
Phase 3: HIV Infections|Tuberculosis
Phase 1: Healthy Volunteers|Malaria
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| DOVETAIL | P3 |
Not yet recruiting |
Tuberculosis |
2028-01-31 |
|
| 219816 | P3 |
Unknown Status |
HIV Infections |
2026-12-09 |
|
| 219700 | P3 |
Unknown Status |
HIV Infections |
2026-08-25 |
|
| NCT05674656 | P2 |
Recruiting |
HIV Infections |
2026-06-01 |