Product Description
Bictegravir is a human immunodeficiency virus (HIV) integrase strand transfer inhibitor, the fourth in this class of agents that target the viral integrase. Bictegravir is used only in combination with other antiretroviral agents in the treatment of HIV infection and it has had limited use. Bictegravir is associated with a low rate of serum aminotransferase elevations during therapy, but has not been linked to instances of acute, clinically apparent liver injury. (Sourced from: https://pubchem.ncbi.nlm.nih.gov/compound/Bictegravir)
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 | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Dominican Republic | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Mexico | Netherlands | New Zealand | Poland | Portugal | Romania | Russia | Serbia | Singapore | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | Turkey | United Arab Emirates | United Kingdom | United States | Uruguay
Approved Indications: None
Known Adverse Events: None
Company: Gilead Sciences
Company Location: FOSTER CITY CA 94404
Company CEO: Daniel P. O’Day
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Austria, Belgium, Canada, Chile, Dominican Republic, France, Germany, Israel, Italy, Japan, Netherlands, Portugal, Puerto Rico, South Africa, Spain, Thailand, Uganda, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 16
Highest Development Phases
Phase 3: HIV Infections
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| jRCT2051240046 | P3 |
Recruiting |
HIV Infections |
2029-12-31 |
|
| GS-US-621-6290 | P3 |
Not yet recruiting |
HIV Infections |
2029-12-28 |
|
| jRCT2051230168 | P3 |
Not yet recruiting |
HIV Infections |
2029-05-31 |
|
| GS-US-621-6289 | P3 |
Recruiting |
HIV Infections |
2028-11-03 |