Product Description
Cobicistat is used to increase the amounts of atazanavir (Reyataz, in Evotaz ) in adults and children weighing at least 77 pounds (35 kg) or darunavir (Prezista, in Prezcobix ) in adults and children weighing at least 88 pounds (40 kg) in the blood when these medications are used to treat human immunodeficiency virus (HIV). Cobicistat is in a class of medications called pharmacokinetic boosters. It works by increasing the amount of atazanavir or darunavir in the body so that they can have a greater effect. (Sourced from: https://medlineplus.gov/druginfo/meds/a616029.html)
Mechanisms of Action: Integrase Inhibitor,CYP3A4 Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Bangladesh | Belgium | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Japan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | New Zealand | Norway | Peru | Poland | Portugal | Romania | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay
Approved Indications: HIV Infections | HIV Infections | HIV Infections
Known Adverse Events: Abdominal Pain | Headache | Pain Unspecified | Diarrhea | Flatulence
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, Belgium, China, France, Germany, Ireland, Italy, Spain, United Kingdom, United States
Active Clinical Trial Count:
Highest Development Phases
Phase 3: Acquired Immunodeficiency Syndrome|HIV Infections
Phase 1: Healthy Volunteers|Kidney Diseases|Malnutrition
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
---|---|---|---|---|---|
F8394-101 | P1 |
Recruiting |
Healthy Volunteers |
2024-10-31 |
|
LAPTOP | P3 |
Completed |
Acquired Immunodeficiency Syndrome|HIV Infections |
2024-06-17 |
|
2021-000738-32 | P1 |
Active, not recruiting |
HIV Infections |
2023-03-15 |
|
PBI-200-106 | P1 |
Completed |
Healthy Volunteers |
2022-11-12 |
28% |
PBI-200-106 | P1 |
Completed |
Healthy Volunteers |
2022-11-12 |
28% |