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: *
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: None
Known Adverse Events: None
Company: Gilead Sciences
Company Location: Western America
Company Founding Year: 1987
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Belgium, France, Germany, Ireland, Italy, Spain, United Kingdom, United States
Active Clinical Trial Count: 7
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Acquired Immunodeficiency Syndrome|COVID-19|HIV Infections
Phase 1: Healthy Volunteers|Kidney Diseases
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT03696160 |
LAPTOP | P3 |
Completed |
HIV Infections|Acquired Immunodeficiency Syndrome |
2024-06-17 |
33% |
2024-09-20 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
2020-001031-27 |
Treatment of COVID-19 Cases and Chemoprophylaxis of Contacts as Prevention | P3 |
Active, not recruiting |
COVID-19 |
2020-06-13 |
2025-05-25 |
Treatments |
|
ACTRN12621000745842p |
2006-7041-83/hah | P1 |
Not yet recruiting |
Kidney Diseases |
2022-02-28 |
|||
2015-000313-40 |
2015-000313-40 | P3 |
Completed |
HIV Infections |
2024-05-25 |
2025-05-25 |
Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
ACTRN12619001607167p |
2006-7041-83/hah | P1 |
Not yet recruiting |
Healthy Volunteers |
None |
|||
NCT06385119 |
F8394-101 | P1 |
Completed |
Healthy Volunteers |
2024-12-22 |
50% |
2025-08-27 |
Primary Endpoints|Treatments |
2021-000738-32 |
2021-000738-32 | P1 |
Active, not recruiting |
HIV Infections |
2023-03-15 |
14% |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
02/10/2026 |
News Article |
Gilead Sciences Announces Fourth Quarter and Full Year 2025 Financial Results |
|
01/21/2026 |
News Article |
Johnson & Johnson reports Q4 and Full-Year 2025 results |
|
10/30/2025 |
News Article |
Gilead Sciences Announces Third Quarter 2025 Financial Results |
|
10/14/2025 |
News Article |
Johnson & Johnson Reports Q3 2025 Results; Raises 2025 Sales Outlook |