Product Description
Darunavir is used with a pharmacokinetic booster (a medication that increases the amount of other medications in the body) such as ritonavir (Norvir) or cobicistat (Tybost), and other medications to treat human immunodeficiency virus (HIV) infection in adults and children 3 years of age and older. Darunavir is in a class of medications called protease inhibitors. It works by decreasing the amount of HIV in the blood. Although darunavir does not cure HIV, it may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses such as serious infections or cancer. Taking these medications along with practicing safer sex and making other life-style changes may decrease the risk of transmitting the HIV virus to other people. (Sourced from: https://medlineplus.gov/druginfo/meds/a607042.html)
Mechanisms of Action: HIV Protease 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 | Bulgaria | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Ireland | Israel | Italy | Japan | Korea | Latvia | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Netherlands | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Thailand | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: HIV Infections | HIV Infections
Known Adverse Events: Abdominal Pain | Headache | Pain Unspecified | Diarrhea | Flatulence
Company: Johnson & Johnson
Company Location: NEW BRUNSWICK NJ 08933
Company CEO: Joaquin Duato
Additonal Commercial Interests: None
Clinical Description

Countries in Clinic: Belgium, France, Germany, Ireland, Italy, South Africa, Spain, United Kingdom, United States
Active Clinical Trial Count: 8
Highest Development Phases
Phase 3: Acquired Immunodeficiency Syndrome|HIV Infections
Phase 1: Malnutrition
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
---|---|---|---|---|---|
ANRS0250s-BI-LIGHT | P2 |
Unknown Status |
HIV Infections |
2027-06-30 |
|
LAPTOP | P3 |
Completed |
Acquired Immunodeficiency Syndrome|HIV Infections |
2024-06-17 |
|
ANRS177DUETTO | P3 |
Active, not recruiting |
HIV Infections |
2024-05-29 |
|
2021-000738-32 | P1 |
Active, not recruiting |
HIV Infections |
2023-03-15 |