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Alternative Names: darunavir, prezista, tmc-114, tmc114, tmc41629, prezcobix, symtuza
Latest Update: 2024-06-19
Latest Update Note: News Article

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

Map of Global Clinical Trials for Darunavir

Countries in Clinic: Belgium, Brazil, Costa Rica, France, Germany, Guatemala, Ireland, Italy, Malaysia, Netherlands, Panama, South Africa, Spain, Thailand, Ukraine, United Kingdom, United States

Active Clinical Trial Count: 17

Highest Development Phases

Phase 3: Acquired Immunodeficiency Syndrome|HIV Infections

Phase 1: Healthy Volunteers|Malnutrition



Trial Status


Primary Completion Date

Probability of Success



Not yet recruiting

HIV Infections




Active, not recruiting

HIV Infections|Acquired Immunodeficiency Syndrome




Active, not recruiting

HIV Infections




Active, not recruiting

HIV Infections


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