Wednesday, July 8, 2026

Drug profile · INN

darunavir

darunavir (DARUNAVIR JUNO) is a human immunodeficiency virus type 1 protease inhibitor. Associated with Janssen-Cilag Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Antiinfectives for systemic use (J05) J05AE10
US status approved
Patents linked 0
Pipeline programs 1
News articles 0
Drug details — darunavir
US status
approved
Class
Antiinfectives for systemic use (J05)
Route
ORAL
Patents
0
Programs
1
Data quality
0.89

Quick answer

darunavir (DARUNAVIR JUNO) is a human immunodeficiency virus type 1 protease inhibitor. Associated with Janssen-Cilag Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN darunavir
Brand DARUNAVIR JUNO
Mechanism Human immunodeficiency virus type 1 protease inhibitor
Target Human immunodeficiency virus type 1 protease
Therapeutic class Antiinfectives for systemic use (J05)
Route ORAL
Formulation SUSPENSION
ATC code J05AE10

Mechanism of action

Human immunodeficiency virus type 1 protease inhibitor

Primary target: Human immunodeficiency virus type 1 protease

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Pipeline programs

  1. GS-US-563-5926 Phase 3 · Gilead Sciences · HIV-1 Infection

Related & competitor drugs

  1. atazanavir sulfate Antiinfectives for systemic use (J05)
  2. colistimethate sodium Antiinfectives for systemic use (J01)
  3. covid-19 mrna vaccine Antiinfectives for systemic use (J07)
  4. daptomycin Antiinfectives for systemic use (J01)
  5. dengue tetravalent vaccine (live, attenuated) Antiinfectives for systemic use (J07)
  6. dolutegravir Antiinfectives for systemic use (J05)

Frequently asked questions

What is darunavir?

darunavir (DARUNAVIR JUNO) is a human immunodeficiency virus type 1 protease inhibitor. Associated with Janssen-Cilag Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for darunavir?

DARUNAVIR JUNO is a marketed brand name for darunavir. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of darunavir?

darunavir has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.