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darunavir (DRV, TMC114)
Darunavir is a protease inhibitor that blocks the protease enzyme in HIV, preventing viral replication.
Darunavir is a protease inhibitor that blocks the protease enzyme in HIV, preventing viral replication. Used for Treatment of HIV-1 infection in adults and children, Prevention of HIV-1 infection in adults and children.
At a glance
| Generic name | darunavir (DRV, TMC114) |
|---|---|
| Sponsor | Janssen-Cilag International NV |
| Drug class | Protease inhibitor |
| Target | HIV protease |
| Modality | Small molecule |
| Therapeutic area | Infectious diseases |
| Phase | Phase 3 |
Mechanism of action
Darunavir works by binding to the protease enzyme, which is essential for the maturation of viral particles. By inhibiting this enzyme, darunavir prevents the production of infectious viral particles, thereby reducing the viral load in the body.
Approved indications
- Treatment of HIV-1 infection in adults and children
- Prevention of HIV-1 infection in adults and children
Common side effects
- Nausea
- Diarrhea
- Abdominal pain
- Headache
- Fatigue
Key clinical trials
- Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV (PHASE2, PHASE3)
- A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments (PHASE4)
- Pharmacokinetics Safety and Acceptability of DRV/r for Children Living With HIV (PHASE1, PHASE2)
- Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
- Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1 (PHASE3)
- Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum
- Estradiol Therapy In Transgender Women to Research Interactions With HIV Therapy (PHASE2)
- Ndovu RCT: Investing the Optimal Management of Dolutegravir Resistance (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- darunavir (DRV, TMC114) CI brief — competitive landscape report
- darunavir (DRV, TMC114) updates RSS · CI watch RSS
- Janssen-Cilag International NV portfolio CI