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Prezista (DARUNAVIR)
Darunavir works by blocking the protease enzyme, which is essential for the replication of the HIV virus.
At a glance
| Generic name | DARUNAVIR |
|---|---|
| Sponsor | Janssen Prods |
| Drug class | Protease Inhibitor [EPC] |
| Target | Multidrug resistance protein 1 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2006 |
Mechanism of action
Darunavir is an HIV-1 antiviral drug [see Microbiology (12.4)].
Approved indications
- Human immunodeficiency virus infection
Common side effects
- Diarrhea
- Abdominal pain
- Nausea
- Headache
- Rash
- Vomiting
- Fatigue
- Anorexia
- Acute pancreatitis
- Dyspepsia
- Flatulence
- Asthenia
Drug interactions
- CYP3A4 Substrates
- P-glycoprotein Substrates
- fosphenytoin
- itraconazole
- ketoconazole
- lovastatin
- maraviroc
- methylergometrine
- midazolam
- phenobarbital
- phenytoin
- pimozide
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)
- Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy (PHASE3)
- The Late Presenter Treatment Optimisation Study (PHASE3)
- Therapeutic Drug Monitoring to oPtimize ANtiretroviral regimeNs in HIV-infected Women Who wAnt to Breastfeed
- 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)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Prezista CI brief — competitive landscape report
- Prezista updates RSS · CI watch RSS
- Janssen Prods portfolio CI