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DARUNAVIR ETHANOLATE
At a glance
| Generic name | DARUNAVIR ETHANOLATE |
|---|---|
| Drug class | Cytochrome P450 3A Inhibitor [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2006 |
Approved indications
Common side effects
- Diarrhea
- Nausea
- Rash
- Headache
- Abdominal Pain
- Vomiting
Serious adverse events
- Hepatotoxicity
- Toxic Epidermal Necrolysis
- Acute Generalized Exanthematous Pustulosis
- Drug Rash with Eosinophilia and Systemic Symptoms
- Rhabdomyolysis
- Crystal Nephropathy
- Crystalluria
- Immune Reconstitution Syndrome
- New Onset or Worsening Renal Impairment
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)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- DARUNAVIR ETHANOLATE CI brief — competitive landscape report
- DARUNAVIR ETHANOLATE updates RSS · CI watch RSS