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Prezista®
Prezista (darunavir) is a protease inhibitor that blocks HIV protease, preventing the cleavage of viral polyproteins and inhibiting viral replication.
Prezista (darunavir) is a protease inhibitor that blocks HIV protease, preventing the cleavage of viral polyproteins and inhibiting viral replication. Used for HIV-1 infection in treatment-experienced patients, HIV-1 infection in treatment-naïve patients (in combination with other antiretrovirals).
At a glance
| Generic name | Prezista® |
|---|---|
| Also known as | First Intervention Period, Second Intervention Period, Darunavir |
| Sponsor | Geropharm |
| Drug class | HIV protease inhibitor |
| Target | HIV protease |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
Darunavir binds to the active site of HIV protease with high affinity, preventing the maturation of viral particles. By inhibiting protease-mediated cleavage of viral precursor proteins, the drug produces immature, non-infectious viral particles. It is typically used in combination with other antiretroviral agents and a ritonavir booster to achieve therapeutic plasma concentrations.
Approved indications
- HIV-1 infection in treatment-experienced patients
- HIV-1 infection in treatment-naïve patients (in combination with other antiretrovirals)
Common side effects
- Diarrhea
- Nausea
- Headache
- Rash
- Abdominal pain
- Vomiting
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)
- 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)
- 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)
- Clinical Trial of Gammora® Plus Antiretroviral Treatment for HIV (PHASE2)
- Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive (PHASE4)
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:
- Prezista® CI brief — competitive landscape report
- Prezista® updates RSS · CI watch RSS
- Geropharm portfolio CI