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Saquinavir (Invirase®)
Saquinavir inhibits HIV protease, preventing the cleavage of viral polyproteins and blocking the maturation of infectious HIV particles.
Saquinavir inhibits HIV protease, preventing the cleavage of viral polyproteins and blocking the maturation of infectious HIV particles. Used for HIV-1 infection (in combination antiretroviral therapy).
At a glance
| Generic name | Saquinavir (Invirase®) |
|---|---|
| Also known as | Invirase® |
| Sponsor | Royal Free Hampstead NHS Trust |
| Drug class | HIV protease inhibitor |
| Target | HIV protease |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
Saquinavir is a protease inhibitor that binds to the active site of HIV protease, a viral enzyme essential for processing precursor proteins into functional viral components. By blocking this enzymatic activity, the drug prevents the formation of mature, infectious viral particles, thereby reducing viral replication and slowing disease progression in HIV-infected patients.
Approved indications
- HIV-1 infection (in combination antiretroviral therapy)
Common side effects
- Gastrointestinal disturbances (diarrhea, nausea)
- Headache
- Elevated liver enzymes
- Lipodystrophy
- Hyperglycemia
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)
- Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy (PHASE3)
- Study to Evaluate Switching From a Regimen of Two Nucleos(t)Ide Reverse Transcriptase Inhibitors (NRTI) Plus a Third Agent to a Fixed Dose Combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), in Virologically-Suppressed, HIV-1 Infected African American Participants (PHASE3)
- Study to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) in Virologically-Suppressed HIV-1 Infected Adults Harboring the Archived Isolated NRTI Resistance Mutation M184V/M184I (PHASE3)
- Switching From a Tenofovir Disoproxil Fumarate (TDF) Containing Regimen to Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide (E/C/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Infected Adults Aged ≥ 60 Years (PHASE3)
- Safety and Efficacy of Switching From Regimens of ABC/3TC + a 3rd Agent to E/C/F/TAF Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV 1 Infected Adults (PHASE3)
- Safety of EVG+RTV Administered With Other Antiretroviral Agents for the Treatment of HIV-1 Infection (PHASE2)
- A Study of Invirase (Saquinavir)/Ritonavir in HIV-Infected Infants and Children. (PHASE2)
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:
- Saquinavir (Invirase®) CI brief — competitive landscape report
- Saquinavir (Invirase®) updates RSS · CI watch RSS
- Royal Free Hampstead NHS Trust portfolio CI