Last reviewed 2026-05-22 · How we verify

Saquinavir (Invirase®)

Saquinavir (Invirase®) is a HIV protease inhibitor Small molecule drug developed by Royal Free Hampstead NHS Trust. It is currently FDA-approved for HIV-1 infection (in combination antiretroviral therapy). Also known as: Invirase®.

Saquinavir inhibits HIV protease, preventing the cleavage of viral polyproteins and blocking the maturation of infectious HIV particles.

Saquinavir (Invirase) is a medication used to treat HIV-1 infections. It is typically used in combination with other antiretroviral medications, such as ritonavir, to help manage the condition.

At a glance

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.

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

Frequently asked questions about Saquinavir (Invirase®)

Related

• Drug class: All HIV protease inhibitor drugs
• Target: All drugs targeting HIV protease
• Manufacturer: Royal Free Hampstead NHS Trust — full pipeline
• Therapeutic area: All drugs in Infectious Disease
• Indication: Drugs for HIV-1 infection (in combination antiretroviral therapy)
• Also known as: Invirase®

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing