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Protease Inhibitor

Protease Inhibitor is a Protease inhibitor Small molecule drug developed by Medical Research Council. It is currently FDA-approved for HIV infection (as part of antiretroviral therapy), Hepatitis C virus infection. Also known as: Prezista® / Norvir®.

Protease inhibitors block viral or bacterial protease enzymes, preventing the processing of viral or pathogenic proteins necessary for replication and survival.

Protease inhibitors block viral or bacterial protease enzymes, preventing the processing of viral or pathogenic proteins necessary for replication and survival. Used for HIV infection (as part of antiretroviral therapy), Hepatitis C virus infection.

At a glance

Mechanism of action

Protease inhibitors work by binding to and inhibiting protease enzymes that are essential for the life cycle of viruses (such as HIV or hepatitis C) or bacteria. By preventing protease activity, these drugs block the cleavage of viral or pathogenic polyproteins into functional components, thereby halting viral replication or bacterial proliferation. This mechanism has been particularly successful in treating retroviral infections and some viral hepatitis cases.

Approved indications

• HIV infection (as part of antiretroviral therapy)
• Hepatitis C virus infection

Common side effects

• Gastrointestinal disturbances (nausea, diarrhea, abdominal pain)
• Lipid abnormalities (elevated cholesterol and triglycerides)
• Hepatotoxicity
• Drug interactions

Key clinical trials

• A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease (PHASE3)
• Influenza Vaccination, ACEI and ARB in the Evolution of SARS-CoV2 Infection
• PFO Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Aged 60 to 80 Years (PHASE3)
• A Study to Evaluate Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy (PHASE3)
• Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV (PHASE2, PHASE3)
• Safety, Tolerability and Efficacy of QRX003 Lotion in Subjects With Netherton Syndrome (PHASE2, PHASE3)
• Influence of NEP Inhibition on Vascular Leak and Inflammation (NEPi-INFLAMMATION) (NA)
• Phase 4, Double-blind Study Evaluating the Response on Computed Tomography (CT) Lung Density Decline Rates of Respreeza / Zemaira Weekly for 3 Years in Adults With alpha1 Antitrypsin Deficiency (AATD) (PHASE4)

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:

• Protease Inhibitor CI brief — competitive landscape report
• Protease Inhibitor updates RSS · CI watch RSS
• Medical Research Council portfolio CI

Frequently asked questions about Protease Inhibitor

Related

• Drug class: All Protease inhibitor drugs
• Manufacturer: Medical Research Council — full pipeline
• Therapeutic area: All drugs in Infectious Disease
• Indication: Drugs for HIV infection (as part of antiretroviral therapy)
• Indication: Drugs for Hepatitis C virus infection
• Also known as: Prezista® / Norvir®

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