NDAORALCAPSULEPriority Review
Approved
Nov 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Priority Review
FORTOVASE (saquinavir) by Roche is mechanism of action saquinavir is an inhibitor of hiv protease. First approved in 1997.
Drug data last refreshed 10h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FORTOVASE (saquinavir) is an oral HIV protease inhibitor approved in 1997 that works by binding to the HIV protease active site and preventing viral polyprotein cleavage, resulting in the formation of noninfectious viral particles. It was a foundational antiretroviral therapy during the protease inhibitor era of HIV treatment.
LOE Approaching
Declining
As a mature protease inhibitor approaching loss of exclusivity, the FORTOVASE team is likely focused on lifecycle extension and cost management rather than growth initiatives.
Mechanism of Action
Mechanism of Action Saquinavir is an inhibitor of HIV protease. HIV protease is an enzyme required for the proteolytic cleavage of viral polyprotein precursors into individual functional proteins found in infectious HIV. Saquinavir is a peptide-like substrate analogue that binds to the protease…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study of Saquinavir Soft Gelatin Capsules Plus Zidovudine Plus Lamivudine in the Treatment of HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs
40 enrolled
HIV Infections
A Phase II Open-Label Exploratory Study of Saquinavir + Zidovudine + Lamivudine in HIV Infected Patients
30 enrolled
HIV Infections
Safety and Tolerance of Indinavir Plus Ritonavir in HIV-Positive Patients Failing Therapy With Amprenavir, Nelfinavir, or Saquinavir
50 enrolled
HIV Infections
A Comparison of Three Anti-HIV Drug Combinations Containing Saquinavir Soft Gelatin Capsules Used in HIV-1 Infected Patients
825 enrolled
HIV Infections
A Comparison of Saquinavir Hard- and Soft-Gelatin Capsules in HIV-Infected Patients
80 enrolled
HIV Infections
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.