LEXIVA
LOE ApproachingNDAORALSUSPENSIONPriority Review
Approved
Jun 2007
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
4/8 — Partial
Priority Review
LEXIVA by GSK is [see microbiology (12. Approved for combination with other antiretroviral agents for the treatment of hiv-1 infection. First approved in 2007.
Drug data last refreshed 7h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LEXIVA (fosamprenavir) is an oral protease inhibitor suspension approved for HIV-1 treatment in combination with other antiretroviral agents. It works by inhibiting HIV-1 protease, preventing viral replication in infected cells. This product represents a mature antiretroviral option in a crowded therapeutic class.
LOE Approaching
Declining commercial relevance as LOE approaches; expect team consolidation and reduced investment in marketing expansion or brand development initiatives.
Mechanism of Action
[see Microbiology (12.4)] .
Clinical Trials (3)
Flexiva Pulse Registry
Started Nov 2021
201 enrolled
Urinary CalculiBenign Prostatic Hyperplasia
Boosted Lexiva With Lovaza Adjunctive Therapy in Hypertriglyceridemic, HIV-Infected Subjects
Started Sep 2009
36 enrolled
HypertriglyceridemiaHIV Infection
KALETRA Or LEXIVA With Ritonavir Combined With EPIVIR And Abacavir In Naive Subjects Over 48 Weeks
Started May 2004
866 enrolled
HIV InfectionInfection, Human Immunodeficiency Virus
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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.