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 21h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LEXIVA is an oral suspension containing fosamprenavir, a protease inhibitor used in combination with other antiretroviral agents for HIV-1 infection treatment. It works by inhibiting HIV protease, preventing viral replication in infected patients. The drug represents a key component of combination antiretroviral therapy (cART) regimens.
LOE Approaching
Declining
This is a legacy HIV product in decline phase; commercial teams are likely consolidating or transitioning to newer generation antiretrovirals.
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.