NDAORALTABLETPriority Review
Approved
Aug 2013
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
1
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 19h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TIVICAY (dolutegravir sodium) is an oral small-molecule HIV-1 integrase strand transfer inhibitor available as a tablet formulation, approved by the FDA in August 2013. It is indicated for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 6 kg. The drug works by inhibiting HIV integrase, an enzyme essential for viral replication. TIVICAY is a foundational component of modern antiretroviral therapy and is widely used as part of first-line and second-line regimens globally.
$0.7BPart D
4.1 years to LOEMechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
A Trial Evaluating Maintenance Therapy With Lamivudine (Epivir®) and Dolutegravir (Tivicay®) in Human Immunodeficiency Virus 1 (HIV-1) Infected Patients Virologically Suppressed With Triple Highly Active Antiretroviral Therapy (HAART) (ANRS 167 Lamidol)
Started Sep 2015
110 enrolled
HIV-1 Infection
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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.