NDAORALTABLETPriority Review
Approved
Apr 2019
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
2
Data completeness
7/8 — Comprehensive
Priority Review
DOVATO (dolutegravir sodium and lamivudine) by GSK is nucleoside reverse transcriptase inhibitors [moa]. Approved for hepatitis b virus nucleoside analog reverse transcriptase inhibitor [epc]. First approved in 2019.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DOVATO is a fixed-dose combination tablet containing dolutegravir sodium and lamivudine, approved by the FDA on April 8, 2019. It is indicated for the treatment of HIV-1 infection and functions as a nucleoside reverse transcriptase inhibitor. The combination provides a simplified two-drug regimen for treatment-naïve and treatment-experienced patients, positioning it as a streamlined alternative to three-drug combinations in the antiretroviral therapy landscape.
$0.4BPart D
4.7 years to LOEMechanism of Action
Nucleoside Reverse Transcriptase Inhibitors
Pharmacologic Class:
Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (2)
Switch to DOVATO in Patients Suppressed on Biktarvy (SOUND)
Started Sep 2021
40 enrolled
Human Immunodeficiency Virus
A Food-effect Study of the Pediatric Dispersible Tablet Formulations of TRIUMEQ® and DOVATO® in Healthy Adult Participants
Started May 2021
33 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.