NDAORALTABLETPriority Review
Approved
Nov 2017
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
1
Data completeness
5/8 — Partial
Priority Review
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
JULUCA is a fixed-dose combination tablet containing dolutegravir sodium (an integrase strand transfer inhibitor) and rilpivirine hydrochloride (a non-nucleoside reverse transcriptase inhibitor) approved by the FDA on November 21, 2017. It is indicated for treatment of HIV-1 infection in treatment-experienced patients with HIV-1 RNA <50 copies/mL on a stable antiretroviral regimen for at least 3 months. JULUCA represents a simplified two-drug maintenance regimen that reduces pill burden compared to multi-drug antiretroviral therapy.
$0.4BPart D
12.3 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)
Study to Evaluate Pharmacokinetics, Safety and Tolerability of Dolutegravir and Rilpivirine (JULUCA™) 50 Milligram (mg)/25 mg Tablets in Healthy Subjects of Japanese Descent
Started Jun 2019
16 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.