NDAORALFILMPriority Review
Lifecycle
Pre-Launch
Clinical Trials
20
Data completeness
2/8 — Basic
Priority Review
DOLUTEGRAVIR (dolutegravir) by Inpharmus is fixed-dose combination of the hiv‑1 antiretroviral agents abacavir, dolutegravir, and lamivudine [see microbiology ()].
Drug data last refreshed 26m ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DOLUTEGRAVIR is a fixed-dose combination oral film containing abacavir, dolutegravir, and lamivudine for treatment of HIV-1 infection. Dolutegravir is an integrase strand transfer inhibitor that blocks HIV replication by preventing viral DNA integration into host chromosomes. This triple-agent combination targets multiple steps in the HIV replication cycle.
Pre-Launch
Pre-launch phase indicates active opportunity for commercial planning, regulatory strategy, and market access roles with potential for significant team expansion upon approval.
Mechanism of Action
fixed-dose combination of the HIV‑1 antiretroviral agents abacavir, dolutegravir, and lamivudine [see Microbiology ()].
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Dolutegravir/Lamivudine in Treatment-Naïve Pregnant Women
Started Sep 2026
210 enrolled
HIV-1-infection
A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Participants (MK-4646)
Started May 2026
16 enrolled
Healthy
Dolutegravir/Lamivudine Dual Therapy for ART-naïve People With HIV and TB Receiving Rifampin-based TB Treatment
Started Sep 2025
150 enrolled
TuberculosisHIV
Switch to Dolutegravir Plus Lamivudine Dual-Therapy in Transgender Women Living With HIV on Virologically Suppressive Antiretroviral Therapy (TRANS-SWITCH)
Started Jul 2025
50 enrolled
HIVHIV-1
Doravirine/Lamivudine (DOR/3TC) as a Maintenance ART in Comparison With Dolutegravir/Lamivudine (DTG/3TC) in PLWH Successfully
Started Apr 2025
408 enrolled
HIV-1-infection
Worked on DOLUTEGRAVIR at Inpharmus? Share your interview experience or compensation data (+7 days Pro)
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.