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Dolutegravir film-coated dispersible tablets
Dolutegravir film-coated dispersible tablets is a Integrase strand transfer inhibitor (INSTI) Small molecule drug developed by ViiV Healthcare. It is currently in Phase 3 development for HIV-1 infection in treatment-naive adults and children, HIV-1 infection in treatment-experienced patients.
Dolutegravir inhibits HIV integrase, preventing the virus from integrating its genetic material into the host cell's DNA.
Dolutegravir inhibits HIV integrase, preventing the virus from integrating its genetic material into the host cell's DNA. Used for HIV-1 infection in treatment-naive adults and children, HIV-1 infection in treatment-experienced patients.
At a glance
| Generic name | Dolutegravir film-coated dispersible tablets |
|---|---|
| Sponsor | ViiV Healthcare |
| Drug class | Integrase strand transfer inhibitor (INSTI) |
| Target | HIV integrase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Dolutegravir is an integrase strand transfer inhibitor (INSTI) that binds to HIV integrase and blocks the enzyme's ability to catalyze the integration of viral DNA into the human genome. By preventing integration, the drug stops HIV replication at a critical step in the viral lifecycle. This mechanism is effective against both treatment-naive and treatment-experienced patients, including those with certain integrase inhibitor-resistant strains.
Approved indications
- HIV-1 infection in treatment-naive adults and children
- HIV-1 infection in treatment-experienced patients
Common side effects
- Insomnia
- Headache
- Diarrhea
- Nausea
- Fatigue
Key clinical trials
- UNIVERSAL 1: Pharmacokinetic Study of a Novel DTG/FTC/TAF Dose Ratio for Children (PHASE2)
- DTG/3TC Fixed Dose Formulations for the Maintenance of Virological Suppression in Children With HIV Infection Aged 2 to <15 Years Old (PHASE2, PHASE3)
- Dolutegravir Study in HIV-1 Participants Completing IMPAACT Studies P1093 and P2019 (PHASE3)
- Safety of and Immune Response to Dolutegravir in HIV-1 Infected Infants, Children, and Adolescents (PHASE1, PHASE2)
- Relative Bioavailability Study of a Fixed-dose Combination Dolutegravir/Abacavir/Lamivudine Dispersible Tablet (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Dolutegravir film-coated dispersible tablets CI brief — competitive landscape report
- Dolutegravir film-coated dispersible tablets updates RSS · CI watch RSS
- ViiV Healthcare portfolio CI
Frequently asked questions about Dolutegravir film-coated dispersible tablets
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Related
- Drug class: All Integrase strand transfer inhibitor (INSTI) drugs
- Target: All drugs targeting HIV integrase
- Manufacturer: ViiV Healthcare — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for HIV-1 infection in treatment-naive adults and children
- Indication: Drugs for HIV-1 infection in treatment-experienced patients
- Compare: Dolutegravir film-coated dispersible tablets vs similar drugs
- Pricing: Dolutegravir film-coated dispersible tablets cost, discount & access