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Dolutegravir Sodium Monohydrate
Dolutegravir sodium monohydrate inhibits HIV integrase, preventing the virus from integrating its genetic material into the host cell's DNA.
Dolutegravir sodium monohydrate inhibits HIV integrase, preventing the virus from integrating its genetic material into the host cell's DNA. Used for HIV-1 infection in treatment-naïve and treatment-experienced adults, HIV-1 infection in adolescents and children (age-appropriate formulations).
At a glance
| Generic name | Dolutegravir Sodium Monohydrate |
|---|---|
| Also known as | TIVICAY |
| Sponsor | University of Colorado, Denver |
| 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 the catalytic site of HIV integrase and blocks the enzyme's ability to insert viral DNA into the human genome. By preventing integration, the drug halts HIV replication and reduces viral load. This mechanism allows for effective suppression of HIV with a high genetic barrier to resistance.
Approved indications
- HIV-1 infection in treatment-naïve and treatment-experienced adults
- HIV-1 infection in adolescents and children (age-appropriate formulations)
Common side effects
- Insomnia
- Headache
- Diarrhea
- Nausea
- Fatigue
Key clinical trials
- Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants (PHASE3)
- Long-Acting Treatment in Adolescents (LATA) (PHASE3)
- Development of a Urine-Based Point-of-Care Test for Adherence to Antiretroviral Drugs (EARLY_PHASE1)
- Compassionate Use of Ibalizumab for the Treatment of HIV Infection
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 Sodium Monohydrate CI brief — competitive landscape report
- Dolutegravir Sodium Monohydrate updates RSS · CI watch RSS
- University of Colorado, Denver portfolio CI