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TMC114/ritonavir
TMC114 (darunavir) is a protease inhibitor that blocks HIV protease, preventing viral replication when boosted with ritonavir.
TMC114 (darunavir) is a protease inhibitor that blocks HIV protease, preventing viral replication when boosted with ritonavir. Used for HIV-1 infection in treatment-experienced patients, HIV-1 infection in treatment-naïve patients.
At a glance
| Generic name | TMC114/ritonavir |
|---|---|
| Also known as | PI |
| Sponsor | Janssen-Cilag Ltd. |
| Drug class | HIV protease inhibitor |
| Target | HIV protease |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
Darunavir inhibits HIV protease, an enzyme essential for processing viral polyproteins into functional components. When combined with ritonavir (a cytochrome P450 inhibitor that boosts darunavir levels), the drug achieves high plasma concentrations and potent suppression of HIV replication. This combination is effective against both wild-type and protease inhibitor-resistant HIV strains.
Approved indications
- HIV-1 infection in treatment-experienced patients
- HIV-1 infection in treatment-naïve patients
Common side effects
- Diarrhea
- Nausea
- Headache
- Rash
- Abdominal pain
- Vomiting
Key clinical trials
- Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV (PHASE2, PHASE3)
- A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments (PHASE4)
- Pharmacokinetics Safety and Acceptability of DRV/r for Children Living With HIV (PHASE1, PHASE2)
- Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy (PHASE3)
- Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
- Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum
- Population Pharmacokinetics of Antiretroviral in Children
- Ndovu RCT: Investing the Optimal Management of Dolutegravir Resistance (PHASE3)
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:
- TMC114/ritonavir CI brief — competitive landscape report
- TMC114/ritonavir updates RSS · CI watch RSS
- Janssen-Cilag Ltd. portfolio CI