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TMC-114/RTV
TMC-114/RTV is a Protease inhibitor Small molecule drug developed by Tibotec Pharmaceuticals, Ireland. It is currently in Phase 3 development for Treatment of HIV-1 infection.
TMC-114/RTV is a protease inhibitor used in the treatment of HIV-1 infection.
TMC-114 is a small molecule used in clinical trials to study its pharmacokinetics and treatment of HIV, HIV-1 infection, and COVID-19. It has been compared to other medications, including darunavir, ritonavir, and truvada, in various clinical trials.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | TMC-114/RTV |
|---|---|
| Sponsor | Tibotec Pharmaceuticals, Ireland |
| Drug class | Protease inhibitor |
| Target | HIV protease |
| Modality | Small molecule |
| Therapeutic area | Infectious diseases |
| Phase | Phase 3 |
Mechanism of action
It works by inhibiting the protease enzyme, which is essential for the replication of the virus. This leads to a decrease in the viral load and an increase in the CD4 cell count. By inhibiting the protease enzyme, TMC-114/RTV prevents the virus from producing new viral particles.
Approved indications
- Treatment of HIV-1 infection
Common side effects
- Nausea
- Diarrhea
- Fatigue
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:
- TMC-114/RTV CI brief — competitive landscape report
- TMC-114/RTV updates RSS · CI watch RSS
- Tibotec Pharmaceuticals, Ireland portfolio CI
Frequently asked questions about TMC-114/RTV
What is TMC-114/RTV?
How does TMC-114/RTV work?
What is TMC-114/RTV used for?
Who makes TMC-114/RTV?
What drug class is TMC-114/RTV in?
What development phase is TMC-114/RTV in?
What are the side effects of TMC-114/RTV?
What does TMC-114/RTV target?
Related
- Drug class: All Protease inhibitor drugs
- Target: All drugs targeting HIV protease
- Manufacturer: Tibotec Pharmaceuticals, Ireland — full pipeline
- Therapeutic area: All drugs in Infectious diseases
- Indication: Drugs for Treatment of HIV-1 infection
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing