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Ritonavir (NRV)
Ritonavir (NRV) is a Protease inhibitor Small molecule drug developed by French National Agency for Research on AIDS and Viral Hepatitis. It is currently in Phase 3 development for Treatment of HIV-1 infection in combination with other antiretroviral agents.
Ritonavir is a protease inhibitor that blocks the protease enzyme, preventing viral replication.
Ritonavir is a small molecule used to treat HIV infections. It has been studied in combination with other medications, such as Zidovudine and Lamivudine, as part of structured treatment interruption 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 | Ritonavir (NRV) |
|---|---|
| Sponsor | French National Agency for Research on AIDS and Viral Hepatitis |
| Drug class | Protease inhibitor |
| Target | HIV protease |
| Modality | Small molecule |
| Therapeutic area | Infectious disease |
| Phase | Phase 3 |
Mechanism of action
Ritonavir works by binding to the protease enzyme, which is essential for the maturation of viral particles. By inhibiting this enzyme, ritonavir prevents the replication of the virus, thereby reducing the viral load in the body.
Approved indications
- Treatment of HIV-1 infection in combination with other antiretroviral agents
Common side effects
- Diarrhea
- Nausea
- Fatigue
- Headache
- Abdominal pain
Key clinical trials
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:
- Ritonavir (NRV) CI brief — competitive landscape report
- Ritonavir (NRV) updates RSS · CI watch RSS
- French National Agency for Research on AIDS and Viral Hepatitis portfolio CI
Frequently asked questions about Ritonavir (NRV)
What is Ritonavir (NRV)?
How does Ritonavir (NRV) work?
What is Ritonavir (NRV) used for?
Who makes Ritonavir (NRV)?
What drug class is Ritonavir (NRV) in?
What development phase is Ritonavir (NRV) in?
What are the side effects of Ritonavir (NRV)?
What does Ritonavir (NRV) target?
Related
- Drug class: All Protease inhibitor drugs
- Target: All drugs targeting HIV protease
- Manufacturer: French National Agency for Research on AIDS and Viral Hepatitis — full pipeline
- Therapeutic area: All drugs in Infectious disease
- Indication: Drugs for Treatment of HIV-1 infection in combination with other antiretroviral agents
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing