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Ribavirine
Ribavirine is a Small molecule drug developed by University Hospital, Limoges. It is currently in Phase 2 development.
Ribavirin is a small molecule that inhibits inosine-5'-monophosphate dehydrogenase 1, classified as an INHIBITOR. It has been studied in clinical trials for various conditions, including Hepatitis C Virus, Chronic Hepatitis C, and End Stage Renal Disease, often in combination with other direct-acting antivirals such as Zepatier, Mavyret, and Sofosbuvir.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Ribavirine |
|---|---|
| Sponsor | University Hospital, Limoges |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- ARN-75039 Lassa Fever Treatment in West Africa (PHASE2)
- ISTH/ANRS 0409s INTEGRATE Lassa Fever Study (PHASE2, PHASE3)
- Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Relapser Genotype 2 Hepatitis C Infected Patients (PHASE3)
- Efficacy and Safety of MP-424, Interferon Beta (IFN Beta), and Ribavirin(RBV) in Treatment-Naïve or Having Received Interferon Based Therapy With Chronic Hepatitis C (CHC) (PHASE3)
- A Phase 1 Study of MP-424, Peginterferon Alfa 2b, and Ribavirin in Hepatitis C (PHASE1)
- Efficacy and Safety of MP-424, Peginterferon Alfa-2b, and Ribavirin in Patients With Chronic Hepatitis C Who Relapsed After Previous Interferon Based Therapy (PHASE3)
- Efficacy and Safety of MP-424/Peginterferon Alfa-2b/Ribavirin Combination in Treatment-Naïve Patients With Chronic Hepatitis C (PHASE3)
- Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Chronic Hepatitis C Who Have Not Achieved an Undetectable HCV RNA Level With Previous Interferon Based Therapy (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:
- Ribavirine CI brief — competitive landscape report
- Ribavirine updates RSS · CI watch RSS
- University Hospital, Limoges portfolio CI
Frequently asked questions about Ribavirine
What is Ribavirine?
Who makes Ribavirine?
What development phase is Ribavirine in?
Related
- Manufacturer: University Hospital, Limoges — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing