Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ribavirin 200 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Ribavirin 200 Capsules (Geneva Pharmaceutical, U.S.A.) |
| 2 | ACTIVE_COMPARATOR | Rebetol 200 Capsules (Schering Corporation, U.S.A.) |
| Name | Type | Description |
|---|---|---|
| Ribavirin 200 Capsules (Geneva Pharmaceutical, U.S.A.) | DRUG | - |
| Rebetol 200 Capsules (Schering Corporation, U.S.A.) | DRUG | - |
Inclusion Criteria: * No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: * Positive test results for HIV or hepatitis B or C. * Treatment for drug or alcohol dependence.
Ribavirin 200 is an oral small molecule being studied for chronic hepatitis C, an infectious disease of the liver. It is a Phase 1 investigational product developed by Novartis AG under the ticker NVS. The clinical work recorded for this asset is a relative bioavailability study conducted in healthy adult female volunteers, not a study of antiviral efficacy in patients.
Ribavirin 200 targets IMPDH1, inosine monophosphate dehydrogenase 1, and acts as an inhibitor of that enzyme. IMPDH1 is involved in guanine nucleotide synthesis, and inhibiting it is the mechanism attributed to this small molecule asset. The drug is being developed by Novartis AG (ticker NVS) for chronic hepatitis C.
Ribavirin 200 is developed by Novartis AG, which trades under the ticker NVS. The product is also referred to as Ribavirin 200 Capsules (Geneva Pharmaceutical, U.S.A.), so searches using that longer name refer to the same asset. It is a small molecule in development for chronic hepatitis C.
Ribavirin 200 is in Phase 1 development. It is an investigational product and is not approved. One Phase 1 trial has been completed, and no trials for this asset are currently active. The completed study enrolled 24 participants and was randomized with an active control, though it was not double blinded.
Ribavirin 200 has been studied in one completed Phase 1 trial, NCT00959933, titled a relative bioavailability study of Ribavirin 200 capsules and Rebetol 200 mg capsules in females under non-fasting conditions. It enrolled 24 healthy female volunteers aged 18 years and older and used an active-controlled, randomized design without blinding.
Yes, Ribavirin 200 and Ribavirin 200 Capsules (Geneva Pharmaceutical, U.S.A.) refer to the same asset. The longer name is an alternative designation used for this Novartis AG (ticker NVS) product, a small molecule IMPDH1 inhibitor in Phase 1 development for chronic hepatitis C.