Overview
Ravidasvir is under investigation in clinical trial NCT02961426 (Sofosbuvir Plus Ravidasvir for the Treatment of HCV Chronic Infection).
Indication
联合利托那韦强化的达诺瑞韦钠片和利巴韦林，用于治疗初治的基因1b型慢性丙型肝炎病毒感染的非肝硬化成人患者，不得作为单药治疗。
Associated Conditions
No associated conditions information available.
Research Report
Ravidasvir (DB15652): A Comprehensive Monograph on a Novel NS5A Inhibitor for Hepatitis C Virus Infection
Executive Summary
[Ravidasvir is a potent, second-generation, pangenotypic direct-acting antiviral (DAA) developed for the treatment of chronic hepatitis C virus (HCV) infection. Classified as a non-structural protein 5A (NS5A) inhibitor, it targets a key viral protein essential for both RNA replication and virion assembly. In combination with the NS5B polymerase inhibitor sofosbuvir, ravidasvir has demonstrated exceptional clinical efficacy, achieving sustained virological response rates of 97% in large, diverse, multinational clinical trials. Its therapeutic profile is particularly notable for its high cure rates in historically difficult-to-treat patient populations, including those with HCV genotype 3, compensated cirrhosis, and HIV co-infection. The drug exhibits a favorable pharmacokinetic profile, characterized by once-daily oral administration, negligible metabolism, and a benign safety profile with a low incidence of serious adverse events. A key feature of its clinical pharmacology is a wide therapeutic index, which allows it to maintain efficacy even in the presence of drug-drug interactions that moderately increase its clearance.]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/05/13 | Phase 2 | Completed | Muhammad Radzi Abu Hassan | ||
2021/02/09 | Phase 3 | Terminated | |||
2020/08/06 | Phase 3 | Terminated | |||
2020/04/24 | Phase 1 | Completed | |||
2018/07/26 | Phase 1 | Completed | Drugs for Neglected Diseases | ||
2018/02/13 | Phase 1 | Completed | |||
2017/12/05 | Phase 2 | Completed | |||
2017/09/20 | Phase 1 | Completed | |||
2017/01/13 | Phase 2 | Completed | |||
2017/01/13 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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