Drugs / Ravidasvir
Ravidasvir
also known as
PPI-668 · BI 238630 · BI 238630 CL2 · BL-238630 DIHYDROCHLORIDE · PPI-668 free base · Ravidasvir dihydrochloride · ravidasvir hydrochloride · RDV
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials | ||||||
| Phase 1 | NCT04358523 | Mar → Dec 2020 | — | Ascletis Pharmaceuticals Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03430830 | Jan → Apr 2018 | chronic hepatitis C virus infection | Ascletis Pharmaceuticals Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03288636 | Aug → Sep 2017 | hepatitis C virus infection | Ascletis Pharmaceuticals Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03020134 | Jul → Aug 2016 | — | Ascletis Pharmaceuticals Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02258321 | Oct 2014 | — | Presidio Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01979484 | Oct → Nov 2013 | — | Presidio Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01786382 | Feb → Mar 2013 | — | Presidio Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01448200 | Oct 2011 → Nov 2012 | chronic hepatitis C virus infection | Presidio Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT03020095 | Aug 2015 → Aug 2016 | chronic hepatitis C virus infection | Ascletis Pharmaceuticals Co., Ltd. | Completed | No outcome recorded |
| Phase 2/34 trials · 1 met primary | ||||||
| Phase 2/3 | NCT04885855 | Mar 2021 → Dec 2023 | chronic hepatitis C virus infection | Muhammad Radzi Abu Hassan | Completed | Met primary |
| Phase 2/3 | NCT03362814 | Jul 2017 → Dec 2018 | hepatitis C virus infection | Ascletis Pharmaceuticals Co., Ltd. | Completed | No outcome recorded |
| Phase 2/3 | NCT02961426 | Sep 2016 → Aug 2021 | hepatitis C virus infection | Drugs for Neglected Diseases | Unknown | No outcome recorded |
| Phase 2/3 | NCT02371408 | Jan 2015 → Jan 2016 | chronic hepatitis C virus infection | Pharco Pharmaceuticals | Unknown | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT01859962 Comparator | May 2013 → May 2014 | chronic hepatitis C virus infection | Presidio Pharmaceuticals, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2026-04-27 | Drugs for Neglected Diseases | Regulatory Thailand registers ravidasvir, a simple-to-use and effective antiviral for hepatitis C, expanding treatment options for Thai patients dndi.org ↗
Thailand’s Food and Drug Administration (FDA) has approved ravidasvir as a safe and effective treatment against hepatitis C following clinical trials conducted in Thailand and Malaysia. |
| 2021-12-03 | Ascletis Pharmaceuticals Co., Ltd. | Regulatory Ascletis Announces Inclusion in New Catalogue of China National Reimbursement Drug List (NRDL) of ASCLEVIR®/ GANOVO® Regimen, an All-oral Direct Anti-HCV Therapy ascletis.com ↗
ASCLEVIR® (Ravidasvir)/ GANOVO® (Danoprevir) regimen has been included in the Medicine Catalog for National Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance (2021) |
| 2021-06-14 | Drugs for Neglected Diseases | Regulatory First hepatitis C treatment developed through South-South cooperation registered in Malaysia dndi.org ↗
The National Pharmaceutical Regulatory Agency (NPRA) of Malaysia has granted a conditional registration for a safe, effective hepatitis C treatment developed by a public-private partnership bringing together the Malaysian Ministry of Health, not-for-profit research and development organization Drugs for Neglected Diseases initiative (DNDi), Egyptian pharmaceutical company Pharco, Malaysian pharmaceutical company Pharmaniaga Berhad, and non-governmental-organization Médecins Sans Frontières/Doctors Without Borders (MSF). |
| 2019-10-21 | Ascletis Pharmaceuticals Co., Ltd. | Results Manuscript Publication of the First All-oral DAA HCV Regimen Developed by Ascletis from China in the Journal of Clinical and Translational Hepatology ascletis.com ↗
The RDV/DNVr regimen was with good safety and tolerability. |
| 2018-11-06 | Ascletis Pharmaceuticals Co., Ltd. | Results Ascletis to Present Phase II / III Clinical Study for Its Innovative All-oral HCV Treatment at the 69th Annual meeting of AASLD ascletis.com ↗
The results show that RDV/DNV Regimen demonstrated a cure rate of 99% (SVR12) with a short treatment duration of 12 weeks in treatment-naïve non-cirrhotic HCV genotype 1 Chinese patients. |
| 2018-10-18 | Ascletis Pharmaceuticals Co., Ltd. | Regulatory Ascletis' Ravidasvir NDA Proposed for Priority Review by the CFDA ascletis.com ↗
Ascletis Pharma Inc. (1672.HK) announces today the New Drug Application (NDA) of Ravidasvir is on the List of Proposed Priority Review, according to the public notification by the China Food and Drug Administration (CFDA) on Oct 17th, 2018. |
| 2018-08-01 | Ascletis Pharmaceuticals Co., Ltd. | Regulatory Ascletis’ NDA for Its All-oral HCV Treatment Accepted by CFDA ascletis.com ↗
Ascletis announced today it has received the acceptance letter from the China Food and Drug Administration (CFDA) for Ravidasvir (RDV) new drug application (NDA). |
| 2018-07-31 | Ascletis Pharmaceuticals Co., Ltd. | Regulatory Ascletis Filed NDA for Its All-oral HCV Treatment ascletis.com ↗
Ascletis announced today that it has filed the new drug application (NDA) for its second Category 1 HCV drug - Ravidasvir (RDV, ASC16). |
| 2018-04-11 | Drugs for Neglected Diseases | Results New affordable hepatitis C combination treatment shows 97% cure rate | DNDi dndi.org ↗ |
| 2015-08-31 | Ascletis Pharmaceuticals Co., Ltd. | Regulatory Ascletis Initiates Phase II Clinical Trial of Its Interferon-Free HCV Regimen in Taiwan ascletis.com ↗
Ascletis today announced it received the approval from the Taiwan Food and Drug Administration (TFDA) to start phase II clinical trial for its all-oral interferon (IFN)-free regimen to treat chronic hepatitis C (CHC). |
| 2015-06-24 | Ascletis Pharmaceuticals Co., Ltd. | Regulatory Ascletis as the First Chinese Company to File Clinical Applications for Interferon-Free HCV Treatment ascletis.com ↗
Ascletis today announced that clinical trial applications for its interferon (IFN)-free regimen to treat chronic hepatitis C (CHC) have been filed and accepted by both China Food and Drug Administration (CFDA) and Taiwan Food and Drug Administration (TFDA). |
| 2013-11-02 | Boehringer Ingelheim | Results Boehringer Ingelheim's interferon-free hepatitis C treatment portfolio strengthened by promising interim Phase 2a data prnewswire.com ↗
all patients (13/13) who reached the 4-week post-treatment follow-up had undetectable levels of hepatitis C virus (SVR4) with an investigational, 12-week, all-oral regimen of faldaprevir and deleobuvir, in combination with Presidio's pan-genotypic NS5A inhibitor, PPI-668 |
| 2013-10-08 | Boehringer Ingelheim | Results Investigational interferon-free regimen demonstrates undetectable hepatitis C virus in all patients reaching end of treatment in ongoing Phase 2 trial prnewswire.com ↗
Additionally, 100 percent of patients who have completed treatment (13/13) achieved non-detectable levels of virus at the end of treatment. |
All press releases naming this drug 13 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 17 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ravidasvir | “ASC18：ravidasvir and sofosbuvir fixed Dose Combination 200 mg/400 mg” NCT04358523 ↗ |
| Known as | BI 238630 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3121849 ↗ |
| Known as | BI 238630 CL2 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3121849 ↗ |
| Known as | BL-238630 DIHYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3121849 ↗ |
| Known as | PPI-668 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01979484 ↗ |
| Known as | PPI-668 free base | ChEMBL registry synonym — accepted as the source's own label CHEMBL3121849 ↗ |
| Known as | Ravidasvir dihydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL3121849 ↗ |
| Known as | ravidasvir hydrochloride | “The study will assess the efficacy of PPI-668 (USAN: ravidasvir hydrochloride) in combination with sofosbuvir, with or without ribavirin, in the following Egyptian HCV gt-4...” NCT02371408 ↗ |
| Known as | RDV | “Ravidasvir (RDV) is a novel oral hepatitis C virus NS5A inhibitor.” PMID 34252301 ↗ Jul 2021 |
| Action | Inhibit | “NS5A inhibitor” NCT01448200 ↗ |
| Modality | Small molecule | “Ravidasvir is an investigational direct-acting antiviral (DAA) a nucleotide analog inhibitor” NCT04885855 ↗ |
| Route | Oral | “new oral hepatitis C drug ravidasvir in combination with the approved oral drug sofosbuvir” PMID 28935432 ↗ Sep 2017 |