Drugs / danoprevir
danoprevir
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | hepatitis C virus infection | — | “Ascletis has filed an NDA in China for its first HCV NS3/4A medicine, danoprevir, at the end of 2016” ascletis.com ↗ |
Trials 27
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 118 trials | ||||||
| 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 | NCT03019991 | Oct → Nov 2015 | — | Ascletis Pharmaceuticals Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01714154 | Nov 2012 → May 2013 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01592305 | May → Jun 2012 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01588002 | Apr → Jun 2012 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01519336 | Feb → Mar 2012 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01531647 | Jan → Mar 2012 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01483729 | Dec 2011 → Jan 2012 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01514968 | Dec 2011 → Feb 2012 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01418274 | Aug → Sep 2011 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01398293 | Aug → Nov 2011 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01392755 | Jul → Sep 2011 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01389544 | Jun → Jul 2011 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01185873 | Feb 2011 → Dec 2013 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01164488 | Jul → Aug 2010 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01185860 | Aug 2009 → Jan 2012 | chronic hepatitis C virus infection | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT00801255 | Nov 2008 → Mar 2010 | chronic hepatitis C virus infection | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 26 trials · 1 met primary | ||||||
| Phase 2 | NCT03020004 | Jan → Nov 2016 | chronic hepatitis C virus infection | Ascletis Pharmaceuticals Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT01749150 | Apr 2013 → Feb 2015 | chronic hepatitis C virus infection | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT01483742 | Apr 2012 → Sep 2013 | chronic hepatitis C virus infection | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT01278134 | Feb 2011 → Oct 2012 | chronic hepatitis C virus infection | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT01220947 | Nov 2010 → Dec 2012 | chronic hepatitis C virus infection | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT00963885 | Aug 2009 → Jan 2012 | chronic hepatitis C virus infection | Hoffmann-La Roche | Completed | Met primary |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03362814 | Jul 2017 → Dec 2018 | hepatitis C virus infection | Ascletis Pharmaceuticals Co., Ltd. | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT03020082 | Jun 2016 → May 2017 | chronic hepatitis C virus infection | Ascletis Pharmaceuticals Co., Ltd. | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT04345276 | Mar → Apr 2020 | COVID-19 | Huoshenshan Hospital | Completed | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 1 | NCT01654211 Comparator | Jul → Nov 2012 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01592318 Comparator | May → Jun 2012 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT03020095 Background | Aug 2015 → Aug 2016 | chronic hepatitis C virus infection | Ascletis Pharmaceuticals Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT01579019 Background | Jul 2012 → Mar 2014 | chronic hepatitis C virus infection | Hoffmann-La Roche | Withdrawn | No outcome recorded |
| Phase 2 | NCT01628094 Background | Jun 2012 → Nov 2013 | chronic hepatitis C virus infection | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT01331850 Background | May 2011 → Jan 2013 | chronic hepatitis C virus infection | Hoffmann-La Roche | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 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) |
| 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. |
| 2018-07-30 | Ascletis Pharmaceuticals Co., Ltd. | Results Ganovo® Phase III Clinical Study Won the Top Award at the Infectious Disease National Congress of Chinese Medical Association ascletis.com ↗
Ganovo regimen demonstrated excellent results of a cure rate of 97% (SVR12) in genotype 1 non-cirrhotic patients, within a 12-week treatment duration. |
| 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). |
| 2015-04-13 | Ascletis Pharmaceuticals Co., Ltd. | Results HCV RACE IN CHINA ascletis.com ↗
Phase II data presented in March showing SVR12 rates of 94% and higher in Asian patients appear to bear out Ascletis’ hypothesis that danoprevir will be competitive in Asian patients. |
All press releases naming this drug 7 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 37 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Danoprevir | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03020134 ↗ |
| Known as | DNV | “between danoprevir (DNV) when coadministered with low-dose ritonavir (r) and tenofovir disoproxil fumarate (TDF) or atazanavir (ATZ) in healthy volunteers” NCT01592305 ↗3“Danoprevir (DNV) is a hepatitis C virus (HCV) protease inhibitor” PMID 24295986 ↗ Dec 2013 “Danoprevir (DNV) 100mg tablet administered orally twice daily” NCT03020004 ↗ “Danoprevir (DNV)administered orally 100mg BID for 12 weeks;” NCT03020082 ↗ |
| Known as | ITMN-191 | “Danoprevir (RG7227; ITMN-191) is a potent inhibitor of the HCV NS3/4A serine protease.” PMID 21354234 ↗ Feb 20111“an HCV protease inhibitor (RO5190591/ITMN-191/danoprevir)” NCT00801255 ↗ |
| Known as | RG7227 | “Danoprevir (RG7227) is a potent macrocyclic inhibitor of the hepatitis C virus NS3/4A protease, which is currently in development in combination with low-dose ritonavir for the...” PMID 23712757 ↗ Sep 20131“Danoprevir (RG7227; ITMN-191) is a potent inhibitor of the HCV NS3/4A serine protease.” PMID 21354234 ↗ Feb 2011 |
| Known as | RO5190591 | “an HCV protease inhibitor (RO5190591/ITMN-191/danoprevir)” NCT00801255 ↗ |
| Action | Inhibit | “danoprevir, an NS3/4A protease inhibitor” PMID 20951424 ↗ Oct 2010 |
| Modality | Small molecule | “an oral Hepatitis C virus protease inhibitor” NCT04345276 ↗ |
| Route | Oral | “up to 13 days oral combination treatment with RG7128 (500 mg or 1000 mg twice daily) and danoprevir” PMID 20951424 ↗ Oct 2010 |