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Last update 12 May 2025

Ravidasvir Hydrochloride

Last update 12 May 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Asclevir, C5, Ravidasvir

+ [6]

Target

NS5A

Action

inhibitors

Mechanism

NS5A inhibitors(Nonstructural protein 5A inhibitors)

Therapeutic Areas

Infectious DiseasesDigestive System Disorders

Active Indication

Hepatitis CChronic hepatitis C genotype 1

Inactive Indication

COVID-19Pseudohyperkalemia Cardiff

Originator Organization

Presidio Pharmaceuticals, Inc.

Active Organization

Ascletis Biopharmaceutical (Hangzhou) Co. Ltd.

Ascletis Pharma, Inc.

Inactive Organization

Presidio Pharmaceuticals, Inc.

Ascletis Pharmaceuticals Co.,Ltd.

Drugs for Neglected Diseases initiative

+ [2]

License Organization

Pharmaniaga Bhd.

Presidio Pharmaceuticals, Inc.

Pharco Pharmaceuticals, Inc.

+ [2]

Drug Highest PhaseApproved

First Approval Date

China (29 Jul 2020),

Hepatitis C

RegulationPriority Review (China), Special Review Project (China)

Structure/Sequence

Molecular FormulaC42H52Cl2N8O6

InChIKeyJYLMWUZJMRNMDA-SPRBZRACSA-N

CAS Registry1303533-81-4

Clinical Trials associated with Ravidasvir Hydrochloride

NCT04885855

/ CompletedPhase 2/3

Efficacy and Safety of 8- Versus 12-week Sofosbuvir-ravidasvir Treatment of Non-cirrhotic Chronic Hepatitis C Patients: An Open-label, Randomized, Multicenter Study in Malaysia

This is open-label, randomized, multicentre study to compare the efficacy and safety of the 8-week versus 12-week of SOF-RVD combination treatment for non-cirrhotic chronic hepatitis C patients.
All the recruited subjects will receive the treatment accordingly and be followed up for 24 weeks following the completion of treatment.

Start Date23 Mar 2021

Sponsor / Collaborator

Hospital Sultanah Bahiyah

ISRCTN21085622

/ CompletedPhase 2/3

Randomized, open-label, prospective study to evaluate the safety and efficacy of sofosbuvir plus daclatasvir or ravidasvir in Egyptian adults with COVID-19

Start Date29 Sep 2020

Sponsor / Collaborator

European Egyptian Pharmaceutical Industry

NCT04358523

/ CompletedPhase 1

Drug Interaction Between RDV and SOF in ASC18 Tablets (RDV/SOF Compound Tablets) and the Influence of Food Effect on the Pharmacokinetics of ASC18 Tablets Were Evaluated in Healthy Subjects. Comparison of the Pharmacokinetic Parameters of ASC18 Tablets（Ravidasvir and Sofosbuvir Fixed Dose Combination）With Reference Tablets (Ravidasvir Sofosbuvir) in Healthy Subjects After Single and Multiple Oral Dosing

The objective of this study is to evaluate potential drug interaction between RDV and SOF in ASC18 tablets (RDV/SOF compound tablets) and the influence of food effect on the pharmacokinetics of ASC18 tablets were evaluated in healthy subjects -and compare the pharmacokinetic parameters of ASC18 tablets（ravidasvir and sofosbuvir fixed dose combination）with ravidasvir tablets and sofosbuvir tablets in healthy subjects after single and multiple oral dosing.

Start Date20 Mar 2020

Sponsor / Collaborator

Ascletis Pharmaceuticals Co.,Ltd.

100 Clinical Results associated with Ravidasvir Hydrochloride

100 Translational Medicine associated with Ravidasvir Hydrochloride

100 Patents (Medical) associated with Ravidasvir Hydrochloride

Literatures (Medical) associated with Ravidasvir Hydrochloride

01 Oct 2024·COMPARATIVE BIOCHEMISTRY AND PHYSIOLOGY C-TOXICOLOGY & PHARMACOLOGY

Ascorbyl palmitate (ASC16) as a potential inhibitor of toxicity induced by Crotalus durissus terrificus venom

Article

Author: Alonso, María ; Maslovski, Franco ; Angelina, Emilio ; Leiva, Laura ; Fusco, Luciano

It is well known that C. d. terrificus venom causes pathophysiological effects such as neuropathies, coagulopathies, and even death. Previous studies have reported that ASC16 can interact with monomeric phospholipases A₂ from the venom of various snake species (e.g., Vipera russelli and Echis carinatus). As a result, ASC16 has been proposed as an inhibitor of the toxic effects induced by the heterodimeric complex (crotoxin) and other components of the venom of C. d. terrificus. To investigate this further, in silico studies were designed using the crotoxin (CTX) protein complex as a model, and experimental assays were conducted to evaluate the inhibitory effect of ASC16 on CTX, as well as on other venom enzymes such as thrombin-like enzyme (TLE), phosphodiesterase (PDE) and l-aminoxidase (LAAO). For in vitro assays, specific substrates were used, and lethal activity was measured over 48 h using an in vivo murine experimental model (CF01). In silico studies have indicated that the hydrophilic portion of ASC16 adopts a stable conformation while interacting with the catalytic site of crotoxin. At the highest concentrations, ASC16 significantly inhibited the activities of PLA₂ (40.89 ± 0.09 %), TLE (11.03 ± 0.69 %), PDE (51.33 ± 2.83 %), and LAAO (56.79 ± 2.91 %). Furthermore, ASC16 neutralized the 2 LD₅₀ lethality of crotalic venom. These findings lay the groundwork for designing promising adjuvants that can facilitate the incorporation of a larger quantity of proteins in immunization schemes. Consequently, this approach aims to achieve higher antibody titers, reduce the number of required immunizations, and minimize local damage in the producer animal.

09 Jul 2024·ANTIMICROBIAL AGENTS AND CHEMOTHERAPY

Population pharmacokinetics of ravidasvir in adults with chronic hepatitis C virus infection and impact of antiretroviral treatment

Article

Author: Salvadori, Nicolas ; Thongsawat, Satawat ; Avihingsanon, Anchalee ; Thanprasertsuk, Sombat ; Menétrey, Caroline ; Swanson, Alistair ; Panjasawatwong, Navarat ; Ribeiro, Isabela ; Cressey, Tim R. ; Tan, Soek-Siam ; Gillon, Jean-Yves

ABSTRACT:

Ravidasvir (RDV) is a novel NS5A inhibitor that exhibits potent pan-genotypic inhibition of hepatitis C virus (HCV) replication. Sofosbuvir (SOF) plus RDV was demonstrated to be efficacious and safe in adults with active HCV infection, including those living with HIV (LWHIV), in the STORM-C-1 trial. We assessed the population pharmacokinetics (PK) of RDV in a sub-study nested within STORM-C-1 conducted in Thailand and Malaysia. SOF (400 mg) plus RDV (200 mg) was administered orally once daily for 12 weeks to adults with chronic HCV infection, but without cirrhosis and for 24 weeks to those with compensated cirrhosis. Intensive and sparse PK samples were collected at 4, 8, and 12 weeks after treatment initiation. Population PK parameters of RDV and the impact of covariates were evaluated using nonlinear mixed-effects modeling. Five hundred ninety-four participants were included, 235 (40%) had compensated cirrhosis, and 189 (32%) were LWHIV. RDV plasma concentrations were best described by a two-compartment model with first-order elimination. Oral clearance (CL/F) and volume of distribution (Vd/F) parameters were allometrically scaled on fat-free mass. Concomitant antiretroviral treatment (ART) increased RDV CL/F by 30%–60%, with efavirenz-based ART having the largest impact. Females had 16% lower RDV CL/F than males, and higher albumin levels reduced RDV central volume of distribution. While several covariates impact RDV CL/F and Vd/F, the effect on RDV exposures was not clinically relevant based on the efficacy data reported in this diverse Asian adult population. There were no meaningful drug-drug interactions in adults LWHIV on ART.

01 Mar 2024·International journal of antimicrobial agents

Small-molecule antiviral treatments for COVID-19: A systematic review and network meta-analysis

Review

Author: Yang, Wenjuan ; Xin, Chuanwei ; Zheng, Bei ; Han, Bing ; Ying, Yin ; Zhu, Jun ; Yang, Bo ; Zhang, Meiling ; Feng, Pinpin ; Zhao, Qinqin ; Li, Gonghua

OBJECTIVE:

This study aimed to explore the efficacy and safety of small-molecule antivirals for treating coronavirus disease 2019 (COVID-19).

METHODS:

Seven databases were searched from their inception to 01 June 2023. The risk of bias in randomised controlled trials and retrospective studies was evaluated individually using the Cochrane risk-of-bias tool and Newcastle Ottawa Scale.

RESULTS:

In total, 160 studies involving 933 409 COVID-19 patients were evaluated. Compared with placebo or standard of care, proxalutamide demonstrated remarkable efficacy in reducing mortality rates, hospitalisation rates, serious adverse events, and the need for mechanical ventilation. Furthermore, it significantly enhanced both the rate of clinical improvement and expedited the duration of clinical recovery when compared with control groups. In patients with mild-to-moderate COVID-19, proxalutamide exhibited the above advantages, except for mortality reduction. Triazavirin was the most effective treatment for reducing the time required for viral clearance and improving the discharge rate. Leritrelvir and VV116 were ranked first in terms of enhancing the viral clearance rate on days 7 and 14, respectively. Molnupiravir was the most effective treatment for reducing the need for oxygen support. Overall, these findings remained consistent across the various subgroups.

CONCLUSIONS:

A thorough evaluation of effectiveness, applicable to both mild-to-moderate and unstratified populations, highlights the specific advantages of proxalutamide, nirmatrelvir/ritonavir, triazavirin, azvudine, molnupiravir, and VV116 in combating COVID-19. Additional clinical data are required to confirm the efficacy and safety of simnotrelvir/ritonavir and leritrelvir. The safety profiles of these antivirals were deemed acceptable.

News (Medical) associated with Ravidasvir Hydrochloride

12 Dec 2023

·synapse.patsnap.com

What are NS5A inhibitors and how do you quickly get the latest development progress?

NS5A is a crucial protein found in the human body that plays a significant role in the life cycle of the hepatitis C virus (HCV). It is involved in viral replication, assembly, and release, making it an attractive target for antiviral therapies. NS5A interacts with various host proteins and cellular pathways, modulating the immune response and promoting viral persistence. Inhibiting NS5A can disrupt HCV replication, leading to reduced viral load and improved clinical outcomes. Understanding the function of NS5A is essential for developing effective treatments against HCV and combating the global burden of this infectious disease. The analysis of the current competitive landscape of target NS5A reveals that Gilead Sciences, Inc., AbbVie, Inc., and Merck & Co., Inc. are the leading companies in terms of R&D progress. These companies have drugs in multiple phases of development, including the approved phase. The indication analysis shows that drugs under the target NS5A have been approved for various indications related to Hepatitis C, Fibrosis, Cirrhosis, and other diseases. The drug types progressing most rapidly are small molecule drugs and synthetic peptides, indicating intense competition in the market. China is a significant player in the development of drugs targeting NS5A, with the highest number of drugs in the approved phase. Other countries such as Japan, European Union, and the United States also have a considerable presence in the development of NS5A drugs. The future development of target NS5A is promising, with ongoing research and development by various companies and institutions. The competition in the market is expected to intensify, especially for small molecule drugs and synthetic peptides. Further advancements in the treatment of Hepatitis C and other related indications can be expected with the continued efforts of the pharmaceutical industry. How do they work?NS5A inhibitors are a type of antiviral medication that target the NS5A protein in the hepatitis C virus (HCV). From a biomedical perspective, these inhibitors work by blocking the function of the NS5A protein, which is essential for viral replication and assembly. By inhibiting NS5A, these drugs help to prevent the spread and multiplication of the hepatitis C virus in the body. NS5A inhibitors are commonly used in combination with other direct-acting antiviral drugs to treat chronic hepatitis C infection. They have shown high efficacy in achieving sustained virologic response (SVR), which means that the virus is undetectable in the blood six months after completing treatment. These inhibitors have revolutionized the treatment of hepatitis C, offering shorter treatment durations, improved tolerability, and higher cure rates compared to older therapies. It's important to note that NS5A inhibitors are specific to the treatment of hepatitis C and are not used for other viral infections or diseases. They are typically prescribed by healthcare professionals and should be taken as directed to ensure optimal treatment outcomes. Common examples of NS5A inhibitors include ledipasvir, daclatasvir, and ombitasvir. List of NS5A InhibitorsThe currently marketed NS5A inhibitors include: Emitasvir PhosphateRavidasvir HydrochlorideCoblopasvir hydrochlorideGlecaprevir/PibrentasvirGlecaprevir/PibrentasvirElbasvirSofosbuvir/VelpatasvirElbasvir/GrazoprevirOmbitasvir/Paritaprevir/RitonavirLedipasvir/SofosbuvirFor more information, please click on the image below. What are NS5A inhibitors used for?NS5A inhibitors are commonly used in combination with other direct-acting antiviral drugs to treat chronic hepatitis C infection. For more information, please click on the image below to log in and search. How to obtain the latest development progress of NS5A inhibitors?In the Synapse database, you can keep abreast of the latest research and development advances of NS5A inhibitors anywhere and anytime, daily or weekly, through the "Set Alert" function. Click on the image below to embark on a brand new journey of drug discovery!

27 Jul 2023

·www.pmlive.com

World Health Organization publishes updated essential medicines list

The World Health Organization (WHO) has published updated editions of the Model Lists of Essential Medicines (EML) and Essential Medicines for Children (EMLc) that contain new medicines for the treatment of multiple sclerosis (MS), cancer, infectious diseases, and cardiovascular conditions, among others. The new Model Lists intends to grant better access to innovative medicines that show major clinical benefits, impacting public health globally without affecting the health budgets of low- and middle-income countries. Dr Tedros Adhanom Ghebreyesus, WHO director-general, said: "For over 40 years, countries all over the world have relied on the WHO EML as a definitive, evidence-based guide [for] the most important medicines for delivering the biggest health impact." The new recommendations consist of 85 applications spanning over 100 medicines and formulations that were considered by the WHO Expert Committee on Selection and Use of Essential Medicines. The recent changes have brought the total number of medicines enlisted on the EML and EMLc to a total of 502 and 361, respectively. MS, a chronic and debilitating disease of the nervous system that affects approximately 2.8 million people globally, previously had no medicines for its treatment included on the EML. Three medicines to delay or slow MS progression – cladribine, glatiramer acetate and rituximab – have now been added. Multiple fixed-dose combinations of cardiovascular medicines for the prevention of diseases of the heart and blood vessels, have also been added to the EML for the first time after multiple countries conducted milestone trials confirming the benefits of these combinations for primary and secondary prevention of heart disease. Four new medicines have been listed for infectious diseases, including ravidasvir for the treatment of chronic hepatitis C virus infection in adults, as well as pretomanid for the treatment of multi-drug resistant or rifampicin-resistant tuberculosis. Pegylated liposomal doxorubicin and pegfilgrastim, two new cancer treatments, were added to the ECL, along with new medicines to include new types of childhood cancers on the EMLc. Other listings also include new medications for conditions including diabetes and mental health, as well as essential medicines for children. Dr Benedikt Huttner, secretariat of the WHO EML, described the list as an "important tool for achieving universal health coverage", adding that it provides "guidance to governments, health facilities and procurers on which medicines are the best value in terms of benefits for individuals and communities".

NDA

26 Jun 2023

·www.prnewswire.com

Ascletis Announces Poster Presentation of Phase II Study of ASC42 FXR Agonist for Functional Cure of Chronic Hepatitis B at EASL CONGRESS 2023

HANGZHOU and SHAOXING, China, June 25, 2023 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX:1672, "Ascletis") today announces the poster presentation of ASC42, a novel farnesoid X receptor (FXR) agonist, in combination with PEGylated interferon (PEG-IFN) and entecavir (ETV) in chronic hepatitis B (CHB) patients with 12-week treatment at European Association for the Study of the Liver (EASL) CONGRESS 2023. The summary of the abstract is shown as below: Title: A phase 2 study of ASC42, a novel farnesoid X receptor (FXR) agonist, in combination with PEGylated interferon (PEG-IFN) and entecavir (ETV) in chronic hepatitis B patients with 12-week treatment Presenter: Jinzi J. Wu, Ph.D. Principal Investigator: Prof. Jinlin Hou, Nanfang Hospital of Southern Medical University Poster Number: SAT-201 Category: Viral Hepatitis B and D Study Design: This Phase 2 trial (NCT05107778) was a multi-center, randomized, single-blind, placebo-controlled study conducted in China. Forty-three HBeAg negative, hepatitis B virus (HBV) DNA Results: In total, 122, 119, and 107 adverse events (AEs) were reported in 10 mg ASC42, 15 mg ASC42 and PBO cohorts, respectively, and most AEs (94.3%) were mild (grade 1) or moderate (grade 2) in severity. One subject in 15 mg ASC42 cohort experienced a grade 3 serious AE (SAE) of liver function injury with a final outcome of recovered. Pruritus is the most common AE, and study drug-related pruritus was reported in 1 (6.7%), 7 (50%) and 0 (0%) subjects in 10 mg ASC42, 15 mg ASC42 and PBO cohorts, respectively. Pruritus rate of 10 mg ASC42 (6.7%) is lower than other FXR agonists in non-alcoholic steatohepatitis (NASH) patients. Conclusion: In CHB patients, 12-week treatment of 10 mg ASC42 in combination of PEG-IFN-α-2a and ETV was safe and well-tolerated and showed minimum and mild pruritus (6.7%). Previous study indicated that in healthy subjects, 14-day treatment of ASC42 alone demonstrated 471%~1,780% increase of fibroblast growth factor 19 (FGF19) and 53%~91% decrease of 7α-hydroxy-4-cholesten-3-one (C4) at a dose range of 5 mg~15 mg. Data suggest that at the therapeutic dose of 10 mg, the novel FXR agonist ASC42 is differentiated from other FXR agonists in terms of pruritus. [1]. Data on file [2]. Younossi Z.M., Ratziu V., Loomba R., et al. Obeticholic acid for the treatment of non-alcoholic steatohepatitis: interim analysis from a multicentre, randomised, placebo-controlled phase 3 trial [J]. The Lancet, 2019, 394(10215): 2184-96.DOI: 10.1016/s0140-6736(19)33041-7 [3]. Lau G.K., Piratvisuth T., Luo K.X., et al. Peginterferon Alfa-2a, lamivudine, and the combination for HBeAg-positive chronic hepatitis B [J]. N Engl J Med, 2005, 352(26): 2682-95.DOI: 10.1056/NEJMoa043470 [4]. Loomba R., Noureddin M., Kowdley K.V., et al. Combination Therapies Including Cilofexor and Firsocostat for Bridging Fibrosis and Cirrhosis Attributable to NASH [J]. Hepatology, 2021, 73(2): 625-43.DOI: 10.1002/hep.31622 [5]. Anstee Q.M., Lucas K.J., Francque S., et al. Tropifexor plus cenicriviroc combination versus monotherapy in non-alcoholic steatohepatitis: Results from the Phase 2b TANDEM study [J]. Hepatology, 2023.DOI: 10.1097/hep.0000000000000439 About EASL EASL, the European Association for the Study of the Liver, founded in 1966, is a medical association dedicated to pursuing excellence in liver research, to the clinical practice of liver disorders, and to providing education to all those interested in hepatology. As of 2022, EASL serves 4,900 members from 112 countries. About Ascletis Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange (1672.HK), covering the entire value chain from discovery and development to manufacturing and commercialization. Led by a management team with deep expertise and a proven track record, Ascletis focuses on three therapeutic areas with unmet medical needs from a global perspective: viral diseases, non-alcoholic steatohepatitis (NASH) and oncology. Through excellent execution, Ascletis rapidly advances its drug pipeline with an aim of leading in global competition. To date, Ascletis has three marketed products, i.e. ritonavir tablets, GANOVO® and ASCLEVIR®, and 23 drug candidates in its R&D pipeline. The most advanced drug candidates include ASC22 (HBV functional cure), ASC10 and ASC11(oral small molecules for COVID-19 treatment), ASC40 (recurrent glioblastoma), ASC42 (PBC, primary biliary cholangitis), and ASC40 (acne). For more information, please visit . SOURCE Ascletis Pharma Inc.

Clinical ResultPhase 2Phase 3

100 Deals associated with Ravidasvir Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
-	Ravidasvir Hydrochloride	J05AP	DB15652

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hepatitis C	China	Ascletis Pharma, Inc.	29 Jul 2020
Hepatitis C	China	Ascletis Biopharmaceutical (Hangzhou) Co. Ltd.	29 Jul 2020

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 3	Egypt	European Egyptian Pharmaceutical Industry	25 Feb 2020
Chronic hepatitis C genotype 1	Phase 3	China	Ascletis Biopharmaceutical (Hangzhou) Co. Ltd.	26 Sep 2018
Pseudohyperkalemia Cardiff	Phase 2	-	Ascletis Pharmaceuticals Co.,Ltd.	01 Aug 2015
Hepatitis C, Chronic	Phase 2	United States	Presidio Pharmaceuticals, Inc.	01 May 2013

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03020095 (EVEREST, CTgov)	Phase 2	Chronic hepatitis C genotype 1 \| Pseudohyperkalemia Cardiff	38	Danoprevir+Ravidasvir+Ritonavir+Ribavirin	uurkplfojo = xmnolqvrav tpxruslciw (anytlpsveh, fyzgxbexhs - vwtjkpijja) View more	-	22 Oct 2020
NCT03362814 (Pubmed \| J Clin Transl Hepatol) Manual	Phase 2/3	Hepatitis C	424	Ravidasvir +ritonavir+danoprevir+ribavirin	xpxkojzpcb(niioqnrssc) = ifsabccqas xzsvqloigl (abhbtnqnfp, 97 - 100) View more	Positive	28 Sep 2019
NCT03362814 (phase 2/3, EASL2019)	Phase 2/3	Chronic hepatitis C genotype 1 NS5A RASs \| IL-28B CC genotype	424	Ravidasvir 200 mg	uyxowfaswk(fpicundifi) = zvjbrhfwfx uqagnrjozc (vuulejpnra ) View more	Positive	11 Apr 2019
NCT03362814 (phase 2/3, EASL2019)	Phase 2/3		424	Danoprevir 100 mg/100 mg	uyxowfaswk(fpicundifi) = siuaxexagu uqagnrjozc (vuulejpnra )	Positive	11 Apr 2019
NCT03020095 (EVEREST, Pubmed \| J Gastroenterol Hepatol) Manual	Phase 2	Hepatitis C	38	Ravidasvir +danoprevir +ribavirin	cnjjizkhyt(dyebyouwfv) = qupxydpcrg rjfeimffmv (uobkebyzru ) View more	Positive	01 Aug 2018
NCT02371408 (Pubmed \| J Hepatol)	Phase 2/3	Hepatitis C, Chronic	300	Ravidasvir plus Sofosbuvir	fmdbykwtrs(dawahqrfkp) = nwpnbcochg bzmnsthzoq (byqzwuinbt )	Positive	19 Sep 2017

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