Hepatitis C virus (HCV) infection is associated with significant morbidity and mortality owing to progression of a high percentage (85%) of HCV infected patients to chronic hepatitis, which might lead to the development of liver cirrhosis or hepato cellular carcinoma..
Egypt has possibly the highest HCV prevalence in the world, 10-20% of the general population .

Start Date01 Oct 2022

Sponsor / Collaborator

Assiut University

NCT05854511

/ RecruitingPhase 3IIT

Pharmacokinetics, Safety, Efficacy and Acceptability Study of Daclatasvir/Sofosbuvir in Children Weighing 14-35 Kilograms With Chronic Hepatitis C Virus Infection

This is an interventional, single center, single arm clinical trial to assess the pharmacokinetics, safety, efficacy, and acceptability of daclatasvir plus sofosbuvir in treatment-naïve children weighing between 14 and 35 kg with chronic HCV GT 1-6 infection.

Start Date05 Jun 2022

Sponsor / Collaborator

Ain Shams University

[+1]

NCT05372874

/ Unknown statusNot ApplicableIIT

Evaluation of the Effect of Direct-Acting Antiviral Agents on Melatonin Level in Chronic Hepatitis C Patients in Egypt.

Patients with hepatitis c showed increased level of oxidative stress. Increased level of serum lipid peroxidation leads to the production of toxic mediators as malondialdehyde (MDA) which lead to disease progression. Chronic stress shunt tryptophan which is essential amino acid toward kynurenic pathway leading to lower level of serotonin and melatonin level. Currently, direct-acting antivirals (DAAs) show well-established efficacy against hepatitis C virus (HCV).

Start Date06 May 2022

Sponsor / Collaborator

Tanta University

100 Clinical Results associated with Daclatasvir Dihydrochloride

100 Translational Medicine associated with Daclatasvir Dihydrochloride

100 Patents (Medical) associated with Daclatasvir Dihydrochloride

2,249

Literatures (Medical) associated with Daclatasvir Dihydrochloride

01 Apr 2025·Hemodialysis International

Hepatitis C Treatment With Generic Sofosbuvir‐Based Regimens in Patients Undergoing Hemodialysis

Article

Author: Afredj, Nawal ; Mahiou, Hassen ; Kerbouche, Rafik ; Boutra, Fouad ; Zaidi, Arezki ; Nakmouche, M'hamed ; Belimi, Hibatallah ; Drir, Othmane ; Cheikh, Ibtissem Ouled ; Guessab, Nawal ; Debzi, Nabil ; Boumendjel, Mustapha

ABSTRACT:

Objectives:

To assess the efficacy and safety of locally manufactured generic sofosbuvir‐based direct‐acting antivirals in the treatment of Hepatitis C virus (HCV) infected patients on maintenance hemodialysis.

Patients and Methods:

We have conducted a retrospective multicenter study including patients on maintenance hemodialysis, treated with sofosbuvir‐based regimens between 01/01/2017 and 09/30/2021. Patients were treated for 12 or 24 weeks, with sofosbuvir 400 mg + ledipasvir 90 mg 3 times/week, or sofosbuvir 3 times/week + daclatasvir 60 mg/d, or sofosbuvir + daclatasvir in coformulation, 3 times/week. Sustained virological response was defined as a negative HCV RNA test 12 weeks after treatment. The occurrence of serious adverse events during treatment defines intolerance to treatment. Statistical analysis was performed using SPSS software (version 25).

Results:

A total of 120 patients were treated; the mean age was 50 ± 14.17 years [18–78], 50% were men. Twenty‐two patients (n = 22; 18.3%) were previously treated with pegylated Interferon. Genotype 1 was predominant (n = 68; 82%). Most of the patients (n = 53; 44.2%) had no significant fibrosis, and 24 (20%) had cirrhosis. The SVR rate was 93.3% (CI 95% [88.8; 97.8]) (n = 112), the serious adverse events rate was 10.8% (CI 95% [0.054–0.166]) (n = 13), including 2 deaths unrelated to direct‐acting antivirals. Early treatment discontinuation occurred in 5.8% (n = 7), and a relapse in 0.8% (n = 1). On multivariate analysis, risk factors for serious adverse events included advanced liver fibrosis, thrombocytopenia, hypoalbuminemia, high bilirubin level, and pre‐treatment status.

Conclusion:

Locally manufactured generic sofosbuvir‐based regimens are safe and effective in maintenance hemodialysis patients. However, they should be closely monitored to manage comorbidities and complications during treatment.

01 Apr 2025·SEPARATION AND PURIFICATION TECHNOLOGY

Using artificial neural networks to elucidate retention interactions on stationary phases with amine moieties dedicated to supercritical fluid chromatography

Author: Plachka, Katerina ; Gazarkova, Tatana ; Pilarova, Veronika ; Plachká, Kateřina ; Nováková, Lucie ; Pilařová, Veronika ; Svec, Frantisek ; Švec, František ; Garrigues, Jean-Christophe ; Novakova, Lucie ; Gazárková, Taťána

The retention mechanisms of small mols. on a wide range of stationary phases using different mobile phase compositions are one of the most discussed topics in current state-of-the-art supercritical fluid chromatog. (SFC).Although various theories have been published on retention behavior, prediction, and stability over time, an in-depth insight into the mechanisms is still lacking.Our study focused on the description of the retention mechanisms on columns with amine moieties, i.e., 2-ethylpyridine, 2-picolylamine, 1-aminoanthracene, and diethylamine, dedicated to SFC, using three different compositions of organic modifier, i.e., methanol, methanol + 10 mmol/L NH₃, and methanol + 2% H₂O, in CO₂.An extensive set of analytes characterized by more than 200 mol. descriptors was used.The importance of the effect of each mol. descriptor on the retention behavior was determined by artificial neural networks.Thus, the descriptors increasing and/or decreasing retention on individual columns using different mobile phase compositions were defined.The data collected over one year of column use were statistically evaluated to describe the retention behavior of small mols. on the tested stationary phases using three organic modifiers and to describe the changes in retention behavior over time.As the development of the SFC method can be laborious and time-consuming, this publication offers a detailed description of the interactions taking place between the analyte and the SFC stationary phase.Understanding these fundamental processes will enable faster development of SFC methods using quality-by-design principles.

01 Apr 2025·Natural Products Journal

A Systematic Review on the Evolution of Natural Mutation-dependent Antiviral Drug Resistance in Hepatitis C Virus (HCV) Genotypes Prevalent in Saudi Arabia: A Genomic and Therapeutic Perspective

Author: Izhari, Mohammad Asrar

Background::

The characterization of resistance-associated amino acid substitution (RAAS) in direct-acting antivirals (DAA) molecular targets could reshape the treatment strategy for HCV infection. Hence, this review aimed to provide evidence on the impact of the RAASs on DAA treatment for HCV.

Methods::

PRISMA model was followed for the literature survey and evaluation (sources: PubMed, Sci-Hub, and Google Scholar). RAASs in DAA target proteins and their locations were mapped on 3-D proteins using two reference protein sequences: NS3/ID: AAA72945.1 and NS5A/NS5B/ID: NP_671491.1. NCBI-Basic Local Alignment Tool, UniProt and AlphaFold2/MMSeqs2, PyMol, and R-base/R-studio were used for alignment, retrieval of protein sequences, 3-D protein structure modeling, visualization of locations of RAASs, and diagrammatic representations, respectively.

Results::

Genotype 4 afterwards genotype 1 was the most prevalent in Saudi Arabia. L2003M, Y2065N, M2000T, L2003V, and Q2002H RAASs were anti-NS5A inhibitor. NS5A-Q2002H was anti-daclatasvir in genotype 4. NS5A-Y2065H and NS5B-S2702T in genotype 1 were antisofosbuvir- resistant. NS3-A1182V, NS3-Q1106K/R, and NS3-T1080S RAASs exhibited resistance to double antivirals. NS3-D1194A RAAS was a multi-drug resistant variant (against 3 DAAs). NS3- V1062A, NS3-D1194G, NS3-D1194E/T, NS3- S1148R, NS3-V1196A, NS3-V1062LNS3-S1148A, and NS3-S1148G RAASs in genotype 1 were single drug-resistant variants. NS3- S1148R and NS3- S1148A in genotypes 2 and 5 were anti-simeprevir-resistant variants.

Conclusions::

An array of identified RAASs, RAAS-dependent DAA treatment failure, and recommended combination DAA therapy in such clinical scenarios of RAASs are the significant outcomes of this research. RAAS-linked in vitro and in vivo resistance profiling at genotype/sub-genotype level will be crucial in treatment choice and for future DAA design strategies.

News (Medical) associated with Daclatasvir Dihydrochloride

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!

28 Feb 2023

·www.biospace.com

Revance Adds Experienced Pharmaceutical Executive to Board of Directors with Appointment of Dr. Vlad Coric, M.D., as Independent Director

Dr. Coric currently serves as the Chairman and Chief Executive Officer of Biohaven (BHVN) NASHVILLE, Tenn.--(BUSINESS WIRE)-- Revance Therapeutics, Inc. (RVNC), announced today the appointment of Dr. Vlad Coric, M.D., to its Board of Directors, effective March 1, 2023. Dr. Coric brings more than 22 years of drug development and executive leadership experience to Revance based on his time at the Yale School of Medicine, Bristol-Myers Squibb, and Biohaven, which was acquired by Pfizer in 2022. The company also announced that long-standing director Philip Vickers has decided that he will be retiring from the Board effective immediately prior to the company’s 2023 Annual Meeting of Stockholders. "Vlad’s leadership and proven track record in biotech value creation from discovery to commercialization, particularly in the field of neurology, will further enhance the collective experience and skillset of our diverse Board," said Mark J. Foley, Chief Executive Officer of Revance. “His appointment comes at a dynamic time for Revance as we accelerate our commercial growth in aesthetics and look to advance our significant opportunity in therapeutics. As we welcome Vlad to the Board, I would also like to thank Phil Vickers for his invaluable contributions over the past eight years in guiding the scientific progress at Revance, marked by the approval of DAXXIFY® in glabellar lines and our successful Phase 3 clinical trials for DAXXIFY® in cervical dystonia.” “Revance’s people, strategy and breakthrough innovation in the neuromodulator category uniquely positions the company to disrupt both the aesthetics and therapeutics market,” said Dr. Valid Coric, M.D. “I look forward to working with Mark, the rest of the leadership team and the Board to support Revance’s continued progress and advancement of innovative therapies that have the potential to maximize the benefit of DAXXIFY’s efficacy and long-duration profile.” Dr. Coric is currently the Chairman and CEO of Biohaven, where he has successfully led the approval and commercialization of its Nurtec® ODT and CGRP franchise in addition to the expansion of company’s therapeutic portfolio targeting neurological and neuropsychiatric diseases. He also led Biohaven’s acquisition of its novel Kv7 channel platform and the sale of the Biohaven to Pfizer in October 2022 for total considerations of $13 billion. Previously, Dr. Coric was the Group Director, Neuroscience and Oncology Global Clinical Research, and Medical Director, Neuroscience Global Clinical Research, at Bristol-Myers Squibb Company. He also previously served on the board of directors of Social Capital Suvretta Holdings Corp. I (DNAA) from 2021-2022 and he currently serves on the boards of directors of private biotech companies including Veradermics, Inc., Vita Therapeutics, Inc., and Pyramid Biosciences, Inc. During his career, Dr. Coric has been involved in multiple drug development programs, including marketed drugs or filed NDAs such as Nurtec® ODT (rimegepant; oral calcitonin related peptide antagonist), zavegepant (intranasal calcitonin related peptide antagonist), Abilify® (aripiprazole; partial dopamine agonist), Opdivo® (nivolumab; anti-PD1), Yervoy® (Ipilimumab; anti-CTLA-4), Daklinza® (daclatasvir; NS5A inhibitor), and Sunvepra® (asunaprevir; NS3 inhibitor). Dr. Coric is an Associate Clinical Professor of Psychiatry at the Yale School of Medicine, has published over 65 peer-reviewed publications and has lectured nationally on neurological and psychiatric disorders. He earned his medical degree from Wake Forest University School of Medicine and was an honors scholar in neurobiology and physiology at the University of Connecticut, where he received his Bachelor of Science degree. About Revance Revance is a biotechnology company setting the new standard in healthcare with innovative aesthetic and therapeutic offerings that elevate patient and physician experiences. Revance’s aesthetics portfolio of expertly created products and services, including DAXXIFY® (DaxibotulinumtoxinA-lanm) for injection, the RHA® Collection of dermal fillers, and OPUL®, the first-of-its-kind Relational Commerce platform for aesthetic practices, deliver a differentiated and exclusive offering for the company’s elite practice partners and their consumers. Revance has also partnered with Viatris Inc. to develop a biosimilar to onabotulinumtoxinA for injection, which will compete in the existing short-acting neuromodulator marketplace. Revance’s therapeutics pipeline is currently focused on muscle movement disorders including evaluating DAXXIFY® in two debilitating conditions, cervical dystonia and upper limb spasticity. Revance is headquartered in Nashville, Tennessee, with additional office locations in Newark, Pleasanton and Irvine, California. Learn more at , , , or connect with us on LinkedIn. “Revance” and the Revance logo, DAXXIFY®, and OPUL® are registered trademarks of Revance Therapeutics, Inc. Resilient Hyaluronic Acid® and RHA® are trademarks of TEOXANE SA. Forward-Looking Statements Any statements in this press release that are not statements of historical fact, including statements related to our ability to set a new standard in healthcare; our commercial growth; our opportunity in the aesthetics and therapeutics markets; our ability to disrupt the aesthetics and therapeutics markets; the outcomes for and experiences of patients and physicians; the development of innovative therapies; the potential benefits, safety, efficacy and duration of DAXXIFY®; and development of a biosimilar to BOTOX® to compete in the short-acting neuromodulator marketplace; constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, events, circumstances or achievements reflected in the forward-looking statements will ever be achieved or occur. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties relate, but are not limited to: our ability to successfully commercialize DAXXIFY® and to continue to successfully commercialize the RHA® Collection of dermal fillers and OPUL®; the results, timing, costs, and completion of our research and development activities and regulatory approvals; our ability to obtain funding for our operations; the timing of capital expenditures; the accuracy of our estimates regarding future expenses, revenues and capital requirements, our financial performance and the economics of DAXXIFY®, the RHA® Collection of dermal fillers and OPUL®; the impact of the COVID-19 pandemic and other macroeconomic factors on our manufacturing operations, supply chain, end user demand for our products and services, the aesthetics market, commercialization efforts, business operations, regulatory meetings, inspections and approvals, clinical trials and other aspects of our business and on the market; our ability and the ability of our partners to manufacture supplies for DAXXIFY® and our product candidates and to acquire supplies of the RHA® Collection of dermal fillers; the uncertain clinical development process; the risk that clinical trials may not have an effective design or generate positive results or that positive results would assure regulatory approval or commercial success; the applicability of clinical study results to actual outcomes; the rate and degree of economic benefit, safety, efficacy, commercial acceptance, market, competition and/or size and growth potential of DAXXIFY®, the RHA® Collection of dermal fillers, and our drug product candidates, if approved; the rate and degree of commercial acceptance, market, competition and growth potential of OPUL®; reports of adverse events or safety concerns involving DAXXIFY® or the RHA® Collection of dermal fillers; the timing and cost of commercialization activities; the proper training and administration of our products by physicians and medical staff; our ability to expand sales and marketing capabilities; the status of commercial collaborations; changes in and failures to comply with privacy and data protection laws; our ability to effectively manage our expanded operations in connection with the acquisition of Hint, Inc; our ability to continue obtaining and maintaining intellectual property protection for DAXXIFY® and our drug product candidates; the cost and our ability to defend ourselves in product liability, intellectual property, class action or other lawsuits; the volatility of our stock price; and other risks. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in our periodic filings with the Securities and Exchange Commission (SEC), including factors described in the section entitled "Risks Factors" on our Form 10-K expected to be filed with the SEC on February 28, 2023. The forward-looking statements in this press release speak only as of the date hereof. We disclaim any obligation to update these forward-looking statements. View source version on businesswire.com: Contacts Investors Revance Therapeutics, Inc.: Jessica Serra, 510-279-6886 Jessica.serra@revance.com or Gilmartin Group, LLC.: Laurence Watts, 619-916-7620 laurence@gilmartinir.com Media Revance Therapeutics, Inc.: Sara Fahy, 949-887-4476 sfahy@revance.com Source: Revance Therapeutics, Inc. View this news release online at:

Executive ChangePhase 3Acquisition

19 Oct 2022

·www.biospace.com

Anji Pharma and Population Health Partners Enter into Strategic Collaboration to Jointly Address High Prevalence Human Disease

BOSTON & NEW YORK--(BUSINESS WIRE)-- Anji Pharmaceuticals and Population Health Partners today announced that they have entered into a strategic collaboration, bringing together two complementary teams to jointly address high prevalence human diseases. Anji Pharmaceuticals (‘Anji’) is an emerging global medicines company founded by CEO Dr. Brian Hubbard, who has led therapeutics discovery and development programs at the Broad Institute of MIT and Harvard, Merck, Novartis, and Millennium Pharmaceuticals. Anji co-founders also include CMO Dr. Dan Meyers, who has designed and led over 40 clinical trials; CSO Dr. Mike Serrano-Wu, who was part of discovery teams that identified daclatasvir, pradigastat, and 5 additional molecules which have reached clinical trials; and COO Dr. Yiwei Zong, an experienced investor and entrepreneur. Anji is progressing high potential late-stage clinical assets in Phase II and Phase III development. Population Health Partners (‘PHP’) is a global life-science investment firm founded by Dr. Clive Meanwell, who has led therapeutics development programs in his roles as Founder and CEO of The Medicines Company, and in a range of executive positions at Roche. Other Partners at PHP include Ian Read, former Chairman and CEO of Pfizer; Dr. Roy Berggren, former lead of McKinsey’s global Life Sciences practice; and Chris Cox, former head of Cadwalader Wickersham and Taft’s global corporate law practice. PHP will work with Anji to support their portfolio and to advise on strategic and operational matters as they advance clinical assets which have high potential to improve the lives and reduce the health burdens on millions of people with prevalent diseases and/or disease risk factors. “We’ve built Anji to be an agile asset-centric biopharma enterprise that can repeatedly unlock value of clinical programs where we see high validation and unmet need,” said Brian Hubbard, Ph.D., co-founder and CEO of Anji. “Teaming up with PHP is clearly one of those ‘1+1 = 3’ moments, where the deep skillsets of each will equip Anji to deliver life-changing medicines to patients even more quickly.” The initial focus of the Anji/PHP collaboration is to accelerate development of the two lead clinical assets in Anji’s pipeline. ANJ900 (delayed-release metformin) is an investigational agent currently in Phase 3 trials to enable safe use of metformin in Type 2 diabetes patients with advanced chronic kidney disease (CKD). Previous trials with ANJ900 demonstrated clinically meaningful glucose lowering with only one-third the plasma concentrations observed with currently marketed formulations of metformin. This finding points to the potential for expanded and improved treatment for CKD patients in whom metformin use is currently contraindicated. ANJ908 (pradigastat) is a novel DGAT1 inhibitor which has completed a successful Phase 2 study in patients with chronic idiopathic constipation (NCT04620161). This proof-of-concept study was performed across 25 clinical trial sites in U.S. and China and demonstrated the potential efficacy, safety, and dose range of pradigastat in patients who met the Rome IV criteria for constipation. Chronic idiopathic constipation affects nearly one in seven Americans, with nearly two million patients seeking pharmacotherapy options worldwide. Anji anticipates sharing preliminary results from the study later this year. “Anji has an extraordinary team – and an inspiring proven leader in Brian. Their ability to unpack the complexities of biology, chemistry, pharmacology, and clinical performance so that they can recognize high potential value and perform efficient drug development programs is highly impressive,” said Clive Meanwell, M.D., Chairman and Managing Partner of PHP. “We will put PHP’s knowledge and experience to work in order to help Anji create value, and produce a positive impact on prevalent diseases.” Locust Walk serves as an advisor to Anji and will work in concert with Anji and PHP to further the goals of the strategic collaboration. About Anji Pharma Anji Pharma is a clinical-stage company dedicated to bringing life-changing therapies to patients across the globe. Anji’s asset-centric business model allows for speed and flexibility in building value, leveraging a clinical and regulatory core that operates with “hub-and-spoke" efficiency. Anji has R&D expertise in Boston, Shanghai, and Berlin, and is preparing additional programs for early clinical development. For more info, visit . About Population Health Partners, L.P. Population Health Partners, L.P. is a private equity firm committed to building great companies around important late-stage therapeutics and solving the health and economic challenges presented by prevalent diseases. While at The Medicines Company, leaders from Population Health Partners secured eight drug approvals involving 21 clinical trials and 91,000 randomized patients and were ranked #1 in the CNBC RQ 50 for biopharmaceutical R&D productivity. For more info, visit .

100 Deals associated with Daclatasvir Dihydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D10105	Daclatasvir Dihydrochloride	J05AP07	DB09102

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hepatitis C	China	Bristol-Myers Squibb (Singapore) Pte Ltd.	24 Apr 2017
Chronic hepatitis C genotype 3	United States	Bristol Myers Squibb Co.	24 Jul 2015
Hepatitis C, Chronic	European Union	Bristol-Myers Squibb Pharma EEIG	22 Aug 2014
Hepatitis C, Chronic	Iceland	Bristol-Myers Squibb Pharma EEIG	22 Aug 2014
Hepatitis C, Chronic	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	22 Aug 2014
Hepatitis C, Chronic	Norway	Bristol-Myers Squibb Pharma EEIG	22 Aug 2014

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Compensated cirrhosis	Phase 3	Australia	Bristol Myers Squibb Co.	01 Feb 2015
Compensated cirrhosis	Phase 3	France	Bristol Myers Squibb Co.	01 Feb 2015
Chronic hepatitis C genotype 1	Phase 3	United States	Bristol Myers Squibb Co.	01 Dec 2013
Chronic hepatitis C genotype 1	Phase 3	Australia	Bristol Myers Squibb Co.	01 Dec 2013
Chronic hepatitis C genotype 1	Phase 3	Canada	Bristol Myers Squibb Co.	01 Dec 2013
Chronic hepatitis C genotype 1	Phase 3	France	Bristol Myers Squibb Co.	01 Dec 2013
Fibrosis	Phase 3	United States	Bristol Myers Squibb Co.	01 Dec 2013
Fibrosis	Phase 3	Australia	Bristol Myers Squibb Co.	01 Dec 2013
Fibrosis	Phase 3	Canada	Bristol Myers Squibb Co.	01 Dec 2013
Fibrosis	Phase 3	France	Bristol Myers Squibb Co.	01 Dec 2013

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03483987 (Pubmed \| J Clin Exp Hepatol)	Not Applicable	Hepatitis C	12	Sofosbuvir	xxiyfwdhfo(owbrskcoiz) = jhqzikivif mjwigulbyu (sqsrgabepj )	Positive	01 Sep 2023
				Daclatasvir	xxiyfwdhfo(owbrskcoiz) = irbczcwyik mjwigulbyu (sqsrgabepj )
NCT01866930 (DIMENSION, CTgov)	Phase 3	Coinfection \| HIV Infections \| Hepatitis C, Chronic	453	Lambda+DCV+Ribavirin (Cohort A: HCV GT-2 or GT-3)	dhftayywei = oqfsrqooqt nkjqeicypn (wyoqsezsna, wnabwxymtr - usecceuorw) View more	-	13 Jun 2023
				Lambda+DCV+Ribavirin (Cohort B: HCV GT-1 or GT-4)	dhftayywei = axydegodzb nkjqeicypn (wyoqsezsna, gtjxvuxpvn - ccaeugwdjp) View more
ISN WCN2023	Not Applicable	-	125	Sofosbuvir 200 mg	kngxjeblum(zbholqudru) = No patient discontinued antiviral therapy due to side effects gdpprygokt (kcfdewfvoc ) View more	Positive	01 Mar 2023
				Daclatasvir 60 mg
NCT03480932 (CTgov)	Phase 2/3	Hepatitis C, Chronic	150	Sofosbuvir+Daclatasvir+Pegylated Interferon alfa-2a (SOF+DAC+PEG)	vmdolqfmpz = ueufkpmrxz esmbvdykax (pcvorftlzb, xijjeydcrc - qhoasqngft) View more	-	18 May 2021
				Sofosbuvir+Daclatasvir (SOF+DAC, DOT)	vmdolqfmpz = ttnfpbulah esmbvdykax (pcvorftlzb, ydnctvipwh - lbwxzvmjbe) View more
NCT03487848 (CTgov)	Phase 2	Hepatitis, Chronic \| Pseudohyperkalemia Cardiff \| Hepatitis C	5	Daclatasvir (DCV)+Sofosbuvir (SOF)	pjankweizg(qqvqkisqee) = aduaypmrdw upxohbjlst (mjvoetjnxs, 48.3) View more	-	20 Apr 2021
P1384 (ERA2020)	Not Applicable	Renal Insufficiency \| Hepatitis C, Chronic hemoglobin \| serum creatinine	235	Direct Acting Anti-Virus (Anemic CKD patients)	mmshltajkx(lgtizyhtsu) = pobjrzlbma cigcngasug (ygfoiivkmf ) View more	Positive	06 Jun 2020
				Direct Acting Anti-Virus (Non-anemic CKD patients)	mmshltajkx(lgtizyhtsu) = qxstjebvkx cigcngasug (ygfoiivkmf ) View more
NCT03200184 (SD1000, Pubmed \| Clin Infect Dis) Manual	Phase 3	Hepatitis C	1,361	Sofosbuvir and daclatasvir (intention-to-treat)	ktoogbnrnk(pplkaqougj) = zkoakhxxsc lshorclngn (kkzhjguosu )	Positive	06 May 2020
				Sofosbuvir and daclatasvir (per-protocol)	ktoogbnrnk(pplkaqougj) = gesqsxknda lshorclngn (kkzhjguosu )
NCT03540212 (Pubmed \| Antivir Ther)	Phase 2/3	Hepatitis C	17	Daclatasvir 60 mg	afrsjdhncc(cnurjrnhve) = yzyqbyhsni udgrltpmkr (mepbdqgjyh ) View more	-	05 May 2020
ISN WCN2020	Not Applicable	Maintenance	82	Half-dose Sofosbuvir [200 mg] and Daclatasvir (60 mg)	tklbqxpnge(awyhckmmxh) = There were nonsignificant gastrointestinal side effects in the full dose Sofosbuvir group. All patients tolerated the DAAs well and none of the patients reported any serious adverse events. No patient discontinued antiviral therapy due to side effects jtcxbnmbng (cfitotdvgv ) View more	Positive	01 Mar 2020
				Full-dose Sofosbuvir 400mg and Velpatasvir (100 mg)
NCT01995266 (CTgov)	Phase 3	Chronic hepatitis C genotype 1b	218	daclatasvir (DCV)	cystbjqzlo = rlyqikmrlx fslyhluqbg (xxlaispybk, zoozshgesh - qvfihxtydr) View more	-	11 Jul 2019

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Bio Sequences Search & Analysis

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Chemical Structures Search & Analysis