Daclatasvir Dihydrochloride

Short Description:

API’s Name Indication Specification US DMF  EU DMF  CEP
Daclatasvir Dihydrochloride HCV In-House    


Product Detail

Product Tags

PRODUCT DETAIL

Description

Daclatasvir dihydrochloride (BMS-790052 dihydrochloride) is a potent and orally active HCV NS5A protein inhibitor with EC50s range of 9-146 pM for multiple HCV replicon genotypes. Daclatasvir dihydrochloride is also a organic anion transporting polypeptide 1B (OATP1B) and OATP1B3 inhibitor with IC50s of 1.5 µM and 3.27 µM, respectively.

IC50 & Target

EC50: 50 pM (HCV replicon genotype 1a), 9 pM (HCV replicon genotype 1b), 71 pM (HCV replicon genotype 2a), 146 pM (HCV replicon genotype 3a), 12 pM (HCV replicon genotype 4a) and 33 pM (HCV replicon genotype 5a)[1]
Kd: 8 nM (NS5A33-202) and 210 nM (NS5A26-202)[2]
IC50: 1.5 µM (OATP1B) and 3.27 µM (OATP1B3)[3]

In Vitro

Daclatasvir (BMS-790052) demonstrates potent inhibitory activity towards all genotypes tested, with EC50 values ranging from 9 pM to 146 pM. Daclatasvir inhibits HCV replicon genotype 1a, 1b, 2a, 3a, 4a and 5a with EC50 values of 50 pM, 9 pM, 71 pM, 146 pM, 12 pM and 33 pM, respectively. Daclatasvir is a potent inhibitor of the JFH-1 genotype 2a infectious virus that replicates in cell culture (EC50=28 pM)[1]. Daclatasvir (BMS-790052) binds tightly to NS5A33-202 and NS5A26-202 with Kds of 8 nM and 210 nM, respectively[2].

Storage

Powder

-20°C

3 years
 

4°C

2 years
In solvent

-80°C

6 months
 

-20°C

1 month


Clinical Trial

NCT Number Sponsor Condition Start Date

Phase

NCT03369327 Tehran University of Medical Sciences|RojanPharma Pharmaceutical Company Hepatitis C Virus Infection, Response to Therapy of|Human Immunodeficiency Virus January 1, 2017

Phase 3

NCT03485846 R-Pharm|Almedis Chronic Hepatitis C Genotype 1b November 27, 2017

Phase 2

NCT01016912 Bristol-Myers Squibb Hepatitis C Infection December 2009

Phase 2

NCT01629732 Bristol-Myers Squibb Hepatitis C Virus March 2013

Phase 2

NCT01497834 Bristol-Myers Squibb Hepatitis C January 2012

Phase 3

NCT01973049 Bristol-Myers Squibb Hepatitis C December 2013

Phase 3

NCT00663208 Bristol-Myers Squibb Chronic Hepatitis C May 2008

Phase 2

NCT02576314 Humanity and Health Research Centre|Beijing 302 Hospital Chronic Hepatitis C Infection May 2015

Phase 3

NCT02756936 Genuine Research Center, Egypt|Zeta Pharma Pharmaceutical Industries Healthy February 2016

Phase 1

NCT02771405 National Hepatology & Tropical Medicine Research Institute|Cairo University Hepatitis C, Chronic|Hepatocellular Carcinoma March 2016

Phase 3

NCT03706898 Viriom HIV-1-infection|Hepatic Impairment October 1, 2018

Phase 1

NCT02319031 Bristol-Myers Squibb Hepatitis C February 2015

Phase 3

NCT02124044 National Institutes of Health Clinical Center (CC)|National Institute of Allergy and Infectious Diseases (NIAID)|Bristol-Myers Squibb HIV-HCV February 2014

Phase 2

NCT02551861 Bristol-Myers Squibb Hepatitis C December 2015

Phase 2

NCT00859053 Bristol-Myers Squibb Hepatic Insufficiency March 2009

Phase 1

NCT01257204 Bristol-Myers Squibb Hepatitis C Virus December 2010

Phase 2

NCT03063879 Tehran University of Medical Sciences|Ahvaz Jundishapur University of Medical Sciences|Shiraz University of Medical Sciences|Hamadan University of Medical Science Hepatitis C, Chronic|Chronic Renal Failure April 1, 2017

Phase 4

NCT01017575 Bristol-Myers Squibb Hepatitis C Infection December 2009

Phase 2

NCT02865369 Sang Gyune Kim|Seoul National University Boramae Hospital|Severance Hospital|Inha University Hospital|Korea University|Gachon University Gil Medical Center|Hanyang University Seoul Hospital|Ewha Womans University Mokdong Hospital|Bristol-Myers Squibb|Soonchunhyang University Hospital Chronic Hepatitis C September 2016

NCT04070235 Nanjing Sanhome Pharmaceutical, Co., Ltd. Hepatitis C, Chronic March 29, 2019

Phase 2|Phase 3

NCT03487848 Bristol-Myers Squibb Hepatitis C|Chronic Hepatitis May 18, 2018

Phase 2

NCT00904059 Bristol-Myers Squibb Hepatitis C May 2009

Phase 1

NCT02107365 French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)|Bristol-Myers Squibb Hepatitis C Virus Genotype 4 Infection November 2013

Phase 2

NCT02397395 Janssen R&D Ireland Renal Impairment|End-stage Renal Disease May 2015

Phase 2

NCT03169348 Assiut University Hepatitis C November 1, 2017

Not Applicable

NCT02323594 Bristol-Myers Squibb Hepatitis C Infection December 2014

Phase 1

NCT03537196 French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) Hepatitis C|Drug Use|Viral Hepatitis C November 13, 2018

Phase 4

NCT02103569 Bristol-Myers Squibb Hepatitis C April 2014

Phase 1

NCT02772744 Zagazig University|Cairo University Hepatitis C November 1, 2017

NCT01718158 Bristol-Myers Squibb Hepatitis C January 2013

Phase 3

NCT02496078 Bristol-Myers Squibb Hepatitis C August 2015

Phase 3

NCT01425970 Bristol-Myers Squibb Hepatitis C May 2012

Phase 2

NCT01471574 Bristol-Myers Squibb Hepatitis C, Genotype 1 December 2011

Phase 3

NCT01573351 Bristol-Myers Squibb Hepatitis C Virus May 2012

Phase 3

NCT01938625 Janssen R&D Ireland Hepatitis C, Chronic December 12, 2013

Phase 2

NCT01492426 Bristol-Myers Squibb Hepatitis C January 2012

Phase 3

NCT03480932 Johns Hopkins Bloomberg School of Public Health|National Institute on Drug Abuse (NIDA)|YR Gaitonde Centre for AIDS Research and Education Hepatitis C, Chronic February 2, 2018

Phase 2|Phase 3

NCT03163849 Assiut University Chronic Hepatitis c September 1, 2019

Phase 3

NCT01581203 Bristol-Myers Squibb Hepatitis C Virus May 2012

Phase 3

NCT01492504 Bristol-Myers Squibb Hepatitis C February 7, 2012

NCT03686722 Mohamed Raslan|Ain Shams University|Drug Research Centre, Cairo, Egypt Diabetes Mellitus, Type 2|Hepatitis C|Drug Interactions September 9, 2017

Phase 1

NCT02262728 Janssen Research & Development, LLC Hepatitis C, Chronic September 30, 2014

Phase 2

NCT02349048 Janssen Research & Development, LLC Hepatitis C Virus January 2015

Phase 2

NCT03882307 Assiut University Hepatitis C, Chronic May 2020

Early Phase 1

NCT02758509 Parc de Salut Mar Chronic Hepatitis C|Cirrhosis January 1, 2010

NCT01795911 Bristol-Myers Squibb Hepatitis C March 2013

Phase 2

NCT03549832 Assiut University|Sohag University|South Valley University HCV Coinfection January 1, 2018

Not Applicable

NCT02161939 Bristol-Myers Squibb Chronic Hepatitis C  

NCT01309932 Bristol-Myers Squibb Hepatitis C March 2011

Phase 2

NCT01995266 Bristol-Myers Squibb Hepatitis C February 28, 2014

Phase 3

NCT02640157 AbbVie Chronic Hepatitis C|Hepatitis C Virus|Genotype 3 Hepatitis C Virus December 2015

Phase 3

NCT02032875 Bristol-Myers Squibb Hepatitis C March 2014

Phase 3

NCT02624063 Federal University of São Paulo Hepatitis C, Chronic December 2015

Phase 4

NCT00546715 Bristol-Myers Squibb Chronic Hepatitis C November 2007

Phase 1|Phase 2

NCT01718145 Bristol-Myers Squibb Hepatitis C Virus Infection November 2012

Phase 3

NCT01616524 Bristol-Myers Squibb Hepatitis C Virus (HCV) July 2012

Phase 3

NCT02032901 Bristol-Myers Squibb Hepatitis C January 2014

Phase 3

NCT03540212 Ain Shams University Chronic HCV Infection December 10, 2017

Phase 2|Phase 3

NCT02097966 Bristol-Myers Squibb Chronic Hepatitis C  

NCT02596880 Tehran University of Medical Sciences Hepatitis C|Cirrhosis September 2015

Phase 3

NCT04019717 Atea Pharmaceuticals, Inc. Hepatitis C|Hepatitis C, Chronic|Chronic Hepatitis C|Hepatitis C Virus Infection|HCV Infection June 20, 2019

Phase 2

NCT02992457 Tanta University Hepatitis C January 2015

Phase 4

NCT03547895 Zagazig University Decompensated Cirrhosis June 1, 2015

Not Applicable

NCT03004625 Kaohsiung Medical University Chung-Ho Memorial Hospital|Chang Gung Memorial Hospital|National Taiwan University Hospital|Taipei Veterans General Hospital, Taiwan|China Medical University Hospital|National Cheng-Kung University Hospital Hepatitis C November 2016

Phase 3

NCT01051414 Bristol-Myers Squibb Hepatitis C Infection April 2010

Phase 2

NCT02309450 French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)|Bristol-Myers Squibb Hepatitis C Virus Genotype 4 Infection December 2014

Phase 2

NCT01628692 Bristol-Myers Squibb|Janssen Research & Development, LLC Hepatitis C Virus July 2012

Phase 2

NCT03186313 Egyptian Liver Hospital|Wadi El Nil Hospital Hepatitis C September 2016

Phase 3

NCT03063723 Third Affiliated Hospital, Sun Yat-Sen University Chronic Hepatitis C (Disorder) January 1, 2016

NCT00983957 Bristol-Myers Squibb Chronic Hepatitis C October 2009

Phase 1

NCT01725542 French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)|Bristol-Myers Squibb HCV-HIV Co-Infection December 2012

Phase 2

NCT02282709 Foundation for Liver Research Chronic Hepatitis C February 2014

Phase 3

NCT02032888 Bristol-Myers Squibb Hepatitis C February 2014

Phase 3

NCT03247296 MTI University Hepatitis C February 28, 2017

NCT01389323 Bristol-Myers Squibb Hepatitis C September 2011

Phase 3

NCT02556086 Bristol-Myers Squibb Hepatitis C December 2015

Phase 2

NCT01741545 Bristol-Myers Squibb Hepatitis C Virus March 31, 2013

Phase 3

NCT01866930 Bristol-Myers Squibb Chronic Hepatitis C Infection July 11, 2013

Phase 3

NCT02268864 Janssen-Cilag International NV Hepatitis C, Chronic January 2015

Phase 2

NCT01797848 Bristol-Myers Squibb Hepatitis C June 2014

Phase 3

NCT03166280 Eman Sayed Hassan Abd Allah|Assiut University Hepatitis C June 2017

NCT02159352 Bristol-Myers Squibb Hepatitis C June 2014

Phase 1

NCT01125189 Bristol-Myers Squibb Hepatitis C Virus July 2010

Phase 2

NCT03748745 Nanjing Sanhome Pharmaceutical, Co., Ltd. Drug Interactions November 19, 2018

Phase 1

NCT01012895 Bristol-Myers Squibb Chronic Hepatitis C December 2009

Phase 2

NCT02565888 Radboud University Hepatitis C|HIV November 2015

Phase 1

NCT02555943 Humanity and Health Research Centre|Beijing 302 Hospital|Nanfang Hospital of Southern Medical University Chronic Hepatitis C Infection|HBV Coinfection|Hepatitis B Reactivation February 2015

Phase 2|Phase 3

NCT02304159 Tarek I. Hassanein, M.D., FACP, FAG, AGAF|Southern California Research Center Hepatitis C|Cirrhosis January 2015

Phase 4

NCT02580474 Myeong Jun Song|Bristol-Myers Squibb|Soonchunhyang University Hospital|Dankook University|Chungnam National University Hospital|Konyang University Hospital|Eulji University Hospital|Saint Vincent´s Hospital, Korea|Konkuk University Hospital|Cheongju St. Mary´s Hospital, Cheongju, Korea|Severance Hospital|Korea University Guro Hospital|Eulji General Hospital|The Catholic University of Korea Hepatitis C February 2016

Phase 4

NCT02104843 Bristol-Myers Squibb Hepatitis C April 2014

Phase 1

NCT01428063 Bristol-Myers Squibb Hepatitis C Virus Infection September 2011

Phase 2

NCT02123654 Bristol-Myers Squibb Hepatitis C Virus Infection April 2014

Phase 3

NCT02565862 Radboud University Hepatitis C|Diabetes Mellitus|Insulin Resistance January 2016

Phase 1

NCT04211844 Ain Shams University Chronic Hepatitis C October 1, 2019

NCT00874770 Bristol-Myers Squibb Hepatitis C Infection June 2009

Phase 2

NCT03883698 Sanjay Gandhi Postgraduate Institute of Medical Sciences Kidney Failure, Chronic|Hepatitis C March 15, 2019

Phase 3

NCT01448044 Bristol-Myers Squibb Hepatitis C December 2011

Phase 3

NCT01359644 Bristol-Myers Squibb|Pharmasset Chronic Hepatitis C June 2011

Phase 2

NCT01842451 Vertex Pharmaceuticals Incorporated Chronic Hepatitis C|CHC|HCV|Hepatitis C June 2013

Phase 2

NCT02762448 Tainan Municipal Hospital Hepatitis c July 2016

NCT02473211 Humanity and Health Research Centre|Beijing 302 Hospital Chronic Hepatitis C Infection January 2015

Phase 2|Phase 3

NCT01455090 Bristol-Myers Squibb Chronic Hepatitis C November 30, 2011

Phase 2

NCT03490097 Ain Shams University Chronic Hepatitis c|Metabolic Syndrome December 1, 2017

Phase 2|Phase 3

NCT01170962 Bristol-Myers Squibb Hepatitis C Virus August 2010

Phase 2

NCT02333292 Valme University Hospital|Hospital del SAS de Jerez|Hospital General Universitario Elche|Hospital La Línea de la Concepción|Complexo Hospitalario Universitario de A Coruña|Hospital de Figueres|Hospital Universitario Puerto Real|Hospital Universitario Virgen de la Victoria|Hospital Universitario de Canarias|Hospital General Universitario de Alicante|Hospital Universitario Araba|Hospital Royo Vilanova|Hospital Universitario de Burgos|Complejo Hospitalario Universitario de Huelva|Hospital Universitario Reina Sofia de Cordoba|Hospital Universitario Virgen Macarena|Complexo Hospitalario Universitario de Vigo|Clinica Universidad de Navarra, Universidad de Navarra|Hospital Clinico Universitario San Cecilio|Hospital Universitario La Fe|Hospital General Universitario de Valencia|Hospital Universitario Infanta Leonor|Hospital Universitario de Gran Canaria|Hospital General Universitario Santa Lucía|Centro Penitenciario Alicante 1|Hospital Regional Universitario Carlos Haya|Hospital Virgen de la Luz|Hospital General Universitario de Castellón|Hospital Parc Taulí, Sabadell Chronic Hepatitis C Infection December 2014

NCT03200184 Tehran University of Medical Sciences Hepatitis C September 1, 2016

Phase 4

NCT03188276 Third Affiliated Hospital, Sun Yat-Sen University Chronic Hepatitis C February 1, 2016

Early Phase 1

NCT01830205 Bristol-Myers Squibb Hepatitis C September 2012

Phase 1

 

CERTIFICATE

2018 GMP-2
原料药GMP证书201811(captopril ,thalidomide etc)
GMP-of-PMDA-in-Chanyoo-平成28年08月03日 Nantong-Chanyoo-Pharmatech-Co
FDA-EIR-Letter-201901

QUALITY MANAGEMENT

Quality management1

Proposal 18 Quality Consistency Evaluation projects which have approved 4, and 6 projects are under approving.

Quality management2

Advanced international quality management system has laid solid foundation for sales.

Quality management3

Quality supervision runs through the whole life cycle of the product to ensure the quality and therapeutic effect. 

Quality management4

Professional Regulatory Affairs team supports the quality demands during the application and registration.

PRODUCTION MANAGEMENT

cpf5
cpf6

Korea Countec Bottled Packaging Line

cpf7
cpf8

Taiwan CVC Bottled Packaging Line

cpf9
cpf10

Italy CAM Board Packaging Line

cpf11

German Fette Compacting Machine

cpf12

Japan Viswill Tablet Detector

cpf14-1

DCS Control Room

PARTNER

International cooperation
International cooperation
Domestic cooperation
Domestic cooperation

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