Daclatasvir Dihydrochloride

Description:

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Daclatasvir Dihydrochloride HCV In-Domus    


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Descriptio

Daclatasvir dihydrochloride (BMS 790052 dihydrochloride) est potens et viva voce activaHCV NS5A interduminhibitor cumEC50s range of 9-146 pM formultiple HCV replicon genotypes.Daclatasvir dihydrochloride etiam aorganicum anion traiciendum polypeptide 1B (OATP1B)etOATP1B3inhibitor cumIC50s 1.5 µM et 3.27 µM, respective.

IC50& Target

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

In vitro

Daclatasvir (BMS 790052) demonstrat potentem actionem inhibitoriam erga omnes genotypos probatos, cum EC.50valores vndique ab 9 pM ad 146 pM.Daclatasvir vetat HCV replicon genotypi 1a, 1b, 2a, 3a, 4a et 5a cum EC.50valores 50 pM, 9 pM, 71 pM, 146 pM, 12 pM et 33 pM resp.Daclatasvir potens est inhibitor viri genotypi JFH-1 2a infectiosi viri qui in cultura cellularum replicat (EC.50= 28 pM)[1].Daclatasvir (BMS 790052) arcte obligat ad NS5A33-202 et NS5A26-202 cum Kds of 8 nM and 210 nM, respectively[2].

Repono

Pulvis

-20°C

III annos
 

4°C

Annis II
In solvendo

-80°C

VI menses
 

-20°C

I mensis


Orci iudicio

NCT Number Sponsor Conditio Satus Date

Phase

NCT03369327 Tehran University of Sciences Medical|RojanPharma Pharmaceutical Company Hepatitis C Virus Infectio, Responsio ad Therapy de Viris Humanis Immunodeficientia Ianuarii 1, 2017

Phase 3

NCT03485846 R-Pharm|Almedis Chronica 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 Martii 2013

Phase 2

NCT01497834 Bristol-Myers Squibb Hepatitis C Ianuarii 2012

Phase 3

NCT01973049 Bristol-Myers Squibb Hepatitis C December 2013

Phase 3

NCT00663208 Bristol-Myers Squibb Chronica Hepatitis C May 2008

Phase 2

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

Phase 3

NCT02756936 Genuina Research Centrum, Aegyptus|Zeta Pharma Pharmaceutical Industriae Sanus Februarii 2016

Phase 1

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

Phase 3

NCT03706898 Viriom HIV-1-infectio|Hepatic Impairment Octobris 1, 2018

Phase 1

NCT02319031 Bristol-Myers Squibb Hepatitis C Februarii 2015

Phase 3

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

Phase 2

NCT02551861 Bristol-Myers Squibb Hepatitis C December 2015

Phase 2

NCT00859053 Bristol-Myers Squibb Insufficientia hepatis March 2009

Phase 1

NCT01257204 Bristol-Myers Squibb Hepatitis C Virus December 2010

Phase 2

NCT03063879 University of Medical Sciences|Ahvaz Jundishapur University of Medical Sciences|Shiraz University of Medical Sciences|Hamadan University of Medical Sciences Hepatitis C, Chronic|Chronic Renal Defectum Aprilis 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 Chronica Hepatitis C Septembris 2016

NCT04070235 Nanjing Sanhome Pharmaceutical, Co., Ltd. Hepatitis C, Chronic Die 29 Martii, 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 Francis National Institute for Health and Medical Research National Agency for Research in AIDS and Virales Hepatitis (Inserm-ANRS) | 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 die 1 mensis Novembris anno 2017

Non pertinet

NCT02323594 Bristol-Myers Squibb Hepatitis C Infection December MMXIV

Phase 1

NCT03537196 Institutum Nationale Gallicum pro Health et Medical Investigationis Nationalis Procuratio pro Investigatione Gallica in AIDS et Hepatitis Viralis (Inserm-ANRS) Hepatitis C|Drug Use|Viral Hepatitis C November 13, 2018

Phase 4

NCT02103569 Bristol-Myers Squibb Hepatitis C Aprilis MMXIV

Phase 1

NCT02772744 Zagazig University| Hepatitis C die 1 mensis Novembris anno 2017

NCT01718158 Bristol-Myers Squibb Hepatitis C Ianuarii 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 Ianuarii 2012

Phase 3

NCT03480932 Johns Hopkins Bloomberg School of Public Health|Institutum Nationale de medicamentis abusus (NIDA)|YR Gaitonde Centre pro AIDS Research and Education Hepatitis C, Chronic Februarii 2, 2018

Phase 2|Phase 3

NCT03163849 Assiut University Chronica Hepatitis c Septembris 1, 2019

Phase 3

NCT01581203 Bristol-Myers Squibb Hepatitis C Virus May 2012

Phase 3

NCT01492504 Bristol-Myers Squibb Hepatitis C Februarii 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 Ianuarii 2015

Phase 2

NCT03882307 Assiut University Hepatitis C, Chronic May 2020

Mane Phase 1

NCT02758509 Parc de Salut Mar Chronica Hepatitis C|Cirrhosis Ianuarii 1, 2010

NCT01795911 Bristol-Myers Squibb Hepatitis C Martii 2013

Phase 2

NCT03549832 Assiut University|Sohag University|Meridionalis Valley University HCV Coinfection Ianuarii 1, 2018

Non pertinet

NCT02161939 Bristol-Myers Squibb Chronica Hepatitis C  

NCT01309932 Bristol-Myers Squibb Hepatitis C Martii 2011

Phase 2

NCT01995266 Bristol-Myers Squibb Hepatitis C Februarii 28, 2014

Phase 3

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

Phase 3

NCT02032875 Bristol-Myers Squibb Hepatitis C Martii MMXIV

Phase 3

NCT02624063 Universitas Foederalis São Paulo Hepatitis C, Chronic December 2015

Phase 4

NCT00546715 Bristol-Myers Squibb Chronica Hepatitis C Novembris 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) Iulii 2012

Phase 3

NCT02032901 Bristol-Myers Squibb Hepatitis C Ianuarii MMXIV

Phase 3

NCT03540212 Ain Shams University Chronica HCV Infection December 10, 2017

Phase 2|Phase 3

NCT02097966 Bristol-Myers Squibb Chronica Hepatitis C  

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

Phase 3

NCT04019717 Atea Pharmaceuticals, Inc. Hepatitis C | Hepatitis C , Chronic | Chronic Hepatitis C | die 20 mensis Iunii MMXIX

Phase 2

NCT02992457 Tanta University Hepatitis C Ianuarii 2015

Phase 4

NCT03547895 Zagazig University Decompensated Cirrhosis Iunii 1, 2015

Non pertinet

NCT03004625 Kaohsiung Universitas Medical Chung-Ho Hospitalis Memorial|Chang Gung Memorial Hospital|National Taiwan University Hospital|Taipei Veterani Hospitalis Generalis, Taiwan|Sinae University Hospitalis Medical University |National Cheng-Kung University Hospital Hepatitis C November 2016

Phase 3

NCT01051414 Bristol-Myers Squibb Hepatitis C Infection April 2010

Phase 2

NCT02309450 Francis National Institute for Health and Medical Research National Agency for Research in AIDS and Virales Hepatitis (Inserm-ANRS) | Hepatitis C Virus Genotype 4 Infection December MMXIV

Phase 2

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

Phase 2

NCT03186313 Hospitalis Jecur Aegyptium|Wadi El Nil Hospital Hepatitis C Septembris 2016

Phase 3

NCT03063723 Tertius Hospitalis foederatus, sol universitatis Yat-Sen Chronica Hepatitis C (Disorder) Ianuarii 1, 2016

NCT00983957 Bristol-Myers Squibb Chronica Hepatitis C October 2009

Phase 1

NCT01725542 Francis National Institute for Health and Medical Research National Agency for Research in AIDS and Virales Hepatitis (Inserm-ANRS) | HCV-HIV Co-Infection Decembris 2012

Phase 2

NCT02282709 Fundamentum pro Jecur Research Chronica Hepatitis C Februarii 2014

Phase 3

NCT02032888 Bristol-Myers Squibb Hepatitis C Februarii 2014

Phase 3

NCT03247296 MTI University Hepatitis C Februarii 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 Martii 31, 2013

Phase 3

NCT01866930 Bristol-Myers Squibb Chronica Hepatitis C Infection 11 Iulii 2013

Phase 3

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

Phase 2

NCT01278848 Bristol-Myers Squibb Hepatitis C Iunii MMXIV

Phase 3

NCT03166280 Eman Sayed Assen Abd Allah | Assiut University Hepatitis C Iunii 2017

NCT02159352 Bristol-Myers Squibb Hepatitis C Iunii MMXIV

Phase 1

NCT01125189 Bristol-Myers Squibb Hepatitis C Virus July 2010

Phase 2

NCT03748745 Nanjing Sanhome Pharmaceutical, Co., Ltd. Medicamento Interactiones November 19, 2018

Phase 1

NCT01012895 Bristol-Myers Squibb Chronica 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 Februarii 2015

Phase 2|Phase 3

NCT02304159 Tarek I. Hassanein, MD, FACP, FAG, AGAF|Southern California Research Center Hepatitis C|Cirrhosis Ianuarii 2015

Phase 4

NCT02580474 Myeong Jun Song|Bristolo-Myers Squibb|Soonchunhyang University Hospital|Dankook University|Chungnam University Hospital|Konyang University Hospital|Eulji University Hospital|Sancti Vincentii Hospitalis, Korea|Konkuk University Hospitalis, Cheongju S. Mary´ Hospitalis, Cheongju , Korea|Severance Hospital|Korea University Guro Hospital|Eulji Hospital| Hepatitis C Februarii 2016

Phase 4

NCT02104843 Bristol-Myers Squibb Hepatitis C Aprilis MMXIV

Phase 1

NCT01428063 Bristol-Myers Squibb Hepatitis C Virus Infection September 2011

Phase 2

NCT02123654 Bristol-Myers Squibb Hepatitis C Virus Infection Aprilis MMXIV

Phase 3

NCT02565862 Radboud University Hepatitis C | Ianuarii 2016

Phase 1

NCT04211844 Ain Shams University Chronica Hepatitis C October 1, 2019

NCT00874770 Bristol-Myers Squibb Hepatitis C Infection Iunii 2009

Phase 2

NCT03883698 Sanjay Gandhi Postgraduate Institute of Sciences Medical Hepatitis C Martii 15, 2019

Phase 3

NCT01448044 Bristol-Myers Squibb Hepatitis C December 2011

Phase 3

NCT01359644 Bristol-Myers Squibb|Pharmasset Chronica Hepatitis C Iunii 2011

Phase 2

NCT01842451 Vertex Pharmaceuticals Incorporatus Hepatitis C | Iunii 2013

Phase 2

NCT02762448 Tainan Hospitalis municipalis Hepatitis c Iulii 2016

NCT02473211 Humanity and Health Research Centre|Beijing 302 Hospital Chronica Hepatitis C Infection Ianuarii 2015

Phase 2|Phase 3

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

Phase 2

NCT03490097 Ain Shams University Chronica Hepatitis c| 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| Hospitalis Generalis Universitario de Alicante | Hospital Universitario Araba Navarra|Hospital Clinico Universitario San Cecilio|Hospital Universitario La Fe|Hospital General Universitario de Valencia | la Luz | Chronica Hepatitis C Infection December MMXIV

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

Phase 4

NCT03188276 Tertius Hospitalis foederatus, sol universitatis Yat-Sen Chronica Hepatitis C Februarii 1, 2016

Mane Phase 1

NCT01830205 Bristol-Myers Squibb Hepatitis C Septembris 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

Rogatio18Qualitas Constantia Aestimatio inceptis quae probaverunt4, et6incepta approbantes.

Quality management2

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Quality management3

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SOCIUS

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International cooperation
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