Daclatasvir Dihydrochloride

Tsanangudzo Pfupi

Zita reAPI Indication Tsanangudzo US DMF EU DMF CEP
Daclatasvir Dihydrochloride HCV Mumba    


Product Detail

Product Tags

PRODUCT DETAIL

Tsanangudzo

Daclatasvir dihydrochloride (BMS-790052 dihydrochloride) ine simba uye inoshanda nemuromo.HCV NS5A proteininhibitor neEC50s siyana ye9-146 pM yeakawanda HCV replicon genotypes.Daclatasvir dihydrochloride iri zvakareorganic anion inotakura polypeptide 1B (OATP1B)uyeOATP1B3inhibitor neIC50s ye1.5 µM uye 3.27 µM, zvichiteerana.

IC50& Chinangwa

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 3 pM) uye (HCV replicon genotype 3 pM) HCV replicon genotype 5a)[1]
Kd: 8 nM (NS5A33-202) uye 210 nM (NS5A26-202)[2]
IC50: 1.5 µM (OATP1B) uye 3.27 µM (OATP1B3)[3]

In Vitro

Daclatasvir (BMS-790052) inoratidza zvine simba inhibitory chiitiko kune ese genotypes akaedzwa, neEC.50kukosha kubva pa9pm kusvika 146pm.Daclatasvir inhibits HCV replicon genotype 1a, 1b, 2a, 3a, 4a uye 5a ine EC50kukosha kwe50 pM, 9 pM, 71 pM, 146 pM, 12 pM uye 33 pM, zvichiteerana.Daclatasvir inhibitor ine simba yeJFH-1 genotype 2a hutachiona hwehutachiona hunodzokorora musero tsika (EC.50=28pm)[1].Daclatasvir (BMS-790052) inosunga zvakasimba kuNS5A33-202 uye NS5A26-202 neKds ye8 nM uye 210 nM, zvichiteerana[2].

Storage

Upfu

-20°C

3 years
 

4°C

2 years
In solvent

-80°C

6 mwedzi
 

-20°C

1 mwedzi


Clinical Muedzo

Nhamba yeNCT Sponsor Condition Zuva Rokutanga

Phase

NCT03369327 Tehran University of Medical Sayenzi | RojanPharma Pharmaceutical Kambani Hepatitis C Virus Infection, Response to Therapy ye|Human Immunodeficiency Virus Ndira 1, 2017

Phase 3

NCT03485846 R-Pharm|Almedis Chisingaperi Hepatitis C Genotype 1b Mbudzi 27, 2017

Phase 2

NCT01016912 Bristol-Myers Squibb Hepatitis C Infection Zvita 2009

Phase 2

NCT01629732 Bristol-Myers Squibb Utachiona hweHepatitis C Kurume 2013

Phase 2

NCT01497834 Bristol-Myers Squibb Hepatitis C Ndira 2012

Phase 3

NCT01973049 Bristol-Myers Squibb Hepatitis C Zvita 2013

Phase 3

NCT00663208 Bristol-Myers Squibb Chronic Hepatitis C Chivabvu 2008

Phase 2

NCT02576314 Humanity and Health Research Center|Beijing 302 Hospital Chronic Hepatitis C Infection Chivabvu 2015

Phase 3

NCT02756936 Genuine Research Center, Egypt|Zeta Pharma Pharmaceutical Industries Hutano Kukadzi 2016

Phase 1

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

Phase 3

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

Phase 1

NCT02319031 Bristol-Myers Squibb Hepatitis C Kukadzi 2015

Phase 3

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

Phase 2

NCT02551861 Bristol-Myers Squibb Hepatitis C Zvita 2015

Phase 2

NCT00859053 Bristol-Myers Squibb Hepatic Insufficiency Kurume 2009

Phase 1

NCT01257204 Bristol-Myers Squibb Utachiona hweHepatitis C Zvita 2010

Phase 2

NCT03063879 Tehran University of Medical Sciences|Ahvaz Jundishapur University of Medical Sayenzi|Shiraz University of Medical Sayenzi|Hamadan University of Medical Science Chirwere cheHepatitis C, Chisingaperi|Kutadza Kwerenal Kusingaperi Kubvumbi 1, 2017

Chikamu chechina

NCT01017575 Bristol-Myers Squibb Hepatitis C Infection Zvita 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 Gunyana 2016

NCT04070235 Nanjing Sanhome Pharmaceutical Co., Ltd. Hepatitis C, Chisingaperi Kurume 29, 2019

Chikamu 2 | Phase 3

NCT03487848 Bristol-Myers Squibb Hepatitis C | Chisingaperi Hepatitis Chivabvu 18, 2018

Phase 2

NCT00904059 Bristol-Myers Squibb Hepatitis C Chivabvu 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 Mbudzi 2013

Phase 2

NCT02397395 Janssen R&D Ireland Renal Impairment | Kupera-nhanho Renal Chirwere Chivabvu 2015

Phase 2

NCT03169348 Assiut University Hepatitis C Mbudzi 1, 2017

Hazvigoneke

NCT02323594 Bristol-Myers Squibb Hepatitis C Infection Zvita 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 | Kushandisa Zvinodhaka|Viral Hepatitis C Mbudzi 13, 2018

Chikamu chechina

NCT02103569 Bristol-Myers Squibb Hepatitis C Kubvumbi 2014

Phase 1

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

NCT01718158 Bristol-Myers Squibb Hepatitis C Ndira 2013

Phase 3

NCT02496078 Bristol-Myers Squibb Hepatitis C Nyamavhuvhu 2015

Phase 3

NCT01425970 Bristol-Myers Squibb Hepatitis C Chivabvu 2012

Phase 2

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

Phase 3

NCT01573351 Bristol-Myers Squibb Utachiona hweHepatitis C Chivabvu 2012

Phase 3

NCT01938625 Janssen R&D Ireland Hepatitis C, Chisingaperi Zvita 12, 2013

Phase 2

NCT01492426 Bristol-Myers Squibb Hepatitis C Ndira 2012

Phase 3

NCT03480932 Johns Hopkins Bloomberg School of Public Health|National Institute on Drug Abuse (NIDA)|YR Gaitonde Center yeAIDS Research and Education Hepatitis C, Chisingaperi Kukadzi 2, 2018

Chikamu 2 | Phase 3

NCT03163849 Assiut University Chirwere Chisingaperi c Gunyana 1, 2019

Phase 3

NCT01581203 Bristol-Myers Squibb Utachiona hweHepatitis C Chivabvu 2012

Phase 3

NCT01492504 Bristol-Myers Squibb Hepatitis C Kukadzi 7, 2012

NCT03686722 Mohamed Raslan|Ain Shams University|Drug Research Center, Cairo, Egypt Diabetes Mellitus, Type 2|Hepatitis C|Kudyidzana Kwezvinodhaka Gunyana 9, 2017

Phase 1

NCT02262728 Janssen Research & Development, LLC Hepatitis C, Chisingaperi Gunyana 30, 2014

Phase 2

NCT02349048 Janssen Research & Development, LLC Utachiona hweHepatitis C Ndira 2015

Phase 2

NCT03882307 Assiut University Hepatitis C, Chisingaperi Chivabvu 2020

Early Phase 1

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

NCT01795911 Bristol-Myers Squibb Hepatitis C Kurume 2013

Phase 2

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

Hazvigoneke

NCT02161939 Bristol-Myers Squibb Chronic Hepatitis C  

NCT01309932 Bristol-Myers Squibb Hepatitis C Kurume 2011

Phase 2

NCT01995266 Bristol-Myers Squibb Hepatitis C Kukadzi 28, 2014

Phase 3

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

Phase 3

NCT02032875 Bristol-Myers Squibb Hepatitis C Kurume 2014

Phase 3

NCT02624063 Federal University yeSão Paulo Hepatitis C, Chisingaperi Zvita 2015

Chikamu chechina

NCT00546715 Bristol-Myers Squibb Chronic Hepatitis C Mbudzi 2007

Chikamu 1 | Chikamu 2

NCT01718145 Bristol-Myers Squibb Hepatitis C Virus Infection Mbudzi 2012

Phase 3

NCT01616524 Bristol-Myers Squibb Utachiona hweHepatitis C (HCV) Chikunguru 2012

Phase 3

NCT02032901 Bristol-Myers Squibb Hepatitis C Ndira 2014

Phase 3

NCT03540212 Ain Shams University Chisingaperi HCV Utachiona Zvita 10, 2017

Chikamu 2 | Phase 3

NCT02097966 Bristol-Myers Squibb Chronic Hepatitis C  

NCT02596880 Tehran Yunivhesiti yeMedical Sayenzi Hepatitis C | Cirrhosis Gunyana 2015

Phase 3

NCT04019717 Nhoroondo ye Atea Pharmaceuticals, Inc. Hepatitis C|Hepatitis C, Chisingaperi|Chisingaperi Hepatitis C|Hepatitis C Virus Infection|HCV Infection Chikumi 20, 2019

Phase 2

NCT02992457 Tanta University Hepatitis C Ndira 2015

Chikamu chechina

NCT03547895 Zagazig University Decompensated Cirrhosis Chikumi 1, 2015

Hazvigoneke

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 Mbudzi 2016

Phase 3

NCT01051414 Bristol-Myers Squibb Hepatitis C Infection Kubvumbi 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 Zvita 2014

Phase 2

NCT01628692 Bristol-Myers Squibb|Janssen Research & Development, LLC Utachiona hweHepatitis C Chikunguru 2012

Phase 2

NCT03186313 Chipatara cheEgyptian Chipatara | Wadi El Nil Hospital Hepatitis C Gunyana 2016

Phase 3

NCT03063723 Chipatara chechitatu chakabatana, Sun Yat-Sen University Chisingaperi Hepatitis C (Chirwere) Ndira 1, 2016

NCT00983957 Bristol-Myers Squibb Chronic Hepatitis C Gumiguru 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 Zvita 2012

Phase 2

NCT02282709 Nheyo yeKutsvaga Chiropa Chronic Hepatitis C Kukadzi 2014

Phase 3

NCT02032888 Bristol-Myers Squibb Hepatitis C Kukadzi 2014

Phase 3

NCT03247296 MTI University Hepatitis C Kukadzi 28, 2017

NCT01389323 Bristol-Myers Squibb Hepatitis C Gunyana 2011

Phase 3

NCT02556086 Bristol-Myers Squibb Hepatitis C Zvita 2015

Phase 2

NCT01741545 Bristol-Myers Squibb Utachiona hweHepatitis C Kurume 31, 2013

Phase 3

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

Phase 3

NCT02268864 Nhoroondo ye Janssen-Cilag International NV Hepatitis C, Chisingaperi Ndira 2015

Phase 2

NCT01797848 Bristol-Myers Squibb Hepatitis C Chikumi 2014

Phase 3

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

NCT02159352 Bristol-Myers Squibb Hepatitis C Chikumi 2014

Phase 1

NCT01125189 Bristol-Myers Squibb Utachiona hweHepatitis C Chikunguru 2010

Phase 2

NCT03748745 Nanjing Sanhome Pharmaceutical Co., Ltd. Kudyidzana Kwezvinodhaka Mbudzi 19, 2018

Phase 1

NCT01012895 Bristol-Myers Squibb Chronic Hepatitis C Zvita 2009

Phase 2

NCT02565888 Radboud University Hepatitis C | HIV Mbudzi 2015

Phase 1

NCT02555943 Humanity and Health Research Center|Beijing 302 Hospital|Nanfang Hospital yeSouthern Medical University Chronic Hepatitis C Infection|HBV Coinfection|Hepatitis B Reactivation Kukadzi 2015

Chikamu 2 | Phase 3

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

Chikamu chechina

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|Chipatara cheSeverance|Korea University Guro Hospital|Eulji General Hospital|The Catholic University of Korea Hepatitis C Kukadzi 2016

Chikamu chechina

NCT02104843 Bristol-Myers Squibb Hepatitis C Kubvumbi 2014

Phase 1

NCT01428063 Bristol-Myers Squibb Hepatitis C Virus Infection Gunyana 2011

Phase 2

NCT02123654 Bristol-Myers Squibb Hepatitis C Virus Infection Kubvumbi 2014

Phase 3

NCT02565862 Radboud University Hepatitis C | Chirwere cheshuga mellitus | Kuramba insulin Ndira 2016

Phase 1

NCT04211844 Ain Shams University Chronic Hepatitis C Gumiguru 1, 2019

NCT00874770 Bristol-Myers Squibb Hepatitis C Infection Chikumi 2009

Phase 2

NCT03883698 Sanjay Gandhi Postgraduate Institute yeMedical Sayenzi Kutadza kweitsvo, Kusingaperi|Hepatitis C Kurume 15, 2019

Phase 3

NCT01448044 Bristol-Myers Squibb Hepatitis C Zvita 2011

Phase 3

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

Phase 2

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

Phase 2

NCT02762448 Tainan Municipal Hospital Hepatitis c Chikunguru 2016

NCT02473211 Humanity and Health Research Center|Beijing 302 Hospital Chronic Hepatitis C Infection Ndira 2015

Chikamu 2 | Phase 3

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

Phase 2

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

Chikamu 2 | Phase 3

NCT01170962 Bristol-Myers Squibb Utachiona hweHepatitis C Nyamavhuvhu 2010

Phase 2

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

NCT03200184 Tehran Yunivhesiti yeMedical Sayenzi Hepatitis C Gunyana 1, 2016

Chikamu chechina

NCT03188276 Chipatara chechitatu chakabatana, Sun Yat-Sen University Chronic Hepatitis C Kukadzi 1, 2016

Early Phase 1

NCT01830205 Bristol-Myers Squibb Hepatitis C Gunyana 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

HUNHU MANAGEMENT

Quality management1

Proposal18Quality Consistency Evaluation mapurojekiti akatenderwa4,uye6mapurojekiti ari pasi pekubvumidzwa.

Quality management2

Yepamberi yepasirese yemhando manejimendi system yakaisa hwaro hwakasimba hwekutengesa.

Quality management3

Kutariswa kwemhando yepamusoro kunofamba kuburikidza nehupenyu hwese kutenderera kwechigadzirwa kuti ive nechokwadi chemhando nekurapa.

Quality management4

Professional Regulatory Affairs timu inotsigira zvinodiwa zvemhando panguva yekushandisa uye kunyoreswa.

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