China Daclatasvir Dihydrochloride manufacturers and suppliers

Daclatasvir Dihydrochloride

Short Description:

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

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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 K_ds 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