Daclatasvir Dihydrochloride
Paglalarawan
Ang Daclatasvir dihydrochloride (BMS-790052 dihydrochloride) ay isang malakas at aktibo sa bibigProtina ng HCV NS5Ainhibitor na mayEC50s saklaw ng 9-146 pM para samaramihang HCV replicon genotypes. Ang Daclatasvir dihydrochloride ay isa ringorganic anion transporting polypeptide 1B (OATP1B)atOATP1B3inhibitor na mayIC50s ng 1.5 µM at 3.27 µM, ayon sa pagkakabanggit.
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) at 33 pM HCV replicon genotype 5a)[1]
Kd: 8 nM (NS5A33-202) at 210 nM (NS5A26-202)[2]
IC50: 1.5 µM (OATP1B) at 3.27 µM (OATP1B3)[3]
Sa Vitro
Ang Daclatasvir (BMS-790052) ay nagpapakita ng makapangyarihang aktibidad ng pagbabawal sa lahat ng genotype na nasubok, na may EC50mga halaga mula 9 pM hanggang 146 pM. Pinipigilan ng Daclatasvir ang HCV replicon genotype 1a, 1b, 2a, 3a, 4a at 5a na may EC50mga halagang 50 pM, 9 pM, 71 pM, 146 pM, 12 pM at 33 pM, ayon sa pagkakabanggit. Ang Daclatasvir ay isang potent inhibitor ng JFH-1 genotype 2a infectious virus na nagrereplika sa cell culture (EC50=28 pM)[1]. Ang Daclatasvir (BMS-790052) ay mahigpit na nagbubuklod sa NS5A33-202 at NS5A26-202 na may Kds ng 8 nM at 210 nM, ayon sa pagkakabanggit[2].
Imbakan
| Pulbos | -20°C | 3 taon |
| 4°C | 2 taon | |
| Sa solvent | -80°C | 6 na buwan |
| -20°C | 1 buwan |
Klinikal na Pagsubok
| Numero ng NCT | Sponsor | Kundisyon | Petsa ng Pagsisimula | Phase |
| NCT03369327 | Tehran University of Medical Sciences|RojanPharma Pharmaceutical Company | Impeksiyon ng Hepatitis C Virus, Tugon sa Therapy ng|Human Immunodeficiency Virus | Enero 1, 2017 | Phase 3 |
| NCT03485846 | R-Pharm|Almedis | Talamak na Hepatitis C Genotype 1b | Nobyembre 27, 2017 | Phase 2 |
| NCT01016912 | Bristol-Myers Squibb | Impeksyon ng Hepatitis C | Disyembre 2009 | Phase 2 |
| NCT01629732 | Bristol-Myers Squibb | Hepatitis C Virus | Marso 2013 | Phase 2 |
| NCT01497834 | Bristol-Myers Squibb | Hepatitis C | Enero 2012 | Phase 3 |
| NCT01973049 | Bristol-Myers Squibb | Hepatitis C | Disyembre 2013 | Phase 3 |
| NCT00663208 | Bristol-Myers Squibb | Talamak na Hepatitis C | Mayo 2008 | Phase 2 |
| NCT02576314 | Humanity and Health Research Center|Beijing 302 Hospital | Talamak na Impeksyon ng Hepatitis C | Mayo 2015 | Phase 3 |
| NCT02756936 | Genuine Research Center, Egypt|Zeta Pharma Pharmaceutical Industries | Malusog | Pebrero 2016 | Phase 1 |
| NCT02771405 | National Hepatology at Tropical Medicine Research Institute|Pamantasan ng Cairo | Hepatitis C, Talamak|Hepatocellular Carcinoma | Marso 2016 | Phase 3 |
| NCT03706898 | Viriom | HIV-1-infection|Hepatic Impairment | Oktubre 1, 2018 | Phase 1 |
| NCT02319031 | Bristol-Myers Squibb | Hepatitis C | Pebrero 2015 | Phase 3 |
| NCT02124044 | National Institutes of Health Clinical Center (CC)|National Institute of Allergy and Infectious Diseases (NIAID)|Bristol-Myers Squibb | HIV-HCV | Pebrero 2014 | Phase 2 |
| NCT02551861 | Bristol-Myers Squibb | Hepatitis C | Disyembre 2015 | Phase 2 |
| NCT00859053 | Bristol-Myers Squibb | Hepatic Insufficiency | Marso 2009 | Phase 1 |
| NCT01257204 | Bristol-Myers Squibb | Hepatitis C Virus | Disyembre 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, Panmatagalang | Panmatagalang Pagkabigo sa Bato | Abril 1, 2017 | Phase 4 |
| NCT01017575 | Bristol-Myers Squibb | Impeksyon ng Hepatitis C | Disyembre 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 | Talamak na Hepatitis C | Setyembre 2016 |
|
| NCT04070235 | Nanjing Sanhome Pharmaceutical, Co., Ltd. | Hepatitis C, Talamak | Marso 29, 2019 | Phase 2|Phase 3 |
| NCT03487848 | Bristol-Myers Squibb | Hepatitis C|Chronic Hepatitis | Mayo 18, 2018 | Phase 2 |
| NCT00904059 | Bristol-Myers Squibb | Hepatitis C | Mayo 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 Impeksyon | Nobyembre 2013 | Phase 2 |
| NCT02397395 | Janssen R&D Ireland | Pinsala sa Bato|End-stage na Sakit sa Bato | Mayo 2015 | Phase 2 |
| NCT03169348 | Unibersidad ng Assiut | Hepatitis C | Nobyembre 1, 2017 | Hindi Naaangkop |
| NCT02323594 | Bristol-Myers Squibb | Impeksyon ng Hepatitis C | Disyembre 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|Paggamit ng Droga|Viral Hepatitis C | Nobyembre 13, 2018 | Phase 4 |
| NCT02103569 | Bristol-Myers Squibb | Hepatitis C | Abril 2014 | Phase 1 |
| NCT02772744 | Unibersidad ng Zagazig|Pamantasan ng Cairo | Hepatitis C | Nobyembre 1, 2017 |
|
| NCT01718158 | Bristol-Myers Squibb | Hepatitis C | Enero 2013 | Phase 3 |
| NCT02496078 | Bristol-Myers Squibb | Hepatitis C | Agosto 2015 | Phase 3 |
| NCT01425970 | Bristol-Myers Squibb | Hepatitis C | Mayo 2012 | Phase 2 |
| NCT01471574 | Bristol-Myers Squibb | Hepatitis C, Genotype 1 | Disyembre 2011 | Phase 3 |
| NCT01573351 | Bristol-Myers Squibb | Hepatitis C Virus | Mayo 2012 | Phase 3 |
| NCT01938625 | Janssen R&D Ireland | Hepatitis C, Talamak | Disyembre 12, 2013 | Phase 2 |
| NCT01492426 | Bristol-Myers Squibb | Hepatitis C | Enero 2012 | Phase 3 |
| NCT03480932 | Johns Hopkins Bloomberg School of Public Health|National Institute on Drug Abuse (NIDA)|YR Gaitonde Center for AIDS Research and Education | Hepatitis C, Talamak | Pebrero 2, 2018 | Phase 2|Phase 3 |
| NCT03163849 | Unibersidad ng Assiut | Talamak na Hepatitis c | Setyembre 1, 2019 | Phase 3 |
| NCT01581203 | Bristol-Myers Squibb | Hepatitis C Virus | Mayo 2012 | Phase 3 |
| NCT01492504 | Bristol-Myers Squibb | Hepatitis C | Pebrero 7, 2012 |
|
| NCT03686722 | Mohamed Raslan|Ain Shams University|Drug Research Center, Cairo, Egypt | Diabetes Mellitus, Type 2|Hepatitis C|Mga Pakikipag-ugnayan sa Droga | Setyembre 9, 2017 | Phase 1 |
| NCT02262728 | Janssen Research & Development, LLC | Hepatitis C, Talamak | Setyembre 30, 2014 | Phase 2 |
| NCT02349048 | Janssen Research & Development, LLC | Hepatitis C Virus | Enero 2015 | Phase 2 |
| NCT03882307 | Unibersidad ng Assiut | Hepatitis C, Talamak | Mayo 2020 | Maagang Phase 1 |
| NCT02758509 | Parc de Salut Mar | Talamak na Hepatitis C|Cirrhosis | Enero 1, 2010 |
|
| NCT01795911 | Bristol-Myers Squibb | Hepatitis C | Marso 2013 | Phase 2 |
| NCT03549832 | Assiut University|Sohag University|South Valley University | HCV Coinfection | Enero 1, 2018 | Hindi Naaangkop |
| NCT02161939 | Bristol-Myers Squibb | Talamak na Hepatitis C |
| |
| NCT01309932 | Bristol-Myers Squibb | Hepatitis C | Marso 2011 | Phase 2 |
| NCT01995266 | Bristol-Myers Squibb | Hepatitis C | Pebrero 28, 2014 | Phase 3 |
| NCT02640157 | AbbVie | Talamak na Hepatitis C|Hepatitis C Virus|Genotype 3 Hepatitis C Virus | Disyembre 2015 | Phase 3 |
| NCT02032875 | Bristol-Myers Squibb | Hepatitis C | Marso 2014 | Phase 3 |
| NCT02624063 | Pederal na Unibersidad ng São Paulo | Hepatitis C, Talamak | Disyembre 2015 | Phase 4 |
| NCT00546715 | Bristol-Myers Squibb | Talamak na Hepatitis C | Nobyembre 2007 | Phase 1|Phase 2 |
| NCT01718145 | Bristol-Myers Squibb | Impeksyon sa Virus ng Hepatitis C | Nobyembre 2012 | Phase 3 |
| NCT01616524 | Bristol-Myers Squibb | Hepatitis C Virus (HCV) | Hulyo 2012 | Phase 3 |
| NCT02032901 | Bristol-Myers Squibb | Hepatitis C | Enero 2014 | Phase 3 |
| NCT03540212 | Unibersidad ng Ain Shams | Talamak na Impeksyon sa HCV | Disyembre 10, 2017 | Phase 2|Phase 3 |
| NCT02097966 | Bristol-Myers Squibb | Talamak na Hepatitis C |
| |
| NCT02596880 | Tehran University of Medical Sciences | Hepatitis C|Cirrhosis | Setyembre 2015 | Phase 3 |
| NCT04019717 | Ang Atea Pharmaceuticals, Inc. | Hepatitis C|Hepatitis C, Chronic|Chronic Hepatitis C|Hepatitis C Virus Infection|HCV Infection | Hunyo 20, 2019 | Phase 2 |
| NCT02992457 | Pamantasan ng Tanta | Hepatitis C | Enero 2015 | Phase 4 |
| NCT03547895 | Unibersidad ng Zagazig | Decompensated Cirrhosis | Hunyo 1, 2015 | Hindi Naaangkop |
| 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 | Nobyembre 2016 | Phase 3 |
| NCT01051414 | Bristol-Myers Squibb | Impeksyon ng Hepatitis C | Abril 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 Impeksyon | Disyembre 2014 | Phase 2 |
| NCT01628692 | Bristol-Myers Squibb|Janssen Research & Development, LLC | Hepatitis C Virus | Hulyo 2012 | Phase 2 |
| NCT03186313 | Egyptian Liver Hospital|Wadi El Nil Hospital | Hepatitis C | Setyembre 2016 | Phase 3 |
| NCT03063723 | Third Affiliated Hospital, Sun Yat-Sen University | Talamak na Hepatitis C (Disorder) | Enero 1, 2016 |
|
| NCT00983957 | Bristol-Myers Squibb | Talamak na Hepatitis C | Oktubre 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 | Disyembre 2012 | Phase 2 |
| NCT02282709 | Foundation para sa Pananaliksik sa Atay | Talamak na Hepatitis C | Pebrero 2014 | Phase 3 |
| NCT02032888 | Bristol-Myers Squibb | Hepatitis C | Pebrero 2014 | Phase 3 |
| NCT03247296 | Unibersidad ng MTI | Hepatitis C | Pebrero 28, 2017 |
|
| NCT01389323 | Bristol-Myers Squibb | Hepatitis C | Setyembre 2011 | Phase 3 |
| NCT02556086 | Bristol-Myers Squibb | Hepatitis C | Disyembre 2015 | Phase 2 |
| NCT01741545 | Bristol-Myers Squibb | Hepatitis C Virus | Marso 31, 2013 | Phase 3 |
| NCT01866930 | Bristol-Myers Squibb | Talamak na Impeksyon ng Hepatitis C | Hulyo 11, 2013 | Phase 3 |
| NCT02268864 | Janssen-Cilag International NV | Hepatitis C, Talamak | Enero 2015 | Phase 2 |
| NCT01797848 | Bristol-Myers Squibb | Hepatitis C | Hunyo 2014 | Phase 3 |
| NCT03166280 | Eman Sayed Hassan Abd Allah|Assiut University | Hepatitis C | Hunyo 2017 |
|
| NCT02159352 | Bristol-Myers Squibb | Hepatitis C | Hunyo 2014 | Phase 1 |
| NCT01125189 | Bristol-Myers Squibb | Hepatitis C Virus | Hulyo 2010 | Phase 2 |
| NCT03748745 | Nanjing Sanhome Pharmaceutical, Co., Ltd. | Mga Pakikipag-ugnayan sa Droga | Nobyembre 19, 2018 | Phase 1 |
| NCT01012895 | Bristol-Myers Squibb | Talamak na Hepatitis C | Disyembre 2009 | Phase 2 |
| NCT02565888 | Radboud University | Hepatitis C|HIV | Nobyembre 2015 | Phase 1 |
| NCT02555943 | Humanity and Health Research Center|Beijing 302 Hospital|Nanfang Hospital ng Southern Medical University | Talamak na Hepatitis C Infection|HBV Coinfection|Reactivation ng Hepatitis B | Pebrero 2015 | Phase 2|Phase 3 |
| NCT02304159 | Tarek I. Hassanein, MD, FACP, FAG, AGAF|Southern California Research Center | Hepatitis C|Cirrhosis | Enero 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 | Pebrero 2016 | Phase 4 |
| NCT02104843 | Bristol-Myers Squibb | Hepatitis C | Abril 2014 | Phase 1 |
| NCT01428063 | Bristol-Myers Squibb | Impeksyon sa Virus ng Hepatitis C | Setyembre 2011 | Phase 2 |
| NCT02123654 | Bristol-Myers Squibb | Impeksyon sa Virus ng Hepatitis C | Abril 2014 | Phase 3 |
| NCT02565862 | Radboud University | Hepatitis C|Diabetes Mellitus|Paglaban sa Insulin | Enero 2016 | Phase 1 |
| NCT04211844 | Unibersidad ng Ain Shams | Talamak na Hepatitis C | Oktubre 1, 2019 |
|
| NCT00874770 | Bristol-Myers Squibb | Impeksyon ng Hepatitis C | Hunyo 2009 | Phase 2 |
| NCT03883698 | Sanjay Gandhi Postgraduate Institute of Medical Sciences | Pagkabigo sa Bato, Talamak|Hepatitis C | Marso 15, 2019 | Phase 3 |
| NCT01448044 | Bristol-Myers Squibb | Hepatitis C | Disyembre 2011 | Phase 3 |
| NCT01359644 | Bristol-Myers Squibb|Pharmasset | Talamak na Hepatitis C | Hunyo 2011 | Phase 2 |
| NCT01842451 | Vertex Pharmaceuticals Incorporated | Talamak na Hepatitis C|CHC|HCV|Hepatitis C | Hunyo 2013 | Phase 2 |
| NCT02762448 | Tainan Municipal Hospital | Hepatitis c | Hulyo 2016 |
|
| NCT02473211 | Humanity and Health Research Center|Beijing 302 Hospital | Talamak na Impeksyon ng Hepatitis C | Enero 2015 | Phase 2|Phase 3 |
| NCT01455090 | Bristol-Myers Squibb | Talamak na Hepatitis C | Nobyembre 30, 2011 | Phase 2 |
| NCT03490097 | Unibersidad ng Ain Shams | Talamak na Hepatitis c|Metabolic Syndrome | Disyembre 1, 2017 | Phase 2|Phase 3 |
| NCT01170962 | Bristol-Myers Squibb | Hepatitis C Virus | Agosto 2010 | Phase 2 |
| NCT02333292 | Ospital ng Valme University|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|Ospital 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|Universidad de Navarra, Universidad de Navarra, Universidad de Navarra 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 de Castellón|Park ng Ospital Taulí, Sabadell | Talamak na Impeksyon ng Hepatitis C | Disyembre 2014 |
|
| NCT03200184 | Tehran University of Medical Sciences | Hepatitis C | Setyembre 1, 2016 | Phase 4 |
| NCT03188276 | Third Affiliated Hospital, Sun Yat-Sen University | Talamak na Hepatitis C | Pebrero 1, 2016 | Maagang Phase 1 |
| NCT01830205 | Bristol-Myers Squibb | Hepatitis C | Setyembre 2012 | Phase 1 |
Panukala18Mga proyekto sa Pagsusuri ng Pagkakaayon ng Kalidad na naaprubahan4, at6ang mga proyekto ay nasa ilalim ng pag-apruba.
Ang advanced na internasyonal na sistema ng pamamahala ng kalidad ay naglatag ng matatag na pundasyon para sa mga benta.
Ang pangangasiwa sa kalidad ay tumatakbo sa buong ikot ng buhay ng produkto upang matiyak ang kalidad at therapeutic effect.
Sinusuportahan ng pangkat ng Professional Regulatory Affairs ang mga hinihingi sa kalidad sa panahon ng aplikasyon at pagpaparehistro.
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