Daclatasvir Dihydrochloride
Deskripsyon
Ang Daclatasvir dihydrochloride (BMS-790052 dihydrochloride) kay potent ug oral activeHCV NS5A nga protinainhibitor uban saEC50s range sa 9-146 pM alang sadaghang HCV replicon genotypes.Ang Daclatasvir dihydrochloride usa usaborganikong anion nga nagdala sa polypeptide 1B (OATP1B)ugOATP1B3inhibitor uban saIC50s sa 1.5 µM ug 3.27 µM, matag usa.
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) ug HCV replicon genotype 5a)[1]
Kd: 8 nM (NS5A33-202) ug 210 nM (NS5A26-202)[2]
IC50: 1.5 µM (OATP1B) ug 3.27 µM (OATP1B3)[3]
Sa Vitro
Ang Daclatasvir (BMS-790052) nagpakita sa kusog nga kalihokan sa pagpugong sa tanan nga mga genotype nga gisulayan, nga adunay EC50mga kantidad gikan sa 9 p.m. hangtod 146 p.m.Ang Daclatasvir nagpugong sa HCV replicon genotype 1a, 1b, 2a, 3a, 4a ug 5a nga adunay EC50mga kantidad nga 50 pm, 9 pm, 71 pm, 146 pm, 12 pm ug 33 pm, matag usa.Ang Daclatasvir usa ka kusgan nga tigpugong sa JFH-1 genotype 2a nga makatakod nga virus nga nag-replika sa cell culture (EC50=28 sa gabii)[1].Ang Daclatasvir (BMS-790052) hugot nga nagbugkos sa NS5A33-202 ug NS5A26-202 nga adunay Kds sa 8 nM ug 210 nM, matag usa[2].
Pagtipig
| Pulbos | -20°C | 3 ka tuig |
| 4°C | 2 ka tuig | |
| Sa solvent | -80°C | 6 ka bulan |
| -20°C | 1 ka bulan |
Klinikal nga Pagsulay
| Numero sa NCT | Sponsor | kahimtang | Petsa sa Pagsugod | hugna |
| NCT03369327 | Tehran University of Medical Sciences|RojanPharma Pharmaceutical Company | Hepatitis C Virus Infection, Tubag sa Therapy sa|Human Immunodeficiency Virus | Enero 1, 2017 | Yugto 3 |
| NCT03485846 | R-Pharm|Almedis | Laygay nga Hepatitis C Genotype 1b | Nobyembre 27, 2017 | Yugto 2 |
| NCT01016912 | Bristol-Myers Squibb | Impeksyon sa Hepatitis C | Disyembre 2009 | Yugto 2 |
| NCT01629732 | Bristol-Myers Squibb | Hepatitis C Virus | Marso 2013 | Yugto 2 |
| NCT01497834 | Bristol-Myers Squibb | Hepatitis C | Enero 2012 | Yugto 3 |
| NCT01973049 | Bristol-Myers Squibb | Hepatitis C | Disyembre 2013 | Yugto 3 |
| NCT00663208 | Bristol-Myers Squibb | Laygay nga Hepatitis C | Mayo 2008 | Yugto 2 |
| NCT02576314 | Humanity and Health Research Center|Beijing 302 Hospital | Laygay nga Impeksyon sa Hepatitis C | Mayo 2015 | Yugto 3 |
| NCT02756936 | Tinuod nga Research Center, Egypt|Zeta Pharma Pharmaceutical Industries | Himsog | Pebrero 2016 | Yugto 1 |
| NCT02771405 | National Hepatology & Tropical Medicine Research Institute|Universidad sa Cairo | Hepatitis C, Laygay nga|Hepatocellular Carcinoma | Marso 2016 | Yugto 3 |
| NCT03706898 | Viriom | HIV-1-infection|Pagdaot sa Hepatic | Oktubre 1, 2018 | Yugto 1 |
| NCT02319031 | Bristol-Myers Squibb | Hepatitis C | Pebrero 2015 | Yugto 3 |
| NCT02124044 | National Institutes of Health Clinical Center (CC)|National Institute of Allergy and Infectious Diseases (NIAID)|Bristol-Myers Squibb | HIV-HCV | Pebrero 2014 | Yugto 2 |
| NCT02551861 | Bristol-Myers Squibb | Hepatitis C | Disyembre 2015 | Yugto 2 |
| NCT00859053 | Bristol-Myers Squibb | Hepatic Insufficiency | Marso 2009 | Yugto 1 |
| NCT01257204 | Bristol-Myers Squibb | Hepatitis C Virus | Disyembre 2010 | Yugto 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, Laygay nga|Laygay nga Renal Failure | Abril 1, 2017 | Yugto 4 |
| NCT01017575 | Bristol-Myers Squibb | Impeksyon sa Hepatitis C | Disyembre 2009 | Yugto 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 | Laygay nga Hepatitis C | Septiyembre 2016 |
|
| NCT04070235 | Nanjing Sanhome Pharmaceutical, Co., Ltd. | Hepatitis C, Laygay | Marso 29, 2019 | Phase 2|Phase 3 |
| NCT03487848 | Bristol-Myers Squibb | Hepatitis C|Laygay nga Hepatitis | Mayo 18, 2018 | Yugto 2 |
| NCT00904059 | Bristol-Myers Squibb | Hepatitis C | Mayo 2009 | Yugto 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 | Yugto 2 |
| NCT02397395 | Janssen R&D Ireland | Pagkadaot sa Renal|Katapusang yugto sa Sakit sa Bato | Mayo 2015 | Yugto 2 |
| NCT03169348 | Unibersidad sa Assiut | Hepatitis C | Nobyembre 1, 2017 | Dili Magamit |
| NCT02323594 | Bristol-Myers Squibb | Impeksyon sa Hepatitis C | Disyembre 2014 | Yugto 1 |
| NCT03537196 | French National Institute for Health and Medical Research-French National Agency for Research on AIDS ug Viral Hepatitis (Inserm-ANRS) | Hepatitis C|Paggamit sa Droga|Viral Hepatitis C | Nobyembre 13, 2018 | Yugto 4 |
| NCT02103569 | Bristol-Myers Squibb | Hepatitis C | Abril 2014 | Yugto 1 |
| NCT02772744 | Zagazig University|Universidad sa Cairo | Hepatitis C | Nobyembre 1, 2017 |
|
| NCT01718158 | Bristol-Myers Squibb | Hepatitis C | Enero 2013 | Yugto 3 |
| NCT02496078 | Bristol-Myers Squibb | Hepatitis C | Agosto 2015 | Yugto 3 |
| NCT01425970 | Bristol-Myers Squibb | Hepatitis C | Mayo 2012 | Yugto 2 |
| NCT01471574 | Bristol-Myers Squibb | Hepatitis C, Genotype 1 | Disyembre 2011 | Yugto 3 |
| NCT01573351 | Bristol-Myers Squibb | Hepatitis C Virus | Mayo 2012 | Yugto 3 |
| NCT01938625 | Janssen R&D Ireland | Hepatitis C, Laygay | Disyembre 12, 2013 | Yugto 2 |
| NCT01492426 | Bristol-Myers Squibb | Hepatitis C | Enero 2012 | Yugto 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, Laygay | Pebrero 2, 2018 | Phase 2|Phase 3 |
| NCT03163849 | Unibersidad sa Assiut | Laygay nga Hepatitis c | Septiyembre 1, 2019 | Yugto 3 |
| NCT01581203 | Bristol-Myers Squibb | Hepatitis C Virus | Mayo 2012 | Yugto 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 Interaksyon sa Droga | Septiyembre 9, 2017 | Yugto 1 |
| NCT02262728 | Janssen Research & Development, LLC | Hepatitis C, Laygay | Septiyembre 30, 2014 | Yugto 2 |
| NCT02349048 | Janssen Research & Development, LLC | Hepatitis C Virus | Enero 2015 | Yugto 2 |
| NCT03882307 | Unibersidad sa Assiut | Hepatitis C, Laygay | Mayo 2020 | Unang Phase 1 |
| NCT02758509 | Parc de Salut Mar | Laygay nga Hepatitis C|Cirrhosis | Enero 1, 2010 |
|
| NCT01795911 | Bristol-Myers Squibb | Hepatitis C | Marso 2013 | Yugto 2 |
| NCT03549832 | Assiut University|Sohag University|South Valley University | HCV Coinfection | Enero 1, 2018 | Dili Magamit |
| NCT02161939 | Bristol-Myers Squibb | Laygay nga Hepatitis C |
| |
| NCT01309932 | Bristol-Myers Squibb | Hepatitis C | Marso 2011 | Yugto 2 |
| NCT01995266 | Bristol-Myers Squibb | Hepatitis C | Pebrero 28, 2014 | Yugto 3 |
| NCT02640157 | AbbVie | Laygay nga Hepatitis C|Hepatitis C Virus|Genotype 3 Hepatitis C Virus | Disyembre 2015 | Yugto 3 |
| NCT02032875 | Bristol-Myers Squibb | Hepatitis C | Marso 2014 | Yugto 3 |
| NCT02624063 | Federal Unibersidad sa São Paulo | Hepatitis C, Laygay | Disyembre 2015 | Yugto 4 |
| NCT00546715 | Bristol-Myers Squibb | Laygay nga Hepatitis C | Nobyembre 2007 | Phase 1|Phase 2 |
| NCT01718145 | Bristol-Myers Squibb | Impeksyon sa Virus sa Hepatitis C | Nobyembre 2012 | Yugto 3 |
| NCT01616524 | Bristol-Myers Squibb | Hepatitis C Virus (HCV) | Hulyo 2012 | Yugto 3 |
| NCT02032901 | Bristol-Myers Squibb | Hepatitis C | Enero 2014 | Yugto 3 |
| NCT03540212 | Unibersidad sa Ain Shams | Laygay nga Impeksyon sa HCV | Disyembre 10, 2017 | Phase 2|Phase 3 |
| NCT02097966 | Bristol-Myers Squibb | Laygay nga Hepatitis C |
| |
| NCT02596880 | Tehran University of Medical Sciences | Hepatitis C | Cirrhosis | Septiyembre 2015 | Yugto 3 |
| NCT04019717 | Ang Atea Pharmaceuticals, Inc. | Hepatitis C|Hepatitis C, Laygay nga|Laygay nga Hepatitis C|Hepatitis C Virus Infection|HCV Impeksyon | Hunyo 20, 2019 | Yugto 2 |
| NCT02992457 | Tanta University | Hepatitis C | Enero 2015 | Yugto 4 |
| NCT03547895 | Unibersidad sa Zagazig | Decompensated Cirrhosis | Hunyo 1, 2015 | Dili Magamit |
| 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 | Yugto 3 |
| NCT01051414 | Bristol-Myers Squibb | Impeksyon sa Hepatitis C | Abril 2010 | Yugto 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 | Yugto 2 |
| NCT01628692 | Bristol-Myers Squibb|Janssen Research & Development, LLC | Hepatitis C Virus | Hulyo 2012 | Yugto 2 |
| NCT03186313 | Egyptian Liver Hospital|Wadi El Nil Hospital | Hepatitis C | Septiyembre 2016 | Yugto 3 |
| NCT03063723 | Third Affiliated Hospital, Sun Yat-Sen University | Laygay nga Hepatitis C (Disorder) | Enero 1, 2016 |
|
| NCT00983957 | Bristol-Myers Squibb | Laygay nga Hepatitis C | Oktubre 2009 | Yugto 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 | Yugto 2 |
| NCT02282709 | Pundasyon alang sa Pagpanukiduki sa Atay | Laygay nga Hepatitis C | Pebrero 2014 | Yugto 3 |
| NCT02032888 | Bristol-Myers Squibb | Hepatitis C | Pebrero 2014 | Yugto 3 |
| NCT03247296 | Unibersidad sa MTI | Hepatitis C | Pebrero 28, 2017 |
|
| NCT01389323 | Bristol-Myers Squibb | Hepatitis C | Septiyembre 2011 | Yugto 3 |
| NCT02556086 | Bristol-Myers Squibb | Hepatitis C | Disyembre 2015 | Yugto 2 |
| NCT01741545 | Bristol-Myers Squibb | Hepatitis C Virus | Marso 31, 2013 | Yugto 3 |
| NCT01866930 | Bristol-Myers Squibb | Laygay nga Impeksyon sa Hepatitis C | Hulyo 11, 2013 | Yugto 3 |
| NCT02268864 | Janssen-Cilag International NV | Hepatitis C, Laygay | Enero 2015 | Yugto 2 |
| NCT01797848 | Bristol-Myers Squibb | Hepatitis C | Hunyo 2014 | Yugto 3 |
| NCT03166280 | Eman Sayed Hassan Abd Allah|Assiut University | Hepatitis C | Hunyo 2017 |
|
| NCT02159352 | Bristol-Myers Squibb | Hepatitis C | Hunyo 2014 | Yugto 1 |
| NCT01125189 | Bristol-Myers Squibb | Hepatitis C Virus | Hulyo 2010 | Yugto 2 |
| NCT03748745 | Nanjing Sanhome Pharmaceutical, Co., Ltd. | Mga Interaksyon sa Droga | Nobyembre 19, 2018 | Yugto 1 |
| NCT01012895 | Bristol-Myers Squibb | Laygay nga Hepatitis C | Disyembre 2009 | Yugto 2 |
| NCT02565888 | Unibersidad sa Radboud | Hepatitis C|HIV | Nobyembre 2015 | Yugto 1 |
| NCT02555943 | Humanity and Health Research Center|Beijing 302 Hospital|Nanfang Hospital sa Southern Medical University | Laygay nga Hepatitis C Infection|HBV Coinfection|Hepatitis B Reactivation | Pebrero 2015 | Phase 2|Phase 3 |
| NCT02304159 | Tarek I. Hassanein, MD, FACP, FAG, AGAF|Southern California Research Center | Hepatitis C | Cirrhosis | Enero 2015 | Yugto 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|Ang Catholic University of Korea | Hepatitis C | Pebrero 2016 | Yugto 4 |
| NCT02104843 | Bristol-Myers Squibb | Hepatitis C | Abril 2014 | Yugto 1 |
| NCT01428063 | Bristol-Myers Squibb | Impeksyon sa Virus sa Hepatitis C | Septiyembre 2011 | Yugto 2 |
| NCT02123654 | Bristol-Myers Squibb | Impeksyon sa Virus sa Hepatitis C | Abril 2014 | Yugto 3 |
| NCT02565862 | Unibersidad sa Radboud | Hepatitis C|Diabetes Mellitus|Pagsukol sa Insulin | Enero 2016 | Yugto 1 |
| NCT04211844 | Unibersidad sa Ain Shams | Laygay nga Hepatitis C | Oktubre 1, 2019 |
|
| NCT00874770 | Bristol-Myers Squibb | Impeksyon sa Hepatitis C | Hunyo 2009 | Yugto 2 |
| NCT03883698 | Sanjay Gandhi Postgraduate Institute of Medical Sciences | Pagkapakyas sa Kidney, Laygay nga|Hepatitis C | Marso 15, 2019 | Yugto 3 |
| NCT01448044 | Bristol-Myers Squibb | Hepatitis C | Disyembre 2011 | Yugto 3 |
| NCT01359644 | Bristol-Myers Squibb|Pharmasset | Laygay nga Hepatitis C | Hunyo 2011 | Yugto 2 |
| NCT01842451 | Ang Vertex Pharmaceuticals Incorporated | Laygay nga Hepatitis C|CHC|HCV|Hepatitis C | Hunyo 2013 | Yugto 2 |
| NCT02762448 | Tainan Municipal Hospital | Hepatitis c | Hulyo 2016 |
|
| NCT02473211 | Humanity and Health Research Center|Beijing 302 Hospital | Laygay nga Impeksyon sa Hepatitis C | Enero 2015 | Phase 2|Phase 3 |
| NCT01455090 | Bristol-Myers Squibb | Laygay nga Hepatitis C | Nobyembre 30, 2011 | Yugto 2 |
| NCT03490097 | Unibersidad sa Ain Shams | Laygay nga Hepatitis c|Metabolic Syndrome | Disyembre 1, 2017 | Phase 2|Phase 3 |
| NCT01170962 | Bristol-Myers Squibb | Hepatitis C Virus | Agosto 2010 | Yugto 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 Unibersidad|Universidad de Vigo 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 Virgen Regional Universitario| ang Luz|Hospital General Universitario de Castellón|Hospital Parc Taulí, Sabadell | Laygay nga Impeksyon sa Hepatitis C | Disyembre 2014 |
|
| NCT03200184 | Tehran University of Medical Sciences | Hepatitis C | Septiyembre 1, 2016 | Yugto 4 |
| NCT03188276 | Third Affiliated Hospital, Sun Yat-Sen University | Laygay nga Hepatitis C | Pebrero 1, 2016 | Unang Phase 1 |
| NCT01830205 | Bristol-Myers Squibb | Hepatitis C | Septiyembre 2012 | Yugto 1 |
Proposal18Quality Consistency Evaluation nga mga proyekto nga naaprobahan4, ug6ang mga proyekto ubos sa pag-apruba.
Ang abante nga internasyonal nga sistema sa pagdumala sa kalidad nagbutang ug lig-on nga pundasyon alang sa pagpamaligya.
Ang kalidad nga pagdumala nagdagan sa tibuuk nga siklo sa kinabuhi sa produkto aron masiguro ang kalidad ug terapyutik nga epekto.
Ang koponan sa Professional Regulatory Affairs nagsuporta sa mga kinahanglanon sa kalidad sa panahon sa aplikasyon ug pagrehistro.
Korea Countec Bottled Packaging Line
Taiwan CVC Bottled Packaging Line
Italy CAM Board Packaging Line
German nga Fette Compacting Machine
Japan Viswill Tablet Detector
DCS Control Room
Internasyonal nga kooperasyon
Kooperasyon sa panimalay
Isulat ang imong mensahe dinhi ug ipadala kini kanamo
