Doxycycline Hyclate

Short Description:

API’s Name Indication Specification US DMF  EU DMF  CEP
Doxycycline Hyclate Antibiotics USP/EP 13771  


Product Detail

Product Tags

PRODUCT DETAIL

Background

Doxycycline hyclate is an antibiotic [1].

Doxycycline hyclate is a derivative of tetracycline and possesses the activities of anti-inflammatory and antimicrobial. Doxycycline inhibits dengue virus replication in vitro with a temperature-dependent manner. The IC50 value is 52.3μM at 37°C and 26.7μM at 40°C. It inhibits the dengue virus via inhibiting the NS2B-NS3 serine protease of the virus. 60μM doxycycline reduces the CPE of the DNEV2-infected cells [1].

Doxycycline is found to be an inhibitor of MMP. Doxycycline treatment reduces MMP-8 and -9 levels and inhibits expression of tissue MMP-2 and MMP-9. Moreover, treatment with doxycycline significantly reduces the incidence of intracranial aneurysms. Doxycycline has also been reported to be an anti-inflammatory agent based on its inhibition of matrix metalloproteinases. In addition, doxycycline has potent antimalarial activity with IC50 value of 320nM at 96h in vitro [2, 3].

References:
[1] Rothan HA, Mohamed Z, Paydar M, Rahman NA, Yusof R. Inhibitory effect of doxycycline against dengue virus replication in vitro. Arch Virol. 2014 Apr;159(4):711-8.
[2] Maradni A, Khoshnevisan A, Mousavi SH, Emamirazavi SH, Noruzijavidan A. Role of matrix metalloproteinases (MMPs) and MMP inhibitors on intracranial aneurysms: a review article. Med J Islam Repub Iran. 2013 Nov;27(4):249-254.
[3] Draper MP, Bhatia B, Assefa H, Honeyman L, Garrity-Ryan LK, Verma AK, Gut J, Larson K, Donatelli J, Macone A, Klausner K, Leahy RG, Odinecs A, Ohemeng K, Rosenthal PJ, Nelson ML. In vitro and in vivo antimalarial efficacies of optimized tetracyclines. Antimicrob Agents Chemother. 2013 Jul;57(7):3131-6.

Description

Doxycycline (hyclate) (Doxycycline hydrochloride hemiethanolate hemihydrate), an antibiotic, is an orally active and broad-spectrum metalloproteinase (MMP) inhibitor[1].

Clinical Trial

NCT Number Sponsor Condition Start Date

Phase

NCT00246324 Louisiana State University Health Sciences Center Shreveport|Biogen Multiple Sclerosis December 2003

Phase 4

NCT00910715 University Medical Centre Ljubljana Erythema Chronicum Migrans June 2009

Not Applicable

NCT00243893 University of California, San Francisco|National Institute of Neurological Disorders and Stroke (NINDS) Aneurysms|Arteriovenous Malformations July 2004

Phase 1

NCT00126399 CollaGenex Pharmaceuticals Rosacea June 2004

Phase 3

NCT01318356 Radboud University|ZonMw: The Netherlands Organisation for Health Research and Development Q Fever|Fatigue Syndrome, Chronic|Coxiella Infection April 2011

Phase 4

NCT00177333 University of Pittsburgh Abortion, Induced|Vomiting September 2005

Phase 4

NCT00007735 US Department of Veterans Affairs|Pfizer|United States Department of Defense|VA Office of Research and Development Persian Gulf Syndrome|Mycoplasma Infections January 1999

Phase 3

NCT00351273 University of South Florida|National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Arthritis, Reactive|Reiter Disease May 2006

Phase 3

NCT00469261 Careggi Hospital Myocardial Infarction|Left Ventricular Remodeling May 2007

Phase 2

NCT00547170 University of Pittsburgh|Tu Du Hospital Endometritis January 2007

Phase 4

NCT01475708 University Medical Centre Ljubljana Lyme Borreliosis May 2011

NCT01368341 Morten Lindbaek|Norwegian Institute of Public Health|Sorlandet Hospital HF|Norwegian University of Life Sciences|University of Oslo Erythema Migrans|Erythema Chronicum Migrans|Borreliosis|Lyme Disease|Early Lyme Disease June 2011

Phase 4

NCT02538224 Islamic Azad University, Tehran Chronic Periodontitis July 2013

Phase 2|Phase 3

NCT00066027 University of Nebraska|National Institute of Dental and Craniofacial Research (NIDCR) Periodontitis June 2002

Phase 3

NCT00376493 Hospital de Clinicas de Porto Alegre Septic Abortion May 2006

Phase 4

NCT03448731 Fundacion CRIS de Investigación para Vencer el Cáncer|Amgen|Apices Soluciones S.L. Skin Toxicity May 10, 2018

Phase 2

NCT00989742 University of Nottingham Lymphangioleiomyomatosis|Tuberous Sclerosis July 2009

Phase 4

NCT01438515 Horizon Health Network Methicillin-resistant Staphylococcus Aureus August 2008

Not Applicable

NCT02929121 The Task Force for Global Health|United States Agency for International Development (USAID) Lymphedema|Lymphatic Filariasis|Filariasis January 15, 2019

Phase 3

NCT00952861 Odense University Hospital|Kolding Sygehus|Svendborg Hospital|Fredericia Hospital|Naestved Hospital|Hillerod Hospital, Denmark|Region Syddanmark|Danmarks Lungeforening|Danish National Research Foundation Pulmonary Disease, Chronic Obstructive October 2009

Phase 4

NCT00138801 Sorlandet Hospital HF Lyme Neuroborreliosis March 2004

Phase 3

NCT00942006 University Medical Centre Ljubljana Suspected Early Lyme Neuroborreliosis July 2009

Not Applicable

NCT02713607 University of California, Davis Acne Vulgaris March 2016

Phase 1|Phase 2

NCT00560703 Galderma Blepharitis|Meibomianitis|Dry Eye November 2007

Phase 2

NCT01014260 Johns Hopkins University Cardiovascular Disease September 2010

Phase 4

NCT00000938 National Institute of Allergy and Infectious Diseases (NIAID) Lyme Disease  

Phase 3

NCT01398072 University College, London|Royal Free Hampstead NHS Trust|University of Cambridge|National Institute for Health Research, United Kingdom Chronic Obstructive Pulmonary Disease (COPD). December 2011

Phase 3

NCT03479502 Vanderbilt University Medical Center|Orthopedic Research and Education Foundation Adhesive Capsulitis|Adhesive Capsulitis of Unspecified Shoulder|Frozen Shoulder January 5, 2018

Phase 4

NCT02929134 The Task Force for Global Health|United States Agency for International Development (USAID) Lymphedema|Lymphatic Filariasis|Filariasis February 16, 2018

Phase 3

NCT00480532 Oregon Health and Science University Contraceptives, Oral May 2007

Not Applicable

NCT01594827 Johns Hopkins University|Case Western Reserve University|Cystic Fibrosis Foundation Cystic Fibrosis October 2012

Phase 2

NCT01744093 Weill Medical College of Cornell University|National Heart, Lung, and Blood Institute (NHLBI) HIV|Chronic Obstructive Pulmonary Disease (COPD)|Emphysema July 17, 2014

Not Applicable

NCT03530319 National Taiwan University Hospital Pneumonia, Mycoplasma November 10, 2018

Not Applicable

NCT04167085 University of California, Los Angeles Epistaxis December 18, 2017

Phase 4

NCT01411202 Ottawa Hospital Research Institute Malignant Pleural Effusion June 2011

Phase 2

NCT01474590 Galderma Acne November 2011

Phase 3

NCT00649571 Mylan Pharmaceuticals Healthy July 2005

Phase 1

NCT02899000 Galderma Laboratories, L.P. Acne Vulgaris July 29, 2016

Phase 4

NCT00538967 Leiden University Medical Center Aortic Aneurysm, Abdominal May 2002

Phase 2

NCT00439400 Alacrity Biosciences, Inc. Dry Eye February 2007

Phase 2

NCT00917553 Thomas Gardner|Penn State University|Juvenile Diabetes Research Foundation|Milton S. Hershey Medical Center Diabetic Retinopathy July 2009

Phase 2

NCT00495313 CollaGenex Pharmaceuticals Rosacea March 2007

Phase 4

NCT01855360 Brigham and Women´s Hospital Amyloidosis; Heart (Manifestation)|Senile Cardiac Amyloidosis June 2013

Phase 1|Phase 2

NCT00419848 Shahid Beheshti University of Medical Sciences Acne August 2006

Phase 2

NCT03532464 University Hospital, Bordeaux|USC EA 3671 Infections humaines à mycoplasmes et à chlamydiae Chlamydia Trachomatis Infection|Vaginal Infection|Anal Infection July 1, 2018

Phase 4

NCT02756403 Medstar Health Research Institute|Society of Family Planning First Trimester Abortion March 2016

Not Applicable

NCT00353158 National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)|National Institutes of Health Clinical Center (CC) Healthy Volunteers|Fungal Infections|Bacterial Infections July 11, 2006

Phase 1

NCT01317433 Institut Cancerologie de l´Ouest Colorectal Cancer Metastatic|Skin Toxicity December 2010

Phase 3

NCT01658995 Petra M. Casey|Mayo Clinic ESI-related Bleeding September 13, 2012

Phase 3

NCT03968562 State University of New York - Downstate Medical Center Hives May 15, 2019

Phase 2

NCT02569437 Icahn School of Medicine at Mount Sinai Polyp of Nasal Sinus September 2014

Phase 2

NCT01198509 NYU Langone Health|National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)|Memorial Sloan Kettering Cancer Center Rheumatoid Arthritis|Psoriatic Arthritis|Periodontal Disease January 2010

Not Applicable

NCT01163994 University Medical Centre Ljubljana Multiple Erythema Migrans June 2010

Not Applicable

NCT02388477 Milton S. Hershey Medical Center Rotator Cuff Injury  

Not Applicable

NCT01010295 International Extranodal Lymphoma Study Group (IELSG) Non-Hodgkin Lymphoma September 2006

Phase 2

NCT00775918 Ranbaxy Laboratories Limited|Ranbaxy Inc. Healthy June 2005

Not Applicable

NCT04050540 University of Washington|Kenya Medical Research Institute|Kenya National AIDS & STI Control Programme|University of California, San Francisco|National Institute of Allergy and Infectious Diseases (NIAID) HIV Infections|HIV+AIDS|Neisseria Gonorrheae Infection|Chlamydia Trachomatis Infection|Syphilis Infection February 5, 2020

Phase 4

NCT02562651 Russian Academy of Medical Sciences Vascular Diseases|Cardiovascular Diseases|Acute Myocardial Infarction February 2014

Phase 2|Phase 3

NCT00001101 National Institute of Allergy and Infectious Diseases (NIAID) Lyme Disease  

Phase 3

NCT00340691 National Institute of Allergy and Infectious Diseases (NIAID)|National Institutes of Health Clinical Center (CC) Mansonella Perstans Infection|Mp Microfilaremia December 6, 2004

Phase 2

NCT01112059 University of Alabama at Birmingham|Cystic Fibrosis Foundation Cystic Fibrosis November 2008

Not Applicable

NCT00652704 Par Pharmaceutical, Inc.|Anapharm To Determine Bioequivalence Under Fed Conditions July 1999

Phase 1

NCT01783860 Tehran University of Medical Sciences Posterior Blepharitis January 2013

Phase 2

NCT02564471 State University of New York - Upstate Medical University|Walter Reed Army Institute of Research (WRAIR)|Kansas State University Rabies April 2016

Phase 4

NCT04206631 Indonesia University Acne Vulgaris April 1, 2015

Phase 1

NCT03956446 University Medical Centre Ljubljana|University of Ljubljana School of Medicine, Slovenia Tick Borne Encephalitis September 1, 2014

Not Applicable

NCT03960411 Felix Chikita Fredy, MD|National Cardiovascular Center Harapan Kita Hospital Indonesia|Indonesia University ST Elevation Myocardial Infarction|Anterior Wall Myocardial Infarction|Heart Failure|Remodeling, Ventricular May 25, 2019

Phase 3

NCT00322465 National Institute of Allergy and Infectious Diseases (NIAID) Urethritis November 2006

Phase 2

NCT01375491 University of California, San Diego|Ruth L. Kirschstein National Research Service Award|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|National Center for Research Resources (NCRR) Type 2 Diabetes|Obesity October 2009

Phase 4

NCT03478436 Medical University of Vienna|Dr. Reddy´s Laboratories Limited Rosacea July 2016

Phase 1

NCT01207739 Radboud University|Sint Maartenskliniek|ZonMw: The Netherlands Organisation for Health Research and Development Lyme Disease|Borrelia Infection September 2010

Phase 4

NCT00939562 Pfizer Bacterial Infection November 2008

Phase 4

NCT03608774 National Institute of Allergy and Infectious Diseases (NIAID) Anal Chlamydia Infection June 26, 2018

Phase 4

NCT02281643 Kwame Nkrumah University of Science and Technology|University of Bonn|Heinrich-Heine University, Duesseldorf Mansonella Perstans Infection|Buruli Ulcer|Tuberculosis|Co-infection October 2014

Phase 2

NCT00066066 The Forsyth Institute|National Institute of Dental and Craniofacial Research (NIDCR) Periodontitis|Periodontal Diseases July 2003

Phase 2

NCT01798225 Medical University of South Carolina|National Center for Research Resources (NCRR) Periodontal Disease|Type 2 Diabetes Mellitus December 2007

Phase 4

NCT00612573 Warner Chilcott Acne Vulgaris February 2008

Phase 2

NCT01631617 National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)|National Institutes of Health Clinical Center (CC) Eczema|Dermatitis|Skin Diseases, Genetic|Dermatitis, Atopic|Skin Diseases September 18, 2012

Phase 2

NCT03173053 Radboud University|ZonMw: The Netherlands Organisation for Health Research and Development|Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|Aalborg University Hospital|Rigshospitalet, Denmark Staphylococcus Aureus|Motility Disorder February 8, 2018

Not Applicable

NCT00715858 McMaster University|The Physicians´ Services Incorporated Foundation Alzheimer´s Disease May 2008

Phase 3

NCT03584919 University Medical Centre Ljubljana Erythema Chronicum Migrans June 1, 2006

Not Applicable

NCT01469585 University of Hawaii|Charles Drew University of Medicine and Science|Meharry Medical College Breakthrough Bleeding November 2011

Not Applicable

NCT02759120 Weill Medical College of Cornell University|Duke Clinical Research Institute|University of Chicago|University of Washington|University of Pittsburgh|National Heart, Lung, and Blood Institute (NHLBI) Idiopathic Pulmonary Fibrosis March 22, 2017

Phase 3

NCT02735837 Amirhossein Farahmand|Islamic Azad University, Tehran Diabetes Mellitus With Periodontal Disease January 2015

Phase 2|Phase 3

NCT03655197 University of California, Davis Rosacea|Ocular Rosacea|Cutaneous Rosacea November 2, 2017

Early Phase 1

NCT01188954 Northwell Health Seroma January 2010

Not Applicable

NCT00388778 Shahid Beheshti University of Medical Sciences Acne|Inflammation October 2005

Phase 2|Phase 3

NCT01087476 Metropolitan Autonomous University|Instituto Nacional de Cancerologia de Mexico Mucositis May 2010

Phase 2

NCT02174757 CD Pharma India Pvt. Ltd.|Sree Mookambika Institute of Dental Sciences Chronic Periodontitis August 2014

Phase 3

NCT03911440 National Taiwan University Hospital Atypical Pneumonia November 10, 2018

Not Applicable

NCT02553083 Rabin Medical Center Bacterial Infection Due to Helicobacter Pylori (H. Pylori) October 22, 2015

Phase 4

NCT04234945 Ahmadu Bello University Teaching Hospital Infertility, Female|Pelvic Inflammatory Disease January 13, 2020

Not Applicable

NCT00892281 Galderma Laboratories, L.P. Rosacea April 2009

Phase 4

NCT02913118 Qingfeng Pharmaceutical Group Community Acquired Pneumonia July 2016

Phase 4

NCT04153604 Methodist Health System Cirrhosis|Spontaneous Bacterial Peritonitis November 4, 2019

NCT03153267 University Medical Centre Ljubljana|University of Ljubljana School of Medicine, Slovenia Erythema Chronicum Migrans June 1, 2017

Not Applicable

NCT03116659 James J. Peters Veterans Affairs Medical Center Lymphoma, T-Cell, Cutaneous February 1, 2018

Early Phase 1

NCT03401372 Jian Li|Peking University First Hospital|Chinese PLA General Hospital|Beijing Chao Yang Hospital|West China Hospital Affiliated with Sichuan University|Tongji Hospital Affiliated with Tongji Medical College of HUST|Union Hospital Affiliated with Tongji Medical College of HUST|Shanghai Changzheng Hospital|Nanfang Hospital of Southern Medical University|Peking Union Medical College Hospital Amyloidosis; Systemic April 21, 2018

Not Applicable

NCT01380496 Par Pharmaceutical, Inc.|Anapharm To Determine Bioequivalence Under Fed Conditions November 1999

Phase 1

NCT03083197 University of Oxford|Shoklo Malaria Research Unit|Chiangrai Prachanukroh Hospital Scrub Typhus October 15, 2017

Phase 4

NCT00237016 Medical Corps, Israel Defense Force Relapsing Fever, Tick-Borne|Jarisch Herxheimer Reaction April 2002

Phase 2|Phase 3

NCT01308619 Galderma Laboratories, L.P. Rosacea April 2011

Phase 4

NCT01198912 University Hospital, Ghent Chronic Rhinosinusitis|Nasal Polyps November 22, 2011

Phase 2

NCT02016365 Umeå University Transthyretin Amyloidosis|Cardiomyopathy February 2012

Phase 2

NCT00783523 University of California, San Francisco Arteriovenous Malformations|Cavernous Angiomas|Brain Aneurysms March 2008

Phase 1

NCT03337932 University Medical Centre Ljubljana Erythema Chronicum Migrans January 1, 2018

Not Applicable

NCT00568711 Dong-Min Kim|Chosun University Hospital Scrub Typhus September 2006

Not Applicable

NCT01874860 University of Louisville|James Graham Brown Cancer Center Colorectal Cancer|Head and Neck Cancer August 2013

Phase 2

NCT01171859 IRCCS Policlinico S. Matteo Transthyretin Amyloidosis July 2010

Phase 2

NCT01653522 The Cleveland Clinic Migraine Disorders|Headache, Migraine|Migraine|Migraine Headache|Migraine With Aura|Migraine Without Aura|Headache Disorders, Primary July 2012

Not Applicable

NCT01820910 International Extranodal Lymphoma Study Group (IELSG) Marginal Zone Lymphoma of Ocular Adnexal March 2013

Phase 2

NCT01323101 University of Southern California Cystic Fibrosis April 2008

Phase 4

NCT00829764 Teva Pharmaceuticals USA Healthy October 2006

Phase 1

NCT01668498 AIO-Studien-gGmbH Ras-wildtype Colorectal Cancer May 2011

Phase 2

NCT01030666 Peter Eickholz|Heidelberg University|Dr. August Wolff GmbH & Co. KG Arzneimittel|Gaba International AG|Goethe University Periodontitis April 2007

Phase 4

NCT00012688 US Department of Veterans Affairs|Colgate-Periogard-Dentsply|VA Office of Research and Development Diabetes Mellitus|Poor Glycemic Control|Peridontal Disease  

Not Applicable

NCT01885910 Derm Research, PLLC|WFH MEDICAL, LLC Acne Vulgaris July 2013

Phase 4

NCT02328469 University Medical Centre Ljubljana|Slovenian Research Agency|University of Ljubljana School of Medicine, Slovenia|Harvard University Aseptic Meningitis June 2014

NCT00355602 University of Dundee|Tenovus Scotland Colitis, Ulcerative July 2006

Not Applicable

NCT02606032 Hamilton Health Sciences Corporation|Hamilton Academic Health Sciences Organization Ulcerative Colitis May 2016

Phase 2

NCT01465802 Pfizer Non Small Cell Lung Cancer (NSCLC) December 26, 2011

Phase 2

NCT02623959 M.D. Anderson Cancer Center Advanced Cancers|Malignant Pleural Effusions April 27, 2016

Phase 4

NCT03481972 IRCCS Policlinico S. Matteo TTR Cardiac Amyloidosis April 11, 2018

Phase 3

NCT00428818 University of Texas Southwestern Medical Center Infection August 2005

Not Applicable

NCT01935622 Virginia Commonwealth University Non-ischemic Cardiomyopathy|Systolic Heart Failure (NYHA II-III) July 2012

Phase 2

NCT01886560 Sun Yat-sen University Eye Burns September 2013

Phase 2|Phase 3

NCT04239755 Damanhour University|Tanta University Traumatic Brain Injury December 15, 2019

Phase 4

NCT02204254 Centre Hospitalier Universitaire de Nice Rosacea March 2014

Not Applicable

NCT00837213 Stiefel, a GSK Company|GlaxoSmithKline Acne August 2007

Phase 4

NCT03115177 Rush University Medical Center Osteoarthritis November 2015

Not Applicable

NCT03618108 Cadrock Pty. Ltd.|Centre for Digestive Diseases, Australia Coronary Heart Disease|Chlamydophila Pneumoniae Infections April 4, 2018

Phase 2

NCT03435952 M.D. Anderson Cancer Center|BioMed Valley Discoveries, Inc|Merck Sharp & Dohme Corp. Malignant Neoplasm of Breast|Malignant Neoplasms of Digestive Organs|Malignant Neoplasms of Eye Brain and Other Parts of Central Nervous System|Malignant Neoplasms of Female Genital Organs|Malignant Neoplasms of Ill-defined Secondary and Unspecified Sites|Malignant Neoplasms of Independent (Primary) Multiple Sites|Malignant Neoplasms of Lip Oral Cavity and Pharynx|Malignant Neoplasms of Male Genital Organs|Malignant Neoplasms of Mesothelial and Soft Tissue|Malignant Neoplasms of Respiratory and Intrathoracic Organs|Malignant Neoplasms of Thyroid and Other Endocrine Glands|Malignant Neoplasms of Urinary Tract July 10, 2018

Phase 1

NCT01867294 Academic and Community Cancer Research United|National Cancer Institute (NCI) Advanced Malignant Neoplasm|Dermatologic Complication August 31, 2012

Phase 2

NCT01677286 Boston University Amyloidosis July 2012

Phase 2

NCT00511875 Thomas Gardner|Juvenile Diabetes Research Foundation|Milton S. Hershey Medical Center Diabetic Retinopathy July 2008

Phase 2

NCT04108897 Johns Hopkins University Rosacea September 17, 2019

Early Phase 1

NCT00631501 Kaunas University of Medicine|University Hospital, Linkoeping Lateral Epicondylalgia (Tennis Elbow)  

Not Applicable

NCT02203682 Sun Yat-sen University Graves Ophthalmopathy|Graves Disease|Eye Diseases|Thyroid Diseases|Endocrine System Diseases|Eye Diseases, Hereditary|Hyperthyroidism|Autoimmune Diseases|Immune System Diseases July 2014

Phase 2

NCT02005653 Indian Council of Medical Research Filarial; Infestation February 2009

Phase 4

NCT03585140 Centro Dermatológico Dr. Ladislao de la Pascua Acne Vulgaris|Diet Modification January 1, 2016

Not Applicable

NCT02147262 University Medical Centre Ljubljana|University of Ljubljana School of Medicine, Slovenia|Medical University of Vienna|Harvard University Chronic Atrophic Acrodermatitis July 2013

Not Applicable

NCT02220751 University of Sao Paulo|Fundação de Amparo à Pesquisa do Estado de São Paulo Periodontitis|Type 2 Diabetes Mellitus March 2009

Phase 3

NCT01825408 University of North Carolina, Chapel Hill Sinusitis February 2013

Phase 4

NCT02884713 King Faisal Specialist Hospital & Research Center GASTRITIS June 2013

Not Applicable

NCT02726646 University of Campinas, Brazil|Pontificia Universidade Catolica de Sao Paulo Chronic Periodontitis June 2015

Phase 2

NCT00883818 Samsung Medical Center Overactive Bladder January 2007

Phase 4

NCT00829790 Teva Pharmaceuticals USA Healthy October 2006

Phase 1

NCT01949233 University of Oxford|Oxford University Hospitals NHS Trust Marfan Syndrome October 2013

Phase 2

NCT01518192 University Medical Centre Ljubljana|Slovenian Research Agency Erythema Migrans|Post-Lyme Disease Symptoms June 2006

Phase 4

NCT02845024 Islamic Azad University, Tehran Diabetes Mellitus With Periodontal Disease September 2014

Not Applicable

NCT01879930 University Hospital Inselspital, Berne Chronic Pelvic Pain Syndrome|Bladder Pain Syndrome November 2012

Phase 4

NCT00041977 CollaGenex Pharmaceuticals Acne Rosacea June 2002

Phase 3

NCT02341209 Rochester General Hospital Cutaneous T-cell Lymphoma|Mycosis Fungoides|Sezary Syndrome February 6, 2018

Phase 2

NCT00002872 Eastern Cooperative Oncology Group|National Cancer Institute (NCI)|North Central Cancer Treatment Group Metastatic Cancer November 1996

Phase 3

NCT03162497 Medical University of Vienna Dry Eye Syndromes|Meibomian Gland Dysfunction January 8, 2018

Phase 4

NCT01418742 Gesellschaft fur Medizinische Innovation ? Hamatologie und Onkologie mbH|ClinAssess GmbH Colorectal Carcinoma August 2011

Phase 2

NCT00980148 National Institute of Allergy and Infectious Diseases (NIAID) Chlamydial Infection December 2009

Phase 3

NCT03342456 The Third Xiangya Hospital of Central South University|Livzon Pharmaceutical Group Inc.|Yung Shin Pharm. Ind. Co., Ltd. Duodenal Ulcer Due to Helicobacter Pylori December 13, 2017

Phase 4

NCT04310930 The University of Queensland|Australian Government Department of Health|Children´s Hospital Foundation|Cystic Fibrosis Foundation|Newcastle University|Griffith University|Erasmus Medical Center|Monash University|University of Copenhagen|Hôpital Cochin|South Australian Health and Medical Research Institute|University of Melbourne|James Cook University, Queensland, Australia|Murdoch Childrens Research Institute Pulmonary Disease Due to Mycobacteria (Diagnosis) March 2020

Phase 2|Phase 3

NCT03709459 Kirby Institute|South Australian Health and Medical Research Institute|Monash University STIs Prevention December 17, 2019

NCT04067011 Emergent BioSolutions|Biomedical Advanced Research and Development Authority Anthrax August 12, 2019

Phase 2

NCT02844634 British Columbia Centre for Disease Control HIV|Syphilis May 15, 2018

Phase 4

NCT00647959 Mylan Pharmaceuticals Healthy March 2006

Phase 1

NCT00170222 Medical Center Alkmaar Chronic Obstructive Pulmonary Disease July 2002

Phase 4

NCT03075891 Galderma Rosacea July 5, 2017

Phase 4

NCT00031499 National Institute of Allergy and Infectious Diseases (NIAID) Syphilis June 2000

Phase 3

NCT01205464 Linkoeping University Fatigue|Radicular Pain|Cognitive Dysfunction|Paresthesia|Paresis February 2005

Not Applicable

NCT01301586 Nexgen Dermatologics, Inc. ACNE VULGARIS November 2010

Phase 1|Phase 2

NCT02305940 Imperial College London Chronic Obstructive Pulmonary Disease (COPD) July 2014

Phase 3

NCT00351182 Dong-Min Kim|Chosun University Hospital Scrub Typhus September 2005

Phase 3

NCT03334682 Nantes University Hospital Acne Vulgaris January 31, 2018

Phase 3

NCT01788215 University of Rochester Polycystic Ovarian Syndrome (PCOS)|Irregular Menstrual Cycles|Androgen Excess November 2010

Phase 3

NCT03076281 Sidney Kimmel Cancer Center at Thomas Jefferson University|Thomas Jefferson University Larynx|LIP|Oral Cavity|Pharynx April 3, 2017

Phase 2

NCT00439166 Hamilton Health Sciences Corporation|The Physicians´ Services Incorporated Foundation|McMaster University Alzheimer´s Disease February 2007

Phase 3

NCT02463942 University Medical Centre Ljubljana|University of Ljubljana School of Medicine, Slovenia Tick-borne Encephalitis September 2014

Not Applicable

NCT00803842 Northwestern University Non Small Cell Lung Cancer October 2008

Not Applicable

NCT02086591 University of Rochester Adult Diffuse Large B-Cell Lymphoma|Mantle Cell Lymphoma Recurrent|Lymphoma, Follicular|Marginal Zone B-Cell Lymphoma|Malignant Lymphoma - Lymphoplasmacytic|Waldenstrom Macroglobulinemia|Small Lymphocytic Lymphoma|Chronic Lymphocytic Leukemia (CLL)|T-Cell Lymphoma March 2014

Phase 2

NCT03980223 University of California, San Francisco|University of Washington|National Institute of Allergy and Infectious Diseases (NIAID)|Mayne Pharma International Pty Ltd|San Francisco Department of Public Health Gonorrhea|Chlamydia|Syphilis November 26, 2019

Phase 4

NCT00355459 University of Texas Southwestern Medical Center Dry Eye Syndrome August 2005

Not Applicable

NCT01254799 Omar Mamdouh Shaaban|Assiut University Uterine Hemorrhage January 2008

Phase 3

NCT01547325 NanoSHIFT LLC|United States Department of Defense Dehisced Surgical Wounds May 2012

Not Applicable

NCT00653380 Par Pharmaceutical, Inc.|Anapharm To Determine Bioequivalence Under Fasting Conditions September 1999

Phase 1

NCT00635609 Warner Chilcott Acne Vulgaris March 2008

Phase 4

NCT03765931 Institut de Recherche pour le Developpement Fever July 2016

Phase 4

NCT01160640 Harold Wiesenfeld|National Institute of Allergy and Infectious Diseases (NIAID)|University of Pittsburgh Pelvic Inflammatory Disease November 2010

Phase 2

NCT01756833 University of Maryland, Baltimore|National Institute on Aging (NIA) Aneurysm May 2013

Phase 2

NCT00688064 Galderma Severe Acne Vulgaris August 2008

Phase 3

NCT01320033 Galderma Acne Vulgaris March 29, 2011

Phase 2

NCT03397004 St. Michael´s Hospital, Toronto|Barrow Neurological Institute|Duke University|Feinstein Institute for Medical Research|University of Pittsburgh|Sunnybrook Health Sciences Centre Hereditary Hemorrhagic Telangiectasia (HHT) September 12, 2018

Phase 2

NCT01635530 Turku University Hospital Lyme Neuroborreliosis August 2012

Phase 4

NCT03727620 Mohammed V Souissi University Aggressive Periodontitis January 6, 2014

Phase 1|Phase 2

NCT02688738 Rothman Institute Orthopaedics Propionibacterium March 2015

Not Applicable

NCT00358462 University of Washington|National Institute of Allergy and Infectious Diseases (NIAID) Urethritis January 2007

Phase 3

NCT02864550 British Columbia Centre for Disease Control Syphilis|Sexually Transmitted Infections August 15, 2019

Phase 4

NCT01595594 University of Sao Paulo|Fundação de Amparo à Pesquisa do Estado de São Paulo Periodontal Disease|Type 2 Diabetes March 2010

Phase 3

NCT00964834 PharmAthene, Inc.|National Institutes of Health (NIH)|Medarex|Quintiles, Inc.|Department of Health and Human Services Anthrax July 2009

Phase 1

NCT01809444 Sun Yat-sen University Thyroid Associated Opthalmopathies November 2012

Phase 2|Phase 3

NCT01590082 M.D. Anderson Cancer Center|National Institutes of Health (NIH)|National Cancer Institute (NCI) Melanoma November 2012

Phase 1|Phase 2

NCT00207584 Centers for Disease Control and Prevention Mycoplasma Pneumoniae January 1994

Not Applicable

NCT00775177 Ranbaxy Laboratories Limited|Ranbaxy Inc. Healthy June 2005

Not Applicable

NCT03462329 University Medical Centre Ljubljana Erythema Migrans June 1, 2018

Not Applicable

NCT00000403 Indiana University|National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)|National Institute on Aging (NIA) Osteoarthritis September 1996

Phase 3

NCT03508232 University of Alberta|Royal Alexandra Hospital ST Segment Elevation Myocardial Infarction|Heart Failure January 6, 2020

Phase 2

NCT02553473 Sorlandet Hospital HF Neuroborreliosis, Borrelia Burgdorferi October 2015

Phase 3

NCT02207556 Medical College of Wisconsin Primary Systemic Amyloidosis October 1, 2014

Phase 2

NCT01783106 Royal Liverpool University Hospital|National Association for Colitis and Crohn´s Disease|National Institute for Health Research, United Kingdom Crohn´s Disease February 1, 2014

Phase 2

NCT00353743 Hospital de Clinicas de Porto Alegre Abortion, Septic May 2006

Not Applicable

NCT01727973 Sun Yat-sen University Graves Ophthalmopathy|Graves Disease|Eye Diseases|Thyroid Diseases|Endocrine System Diseases|Eye Diseases, Hereditary|Hyperthyroidism|Autoimmune Diseases|Immune System Diseases October 2012

Phase 1|Phase 2

NCT00857038 Medical Center Alkmaar|Leiden University Medical Center|University of Amsterdam Chronic Obstructive Pulmonary Disease|Inflammation|Pulmonary Emphysema April 2009

Phase 4

NCT02774993 National University Hospital, Singapore|Tan Tock Seng Hospital|National University, Singapore|A*Star Tuberculosis September 2015

Phase 2

NCT03474458 IRCCS Policlinico S. Matteo Cardiac AL Amyloidosis February 11, 2019

Phase 2|Phase 3

NCT02874430 Sidney Kimmel Cancer Center at Thomas Jefferson University|Thomas Jefferson University Breast Carcinoma|Endometrial Clear Cell Adenocarcinoma|Endometrial Serous Adenocarcinoma|Uterine Corpus Cancer|Uterine Corpus Carcinosarcoma June 8, 2016

Phase 2

NCT00016835 University of Michigan|National Institute of Dental and Craniofacial Research (NIDCR) Periodontal Disease|Diabetes Mellitus, Type 2 October 17, 2001

Phase 2

NCT00064766 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Endometrial Bleeding|Periodontal Disease February 2003

Phase 4

NCT00803452 University of Louisville Blepharitis July 2008

Phase 4

NCT01434173 Bayer|RTI Health Solutions Drug-Induced Liver Injury July 2001

NCT00126204 Barnes-Jewish Hospital Aortic Aneurysm March 2004

Not Applicable

NCT01917721 Hawaii Pacific Health Kawasaki Disease|Coronary Aneurysm October 2013

Phase 2

NCT02775695 Medical College of Wisconsin Resectable Pancreatic Cancer April 3, 2017

Phase 2

NCT03824340 Aljazeera Hospital Infertility January 30, 2019

Not Applicable

NCT01847976 Ottawa Hospital Research Institute|Canadian Breast Cancer Foundation Pain August 2013

Phase 2

NCT02850913 Makerere University|University of Oxford Seizures September 5, 2016

Phase 2

NCT00764361 NanoSHIFT LLC Diabetic Foot Ulcer January 2009

Phase 2

NCT02036528 Royer Biomedical, Inc. Diabetic Foot Ulcers January 2014

Phase 1|Phase 2

NCT01661985 Ostergotland County Council, Sweden|Statens Serum Institut Urethritis|Cervicitis|Genital Mycoplasma Infection|Chlamydia Trachomatis February 2010

Phase 4

NCT01380483 Par Pharmaceutical, Inc.|Anapharm To Determine Bioequivalence Under Fasting Conditions January 2000

Phase 1

NCT00648180 Mylan Pharmaceuticals Healthy July 2005

Phase 1

NCT01426269 Galderma Laboratories, L.P. Rosacea September 2011

Phase 4

NCT02753426 University of California, San Francisco Chronic Kidney Disease|Cardiorenal Syndrome April 2016

Phase 1

NCT02583282 Postgraduate Institute of Medical Education and Research Malignant Pleural Effusion August 1, 2015

Not Applicable

NCT02927496 The Task Force for Global Health|United States Agency for International Development (USAID) Lymphedema|Lymphatic Filariasis|Filariasis June 19, 2018

Phase 3

NCT00652795 Par Pharmaceutical, Inc.|Anapharm To Determine Bioequivalence Under Fasting Conditions July 2004

Phase 1

NCT03956212 University Medical Centre Ljubljana|University of Ljubljana School of Medicine, Slovenia Erythema Migrans June 1, 2017

Not Applicable

NCT00855595 Bayer Papulopustular Rosacea February 2009

Phase 4

NCT03457636 Derm Research, PLLC Acne March 19, 2018

Phase 4

NCT02894268 Sir Run Run Shaw Hospital Helicobacter Pylori Infection February 2016

Phase 4

NCT03465774 M.D. Anderson Cancer Center|National Cancer Institute (NCI) Malignant Pleural Effusion March 8, 2018

Early Phase 1

Chemical structure

Doxycycline-Hyclate

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

Proposal 18 Quality Consistency Evaluation projects which have approved 4, and 6 projects are under approving.

Quality management2

Advanced international quality management system has laid solid foundation for sales.

Quality management3

Quality supervision runs through the whole life cycle of the product to ensure the quality and therapeutic effect. 

Quality management4

Professional Regulatory Affairs team supports the quality demands during the application and registration.

PRODUCTION MANAGEMENT

cpf5
cpf6

Korea Countec Bottled Packaging Line

cpf7
cpf8

Taiwan CVC Bottled Packaging Line

cpf9
cpf10

Italy CAM Board Packaging Line

cpf11

German Fette Compacting Machine

cpf12

Japan Viswill Tablet Detector

cpf14-1

DCS Control Room

PARTNER

International cooperation
International cooperation
Domestic cooperation
Domestic cooperation

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