Azathioprine is documented in numerous clinical trials spanning Phase 1 through Phase 4 alongside non-interventional protocols, evaluating its efficacy in inflammatory bowel diseases, autoimmune hepatitis, systemic lupus erythematosus, uveitis, idiopathic pulmonary fibrosis, and transplant-related disorders. Sponsored by major academic medical centers and health organizations, including Hospices Civils de Lyon and the Institute of Liver and Biliary Sciences, this research portfolio encompasses completed, active, and currently enrolling studies.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07616154 | RECRUITING | Sickle Cell Disease |
St. Jude Children's Research Hospital |
2026-09 | PHASE2 |
| NCT07352566 | NOT_YET_RECRUITING | Psoriasis; Atopic Dermatitis |
University of California, San Francisco |
2026-08-01 | PHASE4 |
| NCT05584228 | NOT_YET_RECRUITING | Crohn Disease |
Nantes University Hospital |
2026-10-01 | |
| NCT07659353 | NOT_YET_RECRUITING | Chrohn's Disease |
University Hospital Schleswig-Holstein |
2026-08-01 | PHASE4 |
| NCT02939573 | RECRUITING | Primary Cutaneous Vasculitis; Cutaneous Polyarteritis Nodosa; IgA Vasculitis; Henoch-Schönlein Purpura |
University of Pennsylvania |
2017-01-01 | PHASE2 |
| NCT07619898 | NOT_YET_RECRUITING | Colitis; Hepatitis; Melanoma (Skin Cancer) |
Therakos LLC |
2026-07 | PHASE2 |
| NCT07424040 | NOT_YET_RECRUITING | Crohn's Diseases; Crohn's Disease in Pediatric Patient |
The Children's Hospital of Zhejiang University School of Medicine |
2026-03-01 | |
| NCT07718308 | NOT_YET_RECRUITING | Kidney Transplantation; Antibody-mediated Rejection |
wujianyong |
2026-07-15 | |
| NCT07235904 | RECRUITING | Ulcerative Colitis (UC) |
University Hospital Schleswig-Holstein |
2025-12-05 | PHASE4 |
| NCT03414502 | RECRUITING | Rheumatoid Arthritis |
University of Nebraska |
2007-12-10 | PHASE3 |
| NCT07138898 | RECRUITING | Rheumatic Disease |
NYU Langone Health |
2025-12-12 | PHASE2 |
| NCT04654988 | RECRUITING | Myocarditis; Heart Failure; Endomyocardial Biopsy; Cardiomyopathies, Secondary; Immunosuppression |
Medical University of Warsaw |
2022-12-01 | PHASE4 |
| NCT06941376 | RECRUITING | Relapsing Polychondritis |
University of Pennsylvania |
2025-11-11 | PHASE2 |
| NCT04469842 | RECRUITING | Lung Transplant; Complications |
Vanderbilt University Medical Center |
2023-12-01 | EARLY_PHASE1 |
| NCT07769333 | NOT_YET_RECRUITING | Pemphigus Vulgaris; Rituximab (RTx) |
Khyber Teaching Hospital |
2026-12-02 | EARLY_PHASE1 |
| NCT07168161 | RECRUITING | ANCA Associated Vasculitis (AAV) |
Staidson (Beijing) Biopharmaceuticals Co., Ltd |
2025-11-10 | PHASE3 |
| NCT05545384 | RECRUITING | Acute Demyelinating Syndrome; Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease |
Assistance Publique - Hôpitaux de Paris |
2025-06-23 | PHASE3 |
| NCT05349006 | RECRUITING | Central Nervous System Inflammation; MOG-IgG Associated Disease |
Hospices Civils de Lyon |
2023-12-12 | PHASE3 |
| NCT05040464 | RECRUITING | Crohn Disease; Azathioprine; Methotrexate |
Centre Hospitalier Universitaire, Amiens |
2021-08-26 | PHASE3 |
| NCT04362293 | ACTIVE_NOT_RECRUITING | Sickle Cell Disease |
St. Jude Children's Research Hospital |
2020-04-30 | PHASE2 |
| NCT05813860 | NOT_YET_RECRUITING | Crohn Disease; Infliximab |
Sixth Affiliated Hospital, Sun Yat-sen University |
2023-04-30 | PHASE4 |
| NCT06650124 | NOT_YET_RECRUITING | Autoimmune Hepatitis |
Institute of Liver and Biliary Sciences, India |
2024-11-01 | PHASE2; PHASE3 |
| NCT05965284 | RECRUITING | ANCA-associated Vasculitis; Maintenance Therapy |
Chinese SLE Treatment And Research Group |
2023-03-09 | PHASE4 |
| NCT06476366 | COMPLETED | Chronic Actinic Dermatitis |
Pak Emirates Military Hospital |
2024-07-14 | EARLY_PHASE1 |
| NCT05030155 | ACTIVE_NOT_RECRUITING | Eosinophilic Granulomatosis With Polyangiitis |
Assistance Publique - Hôpitaux de Paris |
2022-05-30 | PHASE3 |
| NCT07044141 | ACTIVE_NOT_RECRUITING | Vitiligo |
Lahore General Hospital |
2025-03-01 | PHASE1 |
| NCT05237323 | COMPLETED | Lymphocytic Myocarditis (Disorder); Heart Failure; Dilated Cardiomyopathy; Cardiomyopathies; Sudden Cardiac Death |
I.M. Sechenov First Moscow State Medical University |
2020-10-01 | PHASE3 |
| NCT06213857 | RECRUITING | Ulcerative Colitis |
Tanta University |
2025-02-01 | PHASE2 |
| NCT05969730 | COMPLETED | Atopic Dermatitis |
Mazandaran University of Medical Sciences |
2023-08-15 | |
| NCT04737343 | UNKNOWN | ANCA Associated Vasculitis; Maintenance Therapy |
Chinese SLE Treatment And Research Group |
2021-06-30 | |
| NCT03164473 | COMPLETED | Eosinophilic Granulomatosis With Polyangiitis |
Assistance Publique - Hôpitaux de Paris |
2018-03-07 | PHASE3 |
| NCT04660539 | COMPLETED | Neuromyelitis Optica Spectrum Disorder |
Hoffmann-La Roche |
2021-03-02 | PHASE3 |
| NCT06066957 | Recruiting | Cytomegalovirus Infections|Transplant-Related Disorder |
University of Pennsylvania|Merck Sharp & Dohme LLC |
2024-04-04 | Phase 2 |
| NCT02332356 | UNKNOWN | Crohn Disease |
Tokyo Medical and Dental University |
2014-09 | PHASE3 |
| NCT04773392 | TERMINATED | Kidney Transplantation; Kidney Transplant Rejection |
University of Southern California |
2021-11-23 | PHASE4 |
| NCT05861297 | UNKNOWN | Immune Thrombocytopenia Purpura |
Nahda University |
2020-05-05 | PHASE4 |
| NCT03770663 | UNKNOWN | Antisynthetase Syndrome (ASS); Interstitial Lung Disease |
Assistance Publique - Hôpitaux de Paris |
2021-02-05 | PHASE3 |
| NCT04713631 | UNKNOWN | Crohn's Disease |
Sanjay Gandhi Postgraduate Institute of Medical Sciences |
2021-01-21 | PHASE2 |
| NCT04371718 | UNKNOWN | Autoimmune Hepatitis |
TaiwanJ Pharmaceuticals Co., Ltd |
2020-11 | PHASE2 |
| NCT04160325 | UNKNOWN | Crohn Disease |
Zhu Weiming |
2018-01-01 | |
| NCT05263505 | TERMINATED | Mucous Membrane Pemphigoid; Cicatrizing Conjunctivitis |
Washington University School of Medicine |
2022-02-21 | PHASE2 |
| NCT05859191 | Recruiting | Systemic Lupus Erythematosus|Physiopathology |
University Hospital Tours|Research Center for Respiratory Diseases Inserm U1100 |
2023-07-21 | -- |
| NCT02900443 | UNKNOWN | Autoimmune Hepatitis |
Radboud University Medical Center |
2017-01 | PHASE4 |
| NCT06786689 | COMPLETED | Alopecia Areata; Alopecia Areata(AA) |
Sheikh Zayed Medical College |
2023-03-01 | PHASE2 |
| NCT05994716 | Enrolling by invitation | Inflammatory Bowel Diseases|Crohn Disease|Ulcerative Colitis |
Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department|Sechenov University |
2023-04-25 | Not Applicable |
| NCT05349006 | Not yet recruiting | Central Nervous System Inflammation|MOG-IgG Associated Disease |
Hospices Civils de Lyon |
2023-01-01 | Phase 3 |
| NCT05896605 | COMPLETED | NMO Spectrum Disorder; Azathioprine Adverse Reaction |
First Affiliated Hospital of Guangxi Medical University |
2020-01-01 | PHASE4 |
| NCT04761952 | UNKNOWN | Inflammatory Bowel Diseases; Crohn Disease; Polyunsaturated Acid Lipidosis |
Sixth Affiliated Hospital, Sun Yat-sen University |
2021-02-13 | |
| NCT05321485 | UNKNOWN | Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis |
Maxima Medical Center |
2022-03-16 | |
| NCT04882683 | UNKNOWN | Ulcerative Colitis |
Shandong Qilu Stem Cells Engineering Co., Ltd. |
2021-06-01 | |
| NCT02425852 | COMPLETED | Ulcerative Colitis |
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives |
2016-12 | PHASE4 |
| NCT05370690 | Unknown status | Uveitis |
University Hospital Brest |
2022-05-01 | -- |
| NCT04933292 | UNKNOWN | Autoimmune Hepatitis; Primary Biliary Cirrhosis |
Xiaoli Fan |
2021-06-16 | PHASE4 |
| NCT03789006 | UNKNOWN | Kidney Transplant Rejection |
University of Khartoum |
2018-03-21 | PHASE4 |
| NCT05321485 | Unknown status | Inflammatory Bowel Diseases|Crohn Disease|Ulcerative Colitis |
Maxima Medical Center |
2022-03-16 | Not Applicable |
| NCT02498977 | TERMINATED | Transplantation, Liver |
King's College London |
2015-10 | PHASE4 |
| NCT06846255 | COMPLETED | Pemphigus Vulgaris |
Jinnah Postgraduate Medical Centre |
2021-06-15 | PHASE4 |
| NCT01727193 | COMPLETED | Myasthenia Gravis |
First Affiliated Hospital, Sun Yat-Sen University |
2012-09 | PHASE3 |
| NCT02852694 | COMPLETED | Crohn's Disease |
PIBD-Net |
2017-02-28 | PHASE4 |
| NCT02177071 | COMPLETED | Crohn's Disease |
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives |
2015-10-09 | PHASE4 |
| NCT03760003 | COMPLETED | Ulcerative Colitis |
Abivax S.A. |
2019-08-13 | PHASE2 |
| NCT02936375 | UNKNOWN | Lupus Nephritis |
RenJi Hospital |
2017-09-07 | PHASE2 |
| NCT02598596 | COMPLETED | Gout |
Ampel BioSolutions, LLC |
2015-12 | PHASE2 |
| NCT03026907 | UNKNOWN | Hand Eczema |
University Medical Center Groningen |
2016-05 | PHASE3 |
| NCT02517684 | COMPLETED | Crohn's Disease |
Erasmus Medical Center |
2015-04 | PHASE4 |
| NCT03101800 | UNKNOWN | Colitis, Ulcerative; Colitis Ulcerative Exacerbation |
Hvidovre University Hospital |
2016-12-14 | PHASE3 |
| NCT03151525 | UNKNOWN | Colitis, Ulcerative |
Istituto Clinico Humanitas |
2017-05-08 | PHASE4 |
| NCT02994927 | COMPLETED | ANCA-Associated Vasculitis |
Amgen |
2017-03-15 | PHASE3 |
| NCT03350633 | COMPLETED | Neuromyelitis Optica Spectrum Disorders; Neuromyelitis Optica |
Tianjin Medical University General Hospital |
2017-11-01 | PHASE2; PHASE3 |
| NCT03449758 | COMPLETED | Rheumatoid Arthritis |
Sanofi |
2018-03-05 | PHASE4 |
| NCT03498703 | COMPLETED | Recurrent Implantation Failure; In Vitro Fertilization; Intracytoplsmic Sperm Injection |
Ain Shams University |
2018-04-25 | PHASE2 |
| NCT03580876 | UNKNOWN | Clinical Failure After Switch |
Védrines, Philippe, M.D. |
2018-07-23 | PHASE4 |
| NCT03930264 | COMPLETED | Therapeutic Equivalency |
Nova Laboratories Limited |
2019-04-11 | PHASE1 |
| NCT03370601 | TERMINATED | Inflammatory Bowel Diseases |
University Hospital, Lille |
2017-01-03 | |
| NCT02444728 | TERMINATED | Thrombocytopenia |
Chinese SLE Treatment And Research Group |
2015-07 | PHASE3 |
| NCT02579733 | TERMINATED | Ulcerative Colitis |
Kyungpook National University Hospital |
2016-02-01 | PHASE4 |
| NCT01697267 | COMPLETED | Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Microscopic Polyangiitis; Wegener Granulomatosis |
Cambridge University Hospitals NHS Foundation Trust |
2013-04 | PHASE3 |
| NCT03393247 | UNKNOWN | Crohn Disease |
Sixth Affiliated Hospital, Sun Yat-sen University |
2017-06-01 | |
| NCT03229746 | COMPLETED | Immune Thrombocytopenia |
Assiut University |
2017-08-01 | PHASE4 |
| NCT01172002 | UNKNOWN | Nephritis; Lupus |
RenJi Hospital |
2010-03 | |
| NCT02929706 | UNKNOWN | Thiopurine-induced Leukopenia |
Sixth Affiliated Hospital, Sun Yat-sen University |
2016-07 | |
| NCT02789397 | WITHDRAWN | Granulomatous and Lymphocytic Interstitial Lung Disease |
Medical College of Wisconsin |
2016-05-02 | PHASE2 |
| NCT02413047 | TERMINATED | Inflammatory Bowel Disease; Ulcerative Colitis; Crohn's Disease |
Indiana University |
2015-05 | |
| NCT03185611 | UNKNOWN | Crohn Disease |
Sixth Affiliated Hospital, Sun Yat-sen University |
2017-05-18 | PHASE3 |
| NCT02281799 | WITHDRAWN | Pancreatitis; Inflammatory Bowel Diseases |
Shaare Zedek Medical Center |
2015-03 | PHASE4 |
| NCT03250143 | COMPLETED | Chronic Refractory Urticaria |
Post Graduate Institute of Medical Education and Research, Chandigarh |
2016-12-06 | PHASE1; PHASE2 |
| NCT02998827 | UNKNOWN | Crohn Disease |
Sixth Affiliated Hospital, Sun Yat-sen University |
2016-11 | |
| NCT00987116 | COMPLETED | Myasthenia Gravis |
Assistance Publique - Hôpitaux de Paris |
2009-06 | PHASE4 |
| NCT02723786 | TERMINATED | Kidney Transplantation (Status Post) |
GlaxoSmithKline |
2016-08-27 | PHASE2 |
| NCT01663623 | COMPLETED | Vasculitis |
Human Genome Sciences Inc., a GSK Company |
2013-03-20 | PHASE3 |
| NCT02949349 | COMPLETED | Lupus Nephritis |
Genovate Biotechnology Co., Ltd., |
2015-07 | PHASE2 |
| NCT02645565 | COMPLETED | Lupus Nephritis |
Jawaharlal Institute of Postgraduate Medical Education & Research |
2015-12 | PHASE4 |
| NCT01235689 | COMPLETED | Crohn's Disease |
AbbVie (prior sponsor, Abbott) |
2011-02-11 | PHASE3 |
| NCT03002038 | COMPLETED | Neuromyelitis Optica Spectrum Disorder |
Isfahan University of Medical Sciences |
2015-09 | PHASE2; PHASE3 |
| NCT01941095 | COMPLETED | Rheumatoid Arthritis |
Hoffmann-La Roche |
2013-11-20 | PHASE3 |
| NCT00494741 | COMPLETED | Kidney Transplant |
Mario Negri Institute for Pharmacological Research |
2007-05 | PHASE4 |
| NCT02493465 | UNKNOWN | Left Ventricular Hypertrophy |
Instituto de Urologia e Nefrologia |
2015-07 | PHASE4 |
| NCT01284725 | COMPLETED | Nephritis of Lupus |
Assistance Publique Hopitaux De Marseille |
2011-02-16 | PHASE3 |
| NCT01802593 | TERMINATED | Crohn's Disease |
Prof. Arie Levine |
2013-02 | PHASE4 |
| NCT01112215 | COMPLETED | Systemic Lupus Erythematosus |
Hospital Universitari Vall d'Hebron Research Institute |
2009-12 | PHASE4 |
| NCT01877746 | UNKNOWN | Inflammatory Cardiomyopathy |
St. Anne's University Hospital Brno, Czech Republic |
2013-01 | PHASE3 |
| NCT02463331 | COMPLETED | Autoimmune Hepatitis |
University of Sao Paulo General Hospital |
2003-05 | PHASE4 |
| NCT00647166 | COMPLETED | MPA; PAN or EGPA With FFS=0; At Diagnosis or Within the First 15 Days Following Initiation of Corticosteroids |
Assistance Publique - Hôpitaux de Paris |
2008-05 | PHASE3 |
| NCT01564823 | COMPLETED | Crohn´s Disease |
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa |
2012-06 | PHASE3 |
| NCT01880307 | TERMINATED | Crohn's Disease |
Erasmus Medical Center |
2013-01 | PHASE4 |
| NCT01817972 | UNKNOWN | Crohn's Disease |
Gastroenterology Research of America |
2013-03 | PHASE3 |
| NCT00128895 | TERMINATED | Vasculitis |
University Medical Center Groningen |
2003-06 | PHASE4 |
| NCT02247258 | TERMINATED | Crohn Disease; Recurrence; Azathioprine; Prevention |
Universitaire Ziekenhuizen KU Leuven |
2005-10 | PHASE2 |
| NCT03189888 | COMPLETED | Ulcerative Colitis |
Valduce Hospital |
2013-01 | |
| NCT00650091 | COMPLETED | Pulmonary Fibrosis |
Duke University |
2009-10 | PHASE3 |
| NCT01823042 | UNKNOWN | Crohn's Disease |
Jinling Hospital, China |
2012-10 | |
| NCT01015391 | UNKNOWN | Crohn's Disease |
Jinling Hospital, China |
2009-11 | |
| NCT01056237 | COMPLETED | Lupus Nephritis |
Zhi-Hong Liu, M.D. |
2010-02 | |
| NCT01957423 | COMPLETED | Crohn's Disease |
University of Campinas, Brazil |
2012-03 | |
| NCT00748644 | COMPLETED | Wegener Granulomatosis; Microscopic Polyangiitis |
Assistance Publique - Hôpitaux de Paris |
2008-10 | PHASE3 |
| NCT00546546 | COMPLETED | Crohn's Disease |
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives |
2005-07 | PHASE4 |
| NCT00768729 | COMPLETED | Kidney Failure, Chronic; Kidney Transplantation; Immunosuppression |
National Institute of Allergy and Infectious Diseases (NIAID) |
2009-05 | PHASE1 |
| NCT00774852 | COMPLETED | Lupus Nephritis; Lupus Erythematosus, Systemic |
National Institute of Allergy and Infectious Diseases (NIAID) |
2008-11 | PHASE2 |
| NCT01446211 | TERMINATED | Wegeners Granulomatosis |
Nordic Pharma SAS |
2011-11 | PHASE3 |
| NCT00741338 | COMPLETED | Mucopolysaccharidosis I |
Genzyme, a Sanofi Company |
2008-09 | PHASE1; PHASE2 |
| NCT01559142 | UNKNOWN | Crohn Disease |
Children's Memorial Health Institute, Poland |
2008-11 | PHASE3 |
| NCT00984568 | TERMINATED | Colitis, Ulcerative |
Merck Sharp & Dohme LLC |
2009-11 | PHASE3 |
| NCT00521950 | COMPLETED | Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis |
ZonMw: The Netherlands Organisation for Health Research and Development |
2007-09 | |
| NCT00849368 | COMPLETED | Inflammatory Bowel Disease |
University of Zurich |
2009-01 | PHASE1 |
| NCT00204022 | COMPLETED | Lupus Nephritis |
Frédéric A. Houssiau, MD, PhD |
2001-02 | PHASE3 |
| NCT00321906 | COMPLETED | Delayed Graft Function; Acute Graft Rejection |
University of Chicago |
2002-04 | PHASE4 |
| NCT00539838 | TERMINATED | Systemic Lupus Erythematosus |
Genentech, Inc. |
2007-12-19 | PHASE3 |
| NCT00656656 | COMPLETED | Pemphigus |
University of Luebeck |
2008-01 | PHASE2 |
| NCT00307671 | COMPLETED | Vasculitis; Wegener's Granulomatosis; Microscopic Polyangiitis; Churg-Strauss Syndrome; Polyarteritis Nodosa |
Assistance Publique - Hôpitaux de Paris |
2005-07 | PHASE4 |
| NCT00997412 | UNKNOWN | Myasthenia Gravis |
Qualitix Clinical Research Co., Ltd. |
2009-05 | |
| NCT00866684 | TERMINATED | Skin Cancer |
Charite University, Berlin, Germany |
2007-01-01 | PHASE4 |
| NCT00976690 | COMPLETED | Crohn Disease |
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives |
2002-10 | PHASE3 |
| NCT00695344 | UNKNOWN | Cardiac Transplant |
Fundacion Investigacion y Desarrollo |
2006-01 | PHASE4 |
| NCT00377962 | COMPLETED | Disorder Related to Cardiac Transplantation |
Novartis Pharmaceuticals |
2005-12 | PHASE4 |
| NCT00537316 | TERMINATED | Ulcerative Colitis |
Merck Sharp & Dohme LLC |
2007-07 | PHASE3 |
| NCT00626197 | TERMINATED | Lupus Nephritis; Systemic Lupus Erythematosus |
Genentech, Inc. |
2008-02-15 | PHASE3 |
| NCT00170846 | COMPLETED | Renal Transplantation |
Novartis Pharmaceuticals |
2005-02 | PHASE4 |
| NCT00504244 | TERMINATED | Systemic Lupus Erythematosus |
Erasmus Medical Center |
2007-07 | PHASE3 |
| NCT00368264 | TERMINATED | Lupus Erythematosus, Systemic; Lupus Nephritis |
Medical University of Vienna |
2006-09 | PHASE2; PHASE3 |
| NCT00608894 | TERMINATED | Autoimmune Hepatitis |
Veloxis Pharmaceuticals |
2007-12 | PHASE2 |
| NCT00104299 | COMPLETED | Vasculitis; Wegener's Granulomatosis; Microscopic Polyangiitis |
National Institute of Allergy and Infectious Diseases (NIAID) |
2005-01 | PHASE2; PHASE3 |
| NCT00626678 | COMPLETED | Pemphigus Vulgaris |
Tehran University of Medical Sciences |
2008-01 | PHASE2 |
| NCT00615173 | COMPLETED | Kidney Diseases; Lupus Nephritis; Tacrolimus; Induction Phase; Maintenance Phase |
Sun Yat-sen University |
2006-07 | PHASE3 |
| NCT00359814 | COMPLETED | Heart Transplantation |
Hannover Medical School |
2004-11 | |
| NCT00425438 | TERMINATED | Lupus Nephritis |
Hoffmann-La Roche |
2007-03 | PHASE3 |
| NCT00094458 | COMPLETED | Crohn Disease |
Centocor Ortho Biotech Services, L.L.C. |
2005-03 | PHASE3 |
| NCT00113503 | TERMINATED | Crohn's Disease |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
2005-07 | PHASE2 |
| NCT00267189 | COMPLETED | Liver Transplantation |
Novartis Pharmaceuticals |
2005-11 | PHASE3 |
| NCT00098111 | TERMINATED | Crohn's Disease |
Massachusetts General Hospital |
2005-04 | PHASE3 |
| NCT00262405 | COMPLETED | Idiopathic Pulmonary Fibrosis |
University of Michigan |
2001-01 | PHASE2 |
| NCT00946946 | COMPLETED | Crohn's Disease |
Dr. Falk Pharma GmbH |
2002-02 | PHASE3 |
| NCT00377637 | COMPLETED | Lupus Nephritis |
Hoffmann-La Roche |
2005-07 | PHASE3 |
| NCT01392833 | COMPLETED | IgA Nephropathy; Chronic Kidney Disease |
A. Manzoni Hospital |
1999-12 | PHASE3 |
| NCT00753103 | COMPLETED | Wegener's Granulomatosis; Renal Limited Vasculitis; Microscopic Polyangiitis |
University Hospital Birmingham NHS Foundation Trust |
2003-01 | PHASE2 |
| NCT00189397 | COMPLETED | Parthenium Dermatitis |
All India Institute of Medical Sciences |
2003-02 | |
| NCT00796250 | TERMINATED | Crohn's Disease |
Merck Sharp & Dohme LLC |
2003-11-01 | PHASE3 |
| NCT00755859 | COMPLETED | IGA Nephropathy |
A. Manzoni Hospital |
1998-05 | PHASE4 |
| NCT00176059 | COMPLETED | Renal Failure, Chronic; Renal Transplantation |
University of Giessen |
2001-10 | EARLY_PHASE1 |
| NCT00230035 | WITHDRAWN | Systemic Lupus Erythematosus |
National Institute of Allergy and Infectious Diseases (NIAID) |
2005-09 | PHASE2 |
| NCT00461825 | COMPLETED | Kidney Transplantation |
Poitiers University Hospital |
1998-07 | PHASE3 |
| NCT00518310 | UNKNOWN | Idiopathic Pulmonary Fibrosis |
Thorax National Institute |
2005-05 | |
| NCT00336414 | WITHDRAWN | Systemic Lupus Erythematosus Nephritis |
Istituto Giannina Gaslini |
2006-06 | PHASE3 |
| NCT00307645 | TERMINATED | ANCA Associated Systemic Vasculitis Including Wegener's; Granulomatosis and Microscopic Polyangiitis and; Renal Limited Vasculitis |
Assistance Publique - Hôpitaux de Paris |
2003-05 | PHASE3 |
| NCT00349674 | UNKNOWN | Systemic Wegener's Granulomatosis |
Hospices Civils de Lyon |
1999-01 | PHASE3 |
| NCT00431119 | COMPLETED | Bullous Pemphigoid |
University Hospital Muenster |
1997-10 | PHASE2 |
| NCT00052039 | TERMINATED | Lung Disease; Pulmonary Fibrosis |
InterMune |
2002-04 | PHASE3 |
| NCT00400075 | UNKNOWN | Polyarteritis Nodosa; Microscopic Polyangiitis |
Hospices Civils de Lyon |
1996-07 | PHASE4 |
| NCT00268515 | COMPLETED | Lung Diseases |
National Heart, Lung, and Blood Institute (NHLBI) |
1998-04 | PHASE2 |
| NCT00399399 | UNKNOWN | Churg-Strauss Syndrome |
Hospices Civils de Lyon |
1996-07 | PHASE4 |
| NCT00554710 | COMPLETED | Crohn's Disease |
Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW |
2001-05 | PHASE4 |
(data from https://clinicaltrials.gov, updated on 2026-07-23)
Check the
Azathioprine
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.