Azathioprine
Approved · FDA / EMAAlso known as 6-((1-Methyl-4-nitro-1H-imidazol-5-yl)thio)-1H-purine, 6-(1'-Methyl-4'-nitro-5'-imidazolyl)-mercaptopurine, Azamun, Azasan+4 more
6-((1-Methyl-4-nitro-1H-imidazol-5-yl)thio)-1H-purine, 6-(1'-Methyl-4'-nitro-5'-imidazolyl)-mercaptopurine, Azamun, Azasan, Imuran, Azatioprina, AzaTHIOprine Sodium, Azathioprinum.
Recent clinical, regulatory, research and industry developments relating to this drug.
Label change: AZATHIOPRINE (ANDA075568)
Utilization of a Cutaneous Therapy In Situ Microdevice
Haploidentical Donor Hematopoietic Cell Transplant for Sickle Cell Disease
The Genetics of Inflammatory Bowel Disease.
Label change: AZATHIOPRINE (ANDA075568)
Label change: AZATHIOPRINE (ANDA075568)
Profile
Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.
Pharmacology & targets
Known molecular targets and mechanisms supported by curated pharmacology databases.
Regulatory timeline
The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.
Indication: Jayempi is indicated in combination with other immunosuppressive agents for the prophylaxis of transplant rejection in patients receiving allogenic kidney, liver, heart, lung or… Show full indicationShow less
Jayempi is indicated in combination with other immunosuppressive agents for the prophylaxis of transplant rejection in patients receiving allogenic kidney, liver, heart, lung or pancreas transplants. Azathioprine is indicated in immunosuppressive regimens as an adjunct to immunosuppressive agents that form the mainstay of treatment (basis immunosuppression). Jayempi is used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and/ or procedures which influence the immune response. Jayempi is indicated in patients who are intolerant to glucocorticosteroids or if the therapeutic response is inadequate despite treatment with high doses of glucocorticosteroids, in the following diseases: severe active rheumatoid arthritis (chronic polyarthritis) that cannot be kept under control by less toxic agents (disease-modifying anti-rheumatic -medicinal products – DMARDs) auto-immune hepatitis systemic lupus erythematosus dermatomyositis polyarteritis nodosa pemphigus vulgaris and bullous pemphigoid Behçet’s disease refractory auto-immune haemolytic anaemia, caused by warm IgG antibodies chronic refractory idiopathic thrombocytopenic purpura Jayempi is used for the treatment of moderately severe to severe forms of chronic inflammatory bowel disease (IBD) (Crohn’s disease or ulcerative colitis) in patients in whom glucocorticosteroid therapy is necessary, but where glucocorticosteroids are not tolerated, or in whom the disease is untreatable with other common means of first choice. It is also indicated in adult patients in relapsing multiple sclerosis, if an immunomodulatory therapy is indicated but beta interferon therapy is not possible, or a stable course has been achieved with previous treatment with azathioprine. 3 Jayempi is indicated for the treatment of generalised myasthenia gravis. Depending on the severity of the disease, Jayempi should be given in combination with glucocorticosteroids because of slow onset of action at the beginning of treatment and the glucocorticosteroid dose should be gradually reduced after several months of treatment.
Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).
Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.
Clinical trials
The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.
Late-stage studies
Phase III+ trials still open or recently active — where late-stage evidence is being generated.
Utilization of a Cutaneous Therapy In Situ Microdevice
Recent completions
Trials that read out recently, adding to the completed evidence base.
Research activity
Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.
Major research themes3
Journals, researchers & institutions
- Molecular diagnosis & therapy1
- El Hadad J1
- Greuter T1
- Schreiner P1
- Vavricka SR1
- Center for Gastroenterology and Hepatology1
- GZO Zurich Regional Health Center1
- Medical University of Vienna1
- Triemli Hospital1
- University Hospital Lausanne-CHUV1
- University Hospital Zurich1
- RxNorm (U.S. National Library of Medicine) — drug identity
- ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
- Europe PMC — research literature
- ClinicalTrials.gov — clinical trials
- Regulatory event sources are credited in the Regulatory Timeline above.