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Drug

Azathioprine

Approved · FDA / EMA
ClassAmidophosphoribosyltransferase inhibitorEmerging researchLate-stage development
Also 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.

1
Research papers
17
Active clinical trials
Amidophosphoribosyltransferase
Primary target
13
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

Clinical trial2026-07-09Results expected Q1 2028 · ClinicalTrials.gov

Utilization of a Cutaneous Therapy In Situ Microdevice

Clinical trial2026-06-03Results expected Q2 2030 · ClinicalTrials.gov

Haploidentical Donor Hematopoietic Cell Transplant for Sickle Cell Disease

Clinical trial2026-06-01Results expected Q3 2034 · ClinicalTrials.gov

The Genetics of Inflammatory Bowel Disease.

Research2023-10-17Molecular diagnosis & therapy

Approval: Jayempi (EMA)

Regulatory2021-06-21EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Azathioprine
Aliases & brands
6-((1-Methyl-4-nitro-1H-imidazol-5-yl)thio)-1H-purine6-(1'-Methyl-4'-nitro-5'-imidazolyl)-mercaptopurineAzamunAzasanImuranAzatioprinaAzaTHIOprine SodiumAzathioprinum
RxNorm CUI
1256
ChEMBL ID
CHEMBL1542
ATC codes
L04AX01
UNII
MRK240IY2L
Primary mechanism
Amidophosphoribosyltransferase inhibitor
Regulatory jurisdictions
emafda

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

INHIBITORAmidophosphoribosyltransferase inhibitor

Regulatory timeline

13 events

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.

Earliest approval
1999-12-13
Latest approval
2021-06-21
Authorities
FDA · EMA
Total events
13
fdaU.S. Food and Drug Administration· 12 events
2026-07-16Label change
Label change: AZATHIOPRINE (ANDA075568)
Evidence ↗
2019-04-23Label change
Label change: AZATHIOPRINE (ANDA075568)
Evidence ↗
2015-05-29Label change
Label change: AZATHIOPRINE (ANDA075568)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2021-06-21Approval
Approval: Jayempi (EMA)
Indication: Jayempi is indicated in combination with other immunosuppressive agents for the prophylaxis of transplant rejection in patients receiving allogenic kidney, liver, heart, lung orShow full 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 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.

Evidence ↗

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

92 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
92
registered trials across all phases
LATEST COMPLETION 2025
17
Active studies
16
Recruiting
69
Late-stage (III+)
39
Completed
36
Discontinued
PHASE DISTRIBUTIONn = 92
Early Phase 12Phase 12Phase 1 / 21Phase 218Phase 2 / 33Phase 329Phase 427Phase N / A10

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

The Genetics of Inflammatory Bowel Disease.

Molecular diagnosis & therapy · 2024 · 69 cites
Recent papers

The Genetics of Inflammatory Bowel Disease.

Molecular diagnosis & therapy · 2024 · 69 cites
Major research themes3
Colitis, Ulcerative1Crohn Disease1Inflammatory Bowel Diseases1
Journals, researchers & institutions
Top journals
  • Molecular diagnosis & therapy1
Leading researchers
  • El Hadad J1
  • Greuter T1
  • Schreiner P1
  • Vavricka SR1
Leading institutions
free-text, unnormalised
  • Center for Gastroenterology and Hepatology1
  • GZO Zurich Regional Health Center1
  • Medical University of Vienna1
  • Triemli Hospital1
  • University Hospital Lausanne-CHUV1
  • University Hospital Zurich1
References & data sources
  • 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.