Imuran, Jayempi(azathioprine)
Azasan, Azathioprine, Imuran, Jayempi (azathioprine) is a small molecule pharmaceutical. Azathioprine was first approved as Imuran on 1982-01-01. It is used to treat crohn disease, multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus, and thrombocytopenic purpura idiopathic amongst others in the USA. It has been approved in Europe to treat graft rejection.
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Commercial
Therapeutic Areas
Trade Name
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Azasan, Azathioprine, Imuran (discontinued: Imuran)
Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Azathioprine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| IMURAN | Sebela Pharmaceuticals | N-016324 RX | 1982-01-01 | 1 products, RLD, RS |
Show 1 discontinued
Azathioprine sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| IMURAN | Casper Pharma | N-017391 DISCN | 1982-01-01 | 1 products, RLD |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| azasan | ANDA | 2025-03-03 |
| azathioprine | ANDA | 2025-08-14 |
| azathioprine sodium | ANDA | 2025-01-23 |
| imuran | New Drug Application | 2024-07-20 |
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Clinical
Clinical Trials
304 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Crohn disease | D003424 | EFO_0000384 | K50 | — | 3 | 14 | 14 | 23 | 54 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | — | 2 | 3 | 8 | 14 | 27 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | — | 1 | — | 1 | 4 | 18 | 24 |
| Systemic lupus erythematosus | D008180 | EFO_0002690 | M32 | 4 | 7 | 6 | 2 | 4 | 21 |
| Lupus nephritis | D008181 | EFO_0005761 | — | 1 | 6 | 8 | 2 | 4 | 20 |
| Nephritis | D009393 | — | N05 | 1 | 5 | 9 | 2 | 4 | 20 |
| Vasculitis | D014657 | EFO_0006803 | M31 | — | 6 | 9 | 3 | 2 | 19 |
| Colitis | D003092 | EFO_0003872 | K52.9 | — | 2 | 3 | 6 | 7 | 18 |
| Ulcer | D014456 | MPATH_579 | — | — | 2 | 3 | 4 | 6 | 15 |
| Granulomatosis with polyangiitis | D014890 | EFO_0005297 | M31.3 | — | 2 | 11 | 1 | — | 13 |
Show 57 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pulmonary fibrosis | D011658 | — | J84.10 | 1 | 3 | 3 | — | 2 | 7 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 3 | — | 1 | — | 2 | 6 |
| Fibrosis | D005355 | — | — | 1 | 2 | 2 | — | 2 | 6 |
| Renal insufficiency | D051437 | — | N19 | 2 | — | 2 | — | 1 | 5 |
| Idiopathic pulmonary fibrosis | D054990 | — | J84.112 | 1 | 2 | 1 | — | 2 | 5 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | — | 2 | — | 2 | 4 |
| Chronic renal insufficiency | D051436 | — | N18 | — | 1 | 1 | — | 2 | 4 |
| Inflammation | D007249 | MP_0001845 | — | — | — | 2 | — | 2 | 4 |
| Bronchiolitis obliterans syndrome | D000092122 | — | D89.811 | — | 1 | 2 | — | — | 3 |
| Eosinophilic granuloma | D004803 | — | C96.6 | — | — | 3 | — | — | 3 |
Show 22 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 1 | 2 | — | — | 1 | 4 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | — | 2 | — | — | 2 | 4 |
| Diffuse scleroderma | D045743 | EFO_0000404 | — | — | 2 | — | — | 2 | 4 |
| Connective tissue diseases | D003240 | EFO_1001986 | M35 | 1 | 2 | — | — | — | 3 |
| Skin diseases | D012871 | — | L00-L99 | — | 2 | — | — | — | 2 |
| Bullous pemphigoid | D010391 | EFO_0007187 | L12 | — | 2 | — | — | — | 2 |
| Eye diseases | D005128 | EFO_0003966 | H44 | — | 1 | — | — | — | 1 |
| Chronic urticaria | D000080223 | — | L50.8 | 1 | 1 | — | — | — | 1 |
| Urticaria | D014581 | EFO_0005531 | L50 | 1 | 1 | — | — | — | 1 |
| Iga vasculitis | D011695 | EFO_1000965 | D69.0 | — | 1 | — | — | — | 1 |
Show 18 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dermatitis | D003872 | — | L30.9 | 1 | — | — | — | 5 | 6 |
| Autoimmune diseases | D001327 | EFO_0000540 | M30-M36 | 1 | — | — | — | 3 | 4 |
| Therapeutic equivalency | D013810 | — | — | 1 | — | — | — | — | 1 |
| Cutaneous lupus erythematosus | D008178 | EFO_0003834 | L93.1 | 1 | — | — | — | — | 1 |
| Photosensitivity disorders | D010787 | — | L57.1 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | — | — | — | 4 | 4 |
| Sclerosis | D012598 | — | — | — | — | — | — | 3 | 3 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | — | — | — | 2 | 2 |
| Genetic polymorphism | D011110 | — | — | — | — | — | — | 2 | 2 |
| Choroidal neovascularization | D020256 | — | — | — | — | — | — | 1 | 1 |
| Uveomeningoencephalitic syndrome | D014607 | Orphanet_3437 | H20.82 | — | — | — | — | 1 | 1 |
| Squamous intraepithelial lesions | D000081483 | — | — | — | — | — | — | 1 | 1 |
| Retinal diseases | D012164 | — | H35.9 | — | — | — | — | 1 | 1 |
| Scleritis | D015423 | — | H15.0 | — | — | — | — | 1 | 1 |
| Lipidoses | D008064 | — | E75.6 | — | — | — | — | 1 | 1 |
Show 21 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Azathioprine |
| INN | azathioprine |
| Description | Azathioprine is a thiopurine that is 6-mercaptopurine in which the mercapto hydrogen is replaced by a 1-methyl-4-nitroimidazol-5-yl group. It is a prodrug for mercaptopurine and is used as an immunosuppressant, prescribed for the treatment of inflammatory conditions and after organ transplantation and also for treatment of Crohn's didease and MS. It has a role as an antineoplastic agent, an antimetabolite, an immunosuppressive agent, a prodrug, a carcinogenic agent, a DNA synthesis inhibitor and a hepatotoxic agent. It is a thiopurine, a C-nitro compound, a member of imidazoles and an aryl sulfide. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Cn1cnc([N+](=O)[O-])c1Sc1ncnc2[nH]cnc12 |
Identifiers
| PDB | — |
| CAS-ID | 446-86-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1542 |
| ChEBI ID | 2948 |
| PubChem CID | 2265 |
| DrugBank | DB00993 |
| UNII ID | MRK240IY2L (ChemIDplus, GSRS) |
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Azathioprine
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Safety
Black-box Warning
Black-box warning for: Azasan, Azathioprine, Imuran
Adverse Events
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41,164 adverse events reported
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