Azathioprine
Small molecule targets PPAT via inhibition
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Jayempi | — | 2021-06-21 | europa.eu ↗ |
| Label expansion | US (FDA) | IMURAN | — | 1981-04-13 | fda.gov ↗ |
| Approved | US (FDA) | IMURAN | — | 1968-03-20 | fda.gov ↗ |
Trials 69 · started per year
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2018-02-17 | Celltrion | Results CT-P13 (biosimilar infliximab) is comparable to reference infliximab and adalimumab in highly anticipated real-world UK-wide study celltrion.com ↗
According to the study, immunogenicity is a significant factor in non-remission for both infliximab and adalimumab at week 54 but can be mitigated by the use of immunomodulators, azathioprine, mercaptopurine and methotrexate. |
| 2003-12-29 | BioMarin Pharmaceutical | Results PNAS Study from BioMarin Highlights Possible New Approach for Improving the Efficacy of Enzyme and Protein Replacement Therapies biomarin.com ↗
The immunosuppressive regimen required to induce tolerance was comprised of high doses of one common immunosuppressive drug, cyclosporin A, combined with azathioprine, for several weeks during initial exposure to the enzyme |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2018-02-17 | Celltrion | CT-P13 (biosimilar infliximab) is comparable to reference infliximab and adalimumab in highly anticipated real-world UK-wide study celltrion.com ↗ |
| 2003-12-29 | BioMarin Pharmaceutical | PNAS Study from BioMarin Highlights Possible New Approach for Improving the Efficacy of Enzyme and Protein Replacement Therapies biomarin.com ↗ |
Evidence & citations 28 cited values
Every value below carries the sentence it was read from. 216 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Azathioprine | “Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressive...” NCT02885610 ↗194“At 6 months after randomization, patients who receive add-on cyclophosphamide will switch to azathioprine as a maintenance therapy and those who receive corticosteroids alone...” NCT03468972 ↗ “Standard of Care Therapy. Eligible patients should be on a maintenance regimen of immunosuppressive agents including tacrolimus, a second agent such as but not limited to MMF...” NCT03657342 ↗ “As specified in the protocol, one of the following drugs at a stable dose is required as monotherapy for baseline treatment during the double-blind period: azathioprine (AZA);...” NCT02028884 ↗ “Patients on corticosteroids (plus conventional therapy) will be randomized to receive anakinra (Kineret®), or one of the following: methotrexate, azathioprine, leflunomide,...” NCT01033656 ↗ “Hydroxyurea and azathioprine were administered for a 3 month period prior to the initiation of the transplant procedure in an effort to help prevent rejection of the donor product.” NCT00152113 ↗ “Immunosuppressive/immunomodulatory agents including but not limited to antimalarials (i.e. hydroxychloroquine), methotrexate, azathioprine and corticosteroids (i.e. prednisone)” NCT04809623 ↗ “The following DMARDs were permitted in this study: methotrexate (MTX), chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide.” NCT00531817 ↗ “Azathioprine is associated with enhanced skin photosensitivity to ultraviolet A (UVA) and leads to incorporation of 6-thioguanine (6-TG) into DNA of dividing cells.” PMID 21943390 ↗ Sep 2011 “Disease-modifying anti-rheumatic drugs included methotrexate, chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide.” NCT00720798 ↗ “After 3 months, Azathioprine (2 mg / kg / day) is initiated 2 weeks after the last administration of Cyclophosphamide and maintained for the next 21 months.” NCT05207358 ↗ |
| Known as | AZA | “BACKGROUND: We compared protection of mycophenolate mofetil (MMF) and azathioprine (AZA) against acute cellular rejection (ACR) and chronic allograft nephropathy (CAN) in...” PMID 34166370 ↗ Jun 202133“Immunosuppressives, e.g. azathioprine (AZA) and 6-mercaptopurine (6-MP), are important in induction of remission and long term treatment of (ulcerative) colitis and Crohn's...” NCT00521950 ↗ “BACKGROUND: Retrospective studies suggest that for patients with ulcerative colitis (UC) combination therapy with low-dose azathioprine and allopurinol (L-AZA/ALLO) may result...” PMID 35274092 ↗ Mar 2022 “Eligible patients were randomly assigned to receive infliximab (IFX) and azathioprine (AZA) with a 7-day steroid tapering scheme (IFX+AZA arm) or AZA and conventional...” PMID 39586616 ↗ Jan 2025 “Efficacy and myelosuppression of azathioprine/6-mercaptopurine (AZA/6-MP) are correlated with the metabolite 6-thioguanine, while the metabolite 6-methylmercaptopurine...” PMID 36730289 ↗ Feb 2023 “Ulcerative colitis patients treated with Infliximab (IFX) in deep remission after at least 12 months of treatment will be randomized to continue IFX or to stop IFX and start...” NCT03151525 ↗ “OBJECTIVE: To report the 10-year follow-up of the MAINTAIN Nephritis Trial comparing azathioprine (AZA) and mycophenolate mofetil (MMF) as maintenance therapy of proliferative...” PMID 25757867 ↗ Mar 2015 “The drugs that are often used to treat lupus nephritis include prednisone (steroids), cyclophosphamide (Cytoxan), azathioprine (AZA or Imuran), and mycophenolate mofetil (MMF...” NCT00447265 ↗ “To compare the efficacy and safety of enteric-coated mycophenolate sodium (EC-MPS) versus azathioprine (AZA) in patients with active systemic lupus erythematosus (SLE) disease.” PMID 28450313 ↗ Apr 2017 “The purpose of this study is to determine whether a top-down treatment approach, prescribing infliximab (IFX) and azathioprine (AZA) at diagnose, yields better outcome” NCT02517684 ↗ “Azathioprine (AZA), a pro-drug metabolised to the active metabolites 6-tioguanine nucleotides (6TGN), is a steroid-sparing therapy for Crohn's disease (CD).” PMID 24237037 ↗ Nov 2013 |
| Known as | Azamune | ChEMBL registry synonym — accepted as the source's own label CHEMBL1542 ↗ |
| Known as | Azapress | ChEMBL registry synonym — accepted as the source's own label CHEMBL1542 ↗ |
| Known as | Azasan | ChEMBL registry synonym — accepted as the source's own label CHEMBL1542 ↗ |
| Known as | Azathioprin | “2. Hydroxychloroquine according to body weight, patients who develop hypersensitivity will be shifted to Azathioprin.” NCT03289403 ↗2“Pleon RA®), Hydroxychloroquine (e.g. Quensyl®); Azathioprin, Methotrexate” NCT02779114 ↗ |
| Known as | azathioprine (Imuran) | “azathioprine (Imuran)” NCT00132691 ↗ |
| Known as | Azathioprine = brand name = Imurel | “Azathioprine = brand name = Imurel” NCT00546546 ↗ |
| Known as | AZATHIOPRINE SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL1542 ↗ |
| Known as | Azathioprine sodium salt | ChEMBL registry synonym — accepted as the source's own label CHEMBL1542 ↗ |
| Known as | Azathioprine: Imurek (R) 50 mg and 25 mg tablets | “Azathioprine: Imurek (R) 50 mg and 25 mg tablets” NCT00849368 ↗ |
| Known as | Azathioprinum | ChEMBL registry synonym — accepted as the source's own label CHEMBL1542 ↗ |
| Known as | Azatioprina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1542 ↗ |
| Known as | Berkaprine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1542 ↗ |
| Known as | BW-57-322 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1542 ↗ |
| Known as | Immunoprin 50 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1542 ↗ |
| Known as | Imuran | “The drugs that are often used to treat lupus nephritis include prednisone (steroids), cyclophosphamide (Cytoxan), azathioprine (AZA or Imuran), and mycophenolate mofetil (MMF...” NCT00447265 ↗6“the wild type use azathioprine(Imuran，2-2.5mg/kg/d),the CT genotype use half dose of azathioprine（Imuran，1-1.5mg/kg/d).” NCT02929706 ↗ “Budesonide (Budenofalk®), Prednisolone (Deltacortril®), Azathioprine (Imuran®)” NCT04921033 ↗ “Imuran (Azathioprine) Dose-Ranging Study in Crohn's Disease” NCT00098111 ↗ “azathioprine (Imuran)” NCT00132691 ↗ |
| Known as | Imuran injection | ChEMBL registry synonym — accepted as the source's own label CHEMBL1542 ↗ |
| Known as | Imurek | “2 mg per kg BW azathioprine sodium (Imurek®, GlaxoSmithKline, Munich, Germany) once daily” NCT00431119 ↗ |
| Known as | Imurel (Azathioprine) | “Imurel (Azathioprine)” NCT01564823 ↗ |
| Known as | Jayempi | ChEMBL registry synonym — accepted as the source's own label CHEMBL1542 ↗ |
| Known as | Kentaprine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1542 ↗ |
| Known as | NSC-39084 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1542 ↗ |
| Known as | Oprisine 50 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1542 ↗ |
| Action | Inhibit | “Amidophosphoribosyltransferase inhibitor” CHEMBL1542 ↗1“acts by inhibiting the T lymphocytes” NCT00189397 ↗ |
| Modality | Small molecule | “The thiopurines azathioprine and 6-mercaptopurine have longstanding merit in ulcerative colitis” PMID 40013523 ↗ Feb 2025 |
| Route | Oral | “2.5 mg of oral azathioprine per kilogram daily plus a placebo infusion” PMID 20393175 ↗ Apr 2010 |
| Target | PPAT | “Amidophosphoribosyltransferase inhibitor” CHEMBL1542 ↗ |