| Drug ID: | Drug10 |
|---|---|
| Drug Name: | Azathioprine |
| CID: | 2265 |
| DrugBank ID: | DB00993 |
| Modality: | Small Molecule |
| Groups: | approved |
| US Approved: | YES |
| Other Approved: | YES |
| Identifier: | NCT03370601, , NCT02413047, , NCT06213857, , NCT02281799, , NCT03101800, , NCT04882683, , NCT03151525, , NCT00984568, , NCT02579733, , NCT01817972 |
| Molecular Formula: | C9H7N7O2S |
| Molecular Weight: | 277.27 g/mol |
| Isomeric SMILES: | CN1C=NC(=C1SC2=NC=NC3=C2NC=N3)[N+](=O)[O-] |
| Synonyms: | azathioprine; 446-86-6; Azothioprine; Azathioprin; Azamun; Azanin; Azatioprin; Azasan; Ccucol; Imurek |
| Phase 0: | 3 |
| Phase 1: | 7 |
| Phase 2: | 38 |
| Phase 3: | 59 |
| Phase 4: | 44 |
| Description: | An immunosuppressive antimetabolite pro-drug. It is an imidazolyl derivative of 6-mercaptopurine and many of its biological effects are similar to those of the parent compound. Azathioprine is converted into 6-mercaptopurine in the body where it blocks purine metabolism and DNA synthesis. |
Molecular Structure
Knowledge Graph
| dtID | CID | Compound Name | Gene ID | Gene Name | Species | PubMed IDs | Action |
|---|---|---|---|---|---|---|---|
| dt80 | 2265 | Azathioprine | 5243 | ABCB1 | Homo sapiens (human) | 17262810 | ABCB1 gene polymorphism affects the susceptibility to azathioprine |
| dt81 | 2265 | Azathioprine | 8647 | ABCB11 | Rattus norvegicus (Norway rat) | 27765674 | Azathioprine results in decreased expression of ABCB11 mRNA |
| dt82 | 2265 | Azathioprine | 5244 | ABCB4 | Rattus norvegicus (Norway rat) | 27765674 | Azathioprine results in increased expression of ABCB4 mRNA |
| dt83 | 2265 | Azathioprine | 1244 | ABCC2 | Homo sapiens (human) | 22623647 | Azathioprine results in increased expression of ABCC2 mRNA |
| dt84 | 2265 | Azathioprine | 1244 | ABCC2 | Rattus norvegicus (Norway rat) | 27765674 | Azathioprine results in increased expression of ABCC2 mRNA |
| dt85 | 2265 | Azathioprine | 8714 | ABCC3 | Rattus norvegicus (Norway rat) | 27765674 | Azathioprine results in increased expression of ABCC3 mRNA |
| dt86 | 2265 | Azathioprine | 10257 | ABCC4 | Rattus norvegicus (Norway rat) | 27765674 | Azathioprine results in increased expression of ABCC4 mRNA |
| dt87 | 2265 | Azathioprine | 9429 | ABCG2 | Rattus norvegicus (Norway rat) | 27765674 | Azathioprine results in decreased expression of ABCG2 mRNA |
| dt88 | 2265 | Azathioprine | 64240 | ABCG5 | Rattus norvegicus (Norway rat) | 27765674 | Azathioprine results in decreased expression of ABCG5 mRNA |
| dt89 | 2265 | Azathioprine | 63874 | ABHD4 | Homo sapiens (human) | 22623647 | Azathioprine results in increased expression of ABHD4 mRNA |
- No data available
Phase Distribution
Phase Description
- Phase 0: Exploratory trials to assess drug behavior in humans
- Phase 1: Safety trials to determine safe dosage range
- Phase 2: Efficacy trials to evaluate therapeutic effects
- Phase 3: Large-scale trials to confirm efficacy and safety
- Phase 4: Post-marketing surveillance for long-term safety and efficacy
| Trial ID | Title | Phase | Status | Sponsor | Indications | Interventions | |
|---|---|---|---|---|---|---|---|
| NCT04882683 | Clinical Study of Cord Blood Mononuclear Cells on Treatment of Hormone-resistant or Hormone-dependent Ulcerative Colitis | None | UNKNOWN | Shandong Qilu Stem Cells Engineering Co., Ltd. | Ulcerative Colitis | DRUG: Prednisone|DRUG: Azathioprine|DRUG: Adalimu… | Details |
| NCT03151525 | Two Therapeutic Strategies for the Maintenance of Remission in Patients With Ulcerative Colitis | PHASE4 | UNKNOWN | Istituto Clinico Humanitas | Colitis, Ulcerative | DRUG: Azathioprine|DRUG: Infliximab | Details |
| NCT00984568 | Conventional Step-Up Versus Infliximab Monotherapy in Patients With Ulcerative Colitis (P05553) | PHASE3 | TERMINATED | Merck Sharp & Dohme LLC | Colitis, Ulcerative | BIOLOGICAL: Infliximab|DRUG: Prednisolone|DRUG: 5… | Details |
| NCT00537316 | Efficacy & Safety of Infliximab Monotherapy Vs Combination Therapy Vs AZA Monotherapy in Ulcerative Colitis (Part 1) Maintenance Vs Intermittent Therapy for Maintaining Remission (Part 2)(Study P04807) | PHASE3 | TERMINATED | Merck Sharp & Dohme LLC | Ulcerative Colitis | BIOLOGICAL: Infliximab (IFX)|DRUG: Azathioprine (… | Details |
| NCT02579733 | Azathioprine Based on Endoscopy After Clinical Remission in Moderate to Severe Ulcerative Colitis | PHASE4 | TERMINATED | Kyungpook National University Hospital | Ulcerative Colitis | DRUG: Azathioprine|DRUG: Placebo | Details |
| NCT01817972 | Cimzia Versus Cimzia Plus Azathioprine in the Treatment of Active Crohn's Disease | PHASE3 | UNKNOWN | Gastroenterology Research of America | Crohn's Disease | BIOLOGICAL: Certolizumab pegol|DRUG: Azathioprine | Details |
| CTRI/2023/10/058514 | Evaluation of effectiveness and safety of oral tofacitinib in patients with Parthenium dermatitis: A prospective interventional open label study - NIL | Not Available | Not Recruiting | AIIMS, New Delhi | Health Condition 1: L237- Allergic contact dermat… | Intervention1: Oral Tofacitinib: Tofacitinib is a… | Details |
| ISRCTN95420128 | Subcutaneous CT-P13 monotherapy versus combination with immunomodulation when switching from intravenous infliximab in inflammatory bowel disease A multicentre, randomised withdrawal trial | PHASE4 | Recruiting | Kings Health Partners | Crohn's disease and ulcerative colitis Digestive… | The intervention is the withdrawal of immunomodul… | Details |
| NCT05456776 | Azathioprine Linked With Impaired Intestinal Epithelial Postoperative Regeneration in Crohn's Disease | Not Available | Not recruiting | Centre of Postgraduate Medical Education | None | None | Details |
| NCT04761952 | N-3 Polyunsaturated Fatty Acids Prevent Postoperative Recurrence of Crohn's Disease:a Prospective Randomized Controlled Trial | Not Available | Not recruiting | Sixth Affiliated Hospital, Sun Yat-sen University | Inflammatory Bowel Diseases;Crohn Disease;Polyuns… | Drug: azathioprine;Drug: infliximab;Drug: N-3 Pol… | Details |
| EUCTR2019-002942-19-DK | NORDTREAT_The Nordic IBD treatment strategy trial a randomized controlled trial of access to a protein profile_ | PHASE4 | Not Recruiting | Region ebro l | Crohn's disease and Ulcerative colitis MedDRA ve… | Trade Name: Remicade Infliximab Pharmaceutical Fo… | Details |
| DRKS00013246 | 6-TGN levels (azathioprine drug monitoring) and markers of mucosal healing in patients with inflammatory bowel disease | Not Available | Not Recruiting | MHH OE6810 | K50 K51;Crohn disease [regional enteritis];Ulcer… | Group 1: Patients with IBD and azathioprine monot… | Details |
| EUCTR2016-004112-35-SE | Low-dose azathioprine and allopurinol- versus azathioprine monotherapy in patients with Inflammatory Bowel Disease: An investigator-initiated, open, multicentre, parallel-arm, randomized controlled trial __A SOIBD (The Swedish Organisation for the study of Inflammatory Bowel Diseases) study __ | PHASE4 | Authorised | SOIBD (The Swedish Organisation for the study of Inflammatory Bowel Diseases) | Patients with inflammatory bowel diseae (Ulcerati… | Trade Name: Imurel Product Name: Azathioprine Pro… | Details |
| ChiCTR-OOC-17010617 | Study on the relationship between TPMT and NUDT15 gene polymorphism and azathioprine-induced adverse reactions in patients with inflammatory bowel disease | Not Available | Recruiting | Xiangya Hospital, Central South University | Inflammatory Bowel Disease | Two cohorts:azathioprine treatment; | Details |
| NCT02929706 | Effectiveness of Thiopurine Dose Optimization by NUDT 15 R139C on Reducing Thiopurine-induced Leucopenia in Inflammatory Bowel Disease | Not Available | Not recruiting | Sixth Affiliated Hospital, Sun Yat-sen University | Thiopurine-induced Leukopenia | Genetic: Pre-genotype NUDT15 and optimize azathio… | Details |
| EUCTR2016-000522-18-FR | Risk stratified randomized controlled trial in paediatric Crohn Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively a treatment strategy - REDUCE-RISKincd-PIBD-TRIAL | PHASE4 | Not Available | PIBDNet | Crohn disease;Therapeutic area: Diseases [C] - Di… | Product Name: humira Pharmaceutical Form: Solutio… | Details |
| ACTRN12613001347752 | A randomized controlled trial of patients with IBD attending specialist clinics comparing de novo combination allopurinol and thiopurine versus thiopurine and placebo (ie standard practice) in terms of objective and clinical outcomes at six months | PHASE3|PHASE4 | Recruiting | Eastern Health | Inflammatory Bowel Disease; Inflammatory Bowel D… | De novo combination therapy with allopurinol 100m… | Details |
| EUCTR2013-001503-37-DK | Effect of low-dose Azathioprine and Allopurinol compared to Azathioprine on clinical outcomes in Inflammatory Bowel Disease | PHASE3 | Not Recruiting | Marianne Kiszka-Kanowitz | Inflammatory Bowel Disease, (Ulcerativ colitis, C… | Trade Name: Imurel Pharmaceutical Form: Tablet IN… | Details |
| ACTRN12611000363987 | The Triple A (Adjunctive Allopurinol and Azathioprine) Study: Use of Ajunctive Allopurinol in Azathioprine/6-Mercaptopurine Non-responders to Optimize 6-Thioguanine Nucleotide Production and Improve Clinical Outcomes in Patients with Inflammatory Bowel Disease (IBD). | PHASE3|PHASE4 | Not Recruiting | The Alfred Hospital | Inflammatory Bowel Disease (IBD); Inflammatory B… | Eligible IBD patients will be randomly allocated … | Details |
| NL-OMON22783 | Long term hepatotoxicity of azathioprine, 6-mercaptopurine and 6-thioguanine in inflammatory bowel disease. | Not Available | Not Recruiting | Department of Gastroenterology and Hepatology, VU University Medical Center, Amsterdam, The Netherlands | Inflammatory bowel disease, azathioprine, 6-merca… | 1. Liver biopsy; 2. Venapuncture; 3. Abdominal … | Details |
| Disease ID | Disease Name | Definition | Category | Related Drugs | Mechanism | |
|---|---|---|---|---|---|---|
| No data available | ||||||
| Strategy ID | Therapeutic Strategy | Synonyms | Related Drugs | Mechanism | |
|---|---|---|---|---|---|
| S02 | Immunosuppression | Classic immunosuppressive drugs | azathioprine; 6-mercaptopurine; methotrexate; ciclosporin-A; tacrolimus | Ciclosporin-A and tacrolimus bind to specific intracellular… | Details |
Randomised clinical trial: efficacy, safety and dosage of adjunctive allopurino…
PMID: 29468701
Year: 2018
Relationship Type:
Clinical Trial
Score: 6.3
INTRODUCTION: A small but increasing number of patients with inflammatory bowel disease are diagnosed during childhood or adolescence, and disease d…
Effect of genetic polymorphisms of azathioprine-metabolizing enzymes on respons…
PMID: 29441893
Year: 2017
Relationship Type:
Treatment
Score: 6.3
The history of fecal microbiota transplantation (FMT) dates back even to ancient China. Recently, scientific studies have been looking into FMT as a…
Effective long-term solution to therapeutic remission in Inflammatory Bowel Dis…
PMID: 29421584
Year: 2018
Relationship Type:
Treatment
Score: 6.3
Nutritional strategies have been explored as primary or adjunct therapies for inflammatory bowel disease (IBD). Exclusive enteral nutrition is effec…
Granulocyte-Monocyte Apheresis in Steroid-Dependent, Azathioprine-Intolerant/Re…
PMID: 29403531
Year: 2017
Relationship Type:
Treatment
Score: 6.3
Inflammatory bowel diseases (IBDs), including both Crohn's disease (CD) and ulcerative colitis (UC), are chronic autoimmune diseases. Both CD and UC…
Azathioprine-induced acute pancreatitis in inflammatory bowel disease : natural…
PMID: 29364109
Year: 2017
Relationship Type:
Association
Score: 6.3
Low Doses of Azathioprine are Effective in Combination With Infliximab in Infla…
PMID: 29360962
Year: 2018
Relationship Type:
Treatment
Score: 6.3
Letter: addition of azathioprine to infliximab maintenance therapy in patients …
PMID: 29341274
Year: 2018
Relationship Type:
Treatment
Score: 6.3
ITPA Activity in Children Treated by Azathioprine: Relationship to the Occurren…
PMID: 29327413
Year: 2018
Relationship Type:
Treatment
Score: 6.3
BACKGROUND: Gallstones and kidney stones are known complications of inflammatory bowel diseases (IBD). Risk factors have been insufficiently studied…
HLA-DQA1-HLA-DRB1 polymorphism is a major predictor of azathioprine-induced pan…
PMID: 29270995
Year: 2018
Relationship Type:
Treatment
Score: 6.3
BACKGROUND: Therapeutic drug monitoring (TDM) aid therapeutic decision making in patients with inflammatory bowel disease (IBD) who lose response to…
Does Azathioprine induce endoscopic and histologic healing in pediatric inflamm…
PMID: 29174208
Year: 2018
Relationship Type:
Association
Score: 6.3
Comment on Gut. 2017 Jan;66(1):59-69.
Azathioprine-induce acute submandibular sialadenitis in a patient with Crohn's …
PMID: 29150359
Year: 2018
Relationship Type:
Association
Score: 6.3
Rate and Predictors of Endoscopic Mucosal Healing in Biologic Naive Patients wi…
PMID: 29057149
Year: 2016
Relationship Type:
Treatment
Score: 6.3
Gastrointestinal symptoms such as abdominal pain, dyspepsia, and diarrhea are relatively nonspecific and a common cause for seeking medical attentio…
Visceral Leishmaniasis Infection in a Patient with Crohn's Disease Treated with…
PMID: 28967958
Year: 2017
Relationship Type:
Association
Score: 6.3
Screening for Epstein-Barr Virus Status and Risk of Hemophagocytic Lymphohistio…
PMID: 28881189
Year: 2017
Relationship Type:
Association
Score: 6.3
Effect of azathioprine intolerance on outcomes of inflammatory bowel disease: a…
PMID: 28839749
Year: 2014
Relationship Type:
Treatment
Score: 6.3
BACKGROUND: Glucocorticosteroids and aminosalicylates, mainly mesalazine (5-ASA), are both standard therapeutics in the treatment of inflammatory bo…
Development and in vivo evaluation of chitosan beads for the colonic delivery o…
PMID: 28830720
Year: 2017
Relationship Type:
Treatment
Score: 6.3
The present study was conducted to investigate the effects of different levels of dietary arginine (Arg) and methionine (Met) on performance, immune…
More Dose-dependent Side Effects with Mercaptopurine over Azathioprine in IBD T…
PMID: 28644183
Year: 2017
Relationship Type:
Treatment
Score: 6.3
BACKGROUND: Recent trials suggest fecal microbiota transplantation (FMT) with repeated enemas and high-diversity FMT donors is a promising treatment…
Azathioprine-Associated Complete NK Cell Deficiency
PMID: 28639167
Year: 2017
Relationship Type:
Association
Score: 6.3
Azathioprine allows glucocorticoid withdrawal - post hoc results of a prospecti…
PMID: 28499322
Year: 2017
Relationship Type:
Treatment
Score: 6.3
BACKGROUND: Intestinal fibrosis with stricture formation is a common feature of inflammatory bowel disease (IBD) and leads to a significantly impair…
Azathioprine with Allopurinol: Lower Deoxythioguanosine in DNA and Transcriptom…
PMID: 28452864
Year: 2017
Relationship Type:
Treatment
Score: 6.3
AIM: Early endoscopic recurrence is frequently observed in patients following resection for Crohn's disease (CD). However, factors affecting the inc…