| 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 |
Azathioprine Therapy and TPMT and NUDT15 Genotype
PMID: 28520349
Year: 2012
Relationship Type:
Treatment
Score: 10.0
Azathioprine (brand names Imuran, Azasan) is an immunosuppressant that belongs to the drug class of thiopurines. It is used with other drugs to preve…
Azathioprine Hypersensitivity Syndrome Mimicking an Infection in a Systemic Lup…
PMID: 40677507
Year: 2025
Relationship Type:
Adverse Effect
Score: 9.5
Azathioprine (AZA) is used in clinical practice as a steroid-sparing medication to treat diverse systemic autoimmune diseases, such as inflammatory b…
Thiopurine shunting in a renal transplant recipient: prepregnancy consideration…
PMID: 40675654
Year: 2025
Relationship Type:
Treatment
Score: 9.5
Fertility and reproductive counselling are integral for female kidney transplant recipients. Although classified as high-risk, successful pregnancies…
Azathioprine Metabolites in Erythrocytes and DNA for Therapy Monitoring in Very…
PMID: 40672687
Year: 2025
Relationship Type:
Treatment
Score: 9.5
Azathioprine is used for inflammatory bowel disease (IBD) therapy. Patients under 6 years of age (very early onset, VEO-IBD) showed distinctive clini…
Influence of probiotics and deoxycholate on azathioprine transport in the PAMPA…
PMID: 40642001
Year: 2025
Relationship Type:
Treatment
Score: 9.5
INTRODUCTION: Interindividual variability in drug response presents a major clinical challenge, necessitating a deeper understanding of contributing …
Comparison of endoscopic healing and durability between combination therapy wit…
PMID: 40594430
Year: 2025
Relationship Type:
Treatment
Score: 9.5
This retrospective observational study evaluated the effectiveness of endoscopic healing (EH) and the durability of infliximab (IFX) in combination w…
The Non-Peptide MAS-R Agonist AVE0991 Alleviates Colitis Severity in Mice and E…
PMID: 40565247
Year: 2025
Relationship Type:
Treatment
Score: 9.5
A growing body of evidence suggests the potent anti-inflammatory properties of the newly discovered arm of the renin-angiotensin-aldosterone system, …
Case Report: Azathioprine-induced Sweet's syndrome with associated myocardial i…
PMID: 40495975
Year: 2025
Relationship Type:
Association
Score: 9.5
Sweet's syndrome (SS) is an acute febrile neutrophilic dermatosis characterized by a rash with tender erythematous plaques or nodules, fevers and leu…
PTPN2 and Leukopenia in Individuals With Normal TPMT and NUDT15 Metabolizer Sta…
PMID: 40442974
Year: 2025
Relationship Type:
Mechanism
Score: 9.5
Leukopenia is a common dose-dependent side effect of azathioprine, often leading to drug discontinuation. Variants in TPMT and NUDT15 are associated …
[Intervention effect analysis of TPMT and NUDT15 genotyping on the tolerability…
PMID: 40393756
Year: 2025
Relationship Type:
Treatment
Score: 9.5
Objective: To investigate the impact of pre-treatment TPMT and NUDT15 genotyping on medication selection, tolerability and discontinuation rates of a…
Proactive pharmacogenomics in azathioprine-treated pediatric inflammatory bowel…
PMID: 40206080
Year: 2025
Relationship Type:
Treatment
Score: 9.5
BACKGROUND: Despite the emergence of numerous innovative targeted therapies for the management of pediatric inflammatory bowel disease (IBD), azathio…
Perspectives in clinical research on Azathioprine for steroid-dependent ulcerat…
PMID: 40201324
Year: 2025
Relationship Type:
Treatment
Score: 9.5
This study explores the application of Azathioprine in the treatment of ulcerative colitis (UC) and the challenges associated with its long-term use.…
Azathioprine and 6-mercaptopurine for maintenance of remission in ulcerative co…
PMID: 40013523
Year: 2025
Relationship Type:
Treatment
Score: 9.5
BACKGROUND: Maintenance of remission is essential in inflammatory bowel disease (IBD) in terms of disease course and long-term prognosis. The thiopur…
Top-down infliximab plus azathioprine versus azathioprine alone in patients wit…
PMID: 39586616
Year: 2025
Relationship Type:
Treatment
Score: 9.5
BACKGROUND: It is unknown which maintenance therapy is the most effective option for patients admitted for an acute severe ulcerative colitis (ASUC) …
A Case Report of Follicular Lymphoma in a Crohn's Disease Patient Treated With …
PMID: 38125685
Year: 2023
Relationship Type:
Treatment
Score: 9.5
Inflammatory bowel disease (IBD) is an autoimmune disorder marked by chronic inflammation affecting the intestines. Crohn's disease (CD) and ulcerati…
Association of ITPA 94C>A genetic polymorphisms with azathioprine induced adver…
PMID: 38097396
Year: 2023
Relationship Type:
Treatment
Score: 9.5
OBJECTIVES: Azathioprine (AZA) is an effective immunosuppressant commonly used for malignancy and immune-mediated disorders. The association between …
Evaluation of tolerance to mercaptopurine in patients with inflammatory bowel d…
PMID: 38072359
Year: 2024
Relationship Type:
Association
Score: 9.5
BACKGROUND: Thiopurines such as azathioprine (AZA) and mercaptopurine (MP) are commonly utilized to treat inflammatory bowel disease (IBD). Their use…
Azathioprine dose tailoring based on pharmacogenetic information: Insights of c…
PMID: 37857254
Year: 2023
Relationship Type:
Treatment
Score: 9.5
Azathioprine is commonly used as an immunosuppressive antimetabolite in the treatment of acute lymphoblastic leukemia, autoimmune disorders (such as …
Long-term safety and effectiveness of azathioprine in the management of inflamm…
PMID: 37744710
Year: 2023
Relationship Type:
Treatment
Score: 9.5
BACKGROUND AND AIM: Azathioprine (AZA) forms the cornerstone for maintenance of sustained remission in inflammatory bowel disease (IBD). There is app…
Azathioprine and 6-mercaptopurine-induced intrahepatic cholestasis of pregnancy…
PMID: 37679010
Year: 2023
Relationship Type:
Treatment
Score: 9.5
OBJECTIVE: Azathioprine, a prodrug of 6-mercaptopurine (6-MP), is used in the treatment of inflammatory bowel disease and may be continued during pre…