| 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 dose reduction in inflammatory bowel disease patients on combinati…
PMID: 28449228
Year: 2017
Relationship Type:
Treatment
Score: 6.3
Genome-wide association studies have identified autophagy-related susceptibility genes for inflammatory bowel disease (IBD); however, whether autoph…
Azathioprine, Mercaptopurine, and 5-Aminosalicylic Acid Affect the Growth of IB…
PMID: 28424670
Year: 2017
Relationship Type:
Treatment
Score: 6.3
The two main forms of intestinal bowel disease, namely ulcerative colitis and Crohn's disease, are not curable but can be controlled by various medi…
Safety of azathioprine and 6-mercaptopurine in patients with inflammatory bowel…
PMID: 28406092
Year: 2017
Relationship Type:
Treatment
Score: 6.3
Patients with inflammatory bowel disease [IBD] may develop, similarly to individuals from general population, rare cases of human papilloma virus […
Multicentric Case-Control Study on Azathioprine Dose and Pharmacokinetics in Ea…
PMID: 28296824
Year: 2017
Relationship Type:
Pharmacology
Score: 6.3
BACKGROUND AND AIM: There has been increased interest in sleep disorders in patients with inflammatory bowel disease (IBD). Studies in North America…
Trend towards dose reduction of azathioprine as monotherapy in inflammatory bow…
PMID: 28286554
Year: 2017
Relationship Type:
Treatment
Score: 6.3
Azathioprine Therapy in a Pediatric TPMT-Deficient Patient-Still an Option
PMID: 28081040
Year: 2017
Relationship Type:
Treatment
Score: 6.3
Comment on Aliment Pharmacol Ther. 2019 Sep;50(6):675-683. Aliment Pharmacol Ther. 2019 Nov;50(9):1060-1061.
Endoscopic aspect of a severe CMV colitis induced by azathioprine in a patient …
PMID: 27981297
Year: 2016
Relationship Type:
Association
Score: 6.3
Blood group B is associated with azathioprine-induced acute pancreatitis in pat…
PMID: 27849560
Year: 2017
Relationship Type:
Mechanism
Score: 6.3
BACKGROUND: In active inflammatory bowel disease (IBD), microRNA expression profiling consistently features disease-specific signatures, and microRN…
Randomized clinical trial: a pilot study comparing efficacy of low-dose azathio…
PMID: 27686002
Year: 2016
Relationship Type:
Treatment
Score: 6.3
Serum level of IL-21 is increased in patients with inflammatory bowel diseases (IBD), suggesting that IL-21/IL-21 receptor (IL-21R) signaling may be…
Standard-dose versus low-dose azathioprine in the treatment of Crohn's disease:…
PMID: 27653444
Year: 2016
Relationship Type:
Treatment
Score: 6.3
Adalimumab Monotherapy and a Combination with Azathioprine for Crohn's Disease:…
PMID: 27566367
Year: 2016
Relationship Type:
Treatment
Score: 6.3
BACKGROUND AND AIMS: Toll-like receptors [TLRs] are potential drug targets for immunomodulation. We determined the safety and efficacy of the TLR-9 …
No Evidence That Azathioprine Increases Risk of Cholangiocarcinoma in Patients …
PMID: 27521513
Year: 2016
Relationship Type:
Association
Score: 6.3
Not found
Reassuring results on birth outcomes in children fathered by men treated with a…
PMID: 27456154
Year: 2017
Relationship Type:
Mechanism
Score: 6.3
Inflammatory bowel disease (IBD) arises when intestinal immune homeostasis is broken, the maintenance of such homeostasis is principally controlled …
Severe perianal shingles during azathioprine and budesonide treatment for Crohn…
PMID: 27440857
Year: 2016
Relationship Type:
Treatment
Score: 6.3
Infliximab (IFX) is commonly used to induce and maintain remission in inflammatory bowel disease (IBD). We report the first 2 cases of children with…
Adalimumab and Azathioprine Combination Therapy for Crohn's Disease: A Shining …
PMID: 27389085
Year: 2016
Relationship Type:
Treatment
Score: 6.3
A Pitfall to Avoid: Hyperlipasemia, Azathioprine, and Autoimmune Pancreatitis
PMID: 27385401
Year: 2017
Relationship Type:
Association
Score: 6.3
Low-dose azathioprine is effective in maintaining remission in steroid-dependen…
PMID: 27366213
Year: 2016
Relationship Type:
Treatment
Score: 6.3
OBJECTIVE: To confirm the potential therapeutic efficacy of HAO472 against inflammatory bowel disease (IBD), we investigated the modulatory function…
Anaplastic lymphoma kinase (ALK)-positive large B-cell lymphoma in a patient tr…
PMID: 27311871
Year: 2016
Relationship Type:
Association
Score: 6.3
Use of azathioprine and corticosteroids during pregnancy and birth outcome in w…
PMID: 27301563
Year: 2016
Relationship Type:
Treatment
Score: 6.3
BACKGROUND: Inflammatory bowel diseases (IBD) are chronic relapsing inflammatory conditions of unknown cause and likely result from the loss of immu…
Effect of Early Versus Late Azathioprine Therapy in Pediatric Ulcerative Colitis
PMID: 27271489
Year: 2016
Relationship Type:
Treatment
Score: 6.3
Faecalibacterium prausnitzii strain A2-165 was previously reported to have anti-inflammatory properties and prevent colitis in a TNBS model. We comp…