AZASAN (azathioprine)
AZASAN is indicated for the treatment of Organ Rejection; Rheumatoid Arthritis.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1999-06-07
- Routes
- ORAL
- Dosage Forms
- TABLET
AZASAN Approval History
What AZASAN Treats
2 indicationsAZASAN is approved for 2 conditions since its original approval in 1999. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Organ Rejection
- Rheumatoid Arthritis
AZASAN Boxed Warning
WARNING - MALIGNANCY Chronic immunosuppression with AZASAN, a purine antimetabolite increases risk of malignancy in humans. Reports of malignancy include post-transplant lymphoma and hepatosplenic T-cell lymphoma (HSTCL) in patients with inflammatory bowel disease. Physicians using this drug should be very familiar with this risk as well as with the mutagenic potential to both men and women and with possible hematologic toxicities. Physicians should inform patients of the risk of malignancy with...
WARNING - MALIGNANCY Chronic immunosuppression with AZASAN, a purine antimetabolite increases risk of malignancy in humans. Reports of malignancy include post-transplant lymphoma and hepatosplenic T-cell lymphoma (HSTCL) in patients with inflammatory bowel disease. Physicians using this drug should be very familiar with this risk as well as with the mutagenic potential to both men and women and with possible hematologic toxicities. Physicians should inform patients of the risk of malignancy with AZASAN ® . See WARNINGS .
AZASAN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in AZASAN's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications AZASAN treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to AZASAN
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
41 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07168161 | STS-BDB001-10 | Ph 3 | recruiting | BDB-001 Phase III Trial in ANCA-Associated Vasculitis |
| NCT02939573 ARAMIS | VCRC5562 U54AR057319 | Ph 2 | recruiting | A Randomized Multicenter Study for Isolated Skin Vasculitis |
| NCT07352566 | 25-43621 | Ph 4 | not yet recruiting | Utilization of a Microdevice for Psoriasis and Atopic Dermatitis |
| NCT03164473 MAINRITSEG | P150922 2016-000627-53 | Ph 3 | completed | Maintenance of Remission With Rituximab Versus Azathioprine for Newly-diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis. |
| NCT00748644 MAINRITSAN | P 070703 | Ph 3 | completed | Efficacy Study of Two Treatments in the Remission of Vasculitis |
| NCT04773392 SIMPLE | HS-18-00513 | Ph 4 | terminated | Simplified IMmunosuppressive Protocol Utilizing Low Dose EnvarsusXR |
| NCT07138898 | 25-00380 | Ph 2 | not yet recruiting | Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty |
| NCT07044141 NB-UVB | Dermatology LGH | Ph 1 | active not recruiting | Efficacy of Oral Tofacitinib in Combination of Narrow Band UVB in Treatment of Vitiligo |
| NCT02994927 ADVOCATE results posted | CL010_168 ADVOCATE | Ph 3 | completed | A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis |
| NCT06213857 | Silymarin in UC | Ph 2 | recruiting | Beneficial Effect of Silymarin in Ulcerative Colitis |
| NCT05349006 MOGwAI | 69HCL21_1065 | Ph 3 | recruiting | Azathioprine in MOGAD |
| NCT04654988 IMPROVE-MC | PREDAZA/WUM/10-09-2020 2020-003877-23 | Ph 4 | recruiting | Study to Evaluate the Efficacy of Immunosuppression in Myocarditis or Inflammatory Cardiomyopathy. |
| NCT02517684 TISKids | NL52030.078.15 2014-005702-37, MEC-2015-080 | Ph 4 | completed | Top-down Infliximab Study in Kids With Crohn's Disease |
| NCT05263505 results posted | 202107009 | Ph 2 | terminated | Baricitinib for the Treatment of Ocular Mucous Membrane Pemphigoid |
| NCT05965284 | CSTAR-K2374 | Ph 4 | recruiting | Efficacy and Safety for Telitacicept in the Remission Maintenance Treatment of ANCA-associated Vasculitis (TTCAZAREM) |
| NCT05896605 | qingmenghuang | Ph 4 | completed | Monitoring of Azathioprine Metabolite Concentrations and Cytokine Levels in Neuromyelitis Optica Spectrum Disorder |
| NCT02425852 ACTIVE | GETAID 2015-02 | Ph 4 | completed | A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus IFX to Steroids Plus Azathioprine for Acute Severe Colitis |
| NCT05813860 | 2023ZSLYEC-123 | Ph 4 | not yet recruiting | HLADQA1*05 Genotype and the Efficacy of Treatment With Infliximab in Chinese Population Crohn's Disease |
| NCT02177071 SPARE | GETAID 2014-03 | Ph 4 | completed | A proSpective Randomized Controlled Trial comParing infliximAb-antimetabolites Combination Therapy to Anti-metabolites monotheRapy and Infliximab monothErapy in Crohn's Disease Patients in Sustained Steroid-free Remission on Combination Therapy |
| NCT03449758 SariPRO results posted | SARILL08755 U1111-1197-7699, 2017-002951-27 | Ph 4 | completed | Effect of Sarilumab on Patient-reported Outcomes in Patients With Active Rheumatoid Arthritis |
| NCT01727193 | ZS-LEF | Ph 3 | completed | The Efficacy and Safety of Leflunomide or Azathioprine Therapy in Myasthenia Gravis Patients After Expand Thymectomy |
| NCT01697267 RITAZAREM results posted | RITAZAREM 2012-001102-14 | Ph 3 | completed | Rituximab Vasculitis Maintenance Study |
| NCT02444728 CHORUS | CSTAR001 | Ph 3 | terminated | Cyclophosphamide and Hydroxychloroquine for Thrombocytopenia in SLE |
| NCT02598596 TRIPLE | AMP-001 | Ph 2 | completed | Tolerization Reduces Intolerance to Pegloticase and Prolongs the Urate Lowering Effect |
| NCT02281799 | Thiopurine_Pancreatitis | Ph 4 | withdrawn | Thiopurine Induced Pancreatitis in IBD Patients |
| NCT00626197 BELONG results posted | ACT4072g WA20500 | Ph 3 | terminated | A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (BELONG) |
| NCT03002038 results posted | 395275 | Ph 2, Ph 3 | completed | Comparison of Clinical Effects of Azathioprine and Rituximab NMO-SD Patients |
| NCT03350633 TANGO | IRB2017-YX-009 | Ph 2, Ph 3 | completed | Tocilizumab vs Azathioprine in Neuromyelitis Optica Spectrum Disorders |
| NCT02579733 ACE | KMU-151016 | Ph 4 | terminated | Azathioprine Based on Endoscopy After Clinical Remission in Moderate to Severe Ulcerative Colitis |
| NCT01941095 results posted | ML28695 2013-000359-42 | Ph 3 | completed | A Study of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Rheumatoid Arthritis |
| NCT03229746 | 17200058 | Ph 4 | completed | Reposition of Second Line Treatment in Chronic Immune Thrombocytopenia |
| NCT01663623 BREVAS results posted | 115466 | Ph 3 | completed | Belimumab in Remission of VASculitis |
| NCT01235689 CALM results posted | M11-271 2010-020137-10 | Ph 3 | completed | Efficacy and Safety of Two Treatment Algorithms in Adults With Moderate to Severe Crohn's Disease |
| NCT00984568 MUNIX results posted | P05553 2009-010065-23 | Ph 3 | terminated | Conventional Step-Up Versus Infliximab Monotherapy in Patients With Ulcerative Colitis (P05553) |
| NCT02645565 | JIP/IEC/SC/2013/5/435 | Ph 4 | completed | Comparison of Low Dose Versus High Dose Cyclophosphamide as Induction Therapy in the Treatment of Lupus Nephritis |
| NCT02949349 | GBL15-001 | Ph 2 | completed | Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis |
| NCT01112215 | 2008-008934-35 | Ph 4 | completed | Enteric-coated Mycophenolate Sodium Versus Azathioprine for the Extra-renal Lupus Manifestations |
| NCT00774852 ACCESS results posted | DAIT ITN034AI | Ph 2 | completed | Abatacept and Cyclophosphamide Combination Therapy for Lupus Nephritis |
| NCT01880307 ITSKids | NL39202.078.12 2012-000645-13, 2014-005702-37 | Ph 4 | terminated | Infliximab Top-down in Pediatric Crohn |
| NCT01564823 APPRECIA | APPRECIA | Ph 3 | completed | Adalimumab on Preventing Post-chirurgic Recurrence on Crohn´s Disease |
| NCT00626678 | 87- 01-30 - 6907 | Ph 2 | completed | Azathioprine Versus Placebo in Pemphigus Vulgaris Treated With Prednisolone |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
AZASAN FDA Label Details
Indications & Usage
AZASAN is indicated for the treatment of Organ Rejection; Rheumatoid Arthritis.
WARNING - MALIGNANCY Chronic immunosuppression with AZASAN, a purine antimetabolite increases risk of malignancy in humans. Reports of malignancy include post-transplant lymphoma and hepatosplenic T-cell lymphoma (HSTCL) in patients with inflammatory bowel disease. Physicians using this drug should ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment