NDAORALTABLETPriority Review
Approved
Mar 1968
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
14
Data completeness
4/8 — Partial
Priority Review
IMURAN (azathioprine) by Enterprise Therapeutics is nucleic acid synthesis inhibitors [moa]. First approved in 1968.
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
IMURAN (azathioprine) is an oral purine antimetabolite that inhibits nucleic acid synthesis, used primarily as an immunosuppressant for autoimmune conditions and organ transplant rejection. The drug works by suppressing T-cell and B-cell proliferation, reducing the body's immune response. It has been a foundational therapy in immunosuppression for over 55 years.
LOE Approaching
As a legacy product approaching loss of exclusivity with moderate competitive pressure (30), teams are likely focused on managed decline and cost optimization rather than growth initiatives.
Mechanism of Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Class:
Purine Antimetabolite
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (14)
Comparison of Azathioprine to Methotrexate in Combination Therapy With Adalimumab in Crohn's Disease: an Open-label Randomized Controlled Trial
Started Aug 2021
Effect of JKB-122 on Prednisolone and Azathioprine Induced Remission in Autoimmune Hepatitis (AIH)
Started Nov 2020
120 enrolled
Autoimmune Hepatitis
Bioequivalence of Azathioprine Suspension 10 mg/mL (Jayempi) Versus Azathioprine Tablet 50mg (Imurek®)
Started Apr 2019
30 enrolled
Therapeutic Equivalency
Azathioprine Based on Endoscopy After Clinical Remission in Moderate to Severe Ulcerative Colitis
Started Feb 2016
16 enrolled
Ulcerative Colitis
Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis
Started Jul 2015
32 enrolled
Lupus Nephritis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.