Overview
Azathioprine is a prodrug of 6-mercaptopurine, first synthesized in 1956 by Gertrude Elion, William Lange, and George Hitchings in an attempt to produce a derivative of 6-mercaptopurine with a better therapeutic index. Azathioprine is used to treat inflammatory conditions like rheumatoid arthritis and as an immunosuppressant in the prevention of renal transplant rejection. Azathiprine was granted FDA approval on 20 March 1968.
Indication
Azathioprine is indicated to treat rheumatoid arthritis and prevent renal transplant rejection.
Associated Conditions
- Atopic Dermatitis
- Crohn's Disease (CD)
- Immune Thrombocytopenia (ITP)
- Kidney Transplant Rejection
- Lupus Nephritis
- Multiple Sclerosis
- Pericarditis
- Psoriasis
- Rheumatoid Arthritis
- Uveitis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/29 | Not Applicable | Active, not recruiting | |||
2025/06/10 | N/A | Completed | Bangladesh Medical University | ||
2025/04/23 | Phase 2 | Not yet recruiting | |||
2025/01/22 | Phase 2 | Completed | |||
2024/10/21 | Phase 2 | Not yet recruiting | |||
2024/06/26 | Early Phase 1 | Recruiting | Pak Emirates Military Hospital | ||
2024/01/19 | Phase 2 | Recruiting | |||
2023/08/01 | Not Applicable | Active, not recruiting | |||
2023/07/28 | Phase 4 | Recruiting | Chinese SLE Treatment And Research Group | ||
2023/06/09 | Phase 4 | Completed | First Affiliated Hospital of Guangxi Medical University |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| AvKARE | 42291-063 | ORAL | 100 mg in 1 1 | 4/13/2023 | |
| Ascend Laboratories, LLC | 67877-492 | ORAL | 25 mg in 1 1 | 11/22/2021 | |
| Aphena Pharma Solutions - Tennessee, LLC | 71610-124 | ORAL | 50 mg in 1 1 | 9/5/2018 | |
| American Health Packaging | 68084-229 | ORAL | 50 mg in 1 1 | 8/28/2023 | |
| Hikma Pharmaceuticals USA Inc. | 0143-9566 | INTRAVENOUS | 100 mg in 10 mL | 5/15/2023 | |
| Salix Pharmaceuticals | 65649-231 | ORAL | 75 mg in 1 1 | 12/18/2023 | |
| Amneal Pharmaceuticals NY LLC | 60219-2037 | ORAL | 100 mg in 1 1 | 12/28/2023 | |
| Amneal Pharmaceuticals NY LLC | 60219-2036 | ORAL | 75 mg in 1 1 | 12/28/2023 | |
| Zydus Pharmaceuticals USA Inc. | 68382-119 | ORAL | 75 mg in 1 1 | 8/22/2023 | |
| REMEDYREPACK INC. | 70518-3544 | ORAL | 50 mg in 1 1 | 1/15/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 6/21/2021 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| IMURAN TABLET 50 mg | SIN02082P | TABLET, FILM COATED | 50 mg | 6/24/1988 | |
| AZATHIOPRINE PCH TABLET 50 mg | SIN10165P | TABLET | 50.0 mg | 10/3/1998 | |
| AZAFRINE TABS. 50 mg | SIN11000P | TABLET | 50 mg | 6/29/1999 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Azathioprine Tablets | 国药准字H31021423 | 化学药品 | 片剂 | 7/9/2024 | |
| Azathioprine Tablets | 国药准字H41020362 | 化学药品 | 片剂 | 11/8/2019 | |
| Azathioprine Tablets | 国药准字H20003841 | 化学药品 | 片剂 | 11/5/2024 | |
| Azathioprine Tablets | 国药准字H31021422 | 化学药品 | 片剂 | 2/10/2020 | |
| Azathioprine Tablets | 国药准字H33020153 | 化学药品 | 片剂 | 5/12/2020 | |
| Azathioprine Tablets | 国药准字H20234428 | 化学药品 | 片剂 | 10/27/2023 | |
| Azathioprine Tablets | 国药准字HJ20170288 | 化学药品 | 片剂 | 9/30/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| IMAZAN azathioprine 25mg tablet blister pack | 184923 | Medicine | A | 6/5/2012 | |
| GN-AZATHIOPRINE azathioprine 50mg tablet blister pack | 184934 | Medicine | A | 6/5/2012 | |
| AZATHIOPRINE AN azathioprine 25 mg tablet blister pack | 184935 | Medicine | A | 6/5/2012 | |
| NOUMED AZATHIOPRINE azathioprine 50 mg film coated tablet blister pack | 298267 | Medicine | A | 2/26/2018 | |
| AZATHIOPRINE-RJIC azathioprine 25 mg tablet blister pack | 430390 | Medicine | A | 2/22/2024 | |
| THIOPRINE 50 azathioprine 50 mg film-coated tablet blister pack | 221962 | Medicine | A | 11/24/2014 | |
| NOUMED AZATHIOPRINE azathioprine 25 mg film coated tablet blister pack | 298266 | Medicine | A | 2/26/2018 | |
| APO-AZATHIOPRINE azathioprine 50 mg tablet blister pack | 205762 | Medicine | A | 12/3/2013 | |
| APO-AZATHIOPRINE azathioprine 25 mg tablet blister pack | 205759 | Medicine | A | 12/3/2013 | |
| AZATHIOPRINE-WGR azathioprine 50 mg tablet blister pack | 430370 | Medicine | A | 2/22/2024 |
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