Overview
Mycophenolic acid is a potent immunosuppressant agent that inhibits de novo purine biosynthesis. It was derived from Penicillium stoloniferum, and has also shown antibacterial, antifungal and antiviral properties.. Mycophenolic acid is used in immunosuppressive regimens as part of a triple therapy that includes a calcineurin inhibitor (ciclosporin or tacrolimus) and prednisolone. This regimen can be used in place of the older anti-proliferative azathioprine due to its stronger immunosuppressive potency. However, mycophenolic acid treatment is more expensive and requires therapeutic drug monitoring to optimize efficacy and minimize toxicity. Mycophenolic acid is available as enteric-coated tablets of delayed-release, in an effort to improve upper gastrointestinal adverse events by delaying mycophenolic acid release until it reaches the small intestine. Mycophenolate mofetil, a prodrug of mycophenolic acid, is also prescribed to transplant recipients to prevent organ rejection.
Indication
Mycophenolic acid is an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. Mycophenolic acid is used in combination with cyclosporine and corticosteroids.
Associated Conditions
- Kidney Transplant Rejection
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/03/01 | Phase 3 | Completed | National Institute of Blood and Marrow Transplant (NIBMT), Pakistan | ||
2023/10/05 | Phase 2 | Recruiting | |||
2023/09/21 | Phase 4 | Recruiting | |||
2023/05/24 | Phase 4 | Not yet recruiting | Zhishui Chen | ||
2023/02/01 | N/A | Recruiting | Third Affiliated Hospital, Sun Yat-Sen University | ||
2022/11/23 | Phase 4 | Recruiting | Post Graduate Institute of Medical Education and Research, Chandigarh | ||
2022/10/06 | Phase 2 | Terminated | LMU Klinikum | ||
2022/06/29 | Phase 1 | Recruiting | |||
2022/04/01 | Phase 2 | Terminated | |||
2022/03/31 | Phase 4 | UNKNOWN |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Major Pharmaceuticals | 0904-6785 | ORAL | 180 mg in 1 1 | 6/3/2022 | |
| Accord Healthcare Inc. | 16729-261 | ORAL | 180 mg in 1 1 | 1/17/2024 | |
| Ascend Laboratories, LLC | 67877-427 | ORAL | 360 mg in 1 1 | 6/20/2022 | |
| Advagen Pharma Limited | 72888-199 | ORAL | 180 mg in 1 1 | 3/7/2024 | |
| Archis Pharma LLC | 72819-156 | ORAL | 360 mg in 1 1 | 9/21/2023 | |
| Novartis Pharmaceuticals Corporation | 0078-0385 | ORAL | 180 mg in 1 1 | 4/19/2016 | |
| Aurobindo Pharma Limited | 59651-622 | ORAL | 360 mg in 1 1 | 3/4/2024 | |
| Major Pharmaceuticals | 0904-7457 | ORAL | 360 mg in 1 1 | 1/3/2024 | |
| Biocon Pharma Inc. | 70377-040 | ORAL | 360 mg in 1 1 | 6/17/2022 | |
| Accord Healthcare Inc. | 16729-189 | ORAL | 360 mg in 1 1 | 1/17/2024 |
EMA Drug Approvals
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|---|---|---|---|
| No EMA approvals found for this drug. | |||
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| MYCOPHENOLIC ACID ACCORD mycophenolic acid (as sodium) 360 mg enteric coated tablet blister pack | 338497 | Medicine | A | 3/22/2023 | |
| MYCOTEX mycophenolic acid (as sodium) 360 mg enteric coated tablet bottle pack | 391535 | Medicine | A | 9/18/2023 | |
| MYCOPHENOLIC ACID PCOR mycophenolic acid (as sodium) 360 mg enteric coated tablet blister pack | 391537 | Medicine | A | 9/18/2023 | |
| MYCOPHENOLIC ACID PCOR mycophenolic acid (as sodium) 360 mg enteric coated tablet bottle pack | 391532 | Medicine | A | 9/18/2023 | |
| MYCOPHENOLIC ACID INTAS mycophenolic acid (as sodium) 180 mg enteric coated tablet blister pack | 338492 | Medicine | A | 3/22/2023 | |
| MYFORTIC mycophenolic acid 360mg (as sodium) enteric coated tablet blister pack | 91940 | Medicine | A | 3/26/2003 |
Health Canada Drug Approvals
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