Mycophenolic acid

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

Title	Posted	Study ID	Phase	Status	Sponsor
Optimize Immunosuppressive Therapy Using Everolimus and Low-dose Calcineurin Inhibitors in Heart Transplant Patients in Korea	2025/04/24	NCT06942156	Phase 4	Not yet recruiting	Chong Kun Dang Pharmaceutical
Optimizing GVHD Prophylaxis After Allogeneic Hematopoietic Cell Transplantation	2025/01/29	NCT06799195	Phase 2	Recruiting	University of Nebraska
Which of the Commonly Available and Approved Drugs in Addition to Standard of Care Can Significantly Improve the Slope of Estimated Glomerular Filtration Rate at Two Years When Compared to Standard of Care Alone in South-Asian Kidney Biopsy-proven Adult (≥18 Years) Primary IgA Nephropathy?	2024/11/06	NCT06676384	Phase 4	Recruiting	Christian Medical College, Vellore, India
Induction of Remission in Autoimmune Hepatitis With Azathioprine vs. MMF	2024/10/21	NCT06650124	Phase 2	Not yet recruiting	Institute of Liver and Biliary Sciences, India
A Study of Tacrolimus/Methotrexate/Ruxolitinib Versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation (BMT CTN 2203)	2024/09/26	NCT06615050	Phase 3	Recruiting	Incyte Corporation
Reduced Immunosuppression in Older Renal Transplant Recipients With Trugraf®/TRAC Monitoring (RIOT Trial): A Prospective, Randomized, Multicenter Trial.	2024/08/23	NCT06568549	Phase 4	Recruiting	Mayo Clinic
A Study to Evaluate IMC-002 in Neuromyelitis Optica Spectrum Disorder (NMOSD) Patients	2024/08/16	NCT06557174	Phase 1	Not yet recruiting	ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.
Mycophenolate-Based Therapy for Kidney Transplant Recipients Without HLA-DQ Mismatch	2024/07/10	NCT06493526	Phase 4	Recruiting	University Hospital, Antwerp
Belatacept in Heart Transplantation	2024/06/27	NCT06478017	Phase 2	Recruiting	National Institute of Allergy and Infectious Diseases (NIAID)
A Dose Escalation Study of TCD601 Compared to ATG in de Novo Renal Transplantation	2024/04/15	NCT06365437	Phase 2	Completed	ITB-Med LLC

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
mycophenolic acid	PD-Rx Pharmaceuticals, Inc.	72789-247	ORAL	180 mg in 1 1	2/13/2023
Mycophenolic Acid	REMEDYREPACK INC.	70518-3218	ORAL	360 mg in 1 1	3/14/2024
mycophenolic acid	TWi Pharmaceuticals, Inc.	24979-160	ORAL	180 mg in 1 1	3/25/2022
Myfortic	Novartis Pharmaceuticals Corporation	0078-0386	ORAL	360 mg in 1 1	4/19/2016
mycophenolic acid	Advagen Pharma Limited	72888-200	ORAL	360 mg in 1 1	3/7/2024
mycophenolic acid	Major Pharmaceuticals	0904-7456	ORAL	180 mg in 1 1	1/3/2024
Mycophenolic Acid	AMTA LABS LIMITED	72322-1048	ORAL	180 mg in 1 1	2/19/2021
Mycophenolic Acid	American Health Packaging	68084-907	ORAL	180 mg in 1 1	12/22/2023
mycophenolic acid	TWi Pharmaceuticals, Inc.	24979-161	ORAL	360 mg in 1 1	3/25/2022
mycophenolic acid	PD-Rx Pharmaceuticals, Inc.	72789-246	ORAL	360 mg in 1 1	2/13/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
MYFORTIC GASTRO-RESISTANT TABLET 180 mg	Novartis Pharma Produktions GmbH, Lek d.d., PE PROIZVODNJA LENDAVA (Primary & Secondary Packager)	SIN12376P	ENTERIC COATED TABLET	180mg	8/1/2003
ACCOCEPT 360 GASTRO-RESISTANT TABLET 360 MG	Intas Pharmaceuticals Limited.	SIN16787P	TABLET, ENTERIC COATED	360 mg	5/19/2023
MYFORTIC GASTRO-RESISTANT TABLET 360 mg	Novartis Pharma Produktions GmbH, Lek d.d., PE PROIZVODNJA LENDAVA (Primary and Secondary Packager)	SIN12377P	TABLET, FILM COATED	360 mg	8/1/2003
MOFECON-GR 360 GASTRO-RESISTANT TABLETS 360 MG	CONCORD BIOTECH LIMITED	SIN16970P	TABLET, ENTERIC COATED	360mg	3/8/2024
MUREST-DR 180 DELAYED-RELEASE TABLETS 180MG	Biocon Pharma Limited	SIN16638P	TABLET, DELAYED RELEASE	180.00mg	11/9/2022
ACCOCEPT 180 GASTRO-RESISTANT TABLET 180 MG	Intas Pharmaceuticals Limited.	SIN16788P	TABLET, ENTERIC COATED	180 mg	5/19/2023
MUREST-DR 360 DELAYED-RELEASE TABLETS 360MG	Biocon Pharma Limited	SIN16637P	TABLET, DELAYED RELEASE	360.00mg	11/9/2022
MOFECON-GR 180 GASTRO-RESISTANT TABLETS 180 MG	CONCORD BIOTECH LIMITED	SIN16969P	TABLET, ENTERIC COATED	180mg	3/8/2024
VETIC CREAM	SATO PHARMACEUTICAL CO LTD	SIN09862P	CREAM	0.5%	7/2/1998

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

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
MYCOPHENOLIC ACID INTAS mycophenolic acid (as sodium) 360 mg enteric coated tablet blister pack	338495	Accord Healthcare Pty Ltd	Medicine	A	3/22/2023
MYCOPHENOLIC ACID ACCORD mycophenolic acid (as sodium) 180 mg enteric coated tablet blister pack	338493	Accord Healthcare Pty Ltd	Medicine	A	3/22/2023
MYCOPHENOLIC ACID ASTRON mycophenolic acid (as sodium) 180 mg enteric coated tablet blister pack	338490	Accord Healthcare Pty Ltd	Medicine	A	3/22/2023
MYCOFOR mycophenolic acid (as sodium) 360 mg enteric coated tablet blister pack	391541	Pharmacor Pty Ltd	Medicine	A	9/18/2023
MYCOFOR mycophenolic acid (as sodium) 360 mg enteric coated tablet bottle pack	391533	Pharmacor Pty Ltd	Medicine	A	9/18/2023
MYCOPHENOLIC ACID ARX mycophenolic acid (as sodium) 360 mg enteric coated tablet blister pack	338496	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	3/22/2023
MYCOTEX mycophenolic acid (as sodium) 360 mg enteric coated tablet blister pack	391538	Pharmacor Pty Ltd	Medicine	A	9/18/2023
MYFORTIC mycophenolic acid 180mg (as sodium) enteric coated tablet blister pack	91939	Novartis Pharmaceuticals Australia Pty Ltd	Medicine	A	3/25/2003
MYCOPHENOLIC ACID ARX mycophenolic acid (as sodium) 180 mg enteric coated tablet blister pack	338491	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	3/22/2023
MYCOPHENOLIC ACID ASTRON mycophenolic acid (as sodium) 360 mg enteric coated tablet blister pack	338494	Accord Healthcare Pty Ltd	Medicine	A	3/22/2023

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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