FN-1501

Generic Name
FN-1501
Brand Names
Cellcept, Myfenax, CellCept, Mycophenolate mofetil Teva, Myclausen
Drug Type
Small Molecule
Chemical Formula
C22H25N9O
CAS Number
1429515-59-2
Unique Ingredient Identifier
6MC966B505
Background

Mycophenolate mofetil, also known as MMF or CellCept, is a prodrug of mycophenolic acid, and classified as a reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH). This drug is an immunosuppressant combined with drugs such as Cyclosporine and corticosteroids to prevent organ rejection after hepatic, renal, and cardiac transplants. It is marketed by Roche Pharmaceuticals and was granted FDA approval for the prophylaxis of transplant rejection in 1995. In addition to the above uses, mycophenolate mofetil has also been studied for the treatment of nephritis and other complications of autoimmune diseases. Unlike another immunosuppressant class, the calcineurin inhibitors, MMF generally does not cause nephrotoxicity or fibrosis.

Previously, mycophenolic acid (MPA) was administered to individuals with autoimmune diseases beginning in the 1970s, but was discontinued due to gastrointestinal effects and concerns over carcinogenicity. The new semi-synthetic 2-morpholinoethyl ester of MPA was synthesized to avoid the gastrointestinal effects associated with the administration of MPA. It demonstrates an increased bioavailability, a higher efficacy, and reduced gastrointestinal effects when compared to MPA.

Indication

Mycophenolate mofetil is indicated in combination with other immunosuppressants to prevent the rejection of kidney, heart, or liver transplants in adult and pediatric patients ≥3 months old. Mycophenolate mofetil may also be used off-label as a second-line treatment for autoimmune hepatitis that has not responded adequately to first-line therapy. Other off-label uses of this drug include lupus-associated nephritis and dermatitis in children.

Associated Conditions
Transplanted Organ Rejection
Associated Therapies
-

Haploidentical Hematopoietic Stem Cell Transplantation for Patients With Thalassemia Major

First Posted Date
2017-05-31
Last Posted Date
2017-05-31
Lead Sponsor
First Affiliated Hospital of Guangxi Medical University
Target Recruit Count
30
Registration Number
NCT03171831
Locations
🇨🇳

First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China

Newly Diagnosed Immune Thrombocytopenia Testing the Standard Steroid Treatment Against Combined Steroid & Mycophenolate

First Posted Date
2017-05-17
Last Posted Date
2022-10-26
Lead Sponsor
University Hospitals Bristol and Weston NHS Foundation Trust
Target Recruit Count
123
Registration Number
NCT03156452
Locations
🇬🇧

University Hospital Bristol NHS Foundation Trust, Bristol, United Kingdom

Study of HLA-Haploidentical Stem Cell Transplantation to Treat Clinically Aggressive Sickle Cell Disease

First Posted Date
2017-04-19
Last Posted Date
2024-11-12
Lead Sponsor
University of Illinois at Chicago
Target Recruit Count
50
Registration Number
NCT03121001
Locations
🇺🇸

University of Illinois at Chicago, Chicago, Illinois, United States

A Drug Interaction Study Between Danicopan and Midazolam, Fexofenadine, and Mycophenolate Mofetil in Healthy Participants

First Posted Date
2017-04-11
Last Posted Date
2021-06-24
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
35
Registration Number
NCT03108274
Locations
🇳🇿

Clinical Trial Site, Auckland, New Zealand

Haploidentical Stem Cell Transplantation Using Post-Transplant Cyclophosphamide

First Posted Date
2017-03-23
Last Posted Date
2024-07-10
Lead Sponsor
Loyola University
Target Recruit Count
5
Registration Number
NCT03088709
Locations
🇺🇸

Loyola University Medical Center, Maywood, Illinois, United States

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