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
-

Single Center Pilot Study of Corticosteroid Discontinuation in Liver Transplant Recipients

First Posted Date
2006-09-11
Last Posted Date
2015-12-29
Lead Sponsor
University of Cincinnati
Target Recruit Count
40
Registration Number
NCT00374231
Locations
🇺🇸

University of Cincinnati, Cincinnati, Ohio, United States

Study to Evaluate Safety and Efficacy of Early Calcineurin Inhibitor Withdrawal in Primary Renal Allografts

Phase 4
Completed
Conditions
First Posted Date
2006-09-11
Last Posted Date
2021-07-15
Lead Sponsor
University of Cincinnati
Target Recruit Count
17
Registration Number
NCT00374647
Locations
🇺🇸

University of Cincinnati, Cincinnati, Ohio, United States

🇺🇸

The Christ Hospital, Cincinnati, Ohio, United States

Comparing the Efficacy of Tacrolimus and Mycophenolate Mofetil for the Initial Therapy of Active Lupus Nephritis

Phase 4
Completed
Conditions
Interventions
First Posted Date
2006-09-04
Last Posted Date
2014-07-02
Lead Sponsor
Tuen Mun Hospital
Target Recruit Count
150
Registration Number
NCT00371319
Locations
🇨🇳

Tuen Mun Hospital, Hong Kong, China

TBI Dose De-escalation for Fanconi Anemia

First Posted Date
2006-07-17
Last Posted Date
2021-11-24
Lead Sponsor
Masonic Cancer Center, University of Minnesota
Target Recruit Count
83
Registration Number
NCT00352976
Locations
🇺🇸

University of Minnesota Medical Center, Minneapolis, Minnesota, United States

Pilot Study for HLA Identical Living Donor Renal Transplant Recipients

Phase 4
Completed
Conditions
First Posted Date
2006-07-14
Last Posted Date
2014-11-13
Lead Sponsor
University of Cincinnati
Target Recruit Count
20
Registration Number
NCT00352092
Locations
🇺🇸

University of Cincinnati, Cincinnati, Ohio, United States

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