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
-

Mycophenolate Mofetil Versus Intravenous Cyclophosphamide Pulses in the Treatment of Crescentic IgA Nephropathy

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2006-03-13
Last Posted Date
2010-05-27
Lead Sponsor
Nanjing University School of Medicine
Target Recruit Count
40
Registration Number
NCT00301600
Locations
🇨🇳

Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, Jiangsu, China

MMF Versus CTX in the Induction Treatment of ANCA Associated Vasculitis

First Posted Date
2006-03-13
Last Posted Date
2010-06-08
Lead Sponsor
Nanjing University School of Medicine
Target Recruit Count
60
Registration Number
NCT00301652
Locations
🇨🇳

Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, Jiangsu, China

Mycophenolate Mofetil (MMF) Versus Intravenous CTX Pulses in the Treatment of Adult Severe HSPN

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2006-03-13
Last Posted Date
2010-05-27
Lead Sponsor
Nanjing University School of Medicine
Target Recruit Count
60
Registration Number
NCT00301613
Locations
🇨🇳

Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, Jiangsu, China

Efficacy and Safety of Everolimus in Recipients of Heart Transplants to Prevent Acute and Chronic Rejection

First Posted Date
2006-03-08
Last Posted Date
2012-08-16
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
721
Registration Number
NCT00300274
Locations
🇺🇸

Hahnemann University Hospital, Philadelphia, Pennsylvania, United States

🇺🇸

Temple University Hospital, Philadelphia, Pennsylvania, United States

🇺🇸

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States

and more 61 locations

Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer, Metastatic Kidney Cancer, or Aplastic Anemia

First Posted Date
2006-02-24
Last Posted Date
2014-01-06
Lead Sponsor
University of California, San Francisco
Target Recruit Count
35
Registration Number
NCT00295997
Locations
🇺🇸

UCSF Comprehensive Cancer Center, San Francisco, California, United States

🇺🇸

Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States

Chemotherapy and Total-Body Irradiation Followed by Donor Umbilical Cord Blood Transplant, Cyclosporine, and Mycophenolate Mofetil in Treating Patients With Hematologic Cancer

First Posted Date
2006-02-13
Last Posted Date
2017-11-29
Lead Sponsor
Masonic Cancer Center, University of Minnesota
Target Recruit Count
68
Registration Number
NCT00290641
Locations
🇺🇸

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

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