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Mycophenolic acid

Generic Name
Mycophenolic acid
Brand Names
Myfortic
Drug Type
Small Molecule
Chemical Formula
C17H20O6
CAS Number
24280-93-1
Unique Ingredient Identifier
HU9DX48N0T
Background

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
Associated Therapies
-

Desensitization of Renal Transplant Candidates

Phase 1
Completed
Conditions
Kidney Transplantation
End Stage Renal Disease
Interventions
First Posted Date
2006-03-03
Last Posted Date
2012-07-25
Lead Sponsor
University of Florida
Target Recruit Count
9
Registration Number
NCT00298883
Locations
🇺🇸

University of Florida, Gainesville, Florida, United States

Myfortic - Treatment for Extensive cGvHD

Phase 3
Terminated
Conditions
Graft vs Host Disease
Interventions
First Posted Date
2006-03-02
Last Posted Date
2015-04-03
Lead Sponsor
European Society for Blood and Marrow Transplantation
Target Recruit Count
34
Registration Number
NCT00298324
Locations
🇩🇪

University Regensburg, Regensburg, Germany

🇪🇸

Hospital Clínico Universitario, Valencia, Spain

🇨🇭

University Hospital, Basel, Switzerland

and more 4 locations

Mycophenolate for Pulmonary Sarcoidosis

Phase 3
Terminated
Conditions
Pulmonary Sarcoidosis
First Posted Date
2005-12-06
Last Posted Date
2018-06-18
Lead Sponsor
Medical University of South Carolina
Target Recruit Count
20
Registration Number
NCT00262132
Locations
🇺🇸

Medical University of South Carolina, Charleston, South Carolina, United States

Enteric Coated Myfortic for Liver Transplant Recipients

Phase 4
Withdrawn
Conditions
Liver Transplantation
First Posted Date
2005-09-14
Last Posted Date
2013-12-09
Lead Sponsor
The University of Texas Health Science Center, Houston
Registration Number
NCT00167492
Locations
🇺🇸

Memorial Hermann Hospital, Houston, Texas, United States

Steroid-Free Versus Steroid-Based Immunosuppression in Pediatric Renal (Kidney) Transplantation

Phase 1
Completed
Conditions
Kidney Transplant
Renal Transplantation
Kidney Transplantation
Kidney Diseases
Renal Transplant
Interventions
First Posted Date
2005-09-01
Last Posted Date
2016-11-29
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
130
Registration Number
NCT00141037
Locations
🇺🇸

UCLA - Department of Pediatrics, Division of Nephrology, Los Angeles, California, United States

🇺🇸

Children's Hospital Boston - Division of Nephrology, Boston, Massachusetts, United States

🇺🇸

Children's Hospital of New Orleans-Department of Pediatric Nephrology, New Orleans, Louisiana, United States

and more 9 locations

Pharmacokinetics of Mycophenolate Mofetil in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy
First Posted Date
2005-08-10
Last Posted Date
2008-03-04
Lead Sponsor
National Institutes of Health Clinical Center (CC)
Target Recruit Count
130
Registration Number
NCT00128947
Locations
🇺🇸

National Institutes of Health Clinical Center (CC), Bethesda, Maryland, United States

Freedom Study: Myfortic in Kidney Transplant Patients

Phase 3
Completed
Conditions
Kidney Transplantation
First Posted Date
2005-01-13
Last Posted Date
2011-01-31
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
342
Registration Number
NCT00101738
Locations
🇬🇧

Queen Elizabeth Medical Centre, Edgbaston, Birmingham, United Kingdom

🇦🇺

Royal Melbourne Hospital, Parkville, Victoria, Australia

🇬🇧

Walsgrave Hospital NHS Trust, Walsgrave, Coventry, United Kingdom

and more 41 locations
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