Mycophenolic acid

Generic Name: Mycophenolic acid

Brand Names: Myfortic

Drug Type: Small Molecule

Chemical Formula: C_₁₇H_₂₀O_₆

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: -

Clinical Trials

Allogeneic Hematopoietic Stem Cell Transplant for Patients With Inborn Errors of Immunity

Phase 2

Recruiting

Conditions: Autoimmune Lymphoproliferative
Common Variable Immunodeficiency
Immune System Diseases
Primary T-cell Immunodeficiency Disorders
Lymphoproliferative Disorders

Interventions: Drug: Busulfan test dose
Drug: Fludarabine
Drug: Busulfan
Drug: Alemtuzumab
Radiation: Total body Irradiation
Procedure: Allogeneic HSCT
Drug: Tacrolimus (Tacro)
Drug: Mycophenolate mofetil (MMF)
Drug: Cyclophosphamide (Cytoxan)

First Posted Date: 2020-04-09

Last Posted Date: 2024-12-27

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 66

Registration Number: NCT04339777

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Treg Modulation With CD28 and IL-6 Receptor Antagonists

Phase 1

Completed

Conditions: Living-Donor Kidney Transplant
Kidney Transplant Recipients

Interventions: Biological: lulizumab pegol
Biological: antithymocyte globulin (rabbit)
Drug: methylprednisolone
Biological: tocilizumab
Drug: Prednisone
Drug: everolimus
Biological: belatacept
Drug: mycophenolate mofetil
Drug: mycophenolic acid

First Posted Date: 2019-08-26

Last Posted Date: 2024-10-09

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 24

Registration Number: NCT04066114

Locations: 🇺🇸
Cleveland Clinic Foundation: Transplantation, Cleveland, Ohio, United States
🇺🇸
University of California San Francisco School of Medicine: Transplantation, San Francisco, California, United States
🇺🇸
University of Alabama School of Medicine: Transplantation, Birmingham, Alabama, United States

and more 4 locations

Glycyrrhetinic Acid Combined With Dexamethasone in Management of Newly Diagnosed ITP

Phase 4

Conditions: Immune Thrombocytopenia

Interventions: Drug: Dexamethasone
Drug: Glycyrrhetinic Acid

First Posted Date: 2019-06-26

Last Posted Date: 2021-06-11

Lead Sponsor: Shandong University

Target Recruit Count: 30

Registration Number: NCT03998982

Locations: 🇨🇳
Qilu hospital, Shandong University, Jinan, Shandong, China

Mycophenolate Mofetil Pharmacokinetics in Systemic Sclerosis

Completed

Conditions: Systemic Sclerosis
Gastrointestinal Complication

Interventions: Diagnostic Test: P-MPA concentration
Drug: mycophenolic acid

First Posted Date: 2018-09-20

Last Posted Date: 2020-03-13

Lead Sponsor: Region Skane

Target Recruit Count: 35

Registration Number: NCT03678987

Locations: 🇸🇪
Reumatologi SUS Lund, Region Skåne, Lund, Sweden

Tolerance by Engaging Antigen During Cellular Homeostasis

Phase 1

Active, not recruiting

Conditions: Renal Transplantation
Renal Transplant Recipient
Kidney Transplantation

Interventions: Biological: Donor-derived Mesenchymal Stromal Cells
Drug: alemtuzumab
Drug: belatacept
Drug: sirolimus
Drug: mycophenolate mofetil
Drug: mycophenolate acid
Drug: prednisone

First Posted Date: 2018-04-20

Last Posted Date: 2024-01-26

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 8

Registration Number: NCT03504241

Locations: 🇺🇸
Duke University Health System, Durham, North Carolina, United States

Comparison of the Efficacy and Safety of Sirolimus Versus Everolimus Versus Mycophenolate in Kidney Transplantation

Phase 4

Completed

Conditions: Kidney Transplant Infection

Interventions: Drug: Everolimus
Drug: Sirolimus
Drug: Mycophenolic acid

First Posted Date: 2018-03-16

Last Posted Date: 2023-04-24

Lead Sponsor: Hospital do Rim e Hipertensão

Target Recruit Count: 1209

Registration Number: NCT03468478

Locations: 🇧🇷
Hospital do Rim, São Paulo, Sao Paulo, Brazil

Conversion From MPA to Zortress (Everolimus) for GI Toxicity Post-renal Transplantation

Phase 4

Terminated

Conditions: Kidney Transplant Rejection
Gastrointestinal Disorder, Functional

Interventions: Drug: Mycophenolic Acid
Drug: Everolimus

First Posted Date: 2016-11-28

Last Posted Date: 2020-08-10

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 1

Registration Number: NCT02974686

Locations: 🇺🇸
Washington University, Saint Louis, Missouri, United States

Treg Therapy in Subclinical Inflammation in Kidney Transplantation

Phase 1

Completed

Conditions: Renal Transplant
Adult Living Donor Kidney Transplant Recipients
Kidney Transplant
Living Kidney Donor

Interventions: Biological: Polyclonal Regulatory T Cells
Drug: Tacrolimus
Drug: Mycophenolate mofetil
Drug: Everolimus
Drug: Mycophenolic acid
Drug: Acetaminophen
Drug: Diphenhydramine
Procedure: Biopsy, Kidney
Procedure: Blood Draw
Procedure: Leukapheresis
Procedure: IS regimen conversion

First Posted Date: 2016-03-17

Last Posted Date: 2024-10-07

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 32

Registration Number: NCT02711826

Locations: 🇺🇸
University of California at San Francisco, San Francisco, California, United States
🇺🇸
University of Alabama, Birmingham, Birmingham, Alabama, United States
🇺🇸
University of Colorado Health Transplant Center - Anschutz, Aurora, Colorado, United States

and more 3 locations