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

Clinical Trials

Pharmacologic Pretransplant Immunosuppression (PTIS) + Reduced Toxicity Conditioning (RTC) Allogeneic Stem Cell Transplantation in Inherited Hematologic Disorders

Phase 2

Withdrawn

Conditions: Stem Cell Transplantation

Interventions: Drug: Fludarabine
Drug: Dexamethasone
Drug: Cyclophosphamide
Drug: Cyclophosphamide (Cy)
Drug: Bortezomib
Drug: Rituximab
Drug: Mycophenolate mofetil (MMF)
Drug: Busulfan
Drug: Rabbit ATG
Drug: Tacrolimus (or cyclosporine)

First Posted Date: 2022-03-24

Last Posted Date: 2023-09-21

Lead Sponsor: M.D. Anderson Cancer Center

Registration Number: NCT05293509

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Central China Rosai-Dorfman Disease Registry

Phase 4

Conditions: Rosai-Dorfman Disease
Langerhans Cell Histiocytosis

Interventions: Drug: Mycophenolate mofetil combined with oral prednisone

First Posted Date: 2022-03-17

Last Posted Date: 2022-03-17

Lead Sponsor: Tongji Hospital

Target Recruit Count: 20

Registration Number: NCT05284942

Locations: 🇨🇳
Tongji Hospital, Wuhan, Hubei, China

Baricitinib for the Treatment of Ocular Mucous Membrane Pemphigoid

Phase 2

Terminated

Conditions: Mucous Membrane Pemphigoid
Cicatrizing Conjunctivitis

Interventions: Drug: Methotrexate
Drug: Baricitinib 2 MG [Olumiant]
Drug: Azathioprine
Drug: Mycophenolate

First Posted Date: 2022-03-02

Last Posted Date: 2023-11-07

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 2

Registration Number: NCT05263505

Locations: 🇺🇸
Barnes Jewish Hospital / Washington University in St. Louis, Saint Louis, Missouri, United States

Micophenolate Mofetil Versus Azathioprine in Myocarditis

Phase 3

Conditions: Lymphocytic Myocarditis (Disorder)
Dilated Cardiomyopathy
Heart Failure
Cardiomyopathies
Sudden Cardiac Death

Interventions: Drug: azathioprine of 150 [75; 150] mg per day
Drug: mycophenolate mofetil 2 g per day

First Posted Date: 2022-02-14

Last Posted Date: 2022-02-14

Lead Sponsor: I.M. Sechenov First Moscow State Medical University

Target Recruit Count: 50

Registration Number: NCT05237323

Locations: 🇷🇺
I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Bol'shaya Pirogovskaya Street 6, 1 Building ,, Russian Federation

BIVV020 (SAR445088) n Prevention and Treatment of Antibody-mediated Rejection (AMR)

Phase 2

Active, not recruiting

Conditions: Transplant Rejection

Interventions: Drug: BIVV020 (SAR445088)
Drug: Antithymocyte globulin (ATG)
Drug: Intravenous immunoglobulin (IVIg)
Drug: Rituximab or biosimilar
Drug: Corticosteroids
Drug: Tacrolimus
Drug: Mycophenolate

First Posted Date: 2021-12-14

Last Posted Date: 2025-01-10

Lead Sponsor: Sanofi

Target Recruit Count: 48

Registration Number: NCT05156710

Locations: 🇺🇸
Massachusetts General Hospital- Site Number : 8400007, Boston, Massachusetts, United States
🇺🇸
Cedars-Sinai Medical Center- Site Number : 8400100, Los Angeles, California, United States
🇺🇸
University of California Los Angeles Medical Center- Site Number : 8400103, Los Angeles, California, United States

and more 24 locations

New Clinical End-points in Patients With Primary Sjögren's Syndrome

Phase 2

Recruiting

Conditions: Primary Sjögren's Syndrome (pSS)

Interventions: Drug: Hydroxychloroquine 400mg/d
Drug: Placebo of Hydroxychloroquine 400mg/d
Drug: Leflunomide 20mg/d
Drug: Placebo of Leflunomide 20mg/d
Drug: Mycophenolate mofetil 2000mg/d
Drug: Placebo of Mycophenolate mofetil 2000mg/d

First Posted Date: 2021-11-09

Last Posted Date: 2024-11-01

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Target Recruit Count: 300

Registration Number: NCT05113004

Locations: 🇫🇷
Eric Hachulla, Lille, France
🇫🇷
Raphaele Seror, Le Kremlin-Bicêtre, Ile De France, France
🇫🇷
Jacques Morel, Montpellier, France

and more 4 locations

Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft

Phase 1

Recruiting

Conditions: Allogeneic Hematopoietic Cell Transplantation (HCT)
Advanced Hematologic Malignancies
Acute Leukemia
Chronic Myelogenous Leukemia
Myelodysplastic Syndromes
Myeloproliferative Disorders