Drugs / mycophenolic acid
last change Apr 2026 re-read 2 minutes ago

mycophenolic acid

Small molecule

Developed for
end stage renal failure · immunodeficiency disease · acute myeloid leukemia · autoimmune bullous skin disease · cardiovascular disorder · disease related to solid organ transplantation · dry eye syndrome · intermediate uveitis
+9 more · kidney disorder · minimal change disease · myasthenia gravis · nephrotic syndrome · systemic lupus erythematosus · chronic graft versus host disease · hepatocellular carcinoma · polyomavirus infectious disease · transplant rejection
Investigated by
Novartis Pharmaceuticals · Novartis · Assistance Publique - Hôpitaux de Paris · Astellas Pharma Canada, Inc. · Autoimmunity Centers of Excellence · CareDx
+28 more · Centre Hospitalier Universitaire Bordeaux · Centre Hospitalier Universitaire de Toulouse, FRANCE · Charite University, Berlin, Germany · East Carolina University · Erasmus Medical Center · Georgetown University · Hospital Universitario La Paz · Hospital Vall d'Hebron · National Institute of Allergy and Infectious Diseases (NIAID) · National Institutes of Health Clinical Center (CC) · Oriol Manuel · Qualitix Clinical Research Co., Ltd. · Rho Federal Systems Division, Inc. · Rodolfo Alejandro · STZ eyetrial · Surface Ophthalmics, Inc. · The University of Hong Kong · The University of Texas Health Science Center, Houston · University Hospital Tuebingen · University Hospital, Angers · University Hospital, Limoges · University of British Columbia · University of California, Davis · University of Florida · University of Pittsburgh · University of Saskatchewan · University of Utah · University of Wisconsin, Madison

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) MYFORTIC 2004-02-27 fda.gov

Trials 29 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT00298883 Feb 2006 → Aug 2008 end stage renal failure University of Florida Completed No outcome recorded
Phase 1 NCT00128947 Jul 2005 → May 2006 National Institutes of Health Clinical Center (CC) Completed No outcome recorded
Phase 22 trials
Phase 2 NCT05000216 Aug 2021 → Jun 2023 juvenile dermatomyositis, juvenile idiopathic arthritis, pediatric multiple sclerosis, pediatric systemic lupus erythematosus +3 National Institute of Allergy and Infectious Diseases (NIAID) Terminated No outcome recorded
Phase 2 NCT04734197 Jan 2021 → Mar 2022 dry eye syndrome Surface Ophthalmics, Inc. Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT02416388 Jan 2015 → Jul 2025 overdue acute myeloid leukemia University Hospital, Angers Recruiting No outcome recorded
Phase 38 trials
Phase 3 NCT02993133 Dec 2016 → Jan 2019 autoimmune bullous skin disease University Hospital, Limoges Completed No outcome recorded
Phase 3 NCT01092533 Mar 2010 → Oct 2015 intermediate uveitis STZ eyetrial Completed No outcome recorded
Phase 3 NCT01197040 Oct 2009 → Jul 2014 nephrotic syndrome Assistance Publique - Hôpitaux de Paris Completed No outcome recorded
Phase 3 NCT00514514 Jul 2007 → Jun 2015 Novartis Pharmaceuticals Completed No outcome recorded
Phase 3 NCT00504244 Jul 2007 → Aug 2009 systemic lupus erythematosus Erasmus Medical Center Terminated No outcome recorded
Phase 3 NCT00413920 Apr 2007 → Mar 2009 Novartis Completed No outcome recorded
Phase 3 NCT00284934 Dec 2005 → Jun 2008 kidney disorder Novartis Completed No outcome recorded
Phase 3 NCT00101738 Mar 2003 → May 2005 Novartis Pharmaceuticals Completed No outcome recorded
Phase 411 trials
Phase 4 NCT07570433 Apr 2026 → Jan 2028 expected cytomegalovirus infection Oriol Manuel Not yet recruiting No outcome recorded
Phase 4 NCT07203664 Oct 2025 → Dec 2026 expected Hospital Universitario La Paz Not yet recruiting No outcome recorded
Phase 4 NCT05060991 Sep 2021 → Dec 2026 expected COVID-19, immunodeficiency disease University of California, Davis Active not recruiting No outcome recorded
Phase 4 NCT02058875 Feb 2014 → Oct 2015 cardiovascular disorder, disease related to solid organ transplantation University of Saskatchewan Withdrawn No outcome recorded
Phase 4 NCT01185197 Sep 2010 → Jun 2017 minimal change disease The University of Hong Kong Completed No outcome recorded
Phase 4 NCT01149993 Jun 2010 → Jun 2012 Georgetown University Withdrawn No outcome recorded
Phase 4 NCT01044303 Jan 2010 → Apr 2013 East Carolina University Completed No outcome recorded
Phase 4 NCT00862979 Feb 2009 → Mar 2017 Novartis Pharmaceuticals Completed No outcome recorded
Phase 4 NCT00585468 Dec 2007 → Jul 2011 University of Utah Completed No outcome recorded
Phase 4 NCT00167492 Sep 2005 → Feb 2009 The University of Texas Health Science Center, Houston Withdrawn No outcome recorded
Phase not applicable5 trials
NCT02426502 Apr 2016 → Aug 2022 end stage renal failure University of British Columbia Unknown No outcome recorded
NCT01230502 Nov 2011 → May 2012 University of Wisconsin, Madison Terminated No outcome recorded
NCT00997412 May 2009 → May 2011 myasthenia gravis Qualitix Clinical Research Co., Ltd. Unknown No outcome recorded
NCT01999361 Jan 2009 → Jan 2027 expected type 1 diabetes mellitus Rodolfo Alejandro Recruiting No outcome recorded
NCT00336895 Nov 2006 → Nov 2008 immunodeficiency disease University of Pittsburgh Completed No outcome recorded
Also used as a comparator or background therapy in 64 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/25 trials
Phase 1/2 NCT04066114 Background Dec 2019 → Sep 2023 disease related to solid organ transplantation National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1/2 NCT02711826 Background Sep 2016 → Aug 2023 National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1/2 NCT02561767 Background Oct 2015 → Oct 2016 acute kidney tubular necrosis First Affiliated Hospital, Sun Yat-Sen University Unknown No outcome recorded
Phase 1/2 NCT00403416 Comparator Oct 2006 → May 2008 Novartis Pharmaceuticals Completed No outcome recorded
Phase 1/2 NCT00622895 Background Sep 2006 → Nov 2011 systemic sclerosis Fred Hutchinson Cancer Center Completed No outcome recorded
Phase 29 trials
Phase 2 NCT04883619 Background Jan 2026 → Feb 2028 lupus nephritis Janssen Research & Development, LLC Withdrawn No outcome recorded
Phase 2 NCT04376827 Background Sep 2020 → Feb 2023 lupus nephritis Janssen Research & Development, LLC Terminated No outcome recorded
Phase 2 NCT03663335 Background Nov 2018 → Oct 2021 Novartis Pharmaceuticals Completed No outcome recorded
Phase 2 NCT02550652 Background Nov 2015 → Jan 2019 lupus nephritis Hoffmann-La Roche Completed No outcome recorded
Phase 2 NCT01570348 Background Jul 2012 → Feb 2019 Crohn disease Fred Hutchinson Cancer Center Terminated No outcome recorded
Phase 39 trials
Phase 3 NCT04877288 Background Jul 2021 → Dec 2032 expected Bristol-Myers Squibb Recruiting No outcome recorded
Phase 3 NCT01244659 Background May → Aug 2014 EMS Withdrawn No outcome recorded
Phase 3 NCT01843348 Comparator Dec 2012 → Mar 2016 Novartis Pharmaceuticals Completed No outcome recorded
Phase 3 NCT01625377 Background Dec 2012 → Mar 2015 Novartis Pharmaceuticals Completed No outcome recorded
Phase 3 NCT01299922 Background Feb 2011 → Mar 2014 lupus nephritis Hospital Universitario Fundación Alcorcón Withdrawn No outcome recorded
Phase 434 trials
Phase 4 NCT07611214 Background Apr 2026 → Mar 2029 expected lupus nephritis Aurinia Pharmaceuticals Inc. Recruiting No outcome recorded
Phase 4 NCT04773392 Comparator Nov 2021 → Feb 2024 transplant rejection University of Southern California Terminated No outcome recorded
Phase 4 NCT04104438 Comparator Jan 2021 → Sep 2024 Fady M Kaldas, M.D., F.A.C.S. Completed No outcome recorded
Phase 4 NCT03828682 Background Jun 2019 → Jul 2021 immunodeficiency disease Simon Tremblay, PharmD, PhD Unknown No outcome recorded
Phase 4 NCT03555448 Comparator Jun 2018 → Nov 2023 Washington University School of Medicine Terminated No outcome recorded
Phase not applicable6 trials
NCT02736227 Background Mar 2016 → Mar 2021 Northwestern University Completed No outcome recorded
NCT01936519 Background Dec 2013 → Jul 2019 immunodeficiency disease, kidney failure Milton S. Hershey Medical Center Completed No outcome recorded
NCT07074951 Background Mar 2013 → Mar 2026 overdue IgA glomerulonephritis St. Petersburg State Pavlov Medical University Recruiting No outcome recorded
NCT01473732 Background Mar → Aug 2012 chronic transplant rejection, poisoning Montefiore Medical Center Terminated No outcome recorded
NCT00336817 Comparator Nov 2006 → Nov 2008 immunodeficiency disease University of Pittsburgh Completed No outcome recorded
Phase not stated1 trial
NCT01309022 Background type 1 diabetes mellitus National Institute of Allergy and Infectious Diseases (NIAID) No longer available No outcome recorded

Evidence & citations 27 cited values

Every value below carries the sentence it was read from. 96 sources stand behind the page.

FieldValueCited text
Known as mycophenolic acid “Patients will be able to receive the corticosteroid (CS) monotherapy or CS in combination with other immunosuppressive drugs (e.g. cyclophosphamide, mycophenolic acid) by a...” NCT07074951
53

“During the first month post-transplant, the subject receives everolimus (about 5-8 ng/mL) and tacrolimus with or without mycophenolic acid as part of standard of care procedures.” NCT02736227

“Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).” NCT01950819

“All patients will receive Mycophenolic acid at a dose of 2gm/day (Cellcept) or 1440mg/day (Myfortic) post-transplantation with dose adjustment as needed.” NCT00706680

“They will continue receiving their usual treatment with corticosteroids and either mycophenolate mofetil (MMF), mycophenolic acid, or azathioprine (AZA).” NCT00447265

“Basiliximab induction followed by tacrolimus, corticosteroids and mycophenolic acid with a switch to everolimus by post operative day 30” NCT04104438

“Reduction in dose in mycophenolate mofetil/mycophenolic acid (MMF) or azathioprine before and after receiving 3rd dose vaccination” NCT05060991

“Maintenance immunosuppressive therapy consists of low-dose tacrolimus and mycophenolic acid and steroids.” NCT02561767

“patients will receive prednisone 0.5 mg/kg/day combined with mycophenolic acid (MyforticR) 1440 mg/day.” NCT01197040

“standard-of-care treatment of mycophenolate mofetil (MMF) or mycophenolic acid (MPA) and glucocorticoid” NCT04883619

“standard-of-care treatment of mycophenolate mofetil (MMF)/mycophenolic acid (MPA)” NCT04376827

“Group 1 Donor Specific Regulation (DSR) +, Mycophenolic acid (MPA) monotherapy” NCT01230502

“Myfortic® is really the same active drug as Cellcept® (Mycophenolic acid)” NCT00167492

Mycophenolic acid (MPA) is an increasingly used form of corticosteroid.” NCT02993133

“Twice daily medication regimen (Tacrolimus and mycophenolic acid)” NCT03555448

mycophenolic acid plus tacrolimus after kidney transplantation.” NCT00555789

“Other Name: Mycophenolate Mofetil or Mycophenolic AcidNCT01435291

“hereafter referred to as mycophenolic acid [MPA]” NCT07570433

“Myfortic (mycophenolic acid)” NCT01149993

Mycophenolic Acid (Myfortic)” NCT01936519

mycophenolic acidNCT05000216

NCT01625377

NCT00956293

NCT03468478

NCT02123108

NCT00997412

NCT04734197

NCT03828682

NCT02328963

NCT00251004

NCT02974686

NCT01169701

NCT02416388

NCT02550652

NCT02498977

NCT01570348

NCT01309022

NCT01299922

NCT07203664

NCT01473732

NCT04773392

NCT04066114

NCT00128947

NCT01336296

NCT02711826

NCT07611214

NCT01560572

NCT00296244

NCT01624948

NCT01064791

NCT00622895

NCT00377962

NCT02036554

NCT00403416

Known as 68618 ChEMBL registry synonym — accepted as the source's own label CHEMBL866
Known as Acide mycophenolique ChEMBL registry synonym — accepted as the source's own label CHEMBL866
Known as Acido micofenolico ChEMBL registry synonym — accepted as the source's own label CHEMBL866
Known as Ceptava ChEMBL registry synonym — accepted as the source's own label CHEMBL866
Known as EC-MPA “Enteric-coated mycophenolic acid or EC-MPA (Myfortic) will be added to the regimen” NCT00296244
Known as EC-MPS “Enteric-coated Mycophenolate Sodium (EC-MPS) With Reduced-dose Tacrolimus Versus EC-MPS With Standard-dose Tacrolimus” NCT00284934
6

“Drug: Enteric-coated mycophenolate sodium (EC-MPS)” NCT00413920

“Enteric-coated mycophenolate sodium (EC-MPS)” NCT03663335

NCT00229138

NCT01033864

NCT00284947

NCT00611494

Known as Enteric Coated Mycophenolate Sodium (EC-MPS) ClinicalTrials.gov intervention name — accepted as the source's own label NCT01843348
3

NCT00332839

NCT00413920

NCT00634920

Known as Enteric-Coated Mycophenolate Sodium “We propose a prospective study evaluating the efficacy of Enteric Coated Mycophenolate Sodium (Myfortic) in decreasing the titers of anti-HLA alloantibodies in patients...” NCT00298883
9

“Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Kidney Transplant Recipients” NCT00229138

“Mycophenolate mofetil (MMF, CellCept) and Enteric-Coated Mycophenolate Sodium (EC-MPS, Myfortic)” NCT00611494

Enteric-coated mycophenolate sodium (EC-MPS)” NCT03663335

NCT00284934

NCT00443937

NCT00154310

NCT04877288

NCT00522548

NCT00862979

Known as ERL 080 ChEMBL registry synonym — accepted as the source's own label CHEMBL866
Known as MPA “maintenance immunosuppressive treatment regimen consisting of a combination of orally administered drugs (tacrolimus (Prograf®), sirolimus (Rapamune®), mycophenolate mofetil...” NCT01309022
15

“Participants were randomised (1:1) to receive everolimus with reduced-exposure calcineurin inhibitor (EVR+rCNI) or mycophenolic acid with standard-exposure CNI (MPA+sCNI).” PMID 34620664 Oct 2021

“Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone.” NCT01624948

“Mycophenolate mofetil (MMF) (up to 1000mg) or Mycophenolic acid (MPA) (up to 720mg) will be administered twice a day.” NCT04773392

“standard-of-care treatment of mycophenolate mofetil (MMF) or mycophenolic acid (MPA) and glucocorticoid” NCT04883619

“Mycophenolic Acid (MPA) has been shown to be an effective immune suppressant in organ transplantation.” NCT00167492

“Mycophenolic acid (MPA) is an increasingly used form of corticosteroid.” NCT02993133

“Low-dose tacrolimus + Mycophenolic acid (MPA) + steroids” NCT02561767

“hereafter referred to as mycophenolic acid [MPA]” NCT07570433

“Mycophenolic acid (MPA)/azathioprine (AZA)” NCT00377962

“enteric-coated mycophenolic acid (MPA)” PMID 23668931 May 2013

“Drug: Mycophenolic acid (MPA)” NCT01169701

“Drug: Mycophenolic Acid (MPA)” NCT00251004

“mycophenolic acid (MPA)” NCT00956293

“Mycophenolic acid (MPA)” NCT02416388

“mycophenolic acid (MPA)” NCT04376827

Known as Mycophenolate ChEMBL registry synonym — accepted as the source's own label CHEMBL866
Known as Mycophenolate mofetil impurity, mycophenolic acid- ChEMBL registry synonym — accepted as the source's own label CHEMBL866
Known as mycophenolate sodium Mycophenolate sodium (Myfortic®) is an antiproliferative immunosuppressant used in renal transplantation.” NCT00585468
1

“this was later followed by the introduction of mycophenolate sodium (Myfortic).” NCT02426502

Known as Mycophenolic acid sodium salt ChEMBL registry synonym — accepted as the source's own label CHEMBL866
Known as Mycophenolic sod ChEMBL registry synonym — accepted as the source's own label CHEMBL866
Known as Mycophenolic sodium ChEMBL registry synonym — accepted as the source's own label CHEMBL866
Known as Myfortic “The purpose of this study is to replace the mycophenolate mofetil (Cellcept) which is our usual therapy after liver transplantation with sodium mycophenolic acid (Myfortic®)” NCT00167492
28

“Patients taking mycophenolate mofetil (MMF) will receive 1.0 gram once daily, while patients receiving Myfortic will receive 720 mg once daily.” NCT02426502

“Campath-1H 30mg IV x 2 doses, rituximab 375mg/m2 IV x 1 dose, myfortic 720mg bid, cyclosporine po bid (target trough 200ng/ml) x 10-20 days” NCT00579592

“Mycophenolic Acid (Myfortic®) and Standard Dose of Cyclosporine A (Neoral®).” NCT02328963

“Group 1: Tacrolimus from EMS + Myfortic® + Steroids” NCT01244659

“acid mycophenolic (Myfortic)” NCT01197040

“Patients taking MyforticNCT00468936

NCT01038505

NCT01999361

NCT00504244

NCT01185197

NCT01149993

NCT01706471

NCT00298324

NCT02130817

NCT01018914

NCT01596062

NCT00579592

NCT01092533

NCT00585468

NCT02058875

NCT01079143

NCT02081755

NCT00336817

NCT00298883

NCT00101738

NCT00514514

NCT01044303

NCT00336895

Known as MyforticR “patients will receive prednisone 0.5 mg/kg/day combined with mycophenolic acid (MyforticR) 1440 mg/day.” NCT01197040
Known as NSC-116072 ChEMBL registry synonym — accepted as the source's own label CHEMBL866
Known as NSC-129185 ChEMBL registry synonym — accepted as the source's own label CHEMBL866
Known as RS-61443 [AS MOFETIL] ChEMBL registry synonym — accepted as the source's own label CHEMBL866
Known as Sodium mycophenalate ChEMBL registry synonym — accepted as the source's own label CHEMBL866
Known as Sodium mycophenolate ChEMBL registry synonym — accepted as the source's own label CHEMBL866
Known as sodium mycophenolic acid “The purpose of this study is to replace the mycophenolate mofetil (Cellcept) which is our usual therapy after liver transplantation with sodium mycophenolic acid (Myfortic®)” NCT00167492