Drugs / Mycophenolate Sodium
last change Aug 2026 re-read 2 minutes ago

Mycophenolate Sodium

Developed for
disease related to solid organ transplantation · acute transplant rejection · chronic kidney disease · lupus nephritis · transplant rejection · atopic eczema · autoimmune disease · cytomegalovirus infection
+10 more · digestive system disorder · gastrointestinal polyp · psoriasis · pulmonary sarcoidosis · Sjogren syndrome · conjunctivitis · end stage renal failure · graft versus host disease · mucous membrane pemphigoid · systemic lupus erythematosus
Investigated by
Novartis · Novartis Pharmaceuticals · Klemens Budde · Samsung Medical Center · Armin Goralczyk · Asan Medical Center
+24 more · CareDx · Cedars-Sinai Medical Center · Charite University, Berlin, Germany · Chulalongkorn University · Clinical Research Collaborative Network · DESCARTES Working Group On Transplantation · European Kidney Transplant Association (EKITA) · European Renal Association - European Dialysis and Transplant Association · Foothills Medical Centre · Health Intervention and Technology Assessment Program (HITAP) · Hoffmann-La Roche · Irmandade Santa Casa de Misericórdia de Porto Alegre · Massachusetts General Hospital · Medical University of South Carolina · NYU Langone Health · Poitiers University Hospital · Seoul National University Hospital · Transplant Genomics, Inc. · University Hospital Freiburg · University Hospital Muenster · University of Bologna · University of California, Los Angeles · University of California, San Francisco · Zhishui Chen

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

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

Trials 64 · started per year

today
US approved 2004
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20002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT00542763 Apr 2005 → Sep 2007 Sjogren syndrome University Hospital Muenster Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT00856505 Mar 2008 → Mar 2010 hematologic disorder University Hospital Freiburg Unknown No outcome recorded
Phase 23 trials
Phase 2 NCT07138898 Dec 2025 → Jan 2028 expected rheumatic disorder NYU Langone Health Recruiting No outcome recorded
Phase 2 NCT00890253 Jan 2010 → Jan 2012 chronic renal failure syndrome Armin Goralczyk Unknown No outcome recorded
Phase 2 NCT00423098 Feb 2007 → Nov 2009 lupus nephritis Novartis Pharmaceuticals Completed No outcome recorded
Phase 323 trials
Phase 3 NCT02334488 Dec 2014 → May 2019 chronic kidney disease Poitiers University Hospital Completed No outcome recorded
Phase 3 NCT01410448 Nov 2011 → Dec 2015 Novartis Pharmaceuticals Completed No outcome recorded
Phase 3 NCT01015456 Jan 2010 → Jan 2013 lupus nephritis Chulalongkorn University Terminated No outcome recorded
Phase 3 NCT00966836 Apr 2009 → Apr 2012 cytomegalovirus infection University of Bologna Unknown No outcome recorded
Phase 3 NCT00405652 Jan 2007 → Sep 2008 Novartis Pharmaceuticals Completed No outcome recorded
Phase 3 NCT00369278 Jun 2006 → Dec 2008 Novartis Pharmaceuticals Completed No outcome recorded
Phase 3 NCT00351377 Jun 2006 → Jun 2009 autoimmune disease Novartis Pharmaceuticals Completed No outcome recorded
Phase 3 NCT00267150 Nov 2005 → Jan 2008 Novartis Pharmaceuticals Completed No outcome recorded
Phase 3 NCT00149903 Jan 2005 → Jun 2006 Novartis Pharmaceuticals Completed No outcome recorded
Phase 3 NCT00284921 Apr 2004 → Aug 2006 Novartis Pharmaceuticals Terminated No outcome recorded
Phase 436 trials
Phase 4 NCT07352566 Aug 2026 → Jun 2030 expected atopic eczema, psoriasis University of California, San Francisco Not yet recruiting No outcome recorded
Phase 4 NCT05872568 Jun 2023 → Dec 2025 transplant rejection Zhishui Chen Unknown No outcome recorded
Phase 4 NCT04177095 Feb 2020 → Sep 2021 transplant rejection Massachusetts General Hospital Completed No outcome recorded
Phase 4 NCT02453867 Dec 2017 → Jul 2018 disease related to solid organ transplantation Klemens Budde Unknown No outcome recorded
Phase 4 NCT01822483 Apr 2013 → Mar 2015 Irmandade Santa Casa de Misericórdia de Porto Alegre Completed No outcome recorded
Phase 4 NCT01801280 Jan 2012 → Mar 2013 disease related to solid organ transplantation Klemens Budde Completed No outcome recorded
Phase 4 NCT01817322 Jun 2011 → Aug 2013 chronic kidney disease Samsung Medical Center Completed No outcome recorded
Phase 4 NCT01056822 May 2010 → Apr 2013 Novartis Pharmaceuticals Completed No outcome recorded
Phase 4 NCT01159080 Apr 2010 → Oct 2016 Asan Medical Center Completed No outcome recorded
Phase 4 NCT00652834 Apr 2009 → Mar 2011 gastrointestinal polyp University of California, Los Angeles Completed No outcome recorded
Also used as a comparator or background therapy in 44 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 03 trials
Phase 0 NCT06663046 Background Jul 2025 → Dec 2027 plasma cell myeloma, refractory plasma cell neoplasm Wondercel Biotech (ShenZhen) Suspended No outcome recorded
Phase 0 NCT06662227 Background Oct 2024 → Dec 2027 B-cell neoplasm, lymphoid leukemia Wondercel Biotech (ShenZhen) Suspended No outcome recorded
Phase 0 NCT06653023 Background Oct 2024 → Oct 2027 hepatocellular carcinoma, non-small cell lung carcinoma Wondercel Biotech (ShenZhen) Suspended No outcome recorded
Phase 12 trials
Phase 1 NCT04375631 Background Dec 2020 → Feb 2027 expected acute undifferentiated leukemia, chronic myelomonocytic leukemia, mixed phenotype acute leukemia, myelodysplastic syndrome Fred Hutchinson Cancer Center Recruiting No outcome recorded
Phase 1 NCT02167958 Background Feb 2015 → Sep 2019 leukemia, lymphoma, myelodysplastic syndrome, myelofibrosis Rafic Farah, MD Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT00810602 Background Jan 2009 → Apr 2013 graft versus host disease, hematopoietic and lymphoid cell neoplasm Pavan Reddy, MD Completed No outcome recorded
Phase 214 trials
Phase 2 NCT06646497 Background Jan 2025 → Jan 2030 expected acquired aplastic anemia Assistance Publique - Hôpitaux de Paris Recruiting No outcome recorded
Phase 2 NCT05156710 Background Jun 2022 → Oct 2025 overdue transplant rejection Sanofi Active not recruiting No outcome recorded
Phase 2 NCT05263505 Comparator Feb 2022 → Sep 2023 conjunctivitis, mucous membrane pemphigoid Washington University School of Medicine Terminated No outcome recorded
Phase 2 NCT04195633 Background Jan 2021 → Apr 2027 expected Burkitt lymphoma, Hodgkins lymphoma, anaplastic large cell lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma +10 Fred Hutchinson Cancer Center Recruiting No outcome recorded
Phase 2 NCT03917797 Background Apr 2019 → Dec 2024 lupus nephritis, systemic lupus erythematosus Universidad de los Andes, Chile Unknown No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT07412470 Background Mar 2026 → Aug 2029 expected transplant rejection Sanofi Recruiting No outcome recorded
Phase 2/3 NCT00533624 Comparator Dec 2004 → Feb 2006 end stage renal failure University of Miami Completed No outcome recorded
Phase 35 trials
Phase 3 NCT04945096 Background Jul 2021 → Jul 2025 graft versus host disease The First Affiliated Hospital of Soochow University Unknown No outcome recorded
Phase 3 NCT01680861 Comparator Nov 2012 → Dec 2014 Gaetano Ciancio Completed No outcome recorded
Phase 3 NCT01639339 Background Jul 2012 → Jul 2019 lupus nephritis GlaxoSmithKline Completed No outcome recorded
Phase 3 NCT00425308 Comparator Oct 2006 → May 2009 Novartis Pharmaceuticals Completed No outcome recorded
Phase 3 NCT00308425 Background Oct 2002 → Jun 2005 Novartis Completed No outcome recorded
Phase 416 trials
Phase 4 NCT04936282 Comparator Jul 2022 → Jun 2024 chronic transplant rejection Canary Isles Institute for Health Research Foundation Unknown No outcome recorded
Phase 4 NCT04424602 Comparator Apr → Sep 2021 lupus nephritis Al-Azhar University Completed No outcome recorded
Phase 4 NCT02953873 Background May 2017 → Sep 2018 immunodeficiency disease Medical University of South Carolina Completed No outcome recorded
Phase 4 NCT02671318 Comparator Sep 2015 → Dec 2019 cytomegalovirus infection Hospital do Rim e Hipertensão Unknown No outcome recorded
Phase 4 NCT06584773 Comparator Jun 2015 → Aug 2024 overdue disease related to solid organ transplantation University of Sao Paulo General Hospital Recruiting No outcome recorded
Phase not applicable1 trial
NCT01807767 Background Mar 2013 → Jul 2015 Medical College of Wisconsin Withdrawn No outcome recorded

Evidence & citations 15 cited values

Every value below carries the sentence it was read from. 116 sources stand behind the page.

FieldValueCited text
Known as Mycophenolate Sodium “One day after the completion of fludarabine preconditioning (D-2), initiate oral mycophenolate sodium at a dose of 1440 mg twice daily (BID) for 15 consecutive days, or extend...” NCT06653023
76

“Organ Function Preservation by the Combination Treatment of the optImuM Dose of calcineUrin Inhibitor and Mycophenolate Sodium in Kidney Recipients: OPTIMUM Study” NCT01159080

“A Prospective, Open-label, Multicenter Extension Study on the Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Heart Transplant Recipients” NCT00238446

“Myfortic® is an advanced, enteric coated formulation of mycophenolate sodium (EC-MPS) that delays the release of the active ingredient, MPA.” NCT00652834

“de-novo CNI-free immunosuppression with basiliximab, mycophenolate sodium, prednisolone and everolimus” PMID 20380712 Apr 2010

“initiate oral mycophenolate sodium at a dose of 1440 mg twice daily (BID) for 15 consecutive days” NCT06662227

“Mycophenolate mofetil: 750mg po bid x 36 months OR mycophenolate sodium 540mg po bid x 36 months” NCT01053221

“Patients receiving EC mycophenolate sodium will be dosed 720 mg twice daily (1440 mg/day).” NCT01729494

Mycophenolate Sodium(Myfortic)commenced the following day at equimolar doses orally BID.” NCT00676221

“Myfortic® (enteric-coated mycophenolate sodium) will be administered, per protocol.” NCT03644667

“In this study, the IEM was combined to enteric-coated mycophenolate sodium (ECMPS).” PMID 23823651 Aug 2013

“initiate oral mycophenolate sodium at a dose of 1440 mg twice daily (BID)” NCT06663046

“Myfortic® (mycophenolate sodium) may be used as a replacement for MMF.” NCT01790594

“Myfortic (Enteric Coated Mycophenolate Sodium) Conversion” NCT01807767

“standard dose of Enteric-Coated Mycophenolate SodiumNCT01817322

Mycophenolate sodium (MPS)” NCT01056822

NCT00537862

NCT07412470

NCT00434590

NCT00171392

NCT00239044

NCT00149903

NCT00400400

NCT00171379

NCT00150020

NCT00240955

NCT01410448

NCT01680861

NCT00239070

NCT00542763

NCT00239083

NCT00400647

NCT00574197

NCT00238966

NCT01801280

NCT02953873

NCT00154206

NCT00312143

NCT00405652

NCT00308425

NCT00238953

NCT00646737

NCT00239031

NCT01112215

NCT00238940

NCT00154232

NCT01822483

NCT00154245

NCT00241059

NCT00419926

NCT00965094

NCT00371826

NCT01015456

NCT00533624

NCT00574743

NCT05872568

NCT00239018

NCT00529269

NCT00423098

NCT00369278

NCT00267150

NCT00239057

NCT00149864

NCT00239005

NCT00238992

NCT02334488

NCT00351377

NCT00238979

NCT00149968

NCT00149916

NCT00284921

NCT04375631

NCT00150007

NCT00149942

NCT00149929

NCT00856505

NCT04195633

Known as EC-MPS “The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro...” NCT00434590
40

“In a prospective clinical trial, the immunosuppressive therapy of renal graft recipients was converted from MMF to enteric-coated mycophenolate sodium (EC-MPS) to identify a...” PMID 21693250 Jun 2011

“Enteric-Coated Mycophenolate Sodium (EC-MPS) Administration in Maintenance Renal Transplant Patients Receiving Cyclosporine Microemulsion (CsA-ME) and Steroids, for the...” NCT00239057

“To compare the efficacy and safety of enteric-coated mycophenolate sodium (EC-MPS) versus azathioprine (AZA) in patients with active systemic lupus erythematosus (SLE) disease.” PMID 28450313 Apr 2017

“Study of Enteric-Coated Mycophenolate Sodium (EC-MPS) Plus Reduced-dose Cyclosporine Microemulsion (CsA-ME) Compared to EC-MPS Plus Standard Dose CsA-ME” NCT00239031

“The benefit of conversion from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) in terms of gastrointestinal symptom burden” PMID 18091520 Dec 2007

“treatment with enteric-coated mycophenolate sodium (EC-MPS) improves gastrointestinal (GI) tolerability compared with mycophenolate mofetil (MMF).” PMID 21760569 Aug 2011

“Myfortic® is an advanced, enteric coated formulation of mycophenolate sodium (EC-MPS) that delays the release of the active ingredient, MPA.” NCT00652834

“The study group received reduced-dose tacrolimus, 1080-1440 mg/day of enteric-coated mycophenolate sodium (EC-MPS), and corticosteroids.” PMID 29891834 Jun 2018

“Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily.” NCT00351377

“Enteric-coated mycophenolate sodium (ECMPS) has been developed as an alternative agent” PMID 18261583 Jan 2008

“In this study, the IEM was combined to enteric-coated mycophenolate sodium (ECMPS).” PMID 23823651 Aug 2013

“the enteric-coated mycophenolate sodium (EC-MPS) formulation” NCT01822483

“Conversion to Enteric-Coated Mycophenolate Sodium (EC-MPS)” NCT00239005

“Enteric-coated Mycophenolate sodium (EC-MPS), valsartan” NCT00308425

“Enteric-coated Mycophenolate sodium (EC-MPS)” NCT00284921

“Enteric-coated Mycophenolate sodium (EC-MPS)” NCT00312143

“Enteric-Coated Mycophenolate Sodium (EC-MPS)” NCT00529269

“Enteric-coated Mycophenolate sodium (EC-MPS)” NCT00150007

“Enteric-coated mycophenolate sodium (EC-MPS)” NCT00267150

“Enteric-coated Mycophenolate sodium (EC-MPS)” NCT00149942

“Enteric-coated mycophenolate sodium (EC-MPS)” NCT00400400

“Enteric-Coated Mycophenolate Sodium (EC-MPS)” NCT00537862

“Enteric Coated Mycophenolate Sodium (EC-MPS)” NCT01680861

“Enteric-Coated Mycophenolate Sodium (EC-MPS)” NCT00239070

“Enteric-Coated Mycophenolate Sodium (EC-MPS)” NCT05872568

“Enteric-Coated Mycophenolate Sodium (EC-MPS)” NCT00238979

“Enteric-Coated Mycophenolate Sodium (EC-MPS)” NCT00241059

“Enteric-Coated Mycophenolate Sodium (EC-MPS)” NCT00238940

“Enteric-coated Mycophenolate sodium (EC-MPS)” NCT00238992

“Enteric-Coated Mycophenolate Sodium (EC-MPS)” NCT00238966

“Enteric-coated Mycophenolate sodium (EC-MPS)” NCT00240955

“Enteric Coated Mycophenolate Sodium (EC-MPS)” NCT00965094

“Enteric-Coated Mycophenolate Sodium (EC-MPS)” NCT00239018

“Enteric-Coated Mycophenolate sodium (EC-MPS)” NCT00154245

“Enteric-coated mycophenolate sodium (EC-MPS)” NCT00369278

“Enteric-coated Mycophenolate Sodium (EC-MPS)” NCT00574743

“Enteric-coated Mycophenolate sodium (EC-MPS)” NCT00239044

“Enteric-Coated Mycophenolate Sodium (EC-MPS)” NCT00239083

“Enteric-Coated Mycophenolate Sodium (EC-MPS)” NCT00154206

“Enteric-coated Mycophenolate sodium (EC-MPS)” NCT00405652

Known as Enteric-coated Mycophenolate sodium “Study of Enteric-Coated Mycophenolate Sodium (EC-MPS) Plus Reduced-dose Cyclosporine Microemulsion (CsA-ME) Compared to EC-MPS Plus Standard Dose CsA-ME” NCT00239031
6

Enteric-coated Mycophenolate sodium (EC-MPS)” NCT00284921

Enteric-Coated Mycophenolate Sodium (EC-MPS)” NCT00529269

Enteric-Coated Mycophenolate Sodium (EC-MPS)” NCT00537862

“Enteric Coated Mycophenolate Sodium (EC-MPS)” NCT00965094

Enteric-Coated Mycophenolate Sodium (EC-MPS)” NCT00154206

Enteric-Coated Mycophenolate Sodium (EC-MPS)” NCT00239070

Known as Enteric-coated mycophenolate sodium: EC-MPS, Myfortic Enteric-coated mycophenolate sodium: EC-MPS, MyforticNCT00890253
Known as ERL080 “This study will evaluate the safety and efficacy of EC-MPS (ERL080) in comparison to MMF in de novo heart recipients.” NCT00574743
Known as MMF “Mycophenolatemofetil(MMF) is widely used in solid organ transplantation and it reduces the rate of acute rejection following renal transplantation.” NCT04424602
1

“mycophenolate (MMF) will begin from D+5.” NCT06646497

Known as MPA “Mycophenolate sodium (MPA)” NCT00371826
Known as MPS “Mycophenolate sodium (MPS) with enteric coating was developed with intention of reducing such gastrointestinal adverse events associated with MPA.” PMID 26398638 Jul 2015
1

“Mycophenolate sodium (MPS)” NCT01056822

Known as mycophenolate “Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressive...” NCT02885610
29

“Stepwise reduction in the dose, and ultimate discontinuation of, all non-belatacept immunosuppression (mycophenolate, sirolimus, everolimus, prednisone) guided by monitoring of...” NCT04177095

“standard maintenance immunosuppression: tacrolimus, mycophenolate, prednisone” NCT06584773

“Methylprednisolone; Cyclophosphamide; Prednisone; MycophenolateNCT03917797

Mycophenolate 15 mg/kg bid i.v. or per os day +5 through +28.” NCT03434704

“tacrolimus (0.1 mg/kg/day) and mycophenolate (1000 mg/day)” NCT04936282

“conversion of azathioprine or mycophenolate to sirolimus” NCT02671318

“followed by mycophenolate for maintenance therapy” NCT01639339

mycophenolate (MMF) will begin from D+5.” NCT06646497

NCT00810602

NCT00866684

NCT00639717

NCT02683291

NCT01490723

NCT07138898

NCT02453867

NCT04424602

NCT02152345

NCT01927588

NCT00262132

NCT07352566

NCT05156710

NCT02167958

NCT01895049

NCT00425308

NCT05263505

NCT00966836

NCT00775632

NCT04945096

NCT01354301

Known as Mycophenolatemofetil Mycophenolatemofetil(MMF) is widely used in solid organ transplantation and it reduces the rate of acute rejection following renal transplantation.” NCT04424602
Known as Mycopherol sodium enteric-coated tablets Mycopherol sodium enteric-coated tablets (EC-MPS)” NCT05872568
Known as Myfortic “The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro...” NCT00434590
8

“Mycophenolate sodium (Myfortic®) is a newly developed enteric-coated tablet version of mycophenolate mofetil (Cellcept®) which is currently used as therapy for the prevention...” NCT00574197

“Mycophenolate Sodium(Myfortic)commenced the following day at equimolar doses orally BID.” NCT00676221

Myfortic® (mycophenolate sodium) may be used as a replacement for MMF.” NCT01790594

Myfortic (Enteric Coated Mycophenolate Sodium) Conversion” NCT01807767

“Enteric-Coated Mycophenolate Sodium(Myfortic®)” NCT01817322

“Enteric-coated mycophenolate sodium (Myfortic)” NCT00419926

Myfortic® (mycophenolic acid delayed release)” NCT00533624

“Original EC-MPS(myfortic)” NCT05872568

Known as Ruiyirong “Imitation EC-MPS(Ruiyirong)” NCT05872568
Known as Sodium Mycophenolate ClinicalTrials.gov intervention name — accepted as the source's own label NCT02084446
Route Oral Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium” NCT00239005