Drugs / mycophenolic acid
mycophenolic acid
also known as
myfortic · MPA · mycophenolate sodium · 68618 · Acide mycophenolique · Acido micofenolico · Ceptava · EC-MPA · +14 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | MYFORTIC | — | 2004-02-27 | fda.gov ↗ |
Trials 25
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 Stop: Enrollment |
| Phase 2 | NCT04734197 | Jan 2021 → Mar 2022 | dry eye syndrome | Surface Ophthalmics, Inc. | Completed | No outcome recorded |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT02416388 | Jan 2015 → Jul 2025 overdue | acute myeloid leukemia | University Hospital, Angers | Recruiting | Met primary |
| Phase 36 trials · 1 met primary · 1 missed | ||||||
| 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 | Missed primary |
| Phase 3 | NCT00504244 | Jul 2007 → Aug 2009 | systemic lupus erythematosus | Erasmus Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00514514 | Jul 2007 → Jun 2015 | — | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT00101738 | Mar 2003 → May 2005 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 49 trials · 1 met primary | ||||||
| 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 Stop: Business |
| Phase 4 | NCT01185197 | Sep 2010 → Jun 2017 | minimal change disease | The University of Hong Kong | Completed | Met primary |
| 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 | 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 |
| Comparator or background therapy53 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 | Missed primary |
| 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 2 | NCT04883619 Background | Jan 2026 → Feb 2028 | lupus nephritis | Janssen Research & Development, LLC | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT04376827 Background | Sep 2020 → Feb 2023 | lupus nephritis | Janssen Research & Development, LLC | Terminated | Missed primary Stop: Enrollment |
| Phase 2 | NCT02550652 Background | Nov 2015 → Jan 2019 | lupus nephritis | Hoffmann-La Roche | Completed | Met primary |
| Phase 2 | NCT01570348 Background | Jul 2012 → Feb 2019 | Crohn disease | Fred Hutchinson Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01596062 Background | Mar 2012 → Mar 2013 | — | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT01064791 Comparator | Dec 2009 → Aug 2012 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00447265 Background | Feb 2008 → Mar 2009 | lupus nephritis | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded |
| Phase 2 | NCT00555789 Comparator | Oct 2007 → Mar 2008 | — | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT01244659 Background | May → Aug 2014 | — | EMS | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT01625377 Background | Dec 2012 → Mar 2015 | — | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT01299922 Background | Feb 2011 → Mar 2014 | lupus nephritis | Hospital Universitario Fundación Alcorcón | Withdrawn | No outcome recorded |
| Phase 3 | NCT01079143 Background | Sep 2009 → Jun 2012 | renal fibrosis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00468936 Comparator | May 2007 → Dec 2009 | — | McGill University Health Centre/Research Institute of the McGill University Health Centre | Unknown | No outcome recorded |
| Phase 3 | NCT00298324 Comparator | Sep 2006 → Nov 2009 | chronic graft versus host disease | European Society for Blood and Marrow Transplantation | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00251004 Comparator | Oct 2005 → Aug 2009 | transplant rejection | Novartis | Completed | No outcome recorded |
| 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 Stop: Enrollment |
| Phase 4 | NCT03468478 Comparator | Jun 2017 → Mar 2021 | disease related to solid organ transplantation | Hospital do Rim e Hipertensão | Completed | Met primary |
| Phase 4 | NCT02974686 Comparator | Nov 2016 → Sep 2019 | digestive system disorder, transplant rejection | Washington University School of Medicine | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02498977 Comparator | Oct 2015 → Dec 2021 | liver disorder | King's College London | Terminated | No outcome recorded |
| Phase 4 | NCT02130817 Background | Sep 2014 → Oct 2015 | end stage renal failure, transplant rejection | University of Wisconsin, Madison | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02328963 Comparator | May 2014 → Oct 2018 | cytomegalovirus infection, disease related to solid organ transplantation | University Hospital, Bordeaux | Completed | No outcome recorded |
| Phase 4 | NCT02081755 Comparator | Mar 2014 → Mar 2027 expected | hepatocellular carcinoma | Baylor Research Institute | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT01950819 Comparator | Dec 2013 → Feb 2017 | end stage renal failure | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 4 | NCT02036554 Comparator | Mar 2013 → Dec 2015 | — | Seoul St. Mary's Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01624948 Comparator | Sep 2012 → Feb 2015 | polyomavirus infectious disease | University of California, San Francisco | Completed | Missed primary |
| Phase 4 | NCT01435291 Background | Oct 2011 → May 2013 | — | Centre Hospitalier Universitaire de Nice | Completed | No outcome recorded |
| Phase 4 | NCT01560572 Background | Apr 2011 → Apr 2015 | impaired renal function disease | University Medical Center Groningen | Completed | Met primary |
| Phase 4 | NCT02123108 Background | Jan 2011 → Jan 2015 | — | University of California, Los Angeles | Completed | No outcome recorded |
| Phase 4 | NCT01336296 Comparator | Sep 2010 → Apr 2014 | disease related to solid organ transplantation | University of Cincinnati | Completed | No outcome recorded |
| Phase 4 | NCT01169701 Background | Aug 2010 → Mar 2014 | — | Novartis Pharmaceuticals | Completed | Missed primary |
| Phase 4 | NCT01038505 Comparator | Jan 2010 → Jan 2013 | — | University of Miami | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT00956293 Background | Jul 2009 → Mar 2013 | — | Novartis Pharmaceuticals | Terminated | Missed primary |
| Phase 4 | NCT01706471 Comparator | Jun 2009 → Jan 2013 | — | Yonsei University | Completed | No outcome recorded |
| Phase 4 | NCT01018914 Background | Apr 2009 → Dec 2010 | hepatic infarction | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 4 | NCT00706680 Background | Feb 2008 → Feb 2009 | diabetes mellitus, transplant rejection | University Health Network, Toronto | Unknown | No outcome recorded |
| Phase 4 | NCT00296244 Background | Feb 2006 → May 2008 | cirrhosis of liver | Thomas Jefferson University | Completed | No outcome recorded |
| Phase 4 | NCT00377962 Comparator | Dec 2005 → Feb 2010 | disease related to solid organ transplantation | Novartis Pharmaceuticals | Completed | No outcome recorded |
| — | 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 Stop: Enrollment |
| — | NCT00336817 Comparator | Nov 2006 → Nov 2008 | immunodeficiency disease | University of Pittsburgh | Completed | No outcome recorded |
| — | NCT00579592 Background | Apr 2006 → Mar 2007 | acute transplant rejection | University of Wisconsin, Madison | Terminated | No outcome recorded |
| — | NCT01309022 Background | — | type 1 diabetes mellitus | National Institute of Allergy and Infectious Diseases (NIAID) | No longer available | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2019-12-18 | Lupin Limited | Regulatory Lupin’s Alliance Partner Concord Receives Approval for Mycophenolic Acid Delayed-Release Tablets USP lupin.com ↗
announced that ithas received approval from the United States Food and Drug Administration (U.S. FDA) for Mycophenolic Acid Delayed-Release Tablets USP, 180 mg and 360 mg |
| 2019-11-11 | Hoffmann-La Roche | Results Roche’s Gazyva (obinutuzumab), in combination with standard of care, more than doubles the percentage of lupus nephritis patients achieving complete renal response, compared to standard of care alone roche.com ↗
The study met the primary endpoint with Gazyva, in combination with standard of care (mycophenolate mofetil or mycophenolic acid and corticosteroids), demonstrating superiority compared to placebo plus standard of care. |
| 2019-11-07 | Aurinia Pharmaceuticals Inc. | Results Aurinia Completes Voclosporin Drug-Drug Interaction Study Demonstrating No Clinically Significant Interaction With Mycophenolate Mofetil auriniapharma.com ↗
The study results indicate that the coadministration of voclosporin with MMF had no clinically significant impact on MPA blood concentrations. |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-04-06 | Lupin Limited | LuaLupin launches Mycophenolic Acid Delayed-Release Tablets USP lupin.com ↗ |
| 2019-12-18 | Lupin Limited | Lupin’s Alliance Partner Concord Receives Approval for Mycophenolic Acid Delayed-Release Tablets USP lupin.com ↗ |
| 2019-11-11 | Hoffmann-La Roche | Roche’s Gazyva (obinutuzumab), in combination with standard of care, more than doubles the percentage of lupus nephritis patients achieving complete renal response, compared to standard of care alone roche.com ↗ |
| 2019-11-07 | Aurinia Pharmaceuticals Inc. | Aurinia Completes Voclosporin Drug-Drug Interaction Study Demonstrating No Clinically Significant Interaction With Mycophenolate Mofetil auriniapharma.com ↗ |
| 2019-10-14 | Hoffmann-La Roche | Phase III PEMPHIX study shows Roche’s MabThera/Rituxan (rituximab) superior to mycophenolate mofetil in patients with pemphigus vulgaris roche.com ↗ |
Evidence & citations 25 cited values
Every value below carries the sentence it was read from. 81 sources stand behind the page.
| Field | Value | Cited 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 ↗ “They will continue receiving their usual treatment with corticosteroids and either mycophenolate mofetil (MMF), mycophenolic acid, or azathioprine (AZA).” NCT00447265 ↗ “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 ↗ “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 ↗ “standard-of-care treatment of mycophenolate mofetil (MMF) or mycophenolic acid (MPA) and glucocorticoid” NCT04883619 ↗ “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)/mycophenolic acid (MPA)” NCT04376827 ↗ |
| 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 | 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 ↗ |
| 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 |
| 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 Myfortic” NCT00468936 ↗ |
| 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 ↗ |
| Modality | Small molecule | — CHEMBL866 ↗ |
| Route | Oral | “by mouth” NCT00167492 ↗ |