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mycophenolate

Trade name: CellCept

Small moleculeapproved

Approved

May 3, 1995

Mycophenolic acid (MPA) possesses antibacterial, antifungal, antiviral, immunosuppressive and anticancer properties. Mycophenolic acid (MPA) is a fungal metabolite that was initially discovered by Bartolomeo Gosio in 1893 as an antibiotic against anthrax bacillus, Bacillus anthracis. It is an uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), and therefore inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation to DNA. It was approved under the brand name Myfortic for the prophylaxis of organ rejection in adult patients receiving a kidney transplant and is indicated for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant. Myfortic is to be used in combination with cyclosporine and corticosteroids. — NCATS

Clinical trial activity

945 trials · 469 clinical orgs · 41 marketing orgs

Phase 1
145
Phase 2
523
Phase 3
179
Phase 4
226

Earliest trial started Aug 1, 1997 (NCT00008450)

Timeline

1990s

  1. May 3, 1995

    Roche — Earliest FDA Approval

  2. May 3, 1995

    Roche — NDA Organization

  3. Jan 1, 1997

    Earliest Phase 1 Sponsor(trial)

  4. Jan 1, 1997

    Earliest Phase 2 Sponsor(trial)

  5. Jan 1, 1998

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Feb 27, 2004

    Novartis — NDA Secondary Org

  2. Jul 29, 2008

    Hikma — Marketing Organization

  3. Jul 29, 2008

    West-Ward Pharmaceutical — Marketing Organization

  4. Oct 15, 2008

    Sandoz — Marketing Organization

  5. Oct 15, 2008

    Novartis — Marketing Organization

  6. Apr 22, 2009

    Apotex — Marketing Organization

  7. May 4, 2009

    Accord Research — Marketing Organization

  8. May 4, 2009

    Mylan — Marketing Organization

  9. May 4, 2009

    Teva — Marketing Organization

  10. Dec 22, 2009

    Vintage — Marketing Organization

2010s

  1. Jun 10, 2010

    Strides Pharma Science — Marketing Organization

  2. Jul 16, 2010

    Amneal Pharmaceuticals — Marketing Organization

  3. Jul 16, 2010

    Oxford Pharmaceuticals — Marketing Organization

  4. Sep 13, 2010

    Dr. Reddy's Laboratories — Marketing Organization

  5. Sep 30, 2010

    Bedford Pharmaceuticals — Marketing Organization

  6. Nov 4, 2011

    Alkem Labs Ltd — Marketing Organization

  7. Jan 8, 2014

    Apicore — Marketing Organization

  8. Dec 15, 2014

    Jubilant Innovation Ltd. — Marketing Organization

  9. Oct 28, 2016

    Par Pharmaceuticals — Marketing Organization

  10. Oct 28, 2016

    Bristol-Myers Squibb — Marketing Organization

  11. Oct 28, 2016

    Endo Pharmaceuticals — Marketing Organization

  12. Feb 28, 2017

    Akorn, Inc. — Marketing Organization

  13. Feb 28, 2017

    Rising Pharmaceuticals — Marketing Organization

  14. Aug 31, 2017

    Zydus Discovery DMCC — Marketing Organization

  15. Nov 13, 2017

    Zhejiang Hisun Pharmaceutical Co. Ltd. — Marketing Organization

  16. Jan 8, 2019

    Concord Biotech Ltd — Marketing Organization

  17. Jan 8, 2019

    Tigermed Consulting Co., Ltd — Marketing Organization

  18. Feb 12, 2019

    VistaPharm, Inc. — Marketing Organization

2020s

  1. Jan 15, 2021

    Meitheal — Marketing Organization

  2. Feb 10, 2021

    Amta — Marketing Organization

  3. Jul 29, 2021

    Lannett Company, Inc. — Marketing Organization

  4. Nov 3, 2021

    TWi Biotechnology, Inc. — Marketing Organization

  5. Nov 29, 2021

    Biocon Limited — Marketing Organization

  6. Dec 23, 2022

    STERISCIENCE — Marketing Organization

  7. Jun 1, 2023

    BPI — Marketing Organization

  8. Sep 11, 2023

    Hetero Labs Ltd — Marketing Organization

  9. Nov 29, 2023

    Airis Pharma Pvt Ltd — Marketing Organization

  10. Feb 20, 2024

    Aurobindo Pharma — Marketing Organization

  11. May 1, 2024

    Azurity — Marketing Organization

  12. May 29, 2024

    WANBANG BIOPHARMS — Marketing Organization

  13. Nov 7, 2024

    WuXi — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewMay 3, 1995

Chemistry & pharmacology

Loading structure…

SMILES

COC1=C(C\C=C(/C)CCC(O)=O)C(O)=C2C(=O)OCC2=C1C
Mol. weight
320.3371 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Black box warningProdrug

Sources

Also known as

  • 2-morpholinoethyl (e)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-5-phthalanyl)-4-methyl-4-hexenoate
  • 2-morpholinoethyl (e)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-5-phthalanyl)-4-methyl-4-hexenoate
  • 68618
  • 68618
  • acide mycophenolique
  • acide mycophenolique
  • acido micofenolico
  • acido micofenolico
  • acidum mycophenolicum
  • acidum mycophenolicum
  • arzip
  • cellcept
  • cellcept
  • cellcept
  • cellcept
  • cellmune
  • (e)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-5-phthalanyl)-4-methyl-4-hexenoic acid
  • (e)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-5-phthalanyl)-4-methyl-4-hexenoic acid
  • erl-080
  • erl-080
  • linfonex
  • linfonex
  • linfonex
  • linfonex
  • linfonex
  • micofenolico acido
  • micofenolico acido
  • mmf
  • mmf
  • myclausen
  • mycophenolate
  • mycophenolate
  • mycophenolate
  • mycophenolate
  • mycophenolate
  • mycophenolate
  • mycophenolate
  • mycophenolate
  • mycophenolate mofetil
  • mycophenolate mofetil
  • mycophenolate mofetil
  • mycophenolate mofetil
  • mycophenolate mofetil
  • mycophenolate mofetil
  • mycophenolate mofetil
  • mycophenolate mofetil
  • mycophenolate mofetil
  • mycophenolate mofetil hcl
  • mycophenolate mofetil hcl
  • mycophenolate mofetil hcl
  • mycophenolate mofetil hydrochloride
  • mycophenolate mofetil hydrochloride
  • mycophenolate mofetil hydrochloride
  • mycophenolate mofetil hydrochloride
  • mycophenolate sod
  • mycophenolate sod
  • mycophenolate sodium
  • mycophenolate sodium
  • mycophenolate sodium
  • mycophenolate sodium
  • mycophenolic acid
  • mycophenolic acid
  • mycophenolic acid
  • mycophenolic acid
  • mycophenolic acid
  • mycophenolic acid
  • mycophenolic acid
  • mycophenolic acid
  • mycophenolic acid monosodium salt
  • mycophenolic acid morpholinoethyl ester
  • mycophenolic acid morpholinoethyl ester
  • mycophenolsäure
  • mycophenolsäure
  • myfenax
  • myfenax
  • myfenax
  • myfortic
  • myfortic
  • myfortic
  • myforticmycophenolic acid
  • rs-61443
  • rs-61443
  • rs-61443
  • rs-61443-190
  • rs-61443-190
  • rs-61443 [as mofetil]
  • rs-61443 [as mofetil]
  • sodium mycophenolate
  • sodium mycophenolate
  • sodium mycophenolate

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06996119Phase 1May 25, 2026City of Hope National Medical Center, National Cancer Institute (NCI)
NCT07214688Phase 2Nov 15, 2025Hackensack University Medical Center
NCT07162038Phase 1Nov 14, 2025National Cancer Institute (NCI)
NCT07206277N/ANov 1, 2025University of Alberta
NCT07203664Phase 4Oct 30, 2025Autonomous University of Madrid
NCT07138898Phase 2Sep 30, 2025New York University
NCT06942156Phase 4Aug 14, 2025Chong Kun Dang Pharmaceutical, Sungkyunkwan University
NCT06859424Phase 2Jul 25, 2025Center for International Blood and Marrow Transplant Research, Incyte, National Marrow Donor Program
NCT06973668Phase 2Jul 22, 2025University of Texas at Houston
NCT06828796Phase 2Jul 3, 2025Northside Hospital, Inc.
NCT06799195Phase 2Jun 23, 2025University of Nebraska
NCT06752694Phase 2Mar 10, 2025Incyte, University of Washington
NCT06807606Phase 2Mar 3, 2025University of Texas at Houston
NCT06789315N/AJan 20, 2025Institute of Liver and Biliary Sciences, India
NCT06568549Phase 4Jan 2, 2025Eurofins, Mayo Clinic, Transplant Genomics, Inc.
NCT06615050Phase 3Dec 9, 2024Blood and Marrow Transplant Clinical Trials Network, Incyte, National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)
NCT06682169Phase 3Nov 30, 2024Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
NCT06676384Phase 4Nov 30, 2024Christian Medical College, Vellore, India, India Alliance, Medical Research Council, University of Leicester, University of Queensland
NCT06872333Phase 2Nov 19, 2024University of Minnesota
NCT06478017Phase 2Nov 18, 2024Cedars-Sinai Medical Center, Emory University, Harvard University, National Institute of Allergy and Infectious Diseases (NIAID), New York University
Showing 20 of 945 trials
Page 1 / 48

Organizations

Research & Development (469)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government1491541997
NovartisFor profit1238851999
University of WashingtonAcademic/Hospital888741997
RocheFor profit703551997
AstellasFor profit392951999
National Heart, Lung, and Blood Institute (NHLBI)Government37641997
National Institute of Allergy and Infectious Diseases (NIAID)Government373231998
University of MinnesotaAcademic/Hospital282741999
University of Texas at HoustonAcademic/Hospital242432005
Johns Hopkins UniversityAcademic/Hospital191731998
Thomas Jefferson UniversityAcademic/Hospital171531999
University of California, San FranciscoAcademic/Hospital16751999
Bristol-Myers SquibbFor profit15942001
University of CincinnatiAcademic/Hospital151242002
Stanford UniversityAcademic/Hospital141222000
Center for International Blood and Marrow Transplant ResearchGovernment13532005
GenzymeFor profit13152001
Harvard UniversityAcademic/Hospital12742005
Chong Kun Dang PharmaceuticalFor profit11922009
Emory UniversityAcademic/Hospital11342002
469 organizations
Page 1 / 24

Marketing (52)

OrganizationOrg typeRelationshipDate
Accord ResearchFor profitMKTGMay 4, 2009
Airis Pharma Pvt LtdFor profitMKTGNov 29, 2023
Akorn, Inc.For profitMKTGFeb 28, 2017
Akorn, Inc.For profitSYNFeb 28, 2017
Alkem Labs LtdFor profitMKTGNov 4, 2011
Amneal PharmaceuticalsFor profitMKTGJul 16, 2010
AmtaFor profitMKTGFeb 10, 2021
ApicoreFor profitMKTGJan 8, 2014
ApotexFor profitMKTGApr 22, 2009
ApotexFor profitSYNApr 22, 2009
ApotexFor profitSYNAug 21, 2012
Aurobindo PharmaFor profitMKTGFeb 20, 2024
Aurobindo PharmaFor profitSYNJan 5, 2024
AzurityFor profitMKTGMay 1, 2024
BPIFor profitMKTGJun 1, 2023
Bedford PharmaceuticalsFor profitMKTGSep 30, 2010
Biocon LimitedFor profitMKTGNov 29, 2021
Bristol-Myers SquibbFor profitMKTGOct 28, 2016
Concord Biotech LtdFor profitMKTGJan 8, 2019
Dr. Reddy's LaboratoriesFor profitMKTGSep 13, 2010
Endo PharmaceuticalsFor profitMKTGOct 28, 2016
Hetero Labs LtdFor profitMKTGSep 11, 2023
HikmaFor profitMKTGJul 29, 2008
HikmaFor profitSYNJul 29, 2008
Jubilant Innovation Ltd.For profitMKTGDec 15, 2014
Lannett Company, Inc.For profitMKTGJul 29, 2021
MeithealFor profitMKTGJan 15, 2021
MylanFor profitMKTGMay 4, 2009
MylanFor profitSYNMar 31, 2017
MylanFor profitSYNJan 8, 2014
NovartisFor profitNDA2Feb 27, 2004
NovartisFor profitMKTGOct 15, 2008
Oxford PharmaceuticalsFor profitMKTGJul 16, 2010
Par PharmaceuticalsFor profitMKTGOct 28, 2016
Rising PharmaceuticalsFor profitMKTGFeb 28, 2017
RocheFor profitNDAMay 3, 1995
STERISCIENCEFor profitMKTGDec 23, 2022
STERISCIENCEFor profitSYNDec 23, 2022
SandozFor profitMKTGOct 15, 2008
Strides Pharma ScienceFor profitMKTGJun 10, 2010
TWi Biotechnology, Inc.For profitMKTGNov 3, 2021
TevaFor profitMKTGMay 4, 2009
TevaFor profitSYNOct 30, 2014
Tigermed Consulting Co., LtdFor profitMKTGJan 8, 2019
VintageFor profitMKTGDec 22, 2009
VistaPharm, Inc.For profitMKTGFeb 12, 2019
WANBANG BIOPHARMSFor profitMKTGMay 29, 2024
West-Ward PharmaceuticalFor profitMKTGJul 29, 2008
WuXiFor profitMKTGNov 7, 2024
Zhejiang Hisun Pharmaceutical Co. Ltd.For profitMKTGNov 13, 2017
Zydus Discovery DMCCFor profitMKTGAug 31, 2017
Zydus Discovery DMCCFor profitSYNMay 4, 2009