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Drug

Mycophenolate mofetil

Established medicine
ClassInosine-5'-monophosphate dehydrogenase (IMPDH) inhibitorResearchActive indication expansion

Also known as 2-morpholinoethyl (E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-5-phthalanyl)-4-methyl-4-hexenoate, CellCept, Mycophenolic acid morpholinoethyl ester, Myhibbin.

RxNorm68149ChEMBLCHEMBL1456UNII9242ECW6R0
1
Research papers
26
Active clinical trials
2
Protein targets
603
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Recall (Class II): MYCOPHENOLATE MOFETIL

Regulatory2026-08-26FDA

A Prospective Study of Optimal Cord Selection for Haplo-Cord Transplantation: Targeting the Inherited Paternal Antigen (IPA) and Matching for the Non-Inherited Maternal Antigen (NIMA)

Clinical trial2026-08-19Status changed to Completed · ClinicalTrials.gov

Allogeneic Hematopoietic Stem Cell Transplant for Patients With Mutations in GATA2 or the MonoMAC Syndrome

Clinical trial2026-08-07Results expected Q4 2027 · ClinicalTrials.gov

Label change: MYCOPHENOLATE MOFETIL (ANDA208119)

Regulatory2026-08-07FDA

Phase I Trial Integrating HLA-Haploidentical Anti-CD19 CAR T Cells With Post-Transplantation Cyclophosphamide-Based HLA-Haploidentical Hematopoietic Cell Transplantation

Clinical trial2026-08-04Results expected Q4 2030 · ClinicalTrials.gov

Efficacy & Safety of Pharmacokinetically-Driven Dosing of Mycophenolate Mofetil for the Treatment of Pediatric Proliferative Lupus Nephritis- A Double-Blind Placebo Controlled Clinical Trial

Clinical trial2026-07-31Primary completion · ClinicalTrials.gov

Label change: MYCOPHENOLATE MOFETIL (NDA050722)

Regulatory2026-07-29FDA

Label change: MYCOPHENOLATE MOFETIL (NDA050723)

Regulatory2026-07-29FDA

Label change: MYCOPHENOLATE MOFETIL (NDA050759)

Regulatory2026-07-29FDA

Label change: MYCOPHENOLATE MOFETIL (NDA216482)

Regulatory2026-07-29FDA

Label change: MYCOPHENOLATE MOFETIL HYDROCHLORIDE (NDA050758)

Regulatory2026-07-29FDA

Phase 3 clinical trial of steroids/mycophenolate mofetil vs steroids/placebo as therapy for acute GVHD: BMT CTN 0802.

Research2014-08-28Bolaños-Meade J · Blood

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Mycophenolate mofetil
Aliases & brands
2-morpholinoethyl (E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-5-phthalanyl)-4-methyl-4-hexenoateCellCeptMycophenolic acid morpholinoethyl esterMyhibbin
RxNorm CUI
68149
ChEMBL ID
CHEMBL1456
UNII
9242ECW6R0
Primary mechanism
Inosine-5'-monophosphate dehydrogenase (IMPDH) inhibitor
Regulatory jurisdictions
fdamhra

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Inosine-5'-monophosphate dehydrogenase 1
IMPDH1 · P20839
INHIBITORInosine-5'-monophosphate dehydrogenase (IMPDH) inhibitor
Inosine-5'-monophosphate dehydrogenase 2
IMPDH2 · P12268
INHIBITORInosine-5'-monophosphate dehydrogenase (IMPDH) inhibitor

Regulatory timeline

603 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
1995-05-03
Latest approval
2026-07-29
Authorities
FDA · MHRA
Total events
603
fdaU.S. Food and Drug Administration· 602 events
2026-08-26RecallSafety
Recall (Class II): MYCOPHENOLATE MOFETIL
Evidence ↗
2026-08-07Label change
Label change: MYCOPHENOLATE MOFETIL (ANDA208119)
Evidence ↗
2026-07-29Supplemental approval
Supplemental approval: MYCOPHENOLATE MOFETIL (ANDA090253)
Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2014-12-11Safety communicationSafety
Drug Safety Update: Mycophenolate mofetil: pure red cell aplasia
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

195 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
195
registered trials across all phases
LATEST COMPLETION 2025
26
Active studies
19
Recruiting
67
Late-stage (III+)
122
Completed
47
Discontinued
PHASE DISTRIBUTIONn = 195
Early Phase 12Phase 124Phase 1 / 212Phase 290Phase 2 / 35Phase 329Phase 422Phase N / A11

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Randomized, Multicenter Study of Belatacept, Everolimus, rATG and Early Steroid Withdrawal Versus Belatacept, Mycophenolate, rATG and Chronic Steroids in Renal Transplantation

Unknown statusPH IVUniversity of Cincinnatin=1202024

A Multicenter Clinical Trial: Risk Factors of Chinese Kidney Transplant Recipients DSA Based on MPA Immunosuppressive Regimen

Unknown statusPH IVFirst Affiliated Hospital Xi'an Jiaotong Universityn=3002023

A Crossover, Randomized and Multi-center Study to Evaluate the Efficacy and Safety of Abatacept Versus Mycophenolate Mofetil (MMF) in Treatment of PV

Unknown statusPH IVTongji Hospitaln=602022

Budesonide in Liver Transplantation

WithdrawnPH IVMontefiore Medical Center2022

Randomized, Open Label, Multicenter Study of Belatacept-based Early Steroid Withdrawal Regimen With Alemtuzumab or rATG Induction Compared to Tacrolimus-based Early Steroid Withdrawal Regimen With rATG Induction in Renal Transplantation

CompletedPH IVUniversity of Cincinnatin=3162019

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase I/II Clinical Trial of "Off-the-shelf" NK Cell Administration in Combination With Allogeneic SCT to Decrease Disease Relapse in Patients With High-risk Myeloid Malignancies Undergoing Matched Related, Matched Unrelated, One Antigen Mismatched Unrelated, or Haploidentical Stem-cell Transplantation

CompletedPH IIM.D. Anderson Cancer Centern=242025

A Phase II Study Evaluating Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts From HLA-Matched Related and Unrelated Donors for Prevention of GVHD

CompletedPH IIFred Hutchinson Cancer Centern=842025

Hematopoietic Cell Transplantation in the Treatment of Infant Leukemia and Myelodysplastic Syndrome

CompletedPH IIMasonic Cancer Center, University of Minnesotan=342025

A Randomized Open-label Study to Evaluate the Efficacy and Safety of Tacrolimus and Corticosteroids in Comparison With Mycophenolate Mofetil and Corticosteroids in Subjects With Class III/IV±V Lupus Nephritis

CompletedPH IIIThe University of Hong Kongn=1302024

An Outcome Study of Conventional Steroids Vs. Steroids Combined with Mycophenolate for the Management of Newly Diagnosed Immune Thrombocytopenia Purpura: a Cost Effective Measure in Developing Nations.

CompletedPH IIINational Institute of Blood and Marrow Transplant (NIBMT), Pakistann=1182024

A Multicenter, Single Arm, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Satralizumab in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)

CompletedPH IIIHoffmann-La Rochen=1192024

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Journals, researchers & institutions
Top journals
  • Blood1
Leading researchers
  • Alousi AM1
  • Antin JH1
  • Barowski K1
  • Bolaños-Meade J1
  • Carter SL1
  • Goldstein SC1
  • Hexner EO1
  • Ho VT1
Leading institutions
free-text, unnormalised
  • Abramson Cancer Center of the University of Pennsylvania1
  • City of Hope National Medical Center1
  • Clinical Research Division1
  • Dana-Farber Cancer Institute1
  • MD Anderson Cancer Center1
  • Medical College of Wisconsin1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.