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Drug

Mycophenolic Acid

Approved · FDA / EMA
ClassInosine-5'-monophosphate dehydrogenase (IMPDH) inhibitorEmerging researchLate-stage development
Also known as (e)-6-(4-Hydroxy-6-methoxy-7-methyl-3-oxo-5-phthalanyl)-4-methyl-4-hexenoic acid, Acide mycophenolique, Acido micofenolico, Acidum mycophenolicum+3 more

(e)-6-(4-Hydroxy-6-methoxy-7-methyl-3-oxo-5-phthalanyl)-4-methyl-4-hexenoic acid, Acide mycophenolique, Acido micofenolico, Acidum mycophenolicum, Micofenolico acido, Mycophenolsäure, Myfortic.

RxNorm7145ChEMBLCHEMBL866ATCL04AA06UNIIHU9DX48N0T
2
Research papers
3
Active clinical trials
2
Protein targets
98
Regulatory events
Latest activity
beta

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

Label change: MYCOPHENOLIC ACID (NDA050791)

Regulatory2026-07-29FDA

Supplemental approval: MYCOPHENILIC ACID (ANDA091248)

Regulatory2026-07-29FDA

Supplemental approval: MYCOPHENOLIC ACID (ANDA091558)

Regulatory2026-07-29FDA

Supplemental approval: MYCOPHENOLIC ACID (ANDA202555)

Regulatory2026-07-29FDA

Supplemental approval: MYCOPHENOLIC ACID (ANDA208315)

Regulatory2026-07-29FDA

Supplemental approval: MYCOPHENOLIC ACID (ANDA211173)

Regulatory2026-07-29FDA

Myfortic® Monotherapy to Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss

Clinical trial2026-03-23Results expected Q1 2027 · ClinicalTrials.gov

A 36 Month Multi-center, Open Label, Randomized, Comparator Study to Evaluate the Efficacy and Safety of Everolimus Immunosuppression Treatment in Liver Transplantation for Hepatocellular Carcinoma Exceeding Milan Criteria

Clinical trial2026-01-27Results expected Q1 2027 · ClinicalTrials.gov

Phase II/III Randomized Study to Improve Overall Survival in 18 to 60 Year-old Patients, Comparing Daunorubicin Versus High Dose Idarubicin Induction Regimens, High Dose Versus Intermediate Dose Cytarabine Consolidation Regimens, and Standard Versus Mycophenolate Mofetil Prophylaxis of Graft Versus Host Disease in Allografted Patients in First CR : a Backbone InterGroup-1 Trial

Clinical trial2025-07-01Primary completion · ClinicalTrials.gov

Treg Adoptive Therapy in Subclinical Inflammation in Kidney Transplantation (CTOT-21)

Clinical trial2025-04-09Results posted · ClinicalTrials.gov

Clinical course, therapeutic responses and outcomes in relapsing MOG antibody-associated demyelination.

Research2017-11-15Ramanathan S · Journal of neurology, neurosurgery, and psychiatry

Changes in the small bowel of symptomatic kidney transplant recipients converted from mycophenolate mofetil to enteric-coated mycophenolate sodium.

Research2014-09-02Bunnapradist S · American journal of nephrology

Profile

Identifiers & mechanism

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

Canonical name
Mycophenolic Acid
Aliases & brands
(e)-6-(4-Hydroxy-6-methoxy-7-methyl-3-oxo-5-phthalanyl)-4-methyl-4-hexenoic acidAcide mycophenoliqueAcido micofenolicoAcidum mycophenolicumMicofenolico acidoMycophenolsäureMyfortic
RxNorm CUI
7145
ChEMBL ID
CHEMBL866
ATC codes
L04AA06
UNII
HU9DX48N0T
Primary mechanism
Inosine-5'-monophosphate dehydrogenase (IMPDH) inhibitor
Regulatory jurisdictions
fdaema

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

98 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.

Approval / market entry confirmed across FDA and EMA (2010-10-07 → 2012-09-25)
Earliest approval
1996-02-14
Latest approval
2026-07-29
Authorities
FDA · EMA
Total events
98
fdaU.S. Food and Drug Administration· 94 events
2026-07-29Supplemental approval
Supplemental approval: MYCOPHENOLIC ACID (ANDA214376)
Evidence ↗
2026-07-29Supplemental approval
Supplemental approval: MYCOPHENOLIC ACID (ANDA202555)
Evidence ↗
2026-07-29Supplemental approval
Supplemental approval: MYCOPHENOLIC ACID (ANDA208315)
Evidence ↗
emaEuropean Medicines Agency· 4 events
2010-10-07ApprovalMulti-authority
Approval: Myclausen (EMA)
Indication: Myclausen is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or… Show full indication

Myclausen is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.

Evidence ↗
2008-02-21Approval
Approval: Mycophenolate mofetil Teva (EMA)
Indication: Mycophenolate mofetil Teva is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic… Show full indication

Mycophenolate mofetil Teva is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.

Evidence ↗
2008-02-21Approval
Approval: Myfenax (EMA)
Indication: Myfenax is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or… Show full indication

Myfenax is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.

Evidence ↗

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

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

39 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
39
registered trials across all phases
LATEST COMPLETION 2023
3
Active studies
3
Recruiting
30
Late-stage (III+)
23
Completed
13
Discontinued
PHASE DISTRIBUTIONn = 39
Phase 12Phase 1 / 24Phase 23Phase 2 / 31Phase 38Phase 416Phase N / A5

Late-stage studies

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

A 36 Month Multi-center, Open Label, Randomized, Comparator Study to Evaluate the Efficacy and Safety of Everolimus Immunosuppression Treatment in Liver Transplantation for Hepatocellular Carcinoma Exceeding Milan Criteria

Enrolling by invitationPH IVBaylor Research Instituten=3362027

Comparison of the Efficacy and Safety of Sirolimus, Everolimus or Mycophenolate in Renal Transplant Recipients Receiving Induction With Anti-thymocyte Globulin, Tacrolimus and Prednisone

CompletedPH IVKey trialHospital do Rim e Hipertensãon=1,2092021

Conversion From MPA to Zortress (Everolimus) for GI Toxicity Post-renal Transplantation

TerminatedPH IVWashington University School of Medicinen=12019

A Multicenter, Two Arms, Randomized, Open Label Clinical Phase IV Study Investigating the Proportion of CMV Seropositive Kidney Transplant Recipients Who Will Develop a CMV Infection Within the First 6 Months Post-transplantation When Treated With an Immunosuppressive Regimen Including Everolimus (Certican®) and Reduced Dose of Cyclosporine A (Neoral®) Versus an Immunosuppressive Regimen With Mycophenolic Acid (Myfortic®) and Standard Dose of Cyclosporine A (Neoral®).

CompletedPH IVUniversity Hospital, Bordeauxn=1862018

To Evaluate Prevention Effect Of Everolimus and Low-dose Tacrolimus in Comparison With Standard-dose Tacrolimus Therapy With Mycophenolic Acid on the New Onset Diabetes Mellitus After Transplantation in the Renal Allograft Recipients

Unknown statusPH IVSeoul St. Mary's Hospitaln=2342015

Recent completions

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

Regulatory T Cell Modulation in Kidney Transplantation With Biologic Blockade of Dual Effector Pathways, CD28 and IL-6 (CTOT-24)

CompletedPH I/IINational Institute of Allergy and Infectious Diseases (NIAID)n=242023

Treg Adoptive Therapy in Subclinical Inflammation in Kidney Transplantation (CTOT-21)

CompletedPH I/IINational Institute of Allergy and Infectious Diseases (NIAID)n=322023

Comparison of the Efficacy and Safety of Sirolimus, Everolimus or Mycophenolate in Renal Transplant Recipients Receiving Induction With Anti-thymocyte Globulin, Tacrolimus and Prednisone

CompletedPH IVKey trialHospital do Rim e Hipertensãon=1,2092021

A Multicenter, Two Arms, Randomized, Open Label Clinical Phase IV Study Investigating the Proportion of CMV Seropositive Kidney Transplant Recipients Who Will Develop a CMV Infection Within the First 6 Months Post-transplantation When Treated With an Immunosuppressive Regimen Including Everolimus (Certican®) and Reduced Dose of Cyclosporine A (Neoral®) Versus an Immunosuppressive Regimen With Mycophenolic Acid (Myfortic®) and Standard Dose of Cyclosporine A (Neoral®).

CompletedPH IVUniversity Hospital, Bordeauxn=1862018

Allogeneic Hematopoietic Cell Transplantation After Nonmyeloablative Conditioning for Patients With Severe Systemic Sclerosis

CompletedPH I/IIFred Hutchinson Cancer Centern=32017

Myfortic (Enteric-coated Mycophenolate Sodium) for the Treatment of Non-infectious Intermediate Uveitis - a Prospective, Controlled, Randomized Multicenter Trial

CompletedPH IIISTZ eyetrialn=442015

Research activity

2 papers

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

Publications over time
20142018
Journals, researchers & institutions
Top journals
  • American journal of nephrology1
  • Journal of neurology, neurosurgery, and psychiatry1
Leading researchers
  • Anastasi B1
  • Barnett MH1
  • Brilot F1
  • Broadley S1
  • Bunnapradist S1
  • Dale RC1
  • Danovitch GM1
  • Fung VSC1
Leading institutions
free-text, unnormalised
  • Brain and Mind Centre1
  • Children's Hospital1
  • David Geffen School of Medicine1
  • Department of Clinical Medicine1
  • Gold Coast University Hospital1
  • Hunter Medical Research Institute1

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Prednisone

Studied across 5 of the same disease areas as Mycophenolic Acid in the shared literature.

5 shared diseases1 shared paper
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.