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  1. pharmadog
  2. ›drugs
  3. ›MYCOPHENOLATE MOFETIL
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MYCOPHENOLATE MOFETIL

Marketedupdated 3mo ago
by $AMRX Amneal Pharmaceuticals, Inc.🔗 ChEMBL
Approved
community read0 votes

🐶 often sniffed alongside

top 4
  • tagApproval34 co-mentions · 17 sources
  • tagSmall Molecule17 co-mentions · 17 sources
  • companyAurobindo Pharma Ltd8 co-mentions · 8 sources
  • companyStrides Pharma Inc4 co-mentions · 4 sources

Small molecule drug with a maximum clinical stage of Approval (across all indications), with 54 investigational indications.

targets

Inosine-5'-monophosphate dehydrogenase (IMPDH)

all catalysts(17)

approval · 17
Nov 2, 2021
approval
$AMRX17.66+2.26%
5y ago
MYCOPHENOLATE MOFETIL — FDA approval
MYCOPHENOLATE MOFETIL
→
Dec 21, 2022
approval
$AMRX17.66+2.26%
4y ago
MYCOPHENOLATE MOFETIL — FDA approval
MYCOPHENOLATE MOFETIL
→
Dec 21, 2022
approval
$AMRX17.66+2.26%
4y ago
MYCOPHENOLATE MOFETIL — FDA approval
MYCOPHENOLATE MOFETIL
→
Aug 29, 2023
approval
3y ago
MYCOPHENOLATE MOFETIL — FDA approval
MYCOPHENOLATE MOFETIL
→
Jan 5, 2024
approval
3y ago
MYCOPHENOLATE MOFETIL — FDA approval
MYCOPHENOLATE MOFETIL
→
Feb 20, 2024
approval
2y ago
MYCOPHENOLATE MOFETIL — FDA approval
MYCOPHENOLATE MOFETIL
→
May 1, 2024
approval
2y ago
MYCOPHENOLATE MOFETIL — FDA approval
MYCOPHENOLATE MOFETIL
→
Aug 13, 2024
approval
2y ago
MYCOPHENOLATE MOFETIL — FDA approval
MYCOPHENOLATE MOFETIL
→
Aug 13, 2024
approval
$AMRX17.66+2.26%
2y ago
MYCOPHENOLATE MOFETIL — FDA approval
MYCOPHENOLATE MOFETIL
→
Aug 13, 2024
approval
2y ago
MYCOPHENOLATE MOFETIL — FDA approval
MYCOPHENOLATE MOFETIL
→
Aug 13, 2024
approval
2y ago
MYCOPHENOLATE MOFETIL — FDA approval
MYCOPHENOLATE MOFETIL
→
Sep 26, 2024
approval
2y ago
MYCOPHENOLATE MOFETIL — FDA approval
MYCOPHENOLATE MOFETIL
→
Jan 14, 2026
approval
7mo ago
MYCOPHENOLATE MOFETIL — FDA approval
MYCOPHENOLATE MOFETIL
→
Jan 14, 2026
approval
7mo ago
MYCOPHENOLATE MOFETIL — FDA approval
MYCOPHENOLATE MOFETIL
→
Feb 23, 2026
approval
$AMRX17.66+2.26%
6mo ago
MYCOPHENOLATE MOFETIL — FDA approval
MYCOPHENOLATE MOFETIL
→
Mar 18, 2026
approval
5mo ago
MYCOPHENOLATE MOFETIL — FDA approval
MYCOPHENOLATE MOFETIL
→
Apr 10, 2026
approval
4mo ago
MYCOPHENOLATE MOFETIL — FDA approval
MYCOPHENOLATE MOFETIL
→
view all 17 catalysts →

Trials studying MYCOPHENOLATE MOFETIL

  • phase2A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participantsrecruitingn=40
  • phase3A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantationrecruitingn=526
  • phase2Cytokine Induced Memory-like NK Cell Adoptive Therapy After Haploidentical Donor Hematopoietic Cell Transplantationactive not recruitingn=60
  • phase1Ruxolitinib With Azacitidine Maintenance for the Treatment of Patients With Acute Myeloid Leukemia Undergoing Reduced Intensity Allogeneic Stem Cell Transplantationnot yet recruitingn=40
  • phase3A Study of Tacrolimus/Methotrexate/Ruxolitinib Versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation (BMT CTN 2203)recruitingn=572
  • phase4MYREPTIC-N® or MY-REPT® in Stable Patients After Kidney Transplant Recipientscompletedn=158
  • phase4Efficacy and Safety of Everolimus Versus Mycophenolate Mofetil in Liver Transplant Recipients.completedn=150
  • phase1Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graftrecruitingn=77
more trials →

Patent cliff

source: FDA Orange Book
first barrier falls
Aug 16, 2039
~13.0 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (5)

  • Aug 16, 2039formulationUS 11931455
  • Aug 16, 2039formulationUS 12097284
  • Aug 16, 2039formulationUS 12097285
  • Aug 16, 2039formulationUS 12194143
  • Aug 16, 2039formulationUS 12226526

News(0)

no news has mentioned this drug yet

brand
MYCOPHENOLATE MOFETIL
trade names
Arzip, Cellcept, Myclausen, Mycophenolate mofetil, Mycophenolate mofetil teva, Myfenax
generic
MYCOPHENOLATE MOFETIL
MOA
12.1 Mechanism of Action Mycophenolate mofetil (MMF) is absorbed following oral administration and hydrolyzed to mycophenolic acid (MPA), the active metabolite. MPA is a selective uncompetitive inhibitor of the two isoforms (type I and type II) of inosine monophosphate dehydrogenase (IMPDH) leading to inhibition of the de novo pathway of guanosine nucleotide synthesis and blocks DNA synthesis. The mechanism of action of MPA is multifaceted and includes effects on cellular checkpoints responsible for metabolic programming of lymphocytes. MPA shifts transcriptional activities in lymphocytes from a proliferative state to catabolic processes. In vitro studies suggest that MPA modulates transcriptional activities in human CD4+ T-lymphocytes by suppressing the Akt/mTOR and STAT5 pathways that are relevant to metabolism and survival, leading to an anergic state of T-cells whereby the cells become less responsive to antigenic stimulation. Additionally, MPA enhanced the expression of negative co-stimulators such as CD70, PD-1, CTLA-4, and transcription factor FoxP3 as well as decreased the expression of positive co-stimulators CD27 and CD28. MPA decreases proliferative responses of T- and B-lymphocytes to both mitogenic and allo-antigenic stimulation, antibody responses, as well as the production of cytokines from lymphocytes and monocytes such as GM-CSF, IFN-ɣ, IL-17, and TNF-α. Additionally, MPA prevents the glycosylation of lymphocyte and monocyte glycoproteins that are involved in intercellular adhesion to endothelial cells and may inhibit recruitment of leukocytes into sites of inflammation and graft rejection. Overall, the effect of MPA is cytostatic and reversible.
phase
marketed
Data sources
openFDA · ClinicalTrials.gov · OpenTargets
last refreshed 46m ago
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