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Mycophenolate mofetil Tablet/Capsule
Mycophenolate mofetil Tablet/Capsule is a Inosine monophosphate dehydrogenase (IMPDH) inhibitor; immunosuppressant Small molecule drug developed by Chong Kun Dang Pharmaceutical. It is currently FDA-approved for Prevention of organ rejection in patients receiving allogeneic renal, cardiac, or hepatic transplants, Treatment of active lupus nephritis. Also known as: Myrept® Cap./Tab., CellCept, Myfortic.
Mycophenolate mofetil is a prodrug that inhibits inosine monophosphate dehydrogenase (IMPDH), selectively suppressing T and B lymphocyte proliferation.
Mycophenolate mofetil inhibits inosine monophosphate dehydrogenase (IMPDH), selectively suppressing T and B lymphocyte proliferation to prevent organ rejection and autoimmune responses. Used for Prevention of organ rejection in renal, cardiac, and hepatic transplant recipients, Treatment of active lupus nephritis, Treatment of active rheumatoid arthritis (in combination with other agents).
At a glance
| Generic name | Mycophenolate mofetil Tablet/Capsule |
|---|---|
| Also known as | Myrept® Cap./Tab., CellCept, Myfortic |
| Sponsor | Chong Kun Dang Pharmaceutical |
| Drug class | Inosine monophosphate dehydrogenase (IMPDH) inhibitor; immunosuppressant |
| Target | IMPDH type II (inosine monophosphate dehydrogenase) |
| Modality | Small molecule |
| Therapeutic area | Immunology; Transplantation |
| Phase | FDA-approved |
Mechanism of action
Mycophenolate mofetil is rapidly hydrolyzed to mycophenolic acid (MPA), which preferentially inhibits IMPDH type II, the predominant isoform in activated lymphocytes. This blocks the de novo synthesis of guanosine nucleotides required for DNA replication in T and B cells, leading to selective immunosuppression without affecting other cell types that utilize salvage pathways for nucleotide synthesis.
Approved indications
- Prevention of organ rejection in patients receiving allogeneic renal, cardiac, or hepatic transplants
- Treatment of active lupus nephritis
Common side effects
- Diarrhea
- Leukopenia
- Infection
- Nausea
- Vomiting
- Abdominal pain
- Anemia
Key clinical trials
- Study to Compare the Efficacy and Safety After Conversion to RaparoBell® or My-Rept® in Kidney Transplant Patients (PHASE4)
- Optimizing PTCy Dose and Timing (PHASE1, PHASE2)
- Pulse Wave Velocity, Tacrolimus Time in Therapeutic Range and CV in African American Kidney Transplants (PHASE4)
- Mycophenolate Mofetil in Patients With Progressive Idiopathic Membranous Nephropathy (PHASE3)
- Optimize Immunosuppressive Therapy Using Everolimus and Low-dose Calcineurin Inhibitors in Heart Transplant Patients in Korea (PHASE4)
- Prevention of Skin Cancer in High Risk Patients After Conversion to a Sirolimus-based Immunosuppressive Protocol (PHASE4)
- MYREPTIC-N® or MY-REPT® in Stable Patients After Kidney Transplant Recipients (PHASE4)
- Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Mycophenolate mofetil Tablet/Capsule CI brief — competitive landscape report
- Mycophenolate mofetil Tablet/Capsule updates RSS · CI watch RSS
- Chong Kun Dang Pharmaceutical portfolio CI
Frequently asked questions about Mycophenolate mofetil Tablet/Capsule
What is Mycophenolate mofetil Tablet/Capsule?
How does Mycophenolate mofetil Tablet/Capsule work?
What is Mycophenolate mofetil Tablet/Capsule used for?
Who makes Mycophenolate mofetil Tablet/Capsule?
Is Mycophenolate mofetil Tablet/Capsule also known as anything else?
What drug class is Mycophenolate mofetil Tablet/Capsule in?
What development phase is Mycophenolate mofetil Tablet/Capsule in?
What are the side effects of Mycophenolate mofetil Tablet/Capsule?
What does Mycophenolate mofetil Tablet/Capsule target?
Related
- Drug class: All Inosine monophosphate dehydrogenase (IMPDH) inhibitor; immunosuppressant drugs
- Target: All drugs targeting IMPDH type II (inosine monophosphate dehydrogenase)
- Manufacturer: Chong Kun Dang Pharmaceutical — full pipeline
- Therapeutic area: All drugs in Immunology; Transplantation
- Indication: Drugs for Prevention of organ rejection in patients receiving allogeneic renal, cardiac, or hepatic transplants
- Indication: Drugs for Treatment of active lupus nephritis
- Also known as: Myrept® Cap./Tab., CellCept, Myfortic
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing