Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Mycophenolate Mofetil
Mycophenolate Mofetil/Day · 1 trial · 1 indication
The proportion of subjects achieving responder status (defined as no new persistent lesions and prednisone dose of not more than 10 mg/day from Week 48 until study termination at Week 52) in the two active treatment groups combined (2 g/day and 3 g/day mycophenolate mofetil) compared with the placebo group
| Arm | Type | Description |
|---|---|---|
| Mycophenolate Mofetil (MMF) 2 g/Day | EXPERIMENTAL | Mycophenolate mofetil 500 mg tablets; 4 tablets twice daily for 52 weeks |
| Mycophenolate Mofetil (MMF) 3 g/Day | EXPERIMENTAL | Mycophenolate mofetil 500 mg tablets; 6 tablets twice daily for 52 weeks |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Mycophenolate Mofetil 2 g/Day | DRUG | Mycophenolate mofetil 500 mg tablets; 4 tablets twice daily for 52 weeks |
| Mycophenolate Mofetil (MMF) 3 g/Day | DRUG | Mycophenolate mofetil 500 mg tablets; 6 tablets twice daily for 52 weeks |
| Placebo | DRUG | Placebo for MMF 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks |
Inclusion Criteria: * Adult patients 18 to 70 years of age * Diagnosis of mild to moderate pemphigus vulgaris within the past 12 months, requiring high dose corticosteroids Exclusion Criteria: * Female patients who are pregnant, breastfeeding, or lactating * Regularly scheduled plasma exchange (P...
Mycophenolate Mofetil is an immunosuppressant small molecule being studied for use in Pemphigus Vulgaris, Myelodysplastic Syndromes, Chronic Kidney Failure, Heart Transplantation, and Lung Transplantation. It is developed by Roche Holding AG (RHHBY) and is currently in Phase 3 clinical development for these indications.
Mycophenolate Mofetil is an immunosuppressant that inhibits inosine monophosphate dehydrogenase, an enzyme crucial for the de novo synthesis of guanine nucleotides in lymphocytes. By blocking this enzyme, it selectively suppresses T and B cell proliferation, reducing the immune response that contributes to autoimmune and transplant-related conditions.
Mycophenolate Mofetil is developed by Roche Holding AG, a Swiss multinational healthcare company traded on the OTC market under the ticker RHHBY. Roche is conducting clinical trials to evaluate the drug's efficacy and safety in various conditions, including heart transplantation and myelodysplastic syndromes.
Mycophenolate Mofetil is in Phase 3 clinical development. It has completed three trials, including two Phase 3 studies and one Phase 2 study, with a total enrollment of 640 participants. The drug is investigational and not yet approved for the studied indications.
Mycophenolate Mofetil has been studied in three completed trials: NCT00282347 (Phase 3, Lupus Nephritis, 144 participants), NCT00551291 (Phase 2, Myelodysplastic Syndromes, 10 participants), and NCT02091414 (Phase 3, Heart Transplantation, 36 participants). All trials are completed with no active studies ongoing.
Yes, Mycophenolate Mofetil is the same as CellCept, a brand name used in clinical trials. In the study NCT00551291, the drug is referred to as CellCept, and in NCT02091414, it is also called CellCept. Both names refer to the same immunosuppressant compound developed by Roche.