MYCOPHENOLATE MOFETIL HYDROCHLORIDE

Post-LOE

mycophenolate mofetil

Roche

ANDAINJECTIONINJECTABLE

Approved

Dec 2022

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

MYCOPHENOLATE MOFETIL HYDROCHLORIDE (mycophenolate mofetil) by Roche is (mmf) is absorbed following oral administration and hydrolyzed to mycophenolic acid (mpa), the active metabolite. Approved for organ rejection in recipients of allogeneic kidney, heart, liver transplants and 1 more indications. First approved in 2022.

Drug data last refreshed 18h ago

Mechanism of Action

(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…

Indications (4)

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.

Clinical Trials (20)

NCT06615050Phase 3Recruiting

A 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)

Started Apr 2025

572 enrolled

Graft-versus-host Disease (GVHD)

NCT05538208Phase 2Recruiting

The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study

Started Jun 2024

105 enrolled

Lupus Nephritis

NCT05916781Phase 4Recruiting

Effectiveness of Mycophenolate Mofetil Combined With Tacrolimus for Steroid Tapering in Systemic Lupus Erythematosus

Started Jul 2023

220 enrolled

Systemic Lupus ErythematosusLupus Nephritis

NCT06114953Phase 4Unknown

Comparative Efficacy of Mizoribine With Mycophenolate Mofetil for Living Related Kidney Transplantation Recipients

Started Jan 2023

152 enrolled

Kidney Transplant Immunosuppression

NCT04702256Phase 3Recruiting

Induction Therapy for Lupus Nephritis With no Added Oral Steroids: A Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMF

Started Dec 2021

196 enrolled

Lupus NephritisSystemic Lupus Erythematosus (SLE)