MYCOPHENOLATE MOFETIL HYDROCHLORIDE
Mycophenolate mofetil is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients (3 months of age and older) receiving allogeneic kidney, heart, or liver transplants. It is utilized as part of a multi-drug regimen in combination with other immunosuppressive agents, such as cyclosporine and corticosteroids, to improve long-term graft survival.
How MYCOPHENOLATE MOFETIL HYDROCHLORIDE Works
Mycophenolate mofetil is a prodrug that is rapidly hydrolyzed to its active metabolite, mycophenolic acid (MPA). MPA is a selective, uncompetitive, and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), which is the rate-limiting enzyme in the *de novo* pathway of guanosine nucleotide synthesis. Because T- and B-lymphocytes rely almost exclusively on *de novo* synthesis for proliferation (unlike other cell types that utilize salvage pathways), MPA effectively blocks their DNA synthesis and cellular division. Beyond lymphocytotoxicity, MPA shifts lymphocytes into an anergic state, suppresses the production of inflammatory cytokines (e.g., IFN-γ, TNF-α), and inhibits the glycosylation of adhesion molecules, thereby reducing the recruitment of immune cells into the allograft.
Details
- Status
- Discontinued
- First Approved
- 2016-10-28
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
MYCOPHENOLATE MOFETIL HYDROCHLORIDE Approval History
What MYCOPHENOLATE MOFETIL HYDROCHLORIDE Treats
1 indicationsMYCOPHENOLATE MOFETIL HYDROCHLORIDE is approved for 1 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Organ Rejection
MYCOPHENOLATE MOFETIL HYDROCHLORIDE Boxed Warning
EMBRYOFETAL TOXICITY, MALIGNANCIES and SERIOUS INFECTIONS Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pregnancy prevention and planning [see Warnings and Precautions (5.1) , Use in Special Populations (8.1 , 8.3) ] . Increased risk of development of lymphoma and other malignancies, particularly of the skin [see W...
WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES and SERIOUS INFECTIONS Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pregnancy prevention and planning [see Warnings and Precautions (5.1) , Use in Special Populations (8.1 , 8.3) ] . Increased risk of development of lymphoma and other malignancies, particularly of the skin [see Warnings and Precautions (5.2) ] . Increased susceptibility to bacterial, viral, fungal and protozoal infections, including opportunistic infections and viral reactivation of hepatitis B and C, which may lead to hospitalizations and fatal outcomes [see Warnings and Precautions (5.3) ] . WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES and SERIOUS INFECTIONS See full prescribing information for complete boxed warning Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pregnancy prevention and planning [see Warnings and Precautions (5.1) ]. Increased risk of development of lymphoma and other malignancies, particularly of the skin [see Warnings and Precautions (5.2) ] . Increased susceptibility to infections, including opportunistic infections and severe infections with fatal outcomes [see Warnings and Precautions (5.3) ].
MYCOPHENOLATE MOFETIL HYDROCHLORIDE Target & Pathway
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MYCOPHENOLATE MOFETIL HYDROCHLORIDE Competitive Set
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Trial Timeline
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MYCOPHENOLATE MOFETIL HYDROCHLORIDE FDA Label Details
Indications & Usage
MYCOPHENOLATE MOFETIL HYDROCHLORIDE is indicated for the treatment of Organ Rejection.
WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES and SERIOUS INFECTIONS Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pre...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.