MYFORTIC (mycophenolate sodium)
Myfortic is an immunosuppressant used to prevent organ rejection in adults receiving kidney transplants. It also helps pediatric patients aged five and older who are at least six months post-transplant. This medication is used as part of a combination regimen alongside cyclosporine and corticosteroids. Because of differences in how the body absorbs the drug, these delayed-release tablets should not be swapped with other mycophenolate products without medical supervision.
How MYFORTIC Works
This drug works by blocking an enzyme called inosine monophosphate dehydrogenase, which stops the production of guanosine nucleotides needed for DNA. While most cells can find other ways to grow, T- and B-lymphocytes rely specifically on this pathway to multiply. By stopping these immune cells from proliferating, the medication helps prevent the body from attacking the new organ.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2004-02-27
- Routes
- ORAL
- Dosage Forms
- TABLET, DELAYED RELEASE
MYFORTIC Approval History
What MYFORTIC Treats
1 indicationsMYFORTIC is approved for 1 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Organ Rejection
MYFORTIC Boxed Warning
EMBRYO-FETAL TOXICITY, MALIGNANCIES, AND SERIOUS INFECTIONS Use during pregnancy is associated with increased risks of 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 Specific Populations (8.1, 8.3)] . Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should presc...
WARNING: EMBRYO-FETAL TOXICITY, MALIGNANCIES, AND SERIOUS INFECTIONS Use during pregnancy is associated with increased risks of 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 Specific Populations (8.1, 8.3)] . Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe Myfortic. Patients receiving Myfortic should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient [see Warnings and Precautions (5.2)] . Increased risk of development of lymphoma and other malignancies, particularly of the skin, due to immunosuppression [see Warnings and Precautions (5.3)] . Increased susceptibility to bacterial, viral, fungal, and protozoal infections, including opportunistic infections [see Warnings and Precautions (5.4, 5.5)] . WARNING: EMBRYO-FETAL TOXICITY, MALIGNANCIES, and SERIOUS INFECTIONS See full prescribing information for complete boxed warning Use during pregnancy is associated with increased risks of pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pregnancy prevention and planning. ( 5.1 , 8.1 , 8.3 ) Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe Myfortic. ( 5.2 ) Increased risk of development of lymphoma and other malignancies, particularly of the skin, due to immunosuppression. ( 5.3 ) Increased susceptibility to bacterial, viral, fungal, and protozoal infections, including opportunistic infections. ( 5.4 , 5.5 )
MYFORTIC Target & Pathway
ProTarget
MYFORTIC Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to MYFORTIC
3 of 16FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
17 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07412470 FREXERA | EFC18554 2025-521521-33-00 | Ph 2, Ph 3 | recruiting | A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation |
| NCT04375631 | RG1006914 NCI-2020-02616, RG1006914 | Ph 1 | recruiting | CLAG-M or FLAG-Ida Chemotherapy and Reduced-Intensity Conditioning Donor Stem Cell Transplant for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelomonocytic Leukemia |
| NCT04195633 | RG1005742 NCI-2019-07697, 10343 | Ph 2 | recruiting | Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies |
| NCT02081755 | 013-307 | Ph 4 | enrolling by invitation | Safety and Efficacy of Everolimus Treatment in Liver Transplantation for Liver Cancer |
| NCT02334488 | PROMéTé | Ph 3 | completed | Study Evaluating the Benefit of Two Immunosuppressive Strategies on Renal Function |
| NCT02953873 results posted | 00061221 | Ph 4 | completed | Dosing Requirements of Astagraf XL® in African American Kidney Transplant Recipients |
| NCT01801280 results posted | CERL 080A DE 20 T 2010-021275-92 | Ph 4 | completed | Influence of Pantoprazole on the Bioavailability of MMF and EC-MPS |
| NCT02130817 BelatPilot | Should be 2013-0672 IM103-327 | Ph 4 | withdrawn | Belatacept in Kidney Transplantation of Moderately Sensitized Patients |
| NCT01410448 NEVERWOUND results posted | CRAD001AIT25 2011-002866-19 | Ph 3 | completed | Everolimus in de Novo Kidney Transplant Recipients |
| NCT01092533 MYCUV-IIT02 | 2009-009998-10 | Ph 3 | completed | Myfortic for the Treatment of Non-infectious Intermediate Uveitis |
| NCT00646737 | CERL080ABR02 | Ph 4 | completed | Conversion From Mycophenolate Mofetil to Mycophenolate Sodium in Renal Transplant |
| NCT00652834 results posted | 11-001911 | Ph 4 | completed | Small Bowel Capsule Endoscopy Findings in Patients Receiving Cellcept® |
| NCT01018914 | ADVLTx-0901-TW | Ph 4 | completed | A Study to Compare Safety and Efficacy of Prograf + Myfortic and Advagraf + Myfortic in Liver Transplantation Patients |
| NCT01822483 AUC-MPA | CERL080 CERL080ABR08T | Ph 4 | completed | A Prospective Study to Investigate Mycophenolic Acid (MPA) Exposure Through Area Under the Curve (AUC) in Renal Transplants Recipients Treated With Mycophenolate Mofetil (MMF) and After Conversion to Mycophenolate Sodium (EC-MPS) |
| NCT01354301 | CRAD001ABR18T | Ph 4 | completed | Efficacy and Safety of Induction Strategies Combined With Low Tacrolimus Exposure in Kidney Transplant Recipients Receiving Everolimus or Sodium Mycophenolate |
| NCT01015456 CONTROL | 2009-001 Lupus Research Unit, CRCN | Ph 3 | terminated | The Efficacy of Enteric-coated Mycophenolate Sodium (EC-MPS) (Myfortic) in The Treatment of Relapse or Resistant Proliferative Lupus Nephritis |
| NCT01079143 CERTITEM results posted | CRAD001AFR10 2009-011473-33 | Ph 3 | completed | Progression of Renal Interstitial Fibrosis / Tubular Atrophy (IF/TA) According to Epithelial-mesenchymal Transition (EMT) and Immunosuppressive Regimen (Everolimus Based Versus CNI Based) in de Novo Renal Transplant Recipients |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
MYFORTIC FDA Label Details
Indications & Usage
FDA Label (PDF)MYFORTIC is indicated for the treatment of Organ Rejection.
WARNING: EMBRYO-FETAL TOXICITY, MALIGNANCIES, AND SERIOUS INFECTIONS Use during pregnancy is associated with increased risks of pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pregnancy prevent...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment