Last reviewed · How we verify
Myfortic
At a glance
| Generic name | Myfortic |
|---|---|
| Also known as | Mycophenolate sodium, EC-MPS, mycophenolate sodium, MPA derivative, Enteric Coated Mycophenolate Sodium |
| Sponsor | Novartis Pharmaceuticals |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- 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 sho
Common side effects
- Anemia
- Leukopenia
- Constipation
- Nausea
- Diarrhea
- Vomiting
- Dyspepsia
- Urinary tract infection
- CMV infection
- Insomnia
- Postoperative pain
Serious adverse events
- Lymphoma
- Nonmelanoma skin carcinoma
- Graft loss
- Renal impairment
- Intestinal perforation
- Gastrointestinal hemorrhage
- Gastric ulcers
- Duodenal ulcers
- Colitis
Key clinical trials
- Pilot Trial of Allogeneic Blood or Marrow Transplantation for Primary Immunodeficiencies (PHASE2)
- Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis (PHASE2)
- Radiation- and Alkylator-free Bone Marrow Transplantation Regimen for Patients With Dyskeratosis Congenita (PHASE2)
- Tocilizumab in Lung Transplantation (PHASE2)
- A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation (PHASE2, PHASE3)
- MT2025-35 Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning Treosulfan and Fludarabine, With Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases (PHASE2)
- Therapeutic Drug Monitoring of Mycophenolate Mofetil in Lupus Nephritis (NA)
- Upfront Autologous HSCT Versus Immunosuppression in Early Diffuse Cutaneous Systemic Sclerosis (PHASE4)
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:
- Myfortic CI brief — competitive landscape report
- Myfortic updates RSS · CI watch RSS
- Novartis Pharmaceuticals portfolio CI