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Mycophenolate
Mycophenolate is a Small molecule drug developed by Sanofi. It is currently FDA-approved for Prevention of Cardiac Transplant Rejection, Prevention of Kidney Transplant Rejection, Prevention of Liver Transplant Rejection. Also known as: Cellcept, MMF, Mycophenolate Mofetil, CellCept.
At a glance
| Generic name | Mycophenolate |
|---|---|
| Also known as | Cellcept, MMF, Mycophenolate Mofetil, CellCept, Myfortic |
| Sponsor | Sanofi |
| Target | Inosine-5'-monophosphate dehydrogenase 1, Inosine-5'-monophosphate dehydrogenase 2, Inosine-5'-monophosphate dehydrogenase (IMPDH) |
| Modality | Small molecule |
| Therapeutic area | Nephrology |
| Phase | FDA-approved |
Approved indications
- Prevention of Cardiac Transplant Rejection
- Prevention of Kidney Transplant Rejection
- Prevention of Liver Transplant Rejection
Boxed warnings
- 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) ].
Common side effects
- Anemia
- Leukopenia
- Constipation
- Nausea
- Diarrhea
- Vomiting
- Dyspepsia
- Urinary Tract Infection
- CMV Infection
- Insomnia
- Postoperative Pain
- Edema
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:
- Mycophenolate CI brief — competitive landscape report
- Mycophenolate updates RSS · CI watch RSS
- Sanofi portfolio CI
Frequently asked questions about Mycophenolate
What is Mycophenolate?
Mycophenolate is a Small molecule drug developed by Sanofi, indicated for Prevention of Cardiac Transplant Rejection, Prevention of Kidney Transplant Rejection, Prevention of Liver Transplant Rejection.
What is Mycophenolate used for?
Mycophenolate is indicated for Prevention of Cardiac Transplant Rejection, Prevention of Kidney Transplant Rejection, Prevention of Liver Transplant Rejection.
Who makes Mycophenolate?
Mycophenolate is developed and marketed by Sanofi (see full Sanofi pipeline at /company/sanofi).
Is Mycophenolate also known as anything else?
Mycophenolate is also known as Cellcept, MMF, Mycophenolate Mofetil, CellCept, Myfortic.
What development phase is Mycophenolate in?
Mycophenolate is FDA-approved (marketed).
What are the side effects of Mycophenolate?
Common side effects of Mycophenolate include Anemia, Leukopenia, Constipation, Nausea, Diarrhea, Vomiting.
What does Mycophenolate target?
Mycophenolate targets Inosine-5'-monophosphate dehydrogenase 1, Inosine-5'-monophosphate dehydrogenase 2, Inosine-5'-monophosphate dehydrogenase (IMPDH).
Related
- Target: All drugs targeting Inosine-5'-monophosphate dehydrogenase 1, Inosine-5'-monophosphate dehydrogenase 2, Inosine-5'-monophosphate dehydrogenase (IMPDH)
- Manufacturer: Sanofi — full pipeline
- Therapeutic area: All drugs in Nephrology
- Indication: Drugs for Prevention of Cardiac Transplant Rejection
- Indication: Drugs for Prevention of Kidney Transplant Rejection
- Indication: Drugs for Prevention of Liver Transplant Rejection
- Also known as: Cellcept, MMF, Mycophenolate Mofetil, CellCept, Myfortic
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing