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Myfortic

Phase 4FDA approved 2004

Kidney Transplantation | Small molecule | Nephrology |Novartis AG|Trials Updated: Jan 31, 2011

Myfortic development status

FDA approval Feb 27, 2004
Approval holderNovartis
ApplicationNDA050791
Highest phase Phase 4 (NCT00956293)
Phase scored for NVSPhase 3
Registered trials 67 across 13 sponsors since Jan 2005

Label indication Myfortic is an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. ( 1.1 ) Use in combination with cyclosporine and corticosteroids.

Myfortic target and mechanism

ModalitySmall molecule

Also known as Enteric Coated Mycophenolic Acid (MPA), Enteric-coated mycophenolate sodium, Enteric-coated mycophenolate sodium (EC-MPS), MPA, Cellcept, Mycophenolic Acid (MPA), Mycophenolate sodium, Enteric coated mycophenolate sodium (Myfortic®)

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment342

FDA Designations

No designations recorded

Myfortic clinical trials

Myfortic · 1 trial · 1 indication

Phase 3 1
NCT00101738Freedom Study: Myfortic in Kidney Transplant PatientsKidney Transplantation
COMPLETED342 Analytics
PHASE3COMPLETED
Freedom Study: Myfortic in Kidney Transplant Patients
Kidney TransplantationUnlock trial analytics

Study Endpoints

Primary Endpoints

Calculated glomerular filtration rate after 12 months treatment

Secondary Endpoints

Incidence of death, graft loss, biopsy-proven acute rejection after 3 and 12 months.
Patient and graft survival after 12 months.
Incidence of AEs and SAEs after 3 and 12 months.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
MyforticDRUG -
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites44

Inclusion Criteria: * Males and females aged 18 to 75 years. * Recipients of first, heart-beating cadaveric, living unrelated or living related non-HLA identical donor kidney transplant, treated with Simulect® and Neoral® as primary immunosuppression. Exclusion Criteria: * Second or subsequent ki...

Countries:United StatesArgentinaAustraliaBrazilCanadaGermanyItalyMalaysiaNew ZealandSingaporeSpainTaiwanUnited Kingdom
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Frequently asked questions about Myfortic

What is Myfortic used for?

Myfortic is used in kidney transplantation. It is a small molecule therapy studied in patients receiving a kidney transplant, and it belongs to the nephrology therapeutic area. Its clinical development has focused on this transplant population rather than on other conditions.

Who makes Myfortic?

Myfortic is developed by Novartis AG, which trades under the ticker NVS. Novartis is the company associated with the drug's clinical program in kidney transplantation.

What phase is Myfortic in?

Myfortic is in Phase 3 development for kidney transplantation. The Phase 3 program includes one completed trial, and no trials are currently listed as active. Myfortic is an investigational therapy in this development stage rather than a product with a stated approval in the information available.

What clinical trials is Myfortic in?

Myfortic has been studied in the Phase 3 Freedom Study, registered as NCT00101738, titled Myfortic in Kidney Transplant Patients. That trial is completed, enrolled 342 participants, and was conducted across the United States, Argentina, Australia, Brazil, Canada, Germany, Italy, Malaysia, New Zealand, Singapore, Spain, Taiwan, and the United Kingdom.

Is Myfortic the same as Myfortic®?

Yes. Myfortic and Myfortic® refer to the same drug. The registered trademark form Myfortic® is simply the branded spelling of the name, so searches for either version point to the same kidney transplantation therapy developed by Novartis AG.