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FTY 720

Phase 3

Kidney Transplantation | Small molecule | Nephrology |Novartis AG|Last Updated: Jun 7, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials3
Total Enrollment395

FDA Designations

No designations recorded

Clinical trial landscape

FTY 720 · 3 trials · 1 indication

Phase 3 2Phase 2 1
NCT00099801Safety and Efficacy of FTY720 in Adult Patients Who Receive a Kidney TransplantKidney Transplantation
COMPLETED- Analytics
NCT00098735Efficacy and Safety of FTY720 in Patients Who Receive a Kidney TransplantationKidney Transplantation
COMPLETED140 Analytics
PHASE3COMPLETED
Safety and Efficacy of FTY720 in Adult Patients Who Receive a Kidney Transplant
Kidney TransplantationUnlock trial analytics
PHASE3COMPLETED
Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplantation
Kidney TransplantationUnlock trial analytics

Study Endpoints

Primary Endpoints

IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 6 months post transplant
Permanent resumption of dialysis within 6 months post transplant
Surgical removal of graft within 6 months post transplant
Death within 6 months post transplant
Withdrawal of consent, death, or lost to follow up within 6 months post transplant
Biopsy-proven acute rejection (BPAR), graft loss, death and study discontinuation, within 6 months post transplantation.

Secondary Endpoints

IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 12 months post transplant
Permanent resumption of dialysis within 12 months post transplant
Surgical removal of graft within 12 months post transplant
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
FTY720DRUG -
FTY 720DRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patients undergoing their first kidney transplant * Male or female age 18 to 65 years Exclusion Criteria: * Patients in need of second kidney transplant or multi-organ transplants.

Countries:United States
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Frequently asked questions about FTY 720

What is FTY 720 used for?

FTY 720 is an investigational small molecule being studied for renal transplantation, kidney transplantation, asthma, multiple sclerosis, and relapsing multiple sclerosis. It has been evaluated in clinical trials for these conditions, though it remains in development and is not approved.

Who makes FTY 720?

FTY 720 is being developed by Novartis AG, a company traded on the New York Stock Exchange under the ticker symbol NVS. Novartis has sponsored clinical trials investigating the drug across multiple indications.

What phase is FTY 720 in?

FTY 720 has reached Phase 3 clinical development, specifically in a study for relapsing multiple sclerosis. Additional trials in renal transplantation and asthma were conducted in Phase 2. The drug is investigational and not approved.

What clinical trials is FTY 720 in?

FTY 720 has been studied in six completed trials, including NCT00239798 and NCT00239902 in renal transplantation, NCT00785083 in asthma, and NCT01127750 in relapsing multiple sclerosis. All trials are completed, with no active studies ongoing.

Is FTY 720 the same as fingolimod?

FTY 720 is also known as fingolimod. It is a small molecule developed by Novartis that has been investigated in clinical trials for conditions such as multiple sclerosis and renal transplantation.