Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FTY720 · 11 trials · 5 indications
Brain Magnetic Resonance Imaging (MRI) was performed at Month 3 and Month 6. Gadolinium-enhancing lesions (active lesions) represent acute inflammatory activity only and dissipate within 2-8 weeks of appearance. MRI scans were analyzed by blinded readers at the central MRI Evaluation Center to ensure consistency. Any Gd-enhanced T1 weighted MRI data obtained less than 14 days after the steroid used to treat MS relapses is invalid and excluded.
Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.
Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.
Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.
Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis. The last observation was the last observation available for each patient which ranged from 1 to 2801 days
| Arm | Type | Description |
|---|---|---|
| FTY720 | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| FTY720 0.5 mg | EXPERIMENTAL | FTY720 |
| FTY720 1.25 mg | EXPERIMENTAL | FTY720 |
| Placebo | PLACEBO_COMPARATOR | - |
| Fingolimod (FTY720) 1.25 mg/day | EXPERIMENTAL | Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation. |
| Placebo/Fingolimod (FTY720) | PLACEBO_COMPARATOR | Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation. |
| Fingolimod (FTY720) 5.0 mg/day | EXPERIMENTAL | Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 15 to 24 months 1.25mg once daily. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation. |
| Name | Type | Description |
|---|---|---|
| FTY720 | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * 18-65 years of age, must have relapsing MS Exclusion Criteria: * Patients with a type of MS that is not relapsing * Patients with history of chronic immune disease * Patients with a history of certain cancers * Diabetic patients with certain eye disorders * Patients who are ...
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.
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.
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.
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.
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.