Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SAR422459 · 1 trial · 1 indication
The number and percentage of patients with treatment emergent adverse events
| Arm | Type | Description |
|---|---|---|
| Long Term Follow up | OTHER | Long term follow up in all patients who received SAR422459 in previous study TDU13583 |
| Name | Type | Description |
|---|---|---|
| Long term follow up in all patients who received SAR422459 in previous study TDU13583 | DRUG | Blood draw for the laboratory assessment |
Inclusion Criteria: Patients must meet ALL of the following criteria: 1. Provide signed and dated written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act \[HIPAA\]) 2. Must have been enrolled in protocol TDU13583 (SG1/001/10) 3. Mu...
SAR422459 is being developed for the treatment of Stargardt's disease, an inherited form of macular degeneration that causes progressive vision loss. It is an ophthalmology asset and is currently in Phase 2 clinical development. It is investigational and has not been approved for commercial use.
SAR422459 targets ABCA4, a gene associated with Stargardt's disease. Mutations in ABCA4 are linked to the retinal degeneration seen in this condition. SAR422459 is a small molecule directed at this gene target, and it is being studied as a disease-directed approach for Stargardt's disease.
SAR422459 is being developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor of the clinical program evaluating the drug in patients with Stargardt's disease. The asset sits within Sanofi's ophthalmology pipeline and is currently in Phase 2 development.
SAR422459 is in Phase 2 clinical development. It is investigational and has not been approved by the FDA or any other regulatory agency. The program consists of one active trial that is no longer recruiting participants, and no completed trials are recorded for this asset.
SAR422459 is being studied in the trial NCT01736592, titled a Phase I/II follow-up study of SAR422459 in patients with Stargardt's macular degeneration. The trial is active but not recruiting, has enrolled 27 patients, and is being conducted in the United States and France.