Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SAR448851 · 1 trial · 2 indications
Number of participants experiencing at least one treatment-emergent adverse event (TEAE), including amyloid-related imaging abnormalities with edema (ARIA-E) and amyloid-related imaging abnormalities with hemosiderin (ARIA-H) by brain magnetic resonance imaging (MRI), laboratory assessments, vital sign measurements, electrocardiograms (ECGs) and the Columbia-Suicide Severity Rating Scale (C-SSRS)
| Arm | Type | Description |
|---|---|---|
| SAR448851 | EXPERIMENTAL | Participants will receive SAR448851 dose 1 or dose 2 oral daily for 48 weeks |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo oral daily for 48 weeks |
| Name | Type | Description |
|---|---|---|
| SAR448851 | DRUG | Pharmaceutical form: Capsule Route of administration: Oral |
| Placebo | DRUG | Pharmaceutical form: Capsule Route of administration: Oral |
Inclusion Criteria: * Participant must be 55 to 85 years (inclusive) of age, at the time of signing the informed consent. * Diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) (National Institute on Aging-Alzheimer's Association \[NIA-AA\] Stage 3) or mild AD dementia (NIA-...
SAR448851 is an investigational small molecule being developed for the treatment of early Alzheimer's disease, which is a type of dementia. It is currently being studied in a Phase 2 clinical trial to evaluate its safety and effectiveness in participants with this condition.
The specific molecular target of SAR448851 has not been disclosed. It is a small molecule being developed by Sanofi for the treatment of early Alzheimer's disease, and its mechanism of action is not publicly detailed at this time.
SAR448851 is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol SNY. The company is currently conducting a Phase 2 clinical trial to investigate the drug's safety and effectiveness in patients with early Alzheimer's disease.
SAR448851 is currently in Phase 2 of clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. A Phase 2 trial is ongoing to assess its safety and effectiveness in participants with early Alzheimer's disease.
SAR448851 is being studied in a Phase 2 clinical trial with the identifier NCT07688213. This randomized, double-blind, placebo-controlled study is recruiting 160 participants aged 55 years and older with early Alzheimer's disease in the United States.
SAR448851 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development. The ongoing trial, NCT07688213, is designed to evaluate its safety and effectiveness, but it has not yet received regulatory approval for any use.