Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SAR443765 · 1 trial · 1 indication
Incidence of adverse events (AEs) and treatment-emergent adverse events (TEAEs)
| Arm | Type | Description |
|---|---|---|
| SAR443765 | EXPERIMENTAL | Single dose administration of SAR443765 |
| Placebo | PLACEBO_COMPARATOR | Placebo to match SAR443765 |
| Name | Type | Description |
|---|---|---|
| SAR443765 | DRUG | solution for injection |
| Placebo | DRUG | solution for injection |
| Salbutamol or levosalbutamol | DRUG | metered dose inhaler |
Inclusion Criteria: * Diagnosis of asthma for at least 12 months and confirmed at screening based on the Global Initiative for Asthma (GINA) 2020 Guidelines * Controlled asthma defined as no more than 1 canister of rescue inhaler per month over the last 3 months prior to baseline * Elevated FeNO le...
SAR443765 is an investigational small molecule being developed for the treatment of asthma. It is currently in Phase 1 clinical development, meaning it has not yet been approved for any use. The drug is being studied in healthy participants and in asthmatic participants to evaluate its safety and tolerability.
SAR443765 is being developed by Sanofi, a multinational pharmaceutical company. Sanofi is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for asthma. The company is listed on the stock exchange under the ticker symbol SNY.
SAR443765 is in Phase 1 clinical development. This is the earliest stage of testing in humans, focused on assessing the drug's safety, tolerability, and pharmacokinetics. The drug is investigational and has not been approved by regulatory authorities for the treatment of asthma or any other condition.
SAR443765 has one completed Phase 1 clinical trial, identified by the National Clinical Trial number NCT05366764. This was a first-in-human study conducted in Germany and the United Kingdom, enrolling 36 participants, including healthy volunteers and asthmatic participants. The trial was randomized, double-blind, and placebo-controlled.
No, SAR443765 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug has not yet completed the clinical trials and regulatory review process required for approval. It is being studied for the treatment of asthma, but its safety and efficacy have not been established.