Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lecozotan · 7 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | - |
| B | EXPERIMENTAL | - |
| C | EXPERIMENTAL | - |
| D | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| lecozotan SR (SRA-333) | DRUG | one of 3 doses of lecozotan sr dose for 6 months as an extension to a 6 month study with patients required to be on a cholinesterase inhibitor 2, 5, or 10 mg of lecozotan sr |
| lecozotan SR | DRUG | evaluation of long term therapy with 3 doses of lecozotan sr ( 2, 5, and 10 mg)administered to patients with AD who have completed week 12 evaluations in the short-term study. Patient duration is 42 weeks. Arms include lecozotan sr 2 mg, 5mg, and 10 mg as well as donepezil. |
| Donepezil | DRUG | 10 mg donepezil QD dosed up to 40 weeks |
| Lecozotan | DRUG | - |
| Citalopram | DRUG | - |
| Moxifloxacin | DRUG | - |
Inclusion Criteria: * Diagnosis of probable Alzheimer's disease * Current use of cholinesterase inhibitor * Able to give signed and dated informed consent and lives with appropriate caregiver at home or in community dwelling with caregiver accompanying patient to all visits and visiting patient at ...
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Lecozotan is an investigational small molecule being studied for use in Alzheimer Disease and in healthy subjects. It is being developed by Pfizer, Inc. (NYSE: PFE) as a potential treatment for neurology-related conditions. The drug is currently in Phase 2 clinical development, though all six completed trials were Phase 1 studies.
Lecozotan is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical trials of Lecozotan in countries including France, Germany, and the United Kingdom. The drug is an investigational small molecule in the neurology therapeutic area.
Lecozotan is in Phase 2 clinical development. However, all six clinical trials listed for the drug are completed Phase 1 studies. These trials evaluated the safety, tolerability, and pharmacokinetics of Lecozotan in healthy subjects and in patients with Alzheimer Disease. The drug remains investigational and is not yet approved.
Lecozotan has been studied in six completed clinical trials, including NCT00366483, NCT00494962, NCT00499642, and NCT00538889. These Phase 1 trials evaluated safety, tablet formulations, QTc interval effects, and drug interactions with citalopram in healthy subjects. Total enrollment across all trials was 559 participants, with studies conducted in France, Germany, and the United Kingdom.
No, Lecozotan is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Alzheimer Disease. All completed trials for Lecozotan were Phase 1 studies focused on safety and tolerability in healthy subjects. The drug has not yet demonstrated efficacy in late-stage trials and remains under clinical investigation.
Lecozotan is in Phase 2 development for Alzheimer Disease. The completed trials were early-stage Phase 1 studies that enrolled healthy volunteers and subjects with Alzheimer Disease to assess safety and drug interactions. These trials were randomized, double-blind, and controlled. The drug is being developed by Pfizer, Inc. as a potential treatment for the condition.