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Lecozotan

Phase 2

Alzheimer Disease | Small molecule | Neurology |Pfizer, Inc.|Trials Updated: May 6, 2022

Lecozotan development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Nov 2007

Lecozotan target and mechanism

Molecular targetHTR1A
Target classAntagonist
ModalitySmall molecule

Also known as Lecozotan SR, lecozotan SR (SRA-333)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials6
Total Enrollment559

FDA Designations

No designations recorded

Lecozotan clinical trials

Lecozotan · 6 trials · 2 indications

Phase 2 2Phase 1 4
NCT00277810Study Evaluating the Safety, Tolerability, and Efficacy of Lecozotan SR in Outpatients With Alzheimer's DiseaseAlzheimer Disease
COMPLETED250 Analytics
NCT00151398Study Evaluating Lecozotan SR in Mild to Moderate Alzheimer's Disease (AD)Alzheimer Disease
COMPLETED229 Analytics
PHASE2COMPLETED
Study Evaluating the Safety, Tolerability, and Efficacy of Lecozotan SR in Outpatients With Alzheimer's Disease
Alzheimer DiseaseUnlock trial analytics
PHASE2COMPLETED
Study Evaluating Lecozotan SR in Mild to Moderate Alzheimer's Disease (AD)
Alzheimer DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

All events and physical and neurological function and score change from baseline to 24 weeks in ratings for cognitive and global function scales
6 mo extension study: week 24
The primary endpoints will be the change from baseline in ADAS-Cog total score and ADCS-CGIC total score.
weeks 12, 14, 26 and 40.
Evaluation of the effects of multiple doses of lecozotan SR on the PK profile of a single dose of digoxin in healthy adult subjects
Pharmacokinetic (PK) analyses
To assess the effect of drug administration on QTc interval.
The incidence of adverse events and adverse reactions will be calculated. The safety variables (vital signs, ECG parameters, and routine laboratory tests) and PK parameters will be measured throughout study period.

Secondary Endpoints

Score change from baseline to 24 weeks on functional and behavioral scales
week 24
Secondary efficacy outcome variables include additional cognitive, functional,and behavioral measures.
weeks 12, 14, 26 and 40.
Pharmacokinetic analysis after single and multiple dosing
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTAL -
BEXPERIMENTAL -
CEXPERIMENTAL -
DACTIVE_COMPARATOR -

Interventions

NameTypeDescription
lecozotan SR (SRA-333)DRUGone 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 SRDRUGevaluation 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.
DonepezilDRUG10 mg donepezil QD dosed up to 40 weeks
LecozotanDRUG -
MoxifloxacinDRUG -
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Eligibility Criteria

Age Range50 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites83

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 ...

Countries:United StatesArgentinaAustraliaCanadaFinlandFranceItalyPolandSouth AfricaSpainUnited KingdomGermany
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Frequently asked questions about Lecozotan

What is Lecozotan used for?

Lecozotan is an investigational small molecule being studied for the treatment of Alzheimer Disease. It has been evaluated in Phase 2 clinical development. Lecozotan is not approved for any indication and remains an experimental therapy under study.

What does Lecozotan target?

Lecozotan targets HTR1A, the serotonin 1A receptor, and acts as an antagonist at this receptor. By blocking HTR1A, the drug is designed to modulate serotonergic signaling, a mechanism explored in Alzheimer Disease research. Lecozotan is a small molecule developed for neurological indications.

Who is developing Lecozotan?

Lecozotan is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer has sponsored the clinical trial program for Lecozotan, including pharmacokinetic, cardiac safety, and formulation studies conducted in healthy volunteers and patients with Alzheimer Disease.

What phase is Lecozotan in?

Lecozotan is in Phase 2 clinical development for Alzheimer Disease. It is an investigational drug and has not been approved by the FDA. All six of its registered trials are completed, and no trials are currently active.

What clinical trials is Lecozotan in?

Lecozotan has been studied in six completed clinical trials, including NCT00563732, a Phase 1 drug interaction study with digoxin; NCT00499642, a Phase 1 QTc interval study; NCT00494962, a Phase 1 tablet comparison study; and NCT00366483, a Phase 1 safety study in healthy young and elderly subjects.

Is Lecozotan the same as Lecozotan SR?

Yes. Lecozotan SR and lecozotan SR (SRA-333) are alternative names for Lecozotan. The SR designation refers to a sustained-release formulation of the drug. All names refer to the same investigational compound developed by Pfizer for Alzheimer Disease.