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xaliproden

Phase 3

Alzheimer Disease | Small molecule | Neurology |Sanofi|Trials Updated: May 4, 2016

xaliproden development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Jan 2008

xaliproden target and mechanism

Molecular targetHTR1A
Target classAgonist
ModalitySmall molecule

Also known as xaliproden (SR57746A)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials3
Total Enrollment3,640

FDA Designations

No designations recorded

xaliproden clinical trials

xaliproden · 3 trials · 4 indications

Phase 3 3
NCT00305188Evaluation of the Efficacy of Xaliproden (SR57746A) in Preventing the Neurotoxicity of Oxaliplatin / 5FU/LV Chemotherapy.Metastases
COMPLETED879 Analytics
NCT0010364918-Month Study of the Efficacy of Xaliproden (SR57746A) in Patients With Mild-to-Moderate Dementia of the Alzheimer's TypeAlzheimer Disease
COMPLETED1,306 Analytics
NCT00104013Study of Xaliproden (SR57746A) in Patients With Mild-to-Moderate Dementia of the Alzheimer's TypeAlzheimer Disease
COMPLETED1,455 Analytics
PHASE3COMPLETED
Evaluation of the Efficacy of Xaliproden (SR57746A) in Preventing the Neurotoxicity of Oxaliplatin / 5FU/LV Chemotherapy.
MetastasesUnlock trial analytics
PHASE3COMPLETED
18-Month Study of the Efficacy of Xaliproden (SR57746A) in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type
Alzheimer DiseaseUnlock trial analytics
PHASE3COMPLETED
Study of Xaliproden (SR57746A) in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type
Alzheimer DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Clinical evaluation of peripheral sensory neuropathy using the Oxaliplatin specific scale for dose adjustment
Q2W during treatment, Q4W to Q12W during post-treatment follow-up
Alzheimer's Disease assessment scale-cognitive, clinical dementia rating sum of boxes.

Secondary Endpoints

Main: response rate using RECIST criteria
Q8W
Other: nerve conduction studies
baseline, end of treatment with oxaliplatin, end of treatment with study drug
Other: progression free survival and survival
Q8W and study period
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Xaliproden (SR57746A)EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Xaliproden (SR57746A)DRUGoral administration
PlaceboDRUGoral administration
OxaliplatinDRUGIV administration
5-FluorouracilDRUGIV administration
LeucovorinDRUGIV administration
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: Main inclusion criteria : * Histologically or cytologically-proven metastatic cancer of the colon or rectum. * Metastatic disease not amenable to potentially curative treatment (eg: inoperable metastatic disease). * Male or female aged \>18 years. * WHO Performance Status (PS) ...

Countries:United StatesArgentinaAustraliaBrazilCanadaChileGermanyHungaryItalyPolandPortugalSpainUnited KingdomFranceHong KongNetherlandsSingaporeSouth AfricaTaiwan
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Frequently asked questions about xaliproden

What is xaliproden used for?

Xaliproden has been studied in two main areas: Alzheimer disease and the prevention of chemotherapy-induced neurotoxicity in patients with metastatic colorectal cancer. It is an investigational small molecule that has not been approved for any indication. Clinical development reached Phase 3, and all reported trials have been completed.

What does xaliproden target?

Xaliproden targets the serotonin 1A receptor, also known as HTR1A, where it acts as an agonist. This receptor activity is the basis for its investigation in neurological and chemotherapy-related nerve toxicity settings. The drug is a small molecule developed by Sanofi.

Who is developing xaliproden?

Xaliproden is developed by Sanofi, which trades under the ticker SNY. Sanofi sponsored the Phase 3 clinical program evaluating the drug in Alzheimer disease and in patients receiving oxaliplatin-based chemotherapy for metastatic colorectal cancer.

What phase is xaliproden in?

Xaliproden reached Phase 3 clinical development. All three reported trials are completed, and no trials are currently active. The drug remains investigational and has not been approved by the FDA for any indication.

What clinical trials is xaliproden in?

Xaliproden has been evaluated in three completed Phase 3 trials: NCT00305188 in metastatic colorectal cancer, NCT00104013 in mild-to-moderate Alzheimer disease, and NCT00103649, an 18-month Alzheimer disease study. Together these trials enrolled more than 3,600 participants across North America, Europe, Asia, South America, and Australia.

Is xaliproden the same as SR57746A?

Yes, xaliproden is also known as SR57746A. SR57746A is the compound code used by Sanofi in trial titles and publications, while xaliproden is the international nonproprietary name. Both names refer to the same investigational small-molecule HTR1A agonist.