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Xaliproden (SR57746A)
Xaliproden (SR57746A) is a Neuroprotective agent Small molecule drug developed by Sanofi. It is currently in Phase 3 development for Alzheimer's disease.
Xaliproden acts as a neuroprotective agent by modulating the activity of the NMDA receptor.
Xaliproden (SR57746A) is a small molecule serotonin 1a (5-HT1a) receptor agonist. It has been studied in clinical trials for conditions including Alzheimer Disease, Metastases, Colorectal Neoplasms, and Colorectal Carcinoma.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression). -
Big-pharma sponsor
+3.0pp
Sanofi is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Xaliproden (SR57746A) |
|---|---|
| Sponsor | Sanofi |
| Drug class | Neuroprotective agent |
| Target | NMDA receptor |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
It is believed to exert its effects by reducing excitotoxicity and promoting neuronal survival. This is thought to be beneficial in the treatment of neurodegenerative diseases such as Alzheimer's disease. However, the exact mechanism of action is not fully understood.
Approved indications
- Alzheimer's disease
Common side effects
- Headache
- Dizziness
- Nausea
Key clinical trials
- Role of Xaliproden on Recovery Rate From Severe Neuropathy in Patients Who Have Completed Adjuvant Chemotherapy With Oxaliplatin Based Regimens (PHASE3)
- Evaluation of the Efficacy of Xaliproden (SR57746A) in Preventing the Neurotoxicity of Oxaliplatin / 5FU/LV Chemotherapy. (PHASE3)
- 18-Month Study of the Efficacy of Xaliproden (SR57746A) in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type (PHASE3)
- Study of Xaliproden (SR57746A) in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type (PHASE3)
- XENOX - Evaluation of the Efficacy of Xaliproden in Reducing the Neurotoxicity of the Oxaliplatin + 5-FU/LV Chemotherapy (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Xaliproden (SR57746A) CI brief — competitive landscape report
- Xaliproden (SR57746A) updates RSS · CI watch RSS
- Sanofi portfolio CI
Frequently asked questions about Xaliproden (SR57746A)
What is Xaliproden (SR57746A)?
How does Xaliproden (SR57746A) work?
What is Xaliproden (SR57746A) used for?
Who makes Xaliproden (SR57746A)?
What drug class is Xaliproden (SR57746A) in?
What development phase is Xaliproden (SR57746A) in?
What are the side effects of Xaliproden (SR57746A)?
What does Xaliproden (SR57746A) target?
Related
- Drug class: All Neuroprotective agent drugs
- Target: All drugs targeting NMDA receptor
- Manufacturer: Sanofi — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for Alzheimer's disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing