Last reviewed · How we verify
lecozotan SR
lecozotan SR is a Small molecule drug developed by Wyeth is now a wholly owned subsidiary of Pfizer. It is currently in Phase 2 development.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Wyeth is now a wholly owned subsidiary of Pfizer 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 | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | lecozotan SR |
|---|---|
| Sponsor | Wyeth is now a wholly owned subsidiary of Pfizer |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Study Evaluating Lecozotan SR in Mild to Moderate Alzheimer's Disease (AD) (PHASE2)
- Study Evaluating the Safety, Tolerability, and Efficacy of Lecozotan SR in Outpatients With Alzheimer's Disease (PHASE2, PHASE3)
- Study Evaluating Potential Pharmacokinetic (PK) Interaction Between Lecozotan and Digoxin (PHASE1)
- Study Evaluating the Effect of Lecozotan SR on the QTc Interval (PHASE1)
- Study Evaluating a Combined Administration of Lecozotan SR and Citalopram in Young Healthy Subjects (PHASE1)
- Study Comparing Lecozotan SR Two 5-mg Tablets Vs. Lecozotan SR One 10-mg Tablet in Healthy Subjects (PHASE1)
- Study Evaluating the Safety of Lecozotan SR in Healthy Young and Elderly Subjects (PHASE1)
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:
- lecozotan SR CI brief — competitive landscape report
- lecozotan SR updates RSS · CI watch RSS
- Wyeth is now a wholly owned subsidiary of Pfizer portfolio CI
Frequently asked questions about lecozotan SR
What is lecozotan SR?
Who makes lecozotan SR?
What development phase is lecozotan SR in?
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing