Last reviewed · How we verify
Eszopiclone 2 mg- Elderly
Eszopiclone 2 mg- Elderly is a Small molecule drug developed by Eisai Co., Ltd.. It is currently in Phase 3 development. Also known as: SEP-190.
-
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).
| 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 | Eszopiclone 2 mg- Elderly |
|---|---|
| Also known as | SEP-190 |
| Sponsor | Eisai Co., Ltd. |
| Modality | Small molecule |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Investigation of the Safety and Efficacy of Long Term Administration of Eszopiclone in Insomnia Patients
- Investigation of the Safety and Efficacy of Eszopiclone in Insomnia Patients
- A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly With Primary Chronic Insomnia (PHASE4)
- A Phase III Study of Eszopiclone in Patients With Insomnia (Study SEP 190-150) (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:
- Eszopiclone 2 mg- Elderly CI brief — competitive landscape report
- Eszopiclone 2 mg- Elderly updates RSS · CI watch RSS
- Eisai Co., Ltd. portfolio CI
Frequently asked questions about Eszopiclone 2 mg- Elderly
What is Eszopiclone 2 mg- Elderly?
Who makes Eszopiclone 2 mg- Elderly?
Is Eszopiclone 2 mg- Elderly also known as anything else?
What development phase is Eszopiclone 2 mg- Elderly in?
Related
- Manufacturer: Eisai Co., Ltd. — full pipeline
- Also known as: SEP-190
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing