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Lusedra
Lusedra is a Small molecule drug developed by Eisai Inc.. It is currently in Phase 1 development for Sedation as Adjunct to Anesthesia.
Fospropofol is a small molecule intravenous sedative-hypnotic agent, used for sedation in adult patients undergoing diagnostic or therapeutic procedures. It has been studied in clinical trials for safety and efficacy during invasive mechanical ventilation and in comparison to propofol in various medical settings.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Lusedra |
|---|---|
| Sponsor | Eisai Inc. |
| Target | GABA-A receptor |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
- Sedation as Adjunct to Anesthesia
Common side effects
Key clinical trials
- Correlating EEG Dynamics With Consciousness Alteration Under Anesthesia
- Fospropofol Disodium ED95 for Elderly Spinal Anesthesia Sedation (PHASE4)
- Effect of Remifentanil on Pruritus and Paresthesia of Fospropofol Disodium Anesthesia (NA)
- Clinical Study of Fospropofol Disodium for Injection in the Painless Endoscopic Diagnosis and Treatment (NA)
- ED90 of Fospropofol Disodium in Induction and Maintenance of Anesthesia (PHASE4)
- Efficacy and Safety of Fospropofol in Adult Laparoscopic Surgery: A Clinical Trial (PHASE4)
- Safety and Efficacy of Fospropofol vs Propofol During Invasive Mechanical Ventilation. (NA)
- Efficacy and Safety of Fospropofol for Same-day Bidirectional Endoscopy in Elderly Patients (PHASE4)
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:
- Lusedra CI brief — competitive landscape report
- Lusedra updates RSS · CI watch RSS
- Eisai Inc. portfolio CI
Frequently asked questions about Lusedra
What is Lusedra?
What is Lusedra used for?
Who makes Lusedra?
What development phase is Lusedra in?
What does Lusedra target?
Related
- Target: All drugs targeting GABA-A receptor
- Manufacturer: Eisai Inc. — full pipeline
- Therapeutic area: All drugs in Other
- Indication: Drugs for Sedation as Adjunct to Anesthesia
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing