NCT07540364 Samelisant Cataplexy Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07540364 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 13 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07540364 is a hot trial to watch
Cataplexy is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07540364 is notable because it evaluates Samelisant in a Phase 3 design sponsored by Suven Life Sciences Ltd.. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07540364 |
| Official title | A Phase 3 Study to Evaluate the Efficacy and Safety of Samelisant in Patients With Narcolepsy (AWAKE) |
| Phase / status | Phase 3 / Not yet recruiting |
| Intervention | Samelisant |
| Sponsor | Suven Life Sciences Ltd. |
| Geography | Not reported in the indexed record |
| Enrollment | [object Object] |
| Primary endpoint | Change from Baseline in total Epworth Sleepiness Scale (ESS) score at Week 12 |
| Endpoint time frame | Baseline to Week 12 |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
The primary objective of this study is to evaluate the effect of Samelisant on excessive daytime sleepiness (EDS) after 12 weeks of treatment. In addition, the study aims to assess its effectiveness in influencing the weekly frequency of cataplexy episodes (sudden bouts of muscle weakness) that occur while the individual remains conscious. Other objectives include examining the impact of Samelisant on attention and alertness, overall quality of life, the spectrum of narcolepsy symptoms, and daily functioning, as well as evaluating its safety profile.
Allocation is Randomized, masking is Quadruple, and the intervention model is Parallel Assignment. Planned enrollment of [object Object] participants across Not reported in the indexed record shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- Change from Baseline in total Epworth Sleepiness Scale (ESS) score at Week 12 (Baseline to Week 12) — The ESS is a subjective measure of daytime sleepiness. The participant rates on a 4-point Likert scale how likely it is that he/she would doze in 8 different situations. Scoring of the answers is 0 to 3, with 0 being "would never doze" and 3 being "high chance of dozing". The total ESS score ranges from 0 to 24, with higher scores indicating greater daytime sleepiness. A decrease from baseline in ESS score represents
Readout outlook and evidence gap
The current protocol points to [object Object] as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Drug & Asset MCP profile: Samelisant is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.
Company & Deal Intelligence MCP profile: Suven Life Sciences Ltd. is resolved to a normalized organization record in India. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07540364 provides a focused lens on Cataplexy development. Its value will be determined by whether Samelisant can convert the current Phase 3 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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