NCT07587385 HS-10506 Sleep Initiation and Maintenance Disorders Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07587385 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: 22 July 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07587385 is a hot trial to watch
Sleep Initiation and Maintenance Disorders is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07587385 is notable because it evaluates HS-10506 in a Phase 3 design sponsored by Jiangsu Hansoh Pharmaceutical Group Co., 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 | NCT07587385 |
| Official title | A Study of HS-10506 in Chinese Patients With Insomnia Disorder |
| Phase / status | Phase 3 / Not yet recruiting |
| Intervention | HS-10506 |
| Sponsor | Jiangsu Hansoh Pharmaceutical Group Co., Ltd. |
| Geography | Not reported in the indexed record |
| Enrollment | [object Object] |
| Primary endpoint | Change from baseline of mean latency to persistent sleep (LPS) over the last 2 nights of 28 days and 84 days under the treatment of HS-10506 |
| Endpoint time frame | Baseline, Night 27 and Night 28,Night 83 and Night 84 |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
The primary purpose of this phase 3 study is to evaluate the safety and the efficacy of HS-10506 (change versus placebo) on latency to persistent sleep (LPS) and wakefulness after sleep onset (WASO) measured by polysomnography (PSG) in Chinese adult participants with insomnia disorder.
Allocation is Randomized, masking is Double, 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 of mean latency to persistent sleep (LPS) over the last 2 nights of 28 days and 84 days under the treatment of HS-10506 (Baseline, Night 27 and Night 28,Night 83 and Night 84) — LPS was defined as the time in minutes from lights off to the first epoch of 20 consecutive epochs of non-wakefulness as measured by polysomnography (PSG)
- Change from baseline of mean wakefulness after sleep onset (WASO) over the last 2 nights of 28 days and 84 days under the treatment of HS-10506 (Baseline, Night 27 and Night 28, Night 83 and Night 84) — WASO was defined as minutes of wake from the onset of persistent sleep until lights on as measured by PSG
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: HS-10506 is indexed as Small molecule drug, with target OX2R, mechanism OX2R antagonists, and global highest development status Phase 3.
Company & Deal Intelligence MCP profile: Jiangsu Hansoh Pharmaceutical Group Co., Ltd. did not return an exact normalized organization match in this snapshot. 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
NCT07587385 provides a focused lens on Sleep Initiation and Maintenance Disorders development. Its value will be determined by whether HS-10506 can convert the current Phase 3 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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