NCT07635563 Acetazolamide/Dronabinol Sleep Apnea, Obstructive Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook

Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07635563 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: 7 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.

Why NCT07635563 is a hot trial to watch

Sleep Apnea, Obstructive is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07635563 is notable because it evaluates Acetazolamide/Dronabinol in a Phase 2 design sponsored by Incannex Healthcare, Inc.. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.

Trial landscape snapshot

Protocol design and endpoint interpretation

The goal of this randomized, double-blind, multi-dose crossover clinical trial is to determine the safety and efficacy of IHL-42X in subjects with obstructive sleep apnea. The primary endpoint is: Change in AHI4 at the end of each treatment period compared to baseline (each treatment period is 28 days). The study will consist of three separate four-way crossover dose-comparison studies each comparing three dose strengths of IHL-42X to placebo. The double-blind four-way crossover will be conducted according to a Williams design. Each of the crossover studies will test different doses of dronabinol in combination with a distinct, set dose of acetazolamide. In total, nine different combinations of dronabinol and acetazolamide formulated as IHL-42X will be tested in the study. The optimal dose strength will be selected based on safety and efficacy over a 4-week treatment period.

Allocation is Randomized, masking is Quadruple, and the intervention model is Crossover Assignment. Planned enrollment of [object Object] participants across United States 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 in AHI4 at the end of each treatment period compared to baseline (Each treatment period (28 days)) — To assess the change in efficacy at the end of each dosing period compared with baseline.

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: Acetazolamide/Dronabinol 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: Incannex Healthcare, Inc. is resolved to a normalized organization record in Australia. 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

NCT07635563 provides a focused lens on Sleep Apnea, Obstructive development. Its value will be determined by whether Acetazolamide/Dronabinol can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.

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