NCT07459166 Fentanyl Citrate Opiate Overdose Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07459166 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: 27 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07459166 is a hot trial to watch
Opiate Overdose is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07459166 is notable because it evaluates Fentanyl Citrate in a Phase 2 design sponsored by Clear Scientific, Inc.. 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 | NCT07459166 |
| Official title | A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade |
| Phase / status | Phase 2 / Recruiting |
| Intervention | Fentanyl Citrate |
| Sponsor | Clear Scientific, Inc. |
| Geography | United States |
| Enrollment | 16 |
| Primary endpoint | Number of participants with CS-1103-related adverse events (AEs) assessed by physical examinations |
| Endpoint time frame | 3 days plus follow-up on Day 10 |
| Primary completion / readout proxy | 2026-07-22 |
Protocol design and endpoint interpretation
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of CS-1103 (1,000 mg), given by intravenous (IV) infusion in healthy participants in the presence of a clinically relevant dose of fentanyl (200 μg, IV), with naloxone blockade (400 μg, IV).
Allocation is Randomized, masking is Quadruple, and the intervention model is Parallel Assignment. Planned enrollment of 16 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.
- Number of participants with CS-1103-related adverse events (AEs) assessed by physical examinations (3 days plus follow-up on Day 10) — Physical examinations
- Number of participants with CS-1103-related adverse events (AEs) assessed by electrocardiograms (ECGs) (3 days plus follow-up on Day 10) — Digital 12-lead electrocardiograms (ECGs). Any correlation between CS-1103 plasma concentrations and changes in QT intervals will be noted
- Number of participants with CS-1103-related adverse events (AEs) assessed by vital signs (3 days plus follow-up on Day 10) — Blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature
- Number of participants with CS-1103-related adverse events (AEs) assessed by laboratory parameters (3 days plus follow-up on Day 10) — Clinical chemistry, hematology, coagulation, and urinalysis
Readout outlook and evidence gap
The current protocol points to 2026-07-22 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: Fentanyl Citrate 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: Clear Scientific, Inc. is resolved to a normalized organization record in ALACHUA COUNTY, United States. 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
NCT07459166 provides a focused lens on Opiate Overdose development. Its value will be determined by whether Fentanyl Citrate can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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