drugset / Trial / NCT07045701

FMXIN002 in Patients at Risk of Anaphylaxis

NCT07045701

Phase 2/3 Enrolling by invitation 30 enrolled Nasus Pharma
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Study Objective To evaluate the efficacy of FMXIN002, a powder-based intranasal epinephrine spray, for treating anaphylaxis. Study Design • Hypothesis: FMXIN002 will terminate anaphylactic reactions as effectively-or more rapidly-than IM epinephrine, as measured by clinical parameters.

Timeline

Start
2025-06-12
Primary completion
2026-06-12
Completion
2026-07-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Epinephrine Other / unclassified 0.5 mg Intranasal
Subject Epinephrine Other / unclassified 4 mg Intranasal

Indications