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ENROLLING BY INVITATION
NCT07045701
PHASE2/PHASE3

FMXIN002 in Patients at Risk of Anaphylaxis

Sponsor: Nasus Pharma

View on ClinicalTrials.gov

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.

Official title: Efficacy and Safety of FMXIN002 Epinephrine Powder Nasal Spray for the Treatment of Acute Allergic Reactions in Patients at Risk of Anaphylaxis

Key Details

Gender

All

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-06-12

Completion Date

2026-07-12

Last Updated

2025-07-01

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

Epinephrine 4mg nasal powder spray

Epinephrine nasal powder spray in a unidose nasal applicator device. Will be administered together with a placebo saline IM injection

COMBINATION_PRODUCT

Adrenalin 0.5mg Injectable Product

Epinephrine 0.5mg for IM injection. Will be administered together with a placebo nasal powder spray.

Locations (1)

Shamir Medical Center

Be’er Ya‘aqov, Israel