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A pharmacokinetic/pharmacodynamic study assessing repeat doses of neffy compared to repeat doses of an epinephrine injection product under allergen-induced allergic rhinitis conditions

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Trial Profile

A pharmacokinetic/pharmacodynamic study assessing repeat doses of neffy compared to repeat doses of an epinephrine injection product under allergen-induced allergic rhinitis conditions

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 27 Mar 2025

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At a glance

  • Drugs Epinephrine (Primary) ; Epinephrine
  • Indications Allergic rhinitis; Anaphylaxis
  • Focus Pharmacodynamics; Pharmacokinetics; Registrational

Most Recent Events

  • 20 Mar 2025 According to an ARS Pharmaceuticals media release,In December 2024, ARS Pharma licensing partners for China, Japan and Australia submitted applications for neffy 2 mg in their respective countries. A regulatory decision in Japan is expected in the second half of 2025, followed by decisions in China and Australia in the first half of 2026.
  • 20 Mar 2025 According to an ARS Pharmaceuticals media release, ARS Pharma along with its licensing partner, ALK-Abello A/S submitted applications for neffy 2 mg in the U.K. and Canada in December 2024 and January 2025, respectively. Regulatory decisions are anticipated by mid-2025 in the U.K (as EURneffy, if approved), and year-end 2025 in Canada.
  • 24 Oct 2024 According to an ARS Pharmaceuticals media release, data from this study will be presented on Friday, October 25 at the 2024 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting taking place in Boston, Massachusetts.

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