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Phase III study evaluating the efficacy and safety of epinephrine administration with ARS-1 in food allergy patients

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Trial Profile

Phase III study evaluating the efficacy and safety of epinephrine administration with ARS-1 in food allergy patients

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 May 2026

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At a glance

  • Drugs Epinephrine (Primary)
  • Indications Anaphylaxis
  • Focus Registrational; Therapeutic Use
  • Sponsors ARS Pharmaceuticals

Most Recent Events

  • 15 Apr 2026 According to an ALK-Abello media release, Health Canada has approved neffy 2 mg for the emergency treatment of allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products and other allergens, as well as idiopathic or exercise-induced anaphylaxis in adult and paediatric patients (=30 kg), based on the review of data from the neffy development programme involving over 700 participants.
  • 02 Feb 2026 According to an ARS Pharmaceuticals media release, company has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending expanding the marketing authorization for EURneffy to include a 1 mg nasal adrenaline spray.
  • 19 Sep 2025 According to an ARS Pharmaceuticals media release, the Pharmaceuticals and Medical Devices Agency (PMDA), the Japanese authority responsible for the scientific review of drugs and medical devices, has granted approval for neffy (epinephrine nasal spray) 1 mg and 2 mg doses, for the emergency treatment of allergic reactions (anaphylaxis) in adults and children who weigh greater than 15 kilograms.

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