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A Phase 1 study with IN-001 in healthy volunteers

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Trial Profile

A Phase 1 study with IN-001 in healthy volunteers

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 08 Nov 2024

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At a glance

  • Drugs Dipivefrine (Primary) ; Epinephrine
  • Indications Anaphylaxis
  • Focus Adverse reactions

Most Recent Events

  • 05 Nov 2024 According to an Insignis Therapeutics media release, the proposed PK/PD trials in healthy human subjects, if successful, could lead to an NDA submission and the potential FDA approval of IN-001 for the emergency treatment of severe allergic reactions (Type I) to insect stings or bites, foods, drugs, and other allergens as well as anaphylaxis of unknown cause (idiopathic anaphylaxis) or exercise induced anaphylaxis.
  • 05 Nov 2024 According to an Insignis Therapeutics media release, company announced today that it has received positive feedback from the U.S. Food and Drug Administration (FDA) for IN-001 for the emergency treatment of anaphylaxis.
  • 07 Oct 2024 Results presented in a Insignis Therapeutics media release.

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