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Epinephrine oral film - Aquestive Therapeutics

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Drug Profile

Epinephrine oral film - Aquestive Therapeutics

Alternative Names: Anaphylm; AQST-109; DESF Epinephrine; Dibutepinephrine; Epinephrine - Aquestive Therapeutics; Epinephrine SSF - Aquestive Therapeutics; Epinephrine sublingual film - Aquestive Therapeutics; Epinephrine sublingual soluble film - Aquestive Therapeutics

Latest Information Update: 14 Apr 2026

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At a glance

  • Originator MonoSol Rx
  • Developer Aquestive Therapeutics
  • Class Anti-infectives; Antiallergics; Antiasthmatics; Bronchodilators; Catecholamines; Ethanolamines; Skin disorder therapies; Small molecules
  • Mechanism of Action Alpha adrenergic receptor agonists; Beta adrenergic receptor agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Preregistration Anaphylaxis

Most Recent Events

  • 30 Mar 2026 Aquestive Therapeutics announces intention to re-submit NDA to US FDA for severe allergic reactions including anaphylaxis in Q3 2026
  • 30 Mar 2026 Aquestive Therapeutics completes in-person Type A meeting with the US FDA for Epinephrine oral film in Anaphylaxis
  • 05 Mar 2026 Aquestive Therapeutics plans a new human factors validation trial and a pharmacokinetics trial in Anaphylaxis (Sublingual)

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