Product Description
AQST-109 is a polymer matrix-based epinephrine prodrug administered as a sublingual film that is applied under the tongue for the rapid delivery of epinephrine. (Sourced from: https://aquestive.com/aquestive-therapeutics-reports-positive-topline-data-from-part-2-of-epiphast-trial-evaluating-aqst-109-epinephrine-oral-film/)
Mechanisms of Action: Unknown
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Fast Track - Anaphylaxis *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Aquestive Therapeutics
Company Location: Eastern America
Company Founding Year: 2004
Additional Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Recent & Upcoming Milestones
- FDA's decision not to convene an advisory committee bodes well for Aquestive's Anaphylm's January 31, 2026 PDUFA goal date.
- Clinical Outcomes Reported - Aquestive Therapeutics presented P1 Healthy Volunteers results on 2024-05-31 for Dibutepinephrine
- FDA confirmed 505(b)(2) pathway for Aqst-109, with potential for fast track designation. PDUFA target date: December 23, 2021.
Highest Development Phases
Phase 1: Anaphylaxis
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Recent News Events
Date |
Type |
Title |
|---|---|---|
|
03/10/2026 |
News Article |
Class Action Filed Against Aquestive Therapeutics, Inc. (AQST) Seeking Recovery for Investors - Contact The Gross Law Firm |
|
02/02/2026 |
News Article |
Aquestive Therapeutics Announces FDA Issuance of Complete Response Letter for Anaphylm™ |
|
01/09/2026 |
News Article |
Aquestive Therapeutics Announces Regulatory Development for Anaphylm™ (dibutepinephrine) Sublingual Film and Provides Business Update |
|
11/24/2025 |
News Article |
Aquestive Therapeutics to Participate in the Piper Sandler 37th Annual Healthcare Conference |