Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A pivotal Phase 3, single-center, open-label, randomized study to compare the PK and pharmacodynamics (PD) of single and repeat doses of Anaphylm (AQST-109 ) versus single and repeat doses of the epinephrine intra-muscular (IM) injection and epinephrine autoinjectors (EpiPen and Auvi-Q) in healthy adult subjects

Next Previous
Trial Profile

A pivotal Phase 3, single-center, open-label, randomized study to compare the PK and pharmacodynamics (PD) of single and repeat doses of Anaphylm (AQST-109 ) versus single and repeat doses of the epinephrine intra-muscular (IM) injection and epinephrine autoinjectors (EpiPen and Auvi-Q) in healthy adult subjects

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Aug 2025

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs AQST 109 (Primary) ; AQST 109 (Primary)
  • Indications Anaphylaxis
  • Focus Pharmacokinetics; Registrational
  • Sponsors Aquestive Therapeutics

Most Recent Events

  • 15 Jul 2025 According to an Aquestive Therapeutics media release, the company announced that Health Canada has granted the Company a meeting to discuss company's planned New Drug Submission (NDS) for Anaphylm(epinephrine) Sublingual Film in Canada. In addition, the Company has submitted an initial briefing book to the European Medicines Agency (EMA). The Company plans to submit a Marketing Authorization Application (MAA) to the EMA as soon as possible.
  • 25 Jun 2025 According to an Aquestive Therapeutics media release, the company announced that the poster presentation highlighting results from the study was originally presented at the 2025 AAAAI Annual Meeting.
  • 25 Jun 2025 According to an Aquestive Therapeutics media release, the company announced that the poster presentation highlighting results from the study will be presented at the Center for Food Allergy and Asthma Research (CFAAR) Food Allergy Summit , which will be held June 27-29 in Chicago, Ill.

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top