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Anaphylm (dibutepinephrine)

Type I allergic reactions including anaphylaxis

Also known as AQST-109
Regulatory submission
NDA resubmitted September 2026
Launch
Not announced
Last updated
121 sources

Product information and disease descriptionProduct descriptionProduct information

Indication

3 evidence topics · 3 sources

Proposed indication wording

“today announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Anaphylm™ (dibutepinephrine) sublingual film for the treatment of Type I allergic reactions, including anaphylaxis.” (opens the source at this quote in a new tab)

Intended population: participants weighing 30 kg or more

“today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on January 30, 2026 for the New Drug Application (NDA) seeking approval of Anaphylm™ (dibutepinephrine) Sublingual Film for the treatment of Type I allergic reactions, including anaphylaxis, in patients weighing 30kg or more (approximately 66 pounds).” (opens the source at this quote in a new tab)

Age range studied in the pediatric program

“The pediatric study in subjects from the ages of 7 to 17 (weight greater than or equal to 30 kgs) was completed with positive topline data reported on April 1, 2025.” (opens the source at this quote in a new tab)