Evicenter
P&T meetings

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

Company-reported prevalence

Anaphylm

Overview

FieldValue
DrugAnaphylm (dibutepinephrine)
IndicationType I allergic reactions including anaphylaxis
DiseaseAnaphylaxis and severe systemic Type 1 allergic reactions
CompanyAquestive Therapeutics (worldwide rights; no licensee identified)
Documents searchedAquestive Therapeutics website, home, pipeline, and Anaphylm pages, October 2026; Anaphylm product website, October 2026; Aquestive Therapeutics investor presentation, September 14, 2026; Aquestive Therapeutics corporate presentation, February 2026; Aquestive Therapeutics Form 10-K for 2025, filed March 2026; Aquestive Therapeutics press releases of September 2026 (NDA resubmission), August 11, 2026 (second quarter 2026 results), August 2026 (human factors and pharmacokinetic results), February 2, 2026 (complete response letter), June 16, 2025 (NDA acceptance), April 1, 2025 (pediatric study results), 2024 (oral allergy syndrome study results), July 25, 2024 (self-administration study results), June 25, 2024 (temperature and pH study results), and March 14, 2024 (pivotal study results)
Data as ofOctober 14, 2026
Prepared byAI research agent (Claude); not yet reviewed by a person

Company statements of prevalence

United States

Number affected (people at chronic risk for a severe systemic Type 1 reaction): Aquestive Therapeutics investor presentation, September 2026

“32-40 million people at chronic risk for severe systemic Type 1 reaction in the US” (opens the source at this quote in a new tab)

Cited source: 2.1 Wood 2014

Aquestive Therapeutics (2026) investor presentation, September 14, 2026, quoted passage highlighted (opens the full-size image in a new tab)
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Number affected (people at chronic risk for anaphylaxis): Aquestive Therapeutics press release, July 2024

“As many as 49 million people in the United States are at chronic risk for anaphylaxis.” (opens the source at this quote in a new tab)

Cited source: None stated in the document.

Aquestive Therapeutics (2024) press release, July 25, 2024, quoted passage highlighted (opens the full-size image in a new tab)
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Prevalence: Aquestive Therapeutics press release, July 2024

“Lifetime prevalence is at least 5%, or more than 16 million people in the United States.” (opens the source at this quote in a new tab)

Cited source: None stated in the document.

Aquestive Therapeutics (2024) press release, July 25, 2024, quoted passage highlighted (opens the full-size image in a new tab)
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Europe

No evidence found.

Global

No evidence found.

Other countries and regions

No evidence found.

Geography not stated

Incidence: Aquestive Therapeutics Form 10-K for 2025, March 2026

“Anaphylaxis is a potentially life-threatening systemic allergic reaction, with an estimated incidence of 50 to 112 episodes per 100,000 people per year.” (opens the source at this quote in a new tab)

Cited source: None stated in the document.

Aquestive Therapeutics (2026) Form 10-K for 2025, quoted passage highlighted (opens the full-size image in a new tab)
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Prevalence (adults and children, condition not named): Aquestive Therapeutics investor presentation, September 2026

“1 in 10 adults; 1 in 13 children” (opens the source at this quote in a new tab)

Cited source: None stated in the document.

Aquestive Therapeutics (2026) investor presentation, September 14, 2026, quoted passage highlighted (opens the full-size image in a new tab)
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Prevalence (share of people with prior anaphylaxis never prescribed an epinephrine auto-injector): Aquestive Therapeutics investor presentation, September 2026

“52% of surveyed patients with prior anaphylaxis never received an epinephrine autoinjector Rx” (opens the source at this quote in a new tab)

Cited source: 2.2 Fromer 2016

Aquestive Therapeutics (2026) investor presentation, September 14, 2026, quoted passage highlighted (opens the full-size image in a new tab)
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Prevalence (share of people with prior anaphylaxis never prescribed an epinephrine auto-injector): Aquestive Therapeutics press release, July 2024

“Of patients who previously experienced anaphylaxis, 52% had never received an epinephrine auto-injector prescription, and 60% did not have an auto-injector currently available.” (opens the source at this quote in a new tab)

Cited source: None stated in the document.

Aquestive Therapeutics (2024) press release, July 25, 2024, quoted passage highlighted (opens the full-size image in a new tab)
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Sources the company cites

Wood 2014

Reference as the company lists it

“Wood et al. J Allergy Clin Immunol. 2014;133:461-467.” (opens the source at this quote in a new tab)

Aquestive Therapeutics (2026) investor presentation, September 14, 2026, quoted passage highlighted (opens the full-size image in a new tab)
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Passage carrying the nearest figure

“Using increasingly stringent criteria, we estimate that 5.1% (95% CI, 3.4% to 6.8%) and 1.6% (95% CI, 0.8% to 2.4%) had probable and very likely anaphylaxis, respectively.” (opens the source at this quote in a new tab)

“The prevalence of anaphylaxis in the general population is at least 1.6% and probably higher.” (opens the source at this quote in a new tab)

Wood 2014, quoted passage highlighted (opens the full-size image in a new tab)
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Fromer 2016

Reference as the company lists it

“Fromer, L., The American Journal of Medicine (2016); 129, 1244-1250” (opens the source at this quote in a new tab)

Aquestive Therapeutics (2026) investor presentation, September 14, 2026, quoted passage highlighted (opens the full-size image in a new tab)
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Passage carrying the figure

“In one survey, 52% of patients who had previously experienced anaphylaxis had never received a self-injectable epinephrine prescription, and 60% did not have an auto-injector available.” (opens the source at this quote in a new tab)

Fromer 2016, quoted passage highlighted (opens the full-size image in a new tab)
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References

  1. Aquestive Therapeutics (2024) press release, July 25, 2024 (opens in a new tab)
  2. Aquestive Therapeutics (2026) Form 10-K for 2025 (opens in a new tab)
  3. Aquestive Therapeutics (2026) investor presentation, September 14, 2026 (opens in a new tab)
  4. Fromer 2016 (opens in a new tab)
  5. Wood 2014 (opens in a new tab)