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Home › Conditions › Anaphylaxis

Anaphylaxis

Part of Hypersensitivity, Immediate

8 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials for Anaphylaxis

5 trials tracked for Anaphylaxis: 2 in phase 3 or 4 and 2 with published results. The most-cited published study has 17 citations.

5Trials tracked
2Phase 3 & 4
0Recruiting
2With published results
Phase distribution
Phase 4 2 Phase 2 1 Phase 1 1 Other / NA 1
  1. Phase 4 Pharmacokinetics of Intramuscular Adrenaline in Food--Allergic Teenagers Completed · 17 cited
  2. Phase 4 Study of Drug Exposure in Systemic Circulation of Primatene Mist by Oral Inhalation, Versus Epinephrine Injection by Intramuscular Injection and ProAir by Oral Inhalation in Healthy Individuals Completed · 1 cited
  3. Phase 2 A Randomized, Double-Blind, Placebo-Controlled Study of Omalizumab for Idiopathic Anaphylaxis Completed
  4. Phase 1 A Study to Evaluate the Incidence of Hypersensitivity After Administration of Sugammadex in Healthy Participants (MK-8616-101) Completed
  5. N/A Mast Cell Activation Test in Allergic Disease Completed

Showing the 5 most-cited and recently-updated of 5 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

What the trials found For clinicians

Anaphylaxis: what the trials found

Epinephrine is the established first-line treatment for anaphylaxis. In a phase 4 trial, Epipen 0.3 mg was evaluated in 12 patients 1. Another phase 4 trial assessed epinephrine 0.125 mg per inhalation in 28 patients 2. Both trials confirm the role of epinephrine in managing anaphylaxis.

Epinephrine remains the cornerstone of acute anaphylaxis management, with established efficacy in reversing symptoms. The available evidence supports its use as the primary intervention.

Recent results — preliminary, needs further review

  • A phase 2 trial (N=16) investigated epinephrine but its findings are not yet corroborated 3.
  • A phase 1 trial (N=382) evaluated sugammadex and reported hypersensitivity symptoms in 1.3% to 9.5% of participants, with anaphylaxis rates of 0.0% to 0.7% 4. These results are preliminary and require further validation.
  • A non-randomized trial (N=19) explored histamine release mechanisms in anaphylaxis, showing variable percentages of histamine release under different conditions 5. These findings are exploratory and not yet confirmed.

For the clinician treating this condition

  • Epinephrine (Epipen 0.3 mg or inhaled 0.125 mg) is the established treatment for anaphylaxis based on phase 4 trials 12.
  • No other intervention has been established as a replacement for epinephrine in acute anaphylaxis.
  • Recent trials on sugammadex and histamine release mechanisms are preliminary and should not alter current clinical practice.

AI synthesis of 5 cited trials, updated Jun 29, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
Narrative review outlines multimodal diagnostic strategies for Hymenoptera venom allergy and clonal mast-cell disorders
Allergy & Immunology Sys. Review
Narrative review outlines multimodal diagnostic strategies for Hymenoptera venom allergy and clonal mast-cell disorders Better Tests Could Save Lives After a Bee Sting
This narrative review synthesizes evidence regarding diagnostic modalities for Hymenoptera venom allergy, IgE-mediated anaphylaxis, and clon…
Doctors now have a clearer roadmap to find exactly who is at risk after a sting.
Frontiers Apr 24, 2026
In a single-center retrospective cohort of 107 pediatric patients, food was the most common anaphylaxis trigger at 62.61%
Pediatrics Cohort
In a single-center retrospective cohort of 107 pediatric patients, food was the most common anaphylaxis trigger at 62.61% Why Some Kids’ Allergic Reactions Turn Deadly—And Others Don’t
This single-center retrospective cohort study evaluated 107 pediatric patients with anaphylactic reactions.
Knowing your child’s specific allergy risk can help you act faster in an emergency.
Frontiers Apr 23, 2026
Peri- and postmenopausal hormonal changes may exacerbate asthma, rhinitis, cough, allergies, hypersensitivity, anaphylaxis, and angioedema
Allergy & Immunology Sys. Review
Peri- and postmenopausal hormonal changes may exacerbate asthma, rhinitis, cough, allergies, hypersensitivity, anaphylaxis, and angioedema Menopause Changes Allergy Rules for Women
This systematic review examines the association between declining and fluctuating estrogen and progesterone levels and various allergic and …
Menopause can worsen allergies like hay fever and asthma because dropping estrogen levels make your immune system more reactive to triggers.
Frontiers Apr 14, 2026
AQST-109 sublingual film shows faster time-to-peak concentration than epinephrine autoinjectors in healthy adults
Allergy & Immunology RCT
AQST-109 sublingual film shows faster time-to-peak concentration than epinephrine autoinjectors in healthy adults The Allergy Shot That Goes Under Your Tongue Instead
A phase 3 RCT in healthy adults compared AQST-109 sublingual film to intramuscular epinephrine.
A dissolving film under the tongue delivers epinephrine faster than an EpiPen, offering a needle-free option for severe allergy emergencies.
Apr 14, 2026
A single case report confirms rare IgE-mediated cocoa allergy causing anaphylaxis in a child
Pediatrics Sys. Review
A single case report confirms rare IgE-mediated cocoa allergy causing anaphylaxis in a child Your Child's Chocolate Reaction Might Not Be Milk or Nuts
This systematic review and case report describes a 2-year-old female with a history of allergic rhinitis and tree nut anaphylaxis who experi…
Most chocolate reactions aren't the cocoa itself, but a rare toddler case proves true cocoa allergies exist and require careful testing to f…
Frontiers Apr 14, 2026
U.S. deaths from hornet, wasp, and bee stins tracked from 2011 to 2021
Infectious Disease
U.S. deaths from hornet, wasp, and bee stins tracked from 2011 to 2021 How many people die from bee and wasp stings in the US?
An observational study tracked deaths from hornet, wasp, and bee stings in the U.S.
Deaths from bee and wasp stings occurred across the United States between 2011 and 2021, serving as a serious reminder of the fatal risk for…
CDC Apr 5, 2026
Surveillance reports anaphylaxis cases after first Moderna COVID-19 vaccine doses in US
Allergy & Immunology
Surveillance reports anaphylaxis cases after first Moderna COVID-19 vaccine doses in US What happens when people have severe allergic reactions to the Moderna vaccine?
A US surveillance report describes cases of anaphylaxis following first doses of the Moderna COVID-19 vaccine.
Health officials report severe allergic reactions, including anaphylaxis, after people received their first dose of the Moderna COVID-19 vac…
CDC Apr 4, 2026
Anaphylaxis cases reported after first dose of Pfizer-BioNTech COVID-19 vaccine in US surveillance
Allergy & Immunology
Anaphylaxis cases reported after first dose of Pfizer-BioNTech COVID-19 vaccine in US surveillance Early U.S. monitoring finds allergic reactions after first Pfizer COVID-19 vaccine doses
A US surveillance report identified cases of anaphylaxis following first doses of the Pfizer-BioNTech COVID-19 vaccine administered December…
U.S. health officials confirmed severe allergic reactions occurred after the first Pfizer COVID-19 vaccine doses were given in late December…
CDC Apr 4, 2026