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Condition (MeSH)

Urticaria

ClinicalTrials.gov lists 527 trials for Urticaria or a narrower condition beneath it. Novartis Pharmaceuticals has the most among industry and government lead sponsors, with 48.

MeSH D014581 Skin and Connective Tissue Diseases C17 C20
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Phase 1 Phase 1 56 Phase 1/2 Phase 1/2 17 Phase 2 Phase 2 105 Phase 2/3 Phase 2/3 14 Phase 3 Phase 3 127 Phase 4 Phase 4 40 Not applicable Not applicable 32 Observational Observational 126 Phase 1 Phase 1 56 Phase 1/2 Phase 1/2 17 Phase 2 Phase 2 105 Phase 2/3 Phase 2/3 14 Phase 3 Phase 3 127 Phase 4 Phase 4 40 Not applicable Not applicable 32 Observational Observational 126

Trials per phase

1 more section with rows

133 of the 527 trials are tagged with Urticaria itself; the rest are tagged with a narrower condition beneath it.

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The PDF carries up to 50 rows of each section, where the page shows the first few, with the sources listed. Enter a work email and confirm it from the message we send, and the report follows by email.

When did Urticaria trials start? (28)

Shown in this order: most recent first, 1990 onwards. 2026 is partial: trials registered with a 2026 start date so far, not a full year.

Trials over time, by phase

  • Phase 1
  • Phase 1/2
  • Phase 2
  • Phase 2/3
  • Phase 3
  • Phase 4
  • Not applicable
  • Observational

Top of scale: 43

1994: 1 trials (Not applicable 1) 1999: 1 trials (Phase 3 1) 2000: 1 trials (Phase 1/2 1) 2002: 3 trials (Phase 3 2, Phase 2 1) 2003: 7 trials (Observational 1, Phase 4 2, Phase 3 1, Phase 2 2, Phase 1/2 1) 2004: 8 trials (Phase 4 2, Phase 3 3, Phase 2 2, Phase 1 1) 2005: 17 trials (Observational 3, Not applicable 2, Phase 4 1, Phase 3 6, Phase 2/3 2, Phase 2 2, Phase 1 1) 2006: 10 trials (Phase 4 2, Phase 3 4, Phase 2/3 1, Phase 1/2 1, Phase 1 2) 2007: 9 trials (Observational 2, Phase 4 1, Phase 3 4, Phase 2 1, Phase 1 1) 2008: 12 trials (Observational 5, Not applicable 1, Phase 3 4, Phase 2 2) 2009: 18 trials (Observational 7, Phase 4 2, Phase 3 4, Phase 2 4, Phase 1/2 1) 2010: 17 trials (Observational 3, Not applicable 2, Phase 4 1, Phase 3 2, Phase 2/3 3, Phase 2 4, Phase 1/2 2) 2011: 17 trials (Observational 2, Not applicable 2, Phase 4 5, Phase 3 5, Phase 2 2, Phase 1 1) 2012: 18 trials (Observational 4, Phase 3 4, Phase 2/3 2, Phase 2 6, Phase 1/2 1, Phase 1 1) 2013: 15 trials (Observational 2, Not applicable 1, Phase 4 3, Phase 3 3, Phase 2 4, Phase 1 2) 2014: 25 trials (Observational 5, Not applicable 1, Phase 3 8, Phase 2/3 1, Phase 2 3, Phase 1 7) 2015: 14 trials (Observational 1, Not applicable 1, Phase 4 4, Phase 3 4, Phase 2 3, Phase 1 1) 2016: 19 trials (Observational 8, Not applicable 1, Phase 4 2, Phase 3 4, Phase 2 2, Phase 1 2) 2017: 17 trials (Observational 5, Not applicable 2, Phase 4 3, Phase 3 1, Phase 2 2, Phase 1 4) 2018: 29 trials (Observational 10, Not applicable 3, Phase 4 2, Phase 3 5, Phase 2/3 1, Phase 2 7, Phase 1 1) 2019: 23 trials (Observational 5, Phase 4 2, Phase 3 5, Phase 2 7, Phase 1 4) 2020: 22 trials (Observational 4, Not applicable 1, Phase 4 1, Phase 3 4, Phase 2 6, Phase 1 6) 2021: 31 trials (Observational 5, Phase 3 13, Phase 2/3 2, Phase 2 9, Phase 1/2 1, Phase 1 1) 2022: 42 trials (Observational 12, Not applicable 3, Phase 4 1, Phase 3 10, Phase 2/3 1, Phase 2 9, Phase 1/2 2, Phase 1 4) 2023: 26 trials (Observational 7, Not applicable 1, Phase 3 6, Phase 2 5, Phase 1/2 2, Phase 1 5) 2024: 31 trials (Observational 10, Not applicable 1, Phase 4 4, Phase 3 9, Phase 2 4, Phase 1/2 1, Phase 1 2) 2025: 43 trials (Observational 12, Not applicable 4, Phase 4 1, Phase 3 8, Phase 2 11, Phase 1/2 2, Phase 1 5)

Trials registered with a start date in each year, 1990 onward, stacked by phase (complete years only; the current partial year is in the table's notes). The table below lists the same counts, most recent years first.

Trials started per year
Year Trials started
2026 (partial year) 39
2025 43
2024 31
2023 26
2022 42
2021 31
2020 22
2019 23
2018 29
2017 17

Showing 10 of 28 earlier years.

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Forecast of the full-year count, planned starts included, not rows of this table: about 49 trials starting in 2026 and about 43 in 2027, the average of the 24 months through September, counted as registered and carried forward, with about 0.7 times the starts already registered for the rest of 2026 added. The rows of this table count trials registered so far with a start date in the year, planned starts included; the forecast looks ahead to the count for the whole year, so it is not the same measure. In backtests on conditions of this size, forecasts made part-way through the year were typically off by about 15 percent and ran about 1 percent high against the count later registered; forecasts made before the year began were off by about 26 percent and ran about 20 percent low against the count later registered. The part-way figures are from forecasts that used a multiple fitted only on earlier years. These figures rest on a few years of history (target years from 2018 to 2025, varying by figure), place each condition as it is mapped today rather than as it was then, and score against a count for the newest year that was still being revised. Only condition series were scored.

Prediction, not a registry value: median of 36 months from start to primary completion across 53 trials still running at the 2026-10-09 snapshot; registered median of 19 months across 357 trials with a primary completion typed Actual. Source: ClinicalTrials.gov / AACT (CTTI), public domain.

What phase are Urticaria trials in? (9)

Shown in this order: phase order.

Show the trials by phase as a table
Trials by phase
Phase Trials
Phase 1 56
Phase 1/2 17
Phase 2 105
Phase 2/3 14
Phase 3 127
Phase 4 40
Not applicable 32
Observational 126
Expanded access 10

How many Urticaria trials are recruiting? (12)

Shown in this order: the order a trial moves through, from not yet recruiting to unknown.

Trials by recruitment status
Status Trials
Not yet recruiting 19
Recruiting 52
Enrolling by invitation 8
Active, not recruiting 24
Available 5

Showing 5 of 12 statuses.

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Status as registered on ClinicalTrials.gov. Each trial is counted once.

Which lead sponsors run the most Urticaria trials? (13)

Shown in this order: most trials first. Lead sponsors the registry classes as industry, NIH, US federal, other government or network. A hospital or university the registry files as government can appear here. Sponsors it classes as academic or other are shown on the full page, because that class cannot separate an institution from a named investigator.

Lead sponsors
Sponsor Trials
Novartis Pharmaceuticals 48
Shire 40
Takeda 20
BioCryst Pharmaceuticals 17
CSL Behring 15

Showing 5 of 13 sponsors.

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Which drugs are being tested for Urticaria? (9)

Shown in this order: most trials first. One row per drug, matched to a single molecule under all its names, ranked by number of trials.

Drugs tested
Drug Trials
C1 esterase inhibitor [human] (C1INH-nf) 13
Icatibant 13
Lanadelumab 12
Berotralstat 11
Ligelizumab 10

Showing 5 of 9 drugs.

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Interventions as named in the registry (6)

Shown in this order: most trials first.

Interventions as named in the registry
Drug Trials
Drug: Omalizumab 40
Desloratadin 18
Canakinumab, ACZ885 12
Levocetirizine only 10
Dupilumab/Dupixent 6

Showing 5 of 6 interventions.

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These are the names sponsors entered on ClinicalTrials.gov that we have not matched to a single molecule. Some are drugs under a brand or code name; others are procedures, doses or arm labels.

Which serious adverse events do Urticaria trials report? (10)

Shown in this order: most subjects affected first. Subjects affected summed across trials, a cross-trial signal, not a rate.

Serious adverse events in this condition's trials
Adverse event Subjects affected Trials
COVID-19 63 7
Hereditary angioedema 42 18
Angioedema 31 13
Pneumonia 28 19
Urticaria 28 13

Showing 5 of 10 adverse events.

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Which publications cover Urticaria? (187)

Shown in this order: major-topic papers first, then newest, then most linked to trials.

Publications
Publication Journal Year Major topic
Non-Allergic Urticarial Skin Reactions Associated With MOv18 IgE, a First-In-Class IgE Antibody Recognising Folate Receptor Alpha. Allergy 2025 Yes
Efficacy and safety of ligelizumab in adults and adolescents with chronic spontaneous urticaria: results of two phase 3 randomised controlled trials. Lancet (London, England) 2024 Yes
Remibrutinib demonstrates favorable safety profile and sustained efficacy in chronic spontaneous urticaria over 52 weeks. The Journal of allergy and clinical immunology 2024 Yes
Biomarkers of Autologous Whole Blood Injection Efficacy in Patients with Chronic Spontaneous Urticaria with Autoreactivity: A Preliminary Study. International archives of allergy and immunology 2024 Yes
Evaluation of Pharmacological Treatments for Acute Urticaria: A Systematic Review and Meta-Analysis. The journal of allergy and clinical immunology. In practice 2024 Yes

Showing 5 of 187 publications.

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Sub-conditions in MeSH (3)

MeSH descendants one level down with at least one trial, most trials first.

Not on this page

Not measured: delivery record.

Checked, with nothing recorded for this condition: prevalence and rare-disease identity.

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