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Drug Pipeline Review Therapy area: Chronic Urticaria40–50 pages · PDF + Excel tracker

Chronic Urticaria Drug Pipeline: 28 Assets by Phase

Chronic Urticaria pipeline: 28 drug candidates in clinical development, 8 in Phase III, from 27 sponsors. Data as of 3 Oct 2026.

Pipeline Terminal Chronic Urticaria Data as of 3 Oct 2026
Candidates in development 28assets Desk-reviewed How this number is madeEvery drug named in an interventional trial, merged across code, generic and brand names, with a live or recent industry trial. Placebo and comparator arms excluded.
Phase III 829% of pipeline Registry How this number is madeCandidates whose highest phase in a live or recent trial is Phase III (Phase II/III counts as Phase II).
Phase II 1036% of pipeline Registry
Phase I 1036% of pipeline Registry
Sponsors 27top 5 hold 21% Registry How this number is madeCompanies credited with at least one candidate: the lead sponsor on most of that candidate's industry trials.
Registered trials 12141 running Registry How this number is madeInterventional trials on ClinicalTrials.gov for the conditions in scope, updated since 3 Oct 2021.
Readouts in 12 months 10Phase II or later Sponsor dates How this number is madeCandidates with a registered primary completion date in the next 12 months. Dates are the sponsor's own and often move.
Trials with US sites 5445% · Europe 41% Registry How this number is madeTrials with at least one site in the United States; Europe is the EU/EEA, the UK and Switzerland. A trial counts in every region where it has a site.

Candidates by highest phase reached

Phase I10
Phase II10
Phase III8

Next registered primary completions, Phase II or later

CandidatePhasePrimary completion
BarzolvolimabPhase IIIOct 2026 (est.)
CM512Phase IINov 2026 (est.)
RemibrutinibPhase IIINov 2026 (est.)

Candidates in development by lead sponsor

Novartis Pharmaceuticals2
Allakos Inc.1
AlphaMol Science Ltd. (Shanghai)1
Celldex Therapeutics1
Bambusa Therapeutics1

Phase II and III primary completions per quarter

Q4 20266
Q1 20271
Q2 20273
Q3 20270
Q4 20272
Q1 20280
Q2 20281
Q3 20281

Answers at a glance

  • 8 of 28 chronic urticaria candidates (29%) are in Phase III.
  • Novartis Pharmaceuticals runs the largest chronic urticaria pipeline, with 2 candidates.
  • 10 readouts are due in 12 months; the next is Barzolvolimab in Oct 2026.
  • 20 trials are recruiting patients now; 45% of all trials have a US site and 41% a European one.
28 candidates121 trials59 countriesData as of 3 Oct 2026Next refresh by 1 Jan 2027
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Edition: data as of 3 Oct 2026 Next refresh: by 1 Jan 2027 Change: First edition

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Chronic Urticaria has 28 drug candidates in active clinical development, of which 8 are in Phase III, 10 in Phase II and 10 in Phase I, according to Douglas Insights' count of 121 interventional trials registered on ClinicalTrials.gov (data as of 3 Oct 2026).

The chronic urticaria drug pipeline is the set of medicines that sponsors are still testing in people for this condition: each candidate is counted once, at the highest phase it has reached in a running or recently completed trial. Medicines already on the market and studied only in Phase IV trials are kept out of the count.

How many chronic urticaria drugs are in each phase of development?

Douglas Insights counts 8 chronic urticaria candidates in Phase III, 29% of the 28 assets in development; Phase II holds 10 and Phase I holds 10.

Phase I10Phase II10Phase III8
Candidates by highest phase reached. Source: Douglas Insights from ClinicalTrials.gov, data as of 3 Oct 2026.
Phase (highest reached)AssetsShare of pipeline
Phase III829%
Phase II1036%
Phase I1036%
Total28100%

Phase I/II candidates sit in the Phase I row and Phase II/III candidates in the Phase II row, so each chronic urticaria asset appears in exactly one row. The 41 trials still recruiting or running carry 34% of the 121 registered trials in scope.

How many chronic urticaria trials are recruiting patients now?

20 chronic urticaria trials are recruiting patients and 10 more have not started recruiting yet, out of 121 interventional trials in scope; together they make up 25% of the trial base.

Registry statusTrialsShare
Completed5747%
Recruiting2017%
Terminated1412%
Not yet recruiting108.3%
Active, not recruiting97.4%
Status not verified75.8%
Withdrawn21.7%
Enrolling by invitation21.7%

Terminated, suspended and withdrawn chronic urticaria trials stay in the trial base so that a stalled programme is visible, but a candidate whose only trials stopped is no longer counted as in development.

Which companies lead the chronic urticaria pipeline?

Novartis Pharmaceuticals leads the chronic urticaria pipeline with 2 candidates; the top 5 sponsors hold 21% of the 28 assets, and 27 sponsors run at least one.

SponsorAssets in developmentShare
Novartis Pharmaceuticals27.1%
Allakos Inc.13.6%
AlphaMol Science Ltd. (Shanghai)13.6%
Celldex Therapeutics13.6%
Bambusa Therapeutics13.6%

Industry sponsors lead 105 of the 121 chronic urticaria trials (87%); universities, hospitals and public funders lead the rest. A sponsor is credited with an asset when it is the lead sponsor on most of that asset's industry trials.

Which drug types and mechanisms dominate the chronic urticaria pipeline?

Mechanism and drug-type classification for the 28 chronic urticaria candidates is done by the research desk asset by asset, each with a cited source, and is published in the paid review together with the white-space map.

What chronic urticaria trial readouts are coming next?

10 chronic urticaria candidates in Phase II or later have a registered primary completion date in the next 12 months; the next three are below, each linked to its registry record.

CandidateSponsorPhasePrimary completionRegistry
BarzolvolimabCelldex TherapeuticsPhase IIIOct 2026 (estimated)NCT06445023
CM512Keymed Biosciences Co.LtdPhase IINov 2026 (estimated)NCT07166211
RemibrutinibNovartis PharmaceuticalsPhase IIINov 2026 (estimated)NCT05677451

Primary completion is the date a sponsor expects the last patient to finish the main measurement, so data usually follow within months. Dates marked estimated are the sponsor's own forecast on the registry and often move.

How many chronic urticaria readouts fall in each quarter?

14 chronic urticaria candidates in Phase II or later reach registered primary completion over the next eight quarters, with the most, 6, due in Q4 2026.

QuarterPhase III readoutsPhase II readoutsTotal
Q4 2026246
Q1 2027101
Q2 2027123
Q3 2027000
Q4 2027022
Q1 2028000
Q2 2028101
Q3 2028011

Each candidate is counted once, at its next readout. The paid catalyst calendar names every readout with its trial, sponsor and design, adds filings and regulatory decisions, and runs 24 months ahead.

Which countries host the most chronic urticaria trials?

United States hosts the most chronic urticaria trials, with sites in 54 of the 121 studies (45%); trials in scope run in 59 countries in all.

CountryTrials with a siteShare of trials
United States5445%
Germany4134%
Spain2924%
Poland2823%
Canada2722%
China2621%
Japan1916%
France1815%

A multinational chronic urticaria trial is counted once in every country where it has a site, so the shares add up to more than 100%. Country spread shows where sponsors are building the evidence that regulators in each market will ask for.

Where are chronic urticaria drugs being tested?

54 of the 121 chronic urticaria trials (45%) have a site in the United States, 50 (41%) in Europe and 26 (21%) in China; 12 of the 28 candidates in development are tested in the US.

RegionTrials with a siteShare of trialsCandidates testedRegulator
United States5445%12FDA
Europe (EU/EEA, UK, Switzerland)5041%11EMA, MHRA, Swissmedic
China2621%15NMPA
Japan1916%5PMDA
Rest of world5243%12national regulators

Each region's trials are the evidence its regulator will review: the FDA in the United States, the EMA (with the MHRA and Swissmedic) in Europe, the NMPA in China and the PMDA in Japan. A multinational chronic urticaria trial counts once in every region where it has a site, so the shares add up to more than 100%. A candidate tested only outside the US and Europe is often a licensing opportunity for sponsors in those markets.

What has changed in the chronic urticaria pipeline since the last update?

This is the first edition of the chronic urticaria pipeline count, dated 3 Oct 2026. The next refresh is due by 1 Jan 2027, and each refresh lists the assets that entered, advanced or dropped out.

How does Douglas Insights count the chronic urticaria pipeline?

Douglas Insights read 121 interventional trials registered on ClinicalTrials.gov for the conditions "Chronic Urticaria", "Chronic Spontaneous Urticaria" and updated since 3 Oct 2021, then grouped every drug or biologic named in them into 28 unique candidates.

  1. Code names, generic names and brand names of the same molecule are merged into one candidate, and every merge is reviewed by the research desk.
  2. A candidate counts when it has a trial that is recruiting, running, or completed in the last 24 months, and at least one industry-sponsored trial.
  3. Its phase is the highest phase among those trials; placebo, standard-of-care and comparator arms are not candidates.
  4. Each figure on this page is drawn from one frozen dataset that passes ten checks before release, and the owner approves every edition.

Read the full approach on the research methodology page, or browse other Pharmaceuticals research.

What does the Chronic Urticaria Pipeline Review include?

The Chronic Urticaria Pipeline Review covers all 28 candidates in an Excel tracker and profiles the leading 25 in a 40–50 page report, ending with the research desk's ranked view of the candidates most likely to win.

11 chapters40–50 pages25 asset profilesExcel tracker of all 28 candidates
01Executive summary and our call2–3 pp

The pipeline on one page and the desk's verdict on where chronic urticaria treatment is heading.

  • Pipeline size and phase mix
  • The three calls that matter
  • What changed since the last edition
02Disease and unmet need3 pp

Who is treated today, what current therapy leaves unmet, and how regulators judge new medicines.

  • Patient population and diagnosis
  • Treatment guidelines and gaps
  • Regulatory endpoints
03Approved therapies3 pp

The marketed medicines every chronic urticaria candidate will be measured against.

  • Marketed medicines and their sponsors
  • Post-approval trials
  • The bar a new entrant must clear
04Pipeline at a glance4 pp

Every candidate counted by phase, drug type, sponsor and country.

  • Assets by phase and drug type
  • Sponsors by size of pipeline
  • Trial footprint: US, Europe, China, Japan
05Mechanism landscape and white space5 pp

Which mechanisms are crowded and which no sponsor has entered.

  • Mechanism classes and crowding
  • Classes with no candidate yet
  • Differentiation by route and dosing
06Key asset profiles12–15 pp

The leading 25 candidates, one profile each, every claim linked to a source document.

  • Design and endpoints of the pivotal trials
  • Data to date, with sources
  • Next readout and the risk to it
07Catalyst calendar3 pp

Readouts, filings and regulatory decisions 24 months ahead.

  • Readouts by quarter
  • Filings and regulatory decisions
  • Date confidence for each event
08Deals and partnering3 pp

Who is licensing, buying and partnering in chronic urticaria, and on what terms.

  • Licensing and M&A in the area
  • Deal terms where disclosed
  • Sponsors open to partnering
09Sponsor landscape3 pp

Large pharma against biotech, and how concentrated the pipeline is.

  • Pipeline share by sponsor
  • Sponsor-by-phase matrix
  • New entrants since the last edition
10Our call: winners, risks, opportunities3–4 pp

The candidates most likely to win, ranked, with the reasoning and evidence.

  • Ranked candidates
  • Risks that could change the order
  • Openings for new entrants and investors
11Methodology and source log2 pp

How the count is built and every document behind it.

  • How candidates are counted and merged
  • Every source document listed
  • The ten quality checks

Ways to buy the Chronic Urticaria review

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Frequently asked questions about the chronic urticaria pipeline

How many drugs are in the chronic urticaria pipeline?

28 drug candidates are in active clinical development for chronic urticaria, with 8 in Phase III, per Douglas Insights (data as of 3 Oct 2026).

Which company has the most chronic urticaria drugs in development?

2 candidates make Novartis Pharmaceuticals the largest chronic urticaria pipeline sponsor, out of 27 sponsors counted by Douglas Insights.

When is the next chronic urticaria trial readout?

Oct 2026 is the registered primary completion of the Phase III trial of Barzolvolimab (NCT06445023), the next chronic urticaria catalyst in Douglas Insights' calendar.

How many chronic urticaria trials run in the United States and Europe?

54 chronic urticaria trials have a US site and 50 a European site, out of 121 registered trials counted by Douglas Insights (data as of 3 Oct 2026).

How often is the chronic urticaria pipeline count updated?

90 days is the refresh cycle; this edition uses registry data as of 3 Oct 2026 and the next is due by 1 Jan 2027.

Research & citation

This review was researched, written and reviewed by the Douglas Insights Research Desk under the Douglas Insights editorial standards. Material errors are logged in the corrections log. No section is sponsored.

Cite this page Douglas Insights (2026). Chronic Urticaria Drug Pipeline, data as of 3 Oct 2026. https://www.douglasinsights.com/pipeline/chronic-urticaria/