Gout has 20 drug candidates in active clinical development, of which 5 are in Phase III, 8 in Phase II and 7 in Phase I, according to Douglas Insights' count of 134 interventional trials registered on ClinicalTrials.gov (data as of 3 Oct 2026).
The gout 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 gout drugs are in each phase of development?
Douglas Insights counts 5 gout candidates in Phase III, 25% of the 20 assets in development; Phase II holds 8 and Phase I holds 7.
| Phase (highest reached) | Assets | Share of pipeline |
|---|---|---|
| Phase III | 5 | 25% |
| Phase II | 8 | 40% |
| Phase I | 7 | 35% |
| Total | 20 | 100% |
Phase I/II candidates sit in the Phase I row and Phase II/III candidates in the Phase II row, so each gout asset appears in exactly one row. The 39 trials still recruiting or running carry 29% of the 134 registered trials in scope.
Which approved gout medicines are still in trials?
4 medicines already on the market are still being tested in gout Phase IV trials; Febuxostat has the most, with 20 registered trials.
| Medicine | Lead sponsor | Registered trials |
|---|---|---|
| Febuxostat | Several sponsors | 20 |
| Allopurinol | Several sponsors | 14 |
| Pegloticase | Amgen | 10 |
| Dotinurad | Crystalys Therapeutics | 7 |
Post-approval gout trials test new doses, new patient groups and head-to-head comparisons. They set the standard of care that every candidate in development will be measured against, so the paid review profiles each one.
How many gout trials are recruiting patients now?
21 gout trials are recruiting patients and 11 more have not started recruiting yet, out of 134 interventional trials in scope; together they make up 24% of the trial base.
| Registry status | Trials | Share |
|---|---|---|
| Completed | 68 | 51% |
| Recruiting | 21 | 16% |
| Status not verified | 14 | 10% |
| Terminated | 12 | 9.0% |
| Not yet recruiting | 11 | 8.2% |
| Active, not recruiting | 6 | 4.5% |
| Suspended | 1 | 0.7% |
| Enrolling by invitation | 1 | 0.7% |
Terminated, suspended and withdrawn gout trials stay in the trial base so that a stalled programme is visible, but a candidate whose only trials stopped is no longer counted as in development.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 gout pipeline?
Atom Therapeutics Co., Ltd leads the gout pipeline with 2 candidates; the top 5 sponsors hold 35% of the 20 assets, and 18 sponsors run at least one.
| Sponsor | Assets in development | Share |
|---|---|---|
| Atom Therapeutics Co., Ltd | 2 | 10% |
| Jiangsu HengRui Medicine Co., Ltd. | 2 | 10% |
| Arthrosi Therapeutics | 1 | 5.0% |
| BioRay Pharmaceutical Co., Ltd. | 1 | 5.0% |
| InventisBio Co., Ltd | 1 | 5.0% |
Industry sponsors lead 92 of the 134 gout trials (69%); 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 gout pipeline?
Mechanism and drug-type classification for the 20 gout 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 gout trial readouts are coming next?
6 gout 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.
| Candidate | Sponsor | Phase | Primary completion | Registry |
|---|---|---|---|---|
| AR882 | Arthrosi Therapeutics | Phase II | Nov 2026 (estimated) | NCT07116746 |
| Etori + Beta | Laboratorios Silanes S.A. de C.V. | Phase III | Dec 2026 (estimated) | NCT06863701 |
| Dapansutrile | Olatec Therapeutics, Inc. | Phase II/III | Dec 2026 (estimated) | NCT05658575 |
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 gout readouts fall in each quarter?
7 gout candidates in Phase II or later reach registered primary completion over the next eight quarters, with the most, 3, due in Q4 2026.
| Quarter | Phase III readouts | Phase II readouts | Total |
|---|---|---|---|
| Q4 2026 | 1 | 2 | 3 |
| Q1 2027 | 0 | 0 | 0 |
| Q2 2027 | 1 | 0 | 1 |
| Q3 2027 | 0 | 2 | 2 |
| Q4 2027 | 0 | 1 | 1 |
| Q1 2028 | 0 | 0 | 0 |
| Q2 2028 | 0 | 0 | 0 |
| Q3 2028 | 0 | 0 | 0 |
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 gout trials?
United States hosts the most gout trials, with sites in 56 of the 134 studies (42%); trials in scope run in 35 countries in all.
| Country | Trials with a site | Share of trials |
|---|---|---|
| United States | 56 | 42% |
| China | 39 | 29% |
| Australia | 9 | 6.7% |
| Taiwan | 8 | 6.0% |
| France | 6 | 4.5% |
| Georgia | 6 | 4.5% |
| United Kingdom | 4 | 3.0% |
| New Zealand | 4 | 3.0% |
A multinational gout 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 gout drugs being tested?
56 of the 134 gout trials (42%) have a site in the United States, 12 (9.0%) in Europe and 39 (29%) in China; 7 of the 20 candidates in development are tested in the US.
| Region | Trials with a site | Share of trials | Candidates tested | Regulator |
|---|---|---|---|---|
| United States | 56 | 42% | 7 | FDA |
| Europe (EU/EEA, UK, Switzerland) | 12 | 9.0% | 3 | EMA, MHRA, Swissmedic |
| China | 39 | 29% | 13 | NMPA |
| Japan | 1 | 0.7% | 0 | PMDA |
| Rest of world | 29 | 22% | 7 | national 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 gout 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 gout pipeline since the last update?
Since 3 Oct 2026, the gout pipeline count moved by 0 assets to 20, Phase III moved by 0 and the trial base by 0.
How does Douglas Insights count the gout pipeline?
Douglas Insights read 134 interventional trials registered on ClinicalTrials.gov for the conditions "Gout" and updated since 3 Oct 2021, then grouped every drug or biologic named in them into 20 unique candidates.
- 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.
- 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.
- Its phase is the highest phase among those trials; placebo, standard-of-care and comparator arms are not candidates.
- 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 Gout Pipeline Review include?
The Gout Pipeline Review covers all 20 candidates in an Excel tracker and profiles the leading 20 in a 40–50 page report, ending with the research desk's ranked view of the candidates most likely to win.
01Executive summary and our call2–3 pp
The pipeline on one page and the desk's verdict on where gout 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 gout 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 gout, 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 Gout review
| Option | What you get | Delivery | Price | |
|---|---|---|---|---|
| Pipeline Snapshot | This therapy area as published: PDF report + Excel tracker | Ready now | USD 3,000 | Enquire |
| Pipeline Review | Your indication, geography and phase cut-off; ranked calls and an analyst call | 2–3 weeks | From USD 4,000 | Enquire |
| Company Assessment | One sponsor's full pipeline against its peers | 2 weeks | From USD 5,000 | Enquire |
Frequently asked questions about the gout pipeline
How many drugs are in the gout pipeline?
20 drug candidates are in active clinical development for gout, with 5 in Phase III, per Douglas Insights (data as of 3 Oct 2026).
Which company has the most gout drugs in development?
2 candidates make Atom Therapeutics Co., Ltd the largest gout pipeline sponsor, out of 18 sponsors counted by Douglas Insights.
When is the next gout trial readout?
Nov 2026 is the registered primary completion of the Phase II trial of AR882 (NCT07116746), the next gout catalyst in Douglas Insights' calendar.
How many gout trials run in the United States and Europe?
56 gout trials have a US site and 12 a European site, out of 134 registered trials counted by Douglas Insights (data as of 3 Oct 2026).
How often is the gout 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.
Douglas Insights (2026). Gout Drug Pipeline, data as of 3 Oct 2026. https://www.douglasinsights.com/pipeline/gout/