Key findings
- ClinicalTrials.gov lists 1,698 1 interventional drug or biologic studies in ulcerative colitis or Crohn's disease; 372 2 are active and 449 3 are Phase 3.
- 373 4 started between January 2023 and September 2026: 146 5 with a US site and 101 6 with a China site.
- IL-23 p19 antibodies appear in 42 7 new studies and anti-TL1A antibodies in 21 8.
- Ulcerative colitis (224 9 new studies) draws more trials than Crohn's disease (154 10).
Momentum: flat totals, shifting geography
IBD drug trial starts were 73 11 in 2020, 95 12 in 2023 and 94 13 in 2025, a stable level for a mature, well-served market. Studies with a US site stayed between 32 14 and 37 15 a year.
The change is in China. Studies with a China site rose from 12 16 in 2020 to 31 17 in 2025. Chinese hospitals and companies are running biosimilar, JAK and new-mechanism trials, and global sponsors include more Chinese sites in their programmes. IBD incidence in China is rising with urbanisation, which also makes it a growing domestic market.
IBD trial starts are flat, but China-site studies have risen
Interventional inflammatory bowel disease drug studies by start year; a study with sites in both countries counts in both lines
View the underlying data
| Series | Period | Type | Value |
|---|---|---|---|
| All studies | 2025 | Actual | 94 |
| All studies | 2024 | Actual | 87 |
| All studies | 2023 | Actual | 95 |
| All studies | 2022 | Actual | 88 |
| All studies | 2021 | Actual | 88 |
| All studies | 2020 | Actual | 73 |
| With a US site | 2025 | Actual | 37 |
| With a US site | 2024 | Actual | 35 |
| With a US site | 2023 | Actual | 36 |
| With a US site | 2022 | Actual | 35 |
| With a US site | 2021 | Actual | 42 |
| With a US site | 2020 | Actual | 32 |
| With a China site | 2025 | Actual | 31 |
| With a China site | 2024 | Actual | 22 |
| With a China site | 2023 | Actual | 16 |
| With a China site | 2022 | Actual | 18 |
| With a China site | 2021 | Actual | 12 |
| With a China site | 2020 | Actual | 12 |
Live registry counts retrieved 2026-09-27. Studies registered only outside ClinicalTrials.gov, including many China-only trials, are not counted.
Mechanisms: IL-23 leads, TL1A follows, orals arrive
IL-23. Guselkumab, mirikizumab and risankizumab appear in 42 7 studies started since 2023, including a head-to-head trial of guselkumab against risankizumab in Crohn's disease.
TL1A. Anti-TL1A antibodies appear in 21 8 new studies. Merck (tulisokibart, from its 2023 Prometheus acquisition, Merck), Roche (afimkibart, US and Japan rights from its 2023 Telavant deal, Roche) and Sanofi with Teva (duvakitug, Sanofi) are all in Phase 3. TL1A is attractive because it may reduce both inflammation and fibrosis, the cause of strictures in Crohn's disease.
Integrins and JAKs. Anti-integrin drugs appear in 24 29 new studies and JAK inhibitors in 20 30. S1P modulators appear in only 6 31, after two approvals.
New oral drugs. Johnson & Johnson's icotrokinra, an oral peptide that blocks the IL-23 receptor, is in Phase 3 in both diseases (3 32 studies). Abivax's obefazimod (3 33) reported positive Phase 3 induction results in ulcerative colitis in July 2025 (Abivax).
IL-23 antibodies lead new IBD trials, with TL1A close behind
Interventional studies started since January 2023, by asset or class; a study can count in more than one bar
View the underlying data
| Category | Source | Type | Value |
|---|---|---|---|
| IL-23 p19 antibodies | ClinicalTrials.gov | Actual | 42 |
| Anti-integrin (vedolizumab and others) | ClinicalTrials.gov | Actual | 24 |
| Anti-TL1A antibodies | ClinicalTrials.gov | Actual | 21 |
| JAK inhibitors | ClinicalTrials.gov | Actual | 20 |
| S1P modulators | ClinicalTrials.gov | Actual | 6 |
| Oral IL-23 receptor peptide (icotrokinra) | ClinicalTrials.gov | Actual | 3 |
| Obefazimod | ClinicalTrials.gov | Actual | 3 |
Live registry counts retrieved 2026-09-27. Name and code matching can miss studies registered under other identifiers.
Ulcerative colitis versus Crohn's disease
Ulcerative colitis was listed in 224 9 studies started since 2023 and Crohn's disease in 154 10. Many programmes start in ulcerative colitis because trials are shorter and endpoints are simpler, then move to Crohn's disease. Crohn's disease, especially fistulising and stricturing disease, therefore remains the larger unmet need.
Ulcerative colitis has more new trials than Crohn's disease
Interventional studies started since January 2023, by condition; a study can count in more than one bar
View the underlying data
| Category | Source | Type | Value |
|---|---|---|---|
| Ulcerative colitis | ClinicalTrials.gov | Actual | 224 |
| Crohn's disease | ClinicalTrials.gov | Actual | 154 |
Live registry counts retrieved 2026-09-27. Name and code matching can miss studies registered under other identifiers.
Approvals
- Omvoh (mirikizumab, IL-23 p19), first approved for ulcerative colitis on 26 October 2023 (BLA 761279)
- Zymfentra (subcutaneous infliximab), 20 October 2023 (BLA 761358)
- Velsipity (etrasimod, S1P), 12 October 2023 (NDA 216956)
- Entyvio (vedolizumab, α4β7 integrin), 20 May 2014 (BLA 125476)
Skyrizi (risankizumab), Tremfya (guselkumab) and Rinvoq (upadacitinib) were first approved for other diseases and have since added IBD indications. With so many options, new drugs are judged on durable remission and on results in patients who failed earlier biologics.
What it means for founders and R&D teams
- A single new mechanism is no longer enough. Placebo-controlled trials struggle to recruit when many effective drugs exist. Recruitment problems are one of the most common reasons IBD trials stop in the registry.
- Combinations are the next efficacy step. Johnson & Johnson's guselkumab-golimumab combination and TL1A plus IL-23 designs aim to break the ceiling that single drugs hit. A start-up's asset is more valuable if it can combine safely.
- Oral, gut-restricted drugs are a clear niche. Drugs that act in the gut with little systemic exposure can offer biologic-like efficacy with better safety, which suits a smaller company.
- Biomarkers and fibrosis are open problems. Predicting who will respond, and treating strictures, are both largely unsolved and have few competitors.
Methodology and limitations
Every trial count is the totalCount of one ClinicalTrials.gov API v2 query, retrieved on 26 September 2026. Each numbered citation opens a record whose source link re-runs the query. The track includes interventional studies in ulcerative colitis, Crohn's disease or inflammatory bowel disease with a drug or biologic intervention, including biosimilars, repurposed drugs and supplements.
Mechanism bars match drug names and codes within IBD studies and can overlap. Site-country counts overlap and China-only registrations are missing. The statement on recruitment as a reason for stopping comes from a review of stop reasons recorded in the registry. Acquisitions and trial results come from company announcements. Approval dates come from Drugs@FDA.
Approved, Phase 3 and Phase 2 drugs
The named drugs in this report by their furthest stage: US approval from Drugs@FDA, phase from ClinicalTrials.gov. Sort any column or download CSV; each date and trial number links to its source.
| Drug | Stage | First FDA approval | Latest trial at that stage | Trial start | Trial |
|---|---|---|---|---|---|
| Etrasimod (S1P) | Approved | 12 Oct 2023 Velsipity · NDA 216956 | NCT04706793 Phase 3 · Completed | 25 Dec 2020 | Oral Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Adult Japanese Participants (ELEVATE UC 40 JAPAN) |
| Guselkumab (IL-23) | Approved | 13 Jul 2017 Tremfya · BLA 761061 | NCT07499232 Phase 3 · Recruiting | 21 Apr 2026 | A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease |
| Mirikizumab (IL-23) | Approved | 26 Oct 2023 Omvoh · BLA 761279 | NCT06937099 Phase 3 · Recruiting | 26 Jun 2025 | Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight |
| Ozanimod (S1P) | Approved | 25 Mar 2020 Zeposia · NDA 209899 | NCT05470985 Phase 2/3 · Terminated | 22 Aug 2023 | A Study to Evaluate the Efficacy, Safety, and Drug Levels of Oral Ozanimod in Pediatric Participants With Moderately to Severely Active Crohn's Disease With an Inadequate Response to Conventional Therapy |
| Risankizumab (IL-23) | Approved | 23 Apr 2019 Skyrizi · BLA 761105 | NCT07499232 Phase 3 · Recruiting | 21 Apr 2026 | A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease |
| Tofacitinib (JAK) | Approved | 6 Nov 2012 Xeljanz, Xeljanz Xr · NDA 203214 | NCT04624230 Phase 3 · Active, not recruiting | 12 Aug 2021 | Evaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative Colitis |
| Upadacitinib (JAK) | Approved | 16 Aug 2019 Rinvoq, Rinvoq Lq · NDA 211675 | NCT07149467 Phase 3 · Not yet recruiting | 10 Sep 2025 | Ustekinumab and Upadacitinib for Induction and Maintenance Therapy in Patients With Refractory Crohn's Disease: A Multicenter, Randomized, Parallel-Controlled Study |
| Vedolizumab (integrin) | Approved | 20 May 2014 Entyvio · BLA 125476 | NCT06405087 Phase 3 · Recruiting | 27 Oct 2025 | A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD) |
| Afimkibart (TL1A) | Phase 3 | Not FDA approved | NCT07298421 Phase 3 · Recruiting | 18 Aug 2026 | A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in Children With Moderately to Severely Active Crohn's Disease |
| Duvakitug (TL1A) | Phase 3 | Not FDA approved | NCT07184944 Phase 3 · Recruiting | 22 Jan 2026 | A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease |
| Filgotinib (JAK) | Phase 3 | Not FDA approved | NCT06865417 Phase 3 · Recruiting | 29 Sep 2025 | A Study Evaluating the Effects of Filgotinib in Children and Teenagers With Ulcerative Colitis |
| Icotrokinra (oral IL-23R) | Phase 3 | 17 Mar 2026 Icotyde · NDA 220149 For another use; no current US label for ulcerative colitis or Crohn's disease | NCT07196722 Phase 2/3 · Recruiting | 3 Oct 2025 | A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease |
| Obefazimod | Phase 3 | Not FDA approved | NCT05507216 Phase 3 · Completed | 25 Jan 2023 | ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2 |
| Tulisokibart (TL1A) | Phase 3 | Not FDA approved | NCT06651281 Phase 3 · Recruiting | 25 Nov 2024 | Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011) |
| MORF-057 (oral integrin) | Phase 2 | Not checked: development code, no approved name | NCT07186101 Phase 2 · Recruiting | 10 Nov 2025 | LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis: |
How this report is checked
Every figure is a count from ClinicalTrials.gov, the US National Library of Medicine's trial registry. Each links to a StatOrigin record that keeps the exact query, so anyone can run it again; how the counts are made and what they leave out is set out under Methodology and limitations above.
The development-stage table
Checked on 4 October 2026. A drug's US approval is the original approval of its first new drug application or biologics licence application in Drugs@FDA, read through the FDA's openFDA service, with the FDA approval letter where Drugs@FDA links one. A drug counts as approved here only if one of its current FDA labels names ulcerative colitis or Crohn's disease in its Indications and Usage section. Cell and gene therapies are licensed by a different FDA centre (CBER) and are not in Drugs@FDA; an approval for one of them is shown only where it was checked by hand against the FDA's product page. Approvals outside the United States — by the European Medicines Agency or China's NMPA, for example — are not shown. The phase is the highest phase among the drug's interventional ClinicalTrials.gov records. The trial shown is the most recently started one at that phase whose title names the drug, or, where none does, the most recently started one that lists it.
Writing and review
Written by StatOrigin editorial with AI assistance. Each count is checked automatically against the registry's own response before it is published. No named clinical reviewer has checked this report yet. Report an error through the corrections page.
Not medical advice
This report describes research activity and regulatory status. It is not medical advice and does not say whether any medicine is safe or effective for any person. Trial activity is not evidence that a drug works. Decisions about treatment belong with a qualified health professional; for what a medicine is approved to treat, read its current FDA label.
Data behind this report
The industry hubs and indicator series these figures come from. Each page carries the full table, every source and the records this report does not quote.
Industry hubs
Indicator series
- Inflammatory bowel disease drug trial starts 21
- Active inflammatory bowel disease drug trials 1
- Inflammatory bowel disease drug trial starts since 2023: Crohn's disease 1
- Inflammatory bowel disease drug trial starts since 2023: Ulcerative colitis 1
- Phase 3 inflammatory bowel disease drug trials 1
- Registered interventional inflammatory bowel disease drug trials 1
- Trial starts since 2023: Anti-integrin (vedolizumab and others) 1
- Trial starts since 2023: Anti-TL1A antibodies 1
- Trial starts since 2023: IL-23 p19 antibodies 1
- Trial starts since 2023: JAK inhibitors 1
- Trial starts since 2023: Obefazimod 1
- Trial starts since 2023: Oral IL-23 receptor peptide (icotrokinra) 1
- Trial starts since 2023: S1P modulators 1
Sources
Every figure in this report is a published StatOrigin record. The table lists the 33 cited statistics. Sort any column or download CSV. Open a record for APA, MLA, Chicago or BibTeX.
Cite this report
StatOrigin. (2026). Inflammatory bowel disease drugs: TL1A, oral peptides and combinations reshape a steady market. https://statorigin.org/reports/inflammatory-bowel-disease-drug-pipeline-2026
Prefer citing the underlying statistic when you only need one figure. Published 26 September 2026 · updated 27 September 2026. Data licence: CC BY 4.0.