Inflammatory bowel disease drugs: TL1A, oral peptides and…

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

3 series · 18 observations · 2020 to 2025

View the underlying data

IBD trial starts are flat, but China-site studies have risen
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

Source: ClinicalTrials.gov · CC BY 4.0 · statorigin.org

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

7 entries

View the underlying data

IL-23 antibodies lead new IBD trials, with TL1A close behind
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

Source: ClinicalTrials.gov · CC BY 4.0 · statorigin.org

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

2 entries

View the underlying data

Ulcerative colitis has more new trials than Crohn's disease
Category	Source	Type	Value
Ulcerative colitis	ClinicalTrials.gov	Actual	224
Crohn's disease	ClinicalTrials.gov	Actual	154

Source: ClinicalTrials.gov · CC BY 4.0 · statorigin.org

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.

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

Pharmaceuticals 33

Indicator series

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.

Cited statistics in this report
Figure	Indicator	Region	Value	Period	Basis	Source	Record
Registered interventional inflammatory bowel disease drug trials	Registered interventional inflammatory bowel disease drug trials	Global	1,698	as of 27 Sep 2026	actual	ClinicalTrials.gov	STO-E218BJXQHY-FVEWT3NTCF-T50XPP
Active inflammatory bowel disease drug trials	Active inflammatory bowel disease drug trials	Global	372	as of 27 Sep 2026	actual	ClinicalTrials.gov	STO-CX3D9R62ND-QE4RFA5E4F-9A0RPE
Phase 3 inflammatory bowel disease drug trials	Phase 3 inflammatory bowel disease drug trials	Global	449	as of 27 Sep 2026	actual	ClinicalTrials.gov	STO-J4156AP1Z6-QGX6YVWT6E-85FRDP
Inflammatory bowel disease drug trial starts	Inflammatory bowel disease drug trial starts	Global	373	1 Jan 2023 to 27 Sep 2026	actual	ClinicalTrials.gov	STO-92A44R6690-Q9V810Z5Q8-HZB47W
Inflammatory bowel disease drug trial starts	Inflammatory bowel disease drug trial starts	United States	146	1 Jan 2023 to 27 Sep 2026	actual	ClinicalTrials.gov	STO-QTV133ERKA-FV78FRW3KK-HC55DF
Inflammatory bowel disease drug trial starts	Inflammatory bowel disease drug trial starts	China	101	1 Jan 2023 to 27 Sep 2026	actual	ClinicalTrials.gov	STO-K6AHPNNAH9-PE94737PBS-SV1NKQ
Trial starts since 2023: IL-23 p19 antibodies	Trial starts since 2023: IL-23 p19 antibodies	Global	42	1 Jan 2023 to 27 Sep 2026	actual	ClinicalTrials.gov	STO-CFA77H69E7-KSNJHSVJTB-9D5ERV
Trial starts since 2023: Anti-TL1A antibodies	Trial starts since 2023: Anti-TL1A antibodies	Global	21	1 Jan 2023 to 27 Sep 2026	actual	ClinicalTrials.gov	STO-RK7K2MCAWJ-MR1NCH4PT0-TT30SN
Inflammatory bowel disease drug trial starts since 2023: Ulcerative colitis	Inflammatory bowel disease drug trial starts since 2023: Ulcerative colitis	Global	224	1 Jan 2023 to 27 Sep 2026	actual	ClinicalTrials.gov	STO-9DCN2HNK5T-W029EE9W9Z-JGAJ89
Inflammatory bowel disease drug trial starts since 2023: Crohn's disease	Inflammatory bowel disease drug trial starts since 2023: Crohn's disease	Global	154	1 Jan 2023 to 27 Sep 2026	actual	ClinicalTrials.gov	STO-HRC8BAWKBH-2QEQFKES54-M141BJ
Inflammatory bowel disease drug trial starts	Inflammatory bowel disease drug trial starts	Global	73	2020	actual	ClinicalTrials.gov	STO-3G7R890XGA-4CZA3ZA6KA-5J1JSZ
Inflammatory bowel disease drug trial starts	Inflammatory bowel disease drug trial starts	Global	95	2023	actual	ClinicalTrials.gov	STO-0NX4ARSMEY-ERABZDK736-QF15DR
Inflammatory bowel disease drug trial starts	Inflammatory bowel disease drug trial starts	Global	94	2025	actual	ClinicalTrials.gov	STO-N2NB5ARGMF-VTP04S4C25-40G68B
Inflammatory bowel disease drug trial starts	Inflammatory bowel disease drug trial starts	United States	32	2020	actual	ClinicalTrials.gov	STO-3BTGBPSXQR-6HJT62W7F4-5D9QTN
Inflammatory bowel disease drug trial starts	Inflammatory bowel disease drug trial starts	United States	37	2025	actual	ClinicalTrials.gov	STO-QM53N2JX9D-C30ZDFB011-PC08ZT
Inflammatory bowel disease drug trial starts	Inflammatory bowel disease drug trial starts	China	12	2020	actual	ClinicalTrials.gov	STO-6M3H6AN103-XH49C4KNX4-A9X4EF
Inflammatory bowel disease drug trial starts	Inflammatory bowel disease drug trial starts	China	31	2025	actual	ClinicalTrials.gov	STO-MJS0E655AG-ETY48QS7ZE-90TE1K
Inflammatory bowel disease drug trial starts	Inflammatory bowel disease drug trial starts	Global	88	2021	actual	ClinicalTrials.gov	STO-9RAG46FJ27-0QDMSY002D-CMQPDY
Inflammatory bowel disease drug trial starts	Inflammatory bowel disease drug trial starts	Global	88	2022	actual	ClinicalTrials.gov	STO-THWRPSP1M2-R9PFK63JEW-WPVDGD
Inflammatory bowel disease drug trial starts	Inflammatory bowel disease drug trial starts	Global	87	2024	actual	ClinicalTrials.gov	STO-DRRF97KNGF-J4BCAAB7MR-9EDR48
Inflammatory bowel disease drug trial starts	Inflammatory bowel disease drug trial starts	United States	42	2021	actual	ClinicalTrials.gov	STO-473C8X72XE-5HYKKM90W7-A14PY6
Inflammatory bowel disease drug trial starts	Inflammatory bowel disease drug trial starts	United States	35	2022	actual	ClinicalTrials.gov	STO-MCDY6VM8C5-0A0JG9V4N1-71YC8X
Inflammatory bowel disease drug trial starts	Inflammatory bowel disease drug trial starts	United States	36	2023	actual	ClinicalTrials.gov	STO-77D2BG2FYS-XDXJQ211RF-ZNJ1MK
Inflammatory bowel disease drug trial starts	Inflammatory bowel disease drug trial starts	United States	35	2024	actual	ClinicalTrials.gov	STO-C2N0NT4VW0-WCQ0ZZRB5C-RY1FDD
Inflammatory bowel disease drug trial starts	Inflammatory bowel disease drug trial starts	China	12	2021	actual	ClinicalTrials.gov	STO-4GS2SENMW0-HSA5NF3MK1-NG1F1B
Inflammatory bowel disease drug trial starts	Inflammatory bowel disease drug trial starts	China	18	2022	actual	ClinicalTrials.gov	STO-EC63DAECMX-79WTRP3VR7-72P0KB
Inflammatory bowel disease drug trial starts	Inflammatory bowel disease drug trial starts	China	16	2023	actual	ClinicalTrials.gov	STO-RKSP98SNQC-HSXKAQ2C4E-X9T6C2
Inflammatory bowel disease drug trial starts	Inflammatory bowel disease drug trial starts	China	22	2024	actual	ClinicalTrials.gov	STO-YWRD4TJ8VB-R4FAPY8FXW-E7TD2J
Trial starts since 2023: Anti-integrin (vedolizumab and others)	Trial starts since 2023: Anti-integrin (vedolizumab and others)	Global	24	1 Jan 2023 to 27 Sep 2026	actual	ClinicalTrials.gov	STO-1YDGGX7J5Q-0W6VPHXNF6-32Y1XW
Trial starts since 2023: JAK inhibitors	Trial starts since 2023: JAK inhibitors	Global	20	1 Jan 2023 to 27 Sep 2026	actual	ClinicalTrials.gov	STO-DH5S9CTN3S-7QD1VVEJB5-WPVD3S
Trial starts since 2023: S1P modulators	Trial starts since 2023: S1P modulators	Global	6	1 Jan 2023 to 27 Sep 2026	actual	ClinicalTrials.gov	STO-7GTRVZ8G79-F9ZBNY40KF-SZAHN4
Trial starts since 2023: Oral IL-23 receptor peptide (icotrokinra)	Trial starts since 2023: Oral IL-23 receptor peptide (icotrokinra)	Global	3	1 Jan 2023 to 27 Sep 2026	actual	ClinicalTrials.gov	STO-KM3VK9AS9D-QSMYPCC1KB-VMPWA3
Trial starts since 2023: Obefazimod	Trial starts since 2023: Obefazimod	Global	3	1 Jan 2023 to 27 Sep 2026	actual	ClinicalTrials.gov	STO-7W5J68D7KY-41DRNQDVP3-ZAH96X

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.