Exploration of Immunology

Table 3. Drug development pipeline for IBD: small molecule therapies*.

MoA	Drug name	Indication	RoA	Highest clinical stage	Clinical trials
JAK1-biased inhibitor	Filgotinib (Jyseleca; GLPG0634)	UC, CD	PO	UC: EU, UK, and Japan approved CD: Ph3 completed	NCT02914522; NCT06865417; NCT02914535; NCT06964113; NCT02914561
JAK1-biased inhibitor	Ivarmacitinib (SHR0302)	UC, CD	PO	UC: Ph3 unknown status CD: Ph2 completed	NCT05181137; NCT03675477; NCT03677648
Pan JAK inhibitor	Izencitinib (TD-1473)	UC, CD	PO	UC: Ph2/3 terminated CD: Ph2 terminated	NCT03920254; NCT03758443; NCT03635112
Pan JAK inhibitor	Peficitinib (JNJ-54781532)	UC	PO	Ph2 completed	NCT01959282
TYK2/JAK1 inhibitor	Brepocitinib (PF-06700841)	UC, CD	PO	UC: Ph2 completed CD: Ph2 completed	NCT02958865; NCT03395184
JAK3/TEC family inhibitor	Ritlecitinib (PF-06651600)	UC, CD	PO	UC: Ph2 completed CD: Ph2 completed	NCT02958865; NCT03395184
TYK2 inhibitor	Zasocitinib (TAK-279)	UC, CD	PO	UC: Two Ph2 recruiting CD: Two Ph2 recruiting	NCT06254950; NCT06233461; NCT06764615 (joint for UC and CD)
TYK2 inhibitor	Deucravacitinib (BMS-986165)	UC, CD	PO	UC: Ph2 completed CD: Ph2 completed	NCT04613518; NCT03934216; NCT04877990
JAK1/TYK2 inhibitor	TLL018	UC	PO	Ph2 withdrawn	NCT05121402
JAK3/TYK2/Ark5 inhibitor	OST-122	UC	PO	Ph1/2 completed	NCT04353791
S1PR1 modulator	Tamuzimod (VTX002)	UC	PO	Ph2 ongoing	NCT05156125
TNFα inhibitor	Balinatunfib (SAR441566)	CD, UC	PO	UC: Ph2 recruiting CD: Ph2 recruiting	NCT06867094; NCT06637631
PDE4 inhibitor	Mufemilast (Hemay005)	UC	PO	Ph2 ongoing	NCT05486104
PDE4 inhibitor	Apremilast	UC	PO	Ph2 completed	NCT02289417
PDE4 inhibitor	Tetomilast (OPC-6535)	UC, CD	PO	UC: Ph3 completed CD: Ph2/3 completed	NCT00092508; NCT00064454; NCT00064441; NCT00989573
α4β7 inhibitor	GS-1427	UC	PO	Ph2 recruiting	NCT06290934
α4 inhibitor	AJM300 (carotegrast methyl)	UC	PO	Ph3 completed	NCT03531892
α4β7 inhibitor	MORF-057	CD, UC	PO	UC: Ph2b ongoing CD: Ph2 recruiting	NCT05611671; NCT05291689; NCT06226883
SYK inhibitor	Lanraplenib (BI 3032950)	UC	IV, SC	Ph2 ongoing	NCT06636656
TPL2 inhibitor	Tilpisertib fosmecarbil (GS-5290)	UC	PO	Ph2 recruiting	NCT06029972
RIPK1 inhibitor	SAR443122 (DNL758)	UC	PO	Ph2 recruiting	NCT05588843
Renin inhibitor	SPH3127	UC	PO	Ph2 completed	NCT05019742; NCT05770609
NLRP3 inhibitor	Usnoflast (ZYIL1)	UC	PO	Ph2 completed	NCT06398808
ALK5 inhibitor	AGMB-129	CD	PO	Ph2 ongoing	NCT05843578
IL-23 inhibitor	Icotrokinra (JNJ-77242113)	UC	PO	Ph2 ongoing	NCT06049017

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*: The search on ClinicalTrials.gov was completed by July 1st, 2025. IBD: inflammatory bowel disease; MoA: mechanism of action; RoA: route of administration; JAK1: Janus kinase 1; UC: ulcerative colitis; CD: Crohn’s disease; PO: oral administration; TYK2: tyrosine kinase 2; Ark5: AMP-activated protein kinase-related protein kinase 5; S1PR1: sphingosine-1-phosphate receptor 1; TNF: tumor necrosis factor; PDE4: phosphodiesterase 4; SYK: spleen tyrosine kinase; IV: intravenous; SC: subcutaneous; TPL2: tumor progression locus 2; RIPK1: receptor-interacting serine/threonine protein kinase 1; NLRP3: NLR family pyrin domain containing 3; ALK5: activin receptor-like kinase 5; IL: interleukin.

Declarations

Acknowledgments

We extend our sincere appreciation to Dr. Haifeng Tang for his careful review of the manuscript and expert insights into the chemical aspects discussed herein. We are thankful to Dr. Dafydd Thomas for his careful proofreading of our manuscript.

Author contributions

YZ: Conceptualization, Investigation, Writing—original draft, Writing—review & editing. FS: Conceptualization, Writing—review & editing. Both authors read and approved the submitted version.

Conflicts of interest

Authors YZ and FS, and HT and DT mentioned in the Acknowledgments section are full-time employees of QuantX Biosciences Inc.

Ethical approval

Not applicable.

Consent to participate

Not applicable.

Consent to publication

Not applicable.

Availability of data and materials

The datasets for this study can be found in PubMed, ClinicalTrials.gov, and Google Scholar.

Funding

Not applicable.

Copyright

Publisher’s note

Open Exploration maintains a neutral stance on jurisdictional claims in published institutional affiliations and maps. All opinions expressed in this article are the personal views of the author(s) and do not represent the stance of the editorial team or the publisher.

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