Summary
Etanercept has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Inflammatory Bowel Disease (Crohn's / UC) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Inflammatory Bowel Disease (Crohn's / UC). ClinicalTrials.gov lists 5 registered trials linking Etanercept to Inflammatory Bowel Disease (Crohn's / UC): 1 is active or not yet recruiting; 2 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT07138898). The largest enrolment is 800 participants (NCT03729674). Registration activity spans 2009 to 2025. The literature layer holds 15 publications for this pair: 5 Cochrane reviews, 4 meta-analyses, 1 systematic review and 5 clinical trial publications. Publication years run from 2001 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Inflammatory Bowel Disease ranks 200 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Disease course unchanged in ~85% of patients at 10 years on standard care; ~23% (CD) and ~12% (UC) relapse within 12 months of thiopurine withdrawal in sustained remission.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 60.0 (trials 10.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 5 total: 0 recruiting, 1 active / not yet recruiting, 2 completed, 2 other |
| Linked publications | 15 (5 Cochrane reviews, 5 clinical trial publications, 4 meta-analyses, 1 systematic review) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | DGIdb |
| Linked via biomarker / target | CARD8 |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT07138898 | Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty 2025 | not yet recruiting | Phase 2 | 80 |
| NCT01860963 | Anal Dysplasia in Patients With Inflammatory Bowel Disease and Healthy Controls 2010 | completed | Not applicable | 310 |
| NCT02376478 | On the Impact of Therapeutic Tumor Necrosis Factor-alpha Inhibition on Anogenital Human Papillomavirus Infection 2009 | completed | Not applicable | 222 |
| NCT03729674 | Comparative Effectiveness and Safety of Biosimilar and Legacy Drugs 2018 | status unknown | Not applicable | 800 |
| NCT05702879 | Combined Microbiota and Metabolic Signature in Ulcerative Colitis Predicts Anti-Inflammatory Therapy Success 2023 | status unknown | Not applicable | 240 |
Published literature
- Cochrane review Biologic drugs for induction and maintenance of remission in Crohn's disease: a network meta-analysisGordon M, Sinopoulou V, Akobeng AK et al. · The Cochrane database of systematic reviews · 2026 · PMID 42333672
- Meta-analysis Biological Therapy and Small Molecules for Adults With Crohn's Disease: Systematic Review and Network Meta-AnalysisGorski D, Lazo REL, de Souza DA et al. · Pharmacotherapy · 2025 · PMID 40772520
- Cochrane review Management of Concomitant Inflammatory Bowel Disease or Uveitis in Patients with Psoriatic Arthritis: An Updated Review Informing the 2021 GRAPPA Treatment RecommendationsJadon DR, Corp N, van der Windt DA et al. · The Journal of rheumatology · 2023 · PMID 36455946
- Meta-analysis Inflammatory Bowel Disease Risk in Patients With Axial Spondyloarthritis Treated With Biologic Agents Determined Using the BSRBR-AS and a MetaAnalysisMacfarlane GJ, Biallas R, Dean LE et al. · The Journal of rheumatology · 2023 · PMID 35777821
- Systematic review Spotlight on the treatment armamentarium of concomitant psoriasis and inflammatory bowel disease: a systematic reviewConforti C, Dianzani C, Zalaudek I et al. · The Journal of dermatological treatment · 2022 · PMID 33074781
- Clinical trial publication Is Treatment in Patients With Suspected Nonradiographic Axial Spondyloarthritis Effective? Six-Month Results of a Placebo-Controlled TrialRusman T, van der Weijden MAC, Nurmohamed MT et al. · Arthritis & rheumatology (Hoboken, N.J.) · 2021 · PMID 33277982
- Cochrane review Safety of biologic treatments in solid organ transplant recipients: A systematic reviewMeyer F, Weil-Verhoeven D, Prati C et al. · Seminars in arthritis and rheumatism · 2021 · PMID 34507811
- Meta-analysis Paradoxical Hidradenitis Suppurativa in Patients Receiving TNF-α Inhibitors: Case Series, Systematic Review, and Case Meta-AnalysisSalvador-Rodriguez L, Montero-Vílchez T, Arias-Santiago S et al. · Dermatology (Basel, Switzerland) · 2020 · PMID 32135533
- Meta-analysis Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic ReviewStrand V, Balsa A, Al-Saleh J et al. · BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2017 · PMID 28612180
- Clinical trial publication Phase 3 Trials of Ixekizumab in Moderate-to-Severe Plaque PsoriasisGordon KB, Blauvelt A, Papp KA et al. · The New England journal of medicine · 2016 · PMID 27299809
- Cochrane review Efficacy of anti-tumor necrosis factor therapy for extra-articular manifestations in patients with ankylosing spondylitis: a meta-analysisWu D, Guo YY, Xu NN et al. · BMC musculoskeletal disorders · 2015 · PMID 25888248
- Cochrane review The immunogenicity of anti-TNF therapy in immune-mediated inflammatory diseases: a systematic review of the literature with a meta-analysisGarcês S, Demengeot J, Benito-Garcia E · Annals of the rheumatic diseases · 2013 · PMID 23223420
- Clinical trial publication [Side effects of anti-TNFalpha therapy in juvenile idiopathic arthritis]Pontikaki I, Gerloni V, Gattinara M et al. · Reumatismo · 2006 · PMID 16639486
- Clinical trial publication Etanercept for active Crohn's disease: a randomized, double-blind, placebo-controlled trialSandborn WJ, Hanauer SB, Katz S et al. · Gastroenterology · 2001 · PMID 11677200
- Clinical trial publication Etanercept in the treatment of active refractory Crohn's disease: a single-center pilot trialD'Haens G, Swijsen C, Noman M et al. · The American journal of gastroenterology · 2001 · PMID 11569676
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target CARD8. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Etanercept approved for Inflammatory Bowel Disease (Crohn's / UC)?
Etanercept has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Inflammatory Bowel Disease (Crohn's / UC) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Inflammatory Bowel Disease (Crohn's / UC). Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Etanercept in clinical trials for Inflammatory Bowel Disease (Crohn's / UC)?
ClinicalTrials.gov lists 5 registered trials linking Etanercept to Inflammatory Bowel Disease (Crohn's / UC): 1 is active or not yet recruiting; 2 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT07138898). The largest enrolment is 800 participants (NCT03729674). Registration activity spans 2009 to 2025.
What does the evidence show for Etanercept in Inflammatory Bowel Disease (Crohn's / UC)?
Etanercept has both completed registered trials and synthesis-level publications linked to Inflammatory Bowel Disease (Crohn's / UC). That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target CARD8. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.