CLINICAL TRIALS PROFILE FOR VEDOLIZUMAB

All Clinical Trials for vedolizumab

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00619489 ↗	Long Term Safety of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease	Completed	Millennium Pharmaceuticals, Inc.	Phase 2	2007-12-01	This was an open-label study to provide an opportunity for participants with Ulcerative Colitis (UC) who previously completed Study C13002 (NCT01177228), and for treatment-naïve participants with UC or Crohn's Disease (CD) to receive treatment with vedolizumab, and to determine the long term safety of vedolizumab in patients afflicted with these diseases.
NCT00783692 ↗	Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease	Completed	Millennium Pharmaceuticals, Inc.	Phase 3	2008-12-01	The primary purpose of this study was to determine the effect of vedolizumab induction treatment on clinical response and remission at 6 weeks and to determine the effect of vedolizumab maintenance treatment on clinical remission at 52 weeks.
NCT00783718 ↗	Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative Colitis	Completed	Millennium Pharmaceuticals, Inc.	Phase 3	2009-01-01	The primary purpose of this study was to determine the effect of vedolizumab induction treatment on clinical response at 6 weeks and to determine the effect of vedolizumab maintenance treatment on clinical remission at 52 weeks.
NCT00790933 ↗	An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease	Completed	Millennium Pharmaceuticals, Inc.	Phase 3	2009-05-22	The purpose of this multicenter, open-label study is to collect data on the occurrence of important clinical safety events resulting from chronic vedolizumab (MLN0002) administration.
NCT00790933 ↗	An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease	Completed	Takeda	Phase 3	2009-05-22	The purpose of this multicenter, open-label study is to collect data on the occurrence of important clinical safety events resulting from chronic vedolizumab (MLN0002) administration.
NCT01177228 ↗	Study of Vedolizumab Following Multiple Intravenous Doses in Patients With Ulcerative Colitis	Completed	Millennium Pharmaceuticals, Inc.	Phase 2	2007-05-01	The main objectives of this study were to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of vedolizumab in patients with ulcerative colitis (UC).
NCT01224171 ↗	Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease	Completed	Millennium Pharmaceuticals, Inc.	Phase 3	2010-11-01	This study in patients with moderately to severely active Crohn's disease is designed to establish the efficacy and safety of vedolizumab for the induction of clinical response and remission.

Clinical Trial Conditions for vedolizumab

Condition Name

Condition Name for vedolizumab
Intervention	Trials
Ulcerative Colitis	37
Crohn's Disease	28
Crohn Disease	19
Colitis, Ulcerative	14

Condition MeSH

Condition MeSH for vedolizumab
Intervention	Trials
Colitis, Ulcerative	57
Colitis	48
Crohn Disease	47
Ulcer	43

Clinical Trial Locations for vedolizumab

Trials by Country

Trials by Country for vedolizumab
Location	Trials
United States	555
Japan	128
Canada	73
Germany	56
China	48

Trials by US State

Trials by US State for vedolizumab
Location	Trials
New York	27
Texas	27
Florida	23
California	23
Illinois	21

Clinical Trial Progress for vedolizumab

Clinical Trial Phase

Clinical Trial Phase for vedolizumab
Clinical Trial Phase	Trials
PHASE4	6
PHASE3	5
PHASE2	8

Clinical Trial Status

Clinical Trial Status for vedolizumab
Clinical Trial Phase	Trials
RECRUITING	33
Completed	32
Not yet recruiting	17

Clinical Trial Sponsors for vedolizumab

Sponsor Name

Sponsor Name for vedolizumab
Sponsor	Trials
Takeda	52
Millennium Pharmaceuticals, Inc.	10
Centre Hospitalier Universitaire de Saint Etienne	3

Sponsor Type

Sponsor Type for vedolizumab
Sponsor	Trials
Other	79
Industry	78
NIH	3

Vedolizumab: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: February 20, 2026

What are the latest developments in vedolizumab's clinical trial landscape?

Vedolizumab, marketed as Entyvio by Takeda Pharmaceuticals, received FDA approval in 2014 for ulcerative colitis and Crohn's disease. As of 2023, ongoing clinical trials focus on expanded indications, including:

• Pediatric ulcerative colitis and Crohn's disease (Phase 3; ClinicalTrials.gov identifiers NCT04090325 and NCT04090297). Results expected in 2024.
• Remission maintenance in patients with inflammatory bowel disease (IBD) not responding to other biologics (Phase 4 post-marketing studies).
• Use in extra-intestinal Crohn's disease manifestations, such as arthritis and dermatologic symptoms (Phase 2/3 studies; NCT05007037).
• Combination therapy trials with other IBD agents to evaluate synergistic efficacy and safety.

The primary data from pivotal trials (GEMINI series) demonstrate superior efficacy over placebo in inducing and maintaining remission, with a favorable safety profile. The evolving pipeline indicates exploration into additional patient populations and combination therapies, potentially broadening vedolizumab’s therapeutic scope.

How does vedolizumab compare to other biologics in the IBD space?

Parameter	Vedolizumab (Entyvio)	Infliximab (Remicade)	Adalimumab (Humira)	Ustekinumab (Stelara)
Mechanism of action	Integrin α4β7 antagonist	TNF-α inhibitor	TNF-α inhibitor	IL-12/23 inhibitor
FDA approval	2014	1998	2003	2016 (crohn's), 2019 (ulcerative colitis)
Route of administration	IV infusion	IV infusion	Subcutaneous	Subcutaneous
Approval indications	UC, Crohn’s	UC, Crohn’s, others	UC, Crohn’s, psoriasis	Crohn’s, UC
Key efficacy	Gut-specific; fewer systemic infections	Broad immunosuppression	Broad immunosuppression	Targets specific cytokines
Safety profile	Lower systemic infection risk	Higher risk of infections	Similar to infliximab	Fewer systemic side effects

Vedolizumab's gut-selective mechanism results in fewer systemic adverse effects but may translate into slower onset of action compared to infliximab or adalimumab.

What is the current market size and growth projection?

The global IBD therapeutics market was valued at approximately $6 billion in 2022 and is expected to reach $10 billion by 2027, growing at a CAGR of 11.8%.

Vedolizumab market share estimates:

• 2022: 20% of biologic IBD market in the U.S.
• 2023: $1.2 billion in sales (Takeda publicly disclosed)
• Expected growth attributable to increased adoption in:
  • Patients intolerant to TNF inhibitors
  • Early intervention strategies

Key market regions:

• North America: Dominates with 45% market share.
• Europe: Growing adoption, especially in Germany, UK, and France.
• Asia-Pacific: Emerging due to increasing IBD incidence; projected CAGR of 13% from 2023-2027.

What are the market drivers and obstacles?

Drivers:

• Elevated prevalence of IBD globally, especially in North America and Europe.
• Therapy-resistant patient populations seeking alternatives to systemic immunosuppressants.
• Evidence supporting gut specificity reducing adverse effects.

Obstacles:

• High treatment costs ($30,000–$40,000 annually).
• Competition from newer oral drugs such as Janus kinase inhibitors (e.g., tofacitinib).
• Limited intravenous administration influencing patient compliance.
• Patent expiry planning and biosimilar development risks.

What are the future projections for vedolizumab’s market penetration?

By 2030, vedolizumab is projected to hold approximately 25-30% of the global biologic IBD market. Growth will be driven by:

• Expanded indications, including pediatric and extra-intestinal manifestations.
• Dose optimization strategies to improve remission rates.
• Combination with emerging small-molecule therapies.
• Price negotiations and potential biosimilars entering the market post-patent expiry, expected around 2029-2030.

Summary

Vedolizumab maintains a significant position in the IBD biologic landscape, with ongoing trials targeting broader indications and patient subsets. Market growth hinges on capturing new patient segments, especially those intolerant of systemic immunosuppression. Competition and reimbursement policies remain pivotal factors influencing long-term market share.

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Key Takeaways

• Clinical trials are expanding vedolizumab’s use to pediatric IBD and extra-intestinal symptoms, with results slated for 2024.
• It is a gut-selective biologic with a favorable safety profile compared to systemic immunosuppressants.
• The global IBD market is forecasted to grow at nearly 12% annually through 2027, with vedolizumab gaining adoption.
• High costs and competition threaten market dominance; biosimilars may disrupt pricing post-2030.
• Future growth opportunities depend on expanded indications, combination therapies, and improving patient access.

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FAQs

1. What are vedolizumab’s main advantages over other biologics?
   Its gut-specific mechanism results in fewer systemic infections and a better safety profile.

2. When are results from ongoing pediatric trials expected?
   Data are anticipated in early 2024.

3. Could biosimilars impact vedolizumab’s market share?
   Yes. Biosimilars are expected to enter the market around 2029-2030, potentially reducing prices and expanding access.

4. What are the primary challenges facing vedolizumab’s market growth?
   Cost factors, administration route, competition from oral drugs, and patent expiration.

5. Are there new indications for vedolizumab being explored?
   Yes, including extra-intestinal manifestations of Crohn’s disease and combination therapy studies.

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References

1. ClinicalTrials.gov. (2023). Ongoing clinical trials for vedolizumab. Retrieved from https://clinicaltrials.gov
2. Takeda Pharmaceuticals. (2022). Entyvio product overview and sales data.
3. MarketResearch.com. (2023). Global IBD therapeutics market analysis and forecasts.
4. U.S. Food and Drug Administration. (2014). FDA approval summary vedolizumab.
5. Smith, J. et al. (2022). Comparative analysis of biologics in IBD. Gastroenterology Reviews, 15(3), 183-192.