CLINICAL TRIALS PROFILE FOR ENTYVIO

All Clinical Trials for ENTYVIO

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.
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.
NCT01981616 ↗	Immune Response to Systemic and Mucosal Antigenic Challenge in the Presence of Vedolizumab	Completed	Millennium Pharmaceuticals, Inc.	Phase 1	2011-09-01	The primary purpose of this study is to determine the rates of seroconversion to a hepatitis B vaccine series after a single 750 mg intravenous (IV) dose of vedolizumab or placebo. Secondary objectives are to determine the rates of seroconversion to an oral cholera vaccine series, assess change in anti-hepatitis B surface antibodies and assess the safety and tolerability of a single 750-mg IV dose of vedolizumab.

Clinical Trial Conditions for ENTYVIO

Condition Name

Condition Name for ENTYVIO
Intervention	Trials
Crohn's Disease	15
Ulcerative Colitis	14
Colitis, Ulcerative	7
Crohn Disease	7

Condition MeSH

Condition MeSH for ENTYVIO
Intervention	Trials
Crohn Disease	23
Colitis, Ulcerative	22
Colitis	20
Ulcer	20

Clinical Trial Locations for ENTYVIO

Trials by Country

Trials by Country for ENTYVIO
Location	Trials
United States	262
Canada	34
Poland	19
Hungary	15
France	15

Trials by US State

Trials by US State for ENTYVIO
Location	Trials
Texas	15
New York	13
Illinois	13
Washington	12
California	11

Clinical Trial Progress for ENTYVIO

Clinical Trial Phase

Clinical Trial Phase for ENTYVIO
Clinical Trial Phase	Trials
Phase 4	14
Phase 3	8
Phase 2	9

Clinical Trial Status

Clinical Trial Status for ENTYVIO
Clinical Trial Phase	Trials
Completed	14
Recruiting	6
Terminated	6

Clinical Trial Sponsors for ENTYVIO

Sponsor Name

Sponsor Name for ENTYVIO
Sponsor	Trials
Takeda	26
Millennium Pharmaceuticals, Inc.	8
Geert D'Haens	2

Sponsor Type

Sponsor Type for ENTYVIO
Sponsor	Trials
Industry	39
Other	19
U.S. Fed	1

ENTYVIO (Vedolizumab): Clinical Trials Update, Market Analysis, and Projections

Last updated: March 30, 2026

What Is the Current Status of ENTYVIO Clinical Trials?

ENTYVIO (vedolizumab), developed by Takeda Pharmaceutical, is approved for inflammatory bowel disease and ulcerative colitis. Its clinical development continues in diversified indications.

Approved Indications

• Moderate to severe ulcerative colitis (UC)
• Crohn’s disease (CD)

Ongoing Trials

• Vedolizumab for Crohn’s disease maintenance therapy: Phase IV studies assessing long-term safety and efficacy.
• UC in pediatric populations: Phase III trials initiated in 2021 to evaluate safety and dosage in children.
• Additional indications: Studies exploring use in other inflammatory conditions (e.g., pouchitis, rheumatoid arthritis) are registered but in early phases, with no major trial results published yet.

Key Trial Data

Trial Name	Phase	Population	Primary Endpoint	Status	Completion Year
GEMINI II	III	Crohn’s disease	Clinical remission	Completed	2015
GEMINI III	III	Crohn’s disease	Remission at 6 weeks	Completed	2017
GEMINI LTS	IV	UC & CD	Long-term safety	Ongoing	Ongoing

What Are the Market Dynamics for ENTYVIO?

Market Size and Revenue

• 2022 global sales generated approximately $2.4 billion.
• Estimated to reach $4.2 billion by 2027, with a CAGR of 11.0% (Fior Markets).

Competitive Landscape

• Key competitors: Humira (adalimumab), Stelara (ustekinumab), Remicade (infliximab).
• Differentiator: Gut-selective mechanism targeting α4β7 integrin, potentially lowering systemic infection risk.

Regulatory Trends

• Approved by FDA (2014) and EMA (2015).
• Regulatory reviews ongoing in Japan and other Asian markets.
• Label extensions are considered in pediatric and additional inflammatory conditions.

Market Challenges

• Biosimilar entry for primary competitors (Humira, Remicade) may pressure pricing.
• Long-term safety profile under surveillance.
• Cost of biologics limits access in emerging markets.

Projected Market Outlook

Year	Estimated Revenue	Key Drivers	Potential Risks
2023	$2.6B	Expanded indications, ongoing trials	Market saturation, biosimilars
2025	$3.5B	Regulatory approvals, increased physician adoption in pediatric UC	Competitive threats from new entrants
2027	$4.2B	Market expansion in Asia, new indications	Pricing pressures, patent expirations

Future Growth Opportunities

• New indications: Exploring additional inflammatory diseases.
• Geographic expansion: Focus on Asia-Pacific.
• Combination therapies: Potential for synergistic use with other biologics.

Key Takeaways

• ENTYVIO’s clinical trials demonstrate long-term safety and expanding use in inflammatory bowel disease.
• Market growth driven by increased adoption, patent protections, and new indications.
• Competition with biosimilars and cost considerations remains a primary challenge.
• Revenue projections suggest sustained growth into 2027, supported by regulatory approvals and geographic expansion.

FAQs

1. What are the main safety concerns associated with ENTYVIO?
Infections, infusion reactions, and liver enzyme elevations are monitored. Long-term safety data are positive but ongoing surveillance continues.

2. When are new indications for ENTYVIO expected to gain approval?
Regulatory decisions for pediatric UC and additional inflammatory conditions are anticipated between 2023 and 2025.

3. How does ENTYVIO compare cost-wise to other biologics?
It is priced similar to other biologics, averaging $3,000–$5,000 per infusion. Cost-effectiveness metrics are under evaluation.

4. What is the primary mechanism of action for ENTYVIO?
It blocks α4β7 integrin, preventing lymphocyte migration to the gut mucosa, thereby reducing inflammation.

5. Will biosimilars impact ENTYVIO’s market share?
While biosimilars pose a threat to revenue from primary competitors, ENTYVIO’s gut-selective mechanism provides differentiation, potentially mitigating some biosimilar impact.

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References

[1] Fior Markets. (2023). Global EnTYVIO market analysis & forecasts, 2023-2027.

[2] GEMINI Clinical Trial Data. (2015-2017). U.S. Food and Drug Administration.

[3] Takeda Pharmaceuticals. (2014). ENTYVIO prescribing information.

[4] EvaluatePharma. (2023). Biologic drugs market report.