ENTYVIO
ENTYVIO (vedolizumab) is an FDA-approved prescription biologic marketed by Takeda Pharmaceuticals U.S.A., Inc. for treating moderate to severe ulcerative colitis and Crohn's disease in adults, offered as an IV infusion and a subcutaneous self-administered Pen.
- Company typePrivate
- Founded2014
- HeadquartersWooster, United States
- Headcount1–10
- GTM typeB2C
- OfferingHardware or Manufacturing
What ENTYVIO does
ENTYVIO (vedolizumab) is a prescription biologic medication approved by the FDA for the treatment of moderate to severe ulcerative colitis (UC) and Crohn's disease in adults. The active molecule is a monoclonal antibody that selectively targets the α4β7 integrin, blocking gut-homing white blood cells from entering intestinal tissue and thereby providing gut-selective anti-inflammatory activity distinct from systemic immunosuppression. The product is offered in two formulations: ENTYVIO IV (300 mg intravenous infusion administered at 0, 2, and 6 weeks, then every 8 weeks) and ENTYVIO Pen (108 mg subcutaneous self-administered injection every two weeks). The IV formulation received FDA approval in May 2014; the Pen formulation was approved for UC in 2023 and for Crohn's disease in 2024. ENTYVIO is marketed by Takeda Pharmaceuticals U.S.A., Inc., a subsidiary of the publicly listed Japanese pharmaceutical company Takeda Pharmaceutical Company Limited.
The business model is a high-value prescription biologic franchise with US list pricing of $9,359.91 per IV dose and $3,369.57 per Pen dose (as of mid-2025). Revenue is generated through specialty pharmacy distribution (Pen), infusion center and healthcare provider administration (IV), and home infusion services. The product is supported by the EntyvioConnect patient access program, which offers copay assistance up to $20,000 annually, nurse educator support, and a $0 copay option for eligible commercially insured patients, alongside the Entyvio Connections peer ambassador community. Revenue is not separately disclosed at the product level; figures are consolidated into Takeda's overall financial reporting, where ENTYVIO is positioned as a flagship growth asset within the gastrointestinal franchise.
The product has been positioned as the #1 prescribed biologic for Crohn's disease and ulcerative colitis combined, based on claims data analysis covering January 2023 through December 2025, with over 10 years of accumulated patient experience and multiple supportive clinical trials (including VISIBLE 1, VISIBLE 2, VARSITY, and VERSIFY). Distribution and patient-support infrastructure extends to the approximately 1.2 million US adults with ulcerative colitis and 1 million+ US adults with Crohn's disease, with disease-state partnerships such as the collaboration with the Crohn's & Colitis Foundation. The US marketing organization operates out of Takeda's US headquarters in Cambridge, Massachusetts.
ENTYVIO firmographics
Firmographics- Name
- ENTYVIO
- Legal name
- Takeda Pharmaceuticals U.S.A., Inc.
- Website
- https://entyvio.com
- Company type
- Private
- Founded year
- 2014
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- ENTYVIO (vedolizumab) is an FDA-approved prescription biologic marketed by Takeda Pharmaceuticals U.S.A., Inc. for treating moderate to severe ulcerative colitis and Crohn's disease in adults, offered as an IV infusion and a subcutaneous self-administered Pen.
- Ownership category
- akta.pro rank
ENTYVIO industry classification
Industry- Product category
- Biologic Pharmaceuticals — Gastroenterology
- SIC
- Biological Products, (No Disgnostic Substances) (2836)
- akta.pro primary industry
- Specialty Injectable & Infusion Therapies (Cross-therapeutic) (HLAIACAO)
Keywords
Where ENTYVIO is headquartered
LocationHeadquarters
- HQ city
- Wooster
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
ENTYVIO business model
Business model- GTM type
- B2C
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Supply Chain, Marketing or Sales, Personnel, Operations
Revenue model
- Pharmaceutical Product Sales: ENTYVIO (vedolizumab) is a prescription biologic medication sold to patients with moderate to severe ulcerative colitis or Crohn's disease. Revenue is generated through the sale of both the IV infusion formulation (300 mg) and the subcutaneous injection formulation (108 mg ENTYVIO Pen). Distribution occurs through healthcare provider offices, infusion centers, and specialty pharmacies. Takeda Pharmaceuticals U.S.A., Inc. is the manufacturer and marketer.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Unit Pricing | Multi-year contract | ENTYVIO IV (300 mg) - List Price |
| Unit Pricing | Multi-year contract | ENTYVIO Pen (108 mg) - List Price |
| Subscription | Annual | EntyvioConnect Co-Pay Program |
Go-to-market motion1 record
Distribution channels3 records
Marketing channels5 records
ENTYVIO product offering
Product offeringCore offering
ENTYVIO (vedolizumab) is a gut-focused biologic prescription medication for adults with moderate to severe ulcerative colitis or Crohn's disease. It is offered in two formulations: an intravenous infusion (ENTYVIO IV, 300 mg vedolizumab, dosed every 8 weeks) administered by healthcare professionals, and a self-administered subcutaneous injection (ENTYVIO Pen, 108 mg vedolizumab, dosed every 2 weeks) delivered through specialty pharmacies. The product is manufactured and marketed in the U.S. by Takeda Pharmaceuticals U.S.A., Inc.
Product overview
ENTYVIO (vedolizumab) is a gut-focused biologic medication available in two formulations: ENTYVIO IV (300 mg intravenous infusion) and ENTYVIO Pen (108 mg subcutaneous injection). The core products work by blocking certain inflammation-causing cells from entering the gut. All patients begin with at least 2 IV starter doses before transitioning to either IV maintenance every 8 weeks or self-injection with the ENTYVIO Pen every 2 weeks. Supporting the medication are patient programs including EntyvioConnect (financial and nurse support) and Entyvio Connections (peer mentorship).
Differentiator
Problem solved
Functional benefit
Brands
- EntyvioConnect: Patient support program offering co-pay assistance, nurse educator support, treatment reminders, and resources for ENTYVIO patients.
- ENTYVIO IV
- ENTYVIO Pen
- Entyvio Connections
Products and services
- ENTYVIO IV (vedolizumab) 300 mg Intravenous infusion formulation of vedolizumab administered by healthcare professionals at provider offices, infusion centers, or at home with medical support. Starting doses at Weeks 0, 2, and 6 followed by maintenance doses every 8 weeks. Indicated for adults with moderate to severe UC or Crohn's disease who have not responded to or could not tolerate other medicines.
- ENTYVIO Pen (vedolizumab) 108 mg Self-administered subcutaneous injection pen containing 108 mg vedolizumab, for maintenance therapy after at least 2 IV starter doses. Delivered through specialty pharmacy for at-home or on-the-go use, administered every 2 weeks (up to 26 doses per year). Indicated for adults with moderate to severe UC or Crohn's disease.
- EntyvioConnect Patient support program accompanying the ENTYVIO prescription, providing co-pay assistance (eligible commercially insured patients may pay as little as $0 per dose, up to a $20,000 annual maximum benefit), 1-on-1 nurse educator support, treatment reminders, self-injection training kits, and insurance navigation for adults prescribed ENTYVIO.
- Entyvio Connections Takeda-sponsored peer support program connecting current ENTYVIO patients with Patient Ambassadors who share their treatment experiences living with moderate to severe UC or Crohn's disease.
Quantifiable outcome
- UC: 47% achieved response at 6 weeks (vs 26% placebo); 42% achieved remission at 1 year (vs 16% placebo)
- +5 more outcomes
Companies that use ENTYVIO
Customer profileNamed customers6 records
Segments2 records
Ideal customer profiles2 records
ENTYVIO technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature2 records
ENTYVIO partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered minor.
- Crohn's & Colitis FoundationminorTakeda provides funding to the Crohn's & Colitis Foundation in support of its mission to cure Crohn's disease and ulcerative colitis and improve quality of life for those affected. The Foundation sponsors research and offers educational programs for patients and healthcare professionals.
- Entyvio Connections Patient Ambassador ProgramminorEntyvio Connections is a Takeda-sponsored patient ambassador program connecting current ENTYVIO patients with Patient Ambassadors who share their treatment experiences. Registration occurs through UCCDMentorProgram.com.
Scale indicators5 records
Recent moves6 records
Expansion highlights4 records
ENTYVIO competitors and assessment
Company assessmentBroad incumbents
- Janssen (Johnson & Johnson Innovative Medicine): Janssen markets Remicade, Stelara, Simponi, and Tremfya—a portfolio spanning multiple IBD biologic mechanisms. As one of the most diversified immunology players, Janssen is a broad incumbent whose portfolio approach competes directly with ENTYVIO across UC and Crohn's.
- AbbVie: AbbVie is the manufacturer of Humira, Skyrizi, and Rinvoq—multiple direct competitors to ENTYVIO across the IBD biologic landscape. As the dominant IBD competitor with the deepest commercial infrastructure, AbbVie is the most consequential broad incumbent in ENTYVIO's therapeutic area.
Direct peers
- Stelara (ustekinumab) - Janssen: Stelara is Janssen's IL-12/23 inhibitor approved for moderate-to-severe UC and Crohn's disease, with both IV induction and SC maintenance dosing. It competes directly with ENTYVIO across the same IBD indications with a different mechanism of action.
- Rinvoq (upadacitinib) - AbbVie: Rinvoq is AbbVie's oral JAK inhibitor approved for moderate-to-severe UC and under investigation for Crohn's disease. Its oral administration route differentiates it from injectable/infusion biologics like ENTYVIO and represents a meaningful convenience advantage.
- Cimzia (certolizumab pegol) - UCB: Cimzia is UCB's TNF-alpha inhibitor approved for Crohn's disease with a SC administration route. It competes directly with ENTYVIO in the moderate-to-severe Crohn's biologic market with a similar patient and prescriber base.
- Simponi (golimumab) - Janssen: Simponi is Janssen's TNF-alpha inhibitor approved specifically for moderate-to-severe ulcerative colitis with SC administration. It competes directly with ENTYVIO in the UC maintenance setting.
- Skyrizi (risankizumab) - AbbVie: Skyrizi is AbbVie's IL-23 inhibitor approved for Crohn's disease and UC, positioning it as a next-generation competitor to ENTYVIO. Its selective IL-23 mechanism and favorable safety profile make it a primary share-take candidate in biologic-naive IBD patients.
- Humira (adalimumab) - AbbVie: Humira is AbbVie's TNF-alpha inhibitor approved for moderate-to-severe ulcerative colitis and Crohn's disease, the same IBD indications as ENTYVIO. It was ENTYVIO's head-to-head comparator in pivotal UC trials and represents the most-established legacy biologic competitor in IBD.
- Remicade (infliximab) - Janssen: Remicade is Janssen's TNF-alpha inhibitor and one of the original biologics approved for both UC and Crohn's disease. It is administered by IV infusion in clinical settings and represents a long-standing direct competitor in the IBD biologic market.
- Zeposia (ozanimod) - Bristol Myers Squibb: Zeposia is BMS's oral S1P receptor modulator approved for moderate-to-severe ulcerative colitis. Its oral administration and novel mechanism position it as a direct emerging competitor to ENTYVIO in UC maintenance therapy.
Market position
Strengths5 records
Weaknesses4 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
ENTYVIO social profiles
Digital presenceENTYVIO financial estimates
Financial estimateRevenue estimate
Valuation estimate
ENTYVIO leadership team
Management profileNumber of profiles
ENTYVIO subsidiaries and ownership
Company hierarchySubsidiaries1 record
ENTYVIO funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
ENTYVIO M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about ENTYVIO
What does ENTYVIO do?
ENTYVIO (vedolizumab) is a gut-focused biologic prescription medication for adults with moderate to severe ulcerative colitis or Crohn's disease. It is offered in two formulations: an intravenous infusion (ENTYVIO IV, 300 mg vedolizumab, dosed every 8 weeks) administered by healthcare professionals, and a self-administered subcutaneous injection (ENTYVIO Pen, 108 mg vedolizumab, dosed every 2 weeks) delivered through specialty pharmacies. The product is manufactured and marketed in the U.S. by Takeda Pharmaceuticals U.S.A., Inc.
Is ENTYVIO a public or private company?
ENTYVIO is a private company. It is classified as corporate owned and is currently operating.
When was ENTYVIO founded?
ENTYVIO was founded in 2014. It employs 1 to 10 people.
Where is ENTYVIO based?
ENTYVIO is headquartered in Wooster, United States, in the North America region.
How does ENTYVIO make money?
One revenue line is on record: pharmaceutical Product Sales.
Who are ENTYVIO's main competitors?
Broad incumbents on record are Janssen (Johnson & Johnson Innovative Medicine) and AbbVie. Direct peers are Stelara (ustekinumab) - Janssen, Rinvoq (upadacitinib) - AbbVie, Cimzia (certolizumab pegol) - UCB, Simponi (golimumab) - Janssen, Skyrizi (risankizumab) - AbbVie, Humira (adalimumab) - AbbVie, Remicade (infliximab) - Janssen and Zeposia (ozanimod) - Bristol Myers Squibb.
Does ENTYVIO have an API?
No public API is recorded for ENTYVIO.
What industry is ENTYVIO in?
ENTYVIO's product category is Biologic Pharmaceuticals — Gastroenterology. Its primary akta.pro industry code is HLAIACAO, Specialty Injectable & Infusion Therapies (Cross-therapeutic). Its SIC code is 2836.