RegulationFast Track (United States), Priority Review (China), Orphan Drug (Japan), Orphan Drug (Australia), Overseas New Drugs Urgently Needed in Clinical Settings (China)

Structure/Sequence

Sequence Code 9976148H

Source: *****

Sequence Code 13007748L

Source: *****

165

Clinical Trials associated with Vedolizumab

NCT07665294

/ Not yet recruitingPhase 4IIT

CURVE-UC: A Pragmatic Randomized, Double-blind, Placebo Controlled, Treat-through, Multi-site Pragmatic Interventional Study to Evaluate the Efficacy and Safety of Combination Curcumin-QingDai (CurQD) With Vedolizumab in Moderate to Severe Ulcerative Colitis (UC)

The purpose of this research study is to test the efficacy and safety of the study intervention, CurQD or placebo (non-active pill), in combination with vedolizumab prescribed as standard of care for patients with ulcerative colitis (UC)..

Start Date01 Oct 2026

Sponsor / Collaborator

Icahn School of Medicine at Mount Sinai

NCT06337695

/ RecruitingPhase 2/3IIT

VERIFY: Vedolizumab for the Prevention of Immune Checkpoint Inhibitor Related Diarrhea or Colitis in Patients With Cancer: A Randomized, Double-Blinded, Placebo Controlled Trial

The purpose of this study is to assess the prevention of immune checkpoint inhibitors (ICI) related diarrhea/colitis using vedolizumab in participants with unresectable stage III or metastatic stage IV cancer, starting standard of care (SOC) immunotherapy

Start Date13 Aug 2026

Sponsor / Collaborator

AHS Cancer Control Alberta

KCT0011841

/ Not yet recruitingPhase 4IIT

EVALUATING WEEK 12 IMMUNOLOGICAL PROFILES ASSOCIATED WITH RECAPTURE OF CLINICAL RESPONSE AT WEEK 24 IN ULCERATIVE COLITIS PATIENTS WITH SECONDARY LOSS OF RESPONSE TO VEDOLIZUMAB: A MULTI-CENTER, RANDOMIZED, OPEN-LABEL STUDY

Start Date01 Jun 2026

Sponsor / Collaborator

Yonsei University Severance Hospital

100 Clinical Results associated with Vedolizumab

100 Translational Medicine associated with Vedolizumab

100 Patents (Medical) associated with Vedolizumab

2,287

Literatures (Medical) associated with Vedolizumab

02 Oct 2026·Deutsches Arzteblatt International

Refractory Chronic Inflammatory Bowel Disease in Childhood and Adolescence: Options in Primary Non-Response or Secondary Treatment Failure.

Review

Author: Zilbauer, Matthias ; Bergheim, Christa ; Krause, Thomas ; Melchior, Ralph ; Jenke, Andreas ; Rommel, Frank

BACKGROUND:

The incidence of inflammatory bowel disease among children and adolescents in Europe is approximately 10 per 100 000 per year. Refractory disease courses are clinically significant and associated with delayed growth and development, recurrent hospitalizations, and the need for surgery. 10-40% of patients have a primary nonresponse to anti-TNFα therapies, and a further 5-20% per year have secondary treatment failure, defined as loss of response after an initial response while on maintenance treatment. The aim of this review is to summarize current treatment options for primary non-response or secondary treatment failure.

METHOD:

This narrative review is based on current guidelines and pertinent publications retrieved by a selective search in the PubMed, Ovid MEDLINE, and Cochrane databases.

RESULTS:

Before switching to another drug class, a standardized reevaluation is essential, incorporating clinical findings, biomarkers, endoscopy and/or imaging, and therapeutic drug monitoring. Following failure of anti-TNFα therapy, ustekinumab (approved for Crohn’s disease for patients ≥ 2 years of age) and vedolizumab (currently exclusively off-label) represent the best-established options in pediatric care. Reported clinical remission rates are 51% at week 52 for ustekinumab and 32% (Crohn's disease) and 42% (ulcerative colitis) at week 14 for vedolizumab. For IL-23p19 antibodies, Janus kinase inhibitors, and sphingosine-1-phosphate receptor modulators, the available evidence is still derived predominantly from adult studies, with very limited data from pediatric practice. Surgery remains an important option in complicated disease courses.

CONCLUSION:

Given the limited pediatric evidence and the frequent off-label use of newer agents, there is a need for prospective studies, registry data, and structured treatment algorithms to more reliably define the efficacy and long-term safety of treatments for pediatric chronic inflammatory bowel disease. In our view, children and adolescents with refractory inflammatory bowel disease should be managed by an interdisciplinary team in a center with the requisite experience.

01 Aug 2026·CLINICAL NUCLEAR MEDICINE

Crohn Disease Mimicking Tongue Base Neoplasia

Article

Author: Nuñez Gutiérrez, Marta ; García-Talavera San Miguel, Paloma ; Campaña Díaz, Eva ; Gómez-Caminero López, Felipe ; Ortiz Rodríguez-Parets, Javier

A 67-year-old man with long-standing Crohn disease, diagnosed in 1996, presented with progressive dysphagia to solid foods and pain in the right submandibular region. His medical history included ileal disease (Rutgeerts index i2), anal canal stenosis requiring endoscopic dilations, and subsequent ileocecal resection with mechanical anastomosis in 2016. At the time of presentation, he was receiving corticosteroids and vedolizumab.

01 Aug 2026·Clinical Gastroenterology and Hepatology

Real-World Effectiveness of Advanced Therapies in Microscopic Colitis

Article

Author: Amiot, Aurélien ; Van Moerkercke, Wouter ; Verstockt, Bram ; Finlayson, Mhairi ; Marsal, Jan ; Levartovsky, Asaf ; Lutakov, Ivan ; Barreiro-de Acosta, Manuel ; Lenfant, Matthias ; Din, Shahida ; Van Dongen, Jurgen ; Wildt, Signe ; Dewit, Sophie ; Kiudelis, Vytautas ; Vieujean, Sophie ; Rogler, Gerhard ; Maillard, Michel H ; Choden, Tenzin ; Blesl, Andreas ; Ribaldone, Davide Giuseppe ; Backman, Ann-Sofie ; Cohen, Nathaniel A ; de la Revilla Negro, Juan ; Fumery, Mathurin ; Zabana, Yamile ; Nancey, Stephane ; Macaigne, Gilles ; Tontini, Gian Eugenio ; Taelman, Thibault ; Bajer, Lukas ; Julsgaard, Mette ; Savarino, Edoardo Vincenzo ; Rahier, Jean-Francois ; Teich, Niels ; Münch, Andreas ; Cremer, Anneline ; Rivière, Pauline ; Somers, Michael ; Vavricka, Stephan R ; Truyens, Marie

BACKGROUND & AIMS:

Microscopic colitis (MC) is a leading cause of chronic diarrhea, particularly in older adults. Although many patients respond to budesonide, refractory and dependent cases pose major therapeutic challenges. Although the off-label use of advanced inflammatory bowel disease therapies is expanding, robust real-world data remain scarce.

METHODS:

Through the ECCO CONFER network, we conducted a multinational, retrospective study in patients with MC treated with biologics or small molecules following budesonide failure or intolerance. We systematically analyzed clinical outcomes, treatment durability, and predictors of therapeutic success.

RESULTS:

Among 229 treatment cycles in 142 patients, anti-tumor necrosis factor (TNF) agents were most frequently initiated (55.9%), followed by vedolizumab (28.8%) and Janus kinase (JAK) inhibitors (9.2%). Short-term clinical response and remission rates were highest with JAK inhibitors (95.2% and 81.0%, respectively), significantly outperforming anti-TNFs, vedolizumab, and ustekinumab (P < .01). Long-term drug persistence mirrored these findings: JAK inhibitors demonstrated a markedly lower discontinuation rate (23.8%) compared with other agents (56.3%; odds ratio, 5.07; 95% confidence interval, 1.52-16.9; P = .008). Multivariate analysis confirmed drug class as the only independent predictor of therapy continuation. Despite advanced therapies, 4.2% of patients ultimately required surgical intervention.

CONCLUSIONS:

This real-world study demonstrates the promising short- and long-term effectiveness of advanced therapies-particularly JAK inhibitors-in budesonide-refractory and budesonide-dependent MC. These findings pave the way for dedicated prospective trials and highlight evolving therapeutic strategies in MC.

306

News (Medical) associated with Vedolizumab

01 Sep 2026

·allsci.com

FDA expands Stelara into pediatric ulcerative colitis with non-TNF mechanism

Stelara (ustekinumab), the anti-IL-12/23 monoclonal antibody marketed by Janssen Biotech, has received US FDA approval for moderately to severely active ulcerative colitis (UC) in pediatric patients aged 2 years and older — making Stelara the first non-TNF monoclonal antibody approved in the US for both pediatric ulcerative colitis and pediatric Crohn’s disease. Janssen had secured a parallel pediatric approval for Crohn's disease (CD) in April 2026, completing coverage across the two principal IBD diagnoses in children. The FDA granted Stelara Orphan Drug Designation for the pediatric UC indication. The approval was supported by adult UC efficacy data, pharmacokinetic and safety data from pediatric CD patients aged 2 to 17, and a dedicated 52-week study enrolling 112 pediatric UC patients aged 3 to 17 years. The most common adverse reactions reported in pediatric UC patients included nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea. Ustekinumab binds the p40 subunit shared by IL-12 and IL-23, blocking their interaction with the IL-12Rβ1 receptor on T cells and natural killer cells. This suppresses Th1- and Th17-driven mucosal inflammation — a mechanism distinct from the TNFα blockade used by anti-TNF biologics. The non-TNF distinction sets these agents apart from anti-TNF agents, which remain the backbone of biologic therapy in pediatric IBD. Johnson & Johnson's Simponi (golimumab), an anti-TNFα antibody from the same corporate family, received FDA approval for pediatric UC in patients weighing at least 15 kg in October 2025. Takeda's vedolizumab (Entyvio), a gut-selective anti-integrin antibody, has an sBLA under FDA review for pediatric UC and CD with a PDUFA target date in Q1 2027, and would offer a mechanistically distinct alternative if approved. AbbVie's risankizumab (Skyrizi), a selective IL-23 p19 inhibitor approved for adult UC and CD, has not yet secured pediatric IBD labeling. Stelara's adult UC franchise also faces growing biosimilar competition. In the broader UC pipeline, France-based Abivax's obefazimod has reported Phase III maintenance data in adult patients and is targeting an NDA filing in Q4 2026. Spot something wrong? Report an issue with this article

Drug ApprovalPhase 3Orphan DrugNDAClinical Result

31 Aug 2026

·www.globenewswire.com

Alvotech Announces FDA Acceptance for Review of Biologics License Application for AVT80, Expanding Proposed Biosimilar Program for Entyvio® to Subcutaneous Presentations

REYKJAVIK, Iceland, Aug. 31, 2026 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT80, a proposed interchangeable biosimilar to Entyvio® (vedolizumab) prefilled syringe and autoinjector for subcutaneous administration. Under a partnership with Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), Alvotech is responsible for the development and manufacturing of AVT80, while Teva is responsible for commercialization. “FDA’s acceptance for review of our BLA for AVT80 is another important milestone for our vedolizumab biosimilar program,” said Joseph McClellan, Chief Operating Officer of Alvotech. “Together with our BLA for AVT16, which was accepted for review in May, the program encompasses both intravenous and subcutaneous presentations, including a prefilled syringe and autoinjector.” Entyvio is a biologic medicine approved for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease. The BLA submission is supported by a comprehensive data package, including analytical, pharmacokinetic, and immunogenicity data generated to support the demonstration of biosimilarity between AVT80 and the reference product. AVT80 has been submitted as a proposed interchangeable biosimilar. In the United States, an interchangeable biosimilar may be substituted for the reference product at the pharmacy without the intervention of the prescriber, subject to applicable laws. If approved, AVT80 would add to the range of biosimilar options available to patients and healthcare providers in the United States. In February 2026, Alvotech announced positive results from a pivotal pharmacokinetic study for AVT80. The randomized, double-blind, single-dose, parallel-group, three-arm study compared AVT80 to Entyvio in healthy adult participants and met all its primary endpoints. Based on regulatory advice, the clinical study is considered pivotal to support the demonstration of clinical similarity for both AVT16 and AVT80. About AVT80 and AVT16 AVT80 is a proposed interchangeable biosimilar candidate to Entyvio (vedolizumab), a humanized monoclonal antibody. It is being developed as a prefilled syringe and autoinjector for subcutaneous administration. AVT80 complements AVT16, Alvotech’s proposed interchangeable biosimilar to Entyvio for intravenous administration for which the FDA accepted a BLA for review in May 2026. In the European Union, the European Medicines Agency has validated a Marketing Authorization Application covering both AVT16 (lyophilized vial) and AVT80 (pre-filled syringe and autoinjector). Together these two candidates form part of Alvotech’s broader pipeline of biosimilar candidates in immunology aimed at expanding access to biologic medicines in major therapeutic areas. AVT16 and AVT80 are investigational products and have not received regulatory approval in any markets. Biosimilarity and interchangeability have not been established by regulatory authorities and are not claimed. About Entyvio Entyvio (vedolizumab) is an integrin receptor antagonist indicated for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease. Vedolizumab targets and binds specifically to the alpha-4-beta-7 integrin, which is involved in the migration of certain white blood cells into gastrointestinal tissue. Use of trademarks Entyvio is a registered trademark of Millennium Pharmaceuticals, Inc. The use of this trademark is solely for the purpose of identifying the reference product. Alvotech and Teva do not claim any rights to the trademark. For further information, contact: MediaBenedikt StefanssonSarah MacLeodalvotech.media@alvotech.com InvestorsDr. Balaji V PrasadBenedikt StefanssonMikaela Vilchezalvotech.ir@alvotech.com About Alvotech Alvotech is a biotechnology company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high-quality, cost-effective products and services, enabled by a fully integrated approach and broad in-house capabilities. Five biosimilars are already approved and marketed in multiple global markets, including biosimilars to Humira® (adalimumab), Stelara® (ustekinumab), Simponi® (golimumab), Eylea® (aflibercept) and Prolia®/Xgeva® (denosumab). The current development pipeline includes disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. For more information, please visit https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release. For more information, please visit our website or follow us on social media on LinkedIn, Facebook, Instagram, and YouTube. Forward Looking Statements Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed.

Clinical ResultDrug Approval

31 Aug 2026

·www.biospace.com

Alvotech announces FDA acceptance for review of Biologics License Application for AVT80, expanding proposed biosimilar program for Entyvio® to subcutaneous presentations

REYKJAVIK, Iceland, August 31, 2026 - Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT80, a proposed interchangeable biosimilar to Entyvio® (vedolizumab) prefilled syringe and autoinjector for subcutaneous administration. Under a partnership with Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), Alvotech is responsible for the development and manufacturing of AVT80, while Teva is responsible for commercialization. “FDA’s acceptance for review of our BLA for AVT80 is another important milestone for our vedolizumab biosimilar program,” said Joseph McClellan, Chief Operating Officer of Alvotech. “Together with our BLA for AVT16, which was accepted for review in May, the program encompasses both intravenous and subcutaneous presentations, including a prefilled syringe and autoinjector.” Entyvio is a biologic medicine approved for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease. The BLA submission is supported by a comprehensive data package, including analytical, pharmacokinetic, and immunogenicity data generated to support the demonstration of biosimilarity between AVT80 and the reference product. AVT80 has been submitted as a proposed interchangeable biosimilar. In the United States, an interchangeable biosimilar may be substituted for the reference product at the pharmacy without the intervention of the prescriber, subject to applicable laws. If approved, AVT80 would add to the range of biosimilar options available to patients and healthcare providers in the United States. In February 2026, Alvotech announced positive results from a pivotal pharmacokinetic study for AVT80. The randomized, double-blind, single-dose, parallel-group, three-arm study compared AVT80 to Entyvio in healthy adult participants and met all its primary endpoints. Based on regulatory advice, the clinical study is considered pivotal to support the demonstration of clinical similarity for both AVT16 and AVT80. About AVT80 and AVT16 AVT80 is a proposed interchangeable biosimilar candidate to Entyvio (vedolizumab), a humanized monoclonal antibody. It is being developed as a prefilled syringe and autoinjector for subcutaneous administration. AVT80 complements AVT16, Alvotech’s proposed interchangeable biosimilar to Entyvio for intravenous administration for which the FDA accepted a BLA for review in May 2026 . In the European Union, the European Medicines Agency has validated a Marketing Authorization Application covering both AVT16 (lyophilized vial) and AVT80 (pre-filled syringe and autoinjector). Together these two candidates form part of Alvotech’s broader pipeline of biosimilar candidates in immunology aimed at expanding access to biologic medicines in major therapeutic areas. AVT16 and AVT80 are investigational products and have not received regulatory approval in any markets. Biosimilarity and interchangeability have not been established by regulatory authorities and are not claimed. About Entyvio Entyvio (vedolizumab) is an integrin receptor antagonist indicated for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease. Vedolizumab targets and binds specifically to the alpha-4-beta-7 integrin, which is involved in the migration of certain white blood cells into gastrointestinal tissue. Use of trademarks Entyvio is a registered trademark of Millennium Pharmaceuticals, Inc. The use of this trademark is solely for the purpose of identifying the reference product. Alvotech and Teva do not claim any rights to the trademark. For further information, contact: Media Benedikt Stefansson Sarah MacLeod alvotech.media@alvotech.com Investors Dr. Balaji V Prasad Benedikt Stefansson Mikaela Vilchez alvotech.ir@alvotech.com About Alvotech Alvotech is a biotechnology company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high-quality, cost-effective products and services, enabled by a fully integrated approach and broad in-house capabilities. Five biosimilars are already approved and marketed in multiple global markets, including biosimilars to Humira® (adalimumab), Stelara® (ustekinumab), Simponi® (golimumab), Eylea® (aflibercept) and Prolia®/Xgeva® (denosumab). The current development pipeline includes disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. For more information, please visit None of the information on the Alvotech website shall be deemed part of this press release. For more information, please visit our website or follow us on social media on LinkedIn , Facebook , Instagram , and YouTube . Forward Looking Statements Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed.

Clinical ResultDrug ApprovalBiosimilar

100 Deals associated with Vedolizumab

External Link

KEGG	Wiki	ATC	Drug Bank
D08083	Vedolizumab	L04AA33	DB09033

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Ileal Diseases	South Korea	Takeda Pharmaceuticals Korea Co., Ltd.	19 Jun 2015
Crohn's disease, active moderate	European Union	Takeda Pharma A/S	22 May 2014
Crohn's disease, active moderate	Iceland	Takeda Pharma A/S	22 May 2014
Crohn's disease, active moderate	Liechtenstein	Takeda Pharma A/S	22 May 2014
Crohn's disease, active moderate	Norway	Takeda Pharma A/S	22 May 2014
Crohn's disease, active severe	European Union	Takeda Pharma A/S	22 May 2014
Crohn's disease, active severe	Iceland	Takeda Pharma A/S	22 May 2014
Crohn's disease, active severe	Liechtenstein	Takeda Pharma A/S	22 May 2014
Crohn's disease, active severe	Norway	Takeda Pharma A/S	22 May 2014
Pouchitis	European Union	Takeda Pharma A/S	22 May 2014
Pouchitis	Iceland	Takeda Pharma A/S	22 May 2014
Pouchitis	Liechtenstein	Takeda Pharma A/S	22 May 2014
Pouchitis	Norway	Takeda Pharma A/S	22 May 2014
Ulcerative colitis, active moderate	European Union	Takeda Pharma A/S	22 May 2014
Ulcerative colitis, active moderate	Iceland	Takeda Pharma A/S	22 May 2014
Ulcerative colitis, active moderate	Liechtenstein	Takeda Pharma A/S	22 May 2014
Ulcerative colitis, active moderate	Norway	Takeda Pharma A/S	22 May 2014
Ulcerative colitis, active severe	European Union	Takeda Pharma A/S	22 May 2014
Ulcerative colitis, active severe	Iceland	Takeda Pharma A/S	22 May 2014
Ulcerative colitis, active severe	Liechtenstein	Takeda Pharma A/S	22 May 2014

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Pediatric Crohn's Disease	Phase 3	United States	Takeda Pharmaceutical Co., Ltd.	10 Feb 2022
Pediatric Crohn's Disease	Phase 3	China	Takeda Pharmaceutical Co., Ltd.	10 Feb 2022
Pediatric Crohn's Disease	Phase 3	Japan	Takeda Pharmaceutical Co., Ltd.	10 Feb 2022
Pediatric Crohn's Disease	Phase 3	Australia	Takeda Pharmaceutical Co., Ltd.	10 Feb 2022
Pediatric Crohn's Disease	Phase 3	Belgium	Takeda Pharmaceutical Co., Ltd.	10 Feb 2022
Pediatric Crohn's Disease	Phase 3	Canada	Takeda Pharmaceutical Co., Ltd.	10 Feb 2022
Pediatric Crohn's Disease	Phase 3	Croatia	Takeda Pharmaceutical Co., Ltd.	10 Feb 2022
Pediatric Crohn's Disease	Phase 3	Czechia	Takeda Pharmaceutical Co., Ltd.	10 Feb 2022
Pediatric Crohn's Disease	Phase 3	Greece	Takeda Pharmaceutical Co., Ltd.	10 Feb 2022
Pediatric Crohn's Disease	Phase 3	Hungary	Takeda Pharmaceutical Co., Ltd.	10 Feb 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04738942 (CTgov)	Phase 3	Crohn Disease \| Colitis, Ulcerative	56	Vedolizumab (UC Cohort: Vedolizumab 300 mg)	pxuxlhiyeh = hjarjpakik wmlwtqungm (wbnlpnlacm, vssebpwttn - dgfbhixemq) View more	-	15 Jun 2026
				Vedolizumab (CD Cohort: Vedolizumab 300 mg)	benjebfmuk = leobetwtbz updbstohaf (xbjexkuxuv, uegrckyorw - bbcjnoaxsv) View more
DDW2026	Not Applicable	Inflammatory Bowel Diseases	1,814	Vedolizumab subcutaneous (SC)	nyewgkbzuk(auxjbqsrhv) = ninyahkyel htucakvdxt (omrvwbvjcu ) View more	Positive	02 May 2026
DDW2026	Not Applicable	Pouchitis	67	Tumor Necrosis Factor-α Antagonist (anti-TNF)	zmpusepwib(vgrwwhprrd) = aitxstzcxr mqzrugznsn (rtwyrogigd )	Positive	02 May 2026
				Vedolizumab	zmpusepwib(vgrwwhprrd) = steaepgmfi mqzrugznsn (rtwyrogigd )
DDW2026	Not Applicable	Colitis, Microscopic	236	Vedolizumab	nzapuntsqn(qxcsatcckh) = ncngayllxu roknxueppb (edvszkqfsh ) View more	Positive	02 May 2026
				TNFi (infliximab or adalimumab)	nzapuntsqn(qxcsatcckh) = alltvfpxpn roknxueppb (edvszkqfsh ) View more
NCT04259138 (VERDICT, DDW2026)	Phase 2	Colitis, Ulcerative	122	disease clearance (Group 3)	cyitfeajqc(egwhkzkffn) = rjgoqkaxmx olsuppuugp (ddlcmpnaai )	Positive	02 May 2026
DDW2026	Not Applicable	Crohn Disease \| Colitis, Ulcerative	337	Subcutaneous Vedolizumab	neesmsvacy(ukulwokxyn) = enivzpqifb jxyhvmjeep (qvxifutlao, 80 - 88) View more	Positive	02 May 2026
DDW2026 \| ECCO2026	Not Applicable	Inflammatory Bowel Diseases	165	Vedolizumab discontinuation	tisxthukpr(kupgwouaqy) = zwzzpccdnt vfjchzxvkm (lkcsyyjljv ) View more	Negative	02 May 2026
				Vedolizumab maintenance	tisxthukpr(kupgwouaqy) = hycyzdrepo vfjchzxvkm (lkcsyyjljv ) View more
DDW2026	Not Applicable	Inflammatory Bowel Diseases	400	Infliximab	cwqptmuqen(lgwgtlwfod) = wvyahklijv lolzmjtxdn (hurlsavdnt )	Positive	02 May 2026
				Vedolizumab	cwqptmuqen(lgwgtlwfod) = tarwldkxwj lolzmjtxdn (hurlsavdnt )
DDW2026	Not Applicable	Colitis, Ulcerative	230	Vedolizumab	vdbmbnupoy(xpldvnpkar): P-Value = 0.47 View more	Positive	02 May 2026
				Filgotinib
DDW2026	Not Applicable	Gastritis	10	Vedolizumab 300 mg	mgtjgjzeeu(plwuomamqj) = xhwdnvstya qldmdioivs (vxsqztxipy ) View more	Positive	02 May 2026

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