Trial Radar AI

Takeda Pharmaceutical Company Limited Overview

Trial Radar AI Insights

Takeda Pharmaceutical Company Limited (Takeda) operates as a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan. The company focuses on translating science into highly innovative medicines by concentrating its research efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). Takeda also makes targeted R&D investments in Plasma-Derived Therapies and Vaccines to address some of the world's most challenging health conditions.

  • Company Snapshot: Founded 1781; HQ Tokyo, Japan; Public (NYSE: TAK); https://www.takeda.com
  • Scale & Stage: Employees ~47,455; Market Cap ~$54.34B; Commercial stage
  • Research Focus: Gastroenterology, Immunology, and Neuroscience; Therapeutic approaches include small molecules, biologics, plasma-derived therapies, and RNAi.
  • Clinical Footprint: Takeda manages 133 active trials as a lead sponsor, targeting 128,700 participants across 4,504 sites globally, plus 77 additional trials as a collaborator.

Therapeutic Focus

Takeda prioritizes therapeutic areas with high unmet needs and significant market potential. The company's strategy leverages a "modalities-agnostic" R&D engine, allowing it to pursue the most effective biological solutions whether they involve traditional small molecules, complex biologics, or emerging cell and gene therapies. A primary pillar of Takeda’s growth is its GI franchise, anchored by its flagship inflammatory bowel disease (IBD) treatments, which the company continues to expand through next-generation oral therapies.

  • Primary Focus Areas:

    • Gastroenterology: Focuses on IBD, celiac disease, and liver diseases.
    • Immunology & Inflammation: Targeting TYK2 and CD38 pathways for psoriasis, psoriatic arthritis, and rare autoimmune conditions.
    • Neuroscience: Developing orexin receptor agonists for sleep-wake disorders and therapies for neurodegenerative diseases.
    • Rare Diseases: Concentrating on Hereditary Angioedema (HAE), Lysosomal Storage Disorders, and Hematology.
  • Strategy & Capabilities:
    Takeda emphasizes a partnership-heavy model to augment its internal pipeline, frequently acquiring late-stage assets or entering co-development agreements. The company’s recent focus has pivoted toward "best-in-class" oral systemic therapies (e.g., TYK2 inhibitors) and highly specialized plasma-derived therapies that utilize advanced fractionation technologies.

Takeda Pipeline and Products

Marketed Products

Takeda maintains a robust portfolio of commercial assets that generate significant global revenue, particularly in immunology and gastroenterology.

Product Name Generic Name Primary Indications Key Markets Notable Achievements
Entyvio
Vedolizumab
Ulcerative Colitis, Crohn's Disease
Global
Standard of care for gut-selective IBD treatment.
Takhzyro
Lanadelumab
Hereditary Angioedema (HAE)
Global
First monoclonal antibody for HAE prophylaxis.
Vyvanse
Lisdexamfetamine
ADHD, Binge Eating Disorder
Global
Long-standing leader in ADHD treatment.
Hyqvia
Immune Globulin
Primary Immunodeficiency
US, EU
Facilitates subcutaneous delivery of IG at home.
Fruzaqla
Fruquintinib
Colorectal Cancer
US
FDA approved in 2023 for metastatic CRC.

Late-Stage Pipeline (Phase 2b+)

Takeda is currently advancing several high-potential assets through pivotal trials, focusing on oral delivery and precision immunology.

Compound Phase MOA Indications Next Milestone Competitive Edge
Zasocitinib
III
Selective TYK2 inhibitor
Plaque Psoriasis, PsA
NDA Filing FY2026
High selectivity avoids JAK1/2/3 side effects.
Mezagitamab
III
Anti-CD38 mAb
Chronic ITP, IgAN
Target Filing 2026
Potential best-in-class for primary ITP.
Fazirsiran
III
RNAi (AAT silencing)
AATD Liver Disease
Data Readout 2026
Disease-modifying potential via gene silencing.
Rusfertide
Filed
Hepcidin mimetic
Polycythemia Vera
FDA Decision 2026
First-in-class mimetic to control iron levels.
Oveporexton
Filed
Orexin 2R agonist
Narcolepsy Type 1
FDA Decision 2026
Breakthrough status for wakefulness restoration.

Early-Stage Pipeline Highlights

  • TAK-594 (DNL593): A Phase I/II program developed with Denali Therapeutics using Protein Transport Vehicle (PTV) technology to deliver progranulin across the blood-brain barrier for Frontotemporal Dementia.
  • TAK-168 (KQB168): A Phase I immune modulator for solid tumors, developed in collaboration with Kumquat Biosciences.
  • TAK-411: A Phase II hypersialylated immunoglobulin aimed at reducing the inflammatory burden in patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP).

Takeda Clinical Trials Landscape

Trial Statistics

SponsorTakeda
StatusRecruitingNot yet recruitingActive, not recruiting

Takeda maintains an expansive clinical footprint as of February 2026, managing 133 active trials as lead sponsor with an additional 77 trials as a collaborator. The company's active recruitment efforts involve approximately 128,700 participants across 4,504 global sites, with a heavy concentration in the United States, Japan, and China. Clinical activity is primarily focused on Phase III (45 trials) and Phase II (25 trials) programs, emphasizing the maturation of its core pipeline in conditions like Crohn's Disease, Ulcerative Colitis, and Dengue Fever.

Overview

Total StudiesTotal EnrollmentTotal LocationsActive Recruiting StudiesStudies Updated Last Month
39
101,030
895
25
21

Top Conditions by Enrollment

Dengue FeverCrohn's DiseaseUlcerative ColitisPsoriatic ArthritisHereditary Angioedema (HAE)
70,496
23,920
23,900
1,182
739

Phase Distribution by Study

Phase 1Phase 2Phase 3N/A
3
9
12
1

Top Countries by Sites

United States
Japan
China
Poland
Spain
United States
213
Japan
110
China
87
Poland
51
Spain
39

Key Clinical Trial Updates

  • Zasocitinib (TAK-279): In December 2025, Takeda reported positive topline Phase 3 data from the Latitude study in plaque psoriasis, meeting all primary and secondary endpoints.
  • Mezagitamab (TAK-079): Interim Phase 1b data released in late 2025 demonstrated that the therapy provided sustained kidney function protection in IgA Nephropathy patients through 96 weeks.
  • Regulatory Submissions: In January 2026, Takeda submitted NDAs to the FDA for Rusfertide (Polycythemia Vera) and Oveporexton (Narcolepsy Type 1). Additionally, Mirvetuximab Soravtansine was filed for approval in Japan on January 30, 2026, for platinum-resistant ovarian cancer.
  • Phase III Launches: Takeda expects to initiate a Phase 3 study for ADZYNMA in immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP) within 2026.

Business Insights and Analysis

Business Development

Takeda aggressively pursues strategic partnerships to bolster its pipeline and commercial reach. In December 2025, the company finalized a $1.2 billion upfront licensing deal with Innovent Biologics to acquire global rights (excluding Greater China) for two oncology assets: IBI363 (PD-1/IL-2) and IBI343 (CLDN18.2 ADC).

Major historical milestones include the $4 billion acquisition of Nimbus Lakshmi in late 2022, which brought Zasocitinib (TAK-279) into the portfolio. Takeda also maintains significant collaborations with Protagonist Therapeutics for Rusfertide and Arrowhead Pharmaceuticals for the RNAi therapy Fazirsiran. In the neuroscience sector, the acquisition of global rights to ACI-24.060 from AC Immune signals a strategic move toward immunotherapy for neurodegenerative diseases.

Financial Overview

Takeda is a large-cap biopharmaceutical company listed on the New York Stock Exchange (TAK). With a market capitalization of approximately $54.34 billion, the company maintains a stable financial position supported by consistent revenue from its "Growth and Emerging" products like Entyvio and Takhzyro. Takeda’s financial strategy focuses on deleveraging while continuing to invest approximately 20% of its revenue into R&D to sustain its long-term pipeline.

Clinical Trial Participation Guide

Users can leverage Trial Radar’s integrated tools to navigate Takeda’s clinical opportunities:

  • Participation Assistant: Use the "Simplify" tool to break down complex protocol language, view the "What to Expect" section for a timeline of study visits, and use "Check Eligibility" to verify if you meet the specific criteria for a Takeda trial.
  • Contacts & Locations: Use the dedicated tab on the trial page to find the nearest research site and obtain direct contact information for the study coordinator or principal investigator.

Explore Takeda clinical trials


️ For informational purposes only. Not investment, medical, or professional advice. Consult qualified professionals. Verify information with current sources.

  • pharmacally.comWorldwide license for rusfertide (TAK-121); Takeda leads global commercialization. Partners submitted an NDA for Polycythemia Vera in January 2026
  • nasdaq.comWorldwide license for rusfertide (TAK-121); Takeda leads global commercialization. Partners submitted an NDA for Polycythemia Vera in January 2026.
  • takeda.comAcquisition of global rights to ACI-24.060, a move towards neurodegenerative disease immunotherapy

Last Update Posted: 2/2/2026

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50 of 207 clinical trial listings found
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