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TAK-226

Phase 2

Myelodysplastic Syndromes | Small molecule | Oncology |Takeda Pharmaceutical Company Limited|Last Updated: Sep 2, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment42

FDA Designations

No designations recorded

Clinical trial landscape

TAK-226 · 1 trial · 1 indication

Phase 2 1
NCT07319845A Study of TAK-226 for Anemia in Japanese Patients With Lower-Risk Myelodysplastic SyndromesMyelodysplastic Syndromes
RECRUITING42 Analytics
PHASE2RECRUITING
A Study of TAK-226 for Anemia in Japanese Patients With Lower-Risk Myelodysplastic Syndromes
Myelodysplastic SyndromesUnlock trial analytics

Study Endpoints

Primary Endpoints

Transfusion dependent (TD) cohort: Percentage of Participants Achieving Transfusion Independence (TI) for Greater Than or Equal to (>=) 8 Weeks from Baseline through Week 24
Baseline, Up to Week 24

Transfusion independence is defined as the absence of any red blood cells (RBC) transfusions in a period of at least 8 weeks after the first dose of the study treatment through week 24.

Non-transfusion dependent (NTD) cohort: Percentage of Participants Achieving Mean Hgb Increase of >=1.5 grams per deciliter (g/dL) for >=8 Weeks from Baseline through Week 24 And No RBC Transfusion during the Same >=8 Weeks Period
Baseline, Up to Week 24

Secondary Endpoints

TD cohort: Percentage of Participants Achieving TI for >=24 Weeks from Baseline through Week 48
Baseline, Up to Week 48
TD cohort: Percentage of Participants with High Transfusion Burden (HTB) Achieving TI for >=8 Weeks from Baseline through Week 24
Baseline, Up to Week 24
TD cohort: Percentage of Participants Achieving Mean Hemoglobin (Hgb) Increase of >=1.5 g/dL for >=8 Weeks from Baseline through Week 24
Baseline, Up to Week 24
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TAK-226EXPERIMENTALParticipants will receive the study drug, TAK-226, administered subcutaneously every four weeks (Q4W) for approximately one year during Treatment Period.

Interventions

NameTypeDescription
TAK-226DRUGTAK-226 subcutaneous injection
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: 1. Participants or their legally authorized representative must be willing and able to sign the ICF and to adhere to the protocol requirements. 2. Japanese adult male or female participant \>=18 years of age at the time of signing informed consent. 3. Diagnosis of MDS with or wi...

Countries:Japan
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Recent Changes (Last 90 Days)

LOWSep 2, 2026NCT07319845lastUpdatePostDate: changed
LOWSep 2, 2026NCT07319845lastUpdatePostDate: changed
LOWSep 2, 2026NCT07319845lastUpdatePostDate: changed
LOWAug 5, 2026NCT07319845lastUpdatePostDate: changed
LOWJul 17, 2026NCT07319845Status: NOT_YET_RECRUITING → RECRUITING
LOWJul 17, 2026NCT07319845Status: NOT_YET_RECRUITING → RECRUITING
LOWJul 17, 2026NCT07319845Status: NOT_YET_RECRUITING → RECRUITING

Frequently asked questions about TAK-226

What is TAK-226 used for?

TAK-226 is an investigational small molecule being studied for the treatment of anemia in patients with lower-risk myelodysplastic syndromes (MDS). It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who makes TAK-226?

TAK-226 is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company listed on the stock exchange under the ticker symbol TAK. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.

What phase is TAK-226 in?

TAK-226 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness for treating anemia in patients with lower-risk myelodysplastic syndromes.

What clinical trials is TAK-226 in?

TAK-226 is being evaluated in a Phase 2 clinical trial with the identifier NCT07319845. This study is titled 'A Study of TAK-226 for Anemia in Japanese Patients With Lower-Risk Myelodysplastic Syndromes' and is currently recruiting participants in Japan. The trial is an uncontrolled, open-label study with an enrollment target of 42 patients.

Is TAK-226 FDA approved?

No, TAK-226 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for the treatment of anemia in patients with lower-risk myelodysplastic syndromes. The drug has not yet completed clinical trials or received regulatory approval from the FDA or other health authorities.