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Mezagitamab

Phase 3

Immune Thrombocytopenic Purpura (ITP) | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: Jun 5, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment321
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06948318A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune ThrombocytopeniaPHASE3 RECRUITING 150Aug 14, 2025Jul 29, 2029Jun 5, 2026108 United States, Australia +12
NCT06722235A Study of Mezagitamab in Adults With Chronic Primary Immune ThrombocytopeniaPHASE3 RECRUITING 171Feb 27, 2025Mar 16, 2028May 22, 2026112 United States, Australia +14
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Study Endpoints
Primary Endpoints
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Up to approximately 108 weeks

An adverse event (AE) is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the trial intervention. TEAEs are defined as AEs with start dates at the time of or following the first exposure to mezagitamab in the parent trial for Cohort 1 and in this trial for Cohort 2. A serious TEAE is a TEAE that meets 1 or more of the criteria: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or was otherwise considered medically important.

Number of Participants With TEAEs Leading to Permanent Withdrawal of Mezagitamab
Up to approximately 108 weeks

An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the trial intervention. TEAEs are defined as AEs with start dates at the time of or following the first exposure to mezagitamab in the parent trial for Cohort 1 and in this trial for Cohort 2.

Percentage of Participants With Durable Platelet Response
Up to Week 24

Durable platelet response is defined as platelet count greater than or equal to (≥)50,000/microliter (μL) on at least 4 of the 6 weekly platelet measurements between Weeks 19 and 24.

Secondary Endpoints
Duration of Platelet Response
Up to approximately 108 weeks
Duration Between On-Demand Treatment Courses
Up to approximately 108 weeks
Time to Initiation of the First On-Demand Treatment Course
Up to approximately 108 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MezagitamabEXPERIMENTALEligible participants who completed the TAK-079-3002 or TAK-079-1004 studies can receive on-demand treatment in this continuation study. The on-demand treatment course may be repeated as needed based on the pre-specified on-demand dosing criteria and investigator's clinical judgement.
PlaceboPLACEBO_COMPARATORParticipants will receive mezagitamab-matching placebo injection, SC, QW. They will receive 8 weekly doses, followed by 8 weekly doses off, and then receive 8 more weekly doses.
Interventions
NameTypeDescription
MezagitamabDRUGMezagitamab injection administered SC.
PlaceboDRUGMezagitamab-matching placebo injection administered SC.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites108

* Key Inclusion Criteria: 1\. The participant has completed TAK-079-3002 (end of trial \[EOT\]) or TAK-079-1004 (EOT). Participants from TAK-079-1004 must have had a response to mezagitamab as demonstrated by meeting the criteria for "platelet response" specified for that trial during either the ...

Countries:United StatesAustraliaBulgariaChinaCroatiaHong KongItalyJapanNetherlandsPolandSouth KoreaSpainTurkey (Türkiye)United KingdomFranceGreece
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Recent Changes (Last 90 Days)
LOWJun 5, 2026NCT06948318lastUpdatePostDate: changed
LOWJun 5, 2026NCT06948318lastUpdatePostDate: changed
LOWJun 5, 2026NCT06948318lastUpdatePostDate: changed
LOWJun 5, 2026NCT06948318lastUpdatePostDate: changed
MEDIUMMay 26, 2026NCT06722235primaryCompletionDate: changed
LOWMay 26, 2026NCT06948318primaryCompletionDate: changed
LOWMay 24, 2026NCT06722235studyFirstPostDate: changed
LOWMay 24, 2026NCT06948318studyFirstPostDate: changed