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Anagrelide

Phase 3

Essential Thrombocythemia (ET) | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: Jun 9, 2021

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
UNCONTROLLED
Total Trials1
Total Enrollment53
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01214915Effect of SPD422 on Platelet Lowering and Safety in Japanese Adults With At Risk Essential ThrombocythaemiaPHASE3 COMPLETED 53Oct 27, 2010Oct 24, 2012Jun 9, 202119 Japan
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Study Endpoints
Primary Endpoints
Percentage of Subjects Who Responded in Platelet Count
12 months

A response was defined as platelet counts to \<600x10\^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment.

Secondary Endpoints
Percentage of Subjects With at Least 50% Reduction in Platelet Count
12 months
Percentage of Subjects With Normalization in Platelet Count
12 months
Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was ≥600x10^9/L
12 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Anagrelide HydrochlorideEXPERIMENTAL -
Interventions
NameTypeDescription
Anagrelide HydrochlorideDRUGSubjects will be started at 1.0 mg per day and titrated as necessary.
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Eligibility Criteria
Age Range20 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * Subjects must have previously been treated with a cytoreductive therapy and been intolerant or refractory to that therapy. Exclusion Criteria: * Subjects should not have any other underlying conditions or medications that would confound the study analysis or interact with th...

Countries:Japan
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Competitive Landscape -Essential Thrombocythemia 9 trials