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herombopag olamine

Phase 2

Herombopag | Small molecule | Other |China Pharma Holdings, Inc.|Last Updated: Mar 13, 2025

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment80
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06838949A Clinical Study on the Efficacy and Safety of Herombopag in the Treatment of Senile Primary ITPPHASE2 RECRUITING 80Mar 3, 2025Dec 1, 2027Mar 13, 20251 China
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Study Endpoints
Primary Endpoints
Proportion of patients with platelet count ≥30×109/L
8 weeks

Proportion of subjects with a platelet count ≥ 30 × 10\^9/L and at least twice the baseline platelet count without bleeding at week 8

Secondary Endpoints
Proportion of patients with platelet count ≥50×109/L
8 weeks
Proportion of patients with platelet count ≥100×109/L
8 weeks
Duration from treatment initiation to platelet count ≥30×10^9/L and ≥50×10^9/L
24 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
HerombopagEXPERIMENTALHerombopag 2.5mg per tablet
Interventions
NameTypeDescription
herombopag olamine tabletsDRUGThe patient received herombopag 5mg/d at the beginning of the day, was orally taken on an empty stomach in the morning, and could eat 2 hours after taking the drug, once a day for 24 weeks. Investigators will adjust the dosage of herombopag once a week according to the platelet count, with a maximum dosage of 7.5 mg per day. Efficacy and safety were evaluated once a week.
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Eligibility Criteria
Age Range60 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients voluntarily participated in the study and signed informed consent; * Age ≥60 years old, gender unlimited; * ECOG PS ≤2; * Expected survival ≥6 months; * A definitive diagnosis of ITP, including newly diagnosed, chronic, and persistent ITP; * PLT \< 30×109/L for at lea...

Countries:China
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