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PF-06835375

Phase 2

Primary Immune Thrombocytopenia | Monoclonal antibody | Hematology |Pfizer, Inc.|Last Updated: May 12, 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
CONTROLLED
Total Trials1
Total Enrollment91
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05070845Safety and Efficacy Study of PF-06835375 in Primary Immune ThrombocytopeniaPHASE2 RECRUITING 91Feb 2, 2022Aug 2, 2028May 12, 202631 United States, Australia +5
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Study Endpoints
Primary Endpoints
Proportion of participants with change from baseline of platelet counts
baseline through 12 and 16 weeks

To evaluate absolute value of platelet count of treated participants

Secondary Endpoints
proportion of participants with modified overall response (mOR)
baseline through 12 and 16 weeks
proportion of participants with complete response (CR)
baseline through 12 and 16 weeks
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
baseline through end of study (Week 20 for cohort 1 and Week 24 for cohorts 2 and 3)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Open Label PF-06835375 dose 1 TreatmentEXPERIMENTALsubcutaneous injection once monthly for 3 months
Open Label PF-06835375 dose 2 TreatmentEXPERIMENTALsubcutaneous injection once monthly for 4 months
Open Label PF-06835375 dose 3 TreatmentEXPERIMENTALsubcutaneous injection once monthly for 4 months
Open Label PF-06835375 dose 4 TreatmentEXPERIMENTALsubcutaneous injections once monthly for 4 months
Interventions
NameTypeDescription
PF-06835375BIOLOGICALCXCR5 inhibitor
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites31

Inclusion Criteria: * Diagnosis of Primary ITP. Ongoing ITP (platelet counts \<50 x 109/L) \[No severe bleeding within 1 month or during screening\] AND Persistent ITP (3 to 12 months) or Chronic ITP \>12 months Exclusion Criteria: * Bleeding event according to the WHO grading scale ≥2 occurring ...

Countries:United StatesAustraliaCanadaCzechiaHungaryPolandUnited Kingdom
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT05070845Enrollment: 61 → 91
LOWMay 24, 2026NCT05070845studyFirstPostDate: changed