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GSK5471713

Phase 1

Neoplasms, Prostate | Small molecule | Oncology |GSK plc|Last Updated: Apr 22, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment54
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07332455First-Time-in-Human Study of GSK5471713 in Adults With mCRPCPHASE1 RECRUITING 54Feb 10, 2026Mar 26, 2030Apr 22, 20266 United States, Canada +1
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Study Endpoints
Primary Endpoints
Number of participants with dose limiting toxicities (DLTs)
28 days
Number of participants with adverse events (AEs), and serious adverse events (SAEs)
Approximately 45 months
Number of participants with adverse events (AEs), and serious adverse events (SAEs) by Severity
Approximately 45 months
Number of participants with AEs leading to dose modifications
Approximately 45 months
Secondary Endpoints
Maximum plasma concentration (Cmax) of GSK5471713
Approximately 45 months
Area under the plasma concentration-time curve from 0 to t (AUC[0-t]) of GSK5471713
Approximately 45 months
Time to maximum plasma concentration (Tmax) of GSK5471713
Approximately 45 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Participants receiving GSK5471713EXPERIMENTALParticipants will receive GSK5471713, according to their allocated dose level guided by the dose escalation study design.
Interventions
NameTypeDescription
GSK5471713DRUGGSK5471713 will be administered at different dose levels based on the dose escalation study design
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Eligibility Criteria
Age Range18 Years — N/A
SexMALE
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Participants with mCRPC that have histologically or cytologically confirmed adenocarcinoma of the prostate. * Participants with mCRPC that has prostate cancer progression while on Androgen deprivation therapy (ADT). * Eastern Cooperative Oncology Group (ECOG) performance statu...

Countries:United StatesCanadaJapan
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07332455primaryCompletionDate: changed
LOWMay 24, 2026NCT07332455studyFirstPostDate: changed