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GI198745

Phase 2

Benign Prostatic Hyperplasia | Small molecule | Nephrology |GSK plc|Last Updated: Sep 13, 2010

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment121
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00969072Extension Study of GI198745 to Treat Benign Prostatic HyperplasiaPHASE2 COMPLETED 121 — — Aug 1, 2003Feb 1, 2005Sep 13, 2010 - —
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Study Endpoints
Primary Endpoints
adverse events, laboratory test values (hematology, serum chemistry, electrolyte, and urinalysis), prostate specific antigen (PSA), vital signs (blood pressure, pulse rate), and post-void residual volume.
a 28-week extension treatment in the subjects entered into the 24-week dose finding study (ARI20005: multicentre, double-blind, randomised, placebo-controlled, parallel-group)
Secondary Endpoints
prostate volume, symptom scores (IPSS), maximum urinary flow (Qmax), serum dihydrotestosterone (DHT), and testosterone
a 28-week extension treatment in the subjects entered into the 24-week dose finding study (ARI20005: multicentre, double-blind, randomised, placebo-controlled, parallel-group)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GI198745EXPERIMENTAL -
Interventions
NameTypeDescription
GI198745 0.05mgDRUGGI198745 (drug) - benign prostatic hyperplasia
GI198745 0.5mgDRUGGI198745 (drug) - benign prostatic hyperplasia
GI198745 2.5mgDRUGGI198745 (drug) - benign prostatic hyperplasia
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Eligibility Criteria
Age Range50 Years — N/A
SexMALE
Healthy VolunteersNo

Inclusion Criteria: * Has been receiving the investigational product for at least 20 weeks in the preceding dose finding study and the investigator or subinvestigator has confirmed the tolerability and has judged as appropriate to participate continuously in further 28 weeks treatment. Exclusion C...

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Competitive Landscape -Benign Prostatic Hyperplasia 6 trials
CompanyTickerTrialsLead PhaseDrugs
Boston Scientific CorporationBSX2 — Undisclosed
PROCEPT BioRobotics Corp.PRCT2NAUndisclosed
EDAP TMS SA Sponsored ADREDAP1NAUndisclosed
Profound Medical CorpPROF1 — Undisclosed
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