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Pegvisomant

Phase 3

Acromegaly | Small molecule | Endocrine |Pfizer, Inc.|Last Updated: Jul 29, 2008

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 Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00143416Long Term Study With B2036-PEGPHASE3 COMPLETED 16 — — Apr 1, 2004Jul 1, 2007Jul 29, 20088 Japan
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Study Endpoints
Primary Endpoints
To evaluate the safety and efficacy of long-term B2036-PEG therapy in patients with acromegaly
Secondary Endpoints
PK/PD evaluation
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
PegvisomantDRUG -
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Eligibility Criteria
Age Range20 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Patients with acromegaly who have received at least one dose of B2036-PEG in the preceding study (A6291009). Exclusion Criteria: * Switching to other therapeutic methods for acromegaly

Countries:Japan
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