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SOM230 s.c.

Phase 2

Cushing's Syndrome | Small molecule | Endocrine |Novartis AG|Last Updated: Nov 7, 2016

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
UNCONTROLLED
Total Trials1
Total Enrollment26
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00088608A Study to Assess SOM230 in Patients With Pituitary Cushing's DiseasePHASE2 COMPLETED 26Apr 1, 2004 -Nov 7, 20165 United States
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Study Endpoints
Primary Endpoints
Urinary Free Cortisol after 15 days of treatment
Secondary Endpoints
Serum cortisol
ACTH
Clinical manifestations
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
SOM230 s.c.DRUG -
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Patients with pituitary Cushing's disease within the two months prior to study entry * Patients for whom written informed consent to participate in the study has been obtained * Female patients of child bearing potential who have not undergone clinically documented total hyste...

Countries:United States
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