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metyrapone

Phase 3

Cushing's Syndrome | Small molecule | Endocrine |Perrigo Company plc|Last Updated: Sep 25, 2020

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 Enrollment50
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02297945Effects of Metyrapone in Patients With Endogenous Cushing's SyndromePHASE3 COMPLETED 50Apr 1, 2015Apr 29, 2020Sep 25, 202036 Belgium, Germany +6
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Study Endpoints
Primary Endpoints
Normalization of cortisol levels (urinary free cortisol)
3 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MetyraponeEXPERIMENTALMetyrapone will be administered orally in an open-label fashion. Two possible initiation doses will be used depending on the severity of hypercortisolism, dose will then be adjusted (up or down-titrated) during the first month on an individual basis according to clinical tolerance and cortisol levels achieved.
Interventions
NameTypeDescription
metyraponeDRUGSingle arm study
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites36

Inclusion Criteria: 1\. Patients with endogenous Cushing's syndrome: * Cushing disease patients with persistent or recurrent disease (after pituitary surgery) or who are newly diagnosed but are unsuitable for early surgery or wish to defer surgery; * Patients with ectopic ACTH syndrome (either occ...

Countries:BelgiumGermanyHungaryItalyPolandRomaniaSpainTurkey (Türkiye)
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