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metyrapone

Phase 3

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

metyrapone development status

Highest phase Phase 3
Registered trials 2 across 2 sponsors since Jan 2007

metyrapone target and mechanism

Molecular targetCYP11B1
Target classInhibitor
ModalitySmall molecule
ChEMBLCHEMBL934

Also known as Metopirone

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

metyrapone clinical trials

metyrapone · 1 trial · 1 indication

Phase 3 1
NCT02297945Effects of Metyrapone in Patients With Endogenous Cushing's SyndromeCushing's Syndrome
COMPLETED50 Analytics
PHASE3COMPLETED
Effects of Metyrapone in Patients With Endogenous Cushing's Syndrome
Cushing's SyndromeUnlock trial analytics

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 to 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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Frequently asked questions about metyrapone

What is metyrapone used for in Cushing's Syndrome?

Metyrapone is a small molecule being developed by Perrigo Company plc for the treatment of endogenous Cushing's Syndrome. It is designed to lower cortisol production in patients with this endocrine disorder. The drug is currently in Phase 3 clinical development and is not yet approved.

What does metyrapone target?

Metyrapone targets CYP11B1, an enzyme involved in cortisol synthesis. It acts as an inhibitor of this target, which is the basis for its use in Cushing's Syndrome, a condition characterized by excess cortisol. By inhibiting CYP11B1, metyrapone aims to reduce cortisol production.

Who is developing metyrapone for Cushing's Syndrome?

Metyrapone is being developed by Perrigo Company plc, which trades under the ticker PRGO. The company is advancing the drug as a treatment for endogenous Cushing's Syndrome in Phase 3 clinical development.

What phase is metyrapone in for Cushing's Syndrome?

Metyrapone is in Phase 3 clinical development for Cushing's Syndrome. It is an investigational small molecule and has not been approved by the FDA for this indication. The Phase 3 trial has been completed.

What clinical trials is metyrapone in for Cushing's Syndrome?

Metyrapone has been studied in a completed Phase 3 trial, NCT02297945, titled Effects of Metyrapone in Patients With Endogenous Cushing's Syndrome. The trial enrolled 50 patients across Belgium, Germany, Hungary, Italy, Poland, Romania, Spain, and Turkey, and was an uncontrolled study.