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metyrapone

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

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 an investigational small molecule being studied for the treatment of Cushing's Syndrome, a condition caused by excess cortisol. It is currently in Phase 3 clinical development and is not yet approved by regulatory authorities. The drug is being evaluated for its effects on patients with endogenous Cushing's Syndrome.

Who makes metyrapone?

Metyrapone is being developed by Perrigo Company plc, a company publicly traded under the ticker symbol PRGO. Perrigo is conducting clinical research on this small molecule for the treatment of Cushing's Syndrome, an endocrine disorder.

What phase is metyrapone in?

Metyrapone is currently in Phase 3 clinical development for Cushing's Syndrome. It is an investigational drug, meaning it has not yet received regulatory approval and is still undergoing clinical trials to evaluate its safety and efficacy in patients.

What clinical trials is metyrapone in?

Metyrapone has one completed Phase 3 clinical trial registered under NCT02297945, titled 'Effects of Metyrapone in Patients With Endogenous Cushing's Syndrome.' This trial enrolled 50 participants across multiple countries including Belgium, Germany, Hungary, Italy, Poland, Romania, Spain, and Turkey.

How does metyrapone work?

Metyrapone works by inhibiting the enzyme 11-beta-hydroxylase, which is involved in cortisol synthesis in the adrenal glands. By blocking this enzyme, metyrapone reduces cortisol production, which is the underlying cause of Cushing's Syndrome. This mechanism is the basis for its use in treating this endocrine disorder.