TheraRadar
Data updated: Mar 29, 2026

METOPIRONE

METYRAPONE Adrenal Steroid Synthesis Inhibitors
Approved 1961-12-04

Metopirone is indicated, in combination with other diagnostic tests, for the diagnosis of adrenal insufficiency in adult and pediatric patients. Metopirone is indicated, in combination with other diagnostic tests, for the diagnosis of adrenal insufficiency in adult and pediatric patients. ( 1 )...

Source: FDA Label β€’ ESTEVE
1
Indication
--
Phase 3 Trials
1
Priority Reviews
64
Years on Market

Details

Status
Prescription
First Approved
1961-12-04
Routes
ORAL
Dosage Forms
CAPSULE, TABLET

Companies

Active Ingredient: METYRAPONE

METOPIRONE Approval History

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What METOPIRONE Treats

1 indications

METOPIRONE is approved for 1 conditions since its original approval in 1961. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Adrenal Insufficiency
Source: FDA Label
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

METOPIRONE FDA Label Details

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Indications & Usage

FDA Label (PDF)

Metopirone is indicated, in combination with other diagnostic tests, for the diagnosis of adrenal insufficiency in adult and pediatric patients. Metopirone is indicated, in combination with other diagnostic tests, for the diagnosis of adrenal insufficiency in adult and pediatric patients.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.