METOPIRONE (metyrapone)
Metopirone is a diagnostic agent indicated for the evaluation of adrenal insufficiency in adult and pediatric patients. Used in conjunction with other diagnostic tests, it assesses the integrity of the hypothalamic-pituitary-adrenal (HPA) axis by measuring the pituitary gland's ability to increase ACTH production in response to decreased cortisol levels. Clinicians confirm the diagnosis by measuring elevations in cortisol precursors (such as 11-desoxycortisol) in the plasma or their metabolites in the urine.
How METOPIRONE Works
Metopirone inhibits the 11-beta-hydroxylation reaction in the adrenal cortex, which reduces the synthesis of cortisol and corticosterone. The resulting decrease in cortisol levels eliminates the negative feedback signal to the pituitary gland, stimulating the release of adrenocorticotropic hormone (ACTH). In a functioning HPA axis, the rise in ACTH leads to an increased production and accumulation of the precursor 11-desoxycortisol. The diagnostic response is determined by measuring 11-desoxycortisol in the plasma or 17-hydroxycorticosteroids (17-OHCS) in the urine.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1961-12-04
- Routes
- ORAL
- Dosage Forms
- CAPSULE, TABLET
METOPIRONE Approval History
What METOPIRONE Treats
1 indicationsMETOPIRONE is approved for 1 conditions since its original approval in 1961. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Adrenal Insufficiency
METOPIRONE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06106295 | 23-008085 | Ph 2 | active not recruiting | Metyrapone for Mild Autonomous Cortisol Secretion (MACS) |
| NCT02297945 PROMPT | HRA112025-002 | Ph 3 | completed | Effects of Metyrapone in Patients With Endogenous Cushing's Syndrome |
| NCT01673087 | 1R01MH093486-01A1 | Ph 1 | completed | Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures |
| NCT01375920 ADD | EME-08/43/39 ISRCTN, 2009-015165-31 | Ph 3 | completed | Antiglucocorticoid Augmentation of antiDepressants in Depression |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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
Indications & Usage
FDA Label (PDF)METOPIRONE is indicated for the treatment of Adrenal Insufficiency.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment