Clinical Trials

Numerous clinical trials evaluate metyrapone across Early Phase 1 through Phase 4 for indications including Cushing's syndrome, autonomous cortisol secretion, major depressive disorder, cocaine and tobacco use disorders, and obesity-related metabolic dysfunction. Sponsored by academic medical centers, government bodies like the National Institute on Drug Abuse, and pharmaceutical companies including GlaxoSmithKline and Embera NeuroTherapeutics, these studies evaluate both safety and efficacy. Their recruitment statuses encompass completed, active not recruiting, recruiting, not yet recruiting, and unknown status, reflecting sustained clinical interest in modulating cortisol synthesis.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07138274 NOT_YET_RECRUITING
Mild Autonomous Cortisol Secretion (MACS); Autonomous Cortisol Secretion (ACS)
Mayo Clinic
2026-08 PHASE2
NCT07494084 NOT_YET_RECRUITING
Shift Work Schedule; Circadian Rhythm; Insulin Resistance; Circadian Misalignment
Washington State University
2026-07-01 PHASE4
NCT06106295 ACTIVE_NOT_RECRUITING
Autonomous Cortisol Secretion; Mild Autonomous Cortisol Secretion (MACS)
Mayo Clinic
2023-12-19 PHASE2
NCT07268222 RECRUITING
Mild Autonomous Cortisol Secretion (MACS)
Laikο General Hospital, Athens
2025-12-01 PHASE4
NCT06556277 COMPLETED
Glucocorticoids; Overweight and Obesity; Overeating
Eleonora Seelig
2024-09-01
NCT06801249 RECRUITING
Adrenal Incidentalomas; Cushing Syndrome
IRCCS Azienda Ospedaliero-Universitaria di Bologna
2021-02-23 PHASE4
NCT05919992 COMPLETED
Glucocorticoid Effect
Eleonora Seelig
2023-05-15 EARLY_PHASE1
NCT05167084 COMPLETED
Glucocorticoid Effect
Eleonora Seelig
2022-02-08 EARLY_PHASE1
NCT03491696 UNKNOWN
Depressive Disorder; Hormone Disturbance
Centre Hospitalier Rouffach
2018-12-22 PHASE4
NCT02297945 COMPLETED
Cushing's Syndrome
HRA Pharma
2015-04 PHASE3
NCT03491696 Unknown status
Depressive Disorder|Hormone Disturbance
Centre Hospitalier Rouffach|University Hospital Strasbourg France
2018-12-22 Phase 4
NCT01673087 COMPLETED
Stress
University of Michigan
2012-10 PHASE1
NCT02856854 COMPLETED
Cocaine Use Disorder
Embera NeuroTherapeutics, Inc.
2016-07 PHASE1
NCT02368379 COMPLETED
Prader Willi Syndrome; Adrenal Insufficiency
Nationwide Children's Hospital
2014-03
NCT02406066 COMPLETED
Cocaine Use Disorder; Tobacco Use Disorder
Embera NeuroTherapeutics, Inc.
2015-03 PHASE1
NCT02406066 Completed
Cocaine Use Disorder|Tobacco Use Disorder
Embera NeuroTherapeutics Inc.|National Institute on Drug Abuse (NIDA)
2015-03 Phase 1
NCT01620684 UNKNOWN
Metabolic Syndrome; Obesity; Insulin Resistance
Baker Heart Research Institute
2013-02 PHASE4
NCT01375920 COMPLETED
Depression
Jane Barnes
2011-02 PHASE3
NCT00567814 COMPLETED
Cocaine Dependence; Cocaine Addiction
Embera NeuroTherapeutics, Inc.
2007-12
NCT00426608 COMPLETED
Depressive Disorder and Anxiety Disorders
GlaxoSmithKline
2006-10-06 PHASE1
NCT00125554 COMPLETED
Major Depressive Disorder
Universitätsklinikum Hamburg-Eppendorf
1998-05 PHASE2
NCT00033098 UNKNOWN
Cocaine-Related Disorders; Infusions, Intravenous
National Institute on Drug Abuse (NIDA)
2001-11 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-06-29)

Check the Metyrapone product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Metyrapone selectively binds to and inhibits steroid 11-beta-monooxygenase (CYP11B1), blocking the enzymatic conversion of 11-deoxycortisol to cortisol within the adrenal cortex. This targeted suppression of adrenal steroid synthesis decreases circulating systemic cortisol levels, providing clinical utility in controlling hypercortisolism in Cushing's syndrome and modulating stress-response pathways in major depressive disorder and substance use disorders.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Note: Technical data last updated: Sep 1, 2026.