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)
Mechanism and Biochemical Profile
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>).