Metopirone

(Metyrapone)

Phase 2Small molecule

TTerezinha de Jesus Esteves Barata

Metopirone is one of 8 small molecule programs targeting Head Injury. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Head InjuryActive, not recruiting

Mild Autonomous Cortisol Secretion (MACS)Active, not recruiting

Head InjuryPreclinical

Active, not recruiting

Mild Autonomous Cortisol Secretion (MACS)Phase 2

Active, not recruiting

Competition

Competitive Landscape

8 competitors in Head Injury

#DrugCompanyPhaseTrials

Lipitor

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

1 2

Epsom Salt

FFresenius Kabi USA, LLC

Approved

—3

Metopirone

TTerezinha de Jesus Esteves Barata

Phase 2

1 4

Cortrosyn

Novartis

Preclinical

1 5

Depakote

Teva

Preclinical

1 6

Direct Anticoagulant

Bayer

Preclinical

1 7

Antiplatelet Drugs

Bayer

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

Post-ApprovalRecruiting

Autonomous Cortisol Secretion

NCT07268222

Q1 2028

Phase 2Active, not recruiting

Mild Autonomous Cortisol Secretion (MACS)

NCT06106295

Q4 2031

Phase 2Not yet recruiting

Mild Autonomous Cortisol Secretion (MACS)

NCT07138274

Clinical

Trials by Indication[1]

Mild Autonomous Cortisol Secretion (MACS)2 trials

Metyrapone for Mild Autonomous Cortisol Secretion (MACS)

Active, not recruiting·MMayo Clinic·Phase 2·NCT06106295·30 enrolled

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Metyrapone in Subjects Diagnosed With Mild Autonomous Cortisol Secretion (MACS)

Not yet recruiting·MMayo Clinic·Phase 2·NCT07138274·90 enrolled

Cortisol2 trials

Effects of Metyrapone in Patients With Hypercortisolism

Active, not recruiting·IIstituto Auxologico Italiano··NCT05255900·20 enrolled

Cortisol and Nutritional Sympathetic Responsiveness

Unknown status·—·Phase 4·NCT01620684·24 enrolled

Antidepressants1 trial

Antiglucocorticoid Augmentation of antiDepressants in Depression

Completed·JJane Barnes·Phase 3·NCT01375920·190 enrolled

Endogenous Cushing's Syndrome1 trial

Effects of Metyrapone in Patients With Endogenous Cushing's Syndrome

Completed·HHRA Pharma·Phase 3·NCT02297945·50 enrolled

Biomarkers1 trial

Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures

Completed·UUniversity of Michigan·Phase 1·NCT01673087·256 enrolled

9 more indications

Major Depression1 trial

Metyrapone as Additive Treatment in Major Depression

Completed·UUniversitätsklinikum Hamburg-Eppendorf·Phase 2·NCT00125554·63 enrolled

Glucocorticoid1 trial

Acute Consequences Of Food-induced Glucocorticoid Secretion In Healthy Individuals

Completed·EEleonora Seelig·Phase 1·NCT05167084·20 enrolled

Glucocorticoids1 trial

The Role of Glucocorticoids to Maintain Energy Homeostasis During Starvation (Gluco-Starve)

Completed·EEleonora Seelig·Phase 1·NCT05919992·24 enrolled

Autonomous Cortisol Secretion1 trial

Metyrapone Versus Osilodrostat in Patients With Metabolic Autonomous Cortisol Secretion (MACS)

Recruiting·LLaikο General Hospital, Athens·Phase 4·NCT07268222·150 enrolled

Dexamethasone1 trial

Effects of the Addition of Metyrapone to Antidepressant Therapy in Depression With Dexamethasone Suppression Test Non-suppression.

Unknown status·—·Phase 4·NCT03491696·14 enrolled

Interaction1 trial

Cocaine-Metyrapone Interaction Study - 1

Unknown status·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT00033098·12 enrolled

Head Injury1 trial

Study of the Approximate Entropy of Adrenocorticotropic Hormone and Cortisol Secretion in Patients With Head Injury

Unknown status·NNational Center for Research Resources (NCRR)··NCT00006270·32 enrolled

ART1 trial

To Investigate Effects GSK561679 on Part of the Body's System That Controls the Balance of Many of the Hormones.

Completed· GSK logo

GSK·Phase 1·NCT00426608·20 enrolled

Cocaine Dependence1 trial

A Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Two Dose Combinations of Metyrapone and Oxazepam in the Treatment of Cocaine Addiction

Completed·EEmbera NeuroTherapeutics, Inc.·Preclinical·NCT00567814·45 enrolled

Regulatory

FDA Approval Timeline[4]

Aug 9, 1996

METOPIRONE

NDA NDA012911

Sources

References

[1]
ClinicalTrials.gov — 16 trial records for Metyrapone. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Metyrapone compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Metyrapone. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA012911). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Terezinha de Jesus Esteves Barata company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: TTerezinha de Jesus Esteves Barata

Metopirone

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Q1 2028

Q4 2031

Trials by Indication[1]

Mild Autonomous Cortisol Secretion (MACS)2 trials

Cortisol2 trials

Antidepressants1 trial

Endogenous Cushing's Syndrome1 trial

Biomarkers1 trial

Major Depression1 trial

Glucocorticoid1 trial

Glucocorticoids1 trial

Autonomous Cortisol Secretion1 trial

Dexamethasone1 trial

Interaction1 trial

Head Injury1 trial

ART1 trial

Cocaine Dependence1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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