Drugs / Metyrapone

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) METOPIRONE 1961-12-04 fda.gov

Trials 16 · a red edge is where a trial was stopped

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 02 trials
Phase 0 NCT05919992 May 2023 → Jul 2024 glucocorticoid therapy, response to Eleonora Seelig Completed No outcome recorded
Phase 0 NCT05167084 Feb 2022 → Jun 2023 glucocorticoid therapy, response to Eleonora Seelig Completed No outcome recorded
Phase 14 trials
Phase 1 NCT03404817 Mar → Jun 2018 substance-related disorder Embera NeuroTherapeutics, Inc. Completed No outcome recorded
Phase 1 NCT02856854 Jul 2016 → Feb 2017 substance-related disorder Embera NeuroTherapeutics, Inc. Completed No outcome recorded
Phase 1 NCT01673087 Oct 2012 → Aug 2017 University of Michigan Completed No outcome recorded
Phase 1 NCT00033098 Nov 2001 → May 2002 cocaine dependence National Institute on Drug Abuse (NIDA) Unknown No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT04933916 Jun 2021 → Apr 2023 nicotine dependence Embera NeuroTherapeutics, Inc. Terminated No outcome recorded
Phase 24 trials
Phase 2 NCT07138274 Aug 2026 → Jun 2031 expected ACTH-independent Cushing syndrome Mayo Clinic Not yet recruiting No outcome recorded
Phase 2 NCT06106295 Dec 2023 → Jan 2028 expected ACTH-independent Cushing syndrome Mayo Clinic Active not recruiting No outcome recorded
Phase 2 NCT04501874 Jul 2020 → Jul 2022 substance-related disorder Embera NeuroTherapeutics, Inc. Completed No outcome recorded
Phase 2 NCT00125554 May 1998 → Jul 2001 major depressive disorder University Medical Center Hamburg-Eppendorf Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT04868253 May → Dec 2021 nicotine dependence Rose Research Center, LLC Unknown No outcome recorded
Phase 31 trial
Phase 3 NCT02297945 Apr 2015 → Nov 2019 Cushing syndrome HRA Pharma Completed No outcome recorded
Phase 42 trials
Phase 4 NCT07268222 Dec 2025 → Nov 2026 expected ACTH-independent Cushing syndrome Laiko General Hospital, Athens Recruiting No outcome recorded
Phase 4 NCT03491696 Dec 2018 → Jun 2022 depressive disorder Centre Hospitalier Rouffach Unknown No outcome recorded
Phase not applicable1 trial
NCT06556277 Sep 2024 → Feb 2026 overnutrition Eleonora Seelig Completed No outcome recorded
Also used as a comparator or background therapy in 6 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT02406066 Comparator Mar → Dec 2015 substance-related disorder Embera NeuroTherapeutics, Inc. Completed No outcome recorded
Phase 1 NCT00426608 Background Oct 2006 → Jan 2007 GlaxoSmithKline Completed No outcome recorded
Phase 31 trial
Phase 3 NCT01375920 Comparator Feb 2011 → Feb 2013 depressive disorder Jane Barnes Completed No outcome recorded
Phase 42 trials
Phase 4 NCT07494084 Comparator Jul 2026 → Mar 2029 expected circadian rhythm sleep disorder, shift work type Washington State University Not yet recruiting No outcome recorded
Phase 4 NCT01620684 Comparator Feb 2013 → Dec 2014 metabolic syndrome X, obesity disorder Baker Heart Research Institute Unknown No outcome recorded
Phase not applicable1 trial
NCT00567814 Comparator Dec 2007 → Nov 2008 cocaine dependence Embera NeuroTherapeutics, Inc. Completed No outcome recorded

Evidence & citations 14 cited values

Every value below carries the sentence it was read from. 23 sources stand behind the page.

FieldValueCited text
Known as Metyrapone “EMB-001 is a combination of 2 drugs: the cortisol synthesis inhibitor, metyrapone (Metopirone®), and the benzodiazepine receptor agonist, oxazepam (original trade name Serax®;...” NCT04933916
21

“EMB-001 is a combination of 2 drugs: the cortisol synthesis inhibitor, metyrapone (Metopirone®), and the benzodiazepine receptor agonist, oxazepam (original trade name Serax®;...” NCT04501874

“EMB-001 is a proprietary combination of metyrapone (a cortisol synthesis inhibitor) and oxazepam (a short to medium acting benzodiazepine).” NCT04868253

“EMB-001 is a combination of metyrapone (720mg per dose in this study) and oxazepam (24mg per dose in this study)” NCT02856854

“This is a study of EMB-001 (a combination of two FDA-approved drugs, metyrapone and oxazepam) in healthy adults.” NCT03404817

NCT07268222

NCT06556277

NCT02297945

NCT00033098

NCT05167084

NCT02406066

NCT06106295

NCT03491696

NCT01375920

NCT00426608

NCT01673087

NCT00567814

NCT01620684

NCT07138274

NCT07494084

NCT00125554

NCT05919992

Known as Metirapona ChEMBL registry synonym — accepted as the source's own label CHEMBL934
Known as Metopiron ChEMBL registry synonym — accepted as the source's own label CHEMBL934
Known as Metopirone “EMB-001 is a combination of 2 drugs: the cortisol synthesis inhibitor, metyrapone (Metopirone®), and the benzodiazepine receptor agonist, oxazepam (original trade name Serax®;...” NCT04933916
1

“EMB-001 is a combination of 2 drugs: the cortisol synthesis inhibitor, metyrapone (Metopirone®), and the benzodiazepine receptor agonist, oxazepam (original trade name Serax®;...” NCT04501874

Known as Metopirone ditartrate ChEMBL registry synonym — accepted as the source's own label CHEMBL934
Known as Metyrapone also known as Metopirone Metyrapone also known as MetopironeNCT01375920
Known as METYRAPONE TARTRATE ChEMBL registry synonym — accepted as the source's own label CHEMBL934
Known as MRP “To evaluate the safety of metyrapone (MRP) for using in an outpatient study in which participants would be given 2 750 mg doses of MRP per week.” NCT00033098
Known as NSC-25265 ChEMBL registry synonym — accepted as the source's own label CHEMBL934
Known as SU-4885 ChEMBL registry synonym — accepted as the source's own label CHEMBL934
Action Inhibit “this compound inhibits selectively the 11β-hydroxylase and the 11β-hydroxysteroid dehydrogenase type 1 (11β-HSD-1)” NCT00125554
1

“Cytochrome P450 11B1, mitochondrial inhibitor” CHEMBL934

Modality Small molecule CHEMBL934
Route Oral “to be taken orally” NCT01375920
Target CYP11B1 “Cytochrome P450 11B1, mitochondrial inhibitor” CHEMBL934