Drugs / oxazepam

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) SERAX 1965-06-04 fda.gov

Trials 7 · a red edge is where a trial was stopped

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 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 NCT00000661 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed 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 21 trial
Phase 2 NCT04501874 Jul 2020 → Jul 2022 substance-related disorder Embera NeuroTherapeutics, Inc. 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 NCT02374567 Jan 2015 → Jun 2017 anxiety disorder, dementia, depressive disorder, schizophrenia +1 Hannover Medical School Terminated No outcome recorded
Also used as a comparator or background therapy in 4 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 NCT02273453 Comparator Feb → Jun 2003 Boehringer Ingelheim Completed No outcome recorded
Phase 41 trial
Phase 4 NCT02090504 Comparator Feb 2002 → Apr 2009 alcohol dependence, alcohol withdrawal Catholic University of the Sacred Heart Completed 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. 12 sources stand behind the page.

FieldValueCited text
Known as Oxazepam “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
10

“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

“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

NCT02273453

NCT00000661

NCT00567814

NCT02090504

NCT02374567

NCT02406066

Known as J3.308A ChEMBL registry synonym — accepted as the source's own label CHEMBL568
Known as Lederpam ChEMBL registry synonym — accepted as the source's own label CHEMBL568
Known as NSC-169448 ChEMBL registry synonym — accepted as the source's own label CHEMBL568
Known as Oxazepam civ ChEMBL registry synonym — accepted as the source's own label CHEMBL568
Known as Oxozepam ChEMBL registry synonym — accepted as the source's own label CHEMBL568
Known as Serax “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 Serenid fte ChEMBL registry synonym — accepted as the source's own label CHEMBL568
Known as Temazepam impurity, oxazepam- ChEMBL registry synonym — accepted as the source's own label CHEMBL568
Known as WY-3498 ChEMBL registry synonym — accepted as the source's own label CHEMBL568
Known as Zaxopam ChEMBL registry synonym — accepted as the source's own label CHEMBL568
Action Activate “the benzodiazepine receptor agonist, oxazepam” NCT02856854
Modality Small molecule “Benzodiazepines (such as oxazepam)” NCT00000661
Route Oral “single oral dose oxazepam” NCT00000661