Serax

(Oxazepam)

ApprovedSmall molecule

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Serax is one of 12 small molecule programs targeting Alcohol Withdrawal. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Alcohol WithdrawalActive, not recruiting

Alcohol WithdrawalApproved

Active, not recruiting

Competition

Competitive Landscape

12 competitors in Alcohol Withdrawal

#DrugCompanyPhaseTrials

Lioresal

Novartis

Approved

5 2

Minipress

Pfizer

Approved

1 3

Xyrem

Jazz Pharmaceuticals

Approved

1 4

Depakote

Teva

Approved

1 5

Ativan

BBausch Health Americas, Inc.

Approved

7 6

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Approved

4 7

Ketalar

AAultman Health Foundation

Approved

2 8

Epsom Salt

FFresenius Kabi USA, LLC

Pitocin

Serax

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Approved

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

Timeline

Expected Milestones

Q1 2029

Phase 1Recruiting

Alcohol Use Disorder

NCT06795581

Clinical

Trials by Indication[1]

Adult1 trial

Study to Evaluate the Presence of a Hangover Effect in Healthy Adults After Administration of Songha® Night Tablets

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02273453·54 enrolled

Tics1 trial

The Pharmacokinetics of Zidovudine and Oxazepam Alone and in Combination in the HIV-Infected Patient

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000661·8 enrolled

Alcohol Withdrawal1 trial

Comparative Study of Gamma-hydroxy Butyrate Versus Oxazepam in the Treatment of Alcohol Withdrawal Syndrome

Completed·—·Phase 4·NCT02090504·127 enrolled

Alcohol Use Disorder1 trial

PET Imaging of Phosphodiesterase-4B (PDE4B) in Alcohol Use Disorder

Recruiting·NNational Institute of Mental Health (NIMH)·Phase 1·NCT06795581·30 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

1 more indication

Unspecified1 trial

Pharmacovigilance in Gerontopsychiatric Patients

Terminated·HHannover Medical School·Phase 3·NCT02374567·407 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

SERAX

NDA NDA015539

Sources

References

[1]
ClinicalTrials.gov — 6 trial records for Oxazepam. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Oxazepam compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Oxazepam. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA015539). U.S. Food & Drug Administration.
[5]
SEC EDGAR — McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Serax

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2029

Trials by Indication[1]

Adult1 trial

Tics1 trial

Alcohol Withdrawal1 trial

Alcohol Use Disorder1 trial

Cocaine Dependence1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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