Serax

(Oxazepam)

ApprovedSmall molecule

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

Serax is one of 11 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

11 competitors in Alcohol Withdrawal

#DrugCompanyPhaseTrials

Lioresal

Novartis

Approved

5 2

Xyrem

Jazz Pharmaceuticals

Approved

1 3

Ativan

BBausch Health Americas, Inc.

Approved

7 4

Precedex

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

Approved

4 5

Minipress

Pfizer

Approved

—6

Ketalar

AAultman Health Foundation

Approved

2 7

Epsom Salt

FFresenius Kabi USA, LLC

Pitocin

Serax

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

Approved

1 10

Luminal

Sun Pharmaceutical Industries, Inc.

Preclinical

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

Clinical

Trials by Indication[1]

Alcohol Withdrawal1 trial

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

Completed·—·Phase 4·NCT02090504·127 enrolled

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

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

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 — 5 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

Trials by Indication[1]

Alcohol Withdrawal1 trial

Adult1 trial

Tics1 trial

Cocaine Dependence1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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