Xopenex Hfa

(levalbuterol)

ApprovedSmall molecule

HHikma Pharmaceuticals LLC

Xopenex Hfa is one of 14 small molecule programs targeting Status Asthmaticus. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Status AsthmaticusActive, not recruiting

COPDCompleted

Status AsthmaticusApproved

Active, not recruiting

COPDPreclinical

Completed

Competition

Competitive Landscape

17 competitors in COPD

#DrugCompanyPhaseTrials

Spiriva

Boehringer Ingelheim

Approved

13 2

Daliresp

AstraZeneca

Approved

2 3

Striverdi Respimat

Boehringer Ingelheim

Approved

5 4

Zithromax

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

Approved

2 5

Xopenex Hfa

HHikma Pharmaceuticals LLC

Approved

1 6

Tilrekimig

Pfizer

Phase 3

1 7

Medrol

Pfizer

Preclinical

1 8

Dexpramipexole Dihydrochloride

AAreteia Therapeutics

Phase 2

1 9

DUPIXENT

Symbicort

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

Clinical

Trials by Indication[1]

Asthma7 trials

Aerosolized Beta-Agonist Isomers in Asthma

Completed·—·Phase 4·NCT02170532·10 enrolled

Efficacy, Safety, and Tolerability of Dupilumab in Patients With Persistent Moderate to Severe Eosinophilic Asthma

Completed· Sanofi logo

Sanofi·Phase 2·NCT01312961·104 enrolled

Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 3·NCT00073840·386 enrolled

Show 4 more trials

A Pilot Study to Determine the Most Effective Dose of Arformoterol for Treating Acute Asthmatic Patients

Terminated·HHenry Ford Health System·Phase 4·NCT00819637·2 enrolled

A Safety, Efficacy and Tolerability Study in Pediatric Subjects With Asthma

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 3·NCT00809757·197 enrolled

Efficacy and Safety of Levalbuterol Versus Racemic Albuterol in Asthma

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 3·NCT00667407·627 enrolled

A Study of Daily Dosing With Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects With Asthma

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 2·NCT01656811·146 enrolled

Pediatric1 trial

A Safety and Tolerability Study of Arformoterol Tartrate Inhalation Solution in Pediatric Subjects

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 2·NCT00583947·53 enrolled

Heart1 trial

Effect of Nebulized Bronchodilators on Heart Rate

Completed·—·Phase 4·NCT01151579·89 enrolled

COPD1 trial

COPD Assessment and Management Bundle Versus Usual Care

Completed·UUniversity of Illinois at Chicago·N/A·NCT01833026·56 enrolled

Status Asthmaticus1 trial

Continuous Levalbuterol for Treatment of Status Asthmaticus in Children

Completed·—·Phase 4·NCT00124176·81 enrolled

2 more indications

Side Effects1 trial

Levalbuterol Compared to Albuterol Regarding Cardiac Side Effects and Potassium Lowering Effects.

Unknown status·UUniversity of Aleppo·Phase 4·NCT05173584·30 enrolled

Oxygen Consumption1 trial

Change in Oxygen Consumption Following Inhalation Beta Agonists in Healthy Adults

Completed·—·N/A·NCT02802111·24 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 30, 2002

XOPENEX

NDA NDA020837

Mar 11, 2005

XOPENEX HFA

NDA NDA021730

Mar 11, 2005

XOPENEX HFA

NDA NDA021730

Apr 4, 2006

XOPENEX HFA

NDA NDA021730

Sep 15, 2006

XOPENEX HFA

NDA NDA021730

Feb 5, 2008

XOPENEX HFA

NDA NDA021730

Jul 30, 2012

XOPENEX HFA

NDA NDA021730

Dec 7, 2012

XOPENEX HFA

NDA NDA021730

Jan 9, 2013

XOPENEX HFA

NDA NDA021730

Mar 14, 2013

XOPENEX HFA

NDA NDA021730

Sep 10, 2013

XOPENEX HFA

NDA NDA021730

Nov 25, 2013

XOPENEX HFA

NDA NDA021730

Aug 27, 2014

XOPENEX HFA

NDA NDA021730

Mar 12, 2015

XOPENEX HFA

NDA NDA021730

Jan 22, 2016

XOPENEX HFA

NDA NDA021730

Feb 27, 2017

XOPENEX HFA

NDA NDA021730

Sources

References

[1]
ClinicalTrials.gov — 13 trial records for levalbuterol. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — levalbuterol compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for levalbuterol. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA021730). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Hikma Pharmaceuticals LLC company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: HHikma Pharmaceuticals LLC

Xopenex Hfa

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Asthma7 trials

Pediatric1 trial

Heart1 trial

COPD1 trial

Status Asthmaticus1 trial

Side Effects1 trial

Oxygen Consumption1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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