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levalbuterol

Trade name: xopenex

Small moleculeapproved

Approved

Mar 25, 1999

Levalbuterol is the (R)-enantiomer of the drug substance racemic albuterol (salbutamol). Binding studies have demonstrated that (R)-albuterol binds to the beta2-adrenergic receptor with a high affinity, whereas (S)-albuterol binds with 100-fold less affinity than (R)-albuterol. Other evaluations have suggested that (R)-albuterol possesses the bronchodilatory, bronchoprotective, and ciliary-stimulatory properties of racemic albuterol, while (S)-albuterol does not contribute beneficially to the therapeutic effects of the racemate and was originally assumed to be inert. Xopenex (levalbuterol HCl) Inhalation Solution is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. — NCATS

Clinical trial activity

35 trials · 20 clinical orgs · 15 marketing orgs

Phase 1
1
Phase 2
22
Phase 3
13
Phase 4
10

Earliest trial started Nov 1, 2000 (NCT00667407)

Timeline

1990s

  1. Mar 25, 1999

    Sunovion — Earliest FDA Approval

  2. Mar 25, 1999

    Akorn, Inc. — NDA Secondary Org

  3. Mar 25, 1999

    Akorn, Inc. — Marketing Organization

  4. Mar 25, 1999

    Sunovion — NDA Organization

  5. Mar 25, 1999

    Hikma — Marketing Organization

2000s

  1. Jan 1, 2000

    Sunovion — Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2001

    Sunovion — Earliest Phase 2 Sponsor(trial)

  3. Mar 11, 2005

    Sunovion — NDA Secondary Org

  4. Mar 11, 2005

    Lupin — Marketing Organization

  5. Mar 11, 2005

    Lupin — NDA Secondary Org

  6. Apr 9, 2008

    Impax Laboratories — Marketing Organization

  7. Mar 20, 2009

    Mylan — Marketing Organization

2010s

  1. Mar 15, 2013

    PHARMOBEDIENT — Marketing Organization

  2. Dec 13, 2013

    Cipla — Marketing Organization

  3. Sep 11, 2014

    Teva — Marketing Organization

  4. Mar 22, 2016

    Ritedose — Marketing Organization

  5. Dec 30, 2016

    Aurobindo Pharma — Marketing Organization

  6. Dec 30, 2016

    Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. — Marketing Organization

  7. Nov 5, 2018

    Sun Pharmaceuticals — Marketing Organization

2020s

  1. Jan 1, 2022

    Earliest Phase 1 Sponsor(trial)

  2. Oct 21, 2024

    Mankind Pharma — Marketing Organization

  3. May 26, 2026

    Nephron Pharmaceuticals Corporation — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedMar 25, 1999

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)(C)NC[C@H](O)c1ccc(O)c(CO)c1.CC(C)(C)NC[C@H](O)c1ccc(O)c(CO)c1.O=C(O)C(O)C(O)C(=O)O
Mol. weight
628.72 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

Yes

Sources

Also known as

  • (-)-albuterol
  • (-)-albuterol
  • levalbuterol
  • levalbuterol
  • levalbuterol
  • levalbuterol
  • levalbuterol
  • levalbuterol
  • levalbuterol hcl
  • levalbuterol hcl
  • levalbuterol hcl
  • levalbuterol hydrochloride
  • levalbuterol hydrochloride
  • levalbuterol hydrochloride
  • levalbuterol hydrochloride
  • levalbuterol tartrate
  • levalbuterol tartrate
  • levalbuterol tartrate
  • levalbuterol tartrate
  • levalbuterol tartrate
  • levosalbutamol
  • levosalbutamol
  • levosalbutamol
  • levosalbutamol
  • levosalbutamol
  • levosalbutamol
  • (r)-salbutamol
  • (r)-salbutamol
  • (r)-salbutamol
  • r-salbutamol
  • r-salbutamol
  • (-)-salbutamol
  • (-)-salbutamol
  • (-)-salbutamol
  • xopenex
  • xopenex
  • xopenex
  • xopenex
  • xopenex
  • xopenex

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05366764Phase 1Jun 8, 2022Sanofi
NCT05173584Phase 4Nov 4, 2021University of Aleppo
NCT04446637Phase 3Sep 30, 2020Cukurova University, Health Sciences University Sureyyapasa Chest Diseases and Chest Surgery Hospital, NeuTec Pharma
NCT02802111N/AJun 1, 2015University of Southern California
NCT02150499Phase 3Jul 1, 2014Sunovion
NCT01854047Phase 2Jun 1, 2013Regeneron, Sanofi
NCT01833026N/AMar 1, 2013National Heart, Lung, and Blood Institute (NHLBI), University of Illinois at Chicago
NCT01312961Phase 2Mar 1, 2011Regeneron, Sanofi
NCT00831376Phase 4Jan 1, 2009University of Dundee
NCT00819637Phase 4Jan 1, 2009Henry Ford Health System, Sunovion
NCT00830882Phase 4Jan 1, 2009University of Dundee
NCT01151579Phase 4Dec 1, 2008Ascension Health, Genesys Regional Medical Center
NCT00818454Phase 2Dec 1, 2008Boehringer Ingelheim
NCT00809757Phase 3Dec 1, 2008Sunovion
NCT00583947Phase 2Jan 1, 2008Sunovion, Unicon Pharma
NCT02170532Phase 4Jul 1, 2007Duke University
NCT00268723Phase 3Dec 1, 2005Sunovion
NCT00583986Phase 3Sep 1, 2005Sunovion
NCT00585039Phase 4Sep 1, 2005University of Arizona
NCT00325767Phase 4May 1, 2004Johns Hopkins University, Sunovion
Showing 20 of 35 trials
Page 1 / 2

Organizations

Research & Development (20)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
SunovionFor profit221932000
SanofiFor profit3322011
RegeneronFor profit2012011
University of DundeeAcademic/Hospital2212009
Ascension HealthAcademic/Hospital1112008
Boehringer IngelheimFor profit1112008
Cukurova UniversityAcademic/Hospital1012020
Duke UniversityAcademic/Hospital1112007
Genesys Regional Medical CenterAcademic/Hospital1012008
Health Sciences University Sureyyapasa Chest Diseases and Chest Surgery HospitalAcademic/Hospital1012020
Henry Ford Health SystemAcademic/Hospital1112009
Johns Hopkins UniversityAcademic/Hospital1112004
National Heart, Lung, and Blood Institute (NHLBI)Government1012013
NeuTec PharmaFor profit1112020
Unicon PharmaFor profit1012008
University of AleppoAcademic/Hospital1112021
University of ArizonaAcademic/Hospital1112005
University of Illinois at ChicagoAcademic/Hospital1112013
University of PennsylvaniaAcademic/Hospital1112004
University of Southern CaliforniaAcademic/Hospital1112015
20 organizations
Page 1 / 1

Marketing (20)

OrganizationOrg typeRelationshipDate
Akorn, Inc.For profitNDA2Mar 25, 1999
Akorn, Inc.For profitMKTGMar 25, 1999
Aurobindo PharmaFor profitMKTGDec 30, 2016
CiplaFor profitMKTGDec 13, 2013
HikmaFor profitMKTGMar 25, 1999
Impax LaboratoriesFor profitMKTGApr 9, 2008
LupinFor profitMKTGMar 11, 2005
LupinFor profitNDA2Mar 11, 2005
Mankind PharmaFor profitMKTGOct 21, 2024
MylanFor profitMKTGMar 20, 2009
Nephron Pharmaceuticals CorporationFor profitMKTGMay 26, 2026
PHARMOBEDIENTFor profitMKTGMar 15, 2013
RitedoseFor profitMKTGMar 22, 2016
Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.For profitMKTGDec 30, 2016
Sun PharmaceuticalsFor profitSYNNov 5, 2018
Sun PharmaceuticalsFor profitMKTGNov 5, 2018
SunovionFor profitNDA2Mar 11, 2005
SunovionFor profitNDAMar 25, 1999
TevaFor profitMKTGSep 11, 2014
TevaFor profitSYNApr 26, 2013