Drugs / Levalbuterol
Levalbuterol
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | XOPENEX HFA | — | 2015-03-12 | fda.gov ↗ |
| Label expansions (2) | US (FDA) | XOPENEX | — | 2002-01-30 – 2015-01-22 | fda.gov ↗ |
| Approved | US (FDA) | XOPENEX | — | 1999-03-25 | fda.gov ↗ |
Trials 26
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 27 trials | ||||||
| Phase 2 | NCT00583947 | Jan → Dec 2008 | asthma | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00625521 | Nov 2006 → Jul 2007 | discoid lupus erythematosus | Astion Pharma A/S | Completed | No outcome recorded |
| Phase 2 | NCT00685022 | Jun → Aug 2003 | asthma | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00685347 | Jan → Jun 2003 | exercise-induced bronchoconstriction | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00684866 | Jan → Jul 2003 | asthma | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01656811 | Oct 2001 → Jul 2002 | asthma | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00625157 | — | discoid lupus erythematosus | Astion Pharma A/S | Completed | No outcome recorded |
| Phase 311 trials · 1 missed | ||||||
| Phase 3 | NCT05890638 | Aug 2023 → Feb 2024 | chronic obstructive pulmonary disease | Neutec Ar-Ge San ve Tic A.Ş | Unknown | No outcome recorded |
| Phase 3 | NCT04446637 | Sep 2021 → Sep 2022 | chronic obstructive pulmonary disease | Neutec Ar-Ge San ve Tic A.Ş | Withdrawn | No outcome recorded |
| Phase 3 | NCT00809757 | Dec 2008 → Jun 2013 | asthma | Sumitomo Pharma America, Inc. | Completed | Missed primary |
| Phase 3 | NCT00268723 | Dec 2005 → Feb 2006 | exercise-induced bronchoconstriction | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00064389 | Jan 2003 → Jul 2005 | asthma | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00073814 | Dec 2002 → Jun 2003 | asthma | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00685425 | Oct 2002 → Mar 2003 | exercise-induced bronchoconstriction | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00073827 | May 2002 → Jan 2003 | asthma | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00665600 | Feb 2002 → Mar 2003 | chronic obstructive pulmonary disease | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00685126 | Feb 2001 → Jul 2002 | reactive airway disease | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00667407 | Nov 2000 → Aug 2002 | acute asthma | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 47 trials | ||||||
| Phase 4 | NCT05173584 | Nov → Dec 2021 | — | University of Aleppo | Unknown | No outcome recorded |
| Phase 4 | NCT00830882 | Jan 2009 → Jan 2010 | asthma | University of Dundee | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT00831376 | Jan 2009 → Apr 2012 | asthma | University of Dundee | Completed | No outcome recorded |
| Phase 4 | NCT00585039 | Sep 2005 → Mar 2009 | asthma | Phoenix Children's Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00325767 | May 2004 → Sep 2005 | mucus inspissation of respiratory tract | Johns Hopkins University | Completed | No outcome recorded |
| Phase 4 | NCT00124176 | Apr 2004 → Feb 2006 | status asthmaticus | Children's Hospital of Philadelphia | Completed | No outcome recorded |
| Phase 4 | NCT00667797 | Mar 2003 → May 2005 | asthma, chronic obstructive pulmonary disease | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02802111 | Jun 2015 → Sep 2017 | — | Children's Hospital Los Angeles | Completed | No outcome recorded |
| Comparator or background therapy14 trials | ||||||
| Phase 1 | NCT05366764 Background | Jun 2022 → Feb 2023 | asthma | Sanofi | Completed | No outcome recorded |
| Phase 2 | NCT01854047 Background | Jun 2013 → Nov 2014 | asthma | Sanofi | Completed | Met primary |
| Phase 2 | NCT01312961 Background | Mar 2011 → Oct 2012 | asthma | Sanofi | Completed | Met primary |
| Phase 2 | NCT00684827 Comparator | Oct 2002 → Feb 2003 | asthma | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT06040424 Comparator | Sep 2023 → Jun 2024 | chronic obstructive pulmonary disease | Neutec Ar-Ge San ve Tic A.Ş | Unknown | No outcome recorded |
| Phase 3 | NCT02528214 Background | Oct 2015 → Sep 2017 | asthma | Sanofi | Completed | Met primary |
| Phase 3 | NCT02414854 Background | Apr 2015 → Jul 2017 | asthma | Sanofi | Completed | Met primary |
| Phase 3 | NCT00583986 Background | Sep 2005 → Jan 2006 | asthma, chronic obstructive pulmonary disease | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00073840 Comparator | Dec 2002 → Jun 2003 | asthma | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00819637 Comparator | Jan → Nov 2009 | acute asthma | Henry Ford Health System | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01151579 Comparator | Dec 2008 → Nov 2009 | chronic obstructive pulmonary disease, infectious disease with sepsis | Fahim Khorfan, MD | Completed | No outcome recorded |
| Phase 4 | NCT02170532 Comparator | Jul 2007 → Jul 2009 | asthma | Duke University | Completed | No outcome recorded |
| — | NCT01833026 Background | Mar 2013 → May 2016 | chronic obstructive pulmonary disease | University of Illinois at Chicago | Completed | No outcome recorded |
| — | NCT00583778 Background | Aug 2004 → Nov 2008 | asthma | MetroHealth Medical Center | Completed | Met primary |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-10-20 | Sumitomo Pharma America, Inc. | Sumitomo Pharma Announces Intent to Divest Brovana and Xopenex HFA to Lupin sumitomo-pharma.com ↗ |
| 2012-08-20 | Prasco LLC | Prasco and Sunovion Pharmaceuticals Inc. enter into Authorized Generic Agreement for XOPENEX® (levalbuterol HCl) Inhalation Solution prasco.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 41 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | levalbuterol | “three doses of nebulized 1.25 mg of levalbuterol alone every 20 minutes” NCT00583778 ↗ |
| Known as | ASF 1096 | “Efficacy and Safety of ASF-1096 Cream 0.5% in the Treatment of Discoid Lupus Erythematosus (DLE) Lesions (2)” NCT00625157 ↗3“Efficacy and Safety of ASF-1096 Cream 0.5% in the Treatment of Discoid Lupus Erythematosus (DLE) Lesions” NCT00625521 ↗ “ASF 1096 0.5 % cream applied twice daily” NCT00625521 ↗ |
| Known as | Levalbuterol HCl | “Levalbuterol HCl Inhalation Solution” NCT00685126 ↗ |
| Known as | Levalbuterol HFA MDI | “Drug: Levalbuterol HFA MDI” NCT00685425 ↗ |
| Known as | levalbuterol tartrate HFA MDI | “Drug: levalbuterol tartrate HFA MDI” NCT00064389 ↗ |
| Known as | Levosalbutamol | “Drug: Levalbuterol/Levosalbutamol” NCT02414854 ↗8“Levalbuterol/Levosalbutamol” NCT02528214 ↗ |
| Known as | R albuterol | “Levalbuterol (R albuterol)” NCT00124176 ↗ |
| Known as | Xopenex | “The spirometry test will be performed with a breathing medication called Levalbuterol (Xopenex®).” NCT01833026 ↗ |
| Known as | Xopenex HFA (levalbuterol tartrate)Inhalation Aerosol | “Xopenex HFA (levalbuterol tartrate)Inhalation Aerosol” NCT00073840 ↗ |
| Modality | Other / unclassified | “Beta-agonists like Levalbuterol and Albuterol are used in the treatment of Hyperkalemia.” PMID 41437987 ↗ Dec 2025 |
| Route | Inhaled | “levalbuterol MDI 90 mcg QID” NCT00064389 ↗ |