beclomethasone dipropionate
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed seasonal allergic rhinitis 1 milestone | |||||
| Filed | US (FDA) | — | seasonal allergic rhinitis | 2011-05-24 | “FDA has accepted for filing Teva’s New Drug Application (NDA) for beclomethasone dipropionate hydrofluoroalkane (BDP Nasal HFA)” tevapharm.com ↗ |
| Approved Indication not stated 6 milestones | |||||
| Filed | EU (EMA) | — | — | 2026-09-03 | “Single Inhaler Triple Therapy (SITT or ICS/LABA/LAMA, beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium bromide) pMDIs have been submitted under the EU...” chiesi.com ↗ |
| Approved | EU (EMA) | Trimbow | — | 2017-07-17 | europa.eu ↗ |
| Label expansion | US (FDA) | QNASL | — | 2014-12-17 | fda.gov ↗ |
| Label expansion | US (FDA) | QVAR 80 | — | 2002-05-10 | fda.gov ↗ |
| Label expansion | US (FDA) | BECONASE | — | 1985-11-01 | fda.gov ↗ |
| Approved | US (FDA) | VANCERIL | — | 1976-05-12 | fda.gov ↗ |
Trials 92 · started per year
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06139029 | Nov 2022 → Mar 2023 | acute bronchiolitis | Mardan Medical Complex | Completed | No outcome recorded |
| Phase 18 trials | ||||||
| Phase 1 | NCT05830071 | Mar → Oct 2023 | asthma, chronic obstructive pulmonary disease | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 1 | NCT04873063 | Oct 2021 → Apr 2022 | — | SOFAR S.p.A. | Completed | No outcome recorded |
| Phase 1 | NCT03859414 | Mar → Jul 2019 | asthma, chronic obstructive pulmonary disease | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 1 | NCT03795350 | Jan 2019 → Apr 2020 | asthma, chronic obstructive pulmonary disease | Chiesi Farmaceutici S.p.A. | Terminated | No outcome recorded |
| Phase 1 | NCT02975843 | Nov 2016 → Mar 2017 | asthma, chronic obstructive pulmonary disease | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 1 | NCT02030457 | Dec 2013 → Apr 2014 | — | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00936793 | Jul 2009 → Jun 2011 | HIV infectious disease, asthma | National Institutes of Health Clinical Center (CC) | Completed | No outcome recorded |
| Phase 1 | NCT01537692 | Mar → Apr 2009 | allergic rhinitis | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT04817800 | Mar → Apr 2021 | seasonal allergic rhinitis | Humanis | Completed | No outcome recorded |
| Phase 1/2 | NCT01073384 | Dec 2009 → Jan 2012 | enteritis | Soligenix | Completed | No outcome recorded |
| Phase 1/2 | NCT00010283 | Jul 2000 → Jul 2002 | breast cancer, gestational trophoblastic neoplasm, graft versus host disease, kidney cancer +7 | Fred Hutchinson Cancer Center | Completed | No outcome recorded |
| Phase 219 trials · 3 met primary · 1 missed | ||||||
| Phase 2 | NCT07301736 | Dec 2025 → Jun 2027 expected | asthma | Chiesi Farmaceutici S.p.A. | Recruiting | No outcome recorded |
| Phase 2 | NCT03590379 | Jun → Oct 2018 | chronic obstructive pulmonary disease | Chiesi Farmaceutici S.p.A. | Completed | Met primary |
| Phase 2 | NCT03084718 | Jul 2017 → Nov 2018 | asthma | Chiesi Farmaceutici S.p.A. | Completed | Met primary |
| Phase 2 | NCT03108534 | Feb → Sep 2017 | asthma | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 2 | NCT02787967 | Aug 2016 → Jun 2017 | asthma | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 2 | NCT02148120 | Apr → Oct 2014 | asthma | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 2 | NCT02048644 | Mar 2014 → Apr 2015 | idiopathic pulmonary fibrosis | Hull University Teaching Hospitals NHS Trust | Completed | No outcome recorded |
| Phase 2 | NCT01925950 | Dec 2013 → May 2015 | chronic graft versus host disease | Soligenix | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01738087 | Nov 2012 → Jan 2013 | asthma | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 2 | NCT01544634 | Apr 2012 → May 2013 | asthma | University of Dundee | Completed | Missed primary |
| Phase 2 | NCT01650441 | Apr 2012 → Jun 2013 | asthma | University Hospital, Antwerp | Completed | No outcome recorded |
| Phase 2 | NCT01468272 | Nov 2011 → Aug 2012 | childhood onset asthma | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 2 | NCT01349257 | May → Jun 2011 | asthma | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 2 | NCT01191424 | Oct 2010 → Sep 2011 | asthma | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 2 | NCT00854360 | Mar → May 2009 | seasonal allergic rhinitis | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | Met primary |
| Phase 2 | NCT01343745 | Feb → Aug 2008 | asthma | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 2 | NCT00489203 | Apr 2007 → Nov 2010 | Burkitt lymphoma, Hodgkins lymphoma, MALT lymphoma, acute myeloid leukemia with 11q23 abnormalities +27 | Fred Hutchinson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00115089 | Jul → Sep 2005 | seasonal allergic rhinitis | Rigel Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00000752 | ? → Feb 1993 | HIV infectious disease, sinusitis | National Institute of Allergy and Infectious Diseases (NIAID) | Withdrawn | No outcome recorded |
| Phase 342 trials · 18 met primary · 3 missed | ||||||
| Phase 3 | NCT07858123 | Nov 2026 → Jun 2030 expected | asthma | Chiesi Farmaceutici S.p.A. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04876677 | May 2021 → Jan 2022 | chronic obstructive pulmonary disease | Chiesi Farmaceutici S.p.A. | Completed | Missed primary |
| Phase 3 | NCT03562949 | Dec 2018 → Aug 2019 | asthma | Amneal Ireland Limited | Terminated | No outcome recorded |
| Phase 3 | NCT03888131 | Jul 2018 → May 2022 | chronic obstructive pulmonary disease | Chiesi Farmaceutici S.p.A. | Completed | Met primary |
| Phase 3 | NCT03268226 | Nov 2017 → Jan 2019 | chronic obstructive pulmonary disease | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 3 | NCT03453112 | Oct 2017 → Dec 2021 | asthma | Chiesi Farmaceutici S.p.A. | Completed | Met primary |
| Phase 3 | NCT03197818 | Dec 2016 → May 2020 | chronic obstructive pulmonary disease | Chiesi Farmaceutici S.p.A. | Completed | Met primary |
| Phase 3 | NCT02513160 | Sep 2015 → Mar 2016 | chronic asthma | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | Met primary |
| Phase 3 | NCT02467452 | May 2015 → Jan 2017 | chronic obstructive pulmonary disease | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 3 | NCT01658891 | Feb 2014 → Nov 2015 | childhood onset asthma | Chiesi Farmaceutici S.p.A. | Withdrawn | No outcome recorded |
| Phase 3 | NCT01911364 | Jan 2014 → Mar 2016 | chronic obstructive pulmonary disease | Chiesi Farmaceutici S.p.A. | Completed | Met primary |
| Phase 3 | NCT02040779 | Dec 2013 → Dec 2014 | chronic asthma | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | Met primary |
| Phase 3 | NCT02031640 | Dec 2013 → Nov 2014 | asthma | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | Missed primary |
| Phase 3 | NCT01783548 | Jan → Oct 2013 | allergic rhinitis | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | Met primary |
| Phase 3 | NCT01691677 | Jan 2013 → Jan 2014 | sinusitis | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 3 | NCT01697956 | Oct 2012 → Feb 2013 | allergic rhinitis | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | Met primary |
| Phase 3 | NCT01351792 | Sep 2011 → Nov 2012 | chronic obstructive pulmonary disease | Chiesi Farmaceutici S.p.A. | Terminated | No outcome recorded |
| Phase 3 | NCT01450774 | Sep 2011 → Nov 2013 | childhood onset asthma | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 3 | NCT01307319 | Mar → Jul 2011 | seasonal allergic rhinitis | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | Met primary |
| Phase 3 | NCT01345916 | Mar → Aug 2011 | asthma | Chiesi Farmaceutici S.p.A. | Completed | Met primary |
| Phase 3 | NCT01204034 | Sep 2010 → Mar 2012 | chronic obstructive pulmonary disease | University Hospital, Antwerp | Completed | No outcome recorded |
| Phase 3 | NCT01133626 | Jun → Sep 2010 | perennial allergic rhinitis | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | Met primary |
| Phase 3 | NCT01134705 | May → Oct 2010 | perennial allergic rhinitis | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | Met primary |
| Phase 3 | NCT00938353 | Apr → Sep 2010 | croup | Chiesi Farmaceutici S.p.A. | Terminated | No outcome recorded |
| Phase 3 | NCT01113489 | Apr → Jul 2010 | allergic rhinitis, asthma | Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy | Completed | No outcome recorded |
| Phase 3 | NCT01024608 | Dec 2009 → Feb 2010 | seasonal allergic rhinitis | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | Met primary |
| Phase 3 | NCT00988247 | Oct 2009 → Feb 2011 | perennial allergic rhinitis | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | Met primary |
| Phase 3 | NCT00926575 | Oct 2009 → Dec 2011 | acute graft versus host disease | Soligenix | Terminated | No outcome recorded |
| Phase 3 | NCT00929851 | Oct 2009 → Mar 2012 | chronic obstructive pulmonary disease | Chiesi Farmaceutici S.p.A. | Completed | Met primary |
| Phase 3 | NCT00862394 | Feb → Oct 2009 | asthma | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 3 | NCT00565266 | May 2008 → May 2010 | asthma | Milton S. Hershey Medical Center | Completed | Met primary |
| Phase 3 | NCT00528723 | Nov 2007 → Jan 2009 | asthma | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 3 | NCT00394329 | Nov 2006 → Dec 2011 | asthma | Milton S. Hershey Medical Center | Completed | Missed primary |
| Phase 3 | NCT00346775 | May → Jun 2006 | perennial allergic rhinitis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00497523 | Mar 2006 → Jan 2007 | asthma | Chiesi Farmaceutici S.p.A. | Completed | Met primary |
| Phase 3 | NCT00394368 | Nov 2004 → Sep 2005 | asthma | Chiesi Farmaceutici S.p.A. | Completed | Met primary |
| Phase 3 | NCT00094016 | Oct 2004 → Jun 2006 | asthma | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00413387 | Sep 2004 → Aug 2005 | asthma | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 3 | NCT00862264 | Aug 2004 → Sep 2005 | asthma | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 3 | NCT00109668 | Jul 2004 → Sep 2006 | asthma | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00043147 | Apr 2002 → Jan 2005 | graft versus host disease | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 3 | NCT00233896 | Jul 2001 → Dec 2004 | graft versus host disease | Enteron Pharmaceuticals | Completed | No outcome recorded |
| Phase 412 trials · 1 met primary | ||||||
| Phase 4 | NCT06970080 | Jun 2025 → Jun 2028 expected | asthma | McMaster University | Recruiting | No outcome recorded |
| Phase 4 | NCT03141424 | Jun 2022 → Oct 2024 | asthma | Hvidovre University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT07809555 | Aug 2021 → Nov 2024 | lung disorder | Yi-Han Hsiao | Completed | No outcome recorded |
| Phase 4 | NCT02646904 | May 2016 → Jun 2017 | allergic rhinitis | Stefania La Grutta, MD | Completed | No outcome recorded |
| Phase 4 | NCT02381158 | Feb → Dec 2015 | asthma | Istituto per la Ricerca e l'Innovazione Biomedica | Completed | No outcome recorded |
| Phase 4 | NCT02294279 | May 2014 → Aug 2016 | asthma | Research in Real-Life Ltd | Completed | Met primary |
| Phase 4 | NCT01620099 | Nov 2011 → Apr 2014 | asthma | Università degli Studi di Ferrara | Completed | No outcome recorded |
| Phase 4 | NCT00921921 | Jun 2009 → Oct 2011 | chronic obstructive pulmonary disease | University of Dundee | Completed | No outcome recorded |
| Phase 4 | NCT00901368 | May 2009 → Sep 2010 | asthma | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 4 | NCT00910793 | Aug 2008 → Aug 2010 | asthma | Wilfried De Backer | Completed | No outcome recorded |
| Phase 4 | NCT00250341 | Sep 2005 → Sep 2007 | asthma | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00071552 | Jan 2004 → Jul 2006 | asthma | Teva Branded Pharmaceutical Products R&D, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase not applicable7 trials · 1 missed | ||||||
| — | NCT07232264 | Mar → Sep 2025 | asthma | Bugra Kerget | Completed | No outcome recorded |
| — | NCT05888350 | Apr 2023 → Apr 2025 | — | The First Affiliated Hospital of Guangzhou Medical University | Completed | No outcome recorded |
| — | NCT05495698 | Dec 2022 → Dec 2026 expected | chronic obstructive pulmonary disease | Franciscus Gasthuis | Recruiting | No outcome recorded |
| — | NCT01142947 | Oct 2007 → Feb 2017 | asthma | Henry Ford Health System | Completed | No outcome recorded |
| — | NCT03503994 | Jul 2001 → Nov 2006 | bronchopulmonary dysplasia | Mount Sinai Hospital, Canada | Completed | Missed primary |
| — | NCT00055666 | Mar 2001 → Feb 2005 | graft versus host disease | Roswell Park Cancer Institute | Completed | No outcome recorded |
| — | NCT00238082 | Nov 1999 → Feb 2005 | chronic obstructive pulmonary disease | National Jewish Health | Terminated | No outcome recorded |
| Comparator or background therapy31 trials | ||||||
| Phase 1 | NCT05898984 Comparator | Apr → Jul 2023 | asthma | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 1 | NCT02287272 Comparator | May → Jul 2014 | chronic obstructive pulmonary disease | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 1 | NCT01016223 Comparator | Mar 2010 → Jul 2012 | eosinophilic esophagitis | Penn State University | Completed | No outcome recorded |
| Phase 2 | NCT02296411 Background | Nov 2014 → Aug 2015 | asthma | Chiesi Farmaceutici S.p.A. | Completed | Met primary |
| Phase 2 | NCT02000609 Comparator | Dec 2013 → Apr 2014 | chronic obstructive pulmonary disease | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 2 | NCT01615874 Comparator | Jan → Sep 2013 | asthma | Organon and Co | Withdrawn | No outcome recorded |
| Phase 2 | NCT01803087 Comparator | Feb → Oct 2012 | asthma | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 2 | NCT01584492 Comparator | Dec 2011 → Feb 2013 | asthma | Chiesi Farmaceutici S.p.A. | Completed | Met primary |
| Phase 2 | NCT01848769 Comparator | Sep 2009 → Dec 2010 | asthma | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 2 | NCT00868023 Comparator | Feb → Jul 2009 | asthma | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 3 | NCT05292586 Comparator | Aug 2022 → Jun 2024 | asthma | Chiesi Farmaceutici S.p.A. | Completed | Met primary |
| Phase 3 | NCT04320342 Background | Apr 2022 → Jan 2026 | chronic obstructive pulmonary disease | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 3 | NCT04886999 Background | Feb 2022 → Feb 2023 | asthma | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 3 | NCT02676089 Comparator | Apr 2016 → May 2018 | asthma | Chiesi Farmaceutici S.p.A. | Completed | Mixed |
| Phase 3 | NCT02676076 Background | Feb 2016 → May 2018 | asthma | Chiesi Farmaceutici S.p.A. | Completed | Met primary |
| Phase 3 | NCT02139644 Background | Jun 2014 → Sep 2015 | asthma | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | Met primary |
| Phase 3 | NCT02040766 Comparator | Dec 2013 → Feb 2016 | asthma | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01577082 Comparator | Apr → Nov 2012 | asthma | Chiesi Farmaceutici S.p.A. | Completed | Met primary |
| Phase 3 | NCT01475032 Comparator | Sep 2011 → Sep 2012 | asthma | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 3 | NCT00476268 Comparator | Feb 2004 → Jan 2005 | asthma | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 3 | NCT03879772 Comparator | Mar → Jul 1996 | seasonal allergic rhinitis | Organon and Co | Completed | Met primary |
| Phase 3 | NCT03855189 Comparator | Aug → Oct 1993 | seasonal allergic rhinitis | Organon and Co | Completed | Met primary |
| Phase 4 | NCT07666490 Comparator | Jun 2026 → Jun 2028 expected | asthma | Chiesi Farmaceutici S.p.A. | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06869382 Background | Jan → Dec 2023 | asthma | Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation | Completed | No outcome recorded |
| Phase 4 | NCT04737655 Comparator | Feb 2021 → Feb 2023 | chronic obstructive pulmonary disease | PARZIBUT Gilles | Unknown | No outcome recorded |
| Phase 4 | NCT03842904 Comparator | Dec 2018 → Jul 2019 | chronic obstructive pulmonary disease | Medicines Evaluation Unit Ltd | Completed | Met primary |
| Phase 4 | NCT02995733 Comparator | Nov 2017 → Apr 2021 | asthma | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01852513 Comparator | Jan → Nov 2013 | seasonal allergic rhinitis | University of Chicago | Completed | No outcome recorded |
| — | NCT02509299 Background | Sep → Nov 2019 | chronic obstructive pulmonary disease | University of Granada | Completed | No outcome recorded |
| — | NCT03408847 Background | Nov 2017 → Dec 2018 | ulcerative colitis | Casa Sollievo della Sofferenza IRCCS | Unknown | No outcome recorded |
| — | NCT02515318 Comparator | Sep 2015 → Mar 2017 | chronic obstructive pulmonary disease | University of Granada | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 19
| Date | Issuer | Release |
|---|---|---|
| 2026-09-03 | Chiesi Farmaceutici S.p.A. | Regulatory Chiesi advances its Carbon Minimal Inhaler journey as European submissions for its Single Inhaler Triple Therapy (SITT) and ICS/LABA combination next-generation propellant pMDIs are validated chiesi.com ↗
Regulatory submissions for next-generation propellant pMDIs (pressurized metered-dose inhalers) across Chiesi’s Single Inhaler Triple Therapy (SITT; or ICS/LABA/LAMA) and fixed double ICS/LABA combination (inhaled corticosteroid with a long-acting bronchodilator) range have been validated by Regulatory Agencies in Europe. |
| 2026-07-31 | Chiesi Farmaceutici S.p.A. | Regulatory Chiesi receives European Marketing Authorisation for its Single Inhaler Triple Therapy delivered via NEXThaler® for the maintenance treatment of Asthma chiesi.com ↗
The EC approval follows the positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency in May 2026. |
| 2025-11-26 | Chiesi Farmaceutici S.p.A. | Results Chiesi Advanced Carbon Minimal Inhaler (CMI) Program with New Therapeutic Equivalence Data Presented at British Thoracic Society (BTS) Winter Meeting chiesi.com ↗
The two studies presented at BTS demonstrated therapeutic equivalence and similar safety profiles of Chiesi’s beclometasone dipropionate/ formoterol fumarate product formulated with next generation HFA-152a propellant, compared to the current HFA-134a formulation, in two different strengths 1 . |
| 2025-10-29 | Impax Laboratories, LLC | Regulatory Amneal Receives U.S. FDA Tentative Approval for Beclomethasone Dipropionate HFA Inhalation Aerosol amneal.com ↗
Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has tentatively approved the Company’s Abbreviated New Drug Application (ANDA) for beclomethasone dipropionate HFA inhalation aerosol (40 mcg/actuation and 80 mcg/actuation). |
| 2017-08-07 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces FDA Approval of QVAR® RediHaler™ (Beclomethasone Dipropionate HFA) Inhalation Aerosol tevapharm.com ↗ |
| 2015-02-20 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva to Present New Respiratory Data at 2015 Annual Meeting of the American Academy of Allergy, Asthma and Immunology tevapharm.com ↗
Once-Daily Treatment with Beclomethasone Dipropionate Nasal Aerosol Is Effective in Improving Total Nasal Symptom Scores (TNSS) in Children with Perennial Allergic Rhinitis (PAR) Regardless of Baseline Symptom Severity |
| 2014-12-19 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces FDA Approval of QNASL® (Beclomethasone Dipropionate) Nasal Aerosol for Treatment of Children with Seasonal and Perennial Allergic Rhinitis tevapharm.com ↗
Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) announced today that the U.S. Food and Drug Administration (FDA) approved QNASL® (beclomethasone dipropionate) 40 mcg for the treatment of nasal symptoms associated with allergic rhinitis (AR) in children 4-11 years of age. |
| 2014-11-07 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Presents Positive Safety and Efficacy Data for QNASL® (Beclomethasone Dipropionate) Nasal Aerosol in Treating Children with Perennial Allergic Rhinitis tevapharm.com ↗
today announced positive findings from a Phase III clinical study that examined the safety and efficacy of QNASL® (beclomethasone dipropionate) Nasal Aerosol 80 μg/day in children 4-11 years of age with perennial – or “year round” – allergic rhinitis (PAR). |
| 2014-05-23 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Received FDA Approval for QVAR® (beclomethasone dipropionate HFA) with Dose Counter tevapharm.com ↗ |
| 2014-05-13 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces FDA Acceptance of sNDA Filing for Pediatric Indication for QNASL® (Beclomethasone Dipropionate) Nasal Aerosol tevapharm.com ↗
the U.S. Food and Drug Administration (FDA) has accepted for review the company’s supplemental new drug application (sNDA) for a lower dose QNASL® (beclomethasone dipropionate) Nasal Aerosol |
| 2013-02-22 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Additional QNASL® (beclomethasone dipropionate) Nasal Aerosol Data to be Presented at Annual Allergy Meeting tevapharm.com ↗
Furthermore, the data also demonstrated nasal symptom relief in patients with SAR and PAR who received treatment with QNASL® 24 hours after dosing. |
| 2012-11-09 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Phase III Data for Teva’s QNASL® (beclomethasone dipropionate) Demonstrate Efficacy Profile in Pediatric Patients with Seasonal Allergic Rhinitis tevapharm.com ↗
Additional data reported today further support the efficacy of once-daily dosing with QNASL®. |
| 2012-03-26 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces FDA Approval of QNASLTM (beclomethasone dipropionate), a New Nonaqueous Nasal Aerosol, for the Treatment of Allergic Rhinitis tevapharm.com ↗ |
| 2012-03-05 | Teva Branded Pharmaceutical Products R&D, Inc. | Results QNASLTM Phase III Data Indicate Investigational Therapy with New Mode of Delivery has Positive Safety and Effective Profile in Treatment of Seasonal and Perennial Allergic Rhinitis tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced positive findings from four Phase III clinical studies that examined the efficacy and safety profile as well as impact on quality of life (QoL) of QNASLTM (beclomethasone dipropionate [BDP]) Nasal Aerosol. |
| 2011-10-31 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Presents New Data on QNASL™ at the 2011 American College of Allergy, Asthma and Immunology Annual Meeting tevapharm.com ↗
Findings from one Phase III clinical study being presented demonstrate the degree of patient satisfaction with QNASL™, while the others support the safety and efficacy profile for the product. |
| 2011-08-08 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Receives FDA Acceptance of Its New Drug Application for BDP Nasal HFA for the Treatment of Allergic Rhinitis tevapharm.com ↗ |
| 2011-02-09 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Announces Results from A Phase III Study for QNAZE™ Nasal Aerosol in Perennial Allergic Rhinitis tevapharm.com ↗
Results of the study evaluating patients with PAR showed the once-daily, non-aqueous formulation achieved all primary and secondary efficacy endpoints, demonstrating significantly greater relief of nasal symptoms, including runny nose, nasal congestion, nasal itching and sneezing, compared with placebo. |
| 2010-11-15 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Highlights QNAZE™ HFA Phase III Data at the 2010 Annual Meeting of the American College of Allergy, Asthma & Immunology tevapharm.com ↗
The results, presented at the 2010 Annual Meeting of the American College of Allergy, Asthma & Immunology (ACAAI) in Phoenix, Ariz., showed that the non-aqueous formulation met all primary and secondary efficacy endpoints, and that the product demonstrated safety similar to placebo. |
| 2009-03-17 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Study Demonstrates that Qvar® is More Likely to Achieve Successful Asthma Control with Less Exacerbations tevapharm.com ↗
This real life analysis showed that the choice of ICS may impact overall asthma control under actual living conditions, including asthma exacerbation rates. |
All press releases naming this drug 20 releases
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 137 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Beclomethasone Dipropionate | “Patients in the MDI group received Foster® metered-dose inhaler (MDI) containing beclomethasone dipropionate 100 µg + formoterol fumarate 6 µg per actuation, administered as...” NCT07232264 ↗85“Beclomethasone dipropionate (BDP) is an anti-inflammatory corticosteroid that is rapidly metabolized to the pharmacologically active monoester, beclomethasone-17-monopropionate...” PMID 22621776 ↗ May 2012 “free combination of beclomethasone dipropionate 100 ug/unit DPI (two inhalations, total dose 200 ug), and formoterol fumarate 6 ug/unit DPI (four inhalations, total dose 24 ug).” NCT01468272 ↗ “Inhaled glucocorticoids including beclomethasone dipropionate, budesonide, flunisolide, fluticasone propionate and triamcinolone acetonide, depending on the expert criteria.” NCT02509299 ↗ “Active ingredients: Beclomethasone Dipropionate (BDP)//Formoterol Fumarate (FF) /Glycopyrronium Bromide (GB) 100/6/12,5μg per actuation; Excipients: HFA-152a propellant.” NCT07858123 ↗ “Fixed Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide (CHF 5993) Administered Via Pressurized Metered-dose Inhaler (pMDI)” NCT02467452 ↗ “The fixed combination of extrafine beclomethasone dipropionate and formoterol fumarate (BDP/FF) pMDI (Foster(®)) is approved for treatment of adult asthmatic patients.” PMID 25088067 ↗ Aug 2014 “Beclomethasone dipropionate (BDP) nasal aerosol (non-aqueous) is approved for management of seasonal and perennial allergic rhinitis (PAR) in adolescents and adults.” PMID 26115578 ↗ Jun 2015 “Additional ICS will be delivered as equivalent of hydrofloroalkaline-beclomethasone dipropionate (Qvar) through a metered dose inhaler using an AeroChamber spacer.” NCT06970080 ↗ “The dose-dependent anti-inflammatory effects of a recent fixed combination of extrafine beclomethasone dipropionate/formoterol (BDP/F) were investigated” PMID 22188731 ↗ Dec 2011 “Foster® (beclomethasone dipropionate 100 µg plus formoterol 6 µg/unit dose), 2 inhalations b.i.d. (daily dose of BDP "extrafine" 400 µg plus FF 24 µg).” NCT01351792 ↗ |
| Known as | BDP | “Beclomethasone dipropionate (BDP) nasal aerosol, a nonaqueous hydrofluoroalkane formulation in a device with a novel integrated dose counter and an established efficacy/safety...” PMID 24169062 ↗ Nov 201330“An extrafine combination of beclometasone dipropionate (BDP) and formoterol fumarate (FF) via a pressurised metered-dose inhaler (pMDI) has been commercially available for some...” PMID 28065679 ↗ Jan 2017 “CHF 5993 is an extrafine 'triple therapy' combination of the long-acting muscarinic antagonist glycopyrronium bromide (GB), the long-acting β2-agonist formoterol fumarate (FF),...” PMID 27209586 ↗ Apr 2017 “A single-inhaler extrafine triple combination of beclometasone dipropionate (BDP), formoterol fumarate (FF) and glycopyrronium (G) has been developed for maintenance therapy of...” PMID 33757520 ↗ Mar 2021 “The hypothesis to be tested is that a topically-active corticosteroid (beclomethasone dipropionate, BDP), taken orally, would allow rapid tapering of prednisone while...” NCT00233896 ↗ “single-inhaler extrafine combination of beclometasone dipropionate (BDP; inhaled corticosteroid), formoterol fumarate (FF; long-acting β2 agonist), and glycopyrronium (G;...” PMID 31582314 ↗ Sep 2019 “Fixed Combination of Beclometasone Dipropionate (BDP) 35 μg Plus Formoterol Fumarate (FF) 4 μg Versus the Free Combination of Licensed BDP DPI (Dry Powder Inhaler) and FF DPI...” NCT02787967 ↗ “A new pediatric fixed combination of beclometasone dipropionate (BDP) 50 μg and formoterol fumarate (FF) 6 μg via pressurized metered-dose inhaler (pMDI) (CHF1535, Chiesi,...” PMID 33404895 ↗ Jan 2021 “Beclomethasone dipropionate (BDP) is an anti-inflammatory corticosteroid that is rapidly metabolized to the pharmacologically active monoester, beclomethasone-17-monopropionate...” PMID 22621776 ↗ May 2012 “Beclomethasone dipropionate (BDP) hydrofluoroalkane nasal aerosol is a recently developed, nonaqueous, nonchlorofluorocarbon formulation of BDP for the treatment of AR.” PMID 23026180 ↗ Sep 2012 “The dose-dependent anti-inflammatory effects of a recent fixed combination of extrafine beclomethasone dipropionate/formoterol (BDP/F) were investigated” PMID 22188731 ↗ Dec 2011 |
| Known as | BDP (beclomethasone dipropionate) HFA (hydrofluoroalkane) Nasal Aerosol | “BDP (beclomethasone dipropionate) HFA (hydrofluoroalkane) Nasal Aerosol” NCT01307319 ↗ |
| Known as | BDP HFA | “Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.” NCT01307319 ↗ |
| Known as | Beclometasone Dipropionate | “An extrafine combination of beclometasone dipropionate (BDP) and formoterol fumarate (FF) via a pressurised metered-dose inhaler (pMDI) has been commercially available for some...” PMID 28065679 ↗ Jan 201731“Foster is a combination therapy containing beclometasone dipropionate (an inhaled corticosteroid, or ICS) and formoterol fumarate (a long-acting beta-agonist, or LABA), which...” NCT06869382 ↗ “CHF 5993 is an extrafine 'triple therapy' combination of the long-acting muscarinic antagonist glycopyrronium bromide (GB), the long-acting β2-agonist formoterol fumarate (FF),...” PMID 27209586 ↗ Apr 2017 “single-inhaler extrafine combination of beclometasone dipropionate (BDP; inhaled corticosteroid), formoterol fumarate (FF; long-acting β2 agonist), and glycopyrronium (G;...” PMID 31582314 ↗ Sep 2019 “We evaluated the effects of the long acting bronchodilator components of the extrafine single inhaler triple therapy beclometasone dipropionate/formoterol/glycopyrronium...” PMID 33298062 ↗ Dec 2020 “A new pediatric fixed combination of beclometasone dipropionate (BDP) 50 μg and formoterol fumarate (FF) 6 μg via pressurized metered-dose inhaler (pMDI) (CHF1535, Chiesi,...” PMID 33404895 ↗ Jan 2021 “Fixed Combination of Beclometasone Dipropionate (BDP) 35 μg Plus Formoterol Fumarate (FF) 4 μg Versus the Free Combination of Licensed BDP DPI (Dry Powder Inhaler) and FF DPI...” NCT02787967 ↗ “CHF1535 (beclometasone dipropionate 100 µg plus formoterol 6 µg) pMDI aerosol via HFA-134a propellant 2 inhalations b.i.d. (daily dose 400 µg + 24µg)” NCT00901368 ↗ “Fixed combination of extrafine beclometasone dipropionate 100 µg plus formoterol fumarate 6 µg plus glycopyrronium bromide 12.5 µg / metered dose” NCT03197818 ↗ “fixed combination of beclometasone dipropionate (BDP)/formoterol fumarate (FF) in adolescent and adult asthma.” PMID 25808292 ↗ Jun 2015 “fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus glycopyrronium bromide” NCT02676089 ↗ |
| Known as | beclomethasone 17,21-dipropionate | “A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of orBec® (Oral Beclomethasone 17,21-Dipropionate) Administered as...” NCT01925950 ↗ |
| Known as | Beconase | “The agents being compared are: R926112 (a novel anti-allergy medicine), Beconase (beclomethasone dipropionate, an established FDA approved steroid treatment), and an inactive placebo.” NCT00115089 ↗ |
| Known as | CHF 718 | “CHF 718 pMDI = 100 μg pressurised metered dose inhaler (extrafine beclomethasone dipropionate [BDP]).” NCT05292586 ↗ |
| Known as | CHF 718 pMDI | “CHF 718 pMDI (HFA Beclomethasone Dipropionate Via Pressured Metered Dose Inhaler)” NCT03084718 ↗ |
| Known as | HFA-BDP | “Beclomethasone Dipropionate (HFA-BDP, QVAR\*) in the following doses will be evaluated:” NCT03503994 ↗ |
| Known as | orBec | “Immediate release tablets and enteric-coated tablets, each contained 1 mg of BDP (orBec, DOR BioPharma, Miami FL).” NCT00233896 ↗ |
| Known as | QNASL | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01852513 ↗ |
| Known as | QVAR | “Safety and Efficacy Evaluation of Two Doses of HFA-Propelled Beclomethasone Dipropionate (QVAR) Versus Placebo by Breath Operated and Metered Dose Inhalers in Mild to Moderate...” NCT00094016 ↗13“QVAR (beclomethasone dipropionate) 40 mcg inhalation aerosol is a pressurized MDI that contains a Food and Drug Administration (FDA)-approved formulation of beclomethasone dipropionate.” NCT02139644 ↗ “BDP 100 µg pMDI, 4 puffs (Qvar®, total dose: BDP 400 µg) + formoterol fumarate 6 µg pMDI, 4 puffs (Atimos®, total dose: formoterol 24 µg)” NCT01803087 ↗ “Qvar® pMDI 50 µg or 100 µg b.i.d. was provided as background therapy, with a daily dose ranging from 100 µg to 400 µg.” NCT02296411 ↗ “Qvar (HFA-propelled beclomethasone dipropionate metered dose inhaler) 160 mcg twice daily for 12 weeks” NCT00071552 ↗ “Beclomethasone Dipropionate (HFA-BDP, QVAR\*) in the following doses will be evaluated:” NCT03503994 ↗ “HFA-134A Beclomethasone DIpropionate (QVAR)” NCT00238082 ↗ “beclomethasone dipropionate (QVAR)” NCT00109668 ↗ “BDP HFA Inhalation Aerosol (QVAR)” NCT01537692 ↗ |
| Known as | QVAR REDIHALER | “BDP HFA (QVAR REDIHALER®, BDP 80 μg)” NCT05898984 ↗ |
| Known as | SGX201 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01073384 ↗ |
| Modality | Other / unclassified | “a topically-active corticosteroid (beclomethasone dipropionate, BDP)” NCT00233896 ↗ |
| Route | Intranasal | “anti-inflammatory nasal spray ( beclomethasone dipropionate )” NCT00000752 ↗ |