Drugs / Budesonide
Budesonide
also known as
Pulmicort · BUD · Pulmicort Respules · BOS · MAP0010 · Budenofalk · Entocort · OBS · +43 more
Regulatory milestones approvals, filings & regulatory actions · 17 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed asthma 1 milestone | |||||
| Filed | EU (EMA) | Easyhaler | asthma | 2013-03-21 | “On 21 March Orion announced that it had submitted a marketing authorisation application for a combined budesonide-formoterol formulation in the Easyhaler® product family in Europe.” orionpharma.com ↗ “Orion Corporation has submitted a marketing authorisation application for combined budesonide-formoterol formulation of the Easyhaler® product family in Europe.” orionpharma.com ↗ |
| Filed eosinophilic esophagitis 2 milestones | |||||
| Rejected (CRL) | US (FDA) | — | eosinophilic esophagitis | 2021-12-21 | “In December 2021, Takeda received a Complete Response Letter (CRL) from the U.S. FDA for TAK-721 (budesonide oral suspension) for the treatment of eosinophilic esophagitis.” takeda.com ↗ |
| Filed | US (FDA) | Eohilia | eosinophilic esophagitis | 2020-12-15 | “FDA has accepted for review the company’s New Drug Application (NDA) and granted Priority Review for the investigational therapy budesonide oral suspension, TAK-721” takeda.com ↗ |
| Withdrawn Indication not stated 10 milestones | |||||
| Label expansion | US (FDA) | TARPEYO | — | 2023-12-20 | fda.gov ↗ |
| Label expansions (2) | US (FDA) | ENTOCORT EC | — | 2005-04-29 – 2016-04-29 | fda.gov ↗ |
| Label expansions (3) | US (FDA) | RHINOCORT ALLERGY | — | 2001-10-26 – 2015-03-23 | fda.gov ↗ |
| Approved | EU (EMA) | DuoResp Spiromax | — | 2014-04-28 | europa.eu ↗ |
| Refused (EMA) | EU (EMA) | Labazenit | — | 2013-09-06 | europa.eu ↗ |
| Label expansions (2) | US (FDA) | PULMICORT RESPULES | — | 2003-02-26 – 2005-06-30 | fda.gov ↗ |
| Label expansion | US (FDA) | PULMICORT | — | 1998-10-08 | fda.gov ↗ |
| Approved | US (FDA) | RHINOCORT | — | 1994-02-14 | fda.gov ↗ |
| Withdrawn | EU (EMA) | — | — | — | “While the application was being processed, Orion decided to withdraw the application for marketing authorisation in the United Kingdom, France, Germany, the Netherlands and Austria.” orionpharma.com ↗ |
| Withdrawn | UK (MHRA) | — | — | — | “While the application was being processed, Orion decided to withdraw the application for marketing authorisation in the United Kingdom, France, Germany, the Netherlands and Austria.” orionpharma.com ↗ |
Trials 346 · started per year
today
US approved 1994
EU approved 2014
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT07081399 | Aug 2024 → Mar 2025 overdue | — | Damanhour University | Recruiting | No outcome recorded |
| Phase 0 | NCT04476628 | Feb 2021 → Jan 2022 | chronic rhinosinusitis | St. Paul's Hospital, Canada | Withdrawn | No outcome recorded |
| Phase 0 | NCT04077892 | Jun → Sep 2016 | allergic rhinitis | Beijing Tongren Hospital | Completed | No outcome recorded |
| Phase 140 trials · 2 missed | ||||||
| Phase 1 | NCT07433569 | Mar → Jun 2026 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT07267130 | Nov 2025 → Oct 2026 expected | chronic obstructive pulmonary disease | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT06723756 | Jan → Jun 2025 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT06514157 | Aug → Sep 2024 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT06268301 | Feb 2023 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT06367881 | Aug 2022 → Jul 2024 | inflammatory disease, pulmonary immaturity, respiratory distress syndrome in premature infants | Ain Shams University | Unknown | No outcome recorded |
| Phase 1 | NCT05148312 | Nov → Dec 2021 | — | Aquilon Pharmaceuticals S.A. | Completed | No outcome recorded |
| Phase 1 | NCT05519514 | Jul → Aug 2021 | — | Abbott | Completed | No outcome recorded |
| Phase 1 | NCT04848662 | May → Jul 2021 | asthma | Bond Avillion 2 Development LP | Completed | No outcome recorded |
| Phase 1 | NCT04600505 | Oct 2020 → May 2021 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT04080713 | Sep 2019 | — | Ferring Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT04016220 | May → Dec 2019 | acute asthma | University of Monastir | Unknown | No outcome recorded |
| Phase 1 | NCT03934333 | May → Sep 2019 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT03906045 | Apr 2019 → Mar 2020 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT03436225 | Feb 2019 | respiratory syncytial virus bronchiolitis | Assiut University | Unknown | No outcome recorded |
| Phase 1 | NCT03772223 | Jan → May 2019 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT05429775 | Dec 2018 → Jan 2019 | — | Sandoz | Completed | No outcome recorded |
| Phase 1 | NCT03740373 | Sep → Oct 2018 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT03537326 | May → Jul 2018 | — | Parc de Salut Mar | Completed | No outcome recorded |
| Phase 1 | NCT03421730 | Dec 2017 → Mar 2018 | asthma, reactive airway disease | Vectura Limited | Completed | No outcome recorded |
| Phase 1 | NCT03311373 | Oct → Dec 2017 | chronic obstructive pulmonary disease | Pearl Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03250182 | Aug → Dec 2017 | chronic obstructive pulmonary disease | Pearl Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04032834 | Feb → May 2017 | asthma | Vectura Limited | Completed | No outcome recorded |
| Phase 1 | NCT02811016 | Jun → Jul 2016 | acute mountain sickness | Salzburger Landeskliniken | Completed | Missed primary |
| Phase 1 | NCT02631941 | Jan → Jul 2016 | asthma | Zambon SpA | Completed | Mixed |
| Phase 1 | NCT03073057 | Jan → Mar 2016 | asthma | Orion Corporation, Orion Pharma | Completed | No outcome recorded |
| Phase 1 | NCT02237508 | Sep 2014 → Feb 2015 | asthma | Zambon SpA | Completed | Missed primary |
| Phase 1 | NCT02197975 | Aug → Oct 2014 | chronic obstructive pulmonary disease | Pearl Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02187445 | Jun 2014 → Dec 2016 | acute chest syndrome, asthma, sickle cell disease | Vanderbilt University | Completed | No outcome recorded |
| Phase 1 | NCT01950507 | Feb 2014 → May 2018 | graft versus host disease | National Institutes of Health Clinical Center (CC) | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02165033 | Nov 2012 → Jan 2013 | asthma | Intech Biopharm Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01511302 | Jun 2012 → Apr 2013 | asthma | Revalesio Corporation | Completed | No outcome recorded |
| Phase 1 | NCT02165046 | Feb → Apr 2012 | asthma, chronic obstructive pulmonary disease | Intech Biopharm Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01423305 | Aug → Oct 2011 | asthma | Orion Corporation, Orion Pharma | Completed | No outcome recorded |
| Phase 1 | NCT01386996 | Jul → Nov 2011 | asthma | Orion Corporation, Orion Pharma | Completed | No outcome recorded |
| Phase 1 | NCT01181063 | Aug → Oct 2010 | asthma | Orion Corporation, Orion Pharma | Completed | No outcome recorded |
| Phase 1 | NCT00975754 | Sep → Nov 2009 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00569712 | Jan 2007 → Dec 2008 | lung cancer, precancerous condition | British Columbia Cancer Agency | Completed | No outcome recorded |
| Phase 1 | NCT00627679 | Dec 2005 | asthma | Allergan | Completed | No outcome recorded |
| Phase 1 | NCT00004842 | May 1997 → Apr 1999 | cirrhosis of liver, primary sclerosing cholangitis | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
| Phase 1/27 trials · 1 missed | ||||||
| Phase 1/2 | NCT06855043 | Oct 2026 → Mar 2029 expected | respiratory distress syndrome in premature infants | University of Wisconsin, Madison | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07270302 | Dec 2025 → May 2026 overdue | chronic rhinosinusitis | Washington University School of Medicine | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06110403 | Sep 2023 → Sep 2026 overdue | chronic obstructive pulmonary disease | University Hospital, Lille | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04964414 | Sep 2021 → Jan 2023 | COVID-19, anosmia, olfactory nerve disorder | Amanda Stapleton | Terminated | Missed primary Stop: Enrollment |
| Phase 1/2 | NCT04019106 | Oct 2019 → Oct 2020 | bronchopulmonary dysplasia, respiratory distress syndrome in premature infants | University of Manitoba | Unknown | No outcome recorded |
| Phase 1/2 | NCT03250975 | Aug 2017 → Dec 2026 expected | — | Vanderbilt University Medical Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02907593 | Sep 2016 → Apr 2018 | bronchopulmonary dysplasia | Cynthia McEvoy | Terminated | No outcome recorded |
| Phase 250 trials · 8 met primary · 2 missed | ||||||
| Phase 2 | NCT06860542 | Feb 2026 → Dec 2029 expected | pneumonitis | AHS Cancer Control Alberta | Recruiting | No outcome recorded |
| Phase 2 | NCT06830109 | Oct 2024 → Dec 2026 expected | nasal disorder | Washington University School of Medicine | Recruiting | No outcome recorded |
| Phase 2 | NCT06482294 | Jun 2024 → May 2025 | asthma | Università degli Studi di Ferrara | Unknown | No outcome recorded |
| Phase 2 | NCT05915104 | Jan 2024 → Sep 2026 overdue | microscopic colitis | University of Calgary | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05405387 | May 2023 → Dec 2026 expected | plasma cell leukemia, plasma cell myeloma | University of Utah | Recruiting | No outcome recorded |
| Phase 2 | NCT05055414 | Nov 2021 → Oct 2022 | COVID-19 | Korea United Pharm. Inc. | Unknown | No outcome recorded |
| Phase 2 | NCT04918953 | Jun 2021 → Dec 2025 overdue | — | Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05214599 | Apr 2021 → Nov 2024 | eosinophilic esophagitis | Bazell Pharma AG | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT04416399 | Jul 2020 → Jan 2021 | COVID-19 | University of Oxford | Terminated | Met primary |
| Phase 2 | NCT03716115 | May 2020 → Apr 2021 | protein-energy malnutrition | Queen Mary University of London | Completed | Mixed |
| Phase 2 | NCT04064684 | Feb → Mar 2020 | pediatric acute respiratory distress syndrome | The University of Texas Health Science Center, Houston | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01895075 | Jan 2019 → Jul 2020 | bronchopulmonary dysplasia | Dr. Michael Dunn | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT03803787 | Sep 2018 → Dec 2026 expected | radiation pneumonitis | National Cancer Institute of Mexico | Recruiting | No outcome recorded |
| Phase 2 | NCT03304626 | Jun 2017 → Dec 2019 | acute transplant rejection, disease related to solid organ transplantation | University of Cincinnati | Completed | No outcome recorded |
| Phase 2 | NCT02991859 | Feb 2017 → Dec 2018 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT02991768 | Jan 2017 → Apr 2019 | diarrheal disease | University of Kansas Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02862509 | Nov 2015 → Aug 2017 | chronic frontal sinusitis | Khon Kaen University | Unknown | No outcome recorded |
| Phase 2 | NCT02550418 | Oct 2015 → Mar 2017 | ulcerative colitis | Dr. Falk Pharma GmbH | Completed | No outcome recorded |
| Phase 2 | NCT02833480 | Feb 2015 → Jan 2021 | chronic obstructive pulmonary disease | University of British Columbia | Unknown | No outcome recorded |
| Phase 2 | NCT02400476 | Feb 2015 → Apr 2021 | HER2 positive breast carcinoma | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02196077 | Aug 2014 → Mar 2015 | chronic obstructive pulmonary disease | Pearl Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02105012 | Apr 2014 → Sep 2015 | asthma | Pearl Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02069847 | Feb 2014 → Jan 2019 | — | Mayo Clinic | Completed | Missed primary |
| Phase 2 | NCT01966783 | Sep 2013 → Aug 2015 | proctitis | Dr. Falk Pharma GmbH | Completed | No outcome recorded |
| Phase 2 | NCT01783821 | Jul 2013 → Jul 2015 | adult acute respiratory distress syndrome | Mayo Clinic | Completed | Met primary |
| Phase 2 | NCT01814618 | Mar → Nov 2013 | chronic rhinosinusitis, olfactory nerve disorder | University of North Carolina, Chapel Hill | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02162784 | Feb 2013 → Aug 2014 | asthma | Intech Biopharm Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT01738035 | Dec 2012 → Jun 2015 | IgA glomerulonephritis | Calliditas Therapeutics AB | Completed | Met primary |
| Phase 2 | NCT01642212 | Jul 2012 → Oct 2014 | eosinophilic esophagitis | Shire | Completed | Met primary |
| Phase 2 | NCT01858129 | Mar 2012 → May 2015 | persistent tachypnoe of infancy | Bnai Zion Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT02280616 | Jun 2011 → Apr 2013 | eosinophilic esophagitis | Dr. Falk Pharma GmbH | Completed | Met primary |
| Phase 2 | NCT01268215 | Jul 2010 → Jun 2012 | bronchopulmonary dysplasia | East Carolina University | Unknown | No outcome recorded |
| Phase 2 | NCT01136382 | Jul 2010 → Apr 2013 | asthma | AstraZeneca | Completed | Met primary |
| Phase 2 | NCT01070524 | Jan → Jul 2010 | asthma | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 2 | NCT00995904 | Sep → Nov 2009 | asthma | Allergan | Completed | No outcome recorded |
| Phase 2 | NCT00762073 | Jan 2009 → Apr 2010 | eosinophilic esophagitis | Shire | Completed | Met primary |
| Phase 2 | NCT00805285 | Oct 2008 → Oct 2009 | ulcerative colitis | University of Maryland, Baltimore | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00828230 | Sep 2008 → Aug 2011 | radiation proctitis | Dr. Falk Pharma GmbH | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00624754 | Mar 2008 → Jul 2012 | obstructive lung disease | Assistance Publique - Hôpitaux de Paris | Completed | Met primary |
| Phase 2 | NCT00554970 | Nov 2007 → Jan 2008 | asthma | Allergan | Completed | No outcome recorded |
| Phase 2 | NCT00697801 | Jul → Dec 2006 | asthma | Allergan | Completed | No outcome recorded |
| Phase 2 | NCT00321893 | Jan 2006 → Sep 2008 | lung cancer | National Cancer Institute (NCI) | Completed | Missed primary |
| Phase 2 | NCT00271349 | Dec 2005 → Jul 2008 | eosinophilic esophagitis | Swiss EE Study Group | Completed | No outcome recorded |
| Phase 2 | NCT00767221 | Oct 2005 → Nov 2008 | IgA glomerulonephritis | Calliditas Therapeutics AB | Completed | No outcome recorded |
| Phase 2 | NCT00117182 | Jul 2005 → Aug 2006 | chronic obstructive pulmonary disease | Syntara | Completed | No outcome recorded |
| Phase 2 | NCT00641693 | Apr 2004 → May 2005 | allergic rhinitis | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT00658255 | Oct 2002 → May 2003 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT00641979 | Apr → Aug 2002 | seasonal allergic rhinitis | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT00239278 | Jan 2001 → Jan 2005 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT00005880 | Jul 2000 → ? | lung cancer | British Columbia Cancer Agency | Completed | No outcome recorded |
| Phase 2/310 trials · 1 met primary · 1 missed | ||||||
| Phase 2/3 | NCT06719622 | Jul 2024 → Dec 2027 expected | Crohn disease | Medical University of Warsaw | Enrolling by invitation | No outcome recorded |
| Phase 2/3 | NCT05931744 | May 2021 → Feb 2023 | chronic rhinosinusitis | Kafrelsheikh University | Completed | No outcome recorded |
| Phase 2/3 | NCT04920838 | Apr 2021 → Aug 2023 | COVID-19 | ANRS, Emerging Infectious Diseases | Unknown | No outcome recorded |
| Phase 2/3 | NCT04331470 | Apr 2020 | COVID-19 | Fasa University of Medical Sciences | Unknown | No outcome recorded |
| Phase 2/3 | NCT03519061 | Aug 2019 | chronic ethmoidal sinusitis | Kaiser Permanente | Withdrawn | No outcome recorded |
| Phase 2/3 | NCT01907204 | Jul → Aug 2013 | sinusitis | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | Completed | No outcome recorded |
| Phase 2/3 | NCT01269437 | Dec 2010 → Oct 2011 | asthma | NovaMed Pharmaceuticals Inc. | Unknown | No outcome recorded |
| Phase 2/3 | NCT02024659 | Sep 2010 → Dec 2011 | nasal cavity polyp | Beijing Tongren Hospital | Completed | No outcome recorded |
| Phase 2/3 | NCT00838214 | Mar 2001 → Dec 2008 | autoimmune hepatitis | Dr. Falk Pharma GmbH | Completed | Met primary |
| Phase 2/3 | NCT00175747 | Jan 2000 → Dec 2002 | lung cancer | University of British Columbia | Completed | Missed primary |
| Phase 3119 trials · 20 met primary · 14 missed | ||||||
| Phase 3 | NCT06471257 | Jun 2024 → Oct 2027 expected | asthma | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT06429475 | Jun 2024 → Dec 2028 expected | asthma | University of KwaZulu | Recruiting | No outcome recorded |
| Phase 3 | NCT06307665 | May 2024 → Oct 2027 expected | asthma | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT06283966 | Feb 2024 → Dec 2027 expected | chronic obstructive pulmonary disease | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT06075095 | Jan 2024 → Aug 2025 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT06245551 | Dec 2023 → Jun 2024 | exercise-induced bronchoconstriction | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT04233190 | Apr 2023 → Oct 2024 | asthma | Eurofarma Laboratorios S.A. | Completed | No outcome recorded |
| Phase 3 | NCT05509933 | Nov 2022 → Dec 2027 expected | engraftment syndrome | Henry Ford Health System | Recruiting | No outcome recorded |
| Phase 3 | NCT05555290 | Sep 2022 → Nov 2024 | asthma | AstraZeneca | Completed | Mixed |
| Phase 3 | NCT05573464 | Sep 2022 → Mar 2024 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Show all 119 trials opens the full record — a long page | ||||||
| Phase 488 trials · 5 met primary · 5 missed | ||||||
| Phase 4 | NCT05976802 | Jun 2029 → Jun 2030 expected | ulcerative colitis | Bausch Health Americas, Inc. | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06531798 | Jan → Oct 2026 expected | chronic obstructive pulmonary disease | AstraZeneca | Recruiting | No outcome recorded |
| Phase 4 | NCT07073950 | Nov 2025 → May 2027 expected | chronic obstructive pulmonary disease | AstraZeneca | Recruiting | No outcome recorded |
| Phase 4 | NCT07166939 | Nov 2025 → Jun 2027 expected | acute asthma | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT07030894 | Sep 2025 → Dec 2026 expected | IgA glomerulonephritis, chronic kidney disease, proteinuria | The First Hospital of Jilin University | Recruiting | No outcome recorded |
| Phase 4 | NCT07491991 | Mar 2025 → Jan 2026 | — | Qianfoshan Hospital | Completed | No outcome recorded |
| Phase 4 | NCT06676384 | Feb 2025 → Aug 2029 expected | IgA glomerulonephritis, chronic kidney disease, immunoglobulin A vasculitis | Christian Medical College, Vellore, India | Recruiting | No outcome recorded |
| Phase 4 | NCT06785662 | Feb 2025 → Jan 2026 overdue | allergic rhinitis | Siriraj Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06712407 | Dec 2024 → Mar 2027 expected | IgA glomerulonephritis | Calliditas Therapeutics AB | Active not recruiting | No outcome recorded |
| Phase 4 | NCT06590740 | Oct 2024 → Sep 2025 | cough variant asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT06563102 | Sep 2024 → Feb 2026 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT06422689 | May 2024 → Feb 2027 expected | asthma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 4 | NCT06841406 | May 2024 → May 2026 overdue | dyspepsia | Universitaire Ziekenhuizen KU Leuven | Recruiting | No outcome recorded |
| Phase 4 | NCT05970263 | Jan 2024 → Dec 2025 | chronic obstructive pulmonary disease | AstraZeneca | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT06076304 | Nov 2023 → Oct 2028 expected | sinusitis | Daniel Merenstein | Recruiting | No outcome recorded |
| Phase 4 | NCT06571942 | Nov 2023 → Jan 2025 overdue | chronic obstructive pulmonary disease | National Institute of Respiratory Diseases, Mexico | Recruiting | No outcome recorded |
| Phase 4 | NCT04314375 | Sep 2023 → Dec 2026 expected | ulcerative colitis | Bausch Health Americas, Inc. | Recruiting | No outcome recorded |
| Phase 4 | NCT06858423 | Aug 2023 → Mar 2024 | allergic rhinitis | Benha University | Completed | No outcome recorded |
| Phase 4 | NCT05474924 | Aug → Sep 2022 | nasal cavity polyp | Kafrelsheikh University | Unknown | No outcome recorded |
| Phase 4 | NCT03141424 | Jun 2022 → Oct 2024 | asthma | Hvidovre University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT05444543 | Nov 2021 → Oct 2023 | eosinophilic esophagitis | University Hospitals Cleveland Medical Center | Completed | Missed primary |
| Phase 4 | NCT05084222 | Nov 2021 → Jun 2023 | asthma | Orion Corporation, Orion Pharma | Completed | No outcome recorded |
| Phase 4 | NCT04527016 | Oct 2021 → Jun 2023 | childhood onset asthma | Children's Hospital of Fudan University | Completed | No outcome recorded |
| Phase 4 | NCT04374474 | Jan → Dec 2021 | olfactory nerve disorder | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT04159519 | Jul 2020 → Jan 2023 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT04171180 | May → Sep 2020 | cough variant asthma | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
| Phase 4 | NCT04355637 | Apr 2020 → Jun 2021 | COVID-19 | Sara Varea | Completed | No outcome recorded |
| Phase 4 | NCT05364385 | Dec 2019 → Feb 2023 | acute lung injury, bronchopulmonary dysplasia | University of Arizona | Unknown | No outcome recorded |
| Phase 4 | NCT04132570 | Oct 2019 → Jan 2020 | rhinitis | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | Completed | No outcome recorded |
| Phase 4 | NCT03866538 | Sep 2019 → Oct 2021 | autoimmune enteropathy, celiac disease, collagenous sprue, diarrhea, glucose-stimulated secretory, with common variable immunodeficiency | Mayo Clinic | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT05152355 | Apr 2019 → May 2021 | asthma | Intech Biopharm Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT03315052 | Jan 2019 → Jan 2021 | acute transplant rejection | Montefiore Medical Center | Withdrawn | No outcome recorded |
| Phase 4 | NCT03615742 | Dec 2018 → Dec 2025 overdue | environmental induced asthma, glucocorticoid resistance | University of British Columbia | Recruiting | No outcome recorded |
| Phase 4 | NCT03478696 | Jun 2018 → Mar 2019 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT03563001 | Jun → Sep 2018 | chronic obstructive pulmonary disease | Zhujiang Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT03551197 | Jun → Sep 2018 | chronic obstructive pulmonary disease | Zhujiang Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT03521063 | Jan 2018 → Oct 2019 | bronchopulmonary dysplasia, pulmonary immaturity, respiratory distress syndrome in premature infants | Hospital Central "Dr. Ignacio Morones Prieto" | Unknown | No outcome recorded |
| Phase 4 | NCT03219866 | Oct 2017 → Apr 2020 | chronic obstructive pulmonary disease | Wake Forest University Health Sciences | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03369847 | Sep 2017 → May 2019 | asthma, childhood acute lymphoblastic leukemia | New York City Health and Hospitals Corporation | Completed | No outcome recorded |
| Phase 4 | NCT03034005 | Mar 2017 → Feb 2019 | asthma | Bispebjerg Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03394222 | Jul 2016 → Mar 2017 | lung cancer | Fujian Medical University Union Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02771717 | May 2016 → Jul 2017 | asthma | University of Nottingham | Unknown | No outcome recorded |
| Phase 4 | NCT02696850 | Jan 2016 → Apr 2017 | chronic rhinosinusitis | Washington University School of Medicine | Completed | Missed primary |
| Phase 4 | NCT02934945 | Sep 2015 → Jan 2017 | asthma | Zhujiang Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT03028701 | Sep 2015 → Mar 2017 | chronic obstructive pulmonary disease | Neutec Ar-Ge San ve Tic A.Ş | Completed | No outcome recorded |
| Phase 4 | NCT02574975 | Apr 2015 → May 2016 | asthma | Zhujiang Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02357277 | Mar 2015 → Nov 2017 | osteoporosis | Columbia University | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT04520230 | Oct 2014 → Dec 2019 | chronic obstructive pulmonary disease | Tanta University | Completed | No outcome recorded |
| Phase 4 | NCT02055352 | May 2014 → Jan 2016 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 4 | NCT02409563 | Jan → Mar 2014 | allergic rhinitis | Istituto per la Ricerca e l'Innovazione Biomedica | Completed | No outcome recorded |
| Phase 4 | NCT01794780 | Feb 2013 → May 2015 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT01846962 | Nov 2012 → Apr 2013 | eosinophilic esophagitis | Azienda Policlinico Umberto I | Completed | No outcome recorded |
| Phase 4 | NCT01253473 | Apr 2012 → Sep 2015 | chronic obstructive pulmonary disease | National Jewish Health | Completed | No outcome recorded |
| Phase 4 | NCT01520688 | Feb 2012 → Feb 2016 | asthma | West Penn Allegheny Health System | Completed | No outcome recorded |
| Phase 4 | NCT01760304 | Jan → Jul 2012 | chronic obstructive pulmonary disease | Brigham and Women's Hospital | Terminated | Missed primary |
| Phase 4 | NCT01397890 | Jul 2011 → Jun 2013 | chronic obstructive pulmonary disease | AstraZeneca | Completed | Met primary |
| Phase 4 | NCT01329276 | Jun → Nov 2010 | chronic obstructive pulmonary disease | University Hospital, Antwerp | Completed | No outcome recorded |
| Phase 4 | NCT00997477 | Jun → Jul 2010 | asthma | Novartis Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 4 | NCT01340118 | May → Jul 2010 | asthma | Chungbuk National University | Completed | No outcome recorded |
| Phase 4 | NCT01070888 | Feb 2010 → Apr 2014 | exercise-induced bronchoconstriction | Boston Children's Hospital | Terminated | No outcome recorded |
| Phase 4 | NCT00939341 | Jul 2009 → Aug 2010 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00883532 | Apr 2009 → Dec 2012 | bronchopulmonary dysplasia, respiratory distress syndrome in premature infants | China Medical University, China | Unknown | Met primary |
| Phase 4 | NCT00661973 | Apr 2008 → Dec 2010 | asthma | Imperial College London | Withdrawn | No outcome recorded |
| Phase 4 | NCT00624429 | Mar 2008 → Dec 2009 | asthma | Phoenix Children's Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT00584636 | Oct 2007 → Mar 2009 | asthma | Phoenix Children's Hospital | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01225913 | Oct 2007 → Jun 2027 expected | asthma | Gelb, Arthur F., M.D. | Recruiting | No outcome recorded |
| Phase 4 | NCT01186653 | Oct 2007 → May 2010 | chronic obstructive pulmonary disease | Hull University Teaching Hospitals NHS Trust | Completed | No outcome recorded |
| Phase 4 | NCT00489853 | Jul 2007 → Aug 2008 | chronic obstructive pulmonary disease | AstraZeneca | Completed | Met primary |
| Phase 4 | NCT00397267 | Jan → Dec 2007 | acute asthma | Soroka University Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT00393367 | Dec 2006 → Nov 2007 | acute asthma, reactive airway disease | Children's Hospital of Philadelphia | Completed | Missed primary |
| Phase 4 | NCT00395239 | Oct 2006 → Oct 2015 | asthma | University of Alberta | Terminated | No outcome recorded |
| Phase 4 | NCT00380484 | Sep 2006 → Feb 2008 | asthma | Children´s Clinic, Randers | Completed | No outcome recorded |
| Phase 4 | NCT00379028 | Sep 2006 → Jul 2007 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00338910 | May → Jun 2006 | — | University Hospital Tuebingen | Completed | No outcome recorded |
| Phase 4 | NCT01089322 | Dec 2005 → Apr 2009 | asthma | Rafael Stelmach | Completed | No outcome recorded |
| Phase 4 | NCT00202189 | Sep → Nov 2005 | chronic obstructive pulmonary disease | Queen's University | Completed | No outcome recorded |
| Phase 4 | NCT00228475 | Sep 2004 → Oct 2005 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00146497 | Aug 2004 → ? | pulmonary immaturity, respiratory distress syndrome in premature infants | China Medical University Hospital | Terminated | No outcome recorded |
| Phase 4 | NCT00560586 | Apr 2004 → May 2006 | obstructive sleep apnea syndrome | University of Louisville | Completed | No outcome recorded |
| Phase 4 | NCT00272753 | Apr 2004 → Nov 2005 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00490243 | Jul 2003 → Oct 2006 | asthma | Medical University of Lodz | Completed | No outcome recorded |
| Phase 4 | NCT00479739 | Nov 2002 → Jul 2004 | asthma | GlaxoSmithKline | Completed | Met primary |
| Phase 4 | NCT00641472 | Oct 2002 → Feb 2005 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00641446 | Oct 2001 → Oct 2003 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00641212 | Jan 2000 → Apr 2003 | perennial allergic rhinitis | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00232674 | Jul 1999 → Feb 2004 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT00234390 | Nov 1998 → Dec 2004 | asthma | AstraZeneca | Completed | Missed primary |
| Phase 4 | NCT00641914 | Oct 1996 → Feb 2003 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase not applicable29 trials · 1 met primary · 1 missed | ||||||
| — | NCT07528820 | Jul 2026 overdue | chronic rhinosinusitis | St. Paul's Sinus Centre | Not yet recruiting | No outcome recorded |
| — | NCT07595796 | Jun 2026 → Feb 2028 expected | — | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Not yet recruiting | No outcome recorded |
| — | NCT07560462 | May 2026 → May 2029 expected | — | Shaare Zedek Medical Center | Not yet recruiting | No outcome recorded |
| — | NCT07386860 | Mar 2026 → Dec 2028 expected | olfactory nerve disorder | Peking University Third Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06890260 | Apr 2025 → Jun 2027 expected | allergic rhinitis | Pengfei Qiu | Recruiting | No outcome recorded |
| — | NCT06597682 | Mar 2025 → Jul 2027 expected | long COVID-19 | Huashan Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06105671 | Jan → Jul 2024 | — | Morten Hostrup, PhD | Completed | No outcome recorded |
| — | NCT07777796 | Jul 2022 → Jul 2026 | chronic rhinitis | Silesian University of Medicine | Completed | No outcome recorded |
| — | NCT04675463 | Dec 2020 → Jan 2023 | chronic obstructive pulmonary disease | ShiYue Li | Unknown | No outcome recorded |
| — | NCT04002349 | Jul → Dec 2019 | — | Beijing Tongren Hospital | Unknown | No outcome recorded |
| — | NCT05541419 | Aug 2018 → Aug 2022 | chronic rhinosinusitis | State University of Londrina | Unknown | No outcome recorded |
| — | NCT03504527 | May → Nov 2018 | bronchial disorder | Huashan Hospital | Unknown | No outcome recorded |
| — | NCT02562924 | Nov 2015 → Dec 2017 | chronic rhinosinusitis | University of Vermont Medical Center | Completed | No outcome recorded |
| — | NCT02013115 | Jan 2015 → Oct 2017 | newborn respiratory distress syndrome | Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | Completed | No outcome recorded |
| — | NCT01457716 | Oct → Nov 2011 | — | Orion Corporation, Orion Pharma | Completed | No outcome recorded |
| — | NCT01526707 | Jun 2011 → Aug 2014 | asthma | Liam Heaney | Completed | No outcome recorded |
| — | NCT01373528 | Dec 2010 → May 2012 | chronic rhinosinusitis | Ottawa Hospital Research Institute | Terminated | No outcome recorded |
| — | NCT00961233 | Oct 2009 → Aug 2011 | eosinophilic esophagitis | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| — | NCT00859274 | Mar 2009 → Oct 2013 | asthma | Kuopio University Hospital | Completed | Missed primary |
| — | NCT01055041 | Dec 2008 → Jun 2009 | chronic asthma | Government Medical College, Bhavnagar | Completed | No outcome recorded |
| — | NCT01219036 | Oct 2008 → Jul 2011 | asthma | Liam Heaney | Completed | No outcome recorded |
| — | NCT01219738 | Jul 2008 → Aug 2012 | asthma | University of Miami | Completed | No outcome recorded |
| — | NCT00587119 | Dec 2007 → Jul 2009 | autoimmune hepatitis, primary biliary cholangitis | Mayo Clinic | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT00388739 | Nov 2006 | asthma | Baylor College of Medicine | Withdrawn | No outcome recorded |
| — | NCT00159263 | Nov 2004 → Nov 2006 | asthma | Imperial College London | Completed | Met primary |
| — | NCT01378039 | Jun 2004 → Dec 2006 | asthma, chronic obstructive pulmonary disease | Lithuanian University of Health Sciences | Completed | No outcome recorded |
| — | NCT00728715 | Jan 2004 → Jan 2005 | bronchiectasis | Hospital General de Requena | Completed | No outcome recorded |
| — | NCT00184171 | Nov 2001 → Sep 2010 | microscopic colitis | Norwegian University of Science and Technology | Terminated | No outcome recorded |
| — | NCT00135681 | Dec 1996 → Nov 2001 | asthma, lung disorder | University of New Mexico | Completed | No outcome recorded |
| Comparator or background therapy170 trials | ||||||
| Phase 0 | NCT07358234 Comparator | Feb 2026 → Dec 2027 expected | eosinophilic esophagitis | Mayo Clinic | Enrolling by invitation | No outcome recorded |
| Phase 0 | NCT04267042 Comparator | Feb 2020 → Feb 2021 | chronic rhinosinusitis, fungal infectious disease | St. Paul's Hospital, Canada | Unknown | No outcome recorded |
| Phase 0 | NCT04097613 Background | Jul 2017 → Apr 2019 | chronic rhinosinusitis | St. Paul's Hospital, Canada | Completed | No outcome recorded |
| Phase 0 | NCT01257048 Comparator | Aug 2011 → Jun 2012 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT06297668 Comparator | Apr → Jun 2024 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Show all 170 trials opens the full record — a long page | ||||||
News releases announcing trial results or a regulatory action · 36
| Date | Issuer | Release |
|---|---|---|
| 2026-09-23 | AstraZeneca | Regulatory Trixeo approved in the EU for the maintenance treatment of asthma astrazeneca.com ↗
Trixeo is the first and only triple-combination therapy approved in the EU for patients 12 years and older, independent of exacerbation history |
| 2026-06-29 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Results Viatris Announces Positive Top-Line Results from Phase 3 Study of VR-205 in Japanese Adults with Primary Immunoglobulin A Nephropathy viatris.com ↗
The study achieved its primary endpoint, with VR-205 demonstrating a 33.75 percent reduction in geometric mean urine protein-to-creatinine ratio (UPCR) at 9 months compared to baseline [95% CI: -45.27 to -19.80; p < 0.001]. |
| 2026-04-17 | Dr. Falk Pharma GmbH | Regulatory European Commission approves Jorveza® suspension drfalkpharma.com ↗ |
| 2025-11-04 | Zydus Lifesciences Limited | Regulatory Zydus receives tentative approval from USFDA for Budesonide delayed- release capsules, 4 mg zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has received tentative approval from the United States Food and Drug Administration (USFDA) for Budesonide delayed-release capsules, 4 mg (USRLD: Tarpeyo Capsules, 4 mg). |
| 2025-05-12 | AstraZeneca | Regulatory Trixeo Aerosphere approved in the UK as first inhaled respiratory medicine using next-generation propellant with near-zero Global Warming Potential astrazeneca.com ↗ |
| 2025-05-02 | AstraZeneca | Results Breztri met primary endpoints in KALOS and LOGOS Phase III trials in asthma astrazeneca.com ↗
Positive high-level results from the Phase III KALOS and LOGOS trials in patients with uncontrolled asthma showed that AstraZeneca’s fixed-dose triple-combination therapy Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF (320/28.8/9.6μg)) met all primary endpoints |
| 2024-03-29 | Triastek (Shanghai) Limited | Regulatory Triastek's 3D Printed Product for IgA Nephropathy, D23 (budesonide), Receives NMPA Clearance of IND Application triastek.com ↗
On March 29, Triastek announced that the Chinese National Medical Products Administration (NMPA) granted clearance to proceed with the Investigational New Drug (IND) for D23, making it the third 3D printed product to receive this designation in China. |
| 2024-02-12 | Takeda | Regulatory FDA Approves Takeda’s EOHILIA (budesonide oral suspension), the First and Only Oral Treatment in the U.S. for Eosinophilic Esophagitis (EoE) takeda.com ↗
Takeda ( TSE:4502/NYSE:TAK ) today announced that the U.S. Food and Drug Administration (FDA) has approved EOHILIA (budesonide oral suspension), the first and only FDA-approved oral therapy for people 11 years and older with eosinophilic esophagitis (EoE). |
| 2023-09-20 | Takeda | Regulatory Takeda Announces FDA Acceptance of NDA Resubmission of TAK-721 (budesonide oral suspension) for the Short-Term Treatment of Eosinophilic Esophagitis (EoE) takeda.com ↗ |
| 2022-11-09 | AstraZeneca | Regulatory PT027 recommended by FDA Advisory Committee as new rescue treatment for asthma astrazeneca.com ↗ |
| 2022-05-23 | Dr. Falk Pharma GmbH | Results Digestive Disease Week® 2022 drfalkpharma.com ↗
Rectal budesonide formulations are well accepted by patients with ulcerative proctitis, improve work productivity and quality of life |
| 2022-05-15 | AstraZeneca | Results PT027, a novel fixed-dose combination of albuterol and budesonide, used as an as-needed rescue medicine, significantly reduced the risk of a severe exacerbation compared to albuterol by 27% in patients with asthma astrazeneca.com ↗
Compared with albuterol rescue, PT027 at the 180mcg albuterol/160mcg budesonide dose reduced the risk of a severe exacerbation by 27% (p<0.001) in adults and adolescents. |
| 2021-12-21 | Takeda | Regulatory Takeda Receives Complete Response Letter from the U.S. FDA for TAK-721 takeda.com ↗
The CRL indicates the FDA has completed its review of the TAK-721 NDA and determined that it cannot be approved in its present form. |
| 2020-12-15 | Takeda | Regulatory U.S. Food and Drug Administration Accepts New Drug Application for Review, Grants Priority Review for Takeda’s TAK-721 (budesonide oral suspension) for the Treatment of Eosinophilic Esophagitis takeda.com ↗ |
| 2019-11-26 | Marinomed Biotech AG | Results Marinomed Biotech AG: Detailed clinical data show rapid onset of action of Budesolv to alleviate hay fever marinomed.com ↗
As a summary, the data show that Budesolv is the first steroid nasal spray resulting in a clinically relevant reduction of symptoms – with approximately 50% of the maximum efficacy, within few hours after the first single treatment. |
| 2019-10-02 | Puma Biotechnology, Inc. | Results FDA Approves Labeling Supplement for Puma Biotechnology’s NERLYNX® (neratinib) for the Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer Interim data from the Phase II CONTROL Trial showed that the addition of prophylactic treatment with loperamide plus budesonide reduced the rate of discontinuation due to neratinib-associated diarrhea to 11% versus a discontinuation rate of 18% with loperamide alone. pumabiotechnology.com ↗
Interim data from the trial showed that the addition of prophylactic treatment with loperamide plus budesonide reduced the discontinuation rate due to neratinib-associated diarrhea to 11% versus a discontinuation rate of 18% with loperamide alone. |
| 2019-05-15 | Marinomed Biotech AG | Results Marinomed Biotech AG: Budesolv with a strongly decreased dose of the active ingredient compared to the marketed product Rhinocort Aqua shows pronounced efficacy already after first application – clinical validation of the Marinosolv® platform marinomed.com ↗
The available data proves that after one week of treatment, Budesolv 10μg achieves at least the same effect with a dose six times lower than Rhinocort Aqua 64μg, the current marketed reference product. |
| 2018-11-13 | Lupin Limited | Regulatory Lupin receives FDA approval for Budesonide Inhalation Suspension, 0.5 mg/2 mL lupin.com ↗ |
| 2018-02-05 | Tillotts Pharma AG | Regulatory Tillotts Pharma announces MHRA 1 approval of Entocort TM Capsules for Microscopic Colitis tillotts.com ↗ |
| 2018-01-26 | AstraZeneca | Results AstraZeneca reports top-line Phase III KRONOS trial results for PT010 triple combination therapy in chronic obstructive pulmonary disease astrazeneca.com ↗
In total, eight of the nine primary endpoints in the KRONOS trial were met, including two non-inferiority endpoints to qualify PT009, one of the comparators. |
| 2017-09-27 | Kissei Pharmaceutical Co., Ltd. | Regulatory 潰瘍性大腸炎治療剤「レクタブル®2mg注腸フォーム14回」の国内製造販売承認取得のお知らせ kissei.co.jp ↗
本日、EAファーマが、日本において、潰瘍性大腸炎治療剤「レクタブル ® 2mg注腸フォーム14回」（開発番号：AJG511、以下本剤）の製造販売承認を取得しましたのでお知らせいたします。 |
| 2017-05-15 | Paradigm Biopharmaceuticals Ltd. | Results Paradigms preclinical hay fever trial published paradigmbiopharma.com ↗
In the AR model, PPS showed equivalent treatment efficacy to the market leading intranasal corticosteroid, budesonide (Rhinocort Aqua Astra Zeneca) |
| 2017-04-04 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Interim Results of Phase II CONTROL Trial of PB272 in Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer at the 2017 AACR Annual Meeting pumabiotechnology.com ↗
The presentation entitled, “Effects of adding budesonide or colestipol to loperamide prophylaxis on neratinib-associated diarrhea in patients with HER2-positive early stage breast cancer: the CONTROL trial,” was presented as a poster presentation. |
| 2016-12-08 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Interim Results of Phase II CONTROL Trial of PB272 in Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer at the 2016 San Antonio Breast Cancer Symposium pumabiotechnology.com ↗
The interim analysis of the trial presented in the poster included a total of 135 patients who received neratinib plus loperamide prophylaxis (28 patients taking the original dosing and 107 patients taking the modified dosing) and 40 patients who received neratinib plus loperamide prophylaxis for 2 cycles and budesonide for 1 cycle. |
| 2016-09-28 | Zeria Pharmaceutical | Regulatory クローン病治療剤「ゼンタコートカプセル3mg」製造販売承認取得のお知らせ （PDF ファイル 0.09MB） zeria.co.jp ↗ |
| 2016-09-06 | GlaxoSmithKline | Results GSK presents positive results from phase III FULFIL study of closed triple combination therapy FF/UMEC/VI versus Symbicort® Turbohaler® in COPD at ERS International Congress gsk.com ↗
In addition, the proportion of patients who responded with the minimum clinically important difference in SGRQ (-4 units) was 50% on closed triple and 41% on budesonide/formoterol (odds ratio 1.41; p<0.001). |
| 2016-06-13 | Takeda | Regulatory Shire Receives FDA Breakthrough Therapy Designation for SHP621 and SHP625, Investigational Products for Rare Gastrointestinal Conditions takeda.com ↗
Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for two investigational products for rare diseases: SHP621 (budesonide oral suspension, or BOS) for eosinophilic esophagitis (EoE), and SHP625 (maralixibat) for progressive familial intrahepatic cholestasis type 2 (PFIC2). |
| 2014-04-29 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Receives European Marketing Authorization for DuoResp Spiromax® for the Treatment of Asthma and COPD tevapharm.com ↗
Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) announced today that the European Commission has granted marketing authorization for DuoResp Spiromax® for the treatment of patients with asthma and chronic obstructive pulmonary disease (COPD) where the use of a combination of an inhaled corticosteroid and long-acting beta2-adrenoceptor agonist is appropriate. |
| 2014-04-14 | Orion Corporation, Orion Pharma | Regulatory Orion receives first marketing authorisations for Bufomix Easyhaler® product orionpharma.com ↗
Orion Corporation has received Irish and Hungarian marketing authorisation for Bufomix Easyhaler®, an inhaled budesonide-formoterol combination product indicated for asthma and chronic obstructive pulmonary disease (COPD). |
| 2014-03-14 | Revalesio Corporation | Results REVALESIO PRESENTS PHASE I HUMAN DATA AT AAAAI revalesio.com ↗
Additionally, the study provided evidence that the combination of RNS60 with a low dose of budesonide may be as effective and safe as the treatment with a higher dose of budesonide. |
| 2014-02-21 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Receives CHMP Positive Opinion for DuoResp® Spiromax® for the Treatment of Patients Diagnosed with Asthma and COPD in Europe tevapharm.com ↗
This CHMP decision creates a path forward for a final approval decision from the European Commission that is expected in the next few months. |
| 2013-03-21 | Orion Corporation, Orion Pharma | Regulatory Orion has submitted a marketing authorisation application for combined budesonide-formoterol formulation of the Easyhaler® product family orionpharma.com ↗
Orion Corporation has submitted a marketing authorisation application for combined budesonide-formoterol formulation of the Easyhaler® product family in Europe. |
| 2012-02-07 | Orion Corporation, Orion Pharma | Results Orion Group Financial Statement Release for 2011 orionpharma.com ↗
study results received early in 2012 on a budesonide-formoterol formulation product under development for broadening the range of the Easyhaler® product family were promising, but yet insufficient for submission of an application for marketing authorisation. |
| 2012-02-07 | Orion Corporation, Orion Pharma | Results Orion continues development of inhalable budesonide-formoterol combined formulation orionpharma.com ↗
Study results received early in 2012 were promising, but yet insufficient for submission of an application for marketing authorisation. |
| 2009-02-24 | AstraZeneca | Results AstraZeneca’s Partner, MAP Pharmaceuticals, Announces Phase III Study Of Unit Dose Budesonide In Children With Asthma Did Not Meet Primary Endpoints astrazeneca.com ↗ |
| 2008-11-19 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Receives First U.S. Approval for Generic Pulmicort Respules®; Commences Commercial Launch tevapharm.com ↗
the U.S. Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of AstraZeneca's Pulmicort (Budesonide) Respules® |
All press releases naming this drug 65 releases
Evidence & citations 55 cited values
Every value below carries the sentence it was read from. 540 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | budesonide | “participants will use either a combination of budesonide/formoterol or mometasone/formoterol as both controller and rescue therapy or a stand alone inhaled steroid...” NCT06272370 ↗503“The goal of this clinical trial is to assess the efficacy and safety of extended TARPEYO® (delayed-release budesonide capsules) treatment in adult patients with primary IgA...” NCT06712407 ↗ “In the first study period (Period 1), patients with moderate to severe persistent asthma according to GINA criteria, with or without COPD, will be randomized at a 1: 1 ratio to...” NCT04233190 ↗ “compared to the FDC of formoterol 6 mcg/budesonide 200 mcg (Alenia® - Aché Laboratórios Farmacêuticos S.A.) in the maintenance treatment of asthma, allowing its registration as...” NCT05735431 ↗ “BGF 160 (Breztri Aerosphere™ in USA, Trixeo™ in France) Inhalation aerosol: pressurized metered dose inhaler containing a combination of budesonide (160 mcg), glycopyrrolate (9...” NCT06110403 ↗ “160 ug budesonide and 4.5 ug formoterol fumarate dihydrate, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25...” NCT02237508 ↗ “160 ug budesonide and 4.5 ug formoterol fumarate dihydrate, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25...” NCT02631941 ↗ “Relative Bioavailability of Budesonide/Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler Administered With and Without a Spacer: Results of a Phase I, Randomized,...” PMID 32253054 ↗ Apr 2020 “Nasal irrigation with corticosteroid (budesonide) consists of 240-mL nasal irrigation with Pulmicort Respules (0.5mg) across both nose sides via NeilMed Sinus Rinse bottle...” NCT04374474 ↗ “This study will be conducted to establish the relative bioavailability of budesonide and formoterol delivered via Symbicort pressurized metered-dose inhaler (pMDI) with and...” NCT02934607 ↗ “FDA approval of Airsupra (with both albuterol and budesonide in one inhaler) provides a unique opportunity to introduce ICS (along with albuterol) to ED patients with acute asthma.” NCT07166939 ↗ |
| Known as | AQ001S | “AQ001S 0.125 mg/2 ml (budesonide 0.125 mg/2 ml inhalation solution) single-dose administered by nebulization.” NCT05148312 ↗ |
| Known as | BD MDI | “Budesonide metered dose inhaler (BD MDI) 320 μg; PT008 administered as 2 inhalations, twice daily (BID)” NCT02196077 ↗1“Budesonide BD MDI (PT008)” NCT03847896 ↗ |
| Known as | BIS | “budesonide inhalation suspension (BIS) 0.5 QD” NCT02187445 ↗ |
| Known as | BOS | “In this double-blind, placebo-controlled, phase 3 trial, patients 11-55 years of age with EoE and dysphagia were randomized 2:1 to receive budesonide oral suspension (BOS) 2.0...” PMID 33887475 ↗ Apr 20214“The pharmacokinetic (PK) profile of budesonide oral suspension (BOS) was evaluated during a phase 2, randomized, double-blind, placebo-controlled, dose-ranging study in...” PMID 35666852 ↗ Jun 2022 “Budesonide oral suspension (BOS) 2.0 mg twice daily (b.i.d.) was evaluated in two consecutive phase III studies (12 and 36 weeks, respectively).” PMID 39735351 ↗ Dec 2024 “We investigated the long-term safety and efficacy of budesonide oral suspension (BOS) in eosinophilic esophagitis (EoE).” PMID 39954913 ↗ Feb 2025 “budesonide oral suspension (BOS/Eohilia) 2.0 mg twice daily (b.i.d.)” PMID 41711386 ↗ Feb 2026 |
| Known as | BOT | “Budesonide orodispersible tablets (BOT) have been shown to be safe and effective in phase III double-blind trials of induction and 48-week maintenance therapy of eosinophilic...” PMID 39694205 ↗ Dec 20241“a budesonide orodispersible tablet (BOT)” PMID 32721437 ↗ Jul 2020 |
| Known as | BUD | “The participants were then randomized to budesonide/formoterol (Bud + Form; 400/12 μg BID), fluticasone/salmeterol (Flu + Salm; 250/50 μg BID), or formoterol only (12 μg BID)...” PMID 34464242 ↗ Nov 20219“Many studies have shown the superior efficacy of budesonide (BUD)/formoterol (FORM) maintenance and reliever therapy, but still lack evidence of its efficacy in Chinese asthma patients” PMID 22932169 ↗ Sep 2012 “To assess equivalence of twice daily (bid) budesonide/formoterol (BUD/FM) 160/4.5 μg via breath-actuated metered-dose inhaler (BAI) versus pressurized metered-dose inhaler (pMDI).” PMID 25596138 ↗ Jan 2015 “twice-daily inhaled corticosteroid/long-acting β2-agonist therapy [budesonide/formoterol (BUD/FOR)] 400 µg/12 µg in patients with symptomatic COPD at risk of exacerbations” PMID 29313286 ↗ Jan 2018 “Symbicort® Turbohaler® (budesonide 200 μg plus formoterol fumarate 6 μg/actuation), 2 inhalations b.i.d. (daily dose of BUD 800 μg plus FF 24 μg).” NCT01351792 ↗ “Symbicort® total dose 400ug/12ug: is a combination of FORM (6ug) and ICS (Budesonide, (BUD) 200ug)” NCT01787097 ↗ “non-extrafine budesonide/formoterol (BUD/FF) 160/4.5 µg via dry-powder inhaler” PMID 33757520 ↗ Mar 2021 “fluticasone propionate/salmeterol [FP/S] and budesonide/formoterol [BUD/F]” PMID 30053956 ↗ Jun 2018 “Budesonide (BUD) DPI 200 mcg” NCT00442117 ↗ “Budesonide (BUD) Turbuhaler” NCT02991859 ↗ |
| Known as | Budecort | “Fluoxétine (Fluoxétine Arrow® 40 mg ) / Budésonide (Budecort® 2*400 mcg)” NCT04920838 ↗ |
| Known as | budedonide | “formoterol + budedonide (12/400 mcg) twice a day per 12 weeks” NCT01202084 ↗ |
| Known as | Budenofalk | “Budesonide (Budenofalk®), Prednisolone (Deltacortril®), Azathioprine (Imuran®)” NCT04921033 ↗2“received budesonide (Budenofalk, 9 mg/day initially, tapered to 4.5 mg/day)” PMID 25425655 ↗ Nov 2014 “9 mg budesonide once daily, Budenofalk, n = 30” PMID 24440672 ↗ Jan 2014 |
| Known as | Budenofalk granules | “budesonide 9 mg once daily (Budenofalk granules)” PMID 30195447 ↗ Sep 2018 |
| Known as | budesonide (Pulmicort) | “budesonide (Pulmicort)” NCT00462592 ↗ |
| Known as | Budesonide CFC | “Drug: Budesonide CFC” NCT00667992 ↗ |
| Known as | Budesonide Chlorofluorocarbon (CFC) | “Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks” NCT00667992 ↗ |
| Known as | Budesonide controlled ileal release (CR) capsules | “Drug: Budesonide controlled ileal release (CR) capsules” NCT05915104 ↗ |
| Known as | Budesonide Foam | “Drug: Budesonide Foam” NCT01349673 ↗ |
| Known as | Budesonide HFA | “Drug: Budesonide HFA” NCT00667992 ↗ |
| Known as | Budesonide Hydrofluoroalkane (HFA) | “Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks” NCT00667992 ↗ |
| Known as | Budesonide MMX | “Budesonide MMX™ is a once-daily oral formulation of budesonide that extends budesonide release throughout the colon using multi-matrix system (MMX) technology.” PMID 22892337 ↗ Aug 20121“Drug: Budesonide MMX®” NCT05915104 ↗ |
| Known as | Budesonide Nasal Spray | “Budesonide Nasal Spray 128ug/d for 8 week” NCT02668861 ↗ |
| Known as | Budesonide Oral Suspension | “In this double-blind, placebo-controlled, phase 3 trial, patients 11-55 years of age with EoE and dysphagia were randomized 2:1 to receive budesonide oral suspension (BOS) 2.0...” PMID 33887475 ↗ Apr 20211“Long-Term Treatment of Eosinophilic Esophagitis With Budesonide Oral Suspension.” PMID 34182150 ↗ Jun 2021 |
| Known as | Budesonide Powder for Inhalation | “Budesonide Powder for Inhalation” NCT02002715 ↗ |
| Known as | BUS | “2 mg budesonide suppositories (2 mg BUS;” PMID 29702300 ↗ Apr 2018 |
| Known as | Cortiment | “Cortiment (Budesonide 9 mg prolonged release tablet)” NCT05519514 ↗ |
| Known as | Entocort | “Prednisone, Entocort” NCT00109473 ↗ |
| Known as | Entocort CR | “receive (open-label) oral budesonide (Entocort CR 9 mg/day 8 weeks, 6 mg/day 2 weeks, 3 mg/day 2 weeks)” PMID 32681228 ↗ Jul 2020 |
| Known as | Entocort EC | “Budesonide (Entocort EC, AstraZeneca, Wilmington, DE) is an FDA-approved oral topical corticosteroid” NCT01950507 ↗1“Budesonide 80 mcg (Entocort EC) only” NCT01712854 ↗ |
| Known as | Eohilia | “budesonide oral suspension (BOS/Eohilia) 2.0 mg twice daily (b.i.d.)” PMID 41711386 ↗ Feb 20261“budesonide oral suspension (Eohilia)” NCT07358234 ↗ |
| Known as | MAP0010 | “0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks” NCT00697697 ↗4“2 doses of MAP0010 (Unit Dose Budesonide) in asthmatic children/adolescents” NCT00697801 ↗ |
| Known as | MB-9 | “Oral Budesonide Suspension (MB-9)” NCT01642212 ↗ |
| Known as | Nefecon | “Budesonide (Nefecon®), 16mg/d for 36 weeks, taken orally.” NCT07030894 ↗ |
| Known as | NEUMOTEX | “budesonide dry powder inhaler (DPI) 400 mcg twice daily (BID) (NEUMOTEX™ 400)” NCT02233803 ↗ |
| Known as | OBS | “This Phase II study is comparing oral budesonide (OBS) to placebo to demonstrate that OBS induces a histologic response and a symptom response using a Dysphagia Symptom...” NCT01642212 ↗2“We investigated the efficacy and safety of a new formulation of oral budesonide suspension (OBS), a corticosteroid, in a prospective, placebo-controlled, dose-ranging study.” PMID 24907502 ↗ Jun 2014 “Oral Budesonide Suspension (OBS)” NCT02736409 ↗ |
| Known as | Oral Budesonide Suspension (OBS) | “Participants will receive Oral Budesonide Suspension (OBS) 10 milliliter (ml) of 0.2 milligram per milliliter (mg/ml) twice daily up to 16 weeks.” NCT02605837 ↗1“Oral Budesonide Suspension (OBS)” NCT02736409 ↗ |
| Known as | OVB | “Placebo-controlled studies have not been conducted to evaluate the safety and efficacy of oral viscous budesonide (OVB).” PMID 20457157 ↗ May 20102“oral viscous budesonide (OVB) slurry” PMID 30872104 ↗ Mar 2019 “Drug: Oral Viscous Budesonide (OVB)” NCT01846962 ↗ |
| Known as | PT008 | “Budesonide (BD; PT008) and formoterol fumarate (FF; PT005) in a metered-dose inhaler (MDI); (BFF MDI; PT009)” NCT02196077 ↗1“Budesonide BD MDI (PT008)” NCT03847896 ↗ |
| Known as | Pulmicort | “Pulmicort (budesonide) 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening) plus terbutaline 0.4 mg powder for inhalation 'as needed', 52-week treatment” NCT02224157 ↗21“Pulmicort (budesonide) 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening) plus terbutaline 0.4 mg powder for inhalation 'as needed', 52-week treatment” NCT02149199 ↗ “Reference drug 1 : Pulmicort pMDI (Budesonide) Strength: (Budesonide 200ug/puff) Mode of administration: Orally inhaled administration, single dose (4 puffs)” NCT02165046 ↗ “Two puffs of Pulmicort ® turbuhaler 200µg/puff between 7 a.m. and 10 a.m and take orally a tablet of Singulair® 10mg one time per day.” NCT01147510 ↗ “Budesonide (Pulmicort) is a corticosteroid which is the mainstay treatment for CRS patients.” NCT04267042 ↗ “Budesonide (Pulmicort) - inhaled low dose inhaled steroid - I puff to be taken twice daily” NCT02771717 ↗ “Budesonide (Pulmicort®, AstraZeneca Pty Ltd., Australia; 0.5 mg or 1mL/kg/dose)” NCT00146497 ↗ “0.5 mg of budesonide (Pulmicort®, AstraZeneca, solution of 0.5 mg/2 ml)” NCT04016220 ↗ “Pulmicort® : Budesonide Powder for Inhalation (200μg)” NCT07267130 ↗ “or budesonide/Pulmicort, or fluticasone Flovent HFA” NCT06272370 ↗ “Pulmicort (budesonide) Turbuhaler” NCT00232674 ↗ |
| Known as | Pulmicort flexhaler | “Budesonide will be provided as Pulmicort flexhaler.” NCT02357277 ↗ |
| Known as | Pulmicort Respules | “Subjects randomized to receive a single dose of budesonide by nebulization (Pulmicort Respules) 1mg at Visit 2, and a single dose of budesonide/albuterol by metered-dose...” NCT04848662 ↗5“Commercial Pulmicort Respules (budesonide inhalation suspension 1 mg/2 mL) will be delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece operated to sputtering.” NCT04032834 ↗ “2 mL of 0.5 mg/ 2 mL budesonide (Pulmicort Respules, AstraZeneca Canada, Mis sissauga, ON, Canada) will be added to the irrigation bottles of the patients.” NCT06837051 ↗ “Commercial Pulmicort Respules (budesonide inhalation suspension 1 mg/2 mL) delivered by a conventional jet nebulizer operated to sputtering.” NCT03421730 ↗ “Pulmicort Respules® 1.0 mg/2 ml is a budesonide inhalation suspension administered by nebulization.” NCT05148312 ↗ “budesonide 0.5mg/2ml Pulmicort Respules budesonide inhalation suspension(BIS)” NCT05325489 ↗ |
| Known as | Pulmicort Turbuhaler | “Budesonide (Pulmicort® Turbuhaler®) 800ug inhaled twice daily (BID) will be taken in addition to usual care for 36 weeks.” NCT06860542 ↗2“Pulmicort Turbuhaler 200 µg, Dry powder inhaler, budesonide 200 µg/dose, 112 doses/Turbuhaler” NCT00855959 ↗ “budesonide (Pulmicort Turbuhaler; AstraZeneca, Lund, Sweden)” NCT00175747 ↗ |
| Known as | Pulmicourt Turbuhaler | “The patients with eosinophilic bronchitis received Pulmicourt Turbuhaler (Budesonide 100µg) 2puff Q12h for 4 weeks.” NCT02002715 ↗ |
| Known as | Pulmocort turbuhaler | “Budesonide (Pulmocort turbuhaler) 400 mcg (2 inhalations bid)” NCT00728715 ↗ |
| Known as | Rhinocort | “nasal hormones (Rhinocort®), or a combination of two or three drugs, may be used in severe cases” NCT06870292 ↗2“Budesonide Nasal Spray (Rhinocort, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.)” NCT04002349 ↗ |
| Known as | Rhinocort (commercial name for budesonide) | “Rhinocort (commercial name for budesonide)” NCT06830109 ↗ |
| Known as | Rhinocort Aqua | “Nasal budesonide (Rhinocort Aqua, AstraZeneca) is generally well tolerated.” NCT00560586 ↗ |
| Known as | Rhinorcort Astra Zeneca AB | “budesonide (Rhinorcort Astra Zeneca AB)” NCT04077892 ↗ |
| Known as | targeted-release budesonide | “Targeted-release budesonide versus placebo in patients with IgA nephropathy (NEFIGAN): a double-blind, randomised, placebo-controlled phase 2b trial.” PMID 28363480 ↗ Mar 2017 |
| Known as | TARPEYO | “The goal of this clinical trial is to assess the efficacy and safety of extended TARPEYO® (delayed-release budesonide capsules) treatment in adult patients with primary IgA...” NCT06712407 ↗ |
| Known as | TRF-budesonide | “a novel targeted-release formulation of budesonide (TRF-budesonide)” PMID 28363480 ↗ Mar 2017 |
| Known as | Unit Dose Budesonide | “Treatment B = a single dose of MAP0010 (unit dose budesonide) low dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.” NCT00627679 ↗1“2 doses of MAP0010 (Unit Dose Budesonide) in asthmatic children/adolescents” NCT00697801 ↗ |
| Known as | VR647 | “VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with mouthpiece” NCT04032834 ↗ |
| Known as | VR647 Inhalation Suspension | “VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System” NCT03421730 ↗ |
| Action | Inhibit | “The mechanism of action of budesonide is similar to other corticosteroids and includes a wide range of inhibitory activities against multiple cell types” NCT02696850 ↗ |
| Modality | Small molecule | “Budesonide, a corticosteroid with an extensive first-pass hepatic metabolism appeared promising for the treatment of PBC.” PMID 10655252 ↗ Feb 2000 |
| Route | Inhaled | “inhaled budesonide” NCT00000575 ↗ |