Drugs / Symbicort
Symbicort
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | SYMBICORT | — | 2006-07-21 | fda.gov ↗ |
Trials 8 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01980615 | Nov → Dec 2013 | — | Pearl Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT01432080 | Sep 2011 → Dec 2012 | bronchiolitis obliterans syndrome, cryptogenic organizing pneumonia | Maisonneuve-Rosemont Hospital | Terminated | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT00628758 | Dec 2005 → Sep 2008 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT06568445 | Aug 2024 → Apr 2027 expected | asthma | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT03924635 | Aug 2019 → Dec 2022 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT03662711 | Nov 2018 → Oct 2022 | chronic obstructive pulmonary disease | Università degli Studi di Ferrara | Terminated | No outcome recorded |
| Phase 4 | NCT02233803 | Nov 2014 → Dec 2015 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00576316 | Jan → Nov 2008 | asthma | AstraZeneca | Completed | No outcome recorded |
Also used as a comparator or background therapy in 10 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01627158 Comparator | Jun → Oct 2012 | asthma | Orion Corporation, Orion Pharma | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT02093195 Background | Dec 2013 → Dec 2015 | chronic obstructive pulmonary disease | Air Force Military Medical University, China | Unknown | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT06895460 Background | Jun 2025 → Jun 2027 expected | asthma | The First Affiliated Hospital with Nanjing Medical University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05322707 Comparator | Apr 2022 → Aug 2023 | asthma | Cipla Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT04607629 Background | Jun 2018 → Apr 2019 | asthma | AO GENERIUM | Completed | No outcome recorded |
| Phase 3 | NCT03468790 Background | May 2018 → Jan 2021 | allergic asthma | Shanghai Biomabs Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT02495168 Comparator | Jan 2017 → May 2018 | asthma | Actavis Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00536731 Comparator | Sep 2007 → Apr 2008 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT02546297 Comparator | Sep 2017 → Sep 2020 | bronchiectasis | Shanghai Pulmonary Hospital, Shanghai, China | Unknown | No outcome recorded |
| Phase 4 | NCT01769898 Background | Jul 2013 → Sep 2014 | bronchiectasis | The First Affiliated Hospital of Guangzhou Medical University | Completed | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-11-10 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Viatris Wins Court Decision Invalidating AstraZeneca's Symbicort® Patent viatris.com ↗ |
| 2021-03-08 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Viatris Inc. and Kindeva Drug Delivery Announce FDA Tentative Approval of the First Abbreviated New Drug Application Generic Version of Symbicort® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol viatris.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SYMBICORT | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03924635 ↗ |
| Known as | budesonide-formoterol | “Budesonide formoterol” NCT03662711 ↗ |
| Known as | Budesonide/Formoterol Fumarate Dihydrate | “Symbicort® (Budesonide/Formoterol Fumarate Dihydrate)” NCT02495168 ↗ |
| Known as | Formoterol-budesonide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01769898 ↗ |
| Known as | Symbicort 160/4.5 | “Maintenance at initial treatment sequential as-needed therapy with inhaled budesonide-formoterol(Symbicort 160/4.5) ®）” NCT06568445 ↗ |
| Known as | Symbicort MDI | “Symbicort MDI taken as 2 inhalations” NCT01980615 ↗ |
| Known as | Symbicort pMDI | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00536731 ↗ |
| Known as | Symbicort turbuhaler | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02093195 ↗ |
| Route | Inhaled | “Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily” NCT00536731 ↗ |