Drugs / Olodaterol
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | STRIVERDI RESPIMAT | — | 2014-07-31 | fda.gov ↗ |
Trials 64 · started per year
today
US approved 2014
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 114 trials | ||||||
| Phase 1 | NCT02969317 | Feb → Jun 2017 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01703845 | Oct 2012 → Mar 2013 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01153711 | May → Aug 2010 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01153724 | May → Jul 2010 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02171832 | Jul → Dec 2009 | liver disorder | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02172157 | Feb → Apr 2008 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02172105 | Jan → May 2008 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02172144 | Jun → Oct 2007 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02171793 | Jun → Jul 2007 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02259959 | Apr → Sep 2007 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02172131 | Oct 2006 → Feb 2007 | — | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 1 | NCT02259946 | Apr → Jul 2006 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02171806 | Jan → Sep 2006 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02171780 | Feb → Jul 2005 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 213 trials | ||||||
| Phase 2 | NCT02030535 | Jan → Jun 2014 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT01428622 | Oct 2011 → ? | asthma | Boehringer Ingelheim | Withdrawn | No outcome recorded |
| Phase 2 | NCT01311661 | Mar → Dec 2011 | asthma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT01013753 | Feb 2010 → Jan 2011 | asthma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT01040403 | Jan 2010 → Feb 2011 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00846768 | Feb → Jul 2009 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00824382 | Jan 2009 → Mar 2010 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00720499 | Jul 2008 → Feb 2009 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00696020 | Jun 2008 → Feb 2009 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00467740 | May 2007 → Oct 2008 | asthma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00452400 | Mar 2007 → Jan 2008 | asthma, chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00928668 | Jan → Oct 2006 | asthma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT01809262 | Dec 2005 → Nov 2006 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 324 trials | ||||||
| Phase 3 | NCT05927155 | Jun 2021 → Mar 2022 | chronic obstructive pulmonary disease | Erasme University Hospital | Completed | No outcome recorded |
| Phase 3 | NCT02629965 | Feb 2016 → Mar 2017 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT02296138 | Jan 2015 → Mar 2017 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT02085161 | Mar 2014 → Aug 2015 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01964352 | Nov 2013 → Oct 2014 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT02006732 | Nov 2013 → Oct 2014 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01969721 | Oct 2013 → Jan 2015 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01696058 | Sep 2012 → Oct 2013 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01694771 | Sep 2012 → Aug 2013 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01559116 | Mar 2012 → Aug 2013 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01525615 | Feb 2012 → Sep 2013 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01536262 | Feb 2012 → Sep 2013 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01431274 | Sep 2011 → Sep 2013 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01431287 | Sep 2011 → Nov 2013 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01040689 | Jan 2010 → Jan 2011 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01040728 | Jan 2010 → Jan 2011 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01040793 | Jan 2010 → Apr 2011 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01040130 | Jan 2010 → Apr 2011 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT00931385 | Jun 2009 → Apr 2010 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT00932646 | Jun 2009 → May 2010 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT00782509 | Feb 2009 → Sep 2010 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT00793624 | Feb 2009 → Dec 2010 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT00796653 | Jan 2009 → Dec 2010 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT00782210 | Nov 2008 → Sep 2010 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 410 trials | ||||||
| Phase 4 | NCT04231214 | Jan 2020 → Apr 2023 | chronic obstructive pulmonary disease | Fraunhofer-Institute of Toxicology and Experimental Medicine | Completed | No outcome recorded |
| Phase 4 | NCT04223843 | Jan → Sep 2020 | chronic obstructive pulmonary disease | Boehringer Ingelheim | 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 | NCT03265145 | Sep 2017 → Sep 2020 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 4 | NCT03240575 | Aug 2017 → Apr 2019 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 4 | NCT03055988 | Mar 2017 → Mar 2018 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 4 | NCT03425617 | Jan 2017 → Jun 2018 | chronic obstructive pulmonary disease | Queen's University | Completed | No outcome recorded |
| Phase 4 | NCT02853123 | Sep 2016 → Jul 2017 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 4 | NCT02812862 | Aug 2016 → Aug 2017 | chronic obstructive pulmonary disease | RWTH Aachen University | Withdrawn | No outcome recorded |
| Phase 4 | NCT02799784 | Jul 2016 → Apr 2017 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT07541378 | Mar 2024 → Feb 2025 | chronic obstructive pulmonary disease | Medical University of Bialystok | Suspended | No outcome recorded |
| — | NCT04994574 | Aug 2021 → Jul 2024 | chronic obstructive pulmonary disease | Yonsei University | Completed | No outcome recorded |
| — | NCT05295355 | Jan 2021 → Sep 2024 | chronic obstructive pulmonary disease | Guangzhou Institute of Respiratory Disease | Unknown | No outcome recorded |
Also used as a comparator or background therapy in 10 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT02222428 Comparator | Apr → Jul 2009 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02220660 Comparator | Mar → Jun 2009 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02231177 Comparator | Jun → Nov 2008 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT03673670 Background | Jul → Nov 2018 | chronic obstructive pulmonary disease | Verona Pharma, Inc. | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT01533922 Comparator | Mar 2012 → Nov 2013 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01533935 Comparator | Feb 2012 → Nov 2013 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT03152149 Comparator | Jun 2017 → Nov 2019 | chronic obstructive pulmonary disease | University of Dundee | Completed | No outcome recorded |
| Phase 4 | NCT02682862 Comparator | Jul 2016 → May 2019 | asthma | University of Dundee | Completed | No outcome recorded |
| Phase 4 | NCT02683109 Comparator | Mar 2016 → Jan 2017 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07058259 Background | Nov 2024 → Jun 2025 overdue | chronic obstructive pulmonary disease | Istanbul Medeniyet University | Active not recruiting | No outcome recorded |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 76 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Olodaterol | “Relative Bioavailability of 10 mcg Olodaterol (Solution for Inhalation Administered With the Respimat) at Steady State Alone or in Combination With Multiple Doses of 400 mg...” NCT01153711 ↗54“Dual Therapy (LABA + LAMA): Patients receive a long-acting beta-agonist (LABA) such as Formoterol, Salmeterol, Olodaterol, Vilanterol, or Indacaterol, in combination with a...” NCT07058259 ↗ “Assessment In a Real World Setting of the Effect of Inhaled Steroid-based Triple Therapy Versus the Combination of Tiotropium and Olodaterol on Reducing Chronic Obstructive...” NCT03265145 ↗ “Each actuation from the RESPIMAT inhaler delivers 3.124 mcg tiotropium bromide monohydrate (equivalent to 2.5 mcg tiotropium) and 2.736 mcg olodaterol hydrochloride (equivalent...” NCT02799784 ↗ “Olodaterol is a novel, inhaled long-acting β2-agonist (LABA) with >24-hour duration of action investigated in asthma and chronic obstructive pulmonary disease.” PMID 26283085 ↗ Aug 2015 “All eligible patients were randomized to receive 2 µg, 5 µg, or 10 µg of olodaterol or placebo for 4 weeks via the Respimat Soft Mist inhaler.” PMID 26316741 ↗ Aug 2015 “Inhalation of 4 puffs of 2,5 µg of a long-acting beta2-agonist (LABA-olodaterol) administered via a spacer device” NCT05927155 ↗ “Single Dose Ranging Study of BI 1744 CL (Olodaterol) in Chronic Obstructive Pulmonary Disease” NCT01809262 ↗ “Relative Bioavailability of Olodaterol and Fluconazole” NCT01153724 ↗ “Olodaterol” NCT03662711 ↗ |
| Known as | BI 1744 CL | “Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of 4 Weeks of Treatment of Orally Inhaled BI 1744 CL (3 - 4 Doses)...” NCT00452400 ↗ |
| Known as | BI1744 | “Efficacy and Safety of 4 Weeks of Treatment With Orally Inhaled BI1744/Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease (COPD)” NCT00720499 ↗11“BI 1744 (Olodaterol) Low Dose” NCT00932646 ↗ “Drug: Olodaterol (BI 1744)” NCT00782509 ↗ “Drug: Olodaterol (BI 1744)” NCT01040793 ↗ “Drug: Olodaterol (BI 1744)” NCT00796653 ↗ “Drug: Olodaterol (BI 1744)” NCT01040130 ↗ “Drug: Olodaterol (BI1744)” NCT00782210 ↗ “olodaterol (BI 1744) low” NCT01040403 ↗ “Olodaterol (BI1744) Low” NCT01040689 ↗ “Olodaterol (BI1744) Low” NCT01040728 ↗ “Olodaterol (BI 1744)” NCT01013753 ↗ |
| Known as | Odaterol | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05295355 ↗ |
| Known as | olodaterol hydrochloride | “Each actuation from the RESPIMAT inhaler delivers 3.124 mcg tiotropium bromide monohydrate (equivalent to 2.5 mcg tiotropium) and 2.736 mcg olodaterol hydrochloride (equivalent...” NCT02799784 ↗ |
| Known as | Striverdi respimat | ChEMBL registry synonym — accepted as the source's own label CHEMBL605846 ↗ |
| Action | Activate | “Beta-2 adrenergic receptor agonist” CHEMBL605846 ↗1“long-acting β2-agonist” PMID 26283085 ↗ Aug 2015 |
| Modality | Small molecule | — CHEMBL605846 ↗ |
| Route | Inhaled | “Orally inhaled BI 1744 CL” NCT00467740 ↗ |
| Target | ADRB2 | “Beta-2 adrenergic receptor agonist” CHEMBL605846 ↗ |