Drugs / Olodaterol
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed chronic obstructive pulmonary disease 1 milestone | |||||
| Filed | US (FDA) | — | chronic obstructive pulmonary disease | 2014-08-19 | “FDA accepted for review the New Drug Application (NDA) for the fixed-dose combination (FDC) of tiotropium and olodaterol” prnewswire.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | STRIVERDI RESPIMAT | — | 2014-07-31 | fda.gov ↗ |
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News releases announcing trial results or a regulatory action · 21
| Date | Issuer | Release |
|---|---|---|
| 2018-10-11 | Boehringer Ingelheim | Regulatory FDA Approves Stiolto® Respimat® Supplemental New Drug Application (sNDA) to Add Data on COPD Exacerbation Reduction prnewswire.com ↗
The FDA also revised the indication for Stiolto Respimat, which is now approved for the treatment of patients with COPD, including chronic bronchitis and emphysema. |
| 2018-03-29 | Boehringer Ingelheim | Results New Large-Scale Trial Results Show Stiolto® Respimat® Prevents COPD Exacerbations Better Than Spiriva® Respimat® prnewswire.com ↗
The DYNAGITO study results show that treatment with Stiolto Respimat resulted in a 7 percent lower rate of moderate-to-severe COPD exacerbations compared with Spiriva Respimat alone (p=0.0498), not reaching the targeted significance level (p=0.01) as pre-defined in the study. |
| 2017-11-01 | GlaxoSmithKline | Results GSK study demonstrates superiority of Anoro Ellipta to Stiolto Respimat in improving lung function in chronic obstructive pulmonary disease gsk.com ↗
This endpoint was met and, furthermore, UMEC/VI demonstrated superiority to TIO/OLO, with a difference in treatment effect of 52mL on trough FEV1 at week eight (UMEC/VI 180mL vs. TIO/OLO 128mL; 95% CI: 28, 77; p<0.001). |
| 2016-10-17 | Boehringer Ingelheim | Results New Data Analyses Provide Insights That May Help Predict COPD Exacerbation Risk prnewswire.com ↗
Boehringer Ingelheim today announced new data analyses from the Phase III TONADO® 1&2 trials that build upon existing evidence about the factors that increase the risk of a COPD exacerbation. |
| 2016-09-05 | Boehringer Ingelheim | Results New Data: STIOLTO® RESPIMAT® (tiotropium bromide+olodaterol) Inhalation Spray Significantly Improved Exercise Capacity in People with COPD prnewswire.com ↗
Boehringer Ingelheim today announced the first results from the Phase IIIb/IV PHYSACTO trial that showed STIOLTO RESPIMAT, combined with exercise training, helps people with COPD walk for longer periods of time compared to those receiving placebo. |
| 2016-03-29 | Boehringer Ingelheim | Regulatory FDA Approves Supplemental New Drug Application (sNDA) for Boehringer Ingelheim's STIOLTO RESPIMAT for COPD Health-Related Quality of Life prnewswire.com ↗
today announced that the U.S. Food and Drug Administration (FDA) approved a sNDA for STIOLTO RESPIMAT that adds data showing improvement in health-related quality of life among people with chronic obstructive pulmonary disease (COPD) to the product labelling. |
| 2016-02-09 | Boehringer Ingelheim | Results Newly Published Head-to-Head Data Show STIOLTO RESPIMAT Improved Lung Function Across Range of Measures prnewswire.com ↗
These newly published data show a lung function improvement among COPD patients with STIOLTO RESPIMAT across a range of commonly used measures of lung function. |
| 2015-10-27 | Boehringer Ingelheim | Results New Sub-Analyses Presented for STIOLTO RESPIMAT Across a Range of COPD Patient-Reported Outcomes Measures prnewswire.com ↗
One analysis showed significant lung function improvement, as measured by FEV 1 AUC 0–3 , with once daily STIOLTO RESPIMAT across a range of age groups of COPD patients |
| 2015-09-28 | Boehringer Ingelheim | Results New Head-to-Head STIOLTO RESPIMAT Data Presented at ERS Annual Congress prnewswire.com ↗
The results from the head-to-head ENERGITO® study build on the growing body of evidence supporting the ability of STIOLTO RESPIMAT to improve lung function in COPD patients. |
| 2015-08-17 | Boehringer Ingelheim | Results New Published Data Show STIOLTO™ RESPIMAT® Provides Clinically Meaningful Improvements in COPD Health-Related Quality of Life Measure prnewswire.com ↗
Boehringer Ingelheim today announced the publication of new data from the Phase IIIb OTEMTO ® 1&2 trials, which show STIOLTO RESPIMAT provided clinically meaningful improvements in SGRQ total score, compared to placebo, in patients with chronic obstructive pulmonary disease (COPD). |
| 2015-05-26 | Boehringer Ingelheim | Regulatory FDA Approves Boehringer Ingelheim's STIOLTO RESPIMAT Inhalation Spray as Once-Daily Maintenance Treatment for COPD prnewswire.com ↗
Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) approved once-daily STIOLTO ™ RESPIMAT ® (tiotropium bromide and olodaterol) Inhalation Spray. |
| 2015-05-20 | Boehringer Ingelheim | Results New Data Analyses on Investigational Tiotropium/Olodaterol Respimat Showed Greater Lung Function Improvement Compared to Tiotropium and Olodaterol Alone prnewswire.com ↗
In these analyses, we saw that tiotropium/olodaterol RESPIMAT demonstrated a statistically significant improvement in lung function compared to tiotropium and olodaterol alone for COPD patients across all stages of the disease (A-D). |
| 2014-10-27 | Boehringer Ingelheim | Results Boehringer Ingelheim Presents Data for the Co-Administration of Two Approved Products for COPD Patients prnewswire.com ↗
At Week 12, patients receiving T+O showed significant improvements in lung function, as measured by trough forced expiratory volume in one second (FEV 1 ) and FEV 1 area under the curve from 0-3 hours (FEV 1 AUC 0-3h ), compared to patients receiving tiotropium + placebo (T+P). |
| 2014-09-08 | Boehringer Ingelheim | Results Boehringer Ingelheim Presents Pivotal Phase III Data for the Investigational Fixed-Dose Combination of Tiotropium + Olodaterol in COPD prnewswire.com ↗
The results from the TONADO™ studies showed that the combination has the potential to improve lung function compared to the individual components alone in people with COPD, |
| 2014-08-19 | Boehringer Ingelheim | Regulatory Boehringer Ingelheim Announces U.S. Filing for the Fixed-Dose Combination Tiotropium Plus Olodaterol for Patients with COPD prnewswire.com ↗
Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) for the fixed-dose combination (FDC) of tiotropium and olodaterol delivered via the Respimat ® inhaler for the proposed indication of long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. |
| 2014-08-01 | Boehringer Ingelheim | Regulatory FDA Approves Boehringer Ingelheim's Striverdi® Respimat® (olodaterol) Inhalation Spray for Maintenance Treatment of COPD prnewswire.com ↗
Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has approved Striverdi ® Respimat ® (olodaterol) Inhalation Spray 5 mcg as a long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. |
| 2014-05-21 | Boehringer Ingelheim | Results Boehringer Ingelheim Presents First Phase 3 Data on Fixed-Dose Combination of Tiotropium Plus Olodaterol in COPD prnewswire.com ↗
These data were presented as a late-breaking poster at the American Thoracic Society (ATS) 2014 International Conference. |
| 2013-09-08 | Boehringer Ingelheim | Results Olodaterol Shows Sustained Improvements in Lung Function in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) prnewswire.com ↗
The data presented at ERS showed that the improvements seen in lung function with olodaterol, as measured by FEV 1 responses, were maintained over 24 hours ( P < 0.001): |
| 2013-01-29 | Boehringer Ingelheim | Regulatory FDA Advisory Committee Recommends Approval for Boehringer Ingelheim's Olodaterol for Maintenance Treatment of COPD prnewswire.com ↗
The Committee also voted affirmatively that data showed the efficacy and safety of olodaterol supports approval of the 5 microgram dose. |
| 2012-09-03 | Boehringer Ingelheim | Results Boehringer Ingelheim Presents First Results of Phase II Study of Investigational COPD Combination prnewswire.com ↗
Significant improvements were seen for all combinations of doses tested (tiotropium 1.25, 2.5 and 5 microgram / olodaterol 5 microgram, 10 microgram) compared with the respective olodaterol monotherapies. |
| 2012-05-21 | Boehringer Ingelheim | Results Results of Phase II Study of Boehringer Ingelheim's Investigational Bronchodilator for COPD Presented at 2012 ATS International Conference prnewswire.com ↗
In this Phase II randomized, double-blind, cross-over study, olodaterol administered QD as 5 micrograms or 10 micrograms provided a significant and identical increase in the lung function parameter FEV1 over a 24-hour period. |
All press releases naming this drug 23 releases
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)” NCT01040130 ↗ “Drug: Olodaterol (BI 1744)” NCT00796653 ↗ “Olodaterol (BI 1744) High” 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 ↗ |