Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Abediterol · 2 trials · 2 indications
To assess Cmax after single inhaled dose of abediterol 5 μg. Cmax will be taken directly from the individual concentration-time curve.
To assess tmax after single inhaled dose of abediterol 5 μg. tmax will be taken directly from the individual concentration-time curve.
To assess AUClast after single inhaled dose of abediterol 5 μg.
To assess AUC(0-24) after single inhaled dose of abediterol 5 μg.
To assess Cmax after multiple once daily inhaled doses of abediterol 5 μg. Cmax will be taken directly from the individual concentration-time curve.
To assess tmax after multiple once daily inhaled doses of abediterol 5 μg. tmax will be taken directly from the individual concentration-time curve.
To assess λz after multiple once daily inhaled doses of abediterol 5 μg.
To assess t½λz after multiple once daily inhaled doses of abediterol 5 μg.
To assess AUClast after multiple once daily inhaled doses of abediterol 5 μg.
To assess AUC(0-24) after multiple once daily inhaled doses of abediterol 5 μg.
To assess CL/F after multiple once daily inhaled doses of abediterol 5 μg.
To assess Cavg after multiple once daily inhaled doses of abediterol 5 μg.
To assess %Fluctuation after multiple once daily inhaled doses of abediterol 5 μg.
To assess Rac (Cmax) after multiple once daily inhaled doses of abediterol 5 μg.
To assess Rac (AUC0-24) after multiple once daily inhaled doses of abediterol 5 μg.
Systolic and diastolic BP (in mmHg) will be measured after the patient has rested in the supine position for at least 5 minutes and before taking any blood sample and conducting any spirometry.
Pulse (beats per minute \[bpm\]) will be measured after the patient has rested in the supine position for at least 5 minutes and before taking any blood sample and conducting any spirometry.
12-Lead ECG results performed for safety evaluation will be listed for each patient and will include the ECG parameters (where applicable \[Screening, pre-dose Day 1 and Follow-up\]) and changes from baseline, assessment by the Investigator (normal/abnormal not clinically significant/abnormal clinically significant) and details of any abnormalities (rhythm, ectopy, conduction, morphology, myocardial infarction, ST segment, T wave and U wave observations).
Hematology and clinical chemistry values (including serial potassium and glucose) will be listed by patient and time point including changes from baseline (pre-dose Day 1) and repeat/unscheduled measurements. Urinalysis will include glucose, protein, blood, leucocytes, flow cytometry, microscopy.
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition can be symptoms (e.g., nausea, chest pain), signs (e.g., tachycardia, enlarged liver) or the abnormal results of an investigation (e.g., laboratory findings, electrocardiogram). In clinical studies an AE can include an undesirable medical condition occurring at any time after the patient has signed informed consent, including run-in or washout periods, even if no specific treatment has been administered.
Pharmacokinetics of AZD7594 and abediterol following single inhaled doses of AZD7594 alone, abediterol alone and the 2 compounds in FDC or in free combination via 2 separate DPIs
Pharmacokinetics of AZD7594 and abediterol following single inhaled doses of AZD7594 alone, abediterol alone and the 2 compounds in FDC or in free combination via 2 separate DPIs
Pharmacokinetics of AZD7594 and abediterol following single inhaled doses of AZD7594 alone, abediterol alone and the 2 compounds in FDC or in free combination via 2 separate DPIs
Pharmacokinetics of AZD7594 and abediterol following single inhaled doses of AZD7594 alone, abediterol alone and the 2 compounds in FDC or in free combination via 2 separate DPIs
Pharmacokinetics of AZD7594 and abediterol following single inhaled doses of AZD7594 alone, abediterol alone and the 2 compounds in FDC or in free combination via 2 separate DPIs
Pharmacokinetics of AZD7594 and abediterol following single inhaled doses of AZD7594 alone, abediterol alone and the 2 compounds in FDC or in free combination via 2 separate DPIs
Pharmacokinetics of AZD7594 and abediterol following single inhaled doses of AZD7594 alone, abediterol alone and the 2 compounds in FDC or in free combination via 2 separate DPIs
Pharmacokinetics of AZD7594 and abediterol following single inhaled doses of AZD7594 alone, abediterol alone and the 2 compounds in FDC or in free combination via 2 separate DPIs
Pharmacokinetics of AZD7594 and abediterol following single inhaled doses of AZD7594 alone, abediterol alone and the 2 compounds in FDC or in free combination via 2 separate DPIs
Pharmacokinetics of AZD7594 and abediterol following single inhaled doses of AZD7594 alone, abediterol alone and the 2 compounds in FDC or in free combination via 2 separate DPIs
Pharmacokinetics of AZD7594 and abediterol following single inhaled doses of AZD7594 alone, abediterol alone and the 2 compounds in FDC or in free combination via 2 separate DPIs
| Arm | Type | Description |
|---|---|---|
| Abediterol 5 μg | EXPERIMENTAL | Out of 12 randomized patients, 9 will receive abediterol 5 μg as dry inhalation powder orally once daily for 9 days. Patients will be provided salbutamol as rescue medication for use throughout the study. During the treatment period, all patients will be continued on their current ICSs. In addition, each patient will receive Abediterol 5.0 μg QD. |
| Placebo | PLACEBO_COMPARATOR | Out of 12 randomized patients, 3 will receive placebo as dry inhalation powder orally once daily for 9 days. Patients will be provided salbutamol as rescue medication for use throughout the study. During the treatment period, all patients will be continued on their current ICSs. In addition, each patient will receive placebo QD. |
| Treatment A (Abediterol ) | EXPERIMENTAL | Treatment A: The subjects will receive Abediterol 2.5 μg via DPI |
| Treatment B (AZD7594) | EXPERIMENTAL | Treatment B: The subjects will receive AZD7594 440 μg via DPI |
| Treatment C (AZD7594/abediterol ) | EXPERIMENTAL | Treatment C: The subjects will receive AZD7594/ abediterol 440 μg/2.5 μg FDC via DPI |
| Treatment D (AZD7594 and abediterol) | EXPERIMENTAL | Treatment D: The subjects will receive AZD7594 440 μg and abediterol 2.5 μg free combination administered via 2 separate DPIs |
| Name | Type | Description |
|---|---|---|
| Abediterol | DRUG | A β2-adrenoceptor agonists, produce smooth muscle relaxation in the airways and improves lung function. |
| Placebo | DRUG | Abediterol matching placebo without any pharmacological activity. |
| AZD7594 | DRUG | Treatment B: AZD7594 440 μg via DPI |
| AZD7594/abediterol | DRUG | Treatment C: AZD7594/abediterol 440 μg/2.5 μg FDC via DPI |
| AZD7594 and abediterol | DRUG | Treatment D: AZD7594 440 μg and abediterol 2.5 μg free combination administered via 2 separate DPIs |
Inclusion Criteria: * Provision of signed and dated, written informed consent prior to any study specific procedures. * Male and non-pregnant, non-lactating female patients aged 18 - 55 years with asthma and with suitable veins for cannulation or repeated venipuncture. * Non-smoker or former smoker...
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| Novartis AG Sponsored ADR | NVS | 5 | PHASE3 | QVM149, QMF149, Glycopyrronium bromide |
| GSK plc Sponsored ADR | GSK | 10 | PHASE3 | Trelegy Ellipta, Depemokimab, HFA-152a, GSK5784283, Ventolin |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 4 | PHASE3 | TEV-56248, ProAir (albuterol sulfate eMDPI), Budesonide/Formoterol SPIROMAX, Reslizumab |
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Dupilumab, Lunsekimig |
| AstraZeneca PLC | AZN | 28 | PHASE3 | Benralizumab, Tezepelumab, Budesonide/formoterol, Albuterol/budesonide, PT007 |
| Pfizer Inc. | PFE | 4 | PHASE3 | Tilrekimig, PF-07275315, PF-08103402 |
| Generate Biomedicines, Inc. | GENB | 3 | PHASE3 | GB-0895 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE2 | KT-621 |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Brenipatide |
| Incyte Corporation | INCY | 1 | PHASE2 | povorcitinib |
| Upstream Bio, Inc. | UPB | 1 | PHASE2 | Verekitug |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE2 | ARO-RAGE |
| Amgen Inc. | AMGN | 1 | PHASE1 | AMG 691 |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-95597528 |
| Apogee Therapeutics, Inc. | APGE | 1 | PHASE1 | APG777 |
| Celldex Therapeutics, Inc. | CLDX | 1 | PHASE1 | CDX-622 |
Abediterol is an investigational small molecule being developed by AstraZeneca PLC for respiratory conditions, specifically asthma and chronic obstructive pulmonary disease (COPD). It is delivered as an inhaled therapy and remains in clinical development, with Phase 1 studies completed to date.
Abediterol targets ADRB2, the beta-2 adrenergic receptor, and acts as an agonist at this receptor. This target class is well established in respiratory medicine, where beta-2 agonism supports bronchodilation in conditions such as asthma and COPD.
Abediterol is developed by AstraZeneca PLC, which trades under the ticker AZN. The company has sponsored the clinical studies evaluating the drug in asthma and COPD, including trials conducted in Germany.
Abediterol is in Phase 1 clinical development. It is an investigational agent and has not been approved for marketing. One Phase 1 trial has been completed, and no active trials are currently listed.
Abediterol has been studied in two completed Phase 1 trials. NCT03273127 assessed pharmacokinetics, safety, and tolerability over nine days of once-daily dosing in asthma patients on inhaled corticosteroids. NCT02967159 evaluated disposition and safety of single inhaled doses of abediterol and AZD7594 alone and in combination in healthy male participants.
Abediterol is being investigated for the treatment of asthma and chronic obstructive pulmonary disease (COPD). Its clinical program has focused on inhaled administration in these respiratory indications, including a trial in asthma patients already receiving inhaled corticosteroids.