Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Abediterol 0.156 μg · 1 trial · 1 indication
Baseline for FEV1 was defined as the mean of the two measured values for the corresponding variable (2 measurements 30 min apart, at -45 min and -15 min), prior to the morning investigational product (IP) administration on Day 1 of each treatment period. If both were missing the screening value was used instead. Trough is defined as the mean of the FEV1 values obtained at 23 h and 24 h after the morning IP administration. If one of the values was missing, the other one was used as trough.
| Arm | Type | Description |
|---|---|---|
| Abediterol dry powder inhaler 0.156 μg | EXPERIMENTAL | Dry powder for inhalation administered via dry powder inhaler 0.156 μg/inhalation; (1 inhalation) |
| Abediterol dry powder inhaler 2.5 μg | EXPERIMENTAL | Dry powder for inhalation, administered via dry powder, inhaler 2.5 μg/inhalation; (1 inhalation). |
| Abediterol pressurised metered-dose inhaler 0.05μg | EXPERIMENTAL | Pressurised metered-dose, inhaler 0.025 μg/puff; (2 puffs). |
| Abediterol pressurised metered-dose inhaler 0.156 μg | EXPERIMENTAL | Pressurised metered-dose, inhaler 0.078 μg/puff; (2 puffs). |
| Abediterol pressurised metered-dose inhaler 2.5μg | EXPERIMENTAL | Pressurised metered-dose inhaler 1.25 μg/puff; (2 puffs). |
| Placebo | PLACEBO_COMPARATOR | Pressurised metered-dose inhaler (2 puffs) and Dry powder for inhalation administered via dry powder inhaler (1 inhalation). |
| Name | Type | Description |
|---|---|---|
| Abediterol 0.156 μg | DRUG | Dry powder for inhalation |
| Abediterol 2.5 μg | DRUG | Dry powder for inhalation |
| Abediterol 0.05 μg | DRUG | Pressurised metered-dose inhaler |
| Placebo | OTHER | Pressurised metered-dose inhaler and dry powder for inhalation. |
Inclusion Criteria: 1. Provision of informed consent before any study specific procedures. 2. Men or non-pregnant, non-lactating women 18 to 75 years of age, inclusive. 3. Non-smoker or ex-smoker (quit ≥6months prior to Visit 1) with a total smoking history of ≤10 pack years. 4. Documented clinical...
Top 16 of 18 competitors
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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 0.156 μg is an investigational inhaled therapy being studied for asthma. It is a small molecule bronchodilator developed by AstraZeneca PLC. The 0.156 μg designation refers to a specific microgram dose strength evaluated in clinical testing. It has not been approved for any indication and remains in clinical development.
Abediterol 0.156 μg targets ADRB2, the beta-2 adrenergic receptor. It acts as an agonist at this receptor, a mechanism class associated with bronchodilation in respiratory conditions. The target class is agonist. This receptor-level activity is the basis for its evaluation in asthma.
Abediterol 0.156 μg is being developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor associated with the clinical program for this inhaled asthma candidate.
Abediterol 0.156 μg is in Phase 1 clinical development. It is an investigational small molecule and has not been approved by the FDA or any regulatory authority. The program has completed one Phase 1 trial and currently has no active trials listed.
Abediterol 0.156 μg has been evaluated in one completed Phase 1 trial, NCT02777827, titled A Single Dose PD & PK Study With Two Formulations of Abediterol in Patients With Asthma. The trial enrolled 30 participants in Germany, was randomized, double-blind, and placebo-controlled, and included adults 18 years and older.