Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [C14]AZD9668
AZD9668 · 8 trials · 4 indications
AWT-Pi10 (mm) as a measure of structural changes in airways. End of treatment Least Squares Mean.
Forced expiratory volume in 1 second (FEV1) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits
Percentage of neutrophils in white blood cell count.Change from Baseline (mean of 2 baseline visits) to the end of the treatment period (mean of 2 visits at the end of the treatment)
Sputum weight (g) collected during 24 hour periods. Change from Baseline to day 28.
Forced Expiratory Volume in 1 second (L) as a measure of lung function.Change from Baseline to day 28.
Slow Vital capacity (L) as a measure of lung function. Change from Baseline to day 28.
FEF25-75% (L) as a measure of lung function. Change from Baseline to day 28.
Forced Vital Capacity (L) as a measure of lung function. Change from Baseline to day 28.
Morning Peak Expiratory Flow (L/min) as a measure of lung function.Change from baseline value to mean of the last 7 days on treatment
Evening Peak Expiratory Flow (L/min) as a measure of lung function.Change from baseline value to mean of the last 7 days on treatment
The Bronkotest diary card includes 8 questions on signs and symptoms. Symptom scores were recorded for night-time symptoms, breathing, sputum colour, sputum amount, sputum type, wellbeing, and cough, generally scored on a scale from 0 (no symptoms) to 4 (worst symptoms). ANOVA models were fitted to compare the change from baseline between AZD9668 and placebo for each question separately, with a p-value of 0.1 considered statistically significant. The number of number of these 8 measures with significant differences is reported.
Cystic Fibrosis Questionnaire Overall Score as a measure of quality of life and disease symptoms. Scores range from 0 to 100, with higher scores indicating better health. The overall score is the sum of 12 subscores. Change from baseline to day 28.
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits
Sputum weight (g) collected during 24 hour periods.Change from Baseline to day 28
SGRQ total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). Change from baseline to day 28.
ALT level greater than 3 times the upper limit of normal
AST level greater than 3 times the upper limit of normal
Change from baseline to Day 14
Change from baseline to Day 14
Creatinine level greater than the upper limit of normal
Change from baseline to Day 14
Change from baseline to Day 14
Change from baseline to Day 14
QTcF interval greater than 450 ms
QTcF change from baseline greater than 60 ms
Change from baseline to Day 14
AUC(0-12) following 14 days' dosing
Cmax following 14 days' dosing
tmax following 14 days' dosing
t1/2 following 14 days' dosing
CLR following 14 days' dosing
| Arm | Type | Description |
|---|---|---|
| AZD9668 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| 3 | ACTIVE_COMPARATOR | AZD9668 active treatment |
| 4 | PLACEBO_COMPARATOR | AZD9668 placebo treatment |
| AZD9668 active treatment | EXPERIMENTAL | - |
| AZD9668 placebo treatment | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| AZD9668 | DRUG | 2 x 30 mg oral tablets twice daily (bid) for 12 weeks |
| Placebo | DRUG | 2 x matched placebo to oral tablet twice daily (bid) for 12 weeks |
| AZD9668 Placebo | DRUG | 2 x Matched placebo to oral tablet twice daily (bid) for 12 weeks |
| AZD9668 Placebo equivalent | DRUG | Match placebo to 60 mg, oral tablet, twice daily for 28 days |
Inclusion Criteria: * Diagnosis of COPD with symptoms over 1 year * FEV1/FVC \< 70% and FEV1 \>= 40 and \< =70 % of predicted post-bronchodilator * Ex-smokers for at least 12 months Exclusion Criteria: * Past history or current evidence of clinically significant heart disease * Current diagnosis ...
Top 4 of 6 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 3 | PHASE2 | AZD0292 |
| GSK plc Sponsored ADR | GSK | 1 | PHASE2 | GSK3862995B |
| Merck & Co., Inc. | MRK | 1 | PHASE2 | Ensifentrine |
| Genentech, Inc. | RHHBY | 1 | PHASE1 | GDC-6988 |
AZD9668 is an investigational small molecule developed for respiratory conditions, specifically bronchiectasis, chronic obstructive pulmonary disease (COPD), and cystic fibrosis. It has been studied in clinical trials as a treatment for patients with these chronic lung diseases, but it is not an approved therapy.
AZD9668 is developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca sponsored the clinical trial program for the drug across multiple countries including Canada, Denmark, the Netherlands, Romania, Ukraine, Germany, Bulgaria, Czechia, Hungary, Poland, and Slovakia.
AZD9668 reached Phase 2 clinical development. Six trials have been completed in total, including Phase 1 bioavailability studies and Phase 2 efficacy and safety trials in COPD. No trials are currently active, and the drug is not approved for any indication.
Completed AZD9668 trials include NCT01054170, a Phase 2 study of twice daily 60mg AZD9668 for 12 weeks in COPD, and NCT01023516, a Phase 2 efficacy and safety trial of the same dose in 615 COPD patients on background budesonide/formoterol. Phase 1 bioavailability studies NCT01035411 and NCT01034982 were also completed.
Yes, C14AZD9668 is an alternative designation for AZD9668, the AstraZeneca small molecule studied in respiratory disease. Both names refer to the same investigational compound, which has been evaluated in bronchiectasis, chronic obstructive pulmonary disease, and cystic fibrosis.
Across six completed trials, AZD9668 enrolled a total of 1,566 participants. The studies were randomized, double-blind, and placebo-controlled. The largest trial, NCT01023516, enrolled 615 COPD patients, while the smallest, NCT01035411, enrolled 15 healthy volunteers.