Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Lesogaberan
AZD3355 · 9 trials · 10 indications
Number of reflux episodes assessed during ambulatory impedance-pH recording (defined as starting with a drop in impedance to below 50% of baseline and ending when impedance recovers to above 50% of baseline)
Symptom intensity rated by participants twice daily on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) using an electronic Reflux Symptom Questionnaire diary. (GERD = Gastroesophageal Reflux Disease)
Symptom intensity rated on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe)
The number of relaxations for each patient in each period was determined from manometric tracings according to previously published criteria (R.H. Holloway, R. Penagini and A.C. Ireland, Criteria for objective definition of transient lower esophageal sphincter relaxation, Am J Physiol 268 (1995), pp. G128-G133). The analysis of the number of TLESRs was based on an analysis of variance (ANOVA) for log-transformed data. The 95% level confidence interval (CI) limits were transformed back to the original scale to give CIs for the geometric mean for each treatment.
Symptom intensity rated by participants twice daily on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) using an electronic Reflux Disease Questionnaire (RDQ) diary
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | AZD3355 30 mg |
| B | EXPERIMENTAL | AZD3355 90 mg |
| C | EXPERIMENTAL | AZD3355 120 mg |
| D | EXPERIMENTAL | AZD3355 240 mg |
| E | PLACEBO_COMPARATOR | Placebo |
| 60 mg | EXPERIMENTAL | PPI+lesogaberan (AZD3355) 60 mg bid |
| 120 mg | EXPERIMENTAL | PPI+lesogaberan (AZD3355) 120 mg bid |
| 180 mg | EXPERIMENTAL | PPI+lesogaberan (AZD3355) 180 mg bid |
| 240 mg | EXPERIMENTAL | PPI+lesogaberan (AZD3355) 240 mg bid |
| Placebo | PLACEBO_COMPARATOR | PPI+ Placebo |
| AZD3355 | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | AZD3355 |
| 2 | PLACEBO_COMPARATOR | - |
| 3 | EXPERIMENTAL | MR formulation, 1h 65 mg |
| 4 | EXPERIMENTAL | MR Formulation, 1h 150 mg |
| 5 | EXPERIMENTAL | MR Formulation, 2h 150 mg |
| Name | Type | Description |
|---|---|---|
| AZD3355 | DRUG | 30 mg orally in the morning and 30 mg in the evening for 1 day |
| placebo | DRUG | Placebo capsules orally in the morning and placebo capsules in the evening for 1 day |
| lesogaberan (AZD3355) | DRUG | 60 mg, oral, capsules, bid for 4 w |
| Gelusil® | DRUG | Chewable tablets taken as needed |
| Esomeprazole | DRUG | 40 mg od, oral, 7 days |
Inclusion Criteria: * Provide informed consent * History of GERD with persistent symptoms despite treatment with PPI * Otherwise normal physical health Exclusion Criteria: * History of GERD with symptoms that has not improved at all during treatment with PPI * Prior surgery of the upper gastroint...
Top 1 of 5 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Phathom Pharmaceuticals, Inc. | PHAT | 2 | PHASE3 | Vonoprazan |
AZD3355 is an investigational small molecule developed for gastroesophageal reflux disease (GERD) and reflux episodes. It was studied in patients with reflux disease to assess its effect on reflux episodes. AZD3355 has been tested in Phase 1 and Phase 2 clinical trials but is not approved for any indication.
AZD3355 is developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca sponsored the clinical trial program for AZD3355, including studies conducted in the United States and Sweden.
AZD3355 has completed Phase 2 clinical development. Four trials have been completed, including two Phase 2 studies and two Phase 1 studies, with no active trials ongoing. AZD3355 is investigational and has not been approved by the FDA for any indication.
AZD3355 has been evaluated in four completed trials. Phase 2 studies include NCT01043185, which tested four doses on reflux episodes in GERD patients, and NCT00743444, a TLESR-impedance study. Phase 1 studies include NCT00863161, a renal impairment study, and NCT00757419, a dose-escalation study in healthy males.
Across four completed clinical trials, 478 participants were enrolled. The trials were randomized, double-blind, and placebo-controlled. Enrollment ranged from 23 participants in the renal impairment study to 54 in the Phase 1 dose-escalation study, with Phase 2 GERD studies enrolling 27 patients each.