Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as lesogaberan (AZD3355), AZD3355
lesogaberan · 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...
Lesogaberan is an investigational small molecule developed for gastroesophageal reflux disease (GERD). It was studied as an add-on to proton pump inhibitor (PPI) therapy in patients with a partial response to PPI treatment. It is not approved for any indication and remains in clinical development.
Lesogaberan is a gamma-aminobutyric acid type B (GABA-B) receptor agonist. It targets the GABBR2 and GABBR1 receptor subunits. By activating these receptors, it is designed to reduce transient lower esophageal sphincter relaxations, which are a key mechanism underlying reflux episodes in GERD.
Lesogaberan is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca conducted the clinical program for the drug, including a Phase 2 trial in patients with gastroesophageal reflux disease.
Lesogaberan is in Phase 2 development. It has not been approved by the FDA or any other regulatory agency. The completed Phase 2 trial evaluated the drug as an add-on to PPI therapy in GERD patients with partial response to PPI.
Lesogaberan has been studied in one completed Phase 2 trial, NCT01005251. The trial investigated different doses of lesogaberan (AZD3355) as an add-on to PPI in GERD patients with partial response to PPI. It enrolled 661 participants in the United States and was randomized, double-blind, and placebo-controlled.
Yes, lesogaberan is also known as AZD3355. AZD3355 is the AstraZeneca development code for lesogaberan. Both names refer to the same investigational GABA-B receptor agonist studied in gastroesophageal reflux disease.