Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
lesogaberan · 1 trial · 3 indications
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)
| Arm | Type | Description |
|---|---|---|
| 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 |
| Name | Type | Description |
|---|---|---|
| lesogaberan (AZD3355) | DRUG | 60 mg, oral, capsules, bid for 4 w |
| Placebo | DRUG | oral,capsules, bid for 4 w |
Inclusion Criteria: * Provision of informed consent prior to any study specific procedures * Have at least 6 months history of GERD * Continuously treated during the last 4 weeks before enrolment with daily optimized unchanged PPI therapy for any GERD indication Exclusion Criteria: * Patients tha...
Lesogaberan is an investigational small molecule being studied for Gastroesophageal Reflux Disease (GERD), specifically in patients with heartburn and regurgitation who have a partial response to proton pump inhibitors (PPIs). It is not approved and remains in clinical development.
Lesogaberan is a small molecule that acts as a GABA-B receptor agonist. It is being investigated as an add-on therapy to PPIs in GERD patients with partial response, with the goal of reducing reflux symptoms.
Lesogaberan is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The drug is currently in Phase 2 clinical development.
Lesogaberan is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed.
Lesogaberan has one completed Phase 2 trial, NCT01005251, which investigated different doses of lesogaberan (AZD3355) as an add-on to PPI therapy in GERD patients with partial response. The trial enrolled 661 participants in the United States.
Yes, lesogaberan is also known as AZD3355. In clinical trials, the drug is referred to by both names, and the completed Phase 2 study NCT01005251 used the AZD3355 designation.