Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD3355 · 8 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 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 |
| AZD3355 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| 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 |
| 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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE3 | Nexium |
| Catalyst Pharmaceuticals, Inc. | CPRX | 1 | PHASE2 | MHS-1031 |
| Phathom Pharmaceuticals, Inc. | PHAT | 1 | - | Vonoprazan |
AZD3355 is an investigational small molecule being studied for the treatment of gastroesophageal reflux disease (GERD), including symptoms such as heartburn and regurgitation, as well as reflux episodes. It is in Phase 2 clinical development and is not yet approved by regulatory authorities.
AZD3355 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The drug is currently in Phase 2 clinical trials for gastroesophageal reflux disease (GERD).
AZD3355 is in Phase 2 clinical development for gastroesophageal reflux disease (GERD) and related reflux conditions. It is an investigational drug, meaning it has not been approved for commercial use and is still undergoing clinical testing to evaluate its safety and efficacy.
AZD3355 has been studied in three completed Phase 2 clinical trials. These include NCT00394472, which assessed symptom improvements in GERD patients with 244 participants; NCT00703534, which validated patient-reported outcome measures for GERD symptoms with 478 participants; and NCT00743444, which examined reflux episodes in 27 patients.
AZD3355 is the primary name used for this investigational compound in clinical trials. No alternative brand names or generic names have been reported for this drug in the available clinical trial information.