Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
D961H · 3 trials · 5 indications
Maintenance therapy for healed reflux esophagitis study part: Presence/absence of reflux esophagitis relapse from 8 to 32 weeks for all participants by assessment of the composite endpoint (reflux esophagitis -related symptoms or optional esophagogastroduodenoscopy findings) during the maintenance therapy.
Prevention of gastric ulcer or duodenal ulcer recurrence associated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy study part: Presence/absence of gastric ulcer or duodenal ulcer recurrence from 0 to 32 weeks for all participants by assessment of the composite endpoint (gastric ulcer or duodenal ulcer-related symptoms or optional esophagogastroduodenoscopy findings) during the prevention therapy.
Maintenance therapy for healed reflux esophagitis study part: Safety from 8 to 32 weeks for all participants. Number of participants with any adverse event during the period.
Prevention of gastric ulcer or duodenal ulcer recurrence associated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy study part: Safety from 0 to 32 weeks for all participants. Number of participants with any adverse event during the period.
| Arm | Type | Description |
|---|---|---|
| Group1 | EXPERIMENTAL | Initial healing phase (8 weeks), D961H 10 mg once-daily; Maintenance phase (24 or 44 weeks), D961H 10 mg once-daily |
| Group2 | EXPERIMENTAL | Initial healing phase (8 weeks), D961H 20 mg once-daily; Maintenance phase (24 or 44 weeks) starts with D961H 10 mg once-daily and may be increased to 20 mg once-daily based on investigator's discretion |
| Group3 | EXPERIMENTAL | D961H 10 mg once-daily (32 or 52 weeks) |
| Group4 | EXPERIMENTAL | D961H starts with 10 mg once-daily, and may be increased to 20 mg once-daily based on investigator's discretion (32 or 52 weeks) |
| D961H 10 mg capsule | EXPERIMENTAL | 2 way crossover |
| Omeprazole 10 mg tablet | EXPERIMENTAL | 2 way crossover |
| D961H 40 mg gelatin capsule | EXPERIMENTAL | 2 way crossover |
| D961H 40 mg HPMC capsule | EXPERIMENTAL | 2 way crossover |
| Name | Type | Description |
|---|---|---|
| D961H capsule 10mg | DRUG | All Groups can select either capsule or sachet during the study. |
| D961H sachet 10mg | DRUG | All Groups can select either capsule or sachet during the study. |
| D961H | DRUG | Oral, capsule |
| Omeprazole | DRUG | Oral, tablet |
Inclusion Criteria: For healed reflux esophagitis study * Endoscopically verified reflux esophagitis, Grade A or higher according to the Los Angels classification as judged by central evaluation committee. For prevention of gastric ulcer or duodenal ulcer recurrence study * Patients with documen...
D961H is an investigational small molecule being studied for use in reflux esophagitis, gastric ulcer, and duodenal ulcer, primarily in Japanese patients. It has also been evaluated in healthy volunteers for pharmacodynamic and pharmacokinetic studies. The drug is being developed by AstraZeneca PLC (AZN) and is currently in clinical development.
D961H is a small molecule developed by AstraZeneca. While its specific molecular target is not publicly detailed, it is being studied for acid-related gastrointestinal conditions such as reflux esophagitis and peptic ulcers, suggesting it acts to reduce gastric acid secretion. The drug is being evaluated in clinical trials for these indications.
D961H is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the NASDAQ under the ticker AZN. AstraZeneca is conducting clinical trials of D961H in Japan, focusing on gastrointestinal conditions such as reflux esophagitis and peptic ulcers.
D961H is in Phase 1 clinical development, with one completed Phase 1 trial. However, a Phase 3 trial in pediatric patients with reflux esophagitis, gastric ulcer, or duodenal ulcer has also been completed. The drug is investigational and has not been approved by regulatory authorities.
D961H has been studied in three completed clinical trials: NCT00930215, a Phase 1 study comparing gelatine and HPMC capsules in healthy Japanese males; NCT01159145, a Phase 1 pharmacodynamic/pharmacokinetic study; and NCT03553563, a Phase 3 study in Japanese pediatric patients with reflux esophagitis, gastric ulcer, or duodenal ulcer.
Yes, D961H is also known as esomeprazole, as indicated in the Phase 3 trial title. Esomeprazole is a proton pump inhibitor used to treat acid-related conditions. D961H is being studied for similar indications, including reflux esophagitis and peptic ulcers, in Japanese populations.