Approval Probability
TA Base Rate
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ML Risk
D961H · 1 trial · 3 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) |
| 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. |
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 developed by AstraZeneca PLC (ticker AZN) for reflux esophagitis and related upper gastrointestinal conditions. It is also known as D961H capsule 10mg. The program is in Phase 3 development, and the drug has been studied in Japanese pediatric patients.
D961H is being developed for reflux esophagitis, and it has also been studied in gastric ulcer and duodenal ulcer. The clinical program focuses on Japanese pediatric patients with these gastrointestinal conditions. It remains investigational and is not approved for commercial use.
D961H is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical program evaluating D961H in reflux esophagitis and related gastrointestinal conditions.
D961H is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. The completed study enrolled 50 patients in Japan. D961H is investigational and has not been approved by the FDA.
D961H has been evaluated in one completed Phase 3 trial, NCT03553563, titled A Study of Esomeplazole (D961H) in Japanese Paediatric Patients With Reflux Esophagitis, Gastric Ulcer or Duodenal Ulcer. The trial enrolled 50 participants in Japan and included patients aged 1 year and older.