Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD2516 · 1 trial · 1 indication
Total number of reflux episodes 0 to 3 hours post meal
| Arm | Type | Description |
|---|---|---|
| First 5 mg, then placebo, then 16 mg, then 40 mg | EXPERIMENTAL | period 1: AZD2516 5 mg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD2516 16 mg, period 6: washout, period 7: AZD2516 40 mg. |
| First 40 mg, then 16 mg, then placebo, then 5 mg | EXPERIMENTAL | period 1: AZD2516 40 mg, period 2: washout, period 3: AZD2516 16 mg, period 4: washout, period 5: placebo, period 6: washout, period 7: AZD2516 5 mg. |
| First 16 mg, then 5 mg, then 40 mg, then placebo | EXPERIMENTAL | period 1: AZD2516 16 mg, period 2: washout, period 3: AZD2516 5 mg, period 4: washout, period 5: AZD2516 40 mg, period 6: washout, period 7: placebo. |
| First placebo, then 40 mg, then 5 mg, then 16 mg | EXPERIMENTAL | period 1: placebo, period 2: washout, period 3: AZD2516 40 mg, period 4: washout, period 5: AZD2516 5 mg, period 6: washout, period 7: AZD2516 16 mg |
| Name | Type | Description |
|---|---|---|
| AZD2516, 5 mg | DRUG | Capsule, oral |
| AZD2516, 16 mg | DRUG | Capsule, oral |
| AZD2516, 40 mg | DRUG | Capsule, oral |
| Placebo | DRUG | Capsule, oral |
Inclusion Criteria: * Provision of signed informed consent * Healthy male subjects * Age 18-45 years, inclusive Exclusion Criteria: * Clinically significant illness within the 2 weeks prior to the first dose of study drug * History of clinically significant cardiovascular, respiratory, renal, hep...
AZD2516 is being studied for reflux, a gastrointestinal condition. It is an investigational small molecule developed by AstraZeneca PLC and has reached Phase 2 clinical development. It has not been approved for any use, and the reflux program remains in clinical research rather than routine clinical practice.
AZD2516 targets GRM5, also known as metabotropic glutamate receptor 5. It acts as a negative allosteric modulator of GRM5, meaning it reduces signaling through that receptor rather than blocking it directly. This target class places AZD2516 among small molecules designed to modulate glutamatergic activity in the gastrointestinal setting.
AZD2516 is developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the sponsor behind the compound's clinical program in reflux. The drug remains an investigational asset within the company's gastrointestinal pipeline.
AZD2516 is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The compound is investigational and has not been approved by the FDA or any other regulator for reflux or any other indication.
AZD2516 has been evaluated in one completed Phase 2 trial, NCT01154634, titled a study to investigate the pharmacodynamic effect of a single dose of AZD2516 in healthy male subjects. That randomized, double-blind, controlled trial enrolled 20 participants across Belgium and the Netherlands.