Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD2066 · 5 trials · 4 indications
Change of mean pain intensity from 5-day baseline to the last 5 days of treatment, measured twice daily with NRS (12 hours recall). Mean pain intensity for 5-day baseline period (evening Day -6 to moning Day-1) and mean pain intensity for last 5 days on treatment (ie, last dose day and the 4 preceding calendar days) was calculated based on the numerical rating scale (NRS)(0-10). 0=No pain, 10=Worst pain imaginable.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| A | EXPERIMENTAL | AZD2066 |
| B | PLACEBO_COMPARATOR | Placebo |
| C | EXPERIMENTAL | AZD2066 |
| D | EXPERIMENTAL | AZD2066 |
| E | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| AZD2066 | DRUG | Capsule, once daily, 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28. |
| Placebo | DRUG | Capsule, once daily |
| Caffeine | DRUG | 2 doses, Given as Tablet, 2x50 mg |
| Tolbutamide | DRUG | 2 doses, Given as Tablet, half of 500 mg |
| Omeprazole Tablet, 20 mg | DRUG | 2 doses, Given as Tablet, 20 mg |
| Midazolam Tablet, 7.5 mg | DRUG | 2 doses, Given as Tablet, 7.5 mg |
Inclusion Criteria: * Provision of informed consent prior to any study specific procedures. * Clinical diagnosis of painful diabetic neuropathy. * non-fertile females Exclusion Criteria: * Other pain that may confound assessment of neuropathic pain. * Ongoing significant peripheral arterial disea...
AZD2066 is an investigational small molecule developed by AstraZeneca PLC for chronic pain, general pain, and reflux episodes. It has been studied in Phase 1 and Phase 2 clinical trials, including a Phase 2 trial in painful diabetic neuropathy. It is not approved for any indication.
AZD2066 targets GRM5, also known as the metabotropic glutamate receptor 5 (mGluR5). It acts as a modulator of this receptor. GRM5 is a G protein-coupled receptor involved in glutamate signaling, and modulating it is being explored for pain and other conditions.
AZD2066 is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the sponsor of the clinical trials evaluating AZD2066 in pain and reflux-related conditions.
AZD2066 is in Phase 1 clinical development, with completed Phase 1 trials and a completed Phase 2 trial. It is investigational and has not been approved by the FDA or any regulatory agency for any indication.
AZD2066 has been studied in completed trials including NCT00930306 (a Phase 1 cocktail study in chronic pain), NCT00857623 (a Phase 2 trial in painful diabetic neuropathy), NCT00829088 (a Phase 1 excretion study), and NCT00813306 (a Phase 1 proof-of-principle study in reflux episodes).