Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD7268 · 1 trial · 1 indication
MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). Change from baseline was calculated as Week 4 value minus baseline value. \[observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)\]
| Arm | Type | Description |
|---|---|---|
| AZD7268 | EXPERIMENTAL | The AZD7268 15 mg BID arm consisted of 3 AZD7268 5 mg capsules dosed orally in the morning and evening. In addition, 2 placebo tablets to match encapsulated escitalopram tablets were dosed orally in the morning only. |
| Placebo | PLACEBO_COMPARATOR | The placebo arm consisted of 3 placebo capsules to match AZD7268 capsules dosed orally in the morning and evening. In addition, 2 placebos to match encapsulated escitalopram tablets were dosed orally in the morning only. |
| Escitalopram | ACTIVE_COMPARATOR | The escitalopram 20 mg QD arm consisted of 3 placebo to match AZD7268 capsules dosed orally in the morning and evening. In addition, during Week 1, one encapsulated 10-mg escitalopram tablet and 1 placebo to match encapsulated escitalopram tablet were dosed orally in the morning only. During Weeks 2 through 4, two encapsulated 10-mg escitalopram tablets were dosed orally in the morning only. |
| Name | Type | Description |
|---|---|---|
| AZD7268 | DRUG | 15 mg, oral, twice daily (BID) |
| Escitalopram | DRUG | 20 mg, oral, once daily (QD) |
| Placebo capsules | DRUG | Placebo capsules to match AZD7268 |
| Placebo tablets | DRUG | Placebo tablets to match encapsulated escitalopram |
Inclusion Criteria: * Provision of signed, written, and dated Informed Consent prior to any study specific procedures * Documented primary clinical diagnosis meeting criteria from the DSM-IV, Text Revision (APA 2000) for any of the following: * 296.2x Major Depressive Disorder, Single Episode, or *...
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AZD7268 is an investigational small molecule developed by AstraZeneca PLC for Major Depressive Disorder. It is a Phase 2 psychiatry candidate and has been studied in a single completed clinical trial. It is not an approved medicine.
AZD7268 was studied for the treatment of Major Depressive Disorder. The only registered trial of AZD7268 enrolled adults with that condition in the United States. Because the drug remains investigational, it has no approved use outside of clinical research.
AZD7268 targets OPRD1, the delta opioid receptor, and acts as an agonist at that receptor. OPRD1 agonism is the mechanism under study for its effects in Major Depressive Disorder. The compound is a small molecule.
AstraZeneca PLC develops AZD7268. The company is listed under the ticker AZN. AstraZeneca sponsored the Phase 2 trial of AZD7268 in Major Depressive Disorder.
AZD7268 is in Phase 2 development. It is investigational and has not been approved by the FDA. One Phase 2 trial has been completed, and no trials of AZD7268 are currently active.
AZD7268 has been evaluated in one completed Phase 2 trial, NCT01020799, titled AZD7268 Safety and Tolerability Study. It enrolled 247 adults aged 18 and older with Major Depressive Disorder in the United States. The study was randomized, double blind, and placebo controlled.