Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD7268 · 5 trials · 3 indications
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. |
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| 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 |
| Placebo | DRUG | Capsule, Oral, BID |
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 being studied for use in major depressive disorder. It has also been evaluated in healthy volunteers to assess its safety, tolerability, and pharmacokinetics. The drug is not approved and remains in clinical development.
AZD7268 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company has sponsored clinical trials of the drug in healthy volunteers and in patients with major depressive disorder.
AZD7268 has completed Phase 1 and Phase 2 clinical trials. The Phase 2 trial was conducted in patients with major depressive disorder, while Phase 1 trials were conducted in healthy volunteers. The drug is investigational and not yet approved for any use.
AZD7268 has been studied in several completed clinical trials. These include NCT00796965, a single ascending dose study in healthy subjects; NCT00912353, a single ascending dose study in healthy Japanese subjects; NCT01020799, a safety and tolerability study in major depressive disorder; and NCT01116011, a multiple ascending dose study in healthy Japanese male volunteers.
AZD7268 is the primary name used for this investigational drug in clinical trial registrations and scientific literature. No alternative names have been identified for this compound in the available information.