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AZD7325 · 4 trials · 3 indications
HAM-A total score 0-56 units, 14 questions scored on scale of 0-4 (0= Not present, 4=Very severe) . Higher HAM-A scores indicate higher levels of anxiety Change : score at week 4 minus score at randomization
The HAM -A is a 14-item clinician administered scale for the evaluation of anxiety symptoms. Each HAM-A item is rated on a 0 (not present) to 4 (very severe) scale, higher score indicates high level of anxiety. The HAM-A total score is calculated as the sum of 14 individual scores, with 56 as the maximum.
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | AZD7325 5mg twice daily |
| B | EXPERIMENTAL | AZD7325 15mg twice daily |
| C | ACTIVE_COMPARATOR | Lorazepam 2mg twice daily |
| D | PLACEBO_COMPARATOR | Placebo |
| A-AZD7325 2mg | EXPERIMENTAL | AZD7325 2mg BID |
| B-AZD7325 5mg | EXPERIMENTAL | AZD7325 5mg BID |
| C-AZD7325 10mg | EXPERIMENTAL | AZD7325 10mg QD |
| D-Placebo | EXPERIMENTAL | Placebo |
| E | EXPERIMENTAL | AZD7325 |
| F | EXPERIMENTAL | AZD7325 |
| G | EXPERIMENTAL | AZD7325 |
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AZD7325 | DRUG | 4 tablets and 1 capsule taken twice a day for 28 days |
| Lorazepam | DRUG | 4 tablets and 1 capsule taken twice a day for 28 days |
| Placebo | DRUG | 4 tablets and 1 capsule taken twice a day for 28 days |
| Radioligand (11C) flumazenil | DRUG | Single dose of i.v solution. 4 times per subject. (3 times together with AZD7325) |
Inclusion Criteria: * Signed informed consent before any study-related procedures start. * The patient is previously diagnosed with Generalized Anxiety Disorder. * The patient has a HADS-A (anxiety) score ≥10 at both screening and randomization. Exclusion Criteria: * Patient has a lifetime histor...
Top 5 of 9 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Definium Therapeutics, Inc. | DFTX | 2 | PHASE3 | DT120 |
| Vistagen Therapeutics, Inc. | VTGN | 3 | PHASE3 | Fasedienol |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE3 | VQW-765 |
| AbbVie, Inc. | ABBV | 1 | PHASE2 | ABBV-932 |
| Psyence Biomedical Ltd. | PBM | 1 | PHASE2 | Psilocybin therapy |
AZD7325 was studied for anxiety and anxiety disorders, including generalized anxiety disorder, and for its abuse potential in people who recreationally use central nervous system depressants. It is an investigational small molecule that was developed by AstraZeneca and has not been approved for any indication.
AZD7325 targets the GABAA receptor subunits GABRA2 and GABRA3. It acts as a positive allosteric modulator at these subunits, meaning it enhances receptor activity rather than directly activating the receptor. This mechanism was designed to modulate GABA signaling, the brain's main inhibitory pathway.
AZD7325 is developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca sponsored the clinical trials evaluating the compound in anxiety disorders and in recreational CNS depressant users.
AZD7325 is in Phase 1 development according to its overall program status, though individual trials have reached Phase 2. It is investigational and has not been approved by the FDA. All of its recorded trials are completed, and no trials are currently active.
AZD7325 has been studied in four completed trials. These include NCT00902772, a Phase 1 abuse potential study in healthy recreational CNS depressant users in Canada; NCT00808249 and NCT00807937, two Phase 2 proof-of-concept trials in generalized anxiety disorder in the United States; and NCT00681720, a Phase 1 PET receptor occupancy study in Sweden.