Approval Probability
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Also known as ALKS 9072, ALKS 9072, Low
ALKS 9072, Low dose · 4 trials · 1 indication
This measure includes all incidences, including those that occurred \>5%.
This measure includes incidences \>5%.
The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition.
| Arm | Type | Description |
|---|---|---|
| ALKS 9072, Low Dose | EXPERIMENTAL | - |
| ALKS 9072, High Dose | EXPERIMENTAL | - |
| ALKS 9072, Low | EXPERIMENTAL | - |
| ALKS 9072, High | EXPERIMENTAL | - |
| ALKS 9072 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| ALKS 9072, Med dose | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ALKS 9072, Low Dose | DRUG | Intramuscular injection, given monthly |
| ALKS 9072, High Dose | DRUG | Intramuscular injection, given monthly |
| ALKS 9072, Low | DRUG | IM injection, given monthly |
| ALKS 9072, High | DRUG | IM injection, given monthly |
| ALKS 9072 | DRUG | Intramuscular (IM) injection, 441 mg or 882 mg given monthly |
| Placebo | DRUG | Placebo for IM injection, given monthly |
| ALKS 9072, Med dose | DRUG | IM injection, given monthly |
Inclusion Criteria: * Completed the treatment period of Study ALK9072-003EXT * Continues to require chronic treatment with an antipsychotic medication * Continues to reside in a stable living situation * Continues to have an identified reliable informant Exclusion Criteria: * Abnormal clinical la...
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ALKS 9072, Low dose is being developed for the treatment of schizophrenia, a chronic psychiatric condition. It is an investigational small molecule therapy studied in adults aged 18 years and older. The clinical program enrolled approximately 1,480 participants across four completed trials in schizophrenia.
ALKS 9072, Low dose is being developed by Alkermes plc, which trades on the Nasdaq under the ticker ALKS. Alkermes sponsored the clinical program evaluating this low dose in schizophrenia, including the Phase 3 efficacy and safety study and the long-term safety studies.
ALKS 9072, Low dose has been studied in Phase 3 clinical development for schizophrenia. Four trials have been completed, including Phase 3 efficacy and long-term safety studies and one Phase 1 study. No trials are currently active, and the program has enrolled about 1,480 participants in total.
Completed trials include NCT01469039, a Phase 3 efficacy and safety study in schizophrenia with 623 participants, and NCT01626456, a Phase 3 long-term safety study with 478 participants. NCT01895452 was a Phase 3 long-term safety extension with 291 participants, and NCT01493726 was a Phase 1 study with 88 participants.
Yes. ALKS 9072, Low dose is also known as ALKS 9072, and the trial records link it to ALKS 9070, aripiprazole lauroxil, and ARISTADA. These names refer to the same development program, so searches for any of them point to the same schizophrenia trials.
The ALKS 9072, Low dose trials were randomized, double-blind, and placebo-controlled studies in adults with schizophrenia. Participants were 18 years or older, and the program included both efficacy and long-term safety evaluations conducted across the United States, Bulgaria, Malaysia, the Philippines, Romania, Russia, South Korea, and Ukraine.