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Also known as ALKS 2680 Dose 1
ALKS 37 · 2 trials · 2 indications
Overall response will be defined using an algorithm that takes into consideration number of complete spontaneous bowel movements, improvement from baseline, and durability of response.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Capsules for oral administration |
| ALKS 37 | EXPERIMENTAL | Capsules for oral administration |
| Name | Type | Description |
|---|---|---|
| ALKS 37 | DRUG | Capsules for oral administration |
| Placebo | DRUG | Capsules for oral administration |
Inclusion Criteria: * Are at least 18 years of age at time of consent * Have a body mass index (BMI)of 19 to 35 kg/m2 at screening * Are receiving prescribed opioid medication for the management of chronic, non-cancer pain * Meet the criteria of OIC * Agree to use an acceptable method of contracept...
ALKS 2680 Dose 1 is an investigational small molecule being developed for narcolepsy type 1 and narcolepsy type 2. It is currently in Phase 3 clinical trials for these indications. The drug is also being studied for alcohol dependence and opioid-induced constipation, though those trials are in earlier phases.
ALKS 2680 Dose 1 targets the orexin 2 receptor, a G-protein coupled receptor involved in regulating wakefulness and sleep. By acting on this receptor, the drug is designed to address the orexin deficiency that underlies narcolepsy. This mechanism is being evaluated in Phase 3 trials for narcolepsy type 1 and type 2.
ALKS 2680 Dose 1 is being developed by Alkermes plc, a biopharmaceutical company traded on NASDAQ under the ticker ALKS. Alkermes is conducting Phase 3 clinical trials of the drug in adults with narcolepsy type 1 and narcolepsy type 2 across multiple countries including the United States, Australia, and Japan.
ALKS 2680 Dose 1 is in Phase 3 clinical development for narcolepsy type 1 and narcolepsy type 2. Two Phase 3 trials are currently recruiting participants. The drug is investigational and has not been approved by regulatory authorities for any indication.
ALKS 2680 Dose 1 is being evaluated in two Phase 3 trials: NCT07455383 for narcolepsy type 1 with 150 participants, and NCT07502443 for narcolepsy type 2 with 176 participants. Both are randomized, double-blind, placebo-controlled studies enrolling adults aged 18 years and older.
No, ALKS 2680 Dose 1 is a distinct investigational drug from ALKS33 and ALKS 37. ALKS33 was studied in a completed Phase 2 trial for alcohol dependence, and ALKS 37 was studied in a completed Phase 2 trial for opioid-induced constipation. ALKS 2680 is currently in Phase 3 trials for narcolepsy.