Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ALKS 2680 Dose 1 · 3 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| ALKS 2680 Dose 1 | EXPERIMENTAL | - |
| ALKS 2680 Dose 2 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| ALKS 2680 Dose 3 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ALKS 2680 Dose 1 | DRUG | Participants will receive ALKS 2680 tablets, daily, orally, for 12 weeks |
| ALKS 2680 Dose 2 | DRUG | Participants will receive ALKS 2680 tablets, daily, orally, for 12 weeks |
| Placebo | DRUG | Participants will receive placebo tablets, daily, orally for 12 weeks |
| ALKS 2680 Dose 3 | DRUG | Participants will receive ALKS 2680 tablets, daily, orally, for 12 weeks |
Inclusion Criteria: * Meets the diagnostic criteria of NT1 according to ICSD-3-TR guidelines, confirmed by diagnostic evaluations (either PSG/MSLT\* or CSF hypocretin-1 level) Exclusion Criteria: * Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle. * Has a h...
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.