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Also known as ALKS 2680 Dose 1
ALKS 2680 · 7 trials · 3 indications
Participants will be asked to complete the ESS, reporting on the level of sleepiness they experienced over the past 7 days.
| Arm | Type | Description |
|---|---|---|
| ALKS 2680 Dose 1 | EXPERIMENTAL | - |
| ALKS 2680 Dose 2 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| ALKS 2680 Dose 3 | EXPERIMENTAL | - |
| ALKS 2680, 10 mg- Part A | EXPERIMENTAL | Oral tablet containing 10 mg of ALKS 2680 for once daily administration |
| ALKS 2680, 14 mg -Part A | EXPERIMENTAL | Oral tablet containing 14 mg of ALKS 2680 for once daily administration |
| ALKS 2680, 18 mg- Part A | EXPERIMENTAL | Oral tablet containing 18 mg of ALKS 2680 for once daily administration |
| Placebo- Part A | PLACEBO_COMPARATOR | Oral placebo tablet for once daily administration |
| ALKS 2680 Dose 1- Part B | EXPERIMENTAL | Oral tablets of ALKS 2680 taken, orally, daily |
| Placebo - Part B | PLACEBO_COMPARATOR | Oral tablets of placebo taken, orally, daily |
| Narcolepsy Type 1 (NT1) | EXPERIMENTAL | - |
| Narcolepsy Type 2 (NT2) | EXPERIMENTAL | - |
| Idiopathic Hypersomnia (IH) | EXPERIMENTAL | - |
| ALKS 2680, 10 mg | EXPERIMENTAL | Oral tablet containing 10mg of ALKS 2680 for once daily administration |
| ALKS 2680, 14 mg | EXPERIMENTAL | Oral tablet containing 14mg of ALKS 2680 for once daily administration |
| ALKS 2680, 18 mg | EXPERIMENTAL | Oral tablet containing 18mg of ALKS 2680 for once daily administration |
| 4 mg ALKS 2680 | EXPERIMENTAL | - |
| 6 mg ALKS 2680 | EXPERIMENTAL | - |
| 8 mg ALKS 2680 | 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 |
| ALKS 2680 | DRUG | Oral tablet containing ALKS 2680 for daily, oral administration |
| ALKS 2680, 4mg | DRUG | Oral tablet containing 4 mg of ALKS 2680 for once daily administration |
| ALKS 2680, 6mg | DRUG | Oral tablet containing 6 mg of ALKS 2680 for once daily administration |
| ALKS 2680, 8mg | DRUG | Oral tablet containing 8 mg of ALKS 2680 for once daily administration |
| ALKS 2680, 10mg | DRUG | Oral tablet containing 10 mg of ALKS 2680 for once daily administration |
| ALKS 2680, 14mg | DRUG | Oral tablet containing 14 mg of ALKS 2680 for once daily administration |
| ALKS 2680, 18mg | DRUG | Oral tablet containing 18 mg of ALKS 2680 for once daily administration |
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 is an investigational small molecule being developed to treat sleep-wake disorders: idiopathic hypersomnia, narcolepsy type 1, and narcolepsy type 2. It is not yet approved and remains in clinical development. Alkermes plc is studying it in adults 18 years and older across multiple countries.
ALKS 2680 targets OX2R, the orexin-2 receptor. It is a small molecule designed to act at this receptor, which is involved in regulating wakefulness. By targeting OX2R, the drug aims to address the excessive daytime sleepiness associated with narcolepsy and idiopathic hypersomnia.
ALKS 2680 is being developed by Alkermes plc, which trades on the Nasdaq under the ticker ALKS. The company is running a clinical program that includes Phase 3 trials in narcolepsy type 1 and type 2, and a Phase 2 trial in idiopathic hypersomnia.
ALKS 2680 is in Phase 2 and Phase 3 clinical development. Three Phase 3 trials are currently recruiting for narcolepsy type 1 and type 2, while one Phase 2 trial in idiopathic hypersomnia is active but no longer recruiting. The program has enrolled about 1,178 participants across four trials.
ALKS 2680 is being studied in four registered trials. These include NCT07540897 and NCT07455383 in narcolepsy type 1, NCT07502443 in narcolepsy type 2, and NCT06843590 in idiopathic hypersomnia. The narcolepsy trials are randomized, double-blind, placebo-controlled Phase 3 studies; the idiopathic hypersomnia trial is Phase 2.