Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ALKS 2680, 4mg
ALKS 2680 · 4 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, 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 |
| Placebo | PLACEBO_COMPARATOR | Oral tablet containing matching placebo for once daily administration |
| 4 mg ALKS 2680 | EXPERIMENTAL | - |
| 6 mg ALKS 2680 | EXPERIMENTAL | - |
| 8 mg ALKS 2680 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ALKS 2680 | DRUG | Oral tablet containing ALKS 2680 for daily, oral administration |
| Placebo | DRUG | Oral placebo tablet for daily 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: * Is willing and able, in the opinion of the Investigator, to understand and comply with protocol requirements, including: lifestyle considerations and restrictions, adherence to contraception guidance, adherence to actigraphy and diary requirements, if receiving treatment for O...
ALKS 2680 is an investigational small molecule being developed for narcolepsy Type 1, narcolepsy Type 2, and idiopathic hypersomnia. It is currently in Phase 2 clinical trials and has not been approved by regulatory authorities.
ALKS 2680 targets the OX2R receptor, also known as the orexin 2 receptor. By acting on this receptor, the drug is designed to address sleep-wake dysregulation associated with narcolepsy and idiopathic hypersomnia.
ALKS 2680 is being developed by Alkermes plc, a biopharmaceutical company traded on NASDAQ under the ticker ALKS. The company is conducting Phase 2 clinical trials for the drug across multiple countries.
ALKS 2680 is in Phase 2 clinical development. It is an investigational drug, meaning it has not received FDA approval and is still being evaluated for safety and effectiveness in clinical trials.
ALKS 2680 is being studied in several Phase 2 trials, including NCT06358950 for narcolepsy Type 1, NCT06555783 for narcolepsy Type 2, NCT06767683 for narcolepsy and idiopathic hypersomnia, and NCT06843590 for idiopathic hypersomnia. These trials are placebo-controlled and double-blind.
Yes, ALKS 2680 4mg refers to a specific dose of ALKS 2680. The drug is also known by this alternative name, which indicates the 4 milligram formulation being evaluated in clinical studies.