Product Description
Almorexant (ACT-078573) is an orally active dual orexin receptor antagonist that is being developed by Actelion Ltd, in collaboration with GlaxoSmithKline plc, for the treatment of primary insomnia. Almorexant is a first-in-class compound that targets the orexin system, which plays a key role in wake promotion and stabilization, in addition to having other regulatory functions. Decreasing orexin activity was hypothesized to have a sleep-promoting effect. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/20047164/)
Mechanisms of Action: OX1R Antagonist, OX2R Antagonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Midnight Pharma
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Insomnia
Phase 1: Insomnia|Other
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT01243060 |
NEY-1413 | N/A |
Completed |
Healthy Volunteers |
2014-07-01 |
2025-08-27 |
||
NCT01987739 |
AC-057-116 | P1 |
Completed |
Other |
2010-02-01 |
2019-03-20 |
Treatments |
|
NCT00640848 |
Insomnia | P1 |
Completed |
Insomnia |
2007-08-01 |
2019-03-18 |
Treatments |
|
NCT00606593 |
AC-057A201 | P2 |
Completed |
Insomnia |
2008-04-01 |
2019-03-18 |
Treatments |
|
2007-005194-56 |
2007-005194-56 | P3 |
Completed |
Insomnia |
2009-11-06 |
2022-03-12 |
Treatments |
|
NCT00608985 |
RESTORA 1 | P3 |
Completed |
Insomnia |
2009-09-01 |
2019-03-18 |