Asset profile

Lemborexant · Dayvigo

Small molecule

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Approvedregulatory verdict

Evidence outlook

Approved: insomnia, characterized by difficulties with sleep onset and/or sleep maintenance [see... (FDA)

This approval is for an indication outside this terminal's covered markets; the covered program shown here is investigational. Regulatory approval supersedes design-level evidence grading for the approved use.

track record: Partial signal

Source for the program status

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Competitive landscape

60 competitors in this universe: 0 direct rivals (same mechanism and indication), 0 same-class, 60 same-indication; 6 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Lemborexant (Dayvigo): this drugPhase 3Small moleculeOrexin receptor (repositioned)
Benzgalantamine (Zunveyl)ApprovedSmall moleculeAcetylcholinesterase/nicotinic receptor (prodrug)
Brexpiprazole (Rexulti)ApprovedSmall moleculeDopamine D2/D3 and serotonin 5-HT1A receptor
Dextromethorphan / Bupropion (Auvelity)ApprovedSmall moleculesigma-1/NMDA
Donanemab (Kisunla)ApprovedMonoclonal antibodyAmyloid-beta (monoclonal antibody)
Lecanemab (Leqembi)ApprovedMonoclonal antibodyAmyloid-beta (monoclonal antibody)
Xanomeline / Trospium Chloride (Cobenfy)ApprovedSmall moleculeMuscarinic M1/M4 receptor (agonist/antagonist combination)
ACP-204Phase 3Small moleculeSerotonin 5-HT2A receptor (antagonist / inverse agonist)
AR1001Phase 3Small moleculePDE5
BezisterimPhase 3Small moleculeERK/NF-kB inflammatory
BlarcamesinePhase 3Small moleculeSigma-1 receptor / muscarinic receptor (dual)
BuntanetapPhase 3Small moleculeAPP/tau/alpha-synuclein/TDP-43 (translation)
CerebrolysinPhase 3PeptideMulti-target (ginsenoside)
GV1001Phase 3PeptideTelomerase (hTERT)
Hydromethylthionine MesylatePhase 3Small moleculeTau aggregation; Acetylcholine
MasitinibPhase 3Small moleculec-Kit/Lyn/Fyn tyrosine kinases (mast cell/microglia), c-Kit (CD117); also PDGFR, Lck, FAK, FGFR3, CSF1R, KIT (c-Kit), also PDGFR and Lyn/Fyn kinases

…and 45 more. Research shows the complete landscape.

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Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.

Upcoming events

(12 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2026 (1)
December 2026 (1)
Phase 4Parkinson's Disease, Insomnia, Motor DisorderNot yet recruiting
Est. primary completion 2026-12-01 · NCT07384429 · CT.gov ↗
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2027 (6)
February 2027 (1)
Early phase / not applicableInsomnia DisorderRecruiting
Est. primary completion 2027-02 · NCT06779149 · CT.gov ↗
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April 2027 (1)
Phase 2Delirium - Postoperative, Cardiac Surgery, Cardiac Surgery Subjects, Orexin Antagonist, Feasibility Studies, Sleep, In-hospital MortalityNot yet recruiting
Est. primary completion 2027-04-30 · NCT06648681 · CT.gov ↗
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May 2027 (2)
Phase 2OSA - Obstructive Sleep ApneaRecruiting
Est. primary completion 2027-05-01 · NCT06928766 · CT.gov ↗
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Phase 4Delayed Sleep Phase SyndromeRecruiting
Est. primary completion 2027-05-31 · NCT06874855 · CT.gov ↗
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July 2027 (1)
Phase 4Sleep Disturbance, Delirium, Critical IllnessNot yet recruiting
Est. primary completion 2027-07-31 · NCT07407400 · CT.gov ↗
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December 2027 (1)
Phase 2InsomniaRecruiting
Est. primary completion 2027-12 · NCT06823752 · CT.gov ↗
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2028 (2)
June 2028 (1)
Phase 1/2OSA - Obstructive Sleep ApneaNot yet recruiting
Est. primary completion 2028-06-30 · NCT07683442 · CT.gov ↗
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December 2028 (1)
Phase 4Insomnia, Dementia, Frontotemporal DementiaRecruiting
Est. primary completion 2028-12-11 · NCT06093126 · CT.gov ↗
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2029 (2)
July 2029 (1)
Phase 2Opioid Use Disorder, Opioid Use, Insomnia, Orexin AntagonistRecruiting
Est. primary completion 2029-07-30 · NCT06981195 · CT.gov ↗
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September 2029 (1)
Phase 2Postoperative DeliriumNot yet recruiting
Est. primary completion 2029-09-01 · NCT07695285 · CT.gov ↗
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2030 (1)
March 2030 (1)
Phase 2Alzheimer's DiseaseRecruiting
Est. primary completion 2030-03-31 · NCT06274528 · CT.gov ↗
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See the full readout calendar ↗

All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.

Phase 3 (7)
Phase 2 (13)
Phase 1/2 (3)
Phase 1 (19)
Phase 4 (7)
Early phase / not applicable (1)