Asset profile

Sodium Oxybate

Small molecule

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Approvedregulatory verdict

Evidence outlook

Approved: Narcolepsy

Regulatory approval supersedes design-level evidence grading; the trials behind approval are preserved below as the drug's evidence history.

Also in development:Idiopathic Hypersomnia · Phase 3

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Competitive landscape

4 competitors in this universe: 0 direct rivals (same mechanism and indication), 0 same-class, 4 same-indication.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Sodium Oxybate: this drugApprovedSmall moleculeGABA-B receptor
Pitolisant (Wakix)ApprovedSmall moleculeHistamine H3 receptor (antagonist / inverse agonist)
Solriamfetol (Sunosi)ApprovedSmall moleculeDopamine/norepinephrine transporter
ALKS 2680Phase 3Small molecule—
ReboxetinePhase 3Small moleculenorepinephrine transporter
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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

(8 total)

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

2027 (7)
January 2027 (1)
Phase 4Idiopathic HypersomniaRecruiting
Est. primary completion 2027-01-29 · NCT05837091 · CT.gov ↗
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June 2027 (1)
Phase 2NarcolepsyRecruiting
Est. primary completion 2027-06 · NCT06809803 · CT.gov ↗
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September 2027 (3)
Phase 4Idiopathic HypersomniaNot yet recruiting
Est. primary completion 2027-09 · NCT07077278 · CT.gov ↗
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Phase 2Cerebral Amyloid AngiopathyEnrolling by invitation
Est. primary completion 2027-09-27 · NCT06421532 · CT.gov ↗
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Phase 1Spasmodic Dysphonia, Laryngeal Dystonia, Voice TremorNot yet recruiting
Est. primary completion 2027-09-30 · NCT07041203 · CT.gov ↗
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October 2027 (1)
Phase 2Sleep Disorder (Disorder), Critical CareNot yet recruiting
Est. primary completion 2027-10 · NCT07596342 · CT.gov ↗
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December 2027 (1)
Phase 3NarcolepsyRecruiting
Est. primary completion 2027-12-23 · NCT07625280 · CT.gov ↗
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2028 (1)
December 2028 (1)
Phase 2Chronic Cluster HeadacheNot yet recruiting
Est. primary completion 2028-12 · NCT06950281 · 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 (13)
Phase 2/3 (3)
Phase 2 (14)
Phase 1/2 (1)
Phase 1 (4)
Phase 4 (16)
Early phase / not applicable (1)
Used as active comparator (2)
Appears in other studies (1)