Asset profile

Pitolisant (Wakix)

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:Prader-Willi SyndromeMyotonic Dystrophy Type 1

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Competitive landscape

7 competitors in this universe: 0 direct rivals (same mechanism and indication), 1 same-class, 6 same-indication.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Pitolisant (Wakix): this drugApprovedSmall moleculeHistamine H3 receptor (antagonist / inverse agonist)
ALTO-203Phase 2Small moleculeHistamine H3 receptor (antagonist / inverse agonist)
Sodium OxybateApprovedSmall moleculeGABA-B receptor
Solriamfetol (Sunosi)ApprovedSmall moleculeDopamine/norepinephrine transporter
ALKS 2680Phase 3Small molecule—
ReboxetinePhase 3Small moleculenorepinephrine transporter
VX-670Phase 2RNA / oligonucleotide—
SRP-1003Phase 1/2RNA / oligonucleotide—
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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

No upcoming readouts on record for this asset.

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 (11)
Phase 2 (4)
Phase 1 (2)
Early phase / not applicable (1)