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List of investigational narcolepsy and hypersomnia drugs

List of investigational narcolepsy and hypersomnia drugs is a science topic covered in the lgStudy science library. This page brings together a partial reference excerpt, illustrations, worked examples, real-world applications and a short study plan, so you can understand List of investigational narcolepsy and hypersomnia drugs rather than just read about it. In short: This is a list of investigational narcolepsy and hypersomnia drugs, or drugs that are currently under development for clinical use for the treatment of narcolepsy and/or hypersomnia (e.g., excessive daytime sleepiness, idiopathic hypersomnia) but are not yet approved. Many of them may also be referred to as investigational wakefulness-promoting agents (WPAs).

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Reference excerpt

This is a list of investigational narcolepsy and hypersomnia drugs, or drugs that are currently under development for clinical use for the treatment of narcolepsy and/or hypersomnia (e.g., excessive daytime sleepiness, idiopathic hypersomnia) but are not yet approved. Many of them may also be referred to as investigational wakefulness-promoting agents (WPAs). Chemical/generic names are listed first, with developmental code names, synonyms, and brand names in parentheses. The format of list items is "Name (Synonyms) – Mechanism of Action – Indication [Reference]". This list was last comprehensively updated in September 2025. It is likely to become outdated with time.

Under development

Preregistration Reboxetine (AXS-12) – norepinephrine reuptake inhibitor (NRI) – narcolepsy [1] Sodium oxybate (Xyrem) controlled release (TRN-257) – GABAB receptor agonist and GHB receptor agonist – narcolepsy, idiopathic hypersomnia [2]

Phase 3 Alixorexton (ALKS-2680) – orexin OX2 receptor agonist – narcolepsy [3] Pitolisant (BF-2.649; BF-2649; HBS-201; Ozawade; tiprolisant; Wakix) – histamine H3 receptor antagonist – idiopathic hypersomnia [4] Sodium oxybate micropump (FT-218; Lumryz; ON-SXB) – GABAB receptor agonist and GHB receptor agonist – idiopathic hypersomnia [5]

Phase 2/3 Balumorexton (TAK-360) – orexin OX2 receptor agonist – narcolepsy, idiopathic hypersomnia [6]

Phase 2 Alixorexton (ALKS-2680) – orexin OX2 receptor agonist – idiopathic hypersomnia [7] Cleminorexton (ORX750; ORX-750) – orexin OX2 receptor agonist – narcolepsy, idiopathic hypersomnia [8] Firazorexton (TAK-994) – orexin OX2 receptor agonist – narcolepsy [9] Flecainide/modafinil (THN-102) – combination of flecainide (sodium channel blocker) and modafinil (atypical dopamine reuptake inhibitor) – narcolepsy [10] Ledasorexton (E-2086) – orexin OX2 receptor agonist – narcolepsy [11] Mazindol controlled release (NLS-0; NLS-1; NLS-10; NLS-13; NLS-2; Nolazol; Quilience) – serotonin–norepinephrine–dopamine reuptake inhibitor (SNDRI) – narcolepsy, idiopathic hypersomnia [12] Pentylenetetrazole (BTD-001; pentetrazol; PTZ) – GABAA receptor antagonist – narcolepsy, idiopathic hypersomnia [13] Samelisant (SUVN-G3031) – histamine H3 receptor antagonist – narcolepsy [14] Serdexmethylphenidate (KP-484; KP-1077; KP-879) – norepinephrine–dopamine reuptake inhibitor (NDRI) – idiopathic hypersomnia [15]

Phase 1/2 Serdexmethylphenidate (KP-484; KP-1077; KP-879) – norepinephrine–dopamine reuptake inhibitor (NDRI) – narcolepsy [16]

Phase 1 Lu-AH69593 – undefined mechanism of action – narcolepsy [17] MK-6552 – undefined mechanism of action – narcolepsy [18] ORX-142 – orexin OX2 receptor agonist [19] Sodium oxybate once-nightly – GABAB receptor agonist and GHB receptor agonist – narcolepsy [20] Valiloxybate (XW-10172) – GABAB receptor agonist and GHB receptor agonist – narcolepsy [21]

Preclinical AEX-2 – orexin OX1 and OX2 receptor agonist – narcolepsy [22] HBS-102 (CSTI-100) – melanin-concentrating hormone receptor 1 (MCHR1) antagonist – narcolepsy [23] [24] Methylphenidate transdermal (Defent) – norepinephrine–dopamine reuptake inhibitor (NDRI) – narcolepsy [25] NLS-11 – undefined mechanism of action – Kleine–Levin syndrome [26]

Research AEX-19 – orexin OX1 and OX2 receptor agonist – narcolepsy, idiopathic hypersomnia [27] SPN-446 – undefined mechanism of action – narcolepsy [28]

Not under development

No development reported Armesocarb (MLR-1019; (R)-mesocarb) – atypical dopamine reuptake inhibitor (DRI) – sleep disorders [29] Danavorexton (TAK-925) – orexin OX2 receptor agonist – idiopathic hypersomnia [30] Flecainide/modafinil (THN-102) – combination of flecainide (sodium channel blocker) and modafinil (atypical dopamine reuptake inhibitor (DRI)) – hypersomnia [31] Flmodafinil (CRL-40,940; NLS-14; NLS-4; JBG01-41; bisfluoromodafinil; lauflumide) – atypical dopamine reuptake inhibitor (DRI) – idiopathic hypersomnia [32] Golexanolone (GR-3027) – GABAA receptor negative allosteric modulator and neurosteroid – idiopathic hypersomnia [33] GSK-189254 (GSK-189254A) – histamine H3 receptor antagonist – narcolepsy [34] JZP-386 (C-10323; deuterated sodium oxybate; deuterated GHB) – GABAB receptor agonist and GHB receptor agonist – narcolepsy [35] [36] Research programme: neurological diseases therapies - Inexia/Nxera Pharma – orexin OX1 and OX2 receptor agonists – narcolepsy [37] Research programme: small molecule therapeutics - Orexia/X-Chem – orexin OX2 receptor agonists [38] SLS-010 – histamine H3 receptor antagonist – narcolepsy [39] Sodium oxybate controlled release (GHB) – GABAB receptor agonist and GHB receptor agonist – narcolepsy [40] Solriamfetol (YKP-10A; YKP10A; R–228060) – undefined mechanism of action – narcolepsy [41] Valiloxibic acid (XWL-008) – undefined mechanism of action – narcolepsy [42]

Discontinued ABT-652 – histamine H3 receptor modulator – sleep disorders [43] Bavisant (BEN-2001; JNJ-1074; JNJ-31001074) – histamine H3 receptor antagonist – narcolepsy [44] Cipralisant (GT-2331; Perceptin) – histamine H3 receptor antagonist – sleep disorders [45] Danavorexton (TAK-925) – orexin OX2 receptor agonist – narcolepsy [46] Enerisant (TS-091; TS-0911; TS091) – histamine H3 receptor antagonist – narcolepsy and hypersomnia [47] Flmodafinil (CRL-40,940; NLS-14; NLS-4; JBG01-41; bisfluoromodafinil; lauflumide) – atypical dopamine reuptake inhibitor (DRI) – narcolepsy [48] JNJ-17216498 – histamine H3 receptor antagonist – narcolepsy [49] Lisdexamfetamine (LDX; Elvanse; NRP-104; S-877489; SHP-489; SPD-489; Tyvense; Venvanse; Vyvanse) – norepinephrine–dopamine releasing agent (NDRA) – sleep disorders [50] LML-134 (LML134) – histamine H3 receptor antagonist – sleep disorders [51] Oveporexton (TAK-861) – orexin OX2 receptor agonist – idiopathic hypersomnia [52] Phacetoperane (NLS-3) – norepinephrine–dopamine reuptake inhibitor (NDRI) – narcolepsy [53] Research programme: sleep disorder therapeutics - Servier (S-41150) – histamine H3 receptor antagonist – sleep disorders [54] SAR-152954 (SAR152954) – histamine H3 receptor antagonist – sleep disorders [55] Ulotaront (SEP-363856; SEP-856) – trace amine-associated receptor 1 (TAAR1) agonist and serotonin 5-HT1A and 5-HT1D receptor partial agonist – narcolepsy [56]

Formal development never or not yet started Mevidalen (LY-3154207; D1 PAM) – dopamine D1 receptor positive allosteric modulator [57]

Clinically used drugs

Approved drugs

… excerpt ends here. Continue reading the full article.

Worked examples

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Example 3 — an exam-style question

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Applications of List of investigational narcolepsy and hypersomnia drugs

In research: List of investigational narcolepsy and hypersomnia drugs appears in science research whenever the underlying quantities have to be modelled precisely. Papers usually cite it as a starting assumption and then explore where it breaks down.
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In the classroom: List of investigational narcolepsy and hypersomnia drugs is common in secondary-school and first-year university syllabi. It links to neighbouring topics Lists of investigational drugs, so understanding it makes those chapters shorter.
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