Valiloxybate

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Valiloxybate
Clinical data
Other namesValiloxibic acid; Valiloxybic acid; 4-((L-Valyl)oxy)butanoic acid; XW-10172; XW10172; XWL-008; XWL008
Routes of
administration		Oral[1]
Drug classGABAB receptor agonist; GHB receptor agonist; Hypnotic
ATC code
  • None
Identifiers
  • 4-[(2S)-2-amino-3-methylbutanoyl]oxybutanoic acid
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
ChEMBL
Chemical and physical data
FormulaC9H17NO4
Molar mass203.238 g·mol−1
3D model (JSmol)
  • CC(C)[C@@H](C(=O)OCCCC(=O)O)N
  • InChI=1S/C9H17NO4/c1-6(2)8(10)9(13)14-5-3-4-7(11)12/h6,8H,3-5,10H2,1-2H3,(H,11,12)/t8-/m0/s1
  • Key:RMGPNQKZEPTAOC-QMMMGPOBSA-N

Valiloxybate (INNTooltip International Nonproprietary Name, USANTooltip United States Adopted Name;[2] developmental code name XW-10172) is an extended-release prodrug of γ-hydroxybutyrate (GHB; oxybate) which is under development for the treatment of narcolepsy.[1][3][4][5][6] It is also being investigated for treatment of excessive daytime sleepiness (EDS) in people with Parkinson's disease.[7] The drug is taken orally once per night.[1][4][5][8][6]

It is an amino acid (L-valine) ester prodrug of GHB,[6][2] which itself acts as a GABAB and GHB receptor agonist.[9][10] Relative to administration of GHB itself, valiloxybate showed a delayed time to peak levels and an extended duration of GHB exposure in humans.[6] It is said to maintain desired GHB levels for 6 to 7 hours.[11] This profile is compatible with once-nightly dosing,[6] in contrast to GHB itself which is typically administered twice per night due to its very short elimination half-life.[12][13][14] In addition, unlike sodium oxybate, valiloxybate contains no sodium or cation, and hence avoids excessive sodium intake.[6][15]

Valiloxybate is under development by XW labs or XWPharma.[1] As of September 2025, no recent development has been reported, but valiloxybate has reached phase 1 clinical trials for treatment of narcolepsy and phase 2 trials for treatment of sleeping problems in Parkinson's disease.[1][7]

See also

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References

[edit]
  1. ^ a b c d e "Valiloxybate". AdisInsight. 28 September 2025. Retrieved 30 September 2025.
  2. ^ a b "VALILOXYBATE". Inxight Drugs. Retrieved 30 September 2025.
  3. ^ "Valiloxibic acid". AdisInsight. 28 July 2022. Retrieved 30 September 2025.
  4. ^ a b Roth T (March 2025). "Therapeutic Use of γ-Hydroxybutyrate: History and Clinical Utility of Oxybates and Considerations of Once- and Twice-Nightly Dosing in Narcolepsy". CNS Drugs. 39 (Suppl 1): 37–51. doi:10.1007/s40263-024-01150-8. PMC 11950157. PMID 40111735.
  5. ^ a b Abad VC (2023). "Pharmacological options for narcolepsy: are they the way forward?". Expert Rev Neurother. 23 (9): 819–834. doi:10.1080/14737175.2023.2249234. PMID 37585269.
  6. ^ a b c d e f Canafax, Daniel; Xiang, William; Xiang, Jia-Ning (3 May 2021). "501 Clinical PK of XW10172 for Once Nightly Therapy in Patients with Narcolepsy or Sleep Disorders in Neurodegenerative Diseases" (PDF). Sleep. 44 (Supplement_2): A197 – A198. doi:10.1093/sleep/zsab072.500. ISSN 0161-8105. Retrieved 30 September 2025.
  7. ^ a b Wolff A, Schumacher NU, Pürner D, Machetanz G, Demleitner AF, Feneberg E, Hagemeier M, Lingor P (June 2023). "Parkinson's disease therapy: what lies ahead?". J Neural Transm (Vienna). 130 (6): 793–820. doi:10.1007/s00702-023-02641-6. PMC 10199869. PMID 37147404.
  8. ^ Dauvilliers Y, Bogan RK, Šonka K, Partinen M, Foldvary-Schaefer N, Thorpy MJ (2022). "Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution: A Lower-Sodium Alternative for Cataplexy or Excessive Daytime Sleepiness Associated with Narcolepsy". Nat Sci Sleep. 14: 531–546. doi:10.2147/NSS.S279345. PMC 8976528. PMID 35378745.{{cite journal}}: CS1 maint: unflagged free DOI (link)
  9. ^ Trombley TA, Capstick RA, Lindsley CW (December 2020). "DARK Classics in Chemical Neuroscience: Gamma-Hydroxybutyrate (GHB)". ACS Chem Neurosci. 11 (23): 3850–3859. doi:10.1021/acschemneuro.9b00336. PMID 31287661.
  10. ^ Wellendorph P, Gauger SJ, Andersen JV, Kornum BR, Solbak SM, Frølund B (July 2025). "International Union of Basic and Clinical Pharmacology. CXX. γ-Hydroxybutyrate protein targets in the mammalian brain-beyond classic receptors". Pharmacol Rev. 77 (4): 100064. doi:10.1016/j.pharmr.2025.100064. PMID 40449125.{{cite journal}}: CS1 maint: article number as page number (link)
  11. ^ "XWPharma Announces Positive Results from Phase 1 Clinical Trials of XW10172, in Development as Once-Nightly Therapy for Sleep Disorders in Patients with Neurodegenerative Diseases". GlobeNewswire News Room. 14 June 2021. Retrieved 30 September 2025.
  12. ^ Robinson DM, Keating GM (2007). "Sodium oxybate: a review of its use in the management of narcolepsy". CNS Drugs. 21 (4): 337–354. doi:10.2165/00023210-200721040-00007. PMID 17381187.
  13. ^ Staud R (August 2011). "Sodium oxybate for the treatment of fibromyalgia". Expert Opin Pharmacother. 12 (11): 1789–1798. doi:10.1517/14656566.2011.589836. PMID 21679091.
  14. ^ Roth T, Dauvilliers Y, Bogan RK, Plazzi G, Black J (February 2024). "Effects of oxybate dose and regimen on disrupted nighttime sleep and sleep architecture". Sleep Med. 114: 255–265. doi:10.1016/j.sleep.2023.12.015. PMID 38244463.
  15. ^ Abad VC (June 2023). "Calcium, magnesium, potassium, and sodium oxybates oral solution for cataplexy or excessive daytime sleepiness associated with narcolepsy". Expert Opin Pharmacother. 24 (8): 875–885. doi:10.1080/14656566.2023.2204187. PMID 37060579.



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