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    Chemistry

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    Also known as: 502-85-2, Sodium 4-hydroxybutyrate, Anetamin, 4-hydroxybutyric acid sodium salt, Sodium 4-hydroxybutanoate, Somsanit
    Molecular Formula
    C4H7NaO3
    Molecular Weight
    126.09  g/mol
    InChI Key
    XYGBKMMCQDZQOZ-UHFFFAOYSA-M
    FDA UNII
    7G33012534
    Sodium Oxybate
    The sodium salt of 4-hydroxybutyric acid. It is used for both induction and maintenance of ANESTHESIA.
    1 2D Structure

    Sodium Oxybate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    sodium;4-hydroxybutanoate
    2.1.2 InChI
    InChI=1S/C4H8O3.Na/c5-3-1-2-4(6)7;/h5H,1-3H2,(H,6,7);/q;+1/p-1
    2.1.3 InChI Key
    XYGBKMMCQDZQOZ-UHFFFAOYSA-M
    2.1.4 Canonical SMILES
    C(CC(=O)[O-])CO.[Na+]
    2.2 Other Identifiers
    2.2.1 UNII
    7G33012534
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 4 Hydroxybutyrate Sodium

    2. 4-hydroxybutyrate Sodium

    3. Gamma Hydroxybutyrate

    4. Gamma-hydroxybutyrate

    5. Oxybate Sodium

    6. Oxybate, Sodium

    7. Oxybutyrate, Sodium

    8. Sodium Gamma Hydroxybutyrate

    9. Sodium Gamma-hydroxybutyrate

    10. Sodium Oxybutyrate

    11. Somsanit

    12. Xyrem

    2.3.2 Depositor-Supplied Synonyms

    1. 502-85-2

    2. Sodium 4-hydroxybutyrate

    3. Anetamin

    4. 4-hydroxybutyric Acid Sodium Salt

    5. Sodium 4-hydroxybutanoate

    6. Somsanit

    7. Oxybate Sodium

    8. Gamma Oh

    9. Sodium Oxybate [usan]

    10. Sodium Oxybutyrate

    11. Catabate

    12. Sodium Oxybat

    13. Oxybate (sodium)

    14. 4-hydroxybutyrate Sodium

    15. Wy-3478

    16. Butanoic Acid, 4-hydroxy-, Monosodium Salt

    17. Gamma-hydroxybutyrate Sodium

    18. Sodium Gamma-hydroxybutyrate

    19. Sodium;4-hydroxybutanoate

    20. Gamma-hydroxy Sodium Butyrate

    21. Butanoic Acid, 4-hydroxy-, Sodium Salt

    22. Eb 27

    23. Hydroxybutyric Acid Monosodium Salt

    24. 4-hydroxybutyric Acid Monosodium Salt

    25. Wy 3478

    26. .gamma.-hydroxybutyrate Sodium Salt

    27. Nsc-84223

    28. Sodium Oxybate (usan)

    29. 7g33012534

    30. Butyric Acid, 4-hydroxy-, Monosodium Salt

    31. Butyric Acid, 4-hydroxy-, Sodium Salt

    32. Natrium 4-hydroxybutyrat

    33. Sodium-4-hydroxybutyrate

    34. Sodium Oxybate (sodium 4-hydroxybutanoate)

    35. Ghb Sodium Salt (sodium Gammahydroxybutyrate)

    36. 4-hydroxybuttersaeure Natriumsalz

    37. Gamma-hydroxybutyrate Sodium Salt

    38. Ncgc00247714-01

    39. Einecs 207-953-3

    40. Nsc 84223

    41. Gamma-hydroxybutyric Acid, Sodium Salt

    42. Jzp-6

    43. Sodium4-hydroxybutyrate

    44. Acetamide,2,2-dichloro-n-[(1r,2r)-2-hydroxy-1-(hydroxymethyl)-2-(4-nitrophenyl)ethyl]-,rel-

    45. Unii-7g33012534

    46. Xyrem (tn)

    47. Sodium Gammahydroxybutyrate

    48. Dsstox_cid_28866

    49. Dsstox_rid_83135

    50. Dsstox_gsid_48940

    51. Schembl61823

    52. Sodium Oxybate [hsdb]

    53. Sodium Oxybate [vandf]

    54. Dea No. 2012

    55. Sodium Oxybate [mart.]

    56. Chembl1200682

    57. Dtxsid3048940

    58. Oxybate Sodium [who-dd]

    59. Sodium Oxybate [ema Epar]

    60. Hms2091e15

    61. Hy-b1187

    62. Tox21_112871

    63. Sodium Oxybate [orange Book]

    64. Gamma Hydroxybutyric Acid Preparations

    65. Xywav Component Sodium Oxybate

    66. Akos006221428

    67. Ccg-212465

    68. Cs-4796

    69. Db09072

    70. Sodium Oxybate Component Of Xywav

    71. Cas-502-85-2

    72. Db-071156

    73. Ft-0626615

    74. D05866

    75. H-4040

    76. Sodium Salt Of Gamma-hydroxybutyric Acid

    77. .gamma.-hydroxybutyrate Sodium Salt [mi]

    78. Butanoic Acid, 4-hydroxy-, Sodium Salt (1:1)

    79. Q7553347

    80. 90318-49-3

    2.4 Create Date
    2008-02-05
    3 Chemical and Physical Properties
    Molecular Weight 126.09 g/mol
    Molecular Formula C4H7NaO3
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count3
    Rotatable Bond Count3
    Exact Mass126.02928836 g/mol
    Monoisotopic Mass126.02928836 g/mol
    Topological Polar Surface Area60.4 Ų
    Heavy Atom Count8
    Formal Charge0
    Complexity64.3
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameXyrem
    PubMed HealthSodium Oxybate (By mouth)
    Drug ClassesCentral Nervous System Agent
    Drug LabelSodium oxybate, a CNS depressant, is the active ingredient in Xyrem. The chemical name for sodium oxybate is sodium 4-hydroxybutyrate. The molecular formula is C4H7NaO3, and the molecular weight is 126.09 g/mole. The chemical structure is:Sodium oxyb...
    Active IngredientSodium oxybate
    Dosage FormSolution
    RouteOral
    Strength500mg/ml
    Market StatusPrescription
    CompanyJazz Pharms

    2 of 2  
    Drug NameXyrem
    PubMed HealthSodium Oxybate (By mouth)
    Drug ClassesCentral Nervous System Agent
    Drug LabelSodium oxybate, a CNS depressant, is the active ingredient in Xyrem. The chemical name for sodium oxybate is sodium 4-hydroxybutyrate. The molecular formula is C4H7NaO3, and the molecular weight is 126.09 g/mole. The chemical structure is:Sodium oxyb...
    Active IngredientSodium oxybate
    Dosage FormSolution
    RouteOral
    Strength500mg/ml
    Market StatusPrescription
    CompanyJazz Pharms

    4.2 Drug Indication

    For the treatment of cataplexy and excessive daytime sleepiness (EDS) associated with narcolepsy.

    FDA Label

    Treatment of narcolepsy with cataplexy in adult patients.

    Substitution treatment for alcohol dependence within a framework of careful medical supervision along with continuous psychosocial support and social rehabilitation. Treatment should be initiated only in patients resistant to existing interventions or in patients for whom existing therapies are contra-indicated or not recommended. ,

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Sodium oxybate works through an unknown mechanism to treat narcolepsy by inducing sleep within about 5-15 minutes of administration.

    5.2 MeSH Pharmacological Classification

    Adjuvants, Anesthesia

    Agents that are administered in association with anesthetics to increase effectiveness, improve delivery, or decrease required dosage. (See all compounds classified as Adjuvants, Anesthesia.)

    Anesthetics, Intravenous

    Ultrashort-acting anesthetics that are used for induction. Loss of consciousness is rapid and induction is pleasant, but there is no muscle relaxation and reflexes frequently are not reduced adequately. Repeated administration results in accumulation and prolongs the recovery time. Since these agents have little if any analgesic activity, they are seldom used alone except in brief minor procedures. (From AMA Drug Evaluations Annual, 1994, p174) (See all compounds classified as Anesthetics, Intravenous.)

    5.3 FDA Pharmacological Classification
    5.3.1 Pharmacological Classes
    Central Nervous System Depression [PE]; Decreased Central Nervous System Organized Electrical Activity [PE]; Central Nervous System Depressant [EPC]
    5.4 ATC Code

    N07XX04

    N07BB

    B05XA02

    S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

    N - Nervous system

    N01 - Anesthetics

    N01A - Anesthetics, general

    N01AX - Other general anesthetics

    N01AX11 - Sodium oxybate

    N - Nervous system

    N07 - Other nervous system drugs

    N07X - Other nervous system drugs

    N07XX - Other nervous system drugs

    N07XX04 - Sodium oxybate

    5.5 Absorption, Distribution and Excretion

    Absorption

    Absolute bioavailability is approximately 88%. Tmax of 30.7-51.9min.

    Route of Elimination

    The major metabolite is carbon dioxide which is cleared by expiration, less then 5% appears as the unchanged drug in the urine within 6-8 hours after dosing.

    Volume of Distribution

    Vd of 37.7-67.7

    Clearance

    Total clearance of 895-1361mL/min.

    5.6 Metabolism/Metabolites

    Animal studies indicate that the major elimination pathway is metabolism by the creation of carbon dioxide and water through the Krebs cycle and secondarily by beta-oxidation. In the primary pathway hydroxyacid-oxoacid transhydrogenase catalyzes the conversion of sodium oxybate to succinic semialdehyde which is then transformed to succinic acid by succinic semmialdehyde dehydrogenase. Succinic acid is then turned into carbon dioxide and water in the Krebs cycle. Succinic semialdehyde is also metabolised into carbon dioxide and water by a transhydrofenase in the presence of alpha ketoglutarate.

    5.7 Biological Half-Life

    0.5 to 1 hour.

    5.8 Mechanism of Action

    The exact mechanism of action is unknown. It is the sodium salt of the endogenous compound gamma hydroxybutyrate which is a metabolite of the GABA neurotransmitter and it's thought that it's therapeutic effects are mediated via GABA B actions at noradrenergic, dopaminergic and thalamocortical neurons.

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Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730745000,"product":"SODIUM OXYBATE (GAMMA HYDROXY BUTYRATE SODIUM) (GHB)","address":"CENTAUR HOUSE, SHANTI NAGAR,","city":"MUMBAI ,MAHARASHTRA","supplier":"CENTAUR PHARMACEUTICALS PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"MADRID","customer":"UNDISCLOSED","customerCountry":"SPAIN","quantity":"550.00","actualQuantity":"550","unit":"KGS","unitRateFc":"255","totalValueFC":"145198","currency":"EURO","unitRateINR":22278.173636363637,"date":"05-Nov-2024","totalValueINR":"12252995.5","totalValueInUsd":"145198","indian_port":"Bombay Air","hs_no":"29159099","bill_no":"5367339","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"CENTAUR HOUSE, SHANTI NAGAR,, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733164200,"product":"SODIUM OXYBATE (GAMMA HYDROXY BUTYRATE SODIUM) (GHB)","address":"CENTAUR HOUSE, SHANTI NAGAR,","city":"MUMBAI ,MAHARASHTRA","supplier":"CENTAUR PHARMACEUTICALS PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"MADRID","customer":"UNDISCLOSED","customerCountry":"SPAIN","quantity":"550.00","actualQuantity":"550","unit":"KGS","unitRateFc":"255","totalValueFC":"141053","currency":"EURO","unitRateINR":21791.150000000001,"date":"03-Dec-2024","totalValueINR":"11985132.5","totalValueInUsd":"141053","indian_port":"Bombay Air","hs_no":"29339100","bill_no":"6139476","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"CENTAUR HOUSE, SHANTI NAGAR,, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API 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Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740076200,"product":"SODIUM OXYBATE (GAMMA HYDROXY BUTYRATE SODIUM) (GHB) [ACTIVE PHARMACEUTICAL INGREDIENTS]","address":"CENTAUR HOUSE, SHANTI NAGAR,","city":"MUMBAI ,MAHARASHTRA","supplier":"CENTAUR PHARMACEUTICALS PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"ATHENS","customer":"UNDISCLOSED","customerCountry":"GREECE","quantity":"640.00","actualQuantity":"640","unit":"KGS","unitRateFc":"325","totalValueFC":"201278","currency":"USD","unitRateINR":27349.934375000001,"date":"21-Feb-2025","totalValueINR":"17503958","totalValueInUsd":"201278","indian_port":"Bombay Air","hs_no":"29159099","bill_no":"8383300","productDescription":"API","marketType":"REGULATED MARKET","country":"GREECE","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"CENTAUR HOUSE, SHANTI NAGAR,, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740335400,"product":"PHARMACEUTICAL PRODUCTS SODIUM OXYBATE","address":"ALKEM HOUSE, DEVASHISH ADJACENT TO","city":"LOWER PAREL, MUMBAI. MAHARASHTRA","supplier":"ALKEM LABORATORIES LTD","supplierCountry":"INDIA","foreign_port":"BARCELONA","customer":"LABORATORIO REIG JOFRE S A","customerCountry":"SPAIN","quantity":"450.00","actualQuantity":"450","unit":"KGS","unitRateFc":"223","totalValueFC":"94198.8","currency":"USD","unitRateINR":18204.250044444445,"date":"24-Feb-2025","totalValueINR":"8191912.52","totalValueInUsd":"94198.8","indian_port":"Bombay Air","hs_no":"29159099","bill_no":"8445183","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"ALKEM HOUSE, DEVASHISH ADJACENT TO, LOWER PAREL, MUMBAI. MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742322600,"product":"SODIUM OXYBATE (GAMMA HYDROXY BUTYRATE SODIUM)(GHB) [ACTIVE PHARMACEUTICAL INGREDIENTS]","address":"CENTAUR HOUSE, SHANTI NAGAR,","city":"MUMBAI ,MAHARASHTRA","supplier":"CENTAUR PHARMACEUTICALS PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"MADRID","customer":"UNDISCLOSED","customerCountry":"SPAIN","quantity":"550.00","actualQuantity":"550","unit":"KGS","unitRateFc":"255","totalValueFC":"149181.4","currency":"EURO","unitRateINR":23494.061363636363,"date":"19-Mar-2025","totalValueINR":"12921733.75","totalValueInUsd":"149181.4","indian_port":"Bombay Air","hs_no":"29159099","bill_no":"9146156","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"CENTAUR HOUSE, SHANTI NAGAR,, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1743705000,"product":"SODIUM OXYBATE (GAMMA HYDROXY BUTYRATE SODIUM) (GHB) [ACTIVE PHARMACEUTICAL INGREDIENTS]","address":"CENTAUR HOUSE, SHANTI NAGAR,","city":"MUMBAI ,MAHARASHTRA","supplier":"CENTAUR PHARMACEUTICALS PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"ATHENS","customer":"UNDISCLOSED","customerCountry":"GREECE","quantity":"3.00","actualQuantity":"3","unit":"KGS","unitRateFc":"950","totalValueFC":"2631.3","currency":"USD","unitRateINR":75082.016666666663,"date":"04-Apr-2025","totalValueINR":"225246.05","totalValueInUsd":"2631.3","indian_port":"Bombay Air","hs_no":"29159099","bill_no":"9676258","productDescription":"API","marketType":"REGULATED MARKET","country":"GREECE","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"CENTAUR HOUSE, SHANTI NAGAR,, MUMBAI ,MAHARASHTRA","customerAddress":""}]
    27-Jan-2022
    04-Apr-2025
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    Drugs in Development

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    • Development Update
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    Avadel Announces FDA Approval of LUMRYZ™ For Narcolepsy in Patients 7 And Older

    Details:

    Lumryz is an extended-release oral suspension formulation of sodium oxybate being investigated for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy.


    Lead Product(s): Sodium Oxybate

    Therapeutic Area: Sleep Brand Name: Lumryz

    Study Phase: Phase IIIProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 17, 2024

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    01

    Avadel Pharmaceuticals

    Ireland
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    IFT FIRST
    Not Confirmed

    Avadel Pharmaceuticals

    Ireland
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    IFT FIRST
    Not Confirmed
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    Lead Product(s) : Sodium Oxybate

    Therapeutic Area : Sleep

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Avadel Announces FDA Approval of LUMRYZ™ For Narcolepsy in Patients 7 And Older

    Details : Lumryz is an extended-release oral suspension formulation of sodium oxybate being investigated for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy.

    Product Name : Lumryz

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    October 17, 2024

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    Avadel Announces First Patient Dosed in Phase 3 Trial of LUMRYZ for Idiopathic Hypersomnia

    Details:

    Lumryz is an investigational, extended-release oral suspension formulation of sodium oxybate being investigated for the treatment of idiopathic hypersomnia.


    Lead Product(s): Sodium Oxybate

    Therapeutic Area: Sleep Brand Name: Lumryz

    Study Phase: Phase IIIProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable July 31, 2024

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    02

    Avadel Pharmaceuticals

    Ireland
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    Avadel Pharmaceuticals

    Ireland
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    Not Confirmed
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    Lead Product(s) : Sodium Oxybate

    Therapeutic Area : Sleep

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Avadel Announces First Patient Dosed in Phase 3 Trial of LUMRYZ for Idiopathic Hypersomnia

    Details : Lumryz is an investigational, extended-release oral suspension formulation of sodium oxybate being investigated for the treatment of idiopathic hypersomnia.

    Product Name : Lumryz

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    July 31, 2024

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    Avadel Pharmaceuticals Announces U.S. Commercial Launch of LUMRYZ (sodium oxybate) for the Treatment of Cataplexy or Excessive Daytime Sleepiness in Adu...

    Details:

    Lumryz (sodium oxybate) is a once-nightly formulation of the USFDA approved central nervous system depressant sodium oxybate in development for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy.


    Lead Product(s): Sodium Oxybate

    Therapeutic Area: Musculoskeletal Brand Name: Lumryz

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable May 06, 2023

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    03

    Avadel Pharmaceuticals

    Ireland
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    Avadel Pharmaceuticals

    Ireland
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    IFT FIRST
    Not Confirmed
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    Lead Product(s) : Sodium Oxybate

    Therapeutic Area : Musculoskeletal

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Avadel Pharmaceuticals Announces U.S. Commercial Launch of LUMRYZ (sodium oxybate) for the Treatme...

    Details : Lumryz (sodium oxybate) is a once-nightly formulation of the USFDA approved central nervous system depressant sodium oxybate in development for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy.

    Product Name : Lumryz

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    May 06, 2023

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    Avadel Pharmaceuticals Announces Pricing of Public Offering of ADSs and Series B Preferred Shares

    Details:

    The offering will be used for obtaining FDA approval of company's lead candidate, Lumryz, an investigational, extended-release formulation of sodium oxybate for the treatment of cataplexy or EDS in adults with narcolepsy.


    Lead Product(s): Sodium Oxybate

    Therapeutic Area: Sleep Brand Name: Lumryz

    Study Phase: Phase IIIProduct Type: Other Small Molecule

    Sponsor: Jefferies

    Deal Size: $125.0 million Upfront Cash: Undisclosed

    Deal Type: Public Offering March 29, 2023

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    04

    Avadel Pharmaceuticals

    Ireland
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    Avadel Pharmaceuticals

    Ireland
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    Lead Product(s) : Sodium Oxybate

    Therapeutic Area : Sleep

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Jefferies

    Deal Size : $125.0 million

    Deal Type : Public Offering

    DEALS_DEV arrow-down

    Avadel Pharmaceuticals Announces Pricing of Public Offering of ADSs and Series B Preferred Shares

    Details : The offering will be used for obtaining FDA approval of company's lead candidate, Lumryz, an investigational, extended-release formulation of sodium oxybate for the treatment of cataplexy or EDS in adults with narcolepsy.

    Product Name : Lumryz

    Product Type : Other Small Molecule

    Upfront Cash : Undisclosed

    March 29, 2023

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    Avadel Pharmaceuticals Enters into Royalty Agreement with RTW Investments for up to $75 Million

    Details:

    The financing will support the potential commercialization of Lumryz (sodium oxybate) for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.


    Lead Product(s): Sodium Oxybate

    Therapeutic Area: Sleep Brand Name: Lumryz

    Study Phase: Phase IIIProduct Type: Other Small Molecule

    Sponsor: RTW Investments

    Deal Size: $75.0 million Upfront Cash: Undisclosed

    Deal Type: Agreement March 29, 2023

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    05

    Avadel Pharmaceuticals

    Ireland
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    Not Confirmed

    Avadel Pharmaceuticals

    Ireland
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    IFT FIRST
    Not Confirmed
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    Lead Product(s) : Sodium Oxybate

    Therapeutic Area : Sleep

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : RTW Investments

    Deal Size : $75.0 million

    Deal Type : Agreement

    DEALS_DEV arrow-down

    Avadel Pharmaceuticals Enters into Royalty Agreement with RTW Investments for up to $75 Million

    Details : The financing will support the potential commercialization of Lumryz (sodium oxybate) for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.

    Product Name : Lumryz

    Product Type : Other Small Molecule

    Upfront Cash : Undisclosed

    March 29, 2023

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    Avadel Pharmaceuticals Announces FDA Authorization to Import Tentatively-Approved LUMRYZ Ahead of Anticipated Final Approval Decision

    Details:

    Lumryz (sodium oxybate) is a once-nightly formulation of the approved central nervous system depressant sodium oxybate in development for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy.


    Lead Product(s): Sodium Oxybate

    Therapeutic Area: Sleep Brand Name: Lumryz

    Study Phase: Phase IIIProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable March 22, 2023

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    06

    Avadel Pharmaceuticals

    Ireland
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    IFT FIRST
    Not Confirmed

    Avadel Pharmaceuticals

    Ireland
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    IFT FIRST
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Lead Product(s) : Sodium Oxybate

    Therapeutic Area : Sleep

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Avadel Pharmaceuticals Announces FDA Authorization to Import Tentatively-Approved LUMRYZ Ahead of ...

    Details : Lumryz (sodium oxybate) is a once-nightly formulation of the approved central nervous system depressant sodium oxybate in development for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy.

    Product Name : Lumryz

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    March 22, 2023

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    Amneal Launches Authorized Generic for Xyrem (sodium oxybate) and Receives FDA Approval for Five Complex Generics in the Second Quarter

    Details:

    sodium oxybate oral solution indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients seven years of age and older with narcolepsy.


    Lead Product(s): Sodium Oxybate

    Therapeutic Area: Musculoskeletal Brand Name: Xyrem-Generic

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable March 07, 2023

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    07

    Amneal Pharmaceuticals

    U.S.A
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    Not Confirmed

    Amneal Pharmaceuticals

    U.S.A
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    Not Confirmed
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    Lead Product(s) : Sodium Oxybate

    Therapeutic Area : Musculoskeletal

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Amneal Launches Authorized Generic for Xyrem (sodium oxybate) and Receives FDA Approval for Five C...

    Details : sodium oxybate oral solution indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients seven years of age and older with narcolepsy.

    Product Name : Xyrem-Generic

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    March 07, 2023

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    Avadel Pharmaceuticals Requests Final FDA Approval for LUMRYZ™ (sodium oxybate) Extended Release Oral Suspension

    Details:

    Lumryz (sodium oxybate) is a sodium salt of GHB, a naturally occurring CNS depressant that increases dopamine levels and increases serotonin turnover. It is being developed for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy.


    Lead Product(s): Sodium Oxybate

    Therapeutic Area: Musculoskeletal Brand Name: Lumryz

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable February 03, 2023

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    08

    Avadel Pharmaceuticals

    Ireland
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    IFT FIRST
    Not Confirmed

    Avadel Pharmaceuticals

    Ireland
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    IFT FIRST
    Not Confirmed
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    Lead Product(s) : Sodium Oxybate

    Therapeutic Area : Musculoskeletal

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Avadel Pharmaceuticals Requests Final FDA Approval for LUMRYZ™ (sodium oxybate) Extended Release...

    Details : Lumryz (sodium oxybate) is a sodium salt of GHB, a naturally occurring CNS depressant that increases dopamine levels and increases serotonin turnover. It is being developed for the treatment of cataplexy or excessive daytime sleepiness in adults with nar...

    Product Name : Lumryz

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    February 03, 2023

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    Avadel Pharmaceuticals Announces Publication of Real-World Data Highlighting the Risk of Accidental Dosing Errors with Immediate-Release Twice-Nightly O...

    Details:

    Lumryz (sodium oxybate) is a once-nightly formulation of the approved central nervous system depressant sodium oxybate in development for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy.


    Lead Product(s): Sodium Oxybate

    Therapeutic Area: Sleep Brand Name: Lumryz

    Study Phase: Phase IIIProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable January 24, 2023

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    Avadel Pharmaceuticals

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    Lead Product(s) : Sodium Oxybate

    Therapeutic Area : Sleep

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Avadel Pharmaceuticals Announces Publication of Real-World Data Highlighting the Risk of Accidenta...

    Details : Lumryz (sodium oxybate) is a once-nightly formulation of the approved central nervous system depressant sodium oxybate in development for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy.

    Product Name : Lumryz

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    January 24, 2023

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    Avadel Pharmaceuticals Announces Final FDA Approval of LUMRYZ™ (sodium oxybate) for Extended-Release Oral Suspension as the First and Only Once-at-Bed...

    Details:

    Lumryz (sodium oxybate) is a once-nightly formulation of the USFDA approved central nervous system depressant sodium oxybate in development for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy.


    Lead Product(s): Sodium Oxybate

    Therapeutic Area: Musculoskeletal Brand Name: Lumryz

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable January 05, 2023

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    Avadel Pharmaceuticals

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    Lead Product(s) : Sodium Oxybate

    Therapeutic Area : Musculoskeletal

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Avadel Pharmaceuticals Announces Final FDA Approval of LUMRYZ™ (sodium oxybate) for Extended-Rel...

    Details : Lumryz (sodium oxybate) is a once-nightly formulation of the USFDA approved central nervous system depressant sodium oxybate in development for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy.

    Product Name : Lumryz

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    January 05, 2023

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    ABOUT THIS PAGE

    Looking for 90318-49-3 / Sodium Oxybate API manufacturers, exporters & distributors?

    Sodium Oxybate manufacturers, exporters & distributors 1

    26

    PharmaCompass offers a list of Sodium Oxybate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Sodium Oxybate manufacturer or Sodium Oxybate supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sodium Oxybate manufacturer or Sodium Oxybate supplier.

    PharmaCompass also assists you with knowing the Sodium Oxybate API Price utilized in the formulation of products. Sodium Oxybate API Price is not always fixed or binding as the Sodium Oxybate Price is obtained through a variety of data sources. The Sodium Oxybate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Sodium Oxybate

    Synonyms

    502-85-2, Sodium 4-hydroxybutyrate, Anetamin, 4-hydroxybutyric acid sodium salt, Sodium 4-hydroxybutanoate, Somsanit

    Cas Number

    90318-49-3

    Unique Ingredient Identifier (UNII)

    7G33012534

    About Sodium Oxybate

    The sodium salt of 4-hydroxybutyric acid. It is used for both induction and maintenance of ANESTHESIA.

    gamma-Hydroxybutyrate sodium Manufacturers

    A gamma-Hydroxybutyrate sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of gamma-Hydroxybutyrate sodium, including repackagers and relabelers. The FDA regulates gamma-Hydroxybutyrate sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. gamma-Hydroxybutyrate sodium API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of gamma-Hydroxybutyrate sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    gamma-Hydroxybutyrate sodium Suppliers

    A gamma-Hydroxybutyrate sodium supplier is an individual or a company that provides gamma-Hydroxybutyrate sodium active pharmaceutical ingredient (API) or gamma-Hydroxybutyrate sodium finished formulations upon request. The gamma-Hydroxybutyrate sodium suppliers may include gamma-Hydroxybutyrate sodium API manufacturers, exporters, distributors and traders.

    click here to find a list of gamma-Hydroxybutyrate sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    gamma-Hydroxybutyrate sodium USDMF

    A gamma-Hydroxybutyrate sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of gamma-Hydroxybutyrate sodium active pharmaceutical ingredient (API) in detail. Different forms of gamma-Hydroxybutyrate sodium DMFs exist exist since differing nations have different regulations, such as gamma-Hydroxybutyrate sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A gamma-Hydroxybutyrate sodium DMF submitted to regulatory agencies in the US is known as a USDMF. gamma-Hydroxybutyrate sodium USDMF includes data on gamma-Hydroxybutyrate sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The gamma-Hydroxybutyrate sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of gamma-Hydroxybutyrate sodium suppliers with USDMF on PharmaCompass.

    gamma-Hydroxybutyrate sodium WC

    A gamma-Hydroxybutyrate sodium written confirmation (gamma-Hydroxybutyrate sodium WC) is an official document issued by a regulatory agency to a gamma-Hydroxybutyrate sodium manufacturer, verifying that the manufacturing facility of a gamma-Hydroxybutyrate sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting gamma-Hydroxybutyrate sodium APIs or gamma-Hydroxybutyrate sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a gamma-Hydroxybutyrate sodium WC (written confirmation) as part of the regulatory process.

    click here to find a list of gamma-Hydroxybutyrate sodium suppliers with Written Confirmation (WC) on PharmaCompass.

    gamma-Hydroxybutyrate sodium NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing gamma-Hydroxybutyrate sodium as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for gamma-Hydroxybutyrate sodium API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture gamma-Hydroxybutyrate sodium as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain gamma-Hydroxybutyrate sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a gamma-Hydroxybutyrate sodium NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of gamma-Hydroxybutyrate sodium suppliers with NDC on PharmaCompass.

    gamma-Hydroxybutyrate sodium GMP

    gamma-Hydroxybutyrate sodium Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of gamma-Hydroxybutyrate sodium GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right gamma-Hydroxybutyrate sodium GMP manufacturer or gamma-Hydroxybutyrate sodium GMP API supplier for your needs.

    gamma-Hydroxybutyrate sodium CoA

    A gamma-Hydroxybutyrate sodium CoA (Certificate of Analysis) is a formal document that attests to gamma-Hydroxybutyrate sodium's compliance with gamma-Hydroxybutyrate sodium specifications and serves as a tool for batch-level quality control.

    gamma-Hydroxybutyrate sodium CoA mostly includes findings from lab analyses of a specific batch. For each gamma-Hydroxybutyrate sodium CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    gamma-Hydroxybutyrate sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (gamma-Hydroxybutyrate sodium EP), gamma-Hydroxybutyrate sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (gamma-Hydroxybutyrate sodium USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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