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Xyrem(oxybate)
Lumryz, Xyrem, Xywav (oxybate) is a small molecule pharmaceutical. Oxybate was first approved as Xyrem on 2002-07-17. It is used to treat cataplexy in the USA. It has been approved in Europe to treat cataplexy and narcolepsy. It is known to target hydroxycarboxylic acid receptor 1.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
mental disordersD001523
Trade Name
FDA
EMA
Lumryz, Xyrem
Combinations
Xywav
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Calcium oxybate
+
Magnesium oxybate
+
Potassium oxybate
+
Sodium oxybate
Tradename
Company
Number
Date
Products
XYWAVJazz PharmaceuticalsN-212690 RX2020-07-21
1 products, RLD, RS
Sodium oxybate
Tradename
Company
Number
Date
Products
LUMRYZAVADEL CNSN-214755 RX2023-05-01
4 products, RLD
XYREMJazz PharmaceuticalsN-021196 RX2002-07-17
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
lumryzNew Drug Application2023-05-10
xyremNew Drug Application2020-12-18
xywavNew Drug Application2021-02-23
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
cataplexy—D002385—
Agency Specific
FDA
EMA
Expiration
Code
SODIUM OXYBATE, LUMRYZ, AVADEL CNS
2030-05-01ODE-431
2026-05-01NP
CALCIUM OXYBATE / MAGNESIUM OXYBATE / POTASSIUM OXYBATE / SODIUM OXYBATE, XYWAV, JAZZ
2028-08-12ODE-369
2027-07-21ODE-361
2024-08-12I-870
2023-07-21NP
SODIUM OXYBATE, XYREM, JAZZ PHARMS
2026-04-26PED
2025-10-26ODE-231
Patent Expiration
Patent
Expires
Flag
FDA Information
Sodium Oxybate, Lumryz, Avadel Cns
115835102042-02-07U-3578
109258442040-02-28DP
102720622037-07-21DP
107368662037-07-21DP
109529862037-07-21U-3601
109737952037-07-21DP
110004982037-07-21DPU-3580
110520612037-07-21DP
110652242037-07-21DP
114000652037-07-21U-3579
115043472037-07-21DP
116025122037-07-21U-3577
116025132037-07-21U-3576
Calcium Oxybate / Magnesium Oxybate / Potassium Oxybate / Sodium Oxybate, Xywav, Jazz
114263732037-09-19U-3432
87723062033-03-15U-1532, U-3198
90503022033-03-15U-1532
94864262033-03-15U-1532
102134002033-03-15U-2499
108641812033-03-15U-1532, U-3017
112534942033-03-15U-3323, U-3324
85919222033-01-11DP
89011732033-01-11DP
91321072033-01-11DP
101951682033-01-11DP
106752582033-01-11U-2938
115541022033-01-11DP
Sodium Oxybate, Xyrem, Jazz Pharms
76687302024-06-16U-1110
ATC Codes
N: Nervous system drugs
— N01: Anesthetics
— N01A: Anesthetics, general
— N01AX: Other general anesthetics in atc
— N01AX11: Sodium oxybate
— N07: Other nervous system drugs in atc
— N07X: Other nervous system drugs in atc
— N07XX: Other nervous system drugs in atc
— N07XX04: Sodium oxybate
HCPCS
No data
Clinical
Clinical Trials
1 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameOXYBATE
INN—
Description
4-hydroxybutyric acid is a 4-hydroxy monocarboxylic acid that is butyric acid in which one of the hydrogens at position 4 is replaced by a hydroxy group. It has a role as a general anaesthetic, a GHB receptor agonist, a sedative and a neurotoxin. It is a 4-hydroxy monocarboxylic acid and a hydroxybutyric acid. It is functionally related to a butyric acid. It is a conjugate base of a 4-hydroxybutyrate.
Classification
Small molecule
Drug class—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
O=C(O)CCCO
Identifiers
PDB—
CAS-ID591-81-1
RxCUI1546380
ChEMBL IDCHEMBL1342
ChEBI ID30830
PubChem CID10413
DrugBankDB01440
UNII ID—
Target
Agency Approved
No data
Alternate
HCAR1
HCAR1
Organism
Homo sapiens
Gene name
HCAR1
Gene synonyms
GPR104, GPR81, HCA1
NCBI Gene ID
27198
Protein name
hydroxycarboxylic acid receptor 1
Protein synonyms
G protein-coupled receptor 104, G-protein coupled receptor 104, G-protein coupled receptor 81, hydroxy-carboxylic acid receptor 1, lactate receptor 1, T-cell activation G protein-coupled receptor
Uniprot ID
Q9BXC0
Mouse ortholog
Hcar1 (243270)
hydroxycarboxylic acid receptor 1 (Q8C131)
Variants
Clinical Variant
No data
Financial
Xywav - Jazz Pharmaceuticals
$
€
£
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Xyrem - Jazz Pharmaceuticals
$
€
£
₣
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Oxybate - Jazz Pharmaceuticals
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,151 documents
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Safety
Black-box Warning
Black-box warning for: Lumryz, Xyrem, Xywav
Adverse Events
Top Adverse Reactions
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697 adverse events reported
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