Xyrem(sodium oxybate)
Lumryz, Xyrem, Xywav (sodium oxybate) is a small molecule pharmaceutical. Sodium 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.
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Commercial
Trade Name
FDA
EMA
Lumryz, Xyrem
CombinationsXywav
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 |
|---|---|---|---|---|
| XYWAV | Jazz Pharmaceuticals | N-212690 RX | 2020-07-21 | 1 products, RLD, RS |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| cataplexy | — | D002385 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
SODIUM OXYBATE, LUMRYZ, AVADEL CNS | |||
| 2030-05-01 | ODE-431 | ||
| 2026-05-01 | NP | ||
CALCIUM OXYBATE / MAGNESIUM OXYBATE / POTASSIUM OXYBATE / SODIUM OXYBATE, XYWAV, JAZZ | |||
| 2028-08-12 | ODE-369 | ||
| 2027-07-21 | ODE-361 | ||
| 2024-08-12 | I-870 | ||
| 2023-07-21 | NP | ||
SODIUM OXYBATE, XYREM, JAZZ PHARMS | |||
| 2026-04-26 | PED | ||
| 2025-10-26 | ODE-231 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Sodium Oxybate, Lumryz, Avadel Cns | |||
| 11583510 | 2042-02-07 | U-3578 | |
| 10925844 | 2040-02-28 | DP | |
| 10272062 | 2037-07-21 | DP | |
| 10736866 | 2037-07-21 | DP | |
| 10952986 | 2037-07-21 | U-3601 | |
| 10973795 | 2037-07-21 | DP | |
| 11000498 | 2037-07-21 | DP | U-3580 |
| 11052061 | 2037-07-21 | DP | |
| 11065224 | 2037-07-21 | DP | |
| 11400065 | 2037-07-21 | U-3579 | |
| 11504347 | 2037-07-21 | DP | |
| 11602512 | 2037-07-21 | U-3577 | |
| 11602513 | 2037-07-21 | U-3576 | |
| Calcium Oxybate / Magnesium Oxybate / Potassium Oxybate / Sodium Oxybate, Xywav, Jazz | |||
| 11426373 | 2037-09-19 | U-3432 | |
| 8772306 | 2033-03-15 | U-1532, U-3198 | |
| 9050302 | 2033-03-15 | U-1532 | |
| 9486426 | 2033-03-15 | U-1532 | |
| 10213400 | 2033-03-15 | U-2499 | |
| 10864181 | 2033-03-15 | U-1532, U-3017 | |
| 11253494 | 2033-03-15 | U-3323, U-3324 | |
| 8591922 | 2033-01-11 | DP | |
| 8901173 | 2033-01-11 | DP | |
| 9132107 | 2033-01-11 | DP | |
| 10195168 | 2033-01-11 | DP | |
| 10675258 | 2033-01-11 | U-2938 | |
| 11554102 | 2033-01-11 | DP | |
| Sodium Oxybate, Xyrem, Jazz Pharms | |||
| 7668730 | 2024-06-16 | U-1110 | |
HCPCS
No data
Clinical
Clinical Trials
43 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Narcolepsy | D009290 | EFO_0000614 | G47.4 | 3 | — | 4 | 1 | 1 | 9 |
| Chronic fatigue syndrome | D015673 | EFO_0004540 | G93.31 | — | — | — | 3 | — | 3 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | — | — | 1 | 1 | 2 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | — | — | — | 2 | — | 2 |
| Rem sleep behavior disorder | D020187 | EFO_0007462 | G47.52 | — | — | — | 1 | — | 1 |
| Obstructive sleep apnea | D020181 | EFO_0003918 | G47.33 | — | — | — | 1 | — | 1 |
| Sleep | D012890 | GO_0030431 | — | — | — | 1 | — | 1 | |
| Palliative care | D010166 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fibromyalgia | D005356 | EFO_0005687 | M79.1 | — | 1 | 4 | — | — | 5 |
| Idiopathic hypersomnia | D020177 | G47.11 | — | 1 | 1 | — | — | 1 | |
| Cluster headache | D003027 | HP_0012199 | G44.00 | — | — | 1 | — | — | 1 |
| Binge-eating disorder | D056912 | F50.2 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sleep initiation and maintenance disorders | D007319 | F51.01 | — | 2 | — | — | — | 2 | |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | 1 | — | — | — | 1 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | 1 | — | — | — | 1 |
| Essential tremor | D020329 | EFO_0003108 | G25.0 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Traumatic brain injuries | D000070642 | S06 | 1 | — | — | — | — | 1 | |
| Disorders of excessive somnolence | D006970 | G47.1 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Inflammation | D007249 | — | — | — | — | 1 | 1 | ||
| Psychological trauma | D000067073 | — | — | — | — | 1 | 1 | ||
| Physiological stress | D013312 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | SODIUM OXYBATE |
| INN | — |
| Description | Sodium oxybate, sold under the brand name Xyrem among others, is a medication used to treat two symptoms of narcolepsy: sudden muscle weakness and excessive daytime sleepiness. It is used sometimes in France and Italy as an anesthetic given intravenously;: 15, 27–28 it is also used in Italy to treat alcohol addiction and alcohol withdrawal syndrome.
|
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | O=C([O-])CCCO.[Na+] |
Identifiers
| PDB | — |
| CAS-ID | 502-85-2 |
| RxCUI | 9899 |
| ChEMBL ID | CHEMBL1200682 |
| ChEBI ID | — |
| PubChem CID | 23663870 |
| DrugBank | DB09072 |
| UNII ID | — |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Xywav - Jazz Pharmaceuticals
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Xyrem - Jazz Pharmaceuticals
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,128 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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51,645 adverse events reported
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