Keppra(levetiracetam)
Elepsia, Keppra, Spritam (levetiracetam) is a small molecule pharmaceutical. Levetiracetam was first approved as Keppra on 1999-11-30. It is used to treat epilepsy, juvenile myoclonic epilepsy, partial epilepsies, and tonic-clonic epilepsy in the USA. It has been approved in Europe to treat epilepsy. The pharmaceutical is active against synaptic vesicle glycoprotein 2A.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
Trade Name
FDA
EMA
Elepsia, Keppra, Spritam (generic drugs available since 2008-11-04)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Levetiracetam
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SPRITAM | Aprecia Pharmaceuticals | N-207958 RX | 2015-07-31 | 4 products, RLD, RS |
| LEVETIRACETAM IN SODIUM CHLORIDE | HQ Specialty Pharma | N-202543 RX | 2011-11-09 | 4 products, RLD, RS |
| ELEPSIA XR | Tripoint Therapeutics | N-204417 RX | 2018-12-20 | 2 products, RLD, RS |
| KEPPRA | UCB | N-021035 RX | 1999-11-30 | 4 products, RLD |
| KEPPRA | UCB | N-021505 RX | 2003-07-15 | 1 products, RLD, RS |
| KEPPRA | UCB | N-021872 RX | 2006-07-31 | 1 products, RLD, RS |
| KEPPRA XR | UCB | N-022285 RX | 2008-09-12 | 2 products, RLD |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| elepsia xr 1000 mg elepsia xr 1500 mg | New Drug Application | 2021-03-05 |
| keppra | New Drug Application | 2023-06-14 |
| levetiracetam | ANDA | 2023-06-19 |
| spritam | New Drug Application | 2021-02-15 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| epilepsy | EFO_0000474 | D004827 | G40.9 |
| juvenile myoclonic epilepsy | — | D020190 | G40.B |
| partial epilepsies | EFO_0004263 | D004828 | — |
| tonic-clonic epilepsy | EFO_0007262 | D004830 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Levetiracetam, Spritam, Aprecia Pharms | |||
| 9339489 | 2034-03-14 | DP | U-1850 |
| 9669009 | 2034-03-14 | U-1850, U-2021, U-2022 | |
| 11160786 | 2034-03-14 | DP | |
| Levetiracetam, Keppra, Ucb Inc | |||
| 8802142 | 2031-06-07 | DP | |
| Levetiracetam, Keppra Xr, Ucb Inc | |||
| 7858122 | 2028-09-17 | DP | |
| Levetiracetam, Elepsia Xr, Tripoint | |||
| 8431156 | 2027-10-31 | DP | |
| 8470367 | 2027-10-31 | DP | |
| 8163306 | 2027-09-03 | DP | |
| 8425938 | 2026-02-22 | DP | |
| 8535717 | 2026-02-22 | DP | |
HCPCS
Code | Description |
|---|---|
| J1953 | Injection, levetiracetam, 10 mg |
Clinical
Clinical Trials
214 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Epilepsy | D004827 | EFO_0000474 | G40.9 | 4 | 12 | 22 | 11 | 13 | 60 |
| Seizures | D012640 | G40.4 | 6 | 11 | 11 | 7 | 10 | 39 | |
| Partial epilepsies | D004828 | EFO_0004263 | — | 1 | 9 | 7 | — | 17 | |
| Healthy volunteers/patients | — | 10 | — | — | 1 | 1 | 12 | ||
| Alcoholism | D000437 | EFO_0003829 | F10.1 | — | 3 | 1 | 1 | 1 | 6 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | 2 | — | 2 | — | 4 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | — | 1 | — | 2 | — | 3 |
| Rolandic epilepsy | D019305 | 1 | — | 1 | 1 | — | 3 | ||
| Traumatic brain injuries | D000070642 | S06 | — | — | 1 | 2 | — | 3 | |
| Subarachnoid hemorrhage | D013345 | EFO_0000713 | I60 | — | — | — | 2 | 1 | 3 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Status epilepticus | D013226 | EFO_0008526 | G41 | — | 4 | 2 | — | — | 6 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | 1 | 4 | 1 | — | 1 | 6 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 5 | 1 | — | 1 | 6 |
| Cognitive dysfunction | D060825 | G31.84 | — | 4 | 1 | — | — | 4 | |
| Generalized epilepsy | D004829 | — | — | 4 | — | — | 4 | ||
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | 2 | 1 | — | — | 3 |
| Post-traumatic epilepsy | D004834 | — | 1 | 2 | — | — | 3 | ||
| Stroke | D020521 | EFO_0000712 | I63.9 | 1 | — | 1 | — | — | 2 |
| Panic disorder | D016584 | EFO_0004262 | F41.0 | — | 1 | 1 | — | — | 2 |
| Tonic-clonic epilepsy | D004830 | EFO_0007262 | — | — | 2 | — | — | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myeloid leukemia acute | D015470 | C92.0 | — | 2 | — | — | 1 | 3 | |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | — | 1 | — | — | 1 | 2 | |
| Central nervous system neoplasms | D016543 | — | 1 | — | — | 1 | 2 | ||
| Psychotic disorders | D011618 | F20.81 | — | 2 | — | — | — | 2 | |
| Cerebral malaria | D016779 | B50.0 | 1 | 2 | — | — | — | 2 | |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | — | 2 | — | — | — | 2 |
| Cocaine-related disorders | D019970 | F14 | — | 2 | — | — | — | 2 | |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | 1 | — | — | 1 | 2 |
| Torticollis | D014103 | HP_0000473 | F45.8 | — | 1 | — | — | — | 1 |
| Neuroblastoma | D009447 | EFO_0000621 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Aphasia | D001037 | HP_0002381 | R47.01 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acute kidney injury | D058186 | HP_0001919 | N17 | — | — | — | — | 1 | 1 |
| Pharmacokinetics | D010599 | — | — | — | — | 1 | 1 | ||
| Myelodysplastic syndromes | D009190 | D46 | — | — | — | — | 1 | 1 | |
| Fibromyalgia | D005356 | EFO_0005687 | M79.1 | — | — | — | — | 1 | 1 |
| Hemoglobinopathies | D006453 | D58.2 | — | — | — | — | 1 | 1 | |
| Alveolar bone loss | D016301 | — | — | — | — | 1 | 1 | ||
| Substance-related disorders | D019966 | EFO_0003890 | F13 | — | — | — | — | 1 | 1 |
| Premenstrual dysphoric disorder | D065446 | F32.81 | — | — | — | — | 1 | 1 | |
| Neoplasms | D009369 | C80 | — | — | — | — | 1 | 1 | |
| Absence epilepsy | D004832 | G40.A | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | LEVETIRACETAM |
| INN | levetiracetam |
| Description | Levetiracetam is a pyrrolidinone and carboxamide that is N-methylpyrrolidin-2-one in which one of the methyl hydrogens is replaced by an aminocarbonyl group, while another is replaced by an ethyl group (the S enantiomer). An anticonvulsant, it is used for the treatment of epilepsy in both human and veterinary medicine. It has a role as an anticonvulsant, an environmental contaminant and a xenobiotic. |
| Classification | Small molecule |
| Drug class | nootropic agents (learning, cognitive enhancers), piracetam type |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CC[C@@H](C(N)=O)N1CCCC1=O |
Identifiers
| PDB | — |
| CAS-ID | 102767-28-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1286 |
| ChEBI ID | 6437 |
| PubChem CID | 5284583 |
| DrugBank | DB01202 |
| UNII ID | 44YRR34555 (ChemIDplus, GSRS) |
Target
Variants
Clinical Variant
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Financial
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Trends
PubMed Central
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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22,517 adverse events reported
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