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Drug ReportsGabapentin
Gabapentin
Gabapentin, Gralise, Neurontin (gabapentin) is a small molecule pharmaceutical. Gabapentin was first approved as Neurontin on 1993-12-30. It is used to treat bipolar disorder, epilepsy, partial epilepsies, phobic disorders, and postherpetic neuralgia in the USA. It is known to target potassium voltage-gated channel subfamily KQT member 3 and potassium voltage-gated channel subfamily KQT member 5.
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Events Timeline
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FDA approval date
EMA approval date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
signs and symptoms pathological conditionsD013568
mental disordersD001523
Trade Name
FDA
EMA
Gabapentin, Gralise, Neurontin (discontinued: Gabapentin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Gabapentin
Tradename
Company
Number
Date
Products
GRALISEAlmatica PharmaN-022544 RX2011-01-28
5 products, RLD
NEURONTINViatrisN-020235 RX1993-12-30
3 products, RLD, RS
NEURONTINViatrisN-020882 RX1998-10-09
2 products, RLD, RS
NEURONTINViatrisN-021129 RX2000-03-02
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
cyclo/gaba 10/300 packANDA2016-06-22
fanatrexunapproved drug other2016-01-07
gaba 300-ezsunapproved drug other2020-11-16
gabapentinANDA2025-01-15
gabapentin gabapentinANDA2013-08-23
gabaroneANDA2024-12-23
graliseNew Drug Application2024-07-02
horizantNew Drug Application2023-08-29
neurontinNew Drug Application2024-07-22
therapentin-60unapproved drug other2011-08-01
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Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
epilepsyEFO_0000474D004827G40.9
postherpetic neuralgia—D051474—
partial epilepsiesEFO_0004263D004828—
bipolar disorderEFO_0000289D001714F30.9
phobic disordersEFO_1001908D010698F40
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Gabapentin, Gralise, Almatica
74389272024-02-26U-1114
ATC Codes
N: Nervous system drugs
— N02: Analgesics
— N02B: Other analgesics and antipyretics in atc
— N02BF: Gabapentinoids, analgesics and antipyretics
— N02BF01: Gabapentin
HCPCS
No data
Clinical
Clinical Trials
534 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Substance-related disordersD019966EFO_0003890F13———1—1
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameGabapentin
INNgabapentin
Description
Gabapentin is a gamma-amino acid that is cyclohexane substituted at position 1 by aminomethyl and carboxymethyl groups. Used for treatment of neuropathic pain and restless legs syndrome. It has a role as an anticonvulsant, a calcium channel blocker, an environmental contaminant and a xenobiotic. It is functionally related to a gamma-aminobutyric acid.
Classification
Small molecule
Drug classgabamimetics
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
NCC1(CC(=O)O)CCCCC1
Identifiers
PDB—
CAS-ID60142-96-3
RxCUI—
ChEMBL IDCHEMBL940
ChEBI ID42797
PubChem CID3446
DrugBankDB00996
UNII ID6CW7F3G59X (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
KCNQ3
KCNQ3
KCNQ5
KCNQ5
Organism
Homo sapiens
Gene name
KCNQ3
Gene synonyms
NCBI Gene ID
3786
Protein name
potassium voltage-gated channel subfamily KQT member 3
Protein synonyms
KQT-like 3, Potassium channel subunit alpha KvLQT3, potassium channel, voltage gated KQT-like subfamily Q, member 3, potassium channel, voltage-gated, subfamily Q, member 3, potassium voltage-gated channel, KQT-like subfamily, member 3, Voltage-gated potassium channel subunit Kv7.3
Uniprot ID
O43525
Mouse ortholog
Kcnq3 (110862)
potassium voltage-gated channel subfamily KQT member 3 (Q8K3F6)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Gralise – Assertio Therapeutics
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Gralise – Assertio Therapeutics
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Neurontin – Pfizer
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Tabular view
Estimated US medical usage
Gabapentin
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 29,948 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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101,344 adverse events reported
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