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Drug ReportsGabapentin enacarbil
Gabapentin enacarbil
Horizant (gabapentin enacarbil) is a small molecule pharmaceutical. Gabapentin enacarbil was first approved as Horizant on 2011-04-06. It is used to treat bipolar disorder, epilepsy, partial epilepsies, phobic disorders, and postherpetic neuralgia in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
signs and symptoms pathological conditionsD013568
mental disordersD001523
Trade Name
FDA
EMA
Horizant
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Gabapentin enacarbil
Tradename
Company
Number
Date
Products
HORIZANTAzurityN-022399 RX2011-04-06
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
horizantNew Drug Application2023-08-29
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Gabapentin Enacarbil, Horizant, Azurity
87957252029-06-10DPU-1231, U-1247
80262792026-11-10DS, DP
81149092026-04-11U-1231
68187872025-04-06DS, DP
86860342025-01-24U-1231, U-1247
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
521 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Postoperative painD010149—G89.187410281460
PainD010146EFO_0003843R52257151542
Restless legs syndromeD012148EFO_0004270G25.813476323
Healthy volunteers/patients———11—11922
Diabetic neuropathiesD003929EFO_1000783——848—17
NeuralgiaD009437EFO_0009430—1415617
Sleep initiation and maintenance disordersD007319—F51.011471215
Hot flashesD019584———271515
Chronic painD059350HP_0012532——431412
AlcoholismD000437EFO_0003829F10.1—831212
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C50—34—39
FibromyalgiaD005356EFO_0005687M79.1—12—79
NeoplasmsD009369—C80—31—26
Substance-related disordersD019966EFO_0003890F13132—15
DepressionD003863—F33.9—11—35
ScoliosisD012600EFO_0004273M41——3—14
Postoperative complicationsD011183———11—13
Anxiety disordersD001008EFO_0006788F41.1—11—13
MenopauseD008593EFO_0003922N95—11—13
TinnitusD014012HP_0000360H93.1—31——3
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Migraine disordersD008881EFO_0003821G43—1——23
Intervertebral disc displacementD007405EFO_1001800——1——23
Bipolar disorderD001714EFO_0000289F30.9—3———3
HivD006678—O98.7—1——23
Covid-19D000086382—U07.1—1——12
Male breast neoplasmsD018567———1——12
Central nervous system neoplasmsD016543——12———2
Cocaine-related disordersD019970—F14—2———2
Mood disordersD019964EFO_0004247F30-F39—1——12
Psychotic disordersD011618—F20.8112———2
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Refractive errorsD012030EFO_0003908H52.71————1
StomatitisD013280EFO_1001904K12.11————1
Squamous cell carcinoma of head and neckD000077195——1————1
PharmacokineticsD010599——1————1
Weight lossD015431HP_0001824—1————1
Taste disordersD013651——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertensionD006973EFO_0000537I10————22
HysterectomyD007044EFO_0003881—————22
HeadacheD006261HP_0002315R51————22
VulvodyniaD056650—N94.81————22
Renal cell carcinomaD002292EFO_0000376—————22
Pancreatic neoplasmsD010190EFO_0003860C25————22
Kidney neoplasmsD007680EFO_0003865C64————22
Chronic pancreatitisD050500EFO_0000342K86.1————22
Pelvic neoplasmsD010386——————22
HemorrhageD006470MP_0001914R58————11
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameGabapentin enacarbil
INNgabapentin enacarbil
Description
Gabapentin enacarbil is a carbamate ester that is the N-[1-(isobutyryloxy)ethoxy]carbonyl derivative of [1-(aminomethyl)cyclohexyl]acetic acid. The prodrug for gabapentin, used for treatment of neuropathic pain and restless legs syndrome. It has a role as a prodrug, an anticonvulsant and a calcium channel blocker. It is a monocarboxylic acid, a carbamate ester, a carboxylic ester and an acetal. It is functionally related to a gamma-aminobutyric acid and a gabapentin.
Classification
Small molecule
Drug classgabamimetics
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Structure (InChI/SMILES or Protein Sequence)
CC(OC(=O)NCC1(CC(=O)O)CCCCC1)OC(=O)C(C)C
Identifiers
PDB—
CAS-ID478296-72-9
RxCUI—
ChEMBL IDCHEMBL1628502
ChEBI ID68840
PubChem CID9883933
DrugBank—
UNII ID75OCL1SPBQ (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
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Safety
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Adverse Events
Top Adverse Reactions
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1,517 adverse events reported
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