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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 Application2025-04-28
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
555 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—G89.188715352079
PainD010146EFO_0003843R5231111201960
NeuralgiaD009437EFO_0009430—2127101141
Restless legs syndromeD012148EFO_0004270G25.814478326
Chronic painD059350——1743822
Healthy volunteers/patients———11—11922
Postherpetic neuralgiaD051474———643719
SyndromeD013577———374418
AgnosiaD000377EFO_0007136F881229317
Diabetic neuropathiesD003929EFO_1000783——848—17
Show 136 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C50—34—410
FibromyalgiaD005356EFO_0005687M79.1—12—810
DepressionD003863—F33.9—22—48
Myofascial pain syndromesD009209EFO_1001054——11—67
Alcohol drinkingD000428EFO_0004329——31——4
Anterior cruciate ligament injuriesD000070598———23——3
Squamous cell carcinoma of head and neckD000077195——1—1—13
Emergence deliriumD000071257————2—13
Mood disordersD019964EFO_0004247F30-F39—11—13
Diabetes mellitusD003920EFO_0000400E08-E13——1—23
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Covid-19D000086382—U07.1—1——23
GlioblastomaD005909EFO_0000515—23———3
Migraine disordersD008881EFO_0003821G43—1——23
Psychotic disordersD011618—F20.8113———3
Marijuana abuseD002189EFO_0007191F12—3———3
Bipolar disorderD001714EFO_0000289F30.9—3———3
HivD006678—O98.7—1——23
Male breast neoplasmsD018567———1——12
Central nervous system neoplasmsD016543——12———2
GliosarcomaD018316——12———2
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertensionD006973EFO_0000537I101———23
BurnsD002056—T30.01———12
Refractive errorsD012030HP_0000483H52.71————1
StomatitisD013280EFO_1001904K12.11————1
SpondylosisD055009—M471————1
PharmacokineticsD010599——1————1
Weight lossD015431——1————1
Autistic disorderD001321EFO_0003758F84.01————1
Pervasive child development disordersD002659EFO_0003756F841————1
Alopecia areataD000506EFO_0004192L631————1
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
DiseaseD004194EFO_0000408R69————33
Pancreatic neoplasmsD010190EFO_0003860C25————33
Cardiac surgical proceduresD006348——————22
HysterectomyD007044EFO_0003881—————22
SciaticaD012585—M54.3————22
Herpes simplexD006561—B00————22
VulvodyniaD056650—N94.81————22
Renal cell carcinomaD002292EFO_0000376—————22
PancreatitisD010195EFO_0000278K85————22
Kidney neoplasmsD007680EFO_0003865C64————22
Show 87 more
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
Image (chem structure or protein)Loading
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
Black-box Warning
No Black-box warning
Adverse Events
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2,049 adverse events reported
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