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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
537 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—G89.189613352382
PainD010146EFO_0003843R5231010151649
NeuralgiaD009437EFO_0009430—2119111143
SyndromeD013577———4913632
Restless legs syndromeD012148EFO_0004270G25.814478326
Healthy volunteers/patients———11—11922
Psychomotor agitationD011595——1477221
Chronic painD059350HP_0012532—1632617
Diabetic neuropathiesD003929EFO_1000783——848—17
Postherpetic neuralgiaD051474———643517
Show 141 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C50—34—410
Myofascial pain syndromesD009209EFO_1001054——12—810
FibromyalgiaD005356EFO_0005687M79.1—12—810
DepressionD003863—F33.9—22—48
ScoliosisD012600EFO_0004273M41——3—25
Intervertebral disc displacementD007405EFO_1001800——11—24
Alcohol drinkingD000428EFO_0004329——22——4
Anterior cruciate ligament injuriesD000070598———23——3
SpasmD013035—M62.83——1—23
Depressive disorderD003866EFO_1002014F32.A—11—13
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Marijuana abuseD002189EFO_0007191F12—5———5
Covid-19D000086382———1——23
Nervous system neoplasmsD009423——12——13
Migraine disordersD008881EFO_0003821G43—1——23
Psychotic disordersD011618—F20.8113———3
Bipolar disorderD001714EFO_0000289F30.9—3———3
HivD006678———1——23
Male breast neoplasmsD018567———1——12
Central nervous system neoplasmsD016543——12———2
Intractable painD010148———1——12
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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
Squamous cell carcinoma of head and neckD000077195——1———12
Critical illnessD016638——1———12
BurnsD002056—T30.01———12
Refractive errorsD012030EFO_0003908H52.71————1
StomatitisD013280EFO_1001904K12.11————1
SpondylosisD055009—M471————1
PharmacokineticsD010599——1————1
Weight lossD015431HP_0001824—1————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————55
Pancreatic neoplasmsD010190EFO_0003860C25————33
Cardiac surgical proceduresD006348——————22
HysterectomyD007044EFO_0003881—————22
Pathologic constrictionD003251——————22
SciaticaD012585HP_0011868M54.3————22
VulvodyniaD056650—N94.81————22
Renal cell carcinomaD002292EFO_0000376—————22
Diabetes mellitusD003920HP_0000819E08-E13————22
PancreatitisD010195HP_0001733K85————22
Show 84 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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Additional graphs summarizing 424 documents
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Safety
Black-box Warning
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Adverse Events
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1,984 adverse events reported
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