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Topiramate
Eprontia, Qsymia, Qudexy, Topamax, Trokendi (topiramate) is a small molecule pharmaceutical. Topiramate was first approved as Topamax on 1996-12-24. It is used to treat bipolar disorder, epilepsy, infantile spasms, lennox gastaut syndrome, and pain amongst others in the USA. It is known to target carbonic anhydrase 1, carbonic anhydrase 7, carbonic anhydrase 12, and carbonic anhydrase 4.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
hereditary congenital and neonatal diseases and abnormalitiesD009358
signs and symptoms pathological conditionsD013568
psychological phenomenaD011579
mental disordersD001523
musculoskeletal and neural physiological phenomenaD055687
Trade Name
FDA
EMA
Eprontia, Qudexy, Topamax, Trokendi (generic drugs available since 2009-03-27)
Combinations
Qsymia
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Phentermine hydrochloride
+
Topiramate
Tradename
Company
Number
Date
Products
QSYMIAVivusN-022580 RX2012-07-17
4 products, RLD, RS
Topiramate
Tradename
Company
Number
Date
Products
EPRONTIAAzurityN-214679 RX2021-11-05
1 products, RLD, RS
TOPAMAXJohnson & JohnsonN-020505 RX1996-12-24
4 products, RLD
TOPAMAXJohnson & JohnsonN-020844 RX1998-10-26
2 products, RLD, RS
TROKENDI XRSupernus PharmaceuticalsN-201635 RX2013-08-16
4 products, RLD, RS
QUDEXY XRUpsher-Smith LaboratoriesN-205122 RX2014-03-11
5 products, RLD, RS
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
eprontiaNew Drug Application2021-11-05
qsymiaNew Drug Application2022-01-13
qudexy New Drug Application2020-09-28
topamaxNew Drug Application2022-10-27
topiramateANDA2023-06-20
trokendi xrNew Drug Application2020-12-04
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
bipolar disorderEFO_0000289D001714F30.9
epilepsyEFO_0000474D004827G40.9
infantile spasmsEFO_1000643D013036G40.82
lennox gastaut syndrome—D065768G40.81
painEFO_0003843D010146R52
partial epilepsiesEFO_0004263D004828—
tonic-clonic epilepsyEFO_0007262D004830—
Agency Specific
FDA
EMA
Expiration
Code
PHENTERMINE HYDROCHLORIDE / TOPIRAMATE, QSYMIA, VIVUS
2025-06-24NPP
Patent Expiration
Patent
Expires
Flag
FDA Information
Topiramate, Eprontia, Azurity
114330462040-08-21U-3413, U-3414, U-3415
116333742040-08-21DP
Topiramate, Qudexy Xr, Upsher Smith Labs
86525272033-03-19DP
88891902033-03-19DP
91015452033-03-19DP
95550052033-03-19DP
103632242033-03-19U-766
Phentermine Hydrochloride / Topiramate, Qsymia, Vivus
85802992029-06-14U-3399
85802982029-05-15DP
88950572028-06-09U-3398
88950582028-06-09DP
90119052028-06-09DP
90119062028-06-09U-3398
Topiramate, Trokendi Xr, Supernus Pharms
82985762028-04-04DPU-106, U-1992
82985802027-11-16DPU-106, U-1992
86636832027-11-16DPU-106, U-1992
88772482027-11-16DPU-106, U-1992
88891912027-11-16U-106, U-1992
89929892027-11-16DPU-1675, U-1992
95499402027-11-16DPU-1675, U-1992
95550042027-11-16DPU-1675, U-1992
96229832027-11-16DPU-1675, U-1992
103147902027-11-16DPU-1675, U-1992
ATC Codes
N: Nervous system drugs
— N03: Antiepileptics
— N03A: Antiepileptics
— N03AX: Other antiepileptics in atc
— N03AX11: Topiramate
HCPCS
No data
Clinical
Clinical Trials
259 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Migraine disordersD008881EFO_0003821G43531481040
EpilepsyD004827EFO_0000474G40.965156537
ObesityD009765EFO_0001073E66.9110149235
AlcoholismD000437EFO_0003829F10.121487128
SeizuresD012640G40.415111321
Partial epilepsiesD004828EFO_0004263—553—13
HeadacheD006261HP_0002315R51—252211
Bipolar disorderD001714EFO_0000289F30.92—54—11
Type 2 diabetes mellitusD003924EFO_0001360E11—351—9
Post-traumatic stress disordersD013313EFO_0001358F43.1—22519
Show 26 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cocaine-related disordersD019970F14153—19
Tobacco use disorderD014029F17—32——4
Binge-eating disorderD056912F50.2121——3
GamblingD005715F63.0—21——3
Prader-willi syndromeD011218Orphanet_739Q87.11——1—12
Tonic-clonic epilepsyD004830EFO_00072621—1——2
Psychotic affective disordersD000341F39——2——2
Mood disordersD019964EFO_0004247F30-F39——2——2
BulimiaD002032F50.2—11——2
Vascular headachesD014653——2——2
Show 15 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—111——214
Weight lossD015431HP_000182412——14
Pediatric obesityD06376622———4
Parkinson diseaseD010300EFO_0002508G20—2——13
Morbid obesityD009767EFO_0001074—2———2
Bariatric surgeryD050110—2———2
Brain hypoxia-ischemiaD020925EFO_1000846P91.612———2
Ulcerative colitisD003093EFO_0000729K51—1———1
Multiple sclerosisD009103EFO_0003885G35—1———1
Drug-induced dyskinesiaD004409EFO_1000904—1———1
Show 7 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Postoperative painD010149G89.181————1
Hepatic insufficiencyD0485501————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ArthritisD001168EFO_0005856M05-M14————11
TendinopathyD052256EFO_1001434M77.9————11
SynovitisD013585EFO_0008997M67.5————11
SpasmD013035M62.83————11
RadiculopathyD011843M54.1————11
GoutD006073EFO_0004274M10————11
Rett syndromeD015518F84.2————11
Metabolic bone diseasesD001851HP_0000938————11
OsteoporosisD010024EFO_0003882M81.0————11
DizzinessD004244HP_0002321R42————11
Show 4 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTOPIRAMATE
INNtopiramate
Description
Topiramate is a hexose derivative that is 2,3:4,5-di-O-isopropylidene-beta-D-fructopyranose in which the hydroxy group has been converted to the corresponding sulfamate ester. It blocks voltage-dependent sodium channels and is used as an antiepileptic and for the prevention of migraine. It has a role as an anticonvulsant and a sodium channel blocker. It is a cyclic ketal, a sulfamate ester and a ketohexose derivative.
Classification
Small molecule
Drug class—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CC1(C)O[C@@H]2CO[C@@]3(COS(N)(=O)=O)OC(C)(C)O[C@H]3[C@@H]2O1
Identifiers
PDB5JNA
CAS-ID97240-79-4
RxCUI38404
ChEMBL IDCHEMBL220492
ChEBI ID63631
PubChem CID5284627
DrugBankDB00273
UNII ID0H73WJJ391 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
CA1
CA1
CA7
CA7
CA12
CA12
CA4
CA4
Organism
Homo sapiens
Gene name
CA1
Gene synonyms
NCBI Gene ID
759
Protein name
carbonic anhydrase 1
Protein synonyms
CA-I, CAB, Carbonate dehydratase I, Carbonic anhydrase B, Carbonic anhydrase I, Cyanamide hydratase CA1, epididymis secretory protein Li 11, epididymis secretory sperm binding protein
Uniprot ID
P00915
Mouse ortholog
Car1 (12346)
carbonic anhydrase 1 (Q9DC84)
Variants
Clinical Variant
No data
Financial
Trokendi - Supernus Pharmaceuticals
$
€
£
₣
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Qsymia - Vivus
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 15,240 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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9,692 adverse events reported
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