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Drug ReportsTopiramate
Topiramate
Eprontia, Qsymia, Qudexy, Topamax, Topiramate, 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 7, carbonic anhydrase 12, carbonic anhydrase 4, and carbonic anhydrase 1.
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Clinical
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Target
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Events Timeline
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1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Primary completion date
Completion date
Results first post date
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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, Topiramate, Trokendi (discontinued: Topamax, Topiramate)
Combinations
Phentermine topiramate, Qsymia
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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
Phentermine hydrochloride
+
Topiramate
Tradename
Company
Number
Date
Products
QSYMIAVivusN-022580 RX2012-07-17
4 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
eprontiaNew Drug Application2024-05-17
qsymiaNew Drug Application2024-10-03
qudexyNew Drug Application2024-08-05
topamaxNew Drug Application2023-05-12
topiramateANDA2024-10-30
topiramate tablets2009-04-03
topiramate topiramateANDA2016-05-19
trokendi xrNew Drug Application2024-10-10
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
322 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_0003821G435720161764
EpilepsyD004827EFO_0000474G40.97816151357
ObesityD009765EFO_0001073E66.93151714957
AlcoholismD000437EFO_0003829F10.121488230
SeizuresD012640HP_0002069G40.415153327
HeadacheD006261HP_0002315R51—274619
Partial epilepsiesD004828EFO_0004263——554—14
SyndromeD013577———163212
Type 2 diabetes mellitusD003924EFO_0001360E11—461112
Bipolar disorderD001714EFO_0000289F30.92—55—12
Show 63 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cocaine-related disordersD019970—F14153—19
Feeding and eating disordersD001068—F50222—27
Binge-eating disorderD056912—F50.2132—27
Morbid obesityD009767EFO_0001074——41——5
Psychotic disordersD011618—F20.811—2—14
Tobacco use disorderD014029—F17—32——4
GamblingD005715EFO_1001926F63.0—21——3
Lennox gastaut syndromeD065768—G40.81——2—13
SpasmD013035—M62.83—11—12
SclerosisD012598———11——2
Show 29 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———111——214
Central nervous system neoplasmsD016543——12———2
Nervous system neoplasmsD009423——12———2
DyskinesiasD020820HP_0002310G24—2———2
Addictive behaviorD016739EFO_0004347——1——12
Alcoholic intoxicationD000435———2———2
Bariatric surgeryD050110———2———2
IschemiaD007511EFO_0000556—12———2
HypoxiaD000860HP_0012418R09.0212———2
Brain diseasesD001927HP_0001298G93.4012———2
Show 37 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MalnutritionD044342EFO_0008572E40-E462———13
Postoperative painD010149—G89.181————1
Congenital heart defectsD006330HP_0001627Q24.91————1
Heart diseasesD006331EFO_0003777I51.91————1
Renal insufficiencyD051437HP_0000083N191————1
Liver diseasesD008107HP_0002910K70-K771————1
Hepatic insufficiencyD048550——1————1
Wounds and injuriesD014947—T14.81————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AcidosisD000138EFO_1000014E87.2————22
ArthritisD001168HP_0001369M05-M14————11
TendinopathyD052256EFO_1001434M77.9————11
SynovitisD013585EFO_0008997M67.5————11
RadiculopathyD011843—M54.1————11
GoutD006073EFO_0004274M10————11
Rett syndromeD015518Orphanet_778F84.2————11
Financial stressD000086522——————11
Metabolic bone diseasesD001851HP_0000938—————11
OsteoporosisD010024HP_0000939M81.0————11
Show 16 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)Loading
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
PDB—
CAS-ID97240-79-4
RxCUI—
ChEMBL IDCHEMBL220492
ChEBI ID63631
PubChem CID5284627
DrugBankDB00273
UNII ID0H73WJJ391 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
CA7
CA7
CA12
CA12
CA4
CA4
CA1
CA1
Organism
Homo sapiens
Gene name
CA7
Gene synonyms
NCBI Gene ID
Protein name
carbonic anhydrase 7
Protein synonyms
CA-VII, Carbonate dehydratase VII, Carbonic anhydrase VII, carbonic dehydratase VII
Uniprot ID
Mouse ortholog
Car7 (12354)
carbonic anhydrase 7 (Q9ERQ8)
Variants
No data
Financial
Revenue by drug
$
€
ÂŁ
â‚Ł
Trokendi – Supernus Pharmaceuticals
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Qsymia – Vivus
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Estimated US medical usage
Topiramate
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 18,188 documents
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Safety
Black-box Warning
Black-box warning for: Qudexy
Adverse Events
Top Adverse Reactions
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42,297 adverse events reported
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