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Drug ReportsRiluzole
Rilutek(riluzole)
Exservan, Rilutek, Riluzole, Tiglutik (riluzole) is a small molecule pharmaceutical. Riluzole was first approved as Rilutek on 1995-12-12. It is used to treat amyotrophic lateral sclerosis in the USA. It has been approved in Europe to treat amyotrophic lateral sclerosis. It is known to target intermediate conductance calcium-activated potassium channel protein 4, potassium voltage-gated channel subfamily H member 2, short transient receptor potential channel 5, small conductance calcium-activated potassium channel protein 3, potassium voltage-gated channel subfamily D member 2, potassium channel subfamily K member 2, small conductance calcium-activated potassium channel protein 1, small conductance calcium-activated potassium channel protein 2, potassium voltage-gated channel subfamily D member 3, and potassium channel subfamily K member 4.
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Events Timeline
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YTD
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FDA approval date
EMA approval date
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Study first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Exservan, Rilutek, Tiglutik (generic drugs available since 2003-01-29)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Riluzole
Tradename
Company
Number
Date
Products
EXSERVANAquestive TherapeuticsN-212640 RX2019-11-22
1 products, RLD, RS
RILUTEKCovis PharmaN-020599 RX1995-12-12
1 products, RLD, RS
TIGLUTIK KITItalfarmacoN-209080 RX2018-09-05
1 products, RLD, RS
Labels
FDA
EMA
No data
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Riluzole, Tiglutik Kit, Italfarmaco Sa
87651502029-03-12DPU-2401
Riluzole, Exservan, Aquestive
86035142024-04-03DP
87651672024-02-20DP
ATC Codes
N: Nervous system drugs
— N07: Other nervous system drugs in atc
— N07X: Other nervous system drugs in atc
— N07XX: Other nervous system drugs in atc
— N07XX02: Riluzole
HCPCS
No data
Clinical
Clinical Trials
86 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Amyotrophic lateral sclerosisD000690HP_0007354G12.2142592436
InflammationD007249MP_0001845————1—1
FatigueD005221HP_0012378R53.83———1—1
Tourette syndromeD005879EFO_0004895F95.2———1—1
Fragile x syndromeD005600—Q99.2———1—1
Memory disordersD008569—————1—1
AffectD000339—————1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Spinal cord injuriesD013119EFO_1001919——21—13
Cerebellar ataxiaD002524HP_0001251——21——2
Spinocerebellar ataxiasD020754HP_0007263———1——1
Neuromuscular diseasesD009468EFO_1001902G70.9—11——1
Social phobiaD000072861EFO_1001917F40.1—11——1
Performance anxietyD060805———11——1
Huntington diseaseD006816Orphanet_399G10——1——1
Multiple system atrophyD019578————1——1
Progressive supranuclear palsyD013494EFO_0002512G23.1——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Autism spectrum disorderD000067877HP_0000729F84.012——14
Bipolar disorderD001714EFO_0000289F30.9—3——14
Post-traumatic stress disordersD013313EFO_0001358F43.131———3
MelanomaD008545——21———3
Multiple sclerosisD009103EFO_0003885G35—2———2
DepressionD003863—F33.9—2———2
Obsessive-compulsive disorderD009771EFO_0004242F42—2———2
Parkinson diseaseD010300EFO_0002508G20—1———1
Chronic progressive multiple sclerosisD020528EFO_0003840——1———1
Alzheimer diseaseD000544EFO_0000249F03—1———1
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Colorectal neoplasmsD015179——1————1
Therapeutic equivalencyD013810——1————1
NeoplasmsD009369—C801————1
Breast neoplasmsD001943EFO_0003869C501————1
Treatment-resistant schizophreniaD000090663——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SchizophreniaD012559EFO_0000692F20————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameRiluzole
INNriluzole
Description
Riluzole is a member of benzothiazoles.
Classification
Small molecule
Drug class—
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Nc1nc2ccc(OC(F)(F)F)cc2s1
Identifiers
PDB—
CAS-ID1744-22-5
RxCUI—
ChEMBL IDCHEMBL744
ChEBI ID8863
PubChem CID5070
DrugBankDB00740
UNII ID7LJ087RS6F (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
KCNK2
KCNK2
KCNH2
KCNH2
KCNN2
KCNN2
CALM1
CALM1
Organism
Homo sapiens
Gene name
KCNK2
Gene synonyms
TREK, TREK1
NCBI Gene ID
Protein name
potassium channel subfamily K member 2
Protein synonyms
K2P2.1 potassium channel, Outward rectifying potassium channel protein TREK-1, potassium channel, two pore domain subfamily K, member 2, potassium inwardly-rectifying channel, subfamily K, member 2, tandem-pore-domain potassium channel TREK-1, TREK-1 K(+) channel subunit, TWIK-related potassium channel 1, Two pore domain potassium channel TREK-1, Two pore potassium channel TPKC1, two-pore potassium channel 1
Uniprot ID
Mouse ortholog
Kcnk2 (16526)
potassium channel subfamily K member 2 (Q4VQI2)
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 7,814 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,226 adverse events reported
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