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Drug ReportsRiluzole
Rilutek(riluzole)
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, voltage-gated inwardly rectifying potassium channel KCNH2; potassium voltage-gated channel subfamily H member 2, short transient receptor potential channel 5, small conductance calcium-activated potassium channel protein 3, A-type voltage-gated potassium channel KCND2, potassium channel subfamily K member 2, small conductance calcium-activated potassium channel protein 1, small conductance calcium-activated potassium channel protein 2, A-type voltage-gated potassium channel KCND3, and potassium channel subfamily K member 4.
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Events Timeline
5D
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3M
6M
YTD
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2Y
5Y
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FDA approval date
EMA approval date
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Study first post date
Last update post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Riluzole, Tiglutik (discontinued: Exservan, Rilutek, Riluzole)
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
TIGLUTIK KITItalfarmacoN-209080 RX2018-09-05
1 products, RLD, RS
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
riluzoleANDA2024-01-10
teglutikunapproved drug for use in drug shortage2024-06-14
teglutik tiglutikNew Drug Application2024-02-06
tiglutikNew Drug Application2024-02-08
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
90 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_0007354G12.21527102439
Motor neuron diseaseD016472EFO_0003782G12.2527102439
SclerosisD012598——529101339
DepressionD003863—F33.9—4—116
Major depressive disorderD003865EFO_0003761F22—2—1—3
SyndromeD013577—————2—2
InflammationD007249MP_0001845————1—1
FatigueD005221HP_0012378R53.83———1—1
Tourette syndromeD005879EFO_0004895F95.2———1—1
Fragile x syndromeD005600—Q99.2———1—1
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Spinocerebellar degenerationsD013132—G11—22—14
AtaxiaD001259—R27.0—22—14
Cerebellar ataxiaD002524HP_0001251——22—14
Spinal cord injuriesD013119EFO_1001919——21—24
Spinocerebellar ataxiasD020754HP_0007263——12—13
Wounds and injuriesD014947—T14.8—21—13
Anxiety disordersD001008EFO_0006788F41.1—21——2
Neuromuscular diseasesD009468EFO_1001902G70.9—11——1
Social phobiaD000072861EFO_1001917F40.1—11——1
Performance anxietyD060805———11——1
Show 8 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Autism spectrum disorderD000067877HP_0000729F84.012——14
Depressive disorderD003866EFO_1002014F32.A—3——14
Bipolar disorderD001714EFO_0000289F30.9—3——14
Multiple sclerosisD009103EFO_0003885G35—3———3
Post-traumatic stress disordersD013313EFO_0001358F43.131———3
Autistic disorderD001321HP_0000717F84.012———3
MelanomaD008545——21———3
Obsessive-compulsive disorderD009771EFO_0004242F42—2——13
Compulsive personality disorderD003193—F60.5—2——13
Traumatic stress disordersD040921——21———2
Show 15 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C802————2
Brain neoplasmsD001932EFO_0003833C712————2
SchizophreniaD012559EFO_0000692F201———12
Treatment-resistant schizophreniaD000090663——1———12
Colorectal neoplasmsD015179——1————1
Therapeutic equivalencyD013810——1————1
Skin neoplasmsD012878EFO_0004198C441————1
Cutaneous malignant melanomaD000096142——1————1
RecurrenceD012008——1————1
GlioblastomaD005909EFO_0000515—1————1
Indications Without Phase
No data
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 8,231 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,719 adverse events reported
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