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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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
| nutritional and metabolic diseases | D009750 |
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 KIT | Italfarmaco | N-209080 RX | 2018-09-05 | 1 products, RLD, RS |
Show 2 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| riluzole | ANDA | 2025-08-08 |
| teglutik | unapproved drug for use in drug shortage | 2024-06-14 |
| teglutik tiglutik | New Drug Application | 2024-02-06 |
| tiglutik | New Drug Application | 2025-09-16 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| amyotrophic lateral sclerosis | EFO_0000253 | D000690 | G12.21 |
Agency Specific
FDA
EMA
No data
HCPCS
No data
Clinical
Clinical Trials
96 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 sclerosis | D000690 | EFO_0000253 | G12.21 | 6 | 29 | 11 | 2 | 4 | 43 |
| Motor neuron disease | D016472 | EFO_0003782 | G12.2 | 3 | 17 | 4 | 1 | 2 | 23 |
| Sclerosis | D012598 | — | — | 3 | 16 | 3 | 1 | 2 | 21 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | 3 | — | 1 | — | 4 |
| Inflammation | D007249 | MP_0001845 | — | — | — | — | 1 | — | 1 |
| Fatigue | D005221 | — | R53.83 | — | — | — | 1 | — | 1 |
| Cognitive dysfunction | D060825 | — | G31.84 | — | — | — | 1 | — | 1 |
| Behavior | D001519 | GO_0007610 | STY/T053 | — | — | — | 1 | — | 1 |
| Tourette syndrome | D005879 | EFO_0004895 | F95.2 | — | — | — | 1 | — | 1 |
| Tics | D020323 | — | — | — | — | — | 1 | — | 1 |
Show 4 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Spinal cord injuries | D013119 | EFO_1001919 | — | — | 2 | 1 | — | 2 | 4 |
| Spinocerebellar ataxias | D020754 | — | — | — | 1 | 2 | — | 1 | 3 |
| Cerebellar ataxia | D002524 | — | — | — | 2 | 1 | — | 1 | 3 |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | 2 | 1 | — | — | 2 |
| Nerve degeneration | D009410 | — | — | — | 1 | 1 | — | — | 1 |
| Neuromuscular diseases | D009468 | EFO_1001902 | G70.9 | — | 1 | 1 | — | — | 1 |
| Social phobia | D000072861 | EFO_1001917 | F40.1 | — | 1 | 1 | — | — | 1 |
| Performance anxiety | D060805 | — | — | — | 1 | 1 | — | — | 1 |
| Friedreich ataxia | D005621 | Orphanet_95 | G11.11 | — | 1 | 1 | — | — | 1 |
| Huntington disease | D006816 | Orphanet_399 | G10 | — | — | 1 | — | — | 1 |
Show 2 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Depression | D003863 | — | F33.9 | — | 4 | — | — | 1 | 5 |
| Autism spectrum disorder | D000067877 | — | F84.0 | 1 | 2 | — | — | 1 | 4 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | 3 | — | — | 1 | 4 |
| Colorectal neoplasms | D015179 | — | — | 1 | 2 | — | — | — | 3 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | 3 | 1 | — | — | — | 3 |
| Melanoma | D008545 | — | — | 2 | 1 | — | — | — | 3 |
| Cutaneous malignant melanoma | D000096142 | — | — | 2 | 1 | — | — | — | 3 |
| Obsessive-compulsive disorder | D009771 | EFO_0004242 | F42 | — | 2 | — | — | 1 | 3 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | 2 | — | — | — | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 1 | — | — | — | 2 |
Show 24 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 3 | — | — | — | — | 3 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 2 | — | — | — | — | 2 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | 1 | — | — | — | 1 | 2 |
| Neoplasms | D009369 | — | C80 | 1 | — | — | — | — | 1 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 1 | — | — | — | — | 1 |
| Treatment-resistant schizophrenia | D000090663 | — | — | 1 | — | — | — | — | 1 |
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | — | — | — | — | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Riluzole |
| INN | riluzole |
| Description | Riluzole is a member of benzothiazoles. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Nc1nc2ccc(OC(F)(F)F)cc2s1 |
Identifiers
| PDB | — |
| CAS-ID | 1744-22-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL744 |
| ChEBI ID | 8863 |
| PubChem CID | 5070 |
| DrugBank | DB00740 |
| UNII ID | 7LJ087RS6F (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 9,048 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,906 adverse events reported
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