Idebenone
Raxone (idebenone) is a small molecule pharmaceutical. Idebenone was first approved as Raxone on 2015-09-08. It has been approved in Europe to treat hereditary optic atrophy leber.
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Commercial
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Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| lebody lab renewal dual effect idebenone serum | unapproved drug other | 2023-02-24 |
| ultra v idebenone ampoule | unapproved drug other | 2020-04-01 |
| ultra v idebenone nutritional | unapproved drug other | 2020-04-01 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hereditary optic atrophy leber | Orphanet_104 | D029242 | H47.22 |
Agency Specific
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Clinical
Clinical Trials
35 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Optic nerve diseases | D009901 | EFO_1001330 | H47.14 | — | 1 | 1 | 1 | 3 | 6 |
| Hereditary optic atrophy leber | D029242 | Orphanet_104 | H47.22 | — | 1 | 1 | 1 | 3 | 6 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | 1 | 1 | 1 | — | 2 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | — | — | 1 | 1 | — | 2 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | — | 1 | — | 1 |
| Epilepsy | D004827 | EFO_0000474 | G40.9 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ataxia | D001259 | — | R27.0 | 2 | 1 | 5 | — | — | 8 |
| Friedreich ataxia | D005621 | Orphanet_95 | G11.11 | 2 | 1 | 5 | — | — | 8 |
| Cerebellar ataxia | D002524 | HP_0001251 | — | 2 | 1 | 5 | — | — | 8 |
| Muscular dystrophies | D009136 | HP_0003560 | G71.0 | — | 2 | 3 | — | 2 | 7 |
| Duchenne muscular dystrophy | D020388 | EFO_0000429 | — | — | 2 | 3 | — | 1 | 6 |
| Rem sleep behavior disorder | D020187 | EFO_0007462 | G47.52 | — | 2 | 1 | — | — | 2 |
| Mental disorders | D001523 | EFO_0000677 | F91.9 | — | 2 | 1 | — | — | 2 |
| Headache disorders | D020773 | EFO_0009550 | G44 | — | — | 1 | — | — | 1 |
| Headache | D006261 | HP_0002315 | R51 | — | — | 1 | — | — | 1 |
| Ambulatory care | D000553 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | 2 | 2 | — | — | — | 2 |
| Chronic progressive multiple sclerosis | D020528 | EFO_0003840 | — | 2 | 2 | — | — | — | 2 |
| Sclerosis | D012598 | — | — | 2 | 2 | — | — | — | 2 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | 1 | 1 | — | — | — | 1 |
| Fatty liver | D005234 | EFO_0003934 | — | 1 | 1 | — | — | — | 1 |
| Alcoholic fatty liver | D005235 | — | K70.0 | 1 | 1 | — | — | — | 1 |
| Synucleinopathies | D000080874 | — | — | — | 1 | — | — | — | 1 |
| Acidosis | D000138 | EFO_1000014 | E87.2 | — | 1 | — | — | — | 1 |
| Brain diseases | D001927 | HP_0001298 | G93.40 | — | 1 | — | — | — | 1 |
| Lactic acidosis | D000140 | HP_0003128 | E87.20 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug interactions | D004347 | — | — | 1 | — | — | — | — | 1 |
| Huntington disease | D006816 | Orphanet_399 | G10 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Muscular diseases | D009135 | HP_0003198 | G72.9 | — | — | — | — | 1 | 1 |
| Polyneuropathies | D011115 | EFO_0009562 | A69.22 | — | — | — | — | 1 | 1 |
| Hereditary spastic paraplegia | D015419 | EFO_0000529 | G11.4 | — | — | — | — | 1 | 1 |
| Neuromuscular diseases | D009468 | EFO_1001902 | G70.9 | — | — | — | — | 1 | 1 |
| Paraplegia | D010264 | HP_0001258 | G82.2 | — | — | — | — | 1 | 1 |
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Idebenone |
| INN | idebenone |
| Description | Idebenone is a member of the class of 1,4-benzoquinones which is substituted by methoxy groups at positions 2 and 3, by a methyl group at positions 5, and by a 10-hydroxydecyl group at positions 6. Initially developed for the treatment of Alzheimer's disease, benefits were modest; it was subsequently found to be of benefit for the symptomatic treatment of Friedreich's ataxia. It has a role as an antioxidant and a ferroptosis inhibitor. It is a primary alcohol and a member of 1,4-benzoquinones. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | COC1=C(OC)C(=O)C(CCCCCCCCCCO)=C(C)C1=O |
Identifiers
| PDB | — |
| CAS-ID | 58186-27-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL252556 |
| ChEBI ID | 31687 |
| PubChem CID | 3686 |
| DrugBank | DB09081 |
| UNII ID | HB6PN45W4J (ChemIDplus, GSRS) |
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Trends
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Safety
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Adverse Events
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59 adverse events reported
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