OMAVELOXOLONE
Skyclarys (omaveloxolone) is a small molecule pharmaceutical. Omaveloxolone was first approved as Skyclarys on 2023-02-28. It is used to treat friedreich ataxia in the USA.
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Commercial
Therapeutic Areas
Trade Name
FDA
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Skyclarys
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Omaveloxolone
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SKYCLARYS | Reata Pharmaceuticals | N-216718 RX | 2023-02-28 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| skyclarys | New Drug Application | 2024-11-15 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| friedreich ataxia | Orphanet_95 | D005621 | G11.11 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
OMAVELOXOLONE, SKYCLARYS, REATA PHARMS | |||
| 2030-02-28 | ODE-427 | ||
| 2028-02-28 | NCE | ||
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
19 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Friedreich ataxia | D005621 | Orphanet_95 | G11.11 | 1 | 1 | — | — | 2 | 4 |
| Ataxia | D001259 | — | R27.0 | 1 | 1 | — | — | 1 | 3 |
| Cerebellar ataxia | D002524 | HP_0001251 | — | 1 | 1 | — | — | 1 | 3 |
| Melanoma | D008545 | — | — | 2 | 1 | — | — | 1 | 3 |
| Inflammation | D007249 | MP_0001845 | — | — | 2 | — | — | — | 2 |
| Muscular diseases | D009135 | HP_0003198 | G72.9 | — | 1 | — | — | — | 1 |
| Mitochondrial myopathies | D017240 | Orphanet_206966 | G71.3 | — | 1 | — | — | — | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | — | 1 |
| Dermatitis | D003872 | HP_0011123 | L30.9 | — | 1 | — | — | — | 1 |
| Radiodermatitis | D011855 | — | L58 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 6 | — | — | — | — | 6 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Non-small-cell lung carcinoma | D002289 | — | — | 1 | — | — | — | — | 1 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | OMAVELOXOLONE |
| INN | omaveloxolone |
| Description | Omaveloxolone, sold under the brand name Skyclarys, is a medication used for the treatment of Friedreich's ataxia. It is taken by mouth.
|
| Classification | Small molecule |
| Drug class | steroids (not prednisolone derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC1(C)CC[C@]2(NC(=O)C(C)(F)F)CC[C@]3(C)[C@H](C(=O)C=C4[C@@]3(C)CC[C@H]3C(C)(C)C(=O)C(C#N)=C[C@]43C)[C@@H]2C1 |
Identifiers
| PDB | — |
| CAS-ID | 1474034-05-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4303525 |
| ChEBI ID | — |
| PubChem CID | 71811910 |
| DrugBank | DB12513 |
| UNII ID | G69Z98951Q (ChemIDplus, GSRS) |
Target
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Skyclarys – Biogen
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Trends
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Additional graphs summarizing 593 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
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348 adverse events reported
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