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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
Therapeutic Area
MeSH
nervous system diseasesD009422
hereditary congenital and neonatal diseases and abnormalitiesD009358
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
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
SKYCLARYSREATA PHARMSN-216718 RX2023-02-28
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
skyclarysNew Drug Application2023-03-06
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
friedreich ataxiaOrphanet_95D005621G11.11
Agency Specific
FDA
EMA
Expiration
Code
OMAVELOXOLONE, SKYCLARYS, REATA PHARMS
2030-02-28ODE-427
2028-02-28NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Omaveloxolone, Skyclarys, Reata Pharms
89936402033-04-24DS, DP
97017092033-04-24DS, DP
81247992029-12-03DP
84408542029-04-20DP
96701472029-04-20DP
110914302029-04-20U-3552
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
13 clinical trials
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Mock data
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MelanomaD00854521——13
InflammationD007249—2———2
Friedreich ataxiaD005621Orphanet_95G11.11—1———1
Mitochondrial myopathiesD017240Orphanet_206966G71.3—1———1
Breast neoplasmsD001943EFO_0003869C50—1———1
Corneal endothelial cell lossD055954—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—4————4
Hepatic insufficiencyD0485501————1
Non-small-cell lung carcinomaD0022891————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameOMAVELOXOLONE
INNomaveloxolone
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 classsteroids (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-ID1474034-05-3
RxCUI—
ChEMBL IDCHEMBL4303525
ChEBI ID—
PubChem CID71811910
DrugBankDB12513
UNII IDG69Z98951Q (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 206 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
0 adverse events reported
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