omaveloxolone 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| steroids not used as glucocorticosteroids | 5712 | 1474034-05-3 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
The precise mechanism by which omaveloxolone exerts its therapeutic effect in patients with Friedreich’s ataxia is unknown. Omaveloxolone have been shown to activate the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway in vitro and in vivo in animals and humans. The Nrf2 pathway is involved in the cellular response to oxidative stress.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Feb. 28, 2023 | FDA | REATA PHARMACEUTICALS INC |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| FDA MoA | N0000185506 | Cytochrome P450 3A4 Inducers |
| FDA MoA | N0000187063 | Cytochrome P450 2C8 Inducers |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Friedreich’s ataxia | indication | 10394003 | DOID:12705 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 50MG | SKYCLARYS | REATA PHARMS | N216718 | Feb. 28, 2023 | RX | CAPSULE | ORAL | 11091430 | April 20, 2029 | TREATMENT OF FRIEDREICHS ATAXIA IN ADULTS AND ADOLESCENTS AGED 16 YEARS AND OLDER |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 50MG | SKYCLARYS | REATA PHARMS | N216718 | Feb. 28, 2023 | RX | CAPSULE | ORAL | Feb. 28, 2028 | NEW CHEMICAL ENTITY |
| 50MG | SKYCLARYS | REATA PHARMS | N216718 | Feb. 28, 2023 | RX | CAPSULE | ORAL | Feb. 28, 2030 | TREATMENT OF FRIEDREICHS ATAXIA IN ADULTS AND ADOLESCENTS AGED 16 YEARS AND OLDER |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Nuclear factor erythroid 2-related factor 2 | Transcription factor | ACTIVATOR | IC50 | 9.40 | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| CHEMBL4303525 | ChEMBL_ID |
| C000589490 | MESH_SUPPLEMENTAL_RECORD_UI |
| 7573 | IUPHAR_LIGAND_ID |
| DB12513 | DRUGBANK_ID |
| 019329 | NDDF |
| 4042120 | VANDF |
| C4519135 | UMLSCUI |
| 10135 | INN_ID |
| 71811910 | PUBCHEM_CID |
| 2631931 | RXNORM |
| D10964 | KEGG_DRUG |
| G69Z98951Q | UNII |
| 41269 | MMSL |
| d10017 | MMSL |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| SKYCLARYS | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73179-250 | CAPSULE | 50 mg | ORAL | NDA | 27 sections |