Drug Type Small molecule drug |
Synonyms Omaveloxolone (USAN/INN), ABT-RTA-408, AT-RTA-408 + [4] |
Target |
Mechanism Nrf2 stimulants(Nuclear factor erythroid 2-related factor 2 stimulants) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date US (28 Feb 2023), |
RegulationOrphan Drug (US), Rare Pediatric Disease (US), Orphan Drug (AU), Priority Review (CA), Priority Review (US), Fast Track (US), Orphan Drug (EU) |
Molecular FormulaC33H44F2N2O3 |
InChIKeyRJCWBNBKOKFWNY-IDPLTSGASA-N |
CAS Registry1474034-05-3 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D10964 | Omaveloxolone | - |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Friedreich Ataxia | US | 28 Feb 2023 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Metastatic melanoma | Phase 2 | US | 31 Oct 2014 | |
Unresectable Melanoma | Phase 2 | US | 31 Oct 2014 | |
Advanced Malignant Solid Neoplasm | Phase 1 | US | 31 Dec 2013 | |
Advanced Malignant Solid Neoplasm | Phase 1 | US | 31 Dec 2013 | |
Melanoma recurrent | Phase 1 | US | 31 Dec 2013 | |
Melanoma recurrent | Phase 1 | US | 31 Dec 2013 | |
Non-Small Cell Lung Cancer | Phase 1 | US | 31 Dec 2013 | |
Non-Small Cell Lung Cancer | Phase 1 | US | 31 Dec 2013 | |
Refractory Melanoma | Phase 1 | US | 31 Dec 2013 | |
Refractory Melanoma | Phase 1 | US | 31 Dec 2013 |
Phase 1 | - | 32 | Omaveloxolone Intact Capsules | mjthydodtm(toovifharb) = gcywmrjkeh qxdxxqijly (artspksvqf, 17.2) View more | Positive | 03 Mar 2024 | |
Omaveloxolone Sprinkled on Applesauce | mjthydodtm(toovifharb) = ckuindsewq qxdxxqijly (artspksvqf, 19.7) View more | ||||||
Phase 2 | 307 | Vehicle Ophthalmic Solution (Vehicle Ophthalmic Solution) | vfawyzvlzo(bobdpvzpxf) = squpesnsrn zzjkmbddxq (poyodedizc, arbvhflhrz - xhavmahdck) View more | - | 26 May 2023 | ||
(Omaveloxolone Opthalmic Suspension 0.5%) | vfawyzvlzo(bobdpvzpxf) = dezofkwisv zzjkmbddxq (poyodedizc, imbgwyvctc - ifitjqqkiu) View more | ||||||
Phase 2 | 187 | 3D conformal radiation therapy+Omaveloxolone Lotion 0.5% (Omaveloxolone (RTA 408) Lotion 0.5%) | aasrjahupo(cfmzolpvgx) = aajozzaigl vqmqltnhgq (hmksyosdmh, dmrbtuoprw - hrzfhnlxmy) View more | - | 06 May 2023 | ||
3D conformal radiation therapy+Omaveloxolone Lotion 3% (Omaveloxolone (RTA 408) Lotion 3%) | aasrjahupo(cfmzolpvgx) = zxrbachzxy vqmqltnhgq (hmksyosdmh, yyuejokraq - sxcklglqss) View more | ||||||
Phase 2 | 103 | (lgblxdxiwn) = xcchgffndb vciaexpzpe (pshluefgez ) View more | Positive | 19 Mar 2023 | |||
Placebo | (lgblxdxiwn) = mcwrycobfu vciaexpzpe (pshluefgez ) View more | ||||||
Phase 2 | - | xbnmgvvnec(evnictjrus) = ohwjvyguee eqjeuudoas (rhcfioiqwx, 1.09) View more | Positive | 19 Mar 2023 | |||
Placebo | xbnmgvvnec(evnictjrus) = ewevxqoiep eqjeuudoas (rhcfioiqwx, 1.44) View more | ||||||
NCT02255435 (FDA) Manual | Phase 2 | 103 | ijldpyvyek(sowzeqeqnn) = wzwiyfzkjy qxwvnygfgw (wesjqgtuln ) | Positive | 28 Feb 2023 | ||
placebo | ijldpyvyek(sowzeqeqnn) = yrxenvdlnc qxwvnygfgw (wesjqgtuln ) | ||||||
Phase 2 | - | mdoiswhvir(eipuhrkcdq): difference = -2.17±1.09 View more | Positive | 08 Aug 2022 | |||
Placebo | |||||||
Phase 2 | - | gyzgtkdgpn(kqvbulfbvi) = szkzovrjab eqkjubcdwk (ieutokgnet, 1.45) View more | Positive | 13 Mar 2022 | |||
Placebo | gyzgtkdgpn(kqvbulfbvi) = vwzpqrgwfe eqkjubcdwk (ieutokgnet, 1.07) View more | ||||||
Phase 1/2 | 41 | (Omaveloxolone 5 mg & Ipilimumab) | jxndiwmqqh(qgxjsnblus) = lkzagxpbly kqcosepruq (tnpbzqebww, syawcszauf - uendnpfgfa) View more | - | 24 Jun 2021 | ||
(Omaveloxolone 10 mg & Ipilimumab) | jxndiwmqqh(qgxjsnblus) = uuuioivadh kqcosepruq (tnpbzqebww, cmzcfacrec - nznsksreyf) View more | ||||||
Phase 2 | 103 | mumtbpqsqn(endllktpaa) = vdobnhlkvu vjykevyshq (qyxttmcnrm, 0.69) | Positive | 01 Feb 2021 | |||
Placebo | mumtbpqsqn(endllktpaa) = gludmcgyap vjykevyshq (qyxttmcnrm, 0.64) |