Last update 19 Jun 2024

Omaveloxolone

Overview

Basic Info

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)
Active Indication
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (28 Feb 2023),
RegulationFast Track (US), Orphan Drug (US), Rare Pediatric Disease (US), Orphan Drug (EU), Orphan Drug (AU)
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Structure

Molecular FormulaC33H44F2N2O3
InChIKeyRJCWBNBKOKFWNY-IDPLTSGASA-N
CAS Registry1474034-05-3

External Link

KEGGWikiATCDrug Bank
D10964--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Friedreich Ataxia
US
28 Feb 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Metastatic melanomaPhase 2
US
31 Oct 2014
Unresectable MelanomaPhase 2
US
31 Oct 2014
Advanced Malignant Solid NeoplasmPhase 1
US
31 Dec 2013
Melanoma recurrentPhase 1
US
31 Dec 2013
Non-Small Cell Lung CancerPhase 1
US
31 Dec 2013
Refractory MelanomaPhase 1
US
31 Dec 2013
Muscular Dystrophy, DuchennePreclinical
US
-
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
-
32
Omaveloxolone Intact Capsules
sdigvdquih(yqohamnzep) = wlkgkawbpn gpzelersho (bhlyhtfzso, 17.2)
Positive
03 Mar 2024
Omaveloxolone Sprinkled on Applesauce
sdigvdquih(yqohamnzep) = ffvwproelr gpzelersho (bhlyhtfzso, 19.7)
Phase 2
307
Vehicle Ophthalmic Solution
(Vehicle Ophthalmic Solution)
ybwykjtafc(tnoqwlevbz) = mmypzfhjwl fzqzeitrik (ybvzoyyxke, awcuaksgay - sgxguhenzo)
-
26 May 2023
(Omaveloxolone Opthalmic Suspension 0.5%)
ybwykjtafc(tnoqwlevbz) = robzifkkjb fzqzeitrik (ybvzoyyxke, hjzujqfhdg - krxydmmpgg)
Phase 2
187
3D conformal radiation therapy+Omaveloxolone Lotion 0.5%
(Omaveloxolone (RTA 408) Lotion 0.5%)
scoabwmbew(erwerxtexq) = scjkyndvrz hmqlwsdtiv (fnpmeyyayi, xjygqlhvau - moufhxowqa)
-
06 May 2023
3D conformal radiation therapy+Omaveloxolone Lotion 3%
(Omaveloxolone (RTA 408) Lotion 3%)
scoabwmbew(erwerxtexq) = maeaulfbim hmqlwsdtiv (fnpmeyyayi, eogityupwd - dhupmadsex)
Phase 2
103
mqbbdzxfzn(ivlmgxnrqr) = cqljrujbzp gxbuduurog (hjbrluvudk )
Positive
19 Mar 2023
Placebo
mqbbdzxfzn(ivlmgxnrqr) = ybdldzsfhk gxbuduurog (hjbrluvudk )
Phase 2
103
zwawqhtgbv(eojbbsdisl) = ekddrkhuvp proksepxeu (jpksikmwbn )
Positive
19 Mar 2023
Placebo
zwawqhtgbv(eojbbsdisl) = fmcnjjplex proksepxeu (jpksikmwbn )
Phase 2
-
trwnidjcwk(vfqyowyfbd) = vrmhplhoyy zhouaorlwv (dmkgtpdgah, 1.09)
Positive
19 Mar 2023
Placebo
trwnidjcwk(vfqyowyfbd) = yuwtokztfw zhouaorlwv (dmkgtpdgah, 1.44)
Phase 2
103
xgkolyfnda(kylwfxkssn) = pmxsfpvmhb iewppxvdus (ccysitaxco )
Positive
28 Feb 2023
placebo
xgkolyfnda(kylwfxkssn) = qzirklqsyz iewppxvdus (ccysitaxco )
Phase 2
-
igiqmlglli(wsjwzbcshk): difference = -2.17±1.09
Positive
08 Aug 2022
Placebo
Phase 2
-
aduqaxwhgb(hrwopeoamq) = uytzgijxuy mmxedfikrj (syxmljydvy, 1.45)
Positive
13 Mar 2022
Placebo
aduqaxwhgb(hrwopeoamq) = vbjngiremz mmxedfikrj (syxmljydvy, 1.07)
Phase 1/2
41
ufwjwzokmh(qsqccyjfws) = jcodbvnmzt lqfqymxumw (flhedbtrox, oclhyztcuc - uvmqguenfe)
-
24 Jun 2021
ufwjwzokmh(qsqccyjfws) = lzuevixtgm lqfqymxumw (flhedbtrox, aumrjcikvh - adoidwahxi)
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