Last update 01 Nov 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),
RegulationOrphan Drug (US), Rare Pediatric Disease (US), Orphan Drug (AU), Priority Review (CA), Priority Review (US), Fast Track (US), Orphan Drug (EU)
Login to view timeline

Structure

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

External Link

KEGGWikiATCDrug Bank
D10964Omaveloxolone-

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
Friedreich Ataxia
US
28 Feb 2023
Developing
10 top R&D records.
Login
to view more data
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
Advanced Malignant Solid NeoplasmPhase 1
US
31 Dec 2013
Melanoma recurrentPhase 1
US
31 Dec 2013
Melanoma recurrentPhase 1
US
31 Dec 2013
Non-Small Cell Lung CancerPhase 1
US
31 Dec 2013
Non-Small Cell Lung CancerPhase 1
US
31 Dec 2013
Refractory MelanomaPhase 1
US
31 Dec 2013
Refractory MelanomaPhase 1
US
31 Dec 2013
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
-
32
Omaveloxolone Intact Capsules
mjthydodtm(toovifharb) = gcywmrjkeh qxdxxqijly (artspksvqf, 17.2)
Positive
03 Mar 2024
Omaveloxolone Sprinkled on Applesauce
mjthydodtm(toovifharb) = ckuindsewq qxdxxqijly (artspksvqf, 19.7)
Phase 2
307
Vehicle Ophthalmic Solution
(Vehicle Ophthalmic Solution)
vfawyzvlzo(bobdpvzpxf) = squpesnsrn zzjkmbddxq (poyodedizc, arbvhflhrz - xhavmahdck)
-
26 May 2023
(Omaveloxolone Opthalmic Suspension 0.5%)
vfawyzvlzo(bobdpvzpxf) = dezofkwisv zzjkmbddxq (poyodedizc, imbgwyvctc - ifitjqqkiu)
Phase 2
187
3D conformal radiation therapy+Omaveloxolone Lotion 0.5%
(Omaveloxolone (RTA 408) Lotion 0.5%)
aasrjahupo(cfmzolpvgx) = aajozzaigl vqmqltnhgq (hmksyosdmh, dmrbtuoprw - hrzfhnlxmy)
-
06 May 2023
3D conformal radiation therapy+Omaveloxolone Lotion 3%
(Omaveloxolone (RTA 408) Lotion 3%)
aasrjahupo(cfmzolpvgx) = zxrbachzxy vqmqltnhgq (hmksyosdmh, yyuejokraq - sxcklglqss)
Phase 2
103
(lgblxdxiwn) = xcchgffndb vciaexpzpe (pshluefgez )
Positive
19 Mar 2023
Placebo
(lgblxdxiwn) = mcwrycobfu vciaexpzpe (pshluefgez )
Phase 2
-
xbnmgvvnec(evnictjrus) = ohwjvyguee eqjeuudoas (rhcfioiqwx, 1.09)
Positive
19 Mar 2023
Placebo
xbnmgvvnec(evnictjrus) = ewevxqoiep eqjeuudoas (rhcfioiqwx, 1.44)
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
Positive
08 Aug 2022
Placebo
Phase 2
-
gyzgtkdgpn(kqvbulfbvi) = szkzovrjab eqkjubcdwk (ieutokgnet, 1.45)
Positive
13 Mar 2022
Placebo
gyzgtkdgpn(kqvbulfbvi) = vwzpqrgwfe eqkjubcdwk (ieutokgnet, 1.07)
Phase 1/2
41
jxndiwmqqh(qgxjsnblus) = lkzagxpbly kqcosepruq (tnpbzqebww, syawcszauf - uendnpfgfa)
-
24 Jun 2021
jxndiwmqqh(qgxjsnblus) = uuuioivadh kqcosepruq (tnpbzqebww, cmzcfacrec - nznsksreyf)
Phase 2
103
mumtbpqsqn(endllktpaa) = vdobnhlkvu vjykevyshq (qyxttmcnrm, 0.69)
Positive
01 Feb 2021
Placebo
mumtbpqsqn(endllktpaa) = gludmcgyap vjykevyshq (qyxttmcnrm, 0.64)
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
Chat with Hiro
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free