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omaveloxolone

Trade name: SKYCLARYS

Small moleculeapprovedOrphan Drug FDAFast Track FDA

Approved

Feb 28, 2023

Omaveloxolone, sold under the brand name Skyclarys, is a medication used for the treatment of Friedreich's ataxia. It is taken by mouth. — Wikipedia

Clinical trial activity

21 trials · 9 clinical orgs · 1 marketing orgs

Phase 1
14
Phase 2
7
Phase 3
1
Phase 4
0

Earliest trial started Dec 1, 2013 (NCT02029729)

Timeline

2010s

  1. Jan 1, 2013

    Reata Pharmaceuticals, Inc. — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2014

    Reata Pharmaceuticals, Inc. — Earliest Phase 2 Sponsor(trial)

  3. Jun 19, 2017

    Orphan Drug Designation

2020s

  1. Feb 28, 2023

    Reata Pharmaceuticals, Inc. — Earliest FDA Approval

  2. Feb 28, 2023

    Reata Pharmaceuticals, Inc. — Marketing Organization

  3. Feb 28, 2023

    Reata Pharmaceuticals, Inc. — NDA Secondary Org

  4. Feb 28, 2023

    Reata Pharmaceuticals, Inc. — NDA Organization

  5. Jan 1, 2025

    Earliest Phase 3 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewFast trackFeb 28, 2023

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)(C)C(=O)C[C@]12CCC(C)(C)C[C@H]1[C@H]3C(=O)C=C4[C@@](C)(CC[C@H]5C(C)(C)C(=O)C(=C[C@]45C)C#N)[C@]3(C)CC2
Mol. weight
545.81 g/mol
Lipinski Ro5
2 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • n-(11-cyano-2,2,6a,6b,9,9,12a-heptmethyl-10,14-dioxo-1,3,4,5,6a,6b,7,8,8a,9,10,12a,14,14a,14b-hexadecahydro-2h-picen-4a-yl)-2-2-difluoropropionamide
  • omaveloxolone
  • omaveloxolone
  • omaveloxolone
  • omaveloxolone
  • rta 408
  • rta 408
  • rta 408
  • rta-408
  • rta-408

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07297199Phase 1Jan 9, 2026Biogen
NCT07149415Phase 1Sep 2, 2025Biogen
NCT07019064Phase 1Jun 11, 2025Biogen
NCT06953583Phase 3Jun 9, 2025Biogen
NCT06612879Phase 1Oct 18, 2024Biogen
NCT06054893Phase 1Nov 1, 2023Biogen, University of Pennsylvania
NCT05927649Phase 1Jul 11, 2023Biogen, Celerion, Q2 solutions
NCT05909644Phase 1Jul 5, 2023Altasciences Company Inc., Biogen, Celerion, Q2 solutions
NCT03902002Phase 1Jul 31, 2019Reata Pharmaceuticals, Inc.
NCT04008186Phase 1Jun 14, 2019Covance, Reata Pharmaceuticals, Inc.
NCT03931590Phase 1Apr 11, 2019Covance, Reata Pharmaceuticals, Inc.
NCT03664453Phase 1Oct 31, 2018Reata Pharmaceuticals, Inc.
NCT02255422Phase 2Apr 1, 2015AbbVie, Reata Pharmaceuticals, Inc.
NCT02255435Phase 2Jan 1, 2015AbbVie, Friedreich's Ataxia Research Alliance (FARA), Reata Pharmaceuticals, Inc.
NCT02259231Phase 1/Phase 2 (Phase 2)Oct 1, 2014Reata Pharmaceuticals, Inc.
NCT02142959Phase 2Jun 1, 2014AbbVie, Reata Pharmaceuticals, Inc.
NCT02128113Phase 2May 1, 2014AbbVie, Reata Pharmaceuticals, Inc.
NCT02065375Phase 2Feb 1, 2014AbbVie, Reata Pharmaceuticals, Inc.
NCT02029716Phase 1Dec 1, 2013AbbVie, Reata Pharmaceuticals, Inc.
NCT02029729Phase 1Dec 1, 2013AbbVie, Reata Pharmaceuticals, Inc.
Showing 20 of 21 trials
Page 1 / 2

Organizations

Research & Development (9)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Reata Pharmaceuticals, Inc.For profit131332013
BiogenFor profit8822023
AbbVieFor profit7022013
CelerionFor profit2012023
CovanceFor profit2012019
Q2 solutionsFor profit2012023
Altasciences Company Inc.For profit1012023
Friedreich's Ataxia Research Alliance (FARA)Academic/Hospital1012015
University of PennsylvaniaAcademic/Hospital1012023
9 organizations
Page 1 / 1

Marketing (3)

OrganizationOrg typeRelationshipDate
Reata Pharmaceuticals, Inc.For profitMKTGFeb 28, 2023
Reata Pharmaceuticals, Inc.For profitNDA2Feb 28, 2023
Reata Pharmaceuticals, Inc.For profitNDAFeb 28, 2023