Drugs / Omaveloxolone
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | SKYCLARYS | — | 2024-12-20 | fda.gov ↗ |
| Approved | EU (EMA) | Skyclarys | — | 2024-02-09 | europa.eu ↗ |
| Approved | US (FDA) | SKYCLARYS | — | 2023-02-28 | fda.gov ↗ |
Trials 22
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 113 trials | ||||||
| Phase 1 | NCT07297199 | Dec 2025 → May 2026 | — | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT07149415 | Sep → Oct 2025 | — | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT07019064 | Jun → Aug 2025 | — | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT06612879 | Oct 2024 → Mar 2025 | — | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT06054893 | Jul 2024 → Jun 2030 expected | Friedreich ataxia | Biogen | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05927649 | Jul → Sep 2023 | — | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT05909644 | Jul → Aug 2023 | — | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT03902002 | Jul 2019 → Jan 2020 | — | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT04008186 | Jun → Aug 2019 | — | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT03931590 | Apr → May 2019 | — | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT03664453 | Oct → Nov 2018 | — | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT02029716 | Dec 2013 → Apr 2014 | — | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT02029729 | Dec 2013 → Oct 2015 | non-small cell lung carcinoma | Biogen | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02259231 | Oct 2014 → May 2018 | metastatic melanoma | Biogen | Completed | No outcome recorded |
| Phase 25 trials · 3 missed | ||||||
| Phase 2 | NCT02255422 | May 2015 → Nov 2017 | pure mitochondrial myopathy | Biogen | Completed | Missed primary |
| Phase 2 | NCT02255435 | Jan 2015 → Oct 2019 | Friedreich ataxia | Biogen | Completed | Mixed |
| Phase 2 | NCT02142959 | Jun 2014 → Apr 2015 | breast cancer | Biogen | Completed | No outcome recorded |
| Phase 2 | NCT02128113 | May 2014 → Feb 2015 | cataract, corneal disorder | Biogen | Completed | Missed primary |
| Phase 2 | NCT02065375 | Feb → Sep 2014 | eye disorder | Biogen | Completed | Missed primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT06953583 | Jun 2025 → Nov 2027 expected | Friedreich ataxia | Biogen | Active not recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07444333 | Jul 2026 → Feb 2028 expected | Friedreich ataxia | Scott Barbuto | Recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT03593499 | — | melanoma | Biogen | No longer available | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2024-02-12 | Biogen | Regulatory Biogen Received European Commission Approval for SKYCLARYS® (omaveloxolone), the First Therapy to Treat Friedreich’s Ataxia biogen.com ↗
Biogen Inc. (Nasdaq: BIIB) announced the European Commission (EC) has authorized SKYCLARYS ® (omaveloxolone) for the treatment of Friedreich’s ataxia (FA) in adults and adolescents aged 16 years and older. |
| 2023-12-15 | Biogen | Regulatory CHMP Issues Positive Opinion for Biogen’s SKYCLARYS® (omaveloxolone), the First Therapy to Treat Friedreich’s Ataxia, a Rare Neurodegenerative Disease biogen.com ↗
Biogen Inc. (Nasdaq: BIIB) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended marketing authorization for SKYCLARYS ® (omaveloxolone) for the treatment of Friedreich’s ataxia (FA) in people aged 16 years and older. |
All press releases naming this drug 3 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Omaveloxolone | “In February 2023, omaveloxolone became the first Food and Drug Administration (FDA) approved medication for Friedreich's Ataxia (FRDA).” NCT07444333 ↗ |
| Known as | BIIB141 | “In this study, researchers are learning more about RTA 408, also known as omaveloxolone, BIIB141, or SKYCLARYS®. The main goal of this study is to learn more about the safety...” NCT02255435 ↗1“BIIB141” NCT06612879 ↗ |
| Known as | Omaveloxolona | ChEMBL registry synonym — accepted as the source's own label CHEMBL4303525 ↗ |
| Known as | RTA 408 | “In this study, researchers are learning more about RTA 408, also known as omaveloxolone, BIIB141, or SKYCLARYS®. The main goal of this study is to learn more about the safety...” NCT02255435 ↗5“This proposed first-in-human study (408-C-1303) is designed to assess the safety, maximum tolerated dose, pharmacodynamics, and pharmacokinetics of omaveloxolone (RTA 408) in...” NCT02029729 ↗ “Based on data from previous studies in animals and humans, Reata believes that omaveloxolone (RTA 408) Lotion may effectively prevent and mitigate radiation dermatitis in...” NCT02142959 ↗ “This study assesses the efficacy and safety of two concentrations of omaveloxolone (RTA 408) ophthalmic suspension for the prevention of corneal endothelial cell loss following...” NCT02128113 ↗ “omaveloxolone (RTA 408) Capsules, 2.5 mg taken orally once daily for 2 weeks, then 5 mg taken orally once daily for 10 weeks” NCT02255422 ↗ |
| Known as | SKYCLARYS | “In this study, researchers are learning more about RTA 408, also known as omaveloxolone, BIIB141, or SKYCLARYS®. The main goal of this study is to learn more about the safety...” NCT02255435 ↗2“In this study, researchers will learn more about BIIB141, also known as omaveloxolone or SKYCLARYS®.” NCT07149415 ↗ “SKYCLARYS” NCT06612879 ↗ |
| Action | Activate | “Topical application of RTA 408 lotion activates Nrf2 in human skin” PMID 26170027 ↗ Jul 20151“Nuclear factor erythroid 2-related factor 2 activator” CHEMBL4303525 ↗ |
| Modality | Small molecule | “This study is a first-in-human study of a topical dermal lotion formulation of RTA 408, a novel small molecule which suppresses oxidative stress and inflammation.” NCT02029716 ↗ |
| Route | Topical | “Topical application of RTA 408 lotion activates Nrf2 in human skin” PMID 26170027 ↗ Jul 2015 |
| Target | NFE2L2 | “Nuclear factor erythroid 2-related factor 2 activator” CHEMBL4303525 ↗ |