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    DRUG:

    Skyclarys (omaveloxolone)

    i
    Other names: RTA 408, RTA-408, ABT-RTA-408, RTA408
    Associations

    News

    Trials
    Company:
    Biogen
    Drug class:
    NRF2 activator
    Related drugs:
    Associations

    News

    Trials
    20d
    A Study to Find Out How BIIB141 (Omaveloxolone) Moves From the Blood Into the Breastmilk of Healthy Women Who Are Breastfeeding or Pumping Milk (clinicaltrials.gov)
    P1, N=12, Recruiting, Reata, a wholly owned subsidiary of Biogen | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Skyclarys (omaveloxolone)
    1m
    SKYCLARYS® (Omaveloxolone) Pregnancy and Lactation Surveillance Program (clinicaltrials.gov)
    P=N/A, N=20, Recruiting, Reata, a wholly owned subsidiary of Biogen | Not yet recruiting --> Recruiting
    Enrollment open • Adverse events
    |
    Skyclarys (omaveloxolone)
    2ms
    SKYCLARYS® (Omaveloxolone) Pregnancy and Lactation Surveillance Program (clinicaltrials.gov)
    P=N/A, N=20, Not yet recruiting, Reata, a wholly owned subsidiary of Biogen
    New trial • Adverse events
    |
    Skyclarys (omaveloxolone)
    2ms
    A Study to Learn More About the Long-Term Safety of BIIB141 (Omaveloxolone) in Participants With Friedreich's Ataxia Who Are Prescribed it for the First Time (clinicaltrials.gov)
    P=N/A, N=300, Not yet recruiting, Reata, a wholly owned subsidiary of Biogen
    New trial
    |
    Skyclarys (omaveloxolone)
    2ms
    A Study to Find Out How BIIB141 (Omaveloxolone) Moves From the Blood Into the Breastmilk of Healthy Women Who Are Breastfeeding or Pumping Milk (clinicaltrials.gov)
    P1, N=12, Not yet recruiting, Reata, a wholly owned subsidiary of Biogen
    New P1 trial
    |
    Skyclarys (omaveloxolone)
    5ms
    A Study of Omaveloxolone in Children With Friedreich's Ataxia (clinicaltrials.gov)
    P1, N=20, Recruiting, Reata, a wholly owned subsidiary of Biogen | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Skyclarys (omaveloxolone)
    5ms
    A Study of Omaveloxolone in Children With Friedreich's Ataxia (clinicaltrials.gov)
    P1, N=20, Not yet recruiting, Reata, a wholly owned subsidiary of Biogen | Trial completion date: Feb 2024 --> Feb 2030 | Initiation date: Nov 2023 --> Jul 2024 | Trial primary completion date: Feb 2024 --> Feb 2030
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    Skyclarys (omaveloxolone)
    9ms
    RTA 408 Capsules in Patients With Melanoma - REVEAL (clinicaltrials.gov)
    P1/2, N=41, Completed, Reata, a wholly owned subsidiary of Biogen | Phase classification: P1b/2 --> P1/2
    Phase classification • Combination therapy • Metastases
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Skyclarys (omaveloxolone)
    over1year
    Apatinib combined with olaparib induces ferroptosis via a p53-dependent manner in ovarian cancer. (PubMed, J Cancer Res Clin Oncol)
    This discovery revealed the specific mechanism of ferroptosis induced by apatinib combined with olaparib in p53 wild-type ovarian cancer cells and provided a theoretical basis for the clinical combined use of apatinib and olaparib in p53 wild-type ovarian cancer patients.
    Journal • BRCA Biomarker • PARP Biomarker
    |
    BRCA (Breast cancer early onset) • GPX4 (Glutathione Peroxidase 4)
    |
    TP53 mutation • TP53 wild-type • BRCA wild-type • GPX4 expression
    |
    Lynparza (olaparib) • AiTan (rivoceranib) • sirolimus • RITA • Skyclarys (omaveloxolone)
    over2years
    In Vitro Efficacy and Molecular Mechanism of Curcumin Analog in Pathological Regulation of Spinocerebellar Ataxia Type 3. (PubMed, Antioxidants (Basel))
    Unlike other nuclear factor erythroid-2-related factor 2 (Nrf2) activators, the mechanism of action of curcumin analog, ASC-JM17 (JM17), in regulating oxidative homeostasis remains unknown...Presently, we compared actions of JM17 with those of known Nrf2 activators, omaveloxolone (RTA-408) and dimethyl fumarate (DMF), using human neuroblastoma SK-N-SH cells with stable transfection of full-length ataxin-3 protein with 78 CAG repeats (MJD78) to clarify the resulting pathological mechanism by assaying mitochondrial function, mutant ataxin-3 protein toxicity, and oxidative stress...It showed that activation of Nrf2 in response to ROS generated in mitochondria could play an import role in the benefit of JM17. This study presents the diversified regulation of JM17 in a pathological process and helped develop more effective therapeutic strategies for SCA3.
    Preclinical • Journal
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    ATXN3 (Ataxin 3) • SOD2 (Superoxide Dismutase 2)
    |
    NFE2L2 mutation
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    Skyclarys (omaveloxolone)
    3years
    The Effects of Two Nrf2 Activators, Bardoxolone Methyl and Omaveloxolone, on Retinal Ganglion Cell Survival during Ischemic Optic Neuropathy. (PubMed, Antioxidants (Basel))
    Our results provide explicit evidence that RTA 402 modulates the Nrf2 and NFκB signaling pathways to protect RGCs from apoptosis and maintain the visual function in an rAION model. These findings indicate that RTA 402 may a potential therapeutic agent for ischemic optic neuropathy.
    Journal
    |
    IL6 (Interleukin 6) • NQO1 (NAD(P)H dehydrogenase, quinone 1) • TGFB1 (Transforming Growth Factor Beta 1)
    |
    IL6 expression
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    Skyclarys (omaveloxolone)