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  1. pharmadog
  2. ›drugs
  3. ›Skyclarys
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omaveloxolone

Marketedupdated 3mo ago
by Reata Pharmaceuticals Inc
Approved
community read0 votes

🐶 often sniffed alongside

top 2
  • tagApproval20 co-mentions · 5 sources
  • tagSmall Molecule10 co-mentions · 5 sources

all catalysts(0)

nothing on the calendar yet

Trials studying omaveloxolone

  • —A Study to Learn How BIIB141 (Omaveloxolone) Affects the Health of Participants With Friedrich's Ataxia Who Took it During Pregnancy and/or During Breastfeeding and About the Health of Their Babiesrecruitingn=10
  • phase3A Study to Learn More About the Effects and Long-Term Safety of Omaveloxolone (BIIB141) in Children and Teens With Friedreich's Ataxiarecruitingn=255
  • phase1A Study to Learn How the Body Processes BIIB141 (Omaveloxolone) When Taken as a Capsule or as a Tablet Dissolved in Liquid, and to Learn About Its Safety in Healthy Adults Ages 18 to 55recruitingn=70
  • phase2A Study to Learn About the Effects and Safety of RTA 408 (Omaveloxolone) in People Aged 16 to 40 With Friedreich's Ataxiacompletedn=172
  • phase1A Study to Find Out How BIIB141 (Omaveloxolone) is Processed in the Body and to Learn More About Its Safety in Participants With Friedreich's Ataxia Aged 2 to 15 Years Oldrecruitingn=35
  • phase1A Study to Learn if Taking BIIB141 (Omaveloxolone) Affects How Omeprazole is Processed in the Body and About BIIB141's Safety in Healthy Adults Aged 18 to 55completedn=22
  • phase1A Study to Learn How BIIB141 (Omaveloxolone) is Processed in the Body When Taken as Capsules Compared to Sprinkled on Yogurt in Healthy Adults Aged 18 to 55completedn=52
  • phase2RTA 408 Capsules in Patients With Mitochondrial Myopathy - MOTORcompletedn=53
more trials →

Patent cliff

source: FDA Orange Book
first barrier falls
Dec 20, 2027
~1.4 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (7)

  • Apr 24, 2033compositionUS 8993640
  • Apr 24, 2033compositionUS 9701709
  • Dec 3, 2029compositionUS 81247993.3y
  • Apr 20, 2029method-of-use (U-3552)US 110914302.7y
  • Apr 20, 2029method-of-use (U-3863)US 119198382.7y
  • Apr 20, 2029formulationUS 84408542.7y
  • Apr 20, 2029compositionUS 96701472.7y

FDA exclusivities (3)

  • Feb 28, 2030ODE-427Orphan Drug (7y)3.6y
  • Feb 28, 2028NCENew Chemical Entity (5y)1.5y
  • Dec 20, 2027M-270Method (3y)1.4y

News(2)

  • Earnings roundup: Biogen’s ‘resiliency,’ AstraZeneca’s growth pitch and GSK’s oncology push
    Better-than-expected sales helped Biogen regain the support of investors, while AstraZeneca and GSK worked to convince Wall Street that they can hit ambitious revenue targets.
    biopharma_dive · 13d ago
  • Bristol Myers’ legacy lift, Biogen’s blue skies and Regeneron’s murky outlook
    Investors are still waiting to see whether Bristol Myers and Regeneron’s pipelines will deliver, while Biogen was lifted by better-than-expected results for newer drugs like Leqembi and Skyclarys.
    biopharma_dive · 3mo ago
brand
Skyclarys
generic
omaveloxolone
indication
Friedreich Ataxia
phase
marketed
Data sources
ClinicalTrials.gov
last refreshed 1h ago
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