SKYCLARYS

Peak

omaveloxolone

NDAORALCAPSULEPriority Review
Approved
Feb 2023
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
16

Mechanism of Action

Cytochrome P450 3A4 Inducers

Clinical Trials (5)

NCT06628687N/ARecruiting

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 Babies

Started Oct 2026
20 enrolled
Friedreich Ataxia
NCT07297199Phase 1Recruiting

A 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 55

Started Dec 2025
70 enrolled
Healthy Volunteer
NCT07149415Phase 1Completed

A 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 55

Started Sep 2025
22 enrolled
Healthy Volunteer
NCT07019064Phase 1Completed

A 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 55

Started Jun 2025
52 enrolled
Healthy Volunteer
NCT06953583Phase 3Recruiting

A Study to Learn More About the Effects and Long-Term Safety of BIIB141 (Omaveloxolone) in Participants With Friedreich's Ataxia Aged 2 to 15 Years Old (BRAVE)

Started Jun 2025
255 enrolled
Friedreich Ataxia

Loss of Exclusivity

LOE Date
Apr 24, 2033
86 months away
Patent Expiry
Apr 24, 2033
Exclusivity Expiry
Feb 28, 2030

Patent Records (5)

Patent #ExpiryTypeUse Code
8440854
Apr 20, 2029
Product
11919838
Apr 20, 2029
U-3863
11091430
Apr 20, 2029
U-3552
9670147
Apr 20, 2029
Substance
8124799
Dec 3, 2029
Substance