Skyclarys

(Omaveloxolone)

ApprovedSmall molecule

Omaveloxolone is used to treat Friedreich's ataxia, a rare genetic disorder that causes progressive muscle weakness and coordination problems. It works by activating a protective pathway in cells to help reduce nerve damage.[2] Skyclarys is currently approved and in use across 7 indications[4].[1]

Skyclarys is one of 177 small molecule programs targeting Breast Cancer. It is currently in Approved.

Indications

Total Trials

Active Trials

176

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Breast CancerApproved

Liver DiseaseApproved

Non-Small Cell Lung CancerApproved

Psychiatric DisorderActive, not recruiting

AdultCompleted

Friedreich AtaxiaActive, not recruiting

AtaxiaRecruiting

Breast CancerApproved

Approved

Liver DiseaseApproved

Approved

Non-Small Cell Lung CancerApproved

Approved

Psychiatric DisorderPreclinical

Active, not recruiting

AdultPhase 1

Completed

Friedreich AtaxiaApproved

Active, not recruiting

AtaxiaPhase 3

Recruiting

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Skyclarys

Biogen

Approved

21 2

Lexiscan

Astellas

Preclinical

1 3

Voltaren

Novartis

Preclinical

1 4

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 5

Duragesic-100

CCephalon

Preclinical

2 6

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 7

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 8

Tricor

JJagotec

Preclinical

1 9

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

1 10

Vit D

PPost Graduate Institute of Medical Education and Research, Chandigarh

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2029

Recruiting

Ataxia

NCT06623890

Phase 3Recruiting

Ataxia

NCT06953583

Q2 2030

Phase 1Active, not recruiting

Friedreich Ataxia

NCT06054893

Q2 2035

Recruiting

Friedreich Ataxia

NCT06628687

Clinical

Trials by Indication[1]

Adult3 trials

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

Completed· Biogen logo

Biogen·Phase 1·NCT07019064·52 enrolled

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

Completed· Biogen logo

Biogen·Phase 1·NCT07149415·22 enrolled

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

Recruiting· Biogen logo

Biogen·Phase 1·NCT07297199·70 enrolled

Melanoma3 trials

RTA 408 in the Treatment of Advanced Solid Tumors (NSCLC & Melanoma) - DISCOVER

Completed· Biogen logo

Biogen·Phase 1·NCT02029729·11 enrolled

RTA 408 Capsules in Patients With Melanoma - REVEAL

Completed· Biogen logo

Biogen·Phase 1/2·NCT02259231·41 enrolled

Expanded Access to Omaveloxolone for Melanoma for Patients Previously Enrolled in 408-C-1401

No longer available· Biogen logo

Biogen··NCT03593499

Friedreich ataxia3 trials

An Open-Label, Phase 1, Study to Evaluate the Pharmacokinetics, Safety, Tolerability, Pharmacodynamics, and Efficacy of Omaveloxolone in Participants ≥2 to <16 Years of Age With Friedreich's Ataxia

Active, not recruiting· Biogen logo

Biogen·Phase 1·NCT06054893·33 enrolled

A Phase 2 Study of the Safety, Efficacy, and Pharmacodynamics of RTA 408 in the Treatment of Friedreich's Ataxia (MOXIe)

Completed· Biogen logo

Biogen·Phase 2·NCT02255435·172 enrolled

A Post-marketing, Observational, Descriptive Study to Assess the Risk Associated With Pregnancy, the Maternal Complications, and Adverse Effects on the Developing Fetus, Neonate, and Infant Among Individuals Exposed to Omaveloxolone During Pregnancy and/or Lactation

Recruiting· Biogen logo

Biogen··NCT06628687·10 enrolled

Ataxia2 trials

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)

Recruiting· Biogen logo

Biogen·Phase 3·NCT06953583·255 enrolled

A Study to Learn More About the Long-Term Safety of BIIB141 (Omaveloxolone) in Participants With Friedreich's Ataxia Who Are Prescribed it by Their Own Doctors

Recruiting· Biogen logo

Biogen··NCT06623890·300 enrolled

Cataract1 trial

RTA 408 Ophthalmic Suspension for the Prevention of Corneal Endothelial Cell Loss Following Cataract Surgery - GUARD

Completed· Biogen logo

Biogen·Phase 2·NCT02128113·307 enrolled

7 more indications

Ocular Inflammation1 trial

RTA 408 Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain Following Ocular Surgery

Completed· Biogen logo

Biogen·Phase 2·NCT02065375·109 enrolled

Dermatitis1 trial

RTA 408 Lotion in Patients at Risk for Radiation Dermatitis - PRIMROSE

Completed· Biogen logo

Biogen·Phase 2·NCT02142959·187 enrolled

Breastfeeding1 trial

A Study to Find Out How BIIB141 (Omaveloxolone) Moves From the Blood Into the Breastmilk of Healthy Women Who Are Breastfeeding or Pumping Milk

Completed· Biogen logo

Biogen·Phase 1·NCT06612879·12 enrolled

Interaction1 trial

A Clinical Drug-Drug Interaction (DDI) Study With Omaveloxolone

Completed· Biogen logo

Biogen·Phase 1·NCT04008186·61 enrolled

Myopathy1 trial

RTA 408 Capsules in Patients With Mitochondrial Myopathy - MOTOR

Completed· Biogen logo

Biogen·Phase 2·NCT02255422·53 enrolled

Hepatic Impairment1 trial

A Pharmacokinetic Study of Omaveloxolone in Subjects With Hepatic Impairment and Normal Hepatic Function

Completed· Biogen logo

Biogen·Phase 1·NCT03902002·48 enrolled

Unspecified3 trials

A Pharmacokinetic Study of Omaveloxolone in Healthy Volunteers

Completed· Biogen logo

Biogen·Phase 1·NCT03664453·32 enrolled

An Open-label DDI Study of Omaveloxolone in Healthy Subjects

Completed· Biogen logo

Biogen·Phase 1·NCT05909644·20 enrolled

A TQTc Study for Omaveloxolone

Completed· Biogen logo

Biogen·Phase 1·NCT05927649·30 enrolled

Regulatory

FDA Approval Timeline[5]

Feb 28, 2023

SKYCLARYS

NDA NDA216718

Sources

References

[1]
ClinicalTrials.gov — 21 trial records for Omaveloxolone. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Skyclarys drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Omaveloxolone compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Omaveloxolone. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA216718). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Skyclarys. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Biogen company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Nuclear Factor Erythroid 2-Related Factor 2 Activator[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Biogen

Patent Landscape[6]

Patent Cliff

Apr 20, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9670147Apr 20, 2029

11919838Apr 20, 2029

11091430Apr 20, 2029

8440854Apr 20, 2029

8124799Dec 3, 2029

2 more patents

9701709Apr 24, 2033

8993640Apr 24, 2033

Skyclarys

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2029

Q2 2030

Q2 2035

Trials by Indication[1]

Adult3 trials

Melanoma3 trials

Friedreich ataxia3 trials

Ataxia2 trials

Cataract1 trial

Ocular Inflammation1 trial

Dermatitis1 trial

Breastfeeding1 trial

Interaction1 trial

Myopathy1 trial

Hepatic Impairment1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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