NCE-1 Intelligence & Market Opportunity

Skyclarys

Omaveloxolone

Neuroprotective

Capsule

Skyclarys is the first FDA-approved treatment for Friedreich’s ataxia in patients aged 16 years and older. It helps reduce physical impairment associated with the condition.

Approval Date

28-Feb-23

NCE-1 Date

28-Feb-27

NCE Date

28-Feb-28

Commercial snapshot

Market performance & projections

Revenue ($M)

521

CAGR (%)

0.1429

Projected sales, 2026–2032 ($M)

Analyst projection, $M per year

2026

581

2027

692

2028

791

2029

889

2030

967

2031

1033

2032

1094

Molecule profile

Details & specifications

Molecule

Omaveloxolone

Innovator

REATA PHARMACEUTICALS INC

Dosage Form

Capsule

Strength

50 mg

Therapeutic Category

Neuroprotective

Usage

For the treatment of Friedreich ataxia in adults and children 16 years of age and older.

Good to know

Frequently asked questions

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Verified regulatory data

Milestones tracked against primary FDA sources and refreshed continuously.

Analyst-built projections

Seven-year sales outlooks modeled by our pharma intelligence team.

First-to-file focus

Exclusivity windows framed around the decisions generics teams actually make.

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