Friday, July 10, 2026

Drug profile · INN

omaveloxolone

omaveloxolone (SKYCLARYS) is a nuclear factor erythroid 2-related factor 2 activator. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved Nervous system (N07) N07XX25
US status approved
Patents linked 0
Pipeline programs 1
News articles 0
Drug details — omaveloxolone
US status
approved
Class
Nervous system (N07)
Route
ORAL
Patents
0
Programs
1
Data quality
0.84

Quick answer

omaveloxolone (SKYCLARYS) is a nuclear factor erythroid 2-related factor 2 activator. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN omaveloxolone
Brand SKYCLARYS
Mechanism Nuclear factor erythroid 2-related factor 2 activator
Target Nuclear factor erythroid 2-related factor 2
Therapeutic class Nervous system (N07)
Route ORAL
Formulation CAPSULE
ATC code N07XX25

Mechanism of action

Nuclear factor erythroid 2-related factor 2 activator

Primary target: Nuclear factor erythroid 2-related factor 2

Approval history

Authority Status Date
FDA approved
EMA approved

Pipeline programs

  1. 408-C-1402 Phase 2 · Anaxis Pharma · Friedreich's ataxia

Related & competitor drugs

  1. aripiprazole Nervous system (N05)
  2. brexpiprazole Nervous system (N05)
  3. brivaracetam Nervous system (N03)
  4. bupivacaine Nervous system (N01)
  5. buprenorphine Nervous system (N07)
  6. caffeine citrate Nervous system (N06)

Frequently asked questions

What is omaveloxolone?

omaveloxolone (SKYCLARYS) is a nuclear factor erythroid 2-related factor 2 activator. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for omaveloxolone?

SKYCLARYS is a marketed brand name for omaveloxolone. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of omaveloxolone?

omaveloxolone has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.