Friday, July 10, 2026

Drug profile · INN

sebelipase alfa

sebelipase alfa (KANUMA) is a cholesterol ester hydrolytic enzyme. Route of administration: injection. Current US regulatory status: approved.

FDA: approved EMA: approved PMDA: approved Alimentary tract and metabolism (A16) A16
US status approved
Patents linked 0
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Drug details — sebelipase alfa
US status
approved
Class
Alimentary tract and metabolism (A16)
Route
INJECTION
Patents
0
Programs
0
Data quality
0.84

Quick answer

sebelipase alfa (KANUMA) is a cholesterol ester hydrolytic enzyme. Route of administration: injection. Current US regulatory status: approved.

Key facts

INN sebelipase alfa
Brand KANUMA
Mechanism Cholesterol ester hydrolytic enzyme
Target Cholesterol ester
Therapeutic class Alimentary tract and metabolism (A16)
Route INJECTION
Formulation INJECTABLE
ATC code A16

Mechanism of action

Cholesterol ester hydrolytic enzyme

Primary target: Cholesterol ester

Approval history

Authority Status Date
FDA approved
EMA approved
PMDA approved

Related & competitor drugs

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  3. alogliptin benzoate Alimentary tract and metabolism (A10)
  4. aprepitant Alimentary tract and metabolism (A04)
  5. budesonide Alimentary tract and metabolism (A07)
  6. canagliflozin Alimentary tract and metabolism (A10)

Frequently asked questions

What is sebelipase alfa?

sebelipase alfa (KANUMA) is a cholesterol ester hydrolytic enzyme. Route of administration: injection. Current US regulatory status: approved.

What is the brand name for sebelipase alfa?

KANUMA is a marketed brand name for sebelipase alfa. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of sebelipase alfa?

sebelipase alfa 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.