Friday, July 10, 2026

Drug profile · INN

carglumic acid

carglumic acid (CARBAGLU) is a carbamoyl-phosphate synthase [ammonia], mitochondrial positive allosteric modulator. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved Alimentary tract and metabolism (A16) A16AA05
US status approved
Patents linked 0
Pipeline programs 0
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Drug details — carglumic acid
US status
approved
Class
Alimentary tract and metabolism (A16)
Route
ORAL
Patents
0
Programs
0
Data quality
0.84

Quick answer

carglumic acid (CARBAGLU) is a carbamoyl-phosphate synthase [ammonia], mitochondrial positive allosteric modulator. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN carglumic acid
Brand CARBAGLU
Mechanism Carbamoyl-phosphate synthase [ammonia], mitochondrial positive allosteric modulator
Target Carbamoyl-phosphate synthase [ammonia], mitochondrial
Therapeutic class Alimentary tract and metabolism (A16)
Route ORAL
Formulation TABLET, FOR SUSPENSION
ATC code A16AA05

Mechanism of action

Carbamoyl-phosphate synthase [ammonia], mitochondrial positive allosteric modulator

Primary target: Carbamoyl-phosphate synthase [ammonia], mitochondrial

Approval history

Authority Status Date
FDA approved
EMA approved

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  5. budesonide Alimentary tract and metabolism (A07)
  6. canagliflozin Alimentary tract and metabolism (A10)

Frequently asked questions

What is carglumic acid?

carglumic acid (CARBAGLU) is a carbamoyl-phosphate synthase [ammonia], mitochondrial positive allosteric modulator. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for carglumic acid?

CARBAGLU is a marketed brand name for carglumic acid. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of carglumic acid?

carglumic acid 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.