Wednesday, July 8, 2026

Drug profile · INN

sodium phenylbutyrate

sodium phenylbutyrate (PHEBURANE) is a glutamine sequestering agent. Associated with Lacuna Pharma Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Alimentary tract and metabolism (A16) A16AX03
US status approved
Patents linked 5
Pipeline programs 3
News articles 0
Drug details — sodium phenylbutyrate
US status
approved
Class
Alimentary tract and metabolism (A16)
Route
ORAL
Patents
5
Programs
3
Data quality
0.89

Quick answer

sodium phenylbutyrate (PHEBURANE) is a glutamine sequestering agent. Associated with Lacuna Pharma Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN sodium phenylbutyrate
Brand PHEBURANE
Mechanism Glutamine sequestering agent
Target Glutamine
Therapeutic class Alimentary tract and metabolism (A16)
Route ORAL
Formulation FOR SUSPENSION
ATC code A16AX03

Mechanism of action

Glutamine sequestering agent

Primary target: Glutamine

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Pipeline programs

  1. Sodium Phenylbutyrate Phase 2 · Ultragenyx UK · Argininosuccinic Aciduria
  2. Sodium phenylbutyrate Phase 2 · ZEVRA THERAPEUTICS · Medium-chain Acyl-CoA Dehydrogenase Deficiency
  3. Sodium phenylbutyrate Phase 1 · ZEVRA THERAPEUTICS · Combined D,L-2-hydroxyglutaric Aciduria

Related & competitor drugs

  1. agalsidase alfa Alimentary tract and metabolism (A16)
  2. alogliptin Alimentary tract and metabolism (A10)
  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)
  1. US 11583542

    Compositions of bile acids and phenylbutyrate compounds

    Expires Mon Feb 16 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 11071742

    Compositions for improving cell viability and methods of use thereof

    Expires Mon Jul 22 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 10857162

    Compositions for improving cell viability and methods of use thereof

    Expires Mon Dec 03 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 10251896

    Compositions for improving cell viability and methods of use thereof

    Expires Mon Apr 04 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 9872865

    Compositions for improving cell viability and methods of use thereof

    Expires Mon Jan 18 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is sodium phenylbutyrate?

sodium phenylbutyrate (PHEBURANE) is a glutamine sequestering agent. Associated with Lacuna Pharma Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for sodium phenylbutyrate?

PHEBURANE is a marketed brand name for sodium phenylbutyrate. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of sodium phenylbutyrate?

sodium phenylbutyrate 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.