Phenylacetic acid

Overview

Phenylacetic acid is an organic compound containing a phenyl functional group and a carboxylic acid functional group. It is a white solid with a disagreeable odor. Because it is used in the illicit production of phenylacetone (used in the manufacture of substituted amphetamines), it is subject to controls in countries including the United States and China.

Indication

For use as adjunctive therapy for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle.

Associated Conditions

Hyperammonaemia

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of TAK-123 After Intravenous Infusion in Japanese Healthy Adult Male Participants	2019/11/07	NCT04155567	Phase 1	Completed	Takeda
A Study of Glyceryl Tri-(4-phenylbutyrate) (GT4P)	2009/09/16	NCT00977600	Phase 1	Completed	Amgen
Phase II Study of Sodium Phenylbutyrate, Sodium Benzoate, Sodium Phenylacetate, and Dietary Intervention for Urea Cycle Disorders	2000/02/25	NCT00004767	Phase 2	Completed	National Center for Research Resources (NCRR)

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Sodium Phenylacetate and Sodium Benzoate	MAIA PHARMACEUTICALS	70511-102	INTRAVENOUS	100 mg in 1 mL	6/24/2021
SODIUM PHENYLACETATE AND SODIUM BENZOATE	Oceanside Pharmaceuticals	68682-001	INTRAVENOUS	100 mg in 1 mL	12/1/2020
Sodium Phenylacetate and Sodium Benzoate	Mylan Institutional LLC	67457-844	INTRAVENOUS	100 mg in 1 mL	3/16/2021
SODIUM PHENYLACETATE and SODIUM BENZOATE	Woodward Pharma Services LLC	69784-811	INTRAVENOUS	100 mg in 1 mL	12/15/2021
Ammonul	Bausch Health US LLC	0187-0010	INTRAVENOUS	100 mg in 1 mL	12/1/2020
SODIUM PHENYLACETATE and SODIUM BENZOATE	Ailex Pharmaceuticals, LLC	70556-100	INTRAVENOUS	100 mg in 1 mL	4/20/2018
Sodium phenylacetate and Sodium benzoate	Zydus Pharmaceuticals USA Inc.	70710-1926	INTRAVENOUS	100 mg in 1 mL	10/30/2023
Sodium Phenylacetate and sodium benzoate	Navinta LLC	68475-001	INTRAVENOUS	100 mg in 1 mL	12/2/2022
Ammonul	Ucyclyd Pharma Inc.	62592-720	INTRAVENOUS	100 mg in 1 mL	1/12/2018
Sodium Phenylacetate and Sodium Benzoate	FOSUN PHARMA USA INC	72266-236	INTRAVENOUS	100 mg in 1 mL	10/21/2021

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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