Ornithine

Overview

Produced during the urea cycle, ornithine is an amino acid produced from the splitting off of urea from arginine. L-Ornithine allows for the disposal of excess nitrogen and acts as a precursor of citrulline and arginine.

Indication

Used for nutritional supplementation, also for treating dietary shortage or imbalance. It has been claimed that ornithine improves athletic performance, has anabolic effects, has wound-healing effects, and is immuno-enhancing.

Associated Conditions

Hepatic Encephalopathy (HE)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
An Open-Label, Bayesian Adaptive Phase II Clinical Study in HR+/HER2- Advanced Breast Cancer After Progression on Standard Therapy	2025/08/12	NCT07117630	Not Applicable	Not yet recruiting	Fudan University
Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE)	2024/07/03	NCT06483737	Not Applicable	Recruiting	General Hospital of Shenyang Military Region
Efficacy of L-Ornithine L-Aspartate and Polyethylene Glycol in Cirrhotic Patients With Overt Hepatic Encephalopathy	2023/06/27	NCT05920213	Phase 4	Not yet recruiting	Jinnah Postgraduate Medical Centre
Efficacy of L-ornithine L-aspartate and Therapeutic Plasma Exchange Versus Plasma Exchange Alone in Lowering Ammonia and Improving Outcomes in Pediatric Acute Liver Failure.	2023/03/21	NCT05778461	Not Applicable	Not yet recruiting	Institute of Liver and Biliary Sciences, India
Effect of L-ornithine-L-aspertate (LOLA) on the Gut Microbiome	2023/02/21	NCT05737030	Phase 4	Active, not recruiting	Medical University of Graz
The Efficacy and Safety of Ornithine Aspartic Acid Granules in NAFLD Against Silymarin Capsules	2021/09/13	NCT05042245	Phase 4	UNKNOWN	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Lactulose, L-ornithine L-aspartate, or Rifaximin Versus Placebo for Preventing Hepatic Encephalopathy in Variceal Bleeding	2014/06/06	NCT02158182	Phase 4	Completed	Hospital General de Mexico
Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE)	2013/10/21	NCT01966419	Phase 2	Completed	Ocera Therapeutics, Inc.
L-ornithine L-aspartate in Overt Hepatic Encephalopathy	2012/11/07	NCT01722578	Phase 4	Completed	Dayanand Medical College and Hospital
Emergency Use of OCR-002 in Acute Liver Failure (ALF)	2012/07/06	NCT01634230	N/A	NO_LONGER_AVAILABLE	Ocera Therapeutics, Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

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
PRIMENE 10% AMINO ACID INTRAVENOUS INFUSION	BIEFFE MEDITAL S.P.A.	SIN10252P	INJECTION	3.18 g/l	9/23/1998

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
HEPA-MERZ GRANULATE 3G/SACHET	N/A	JACOBSON MEDICAL (HONG KONG) LIMITED	N/A	N/A	7/10/1985
HEPA-MERZ INFUSION CONC FOR IV INFUSION	N/A	JACOBSON MEDICAL (HONG KONG) LIMITED	N/A	N/A	12/19/1985

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
Kynd Australia Collagen + Endo 180	475645	Global Health Initiative Pty Ltd	Medicine	A	1/13/2025
METAGENICS SLEEPX	336051	Metagenics (Aust) Pty Ltd	Medicine	A	5/8/2020
Weight Management Diet Drops	256014	The Trustee for Weigh Less With Jess Trust	Medicine	A	8/18/2015
PM Essentials	342492	Regulatory Services Australia	Medicine	A	8/27/2020
Neuro Balance	444670	Mind Gut Co Pty Ltd	Medicine	A	3/27/2024
Eagle Clinical DetoxaChol	370981	Integria Healthcare Australia Pty Ltd	Medicine	A	7/13/2021
LORILAP Premix	493128	Zifam Pinnacle Pty Ltd	Medicine	A	6/24/2025
LORILAP	339633	Zifam Pinnacle Pty Ltd	Medicine	A	7/16/2020
Eagle Clinical Tresos PRO Neurocrine	396677	Integria Healthcare Australia Pty Ltd	Medicine	A	9/29/2022
INC. BCAA POWDER PLUS APPLE	369791	RF Six Pty Ltd	Medicine	A	6/18/2021

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
PRIMENE 10%-LIQ IV	clintec nutrition company	02161192	Liquid - Intravenous	249 MG / 100 ML	12/31/1995

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
NUMETA G19%E, EMULSION PARA PERFUSION	Baxter S.L.	74020	EMULSIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
NUMETA G16%E, EMULSION PARA PERFUSION	Baxter S.L.	74019	EMULSIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized

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.

Related News

Yaqrit Bolsters Leadership Team to Advance Late-Stage Liver Disease Treatments

4 months ago

Yaqrit has appointed Ronen Israel, a healthcare innovator and hedge fund strategist, to its management board, strengthening North American investment connectivity for its advanced liver disease portfolio.

Help Us Improve

Your feedback helps us provide better drug information and insights.

AI-Powered Research

Premium Access