ornithine

Small moleculeexperimental

Ornithine is an amino acid produced in the urea cycle by the splitting off of urea from arginine. It is a central part of the urea cycle, which allows for the disposal of excess nitrogen. Ornithine is also a precursor of citrulline and arginine. Arginine stimulates the pituitary release of growth hormone. Burns or other injuries affect the state of arginine in tissues throughout the body. As de novo synthesis of arginine during these conditions is usually not sufficient for normal immune function, nor for normal protein synthesis, ornithine may have immunomodulatory and wound-healing activities under these conditions (by virtue of its metabolism to arginine). — NCATS

Clinical trial activity

9 trials · 9 clinical orgs · 0 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Oct 1, 2011 (NCT01434108)

Timeline

2010s

Jan 1, 2011
Earliest Phase 2 Sponsor(trial)
Jan 1, 2016
Earliest Phase 1 Sponsor(trial)
Jan 1, 2017
Earliest Phase 3 Sponsor(trial)

Indications

Approved for

Nutrition Disorders

Studied for

Mechanism of action

Unspecified targetUnclear
Unclear

Chemistry & pharmacology

Loading structure…

SMILES

NCCC[C@H](N)C(O)=O

Mol. weight: 132.161 g/mol
Lipinski Ro5: Pass
Rule of 3: No
Chirality: Single Stereoisomer
Inorganic: No
Polymer: No

Oral

Parenteral

Topical

Sources

Also known as

levo-ornithine
levo-ornithine
l-ornithine
l-ornithine
l-ornithine
ocr-002
ocr-002
ornithine
ornithine
ornithine
ornithine
ornithine
ornithine
ornithine
ornithine phenylacetate
ornithine phenylacetate
(s)-2,5-diaminopentanoate
(s)-2,5-diaminopentanoate
(s)-2,5-diaminopentanoic acid
(s)-2,5-diaminopentanoic acid
(s)-2,5-diaminopentanoic acid
(s)-2,5-diaminovaleric acid
(s)-2,5-diaminovaleric acid
(s)-alpha,delta-diaminovaleric acid
(s)-alpha,delta-diaminovaleric acid
(s)-ornithine
(s)-ornithine
(s)-ornithine
(s)-α,δ-diaminovaleric acid
(s)-α,δ-diaminovaleric acid

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT05539027	Phase 4	Sep 20, 2022	Ain Shams University
NCT04128462	Phase 3	Nov 30, 2019	Mallinckrodt
NCT03712280	Phase 2	Dec 1, 2018	Mallinckrodt
NCT05042024	Phase 3	Oct 20, 2017	Ukrainian Medical Stomatological Academy
NCT03846843	Phase 1/Phase 2 (Phase 2)	Aug 15, 2016	Ocera Therapeutics, Southern California Research Center
NCT01966419	Phase 2	Nov 1, 2013	Ocera Therapeutics
NCT01634230	Phase 2	Jun 1, 2012	Ocera Therapeutics
NCT01548690	Phase 2	Jun 1, 2012	Medical University of South Carolina, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Ocera Therapeutics, The University of Texas, Dallas
NCT01434108	Phase 2/Phase 3 (Phase 3)	Oct 1, 2011	Universidad Autonoma de Barcelona

Showing 9 of 9 trials

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Organizations

Research & Development (9)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Ocera Therapeutics	For profit	4	3	1	2012
Mallinckrodt	For profit	2	2	2	2018
Ain Shams University	Academic/Hospital	1	1	1	2022
Medical University of South Carolina	Academic/Hospital	1	0	1	2012
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Government	1	0	1	2012
Southern California Research Center	For profit	1	0	1	2016
The University of Texas, Dallas	Academic/Hospital	1	1	1	2012
Ukrainian Medical Stomatological Academy	Academic/Hospital	1	1	1	2017
Universidad Autonoma de Barcelona	Academic/Hospital	1	1	1	2011

9 organizations

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