Delving into the Latest Updates on Ornithine Phenylacetate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

L-OP, L-Ornithine phenylacetate, OP

+ [9]

Target

NF-κB x NOS2

Mechanism

NF-κB inhibitors(Nuclear factor NF-kappa-B complex inhibitors), NOS2 modulators(Nitric oxide synthase, inducible modulators)

Therapeutic Areas

Nervous System DiseasesDigestive System DisordersEndocrinology and Metabolic Disease+ [1]

Active Indication-

Inactive Indication

Chemical and Drug Induced Liver InjuryFibrosisHepatic Encephalopathy+ [3]

Originator Organization

University College London

Active Organization-

Inactive Organization

OCERA Therapeutics LLC

Mallinckrodt Plc

Drug Highest PhaseDiscontinuedPhase 3

First Approval Date-

RegulationOrphan Drug (EU)

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Structure

Molecular FormulaC13H20N2O4

InChIKeyLRSYFEZBIMVWRY-VWMHFEHESA-N

CAS Registry952154-79-9

View All Structures (2)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of MNK6105 (an Intravenous Formulation of L-Ornithine Phenylacetate) in Hospitalized Patients With Cirrhosis and Hyperammonemia Associated With an Episode of Hepatic Encephalopathy

This study is for patients with cirrhosis and hepatic encephalopathy who are in the hospital. This means they have a high ammonia level which is affecting their brain function.
All patients will receive the standard of (regular) care. Each will have an equal chance (like flipping a coin) of receiving the experimental drug or placebo along with the standard care.
Each patient will have tests during the first 24 hours, receive treatment for up to 5 days, and have 30 days of follow-up.

Start Date01 Nov 2021

Sponsor / Collaborator

Mallinckrodt Plc

NCT03712280 / CompletedPhase 2

A Randomized, Open-Label, Phase 2a Comparator Study to Assess the Pharmacodynamics, Safety and Pharmacokinetics of Oral Administration MNK6106 (L-Ornithine Phenylacetate) Versus Rifaximin in Subjects With Hepatic Cirrhosis and a History of Prior Episodes of Hepatic Encephalopathy

The main reason for this study is to see how the study drug interacts with the body.
It will compare different doses of the study drug with a drug already in use.
Participants will be adults with liver disease that has affected the brain in the past.

Start Date01 Dec 2018

Sponsor / Collaborator

Mallinckrodt Plc

NCT03846843 / CompletedPhase 1

An Open-Label, Two-Part, Phase 1/2a, Crossover Study to Determine the Absolute Bioavailability and Pharmacokinetics of Oral Immediate-Release Doses of OCR-002 in Subjects With Varying Degrees of Cirrhosis

This is an open-label Phase 1, 2-part, crossover study in approximately 33 adult subjects (12 subjects in Part 1 and 21 subjects in Part 2), with varying degrees of cirrhosis with analysis of pharmacokinetic (PK) data after Part 1 to guide dose regimen selection and PK sampling time points for OCR-002 in Part 2.

Start Date15 Aug 2016

Sponsor / Collaborator

OCERA Therapeutics LLC

100 Clinical Results associated with Ornithine Phenylacetate

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100 Translational Medicine associated with Ornithine Phenylacetate

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100 Patents (Medical) associated with Ornithine Phenylacetate

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1,549

Literatures (Medical) associated with Ornithine Phenylacetate

01 Feb 2025·Current Computer-Aided Drug Design

Exploring the Mechanisms of Sanguinarine in the Treatment of Osteoporosis by Integrating Network Pharmacology Analysis and Deep Learning Technology

Article

Author: Zhou, Daoqing ; Yao, Zhicheng ; Tang, Yonghong ; Zeng, Yuqing ; Gan, Fengping

Background:Sanguinarine (SAN) has been reported to have antioxidant, antiinflammatory, and antimicrobial activities with potential for the treatment of osteoporosis (OP).Objective:This work purposed to unravel the molecular mechanisms of SAN in the treatment of OP.Methods:OP-related genes and SAN-related targets were predicted from public databases. Differential expression analysis and VennDiagram were adopted to detect SAN-related targets against OP. Protein-protein interaction (PPI) network was served for core target identification. Molecular docking and DeepPurpose algorithm were further adopted to investigate the binding ability between core targets and SAN. Gene pathway scoring of these targets was calculated utilizing gene set variation analysis (GSVA). Finally, we explored the effect of SAN on the expressions of core targets in preosteoblastic MC3T3-E1 cells.Results:A total of 21 candidate targets of SAN against OP were acquired. Furthermore, six core targets were identified, among which CASP3, CTNNB1, and ERBB2 were remarkably differentially expressed in OP and healthy individuals. The binding energies of SAN with CASP3, CTNNB1, and ERBB2 were -6, -6.731, and -7.162 kcal/mol, respectively. Moreover, the GSVA scores of the Wnt/calcium signaling pathway were significantly lower in OP cases than in healthy individuals. In addition, the expression of CASP3 was positively associated with Wnt/calcium signaling pathway. CASP3 and ERBB2 were significantly lower expressed in SAN group than in DMSO group, whereas the expression of CTNNB1 was in contrast.Conclusion:CASP3, CTNNB1, and ERBB2 emerge as potential targets of SAN in OP prevention and treatment.

01 Jul 2024·The Journal of Arthroplasty

Can an Enhanced Recovery Protocol Result in a Safe and Effective Outpatient Simultaneous Bilateral Total Knee Arthroplasty?

Article

Author: Katragadda, Bharat C ; Suresh, Anoop ; Azeez, Arshad

BACKGROUNDOutpatient total knee arthroplasty (OP TKA) is found to benefit patients as well as the health care system. Studies on OP TKA have been limited to unilateral total knee arthroplasty (TKA). This study aimed to determine if enhanced recovery after surgery (ERAS) protocols can result in performing simultaneous bilateral TKA (SBTKA) safely and effectively in the OP setting.METHODSThis retrospective study compared patients who underwent SBTKA in an OP setting (OP group, n = 100) using an ERAS protocol from April 1, 2021, to June 30, 2022, and a propensity-matched historical group (inpatient group, n = 100) operated in an inpatient setting via conventional protocol from July 1, 2019, to June 30, 2020. The complication rate, readmission rate, visual analog score (VAS), range of motion (ROM), and Knee Society Score (KSS) were compared between the groups in the early postoperative and follow-up periods up to 1 year.RESULTSWe found a comparable complication rate (4 versus 7%, P = .4) and readmission rate (2 versus 3%, P = .7). The VAS score was significantly lower in the OP group on day 1, day 2, day 7, and day 14 postsurgery (P < .001). The KSS and ROM were significantly better in the OP group after 14 days (P < .001). The VAS, KSS, and ROM were comparable between the groups at 1 month and later follow-up periods (P > .05).CONCLUSIONSAn ERAS protocol in SBTKA patients resulted in safe same-day discharge with better early functional outcomes compared with conventional practices. The results from similar future studies can alleviate surgeon and patient concerns about OP TKA.

01 Jun 2024·Environmental Research

Metals accumulation affects bone and muscle in osteoporotic patients: A pilot study

Article

Author: Messina, Alessandra ; Visconti, Virginia Veronica ; Tarantino, Umberto ; De Filippis, Patrizia ; Greggi, Chiara ; Albanese, Marco ; Falvino, Angela ; Gasperini, Beatrice ; Piscitelli, Prisco ; Palombi, Leonardo ; Battistini, Beatrice

Osteoporosis is the most common bone disease, characterized by decreased bone mineral density (BMD) and often associated to decreased muscle mass and function. Metal exposure plays a role in the pathophysiology of osteoporosis and affects also muscle quality. The aim of this study was to assess the association between metal levels in bone and muscle samples and the degeneration of these tissues. A total of 58 subjects (30 male and 28 female) was enrolled and classified in osteoporotic (OP, n = 8), osteopenic (Ope, n = 30) and healthy (CTR, n = 20) subjects, according to BMD measures. Femoral head bone samples and vastus lateralis muscle samples were collected during hip arthroplasty surgeries. Inductively Coupled Plasma Mass Spectrometry (ICP-MS) analysis showed increased levels of Al, Cd and Pb in OP and Ope bone tissue compared to CTR subjects (p = 0.04, p = 0.005 and p = 0.01, respectively). Whereas, increased levels of Co, Cd and Pb were measured in OP and Ope muscle tissues, compared to CTRs (p < 0.001, p = 0.02 and p = 0.01, respectively). In addition, Al, Cd and Pb levels in bone and Cd and Co levels in muscle were negatively correlated with BMD. A negative association among Co, Cd, Cr and Hg levels and muscle fibers diameter was also observed in muscle tissues. This study assessed that metal exposure can affects bone and muscle tissue quality and may contribute to the onset and progression of musculoskeletal diseases such as osteoporosis. Therefore, it is important to implement metal exposure assessment and their impact on disease development, in order to manage and prevent metal accumulation effects on bone and muscle quality.

100 Deals associated with Ornithine Phenylacetate

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External Link

KEGG	Wiki	ATC	Drug Bank
D09942	-	-	-

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hyperammonemia	NDA/BLA	-	Mallinckrodt Plc	01 Nov 2021
Fibrosis	Phase 3	-	Mallinckrodt Plc	01 Nov 2021
Fibrosis	Phase 3	-	Mallinckrodt Plc	01 Nov 2021
Hepatic Encephalopathy	Phase 3	-	Mallinckrodt Plc	01 Nov 2021
Hepatic Encephalopathy	Phase 3	-	Mallinckrodt Plc	01 Nov 2021
Hyperammonemia	Phase 3	-	Mallinckrodt Plc	01 Nov 2021
Liver Cirrhosis	Phase 3	PR	Mallinckrodt Plc	01 Dec 2018
Liver Cirrhosis	Phase 3	US	Mallinckrodt Plc	01 Dec 2018
Chemical and Drug Induced Liver Injury	Phase 3	US	OCERA Therapeutics LLC	01 Jun 2012
Liver Failure, Acute	Phase 3	US	OCERA Therapeutics LLC	01 Jun 2012

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01966419 (STOP-HE, Pubmed \| Clin Gastroenterol Hepatol) Manual	Phase 2	Hepatic Encephalopathy	226	Ornithine Phenylacetate	(iahzvqesiw) = rjozjxbiwo wurdrvdptc (nfjdcuurpv, 34 - 69) View more	Negative	01 Dec 2021
				Placebo	(iahzvqesiw) = ftbknuutxm wurdrvdptc (nfjdcuurpv, 53 - 98) View more
NCT01966419 (STOP-HE, CTgov)	Phase 2	Hepatic Encephalopathy \| Fibrosis \| Hyperammonemia	231	placebo intravenous infusion (Placebo)	vxgvtbbqyz(muerwimvbi) = mtnrmcgmuu ffvrysadvi (essuqvlzqr, gtykrylxfe - todfdcmtfn) View more	-	16 Sep 2021
				ornithine phenylacetate (Ornithine Phenylacetate)	vxgvtbbqyz(muerwimvbi) = ufuxtpxsew ffvrysadvi (essuqvlzqr, qlogbxrdwj - xnwxyljogn) View more
NCT03712280 (CTgov)	Phase 2	Hepatic Encephalopathy \| Liver Cirrhosis	50	MNK6106 (Group A: MNK6106 2 Grams (Tid))	umqtogzwgg(cbkbcorgdg) = rdayxfjczt jxrsokxgib (avbvnuobfq, uxyxnqyzjm - zvkszydswv) View more	-	20 Jul 2021
				MNK6106 (Group B: MNK6106 4 Grams (Bid))	umqtogzwgg(cbkbcorgdg) = dbcmiovomy jxrsokxgib (avbvnuobfq, nyqseqvaxh - abbieaebix) View more