Delving into the Latest Updates on Ilaprazole with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Aldenon, Aldenonc, IY-NT-R

+ [7]

Target

Proton pump

Mechanism

Proton pump inhibitors

Therapeutic Areas

Digestive System DisordersMouth and Tooth DiseasesOtorhinolaryngologic Diseases+ [1]

Active Indication

Esophagitis, PepticGastroesophageal RefluxErosive esophagitis+ [4]

Inactive Indication

Non-erosive reflux diseasePeptic Ulcer Hemorrhage

Originator Organization

Livzon Group Livzon Pharmaceutical Factory

Active Organization

Livzon Group Livzon Pharmaceutical Factory

Livzon Pharmaceutical Group, Inc.

IlYang Pharmaceutical Co., Ltd.

Inactive Organization

Lizhu Group Lizhu Medicine Research Institute

Takeda Pharmaceutical Co., Ltd.

Drug Highest PhaseApproved

First Approval Date

CN (11 Dec 2007),

Duodenal Ulcer

Regulation-

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Structure/Sequence

Molecular FormulaC19H18N4O2S

InChIKeyHRRXCXABAPSOCP-UHFFFAOYSA-N

CAS Registry172152-36-2

本试验旨在研究单次空腹和餐后口服宁波科尔康美诺华药业有限公司研制、宁波美诺华天康药业有限公司生产的艾普拉唑肠溶片（5 mg）的药代动力学特征；以丽珠集团丽珠制药厂持证、生产的艾普拉唑肠溶片（壹丽安®，5 mg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞，评价两制剂的人体生物等效性，并观察两制剂在健康受试者中的安全性。

[Translation]

This study aimed to investigate the pharmacokinetic characteristics of ilaprazole enteric-coated tablets (5 mg) developed by Ningbo Keerkang Minova Pharmaceutical Co., Ltd. and produced by Ningbo Minova Tiankang Pharmaceutical Co., Ltd. after single fasting and postprandial oral administration; using ilaprazole enteric-coated tablets (Yilian®, 5 mg) certified and produced by Livzon Pharmaceutical Factory of Livzon Group as the reference preparation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared, the human bioequivalence of the two preparations was evaluated, and the safety of the two preparations in healthy subjects was observed.

Start Date07 Dec 2024

Sponsor / Collaborator

Ningbo Krka Menovo Pharmaceutical Co., Ltd.

NCT05617651

/ Not yet recruitingPhase 1

Phase 1 Study to Evaluate the Safety and the Pharmacokinetics of IY-NT-T in Healthy Adult Volunteers Under Fed Condition

This study evaluate the pharmacokinetic and safety of IY-NT-T in healthy adults

Start Date30 Nov 2024

Sponsor / Collaborator

IlYang Pharmaceutical Co., Ltd.

100 Clinical Results associated with Ilaprazole

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100 Translational Medicine associated with Ilaprazole

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100 Patents (Medical) associated with Ilaprazole

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100

Literatures (Medical) associated with Ilaprazole

31 Dec 2024·Future Science OA

Computational drug–drug interaction prediction mediated by CYP450 isoforms of Ilaprazole coadministered with clopidogrel

Article

Author: Narayanasamy, Damodharan ; Ananthathandavan, Priyadharshini

Ilaprazole due to its pharmacokinetic variability does not affect the clopidogrel efficacy during concomitant use. Methodology: Prediction of DDI for Clopidogrel and PPIs performed using (DDI-Pred) Way2Drug software. The probabilities ΔP, which estimate the potential DDIs resulting from interaction with CYP450 isoenzymes. Results: Positive ΔP-values for CYP2C19 (0.955) indicate that it is involved in the drug interaction of Ilaprazole and Clopidogrel. Discussion: Pantoprazole and Ilaprazole were found to have a low probability of CYP2C19 inhibition Conclusion: Compared with other PPIs, Pantoprazole and Ilaprazole were found to have a low probability of CYP2C19 inhibition; Since Ilaprazole has pharmacokinetic variability, further in vivo and in vitro studies are required on the ilaprazole and clopidogrel combination to assess the effect of drug-drug interaction.

30 Oct 2024·Journal of Neurogastroenterology and Motility

The Impact of a Twice-daily Versus Once-daily Proton Pump Inhibitor Dosing Regimen on Laryngopharyngeal Reflux Symptoms: A Prospective Randomized Controlled Trial

Article

Author: Jung, Young Ho ; Kang, Seung Heon ; Lee, Jin Yi ; Cha, Wonjae ; Ji, Eunjeong ; Ji, Jeong-Yeon ; Huh, Gene ; Jeong, Woo-Jin

Background/AimsProton pump inhibitors (PPIs) play a crucial role in managing laryngopharyngeal reflux (LPR), but the optimal dosing regimen remains unclear. We aim to compare the effectiveness of the same total PPI dose administered twice daily versus once daily in LPR patients.MethodsWe conducted a prospective randomized controlled trial at a tertiary referral hospital, enrolling a total of 132 patients aged 19 to 79 with LPR. These patients were randomly assigned to receive either a 10 mg twice daily (BID) or a 20 mg once daily (QD) dose of ilaprazole for 12 weeks. The Reflux Symptom Index (RSI) and Reflux Finding Score (RFS) were assessed at 8 weeks and 16 weeks. The primary endpoint was the RSI response, defined as a reduction of 50% or more in the total RSI score from baseline. We also analyzed the efficacy of the dosing regimens and the impact of dosing and duration on treatment outcomes.ResultsThe BID group did not display a higher response rate for RSI than the QD group. The changes in total RSI scores at the 8-week and 16- week visits showed no significant differences between the 2 groups. Total RFS alterations were also comparable between both groups. Each dosing regimen demonstrated significant decreases in RSI and RFS.ConclusionsBoth BID and QD PPI dosing regimens improved subjective symptom scores and objective laryngoscopic findings. There was no significant difference in RSI improvement between the 2 dosing regimens, indicating that either dosing regimen could be considered a viable treatment option.

01 Jul 2024·Pakistan journal of pharmaceutical sciences

Clinical efficacy of ilaprazole combined with somatostatin on severe acute pancreatitis and the effects on oxidative stress and inflammatory response.

Article

Author: Yang, Fen ; Zhang, Hao ; Xiang, Fengming ; Zhang, Guanghui

This study investigates the clinical efficacy of ilaprazole combined with somatostatin on severe acute pancreatitis (SAP) and the effects on oxidative stress and inflammatory response. Seventy SAP patients were randomized to the control and observation groups, which received the somatostatin treatment and ilaprazole combined with somatostatin treatment for seven days, respectively. Results found that, the time of abdominal pain relief, time of serum amylase recovery, time of urinary amylase recovery and time of defecation recovery in the observation group were shorter than those in the control group (P<0.05). After the treatment, comparing to the control group, in the observation group the heart rate decreased (P<0.05), the mean arterial pressure and the central venous pressure increased (P<0.05), the serum levels of super oxide dismutase and glutathione peroxidase increased (P<0.05) and the serum levels of malondialdehyde, tumor necrosis factor α, interleukin-6, C-reactive protein decreased (P<0.05). In treatment of SAP, ilaprazole combined with somatostatin can enhance the curative efficacy and decrease the oxidative stress and the inflammatory response in patients. In addition, it cannot increase the adverse reactions, with good safety.

100 Deals associated with Ilaprazole

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Ilaprazole	A02BC	DB11964

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Esophagitis, Peptic	ID	Livzon Pharmaceutical Group, Inc.	27 Sep 2022
Gastroesophageal Reflux	CN	Livzon Pharmaceutical Group, Inc.	16 Apr 2015
Erosive esophagitis	KR	IlYang Pharmaceutical Co., Ltd.	28 Oct 2008
Stomach Ulcer	KR	IlYang Pharmaceutical Co., Ltd.	28 Oct 2008
Duodenal Ulcer	CN	Livzon Group Livzon Pharmaceutical Factory	11 Dec 2007

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Helicobacter pylori infection	IND Approval	CN	Livzon Group Livzon Pharmaceutical Factory	01 Nov 2022
Non-erosive gastro-esophageal reflux disease	Discovery	KR	IlYang Pharmaceutical Co., Ltd.	31 Oct 2018
Non-erosive reflux disease	Discovery	KR	IlYang Pharmaceutical Co., Ltd.	31 Oct 2018
Peptic Ulcer Hemorrhage	Discovery	-	Livzon Pharmaceutical Group, Inc.	01 Oct 2014
Gastroesophageal Reflux	Discovery	-	Livzon Pharmaceutical Group, Inc.	01 Dec 2011
Erosive esophagitis	Discovery	US	Takeda Pharmaceutical Co., Ltd.	01 May 2007

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AAAAI2020	Not Applicable	IL-13 \| eotaxin-3 \| CCL26	-	Ilaprazole	umxicbfiar(nmxqbffewu) = ymrkocfqug mqwuhxbtkt (wudrkdvozi )	Positive	01 Feb 2020
				Vonoprazan	umxicbfiar(nmxqbffewu) = xvmofuopbe mqwuhxbtkt (wudrkdvozi )
NCT02638584 (Pubmed \| Surg Endosc) Manual	Phase 4	Stomach Ulcer	176	ilaprazole	bbylyfitay(bzmmswgyqk) = wuoaifwpon ggpyrkmfso (braokmejuq ) View more	Positive	01 May 2019
				rabeprazole	bbylyfitay(bzmmswgyqk) = xdrcifzdnm ggpyrkmfso (braokmejuq ) View more
NCT02860624 (Pubmed) Manual	Phase 3	Esophagitis, Peptic	537	Ilaparazole	(mcietdvrqh) = ivezrotckd vxnnkezwaq (bpkeallhvu ) View more	Similar	01 May 2018
				esomeprazole	(mcietdvrqh) = wiskbmjrao vxnnkezwaq (bpkeallhvu ) View more
UEGW2017	Not Applicable	Stomach Ulcer	88	Ilaprazole 20 mg	tiasjnhzct(xsmgfdniqn) = rshytbvpuq lbndovcdvr (kphrsccmlu )	Negative	01 Oct 2017
				Rabeprazole 20 mg	tiasjnhzct(xsmgfdniqn) = xymdptxfgi lbndovcdvr (kphrsccmlu )
NCT01107938 (Pubmed \| Clin Drug Investig)	Phase 2	Esophagitis, Peptic	-	Ilaprazole 10 mg/day	(iuhmpxhfqn) = xpoxkipril nxejeivunq (guckrrzgah, (86.73%)) View more	-	01 Dec 2016
				Ilaprazole 15 mg/day	(iuhmpxhfqn) = odfhitcxns nxejeivunq (guckrrzgah, (81.40%)) View more