Delving into the Latest Updates on Ilaprazole with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Aldenon, Aldenonc, IY-NT-R

+ [6]

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

Molecular FormulaC19H18N4O2S

InChIKeyHRRXCXABAPSOCP-UHFFFAOYSA-N

CAS Registry172152-36-2

主要目的：以浙江美迪深生物医药有限公司持有的艾普拉唑肠溶片（5mg）为受试制剂，按生物等效性试验的有关规定，与丽珠集团丽珠制药厂持有的艾普拉唑肠溶片（商品名：壹丽安，规格：5mg）为参比制剂，进行生物等效性试验，比较两种制剂在空腹和餐后条件下单次给药的生物等效性。次要目的：评估单剂口服受试制剂（艾普拉唑肠溶片，T）和参比制剂（壹丽安，R）在中国健康成年受试者中的安全性。

[Translation]

Primary objective: To conduct a bioequivalence study using ilaprazole enteric-coated tablets (5 mg) held by Zhejiang Medishen Biopharmaceutical Co., Ltd. as the test preparation and ilaprazole enteric-coated tablets (trade name: Yilian, specification: 5 mg) held by Livzon Pharmaceutical Factory of Livzon Group as the reference preparation according to the relevant provisions of the bioequivalence study, and to compare the bioequivalence of the two preparations under fasting and postprandial conditions after a single dose. Secondary objective: To evaluate the safety of a single oral dose of the test preparation (ilaprazole enteric-coated tablets, T) and the reference preparation (Yilian, R) in healthy adult subjects in China.

Start Date30 Sep 2024

Sponsor / Collaborator

Zhejiang Meidishen Biomedical Co., Ltd.

CTR20243050 / RecruitingNot Applicable

艾普拉唑肠溶片在健康受试者中空腹和餐后状态下的生物等效性试验

[Translation] Bioequivalence study of ilaprazole enteric-coated tablets in healthy volunteers under fasting and fed conditions

主要目的：比较空腹和餐后给药条件下，山东百诺医药股份有限公司的艾普拉唑肠溶片（5mg）与丽珠集团丽珠制药厂持证的艾普拉唑肠溶片（5mg，商品名：壹丽安）在健康成年人群中吸收程度和速度的差异，评价其生物等效性。次要目的：评价空腹和餐后给药条件下，山东百诺医药股份有限公司的艾普拉唑肠溶片（5mg）与丽珠集团丽珠制药厂持证的艾普拉唑肠溶片（5mg，商品名：壹丽安）在健康成年人群中的安全性。

[Translation]

Primary objective: To compare the differences in absorption extent and rate between ilaprazole enteric-coated tablets (5 mg) of Shandong Bainuo Pharmaceutical Co., Ltd. and ilaprazole enteric-coated tablets (5 mg, trade name: Yilian) certified by Livzon Pharmaceutical Factory of Livzon Group in healthy adults under fasting and postprandial administration conditions, and to evaluate their bioequivalence. Secondary objective: To evaluate the safety of ilaprazole enteric-coated tablets (5 mg) of Shandong Bainuo Pharmaceutical Co., Ltd. and ilaprazole enteric-coated tablets (5 mg, trade name: Yilian) certified by Livzon Pharmaceutical Factory of Livzon Group in healthy adults under fasting and postprandial administration conditions.

Start Date11 Sep 2024

Sponsor / Collaborator

Shandong Bestcomm 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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97

Literatures (Medical) associated with Ilaprazole

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 ; Ji, Eunjeong ; Cha, Wonjae ; 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.

17 May 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.

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
Non-erosive gastro-esophageal reflux disease	Phase 1	KR	IlYang Pharmaceutical Co., Ltd.	31 Oct 2018
Non-erosive reflux disease	Phase 1	KR	IlYang Pharmaceutical Co., Ltd.	31 Oct 2018
Peptic Ulcer Hemorrhage	Phase 1	CN	Lizhu Group Lizhu Medicine Research Institute	18 Jan 2014
Peptic Ulcer Hemorrhage	Phase 1	CN	Livzon Group Livzon Pharmaceutical Factory	18 Jan 2014
Gastroesophageal Reflux	Phase 1	-	Livzon Pharmaceutical Group, Inc.	01 Dec 2011
Erosive esophagitis	Phase 1	US	Takeda Pharmaceutical Co., Ltd.	01 May 2007
Helicobacter pylori infection	IND Approval	CN	Livzon Group Livzon Pharmaceutical Factory	01 Nov 2022

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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	srkagffoyg(hdseorwimu) = xxvmspjdiu smvcpkwuwl (uuhzmfcjyd )	Positive	01 Feb 2020
				Vonoprazan	srkagffoyg(hdseorwimu) = ftrrrevzrs smvcpkwuwl (uuhzmfcjyd )
NCT02638584 (Pubmed \| Surg Endosc) Manual	Phase 4	Stomach Ulcer	176	ilaprazole	dhhmcwajgv(xfiokraczt) = qxkozhzjty mblumkwosp (fbchgosxht ) View more	Positive	01 May 2019
				rabeprazole	dhhmcwajgv(xfiokraczt) = ysvjivhovn mblumkwosp (fbchgosxht ) View more
NCT02860624 (Pubmed) Manual	Phase 3	Esophagitis, Peptic	537	Ilaparazole	(cfbnvovhqj) = xbwvhdebpj nndesqaztx (dagezdbjia ) View more	Similar	01 May 2018
				esomeprazole	(cfbnvovhqj) = ijvxzczeya nndesqaztx (dagezdbjia ) View more
UEGW	Not Applicable	Stomach Ulcer	88	Ilaprazole 20 mg	jhcrdjbocf(tdfrdxkqqi) = stfknjzggo xhyrxxtbjd (mbravzbcbi )	Negative	01 Oct 2017
				Rabeprazole 20 mg	jhcrdjbocf(tdfrdxkqqi) = fvjhsfytut xhyrxxtbjd (mbravzbcbi )
NCT01107938 (Pubmed \| Clin Drug Investig)	Phase 2	Esophagitis, Peptic	-	Ilaprazole 10 mg/day	(pcxluivuqg) = slrajbfbmm xtbpizafli (iovqptmyya, (86.73%)) View more	-	01 Dec 2016
				Ilaprazole 15 mg/day	(pcxluivuqg) = gwdjfmalpo xtbpizafli (iovqptmyya, (81.40%)) View more
NCT00952978 (Pubmed \| Curr Med Res Opin)	Phase 3	Duodenal Ulcer	494	Ilaprazole 10mg/d	blizdemxzj(yiyaxyedfl) = tblwwplkxc nvmvabmkfn (dwobzxeqcd )	Positive	01 Jan 2012
				Omeprazole 20mg/d	blizdemxzj(yiyaxyedfl) = mcklkojzma nvmvabmkfn (dwobzxeqcd )