Delving into the Latest Updates on Esomeprazole Strontium with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Esomeprazole strontium (USAN), Esomeprazole strontium tetrahydrate

+ [1]

Target

Proton pump

Mechanism

Proton pump inhibitors

Therapeutic Areas

Digestive System Disorders

Active Indication

Duodenal Ulcer

Inactive Indication

Gastroesophageal RefluxHelicobacter pylori infectionStomach Ulcer+ [1]

Originator Organization

Hanmi Pharmaceutical Co., Ltd.

Active Organization

Hanmi Pharmaceutical Co., Ltd.

Inactive Organization

Belcher Pharmatech LLC

Drug Highest PhaseApproved

First Approval Date

US (06 Aug 2013),

Duodenal UlcerGastroesophageal RefluxHelicobacter pylori infection+ [2]

Regulation-

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Structure/Sequence

Molecular FormulaC17H19N3O3S

InChIKeySUBDBMMJDZJVOS-DEOSSOPVSA-N

CAS Registry119141-88-7

View All Structures (2)

This is a randomized, open-label, two-cycle clinical study to evaluate the drug interaction, food effect and pharmacokinetics of IBI351 and esomeprazole in healthy subjects. A total of two cohorts were planned to be enrolled in each cohort. Cohort 1: This cohort investigated the effect of esomeprazole on the pharmacokinetics of IBI351 in healthy subjects. Cohort 2: This cohort investigated the effect of food on the pharmacokinetics of IBI351 in healthy subjects.

Start Date16 Feb 2023

Sponsor / Collaborator

Innovent Biologics (Suzhou) Co. Ltd.

NCT05250050

/ Unknown statusPhase 4IIT

Clinical Efficacy and Health Economic Evaluation of Susceptibility-Guided Therapy for Helicobacter Pylori Infection Treatment：Multicenter Randomized Controlled Study

This multicenter randomized controlled clinical trial was conducted to compare the eradication efficacy and health economic benefits of individualized regimens based on HP drug resistance mutation gene detection (multiple PCR method), individualized regimens based on HP traditional drug sensitivity testing (E-test method) and empirical regimens in the Helicobacter pylori treatment.

Start Date25 Mar 2022

Sponsor / Collaborator

Zhongshan Hospital Fudan University

100 Clinical Results associated with Esomeprazole Strontium

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100 Translational Medicine associated with Esomeprazole Strontium

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100 Patents (Medical) associated with Esomeprazole Strontium

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17

Literatures (Medical) associated with Esomeprazole Strontium

01 Aug 2023·Clinical and experimental otorhinolaryngology

Predictors of Early and Late Response to Esomezol and Lifestyle Modification in Adults With Laryngopharyngeal Reflux Disease: A Prospective, Multicenter, Open-Label Cohort Study.

Article

Author: Sun, Dong-Il ; Park, Il-Seok ; Park, Young Hak ; Lee, Byung-Joo ; Chung, Eun-Jae ; Sohn, Jin-Ho ; Kwon, Seong Keun ; Cho, Jae-Gu ; Park, Sung Joon ; Jin, Sung Min

OBJECTIVESThis study aimed to assess predictors of the response to varying durations of proton pump inhibitor (PPI) use and lifestyle modification treatment for laryngopharyngeal reflux disease (LPRD).METHODSBetween October 2014 and June 2016, a prospective, multicenter, open-label, single-cohort, intention-to-treat, observational study was conducted at eight referral hospitals across the Republic of Korea to examine predictors of early and late response to treatment in adult patients (age ≥19 years) with LPRD. Participants underwent standard treatment (PPI [Esomezol] and lifestyle modification) for 3 months. Response to treatment was defined as greater than 50% improvement in reflux symptom index score. The primary outcome was potential predictors of treatment response at 1 and 3 months. The secondary outcome was potential predictors distinguishing early from late responders.RESULTSIn total, 394 patients were enrolled. Improved sleep habits was a positive predictor (odds ratio [OR], 1.785; 95% confidence interval [CI], 1.06-3.007; P=0.029), while initial alcohol consumption (OR, 0.587; 95% CI, 0.355-0.969; P=0.037) and past medication history (OR, 0.438; 95% CI, 0.215-0.891; P=0.005) were negative predictors of response after 1 month of treatment. High pre-reflux finding score was a positive predictor (OR, 1.187; 95% CI, 1.049- 1.344; P=0.007), while male sex (OR, 0.516; 95% CI, 0.269-0.987; P=0.046), higher depression score (OR, 0.867; 95% CI, 0.784-0.958; P=0.005), and past thyroid hormone medication history (OR, 0.161; 95% CI, 0.033-0.788; P=0.024) were negative predictors of response after 3 months of treatment. Past medication history (OR, 0.438; 95% CI, 0.215-0.891; P=0.023) was the only negative predictor for early responders compared to late responders.CONCLUSIONAdult patients with LPRD and a history of prior medication use may require longer treatment durations to achieve a therapeutic response. Future research should explore the incorporation of diverse treatment approaches to improve treatment outcomes for patients exhibiting negative prognostic indicators.

01 Jan 2023·Drug design, development and therapy

Pharmacokinetics and Pharmacodynamics of Esomezol DR, a New Dual Delayed-Release Formulation of Esomeprazole 20 Mg or 40 Mg, in Healthy Subjects.

Article

Author: Jang, In-Jin ; Jung, Jina ; Lee, SeungHwan ; Yang, Eunsol ; Ban, Mu Seong ; Hong, Sung Hee ; Kim, Hyun Chul ; Kim, Yu Kyong

BackgroundEsomeprazole, a proton pump inhibitor (PPI), is widely used to treat acid-related disorders, but it has short plasma half-life which can cause insufficient gastric acid suppression, such as nocturnal acid breakthrough. A new dual delayed-release (DR) formulation of esomeprazole (Esomezol DR), was developed to extend the duration of gastric acid suppression.PurposeThis study aimed to evaluate the pharmacokinetics (PKs) and pharmacodynamics (PDs) of esomeprazole for the DR formulation compared to a conventional enteric-coated (EC) formulation (Nexium) in healthy male subjects.MethodsTwo randomized, open-label, multiple-dose, two-way crossover studies with esomeprazole 20 mg and 40 mg were conducted. Subjects received the DR formulation or the EC formulation once daily for 7 days in each period with a 7-day washout. Serial blood samples were collected up to 24 hours after the 1st dose, and 24-hour intragastric pH was continuously monitored before the 1st dose as baseline and after the 1st and the 7th dose.ResultsIn 20 mg and 40 mg dose groups, 38 and 44 subjects completed the study, respectively. The DR formulation exhibited the dual-release pattern of esomeprazole, resulting in more sustained plasma concentration-time profiles compared to the EC formulation. The systemic exposure of esomeprazole for the DR formulation was comparable to that for the EC formulation, showing the similar area under the plasma concentration-time curve. The 24-hour gastric acid suppression was also similar between the two formulations, while the inhibition during night-time (22:00-06:00) showed a better tendency in the DR formulation.ConclusionThe sustained exposure of esomeprazole in the DR formulation led to well-maintained and higher acid inhibition compared to the EC formulation, especially during the night-time. These results suggest that the DR formulation can be an alternative formulation to the conventional EC formulation, expecting the potential of relieving nocturnal acid-related symptoms.

01 Sep 2017·Zeitschrift für GastroenterologieQ4 · MEDICINE

Esomeprazol-induzierter kutaner Lupus erythematodes

Q4 · MEDICINE

Article

Author: Broekaert, Sigrid ; Schön, Michael ; Gliem, Nina ; Ellenrieder, Volker ; Seitz, Cornelia

100 Deals associated with Esomeprazole Strontium

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External Link

KEGG	Wiki	ATC	Drug Bank
D10120	Esomeprazole Strontium	A02BC05	DBSALT001224

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Duodenal Ulcer	KR	Hanmi Pharmaceutical Co., Ltd.	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Gastroesophageal Reflux	Preclinical	US	Belcher Pharmatech LLC	06 Aug 2013

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02743949 (CTgov)	Phase 2	Gastroesophageal Reflux	256	Esomeprazole Placebo+Esomeprazole+Vonoprazan (Esomeprazole 40 mg)	ogssdrifly(zdxpcrpmvv) = mphpazzqeq hmzyabzzao (kjdcvouhaz, abckxseols - giiyxczdvd) View more	-	18 Feb 2020
				Esomeprazole Placebo+Esomeprazole+Vonoprazan (Vonoprazan 20 mg)	ogssdrifly(zdxpcrpmvv) = ljxoqmfytq hmzyabzzao (kjdcvouhaz, xvfzqsyeow - onizhhlsar) View more
NCT02708355 (CTgov)	Phase 4	Heartburn	55	Esomeprazole 20 mg (Esomeprazole 20 mg Twice Daily)	dysugfybor(nkwxkpryyw) = anhgjwppql bdrtkevkca (bsmctvycld, elvxmywfsp - xtouquctek) View more	-	19 Apr 2017
				Placebo (Placebo)	dysugfybor(nkwxkpryyw) = frlgzssgxt bdrtkevkca (bsmctvycld, dtgfcijedq - iaudeszvvh) View more
NCT00895817 (CTgov)	Not Applicable	Eosinophilic Esophagitis	42	Esomeprazole (Esomeprazole)	jfltiuwned(crzajfmnug) = oglsftvrcq hxuoemugbu (koyvvypxta, jqsasiiojy - yjvfzrilag) View more	-	12 Mar 2013
				Swallowed fluticasone (Swallowed Fluticasone)	jfltiuwned(crzajfmnug) = rxqehjdcum hxuoemugbu (koyvvypxta, ubfrapjadx - pzgxtwmvgo) View more
NCT01138969 (CTgov)	Phase 2	Peptic Ulcer \| Gastrointestinal Hemorrhage	165	esomeprazole (Esomeprazole Plus Clopidogrel Group)	bwzcxtmsmj(ubbocziwbt) = khoyvloywx grwypqpmpy (gzgkaqaxmr, ucqqjztsxo - zuumjunshf) View more	-	04 Feb 2013
				clopidogrel (Clopidogrel Group)	bwzcxtmsmj(ubbocziwbt) = blokmqnyxk grwypqpmpy (gzgkaqaxmr, foqmqhrtos - uhzopuytos) View more
NCT00719160 (CTgov)	Phase 4	Osteoporosis	12	Placebo+Esomeprazole (Esomeprazole)	jskpydvvvt(igqobmkqvg) = hcgfzouaqv fxhosiehxy (lsoppwutst, pkjkvtjujc - lyibcjodyl)	-	04 Jan 2013
				Placebo+Esomeprazole (Placebo)	jskpydvvvt(igqobmkqvg) = xwvnzvrtzg fxhosiehxy (lsoppwutst, ckjusxksmq - khxzmlotrp) View more
NCT00728481 (CTgov)	Phase 2/3	Gastroesophageal Reflux \| Eosinophilic Esophagitis	51	Esomeprazole (Esomeprazole)	sekrnmvuti(rfqunpcrdr) = kvcmasffrp ifjtkpuwen (xrunugwuee, gdvkrbsurw - zbgphelhmv) View more	-	06 Dec 2012
				Budesonide (Budesonide)	sekrnmvuti(rfqunpcrdr) = nqqmmhxjny ifjtkpuwen (xrunugwuee, egruqfspif - cqioskrcbv) View more
NCT01069939 (LAVENDER*, CTgov)	Phase 3	Gastrointestinal ulcer	427	Esomeprazole (Esomeprazole 20mg)	thqfumbfoi(wyrogbsfdt) = tlwcwzikub zuvrnfivak (fdehzvgshn, nqjybzplzw - kcqhqgnadv) View more	-	22 Nov 2012
				Placebo (Placebo)	thqfumbfoi(wyrogbsfdt) = qrsurwpssy zuvrnfivak (fdehzvgshn, vzemccsdpz - piucvvmljn) View more
NCT01119768 (CTgov)	Phase 4	Chronic gastritis \| Non-erosive reflux disease	305	Esomeprazole (Esomeprazole 8 Weeks Treatment)	qsduytcqob(dvqegxbyzw) = bqpsfpdgtw laqirxzmkw (dpldgkbdxp, qmyusguzvk - ihblkyrarz) View more	-	28 Sep 2012
				Esomeprazole (Esomeprazole 2 Weeks Treatment)	qsduytcqob(dvqegxbyzw) = vmsfabpwsl laqirxzmkw (dpldgkbdxp, wythingwvi - ogdwczkfvy) View more