Delving into the Latest Updates on Bismuth Tartrate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

colloidal bismuth tartrate

Target-

Action-

Mechanism-

Therapeutic Areas

Infectious DiseasesDigestive System Disorders

Active Indication

Colitis, UlcerativeGastritis, AtrophicHelicobacter pylori infection+ [1]

Inactive Indication-

Originator Organization-

Active Organization

Yingxin Pharmaceutical(Shantou)Co.,Ltd.

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC12H18Bi2O18

InChIKeyYRPZNDFSTXWHOM-YDXPQRMKSA-N

CAS Registry6591-56-6

In order to evaluate the effectiveness and safety of high-dose dual therapy with vonoprazan for eradicating Helicobacter pylori, we searched seven electronic databases from the establishment of the database to March 2025, collecting randomized controlled clinical trials (RCTs) comparing high-dose dual therapy with vonoprazan to high-dose dual therapy with PPI and quadruple therapy with bismuth, including 13 RCTs with 4023 patients. The primary outcome is the eradication rate determined based on intention to treat analysis and protocol analysis, while secondary outcomes include incidence of adverse events and compliance. According to ITT analysis and PP treatment analysis, the eradication rates of VA therapy were 88.81 % and 93.56 %, respectively. The incidence of adverse reactions was significantly lower (14.56 % vs 26.00 %, RR=0.57, 95 % CI: 0.48-0.67, p < 0.0001), and compliance was better (96.29 % vs 93.56 %, RR=1.03, 95 % CI: 1.01-1.05, p = 0.003), making it a reliable alternative therapy.

01 May 2025·Reviews on Recent Clinical Trials

The Efficacy of Two Triple Therapy Regimens and One Quadruple Regimen [Omeprazole, Amoxicillin, Metronidazole with Bismuth] in Eradicating Helicobacter pylori in Patients with Peptic Ulcer: A Randomized Clinical Trial

Article

Author: Bahrami, Anvar ; Salehi, Amir Mohammad ; Ebrahimi, Alireza ; Hasanzarrini, Maryam ; Khanlarzadeh, Elham

Background:Helicobacter pylori (H. pylori) infection is the main cause of most PUD; therefore, the eradication of H. pylori is extremely important in the treatment of PUD. There are several recommended treatment regimens suggested to eradicate this organismAim:This study compared the efficacy of three anti-Helicobacter pylori regimens in patients with dyspepsia or peptic ulcer disease (PUD).Objective:The objective of this study was to assess the efficacy of three anti-H pylori treatments in patients based on C14 urease breath test (C-UBT) results, drug compliance, and adverse effects.Methods:This randomized, open-label clinical trial included 136 H. pylori-infected patients without prior treatment. Patients were randomly divided into three groups. The OAC group received 20 mg Omeprazole capsules twice a day, two 500 mg Amoxicillin capsules twice a day, and 500 mg Clarithromycin capsules twice a day for 14 days. The OAL group received 20 mg Omeprazole capsules twice a day, two 500 mg Amoxicillin capsules twice a day, and Levofloxacin 500 mg capsules twice a day for 14 days. The OAMB group received 20 mg Omeprazole capsules twice a day, two 500 mg Amoxicillin capsules twice a day, Metronidazole 500 mg three times a day, and Bismuth 240 mg twice a day for 14 days. Evaluation for compliance and drug-related adverse effects were assessed at the end of two weeks. H. pylori eradication was evaluated eight weeks after treatment using the C-UBT.Results:A total of 136 patients participated in this study, and their groups were matched based on age and sex. The results of the C-UBT test showed that the eradication rate of H. Pylori was 82.2%, 91.3%, and 97.3% for the three-drug OAC, OAMB, and OAL treatment regimens, respectively. Moreover, all the regimens showed high compliance among the patients. Only OAC and OAL showed a significant difference in the H. Pylori eradication rate, and no superiority was found between OAMB and OAL or OAC therapies.Conclusion:The regime of OAL achieved a satisfactory rate of H. pylori infection eradication with good tolerance in patients with PUD, without any acute side effects.

02 Apr 2025·Journal of Antimicrobial Chemotherapy

Vonoprazan improves the efficacy of bismuth quadruple therapy containing doxycycline and metronidazole as first-line Helicobacter pylori treatment in penicillin-allergic patients: a randomized controlled trial

Article

Author: Zhu, Renke ; Sun, Kefang ; Gu, Qing ; Wang, Jinghua ; Yan, Tianlian ; Chen, Ye ; Gao, Jianguo ; Ma, Dan ; Li, Lan ; Wang, Jiewei

AbstractBackgroundHelicobacter pylori eradication in penicillin-allergic patients presents challenges. Options of effective regimens are lacking in areas where tetracycline is unavailable.ObjectivesTo evaluate the efficacy of replacing the proton pump inhibitor (PPI) with a potassium-competitive acid blocker (P-CAB, vonoprazan) in standard bismuth quadruple therapy containing doxycycline and metronidazole as a first-line treatment for H. pylori.MethodsThis prospective randomized clinical trial enrolled 332 naive patients with H. pylori infection and penicillin allergy. Participants were randomly assigned in a 1:1 ratio to either the 14 day P-CAB/BDM group (vonoprazan 20 mg twice daily, colloidal bismuth 200 mg twice daily, doxycycline 100 mg twice daily and metronidazole 400 mg three times daily) or the 14 day PPI/BDM group (rabeprazole 10 mg twice daily, and the same dose of the three other drugs as in the 14 day P-CAB/BDM group).ResultsEradication rates in the P-CAB/BDM and PPI/BDM groups were 90.4% and 71.1% (P value for superiority was 0.013), respectively, by ITT analysis. The efficacy of P-CAB/BDM remained non-inferior and even superior to PPI/BDM therapy in all ITT, modified ITT and PP analyses. The overall frequency of adverse events (39.8% and 40.4%; P = 0.911) and compliance (88.0% and 91.0%; P = 0.372) were similar between P-CAB and PPI regimens. Patients with higher body surface area were significantly associated with eradication failure in both groups (P < 0.05).ConclusionsThe 14 day P-CAB/BDM therapy provided a satisfactory eradication rate of >90% (ITT analysis) and had a good safety profile as first-line H. pylori therapy, providing an alternative option for penicillin-allergic patients.

100 Deals associated with Bismuth Tartrate

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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Colitis, Ulcerative	China	Yingxin Pharmaceutical(Shantou)Co.,Ltd.	-
Gastritis, Atrophic	China	Yingxin Pharmaceutical(Shantou)Co.,Ltd.	-
Helicobacter pylori infection	China	Yingxin Pharmaceutical(Shantou)Co.,Ltd.	-
Peptic Ulcer	China	Yingxin Pharmaceutical(Shantou)Co.,Ltd.	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


UEGW2022	Not Applicable	Helicobacter pylori infection First line	126	VAS group (vonoprazan 20 mg twice/day, amoxicillin 750 mg three times/day and S. boulardii250 mg twice/day)	(zrbsiodbhq) = zcxzmiujnf pmnsvcmhjg (ibbdevfhpi ) View more	Positive	09 Oct 2022
				PCAB group (Esomeprazole 20 mg, amoxicillin 1000 mg, clarithromycin 500 mg and bismuth 220 mg twice/day)	(zrbsiodbhq) = nwgoamusqv pmnsvcmhjg (ibbdevfhpi ) View more
HP-EUREG (UEGW2016)	Not Applicable	First line	-	Bismuth, Amoxicillin, Clarithromycin (BCA)	eemofxvsqa(dperdwauah) = Adverse events were reported in 28% of cases and caused treatment discontinuation in 1 patient nhhrtmywta (jsaznmoyui )	Positive	01 Oct 2016
				Esomeprazole