Drugs / bismuth subcitrate

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) PYLERA 2006-09-28 fda.gov

Trials 27 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 26 trials
Phase 2 NCT06510010 Dec 2024 → Dec 2026 expected chemotherapy-induced toxicity Sixth Affiliated Hospital, Sun Yat-sen University Recruiting No outcome recorded
Phase 2 NCT03968302 Jun 2018 → May 2019 Helicobacter pylori infectious disease Ziauddin University Completed No outcome recorded
Phase 2 NCT01712711 Sep 2012 → Feb 2013 NAFLD1 Tehran University of Medical Sciences Completed No outcome recorded
Phase 2 NCT01876108 Jul 2012 → Jul 2013 fatty liver disease Tehran University of Medical Sciences Completed No outcome recorded
Phase 2 NCT01654549 Apr → Sep 2012 NAFLD1 Tehran University of Medical Sciences Completed No outcome recorded
Phase 2 NCT01759628 Apr 2012 → Jun 2013 NAFLD1 Tehran University of Medical Sciences Completed No outcome recorded
Phase 33 trials
Phase 3 NCT07104318 Jul 2026 → Jun 2029 expected Helicobacter pylori infectious disease VA Office of Research and Development Not yet recruiting No outcome recorded
Phase 3 NCT04107194 Jan 2020 → Feb 2021 Helicobacter pylori infectious disease University of Bari Unknown No outcome recorded
Phase 3 NCT00712413 Aug → Dec 2008 Helicobacter pylori infectious disease Forest Laboratories Withdrawn No outcome recorded
Phase 49 trials
Phase 4 NCT06687499 Aug 2022 → Dec 2023 Helicobacter pylori infectious disease National Cheng-Kung University Hospital Completed No outcome recorded
Phase 4 NCT06687473 Jan 2022 → Mar 2023 Helicobacter pylori infectious disease National Cheng-Kung University Hospital Completed No outcome recorded
Phase 4 NCT04853875 Apr 2021 → Aug 2022 Helicobacter pylori infectious disease Mackay Memorial Hospital Completed No outcome recorded
Phase 4 NCT03299725 Nov 2017 → Nov 2019 Helicobacter pylori infectious disease Queen Fabiola Children's University Hospital Unknown No outcome recorded
Phase 4 NCT02045251 Jun 2013 → Jul 2016 American University of Beirut Medical Center Withdrawn No outcome recorded
Phase 4 NCT01906879 Jun 2013 → Dec 2017 Helicobacter pylori infectious disease National Taiwan University Hospital Unknown No outcome recorded
Phase 4 NCT03108287 Apr 2013 → Jan 2015 Helicobacter pylori infectious disease Kaohsiung Medical University Chung-Ho Memorial Hospital Completed No outcome recorded
Phase 4 NCT03146325 Nov 2012 → Jun 2016 Helicobacter pylori infectious disease The University of Texas Health Science Center, Houston Withdrawn No outcome recorded
Phase 4 NCT01335334 Mar → Jun 2011 Helicobacter pylori infectious disease The University of Texas Health Science Center, Houston Unknown No outcome recorded
Phase not applicable9 trials
NCT07010744 Jul 2025 → Jun 2026 overdue dyspepsia Akil Al Islam Enrolling by invitation No outcome recorded
NCT07260006 Oct 2024 → May 2026 overdue Helicobacter pylori infectious disease, peptic ulcer disease Can Tho University of Medicine and Pharmacy Recruiting No outcome recorded
NCT03365609 Sep 2017 → Oct 2025 overdue Helicobacter pylori infectious disease Ying HUANG Recruiting No outcome recorded
NCT03925818 Aug 2017 → Nov 2018 Helicobacter pylori infectious disease Università degli Studi di Sassari Terminated No outcome recorded
NCT03321773 Jan 2017 → Dec 2020 Helicobacter pylori infectious disease Kaohsiung Veterans General Hospital. Unknown No outcome recorded
NCT02547038 Feb 2015 → Oct 2018 Helicobacter pylori infectious disease Kaohsiung Veterans General Hospital. Completed No outcome recorded
NCT02541864 Jul 2013 → Aug 2015 Helicobacter pylori infectious disease Kaohsiung Veterans General Hospital. Completed No outcome recorded
NCT02547025 Aug 2012 → Oct 2021 Helicobacter pylori infectious disease Kaohsiung Veterans General Hospital. Completed No outcome recorded
NCT01760824 May 2011 → Oct 2012 Helicobacter pylori infectious disease The University of Hong Kong Completed No outcome recorded
Also used as a comparator or background therapy in 9 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 46 trials
Phase 4 NCT07146594 Comparator Aug 2025 → May 2026 overdue Helicobacter pylori infectious disease, active peptic ulcer disease Athens Medical Center Not yet recruiting No outcome recorded
Phase 4 NCT06509139 Comparator Jul 2024 → Jul 2032 expected Helicobacter pylori infectious disease National Cheng-Kung University Hospital Enrolling by invitation No outcome recorded
Phase 4 NCT06143124 Comparator Mar 2022 → Nov 2025 Helicobacter pylori infectious disease University Medical Centre Ljubljana Unknown No outcome recorded
Phase 4 NCT04527055 Comparator May 2020 → Jul 2028 expected Helicobacter pylori infectious disease, immune dysregulation, neurodevelopmental defects, and colitis National Cheng-Kung University Hospital Enrolling by invitation No outcome recorded
Phase 4 NCT04101708 Comparator Sep 2019 → Sep 2021 Helicobacter pylori infectious disease Shandong University Unknown No outcome recorded
Phase not applicable3 trials
NCT04359966 Comparator May 2020 → May 2023 Helicobacter pylori infectious disease Slovenian Society for Gastroenterology and Hepatology Unknown No outcome recorded
NCT04566211 Comparator Jan 2020 → Sep 2022 Helicobacter pylori infectious disease Kaohsiung Veterans General Hospital. Unknown No outcome recorded
NCT01306786 Comparator Nov 2008 → Oct 2010 Helicobacter pylori infectious disease The University of Hong Kong Completed No outcome recorded

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 36 sources stand behind the page.

FieldValueCited text
Known as bismuth subcitrate “14-day bismuth quadruple therapy (pantoprazole, bismuth subcitrate, tetracycline, and metronidazole for 14 days) or 14-day hybrid therapy (a 7-day dual therapy with...” PMID 28807915 Oct 2017
22

“BQT consists of bismuth subsalicylate 524mg QID (or bismuth subcitrate if salicylate allergy), tetracycline 500mg QID, metronidazole 500mg QID, and twice daily standard dose...” NCT07104318

“A modified and optimized bismuth quadruple therapy that comprises: 40 mg of esomeprazole bid, amoxicillin 1g tds, metronidazole 500mg tds and bismuth subcitrate 240mg bid, all...” NCT07146594

“pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days” NCT02547038

“A 14-day regimen including proton pump inhibitor (PPI; esomeprazole \[Nexium MUPS\]), bismuth subcitrate (or bismuth subsalicylate), amoxicillin, and metronidazole.” NCT07260006

“pantoprazole 40 mg twice daily, bismuth subcitrate 240 mg twice daily, and amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily for 10 days” NCT04566211

“The regimen consists of Omeprazole (20 mg/BD)+ Amoxicillin (1 g/day)+ Bismuth subcitrate (240 mg/BD)+ Azithromycin (500 mg/BD)for two weeks” NCT01759628

“The regimen consists of Omeprazole (20 mg/BD)+ Amoxicillin (1 g/day)+ Bismuth subcitrate (240 mg/BD)+ Azithromycin (500 mg/BD)for two weeks” NCT01712711

“Bismuth Quadruple therapy consists of Bismuth subcitrate 120mg QDS, Tetracycline 500mg QDS and Metronidazole 500mg TDS.” NCT07010744

“esomeprazole 20mg b.d., bismuth subcitrate 120mg q.i.d., tetracycline 250mg q.i.d. and metronidazole 250mg q.i.d.” NCT01306786

“Omeprazole (20 mg/BD)+ Amoxicillin (1 g/day)+ Bismuth subcitrate (240 mg/BD)+ Azithromycin (500 mg/BD)” NCT01654549

“rabeprazole 20mg, amoxicillin 1g and clarithromycin 500mg, bismuth subcitrate 360mg twice-daily” NCT03108287

bismuth subcitrate 120 mg q.d.s. and all the effective antibiotics) for 14 days” NCT02547025

bismuth subcitrate 240mg twice daily for 14 days” NCT03321773

Bismuth subcitrate 120mg qid” NCT01760824

NCT04107194

NCT06509139

NCT04359966

NCT01876108

NCT04853875

NCT06143124

NCT04101708

NCT04527055

Known as bismuth subcitrate potassium “Omeprazole 20 mg twice daily, in combination with bismuth subcitrate potassium (40 mg), metronidazole 125 mg and tetracycline 125 mg HCl. All patients must take 6 capsules of...” NCT00712413
4

“a capsule containing 3 agents (Pylera®) containing 125mg metronidazole, 140mg bismuth subcitrate potassium, and 125mg tetracycline was made available.” NCT02045251

“each containing 420 mg of bismuth subcitrate potassium, 375 mg of metronidazole and 375 mg of tetracycline hydrochloride” NCT03146325

NCT01335334

NCT03925818

Known as Colloidal Bismuth Pectin “bismuth subcitrate (Colloidal Bismuth Pectin) 200mg po bid” NCT04101708
Known as colloidal bismuth subcitrate “A is amoxicillin (1000 mg thrice daily), B is colloidal bismuth subcitrate (120 mg thrice daily), M is metronidazole (500 mg thrice daily), P is a proton pump inhibitor, i.e.,...” NCT06687473
7

“Quadruple therapy included colloidal bismuth subcitrate 240 mg twice daily,amoxicillin 1 gm twice a day, clarithromycin 500 mg twice a day and omeprazole is given in 40 mg...” NCT03968302

“lansoprazole 30mg bid + colloidal bismuth subcitrate 300mg tid + metronidazole 500mg tid + tetracycline 500mg tid” NCT01906879

“Omeprazole+Amoxicillin+Metronidazole+Colloidal Bismuth SubcitrateNCT03365609

“B is colloidal bismuth subcitrate (120 mg thrice daily)” NCT06687499

NCT06510010

NCT03299725

NCT02894268

Known as dibismuth trioxide “bismuth subcitrate (dibismuth trioxide) (KCB F.C. 120 mg) 1 tab four times a day” NCT04527055
1

“bismuth subcitrate (dibismuth trioxide) (KCB F.C. 120 mg)” NCT06509139

Action Inhibit “Bismuth may be able to form complexes in bacterial wall and periplasmic space, as well as inhibits enzymes, ATP synthesis and bacterial adherence to gastric mucosa.” NCT06687473
Route Oral “3 Pylera capsules b.i.d (per capsule: 125mg metronidazole, 125mg tetracycline, 140mg bismuth; i.e. 250mg metronidazole, 250 tetracycline, and 280mg bismuth b.i.d)” NCT02045251