Potassium Citrate

(Bismuth Potassium Citrate)

ApprovedSmall molecule

MMission Pharmacal

Potassium Citrate is one of 48 small molecule programs targeting Helicobacter Pylori. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Helicobacter PyloriCompleted

HELICOBACTER PYLORI INFECTIONSNot yet recruiting

AllergyCompleted

Helicobacter Pylori InfectionCompleted

Helicobacter Pylori EradicationCompleted

Helicobacter PyloriApproved

Completed

HELICOBACTER PYLORI INFECTIONSApproved

Not yet recruiting

AllergyApproved

Completed

Helicobacter Pylori InfectionApproved

Completed

Helicobacter Pylori EradicationApproved

Completed

Competition

Competitive Landscape

30 competitors in Allergy

#DrugCompanyPhaseTrials

Biaxin

AbbVie

Approved

1 2

Amoxil

GGlobal Antibiotics Research and Development Partnership

Approved

6 3

Potassium Citrate

MMission Pharmacal

Approved

1 4

Claritin

PPerrigo Company

Approved

1 5

Nexium

DDexcel Pharma Technologies Ltd.

Approved

1 6

Flagyl

DDePuy Orthopaedics

Approved

1 7

Levaquin

WWim Janssens

Approved

1 8

Achromycin V

WWyeth-Lederle Vaccines

Approved

1 9

Allegra

CChattem

Approved

1 10

Lastacaft

AbbVie

Approved

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2028

ApprovedNot yet recruiting

HELICOBACTER PYLORI INFECTIONS

NCT07750938

Clinical

Trials by Indication[1]

Helicobacter Pylori11 trials

Analysis of the Impact of Helicobacter Pylori on Salivary Microbiome in Adults

Unknown status·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT03730766·60 enrolled

Optimization of Minocycline for Helicobacter Pylori Rescue Treatment

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT06561711·480 enrolled

Tailored Therapy for Helicobacter Pylori Rescue Treatment

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT03413020·200 enrolled

Show 8 more trials

Evaluation of Saccharomyces Boulardii Combined With Standard Quadruple Therapy for Eradication of Helicobacter Pylori

Completed·HHuazhong University of Science and Technology·N/A·NCT03688828·360 enrolled

Doxycycline for Helicobacter Pylori Rescue Treatment

Recruiting·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT05874570·368 enrolled

Tailored Versus Empiric Therapy for Helicobacter Pylori Treatment

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT02935010·382 enrolled

High Dose of Amoxicillin and Metronidazole Plus Bismuth For Helicobacter Pylori Treatment

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT03557437·216 enrolled

High Dose of Dual Therapy Plus Bismuth for Helicobacter Pylori Treatment

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT03405584·160 enrolled

A Study of Vonoprazan in Adults With Helicobacter Pylori

Completed· Takeda logo

Takeda·Phase 1·NCT04753437·44 enrolled

Rifabutin-containing Triple Therapy for Treatment of Helicobacter Pylori

Completed·SShanghai Jiao Tong University School of Medicine·N/A·NCT04879992·413 enrolled

The Evaluation of Triple Therapy With Vonoprazan, Amoxicillin and Bismuth for Eradication of Helicobacter Pylori

Unknown status·HHuazhong University of Science and Technology·N/A·NCT05189444·672 enrolled

Helicobacter Pylori Infection4 trials

A Study to Evaluate the Efficacy and Safety of Bismuth-Containing Quadruple Therapy With Oral Vonoprazan (TAK-438) 20 mg Compared to Esomeprazole 20 mg Twice Daily in Paticipants With Helicobacter Pylori Infection

Completed· Takeda logo

Takeda·Phase 3·NCT04198363·510 enrolled

High Dose Amoxicillin Versus Tetracycline as Second-line Treatment of Resistant Helicobacter Pylori Infection

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT02175927·312 enrolled

High-dose Dual Therapy and Minocycline-cotaining Quadruple Therapy for Helicobacter Pylori Infection

Recruiting·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT06561698·200 enrolled

Show 1 more trial

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

Withdrawn·SShanghai Zhongshan Hospital·Approved·NCT05250050

Helicobacter Pylori Eradication4 trials

Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication

Completed·SShandong University·Phase 4·NCT05049902·1,300 enrolled

Amoxicillin/Metronidazole Based Quadruple Therapy for Helicobacter Pylori Eradication

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT02175901·215 enrolled

Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication: A Randomized Clinical Trial of 10 and 14 Days

Unknown status·SShandong University·Phase 4·NCT04901117·1,300 enrolled

Show 1 more trial

Helicobacter Pylori Eradication and Follow-up

Recruiting·SShanghai Zhongshan Hospital·Phase 4·NCT05061732·4,447 enrolled

First-line Treatment3 trials

Clarithromycin Triple Therapy Plus Bismuth for Helicobacter Pylori First-line Treatment

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT02732249·66 enrolled

Bismuth-containing Quadruple Therapy for Helicobacter Pylori First-line Treatment of Different Tetracycline Doses

Completed·SShandong University·Phase 4·NCT05431075·406 enrolled

Bismuth-Metronidazole Triple Therapy for H. Pylori First-line Treatment

Unknown status·SShanghai Zhongshan Hospital·Phase 4·NCT04667299·270 enrolled

Rescue Therapy for Helicobacter Pylori2 trials

Rescue Therapy for Helicobacter Pylori Eradication Treatment

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT04531059·368 enrolled

Rescue Therapy for Helicobacter Pylori Infection

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT05874544·360 enrolled

10 more indications

H Pylori Infection1 trial

Efficacy and Safety of Rifasutenizol (TNP 2198), Rabeprazole and Amoxicillin in Participants With H. Pylori Infection

Completed·TTenNor Therapeutics (Suzhou) Limited·Phase 3·NCT05857163·700 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Tegoprazan and Minocycline Dual Therapy for Helicobacter Pylori Initial Treatment

Active, not recruiting·XXijing Hospital of Digestive Diseases·Phase 4·NCT06523764·208 enrolled

Bismuth Quadruple Therapy1 trial

Vonoprazan-containing Triple Therapy Versus Empiric Bismuth Quadruple Therapy for First-line Helicobacter Pylori Treatment: a Randomized Clinical Trial

Unknown status·SShanghai East Hospital·Phase 4·NCT05726734·100 enrolled

Treatment1 trial

PPI-amoxicillin for H. Pylori Treatment

Unknown status·SShanghai Zhongshan Hospital·Phase 4·NCT05014685·732 enrolled

Allergy1 trial

Tailored Therapy for Helicobacter Pylori Treatment in Patients With Penicillin Allergy

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT03708848·112 enrolled

Antibiotic1 trial

Antibiotic Combination for H. Pylori Eradication in Penicillin-allergic Patients

Unknown status·SShanghai Zhongshan Hospital·Phase 4·NCT05023577·504 enrolled

Interaction1 trial

Drug Interaction Study on Linaprazan Glurate Capsules

Completed·JJiangsu Sinorda Biomedicine Co., Ltd·Phase 1·NCT07294846·56 enrolled

AIN1 trial

Efficiency Study of Clarithromycin and Bismuth-containing Quadruple Therapy to Treat H.Pylori

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT01667575·180 enrolled

HELICOBACTER PYLORI INFECTIONS1 trial

Intensified Acid Suppression Strategy for Optimizing Helicobacter Pylori Eradication Regimen Duration and Drug Combination: A Multicenter, Open-Label, Randomized Controlled Trial

Not yet recruiting·QQilu Hospital of Shandong University·Approved·NCT07750938·316 enrolled

Unspecified1 trial

Tetracycline Versus Doxycycline for HP Rescue Therapy

Unknown status·SShanghai Zhongshan Hospital·Phase 4·NCT05018923·242 enrolled

Regulatory

FDA Approval Timeline[4]

Aug 30, 1985

UROCIT-K

NDA NDA019071

Oct 13, 1988

POTASSIUM CITRATE

NDA NDA019647

Sources

References

[1]
ClinicalTrials.gov — 34 trial records for Bismuth Potassium Citrate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Bismuth Potassium Citrate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Bismuth Potassium Citrate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA019647). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Mission Pharmacal company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: MMission Pharmacal

Potassium Citrate

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2028

Trials by Indication[1]

Helicobacter Pylori11 trials

Helicobacter Pylori Infection4 trials

Helicobacter Pylori Eradication4 trials

First-line Treatment3 trials

Rescue Therapy for Helicobacter Pylori2 trials

H Pylori Infection1 trial

Efficacy and Safety1 trial

Bismuth Quadruple Therapy1 trial

Treatment1 trial

Allergy1 trial

Antibiotic1 trial

Interaction1 trial

AIN1 trial

HELICOBACTER PYLORI INFECTIONS1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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