TheraRadar
Data updated: May 26, 2026

BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE (bismuth subsalicylate)

Trial Activity: Mature
Gastrointestinal Approved 2018-11-30

BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE is indicated for the treatment of Traveler's Diarrhea; Diarrhea; Upset Stomach; Heartburn; Indigestion; Nausea; Gas.

Source: FDA Label • AILEX PHARMS LLC
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

Development Insights

Centers for Disease Control and Prevention conducting 1 trials (20%)
7 indications explored (Moderate)
→ diarrhea travelers (1 trials)
→ antibiotic resistant infection (1 trials)
→ healthy adults (1 trials)
1
Indication
--
Phase 3 Trials
7
Years on Market

Details

Status
Prescription
First Approved
2018-11-30
Routes
ORAL
Dosage Forms
TABLET, CHEWABLE, TABLET, CAPSULE

Companies

AILEX PHARMS LLC
Active Ingredient: BISMUTH SUBSALICYLATE , METRONIDAZOLE , TETRACYCLINE HYDROCHLORIDE

BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE Approval History

2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
5 FDA actions from 2018 to 2025
Mar 2025 SUPPL
Label · Labeling
Jul 2024 SUPPL
Label · Labeling
Dec 2021 SUPPL
Label · Labeling

What BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE Treats

7 indications

BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE is approved for 7 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Traveler's Diarrhea
  • Diarrhea
  • Upset Stomach
  • Heartburn
  • Indigestion
  • Nausea
  • Gas
Source: FDA Label

BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

BYNFEZIA PEN
Sun Pharma
2024 5 indic.
PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE
Baxter
2024 4 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE

3 of 20

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AKYNZEO
NETUPITANT
1 shared
HELSINN HLTHCARE
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ALOSETRON HYDROCHLORIDE
ALOSETRON HYDROCHLORIDE
1 shared
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Clinical Trial Registry

5 trials
Trial Sponsor ID Phase Status Title
NCT03535272 results posted 7082 Ph 3 terminated Bismuth Subsalicylate's Role in the Prevention of Travelers' Diarrhea
NCT05930197 results posted 10001631 001631-I Ph 1 completed Effect of Bismuth Subsalicylate on the Gut Microbiome and Host Response in Healthy Adults
NCT03757650 ANIL ERGIN Ph 4 completed THE EFFECT OF HELICOBACTER PYLORI ERADICATION THERAPY TO GASTRIC WALL THICKNESS BEFORE THE LAPAROSCOPIC SLEEVE GASTRECTOMY
NCT03592082 2089 Ph 4 withdrawn Use of Bismuth Subsalicylate in Clostridium Difficile Colitis
NCT01742429 rjkls2012008 Ph 4 completed Levofloxacin and Bismuth-containing Therapy Versus Quadruple Therapy as Second-line Treatment of Resistant Helicobacter Pylori Infection
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE FDA Label Details

Indications & Usage

BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE is indicated for the treatment of Traveler's Diarrhea; Diarrhea; Upset Stomach; Heartburn; Indigestion; Nausea; Gas.

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Data Sources

FDA Approval: ANDA202584 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment