Amoxil

(Amoxicillin)

ApprovedSmall molecule

GGlobal Antibiotics Research and Development Partnership

Amoxicillin is an antibiotic used to treat bacterial infections such as ear infections, strep throat, pneumonia, and urinary tract infections. It works by killing bacteria that cause these infections.[2] Amoxil is currently approved and in use across 81 indications[4].[1]

Amoxil is one of 697 small molecule programs targeting Helicobacter Pylori Infection. It is currently in Approved.

Indications

262

Total Trials

Active Trials

696

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Helicobacter Pylori InfectionCompleted

Helicobacter Pylori EradicationCompleted

Head and Neck Malignant NeoplasiaApproved

Helicobacter Pylori Infectious DiseaseApproved

Infective EndocarditisApproved

ObesityApproved

Commensal Clostridium Infectious DiseaseApproved

CholecystitisApproved

Gastric Diffuse Large B-Cell LymphomaApproved

Response to PenicillinApproved

Helicobacter Pylori InfectionApproved

Completed

Helicobacter Pylori EradicationApproved

Completed

Head and Neck Malignant NeoplasiaApproved

Approved

Helicobacter Pylori Infectious DiseaseApproved

Approved

Infective EndocarditisApproved

Approved

ObesityApproved

Approved

Commensal Clostridium Infectious DiseaseApproved

Approved

CholecystitisApproved

Approved

Gastric Diffuse Large B-Cell LymphomaApproved

Approved

Response to PenicillinApproved

Approved

Showing 10 of 78 indications

Competition

Competitive Landscape

309 competitors in COVID-19

#DrugCompanyPhaseTrials

Amoxil

GGlobal Antibiotics Research and Development Partnership

Approved

1 2

Stivarga

Bayer

Preclinical

1 3

Aimovig

Amgen

Preclinical

1 4

Aldactone

Pfizer

Preclinical

1 5

Nexavar

Bayer

Preclinical

1 6

Calciferol

Activella

Angiomax

BBaxter Healthcare Corporation

Preclinical

2 9

Tricor

JJagotec

Preclinical

1 10

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

PPROM

NCT06396078

Phase 3Recruiting

Allergy

NCT06303128

Not yet recruiting

Helicobacter Pylori Infection

NCT06731023

Q1 2027

Post-ApprovalRecruiting

Antibiotic Prophylaxis

NCT06709196

Q2 2027

Phase 3Recruiting

Pneumonia

NCT06229288

Phase 2/3Recruiting

Pneumonia

NCT03031210

Clinical

Trials by Indication[1]

Helicobacter Pylori Eradication18 trials

Vonoprazan for Helicobacter Pylori Eradication in Adolescents

Completed·—·Phase 3·NCT06162949·242 enrolled

Amoxicillin/Metronidazole Based Quadruple Therapy for Helicobacter Pylori Eradication

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

Efficacy and Safety of Vonoprazan as First-line Treatment for Helicobacter Pylori Eradication

Unknown status·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 4·NCT04907747·234 enrolled

Show 15 more trials

Comparison of the Efficacies of Two Novel Dose Dual Therapies in the First-line Helicobacter Pylori Eradication

Unknown status·—·Phase 3·NCT06811207·300 enrolled

Efficacy and Safety of Dual Therapy for Helicobacter Pylori Eradication

Completed·NNanjing First Hospital, Nanjing Medical University·Phase 4·NCT05469685·914 enrolled

Helicobacter Pylori Eradication With Berberine Plus Amoxicillin Triple Therapy Versus Bismuth-containing Quadruple Therapy

Completed·XXijing Hospital of Digestive Diseases·Phase 4·NCT04697186·524 enrolled

Effectiveness of Minocycline-Containing Bismuth Quadruple Therapy for Helicobacter Pylori Eradication

Unknown status·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 4·NCT04558502·339 enrolled

The Efficacy and Safety of Keverprazan for Helicobacter Pylori Eradication

Not yet recruiting·NNanjing First Hospital, Nanjing Medical University·Phase 1·NCT06777732·672 enrolled

Efficacy and Safety Evaluation of Levofloxacin Triple Therapy for Helicobacter Pylori Eradication

Completed·DDeva Holding A.S.·Phase 3·NCT01131026·60 enrolled

Efficacy Comparison of Vonoprazan Combined With Different Antibiotics in Dual Therapy for Helicobacter Pylori Eradication: A Prospective, Randomized Controlled Clinical Trial

Recruiting·YYongquan Shi·Phase 4·NCT07068607·400 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

Helicobacter Pylori Eradication and Follow-up

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

A Study to Evaluate Preliminary Helicobacter Pylori Eradication After Multiple Doses of TNP-2198 Capsules Combined With Rabeprazole Sodium Enteric-coated Tablets, or Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules

Completed·TTenNor Therapeutics (Suzhou) Limited·Phase 1/2·NCT06076681·40 enrolled

Helicobacter Pylori Eradication With Probiotics Combined With Triple Therapy Versus Bismuth-containing Quadruple Therapy

Completed·XXijing Hospital of Digestive Diseases·Phase 4·NCT05237115·600 enrolled

Helicobacter Pylori Eradication With Berberine Quadruple Therapy Versus Clarithromycin Quadruple Therapy

Completed·XXijing Hospital of Digestive Diseases·Phase 4·NCT02633930·566 enrolled

Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication

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

Effects of High-dose Dual Therapy and Bismuth Quadruple Therapy for Helicobacter Pylori Eradication on Intestinal Microecology

Completed·XXijing Hospital of Digestive Diseases·Phase 4·NCT05742568·124 enrolled

Helicobacter Pylori Eradication With Berberine Quadruple Therapy Versus Bismuth-containing Quadruple Therapy

Completed·XXijing Hospital of Digestive Diseases·Phase 4·NCT02296021·612 enrolled

Pneumonia18 trials

3 Days Versus 5 Days Amoxicillin for Chest-indrawing Childhood Pneumonia in Malawi

Completed·SSave the Children·Phase 4·NCT02678195·3,000 enrolled

Twice Daily Treatment With Amoxicillin for Non-severe Community Acquired Pneumonia.

Recruiting·SSt. Justine's Hospital·Phase 2/3·NCT03031210·1,370 enrolled

Amoxicillin Versus Benzyl Penicillin for Treatment of Children Hospitalised With Severe Pneumonia

Completed·KKEMRI-Wellcome Trust Collaborative Research Program·Phase 3·NCT01399723·561 enrolled

Show 15 more trials

Efficacy of High Doses Penicillin V Versus High Doses Amoxicillin in the Treatment of Non-severe Pneumonia.

Terminated·FFundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina·Phase 3·NCT03208361·43 enrolled

The Norwegian Antibiotics for Pneumonia in Children Study

Unknown status·OOslo University Hospital·Phase 4·NCT03446534·884 enrolled

Study to Compare the Efficacy of Pristinamycin (Pyostacine ®) Versus Amoxicillin in the Treatment of Acute Community Acquired Pneumonia

Terminated· Sanofi logo

Sanofi·Phase 4·NCT02332577·161 enrolled

Procalcitonin to Reduce Antibiotic Use in Pediatric Pneumonia

Completed·—·Phase 1·NCT04963764·5 enrolled

Community Case Management of the Severe Pneumonia With Oral Amoxicillin in Children 2-59 Months of Age

Completed·—·N/A·NCT01192789·4,070 enrolled

Trial to Evaluate Beta-Lactam Antimicrobial Therapy of Community Acquired Pneumonia in Children

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 4·NCT02891915·385 enrolled

3 Days Amoxicillin Versus Placebo for Fast Breathing Childhood Pneumonia in Malawi

Completed·SSave the Children·Phase 4·NCT02760420·1,126 enrolled

Clinical Efficacy of Amoxicillin Given Twice or Three Times a Day Among Children With Non-severe Pneumonia

Completed·FFederal University of Bahia·Phase 4·NCT01200706·820 enrolled

Amoxicillin Alone Versus Amoxicillin/Clavulanate for Community-acquired Pneumonia in Patients Aged 65 Years or Older, and Hospitalized in a Non-intensive Care Unit Ward

Recruiting·NNantes University Hospital·Phase 3·NCT06229288·326 enrolled

Optimizing Care for Children Hospitalized With Community-acquired Pneumonia: Short-course Therapy

Recruiting·JJeffrey·Phase 4·NCT06125340·75 enrolled

Cotrimoxazole Versus Amoxicillin in the Treatment of Community Acquired Pneumonia in Children Aged 2-59 Months

Completed·MMakerere University·Phase 3·NCT00933049·505 enrolled

Trial of Amoxicillin Compared With Placebo for Pneumonia in Children Aged 2-59 Months

Completed·PPakistan Institute of Medical Sciences·N/A·NCT00851487·900 enrolled

Randomized Trial of Amoxicillin Versus Placebo for (Fast Breathing) Pneumonia

Completed·—·N/A·NCT02372461·4,000 enrolled

Equivalency Of Oral Amoxicillin Vs Injectable Penicillin In Children With Severe Pneumonia

Completed·—·N/A·NCT00227331

Efficacy of Single Versus Double Dose of Oral Amoxicillin for Non-Severe Pneumonia in Children

Completed·AARI Research Cell·Phase 1/2·NCT00130013·900 enrolled

Helicobacter Pylori Infection16 trials

Levoﬂoxacin and Bismuth-containing Therapy Versus Quadruple Therapy as Second-line Treatment of Resistant Helicobacter Pylori Infection

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT01742429·200 enrolled

Intraluminal Amoxicillin Powder Monotherapy for Helicobacter Pylori Infection

Completed·MMackay Memorial Hospital·Phase 4·NCT03521726·20 enrolled

The Effect of Vitamin D Supplement as Adjuvant Therapy in Eradication of Helicobacter Pylori Infection

Not yet recruiting·—·Phase 3·NCT06964334·70 enrolled

Show 13 more trials

Intraluminal Therapy for Helicobacter Pylori Infection

Completed·MMackay Memorial Hospital·Phase 4·NCT03124420·100 enrolled

Quadruple vs Tailored Therapy in the Treatment of Helicobacter Pylori Infection

Completed·UUniversity of Split, School of Medicine·N/A·NCT04621487·80 enrolled

Efficacy of a 14-Day Bismuth-Containing Quadruple Therapy Guided by Drug Susceptibility Testing in Patients with Extremely Refractory Helicobacter Pylori Infection: an Exploratory Study

Not yet recruiting·XXiuli Zuo··NCT06731023·30 enrolled

Efficacy of Therapy Based on Fecal Molecular Antimicrobial Susceptibility Tests for Helicobacter Pylori Infection

Unknown status·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 4·NCT05718609·855 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

Comparison of Two Dual Therapies in the First-line Treatment of Helicobacter Pylori Infection （SHARE2301）

Unknown status·YYanqing Li·N/A·NCT05870683·368 enrolled

Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Helicobacter Pylori Infection

Completed·PPhathom Pharmaceuticals, Inc.·Phase 3·NCT04167670·1,046 enrolled

Empirical Rescue Therapies of Helicobacter Pylori Infection

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT01668927·424 enrolled

Esomeprazole, Moxifloxacin and Amoxicilin for Rescue Therapy of Helicobacter Pylori Infection

Unknown status·TTechnische Universität Dresden·Phase 3·NCT00455806·132 enrolled

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

The Effects of a Synbiotic Addition on Eradication Therapy of Helicobacter Pylori Infection in Children

Completed·—·N/A·NCT03165253·69 enrolled

A RCT of the Efficacy of Vonoprazan 20mg QD in the Treatment of Helicobacter Pylori Infection

Unknown status·FFirst People's Hospital of Hangzhou·Phase 4·NCT05590286·100 enrolled

Non-invasive Test-guided Tailored Therapy Versus Empiric Treatment for Helicobacter Pylori Infection.

Unknown status·UUniversity of Bari·Phase 3·NCT04107194·362 enrolled

Helicobacter Pylori11 trials

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

Optimization of Keverprazan-amoxicilli Dual Therapy for Helicobacter Pylori

Not yet recruiting·NNanjing First Hospital, Nanjing Medical University·Phase 4·NCT06412640·268 enrolled

Show 8 more trials

Antimicrobial Susceptibility Testing Guided Triple Therapy in Salvage Helicobacter Pylori Treatment

Unknown status·YYanqing Li·Phase 4·NCT03139253·120 enrolled

Bismuth Improves the Efficacy of Levofloxacin-containing Triple Therapy for Helicobacter Pylori Treatment

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT01667718·161 enrolled

The Effect of Broccoli Sprout Extract and Probiotics for Eradication of Helicobacter Pylori

Unknown status·KKyunghee University Medical Center·Phase 4·NCT03220542·360 enrolled

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

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

Keverprazan Combined with Amoxicillin for the Treatment of Helicobacter Pylori

Not yet recruiting·KKey Laboratory for Gastrointestinal Diseases of Gansu Province·N/A·NCT06851468·264 enrolled

Effectiveness of Rifabutin for Treatment of Helicobacter Pylori

Unknown status·RRabin Medical Center·Phase 3·NCT04652284·300 enrolled

The Epidemiology and Optimal Treatment of Helicobacter Pylori in Myanmar

Completed·KKirby Institute·Phase 4·NCT04132479·313 enrolled

Malnutrition5 trials

Modified Dosage for Severe Acute Malnutrition

Recruiting·AAction Against Hunger USA·N/A·NCT06061484·2,400 enrolled

Azithromycin for Severe Acute Malnutrition in CMAM, Nigeria

Terminated·UUniversity of California, San Francisco·Phase 3·NCT05473234·310 enrolled

Pilot Study of PUFA-optimized RUTF for Severe Acute Malnutrition

Completed·WWashington University School of Medicine·N/A·NCT02053857·141 enrolled

Show 2 more trials

Azithromycin for Uncomplicated Severe Acute Malnutrition in Burkina Faso (Pilot)

Completed·UUniversity of California, San Francisco·Phase 3·NCT03568643·301 enrolled

Azithromycin as Adjunctive Treatment for Uncomplicated Severe Acute Malnutrition

Recruiting·UUniversity of California, San Francisco·Phase 4·NCT06010719·3,000 enrolled

79 more indications

H Pylori Infection5 trials

Genotypic Resistance Guided Therapy for Refractory H. Pylori Infection

Unknown status·NNational Taiwan University Hospital·Phase 4·NCT03555526·320 enrolled

Feasibility Study of the Proposed Test-and-treat Screening Program in Younger Participants With H. Pylori Infection

Unknown status·NNational Institute of Public Health, Slovenia··NCT06216639·2,000 enrolled

High Dose Dual Therapy vs Clarithromycin Triple Therapy for Treatment Naive H Pylori Infection in an Urban Population

Completed·IIcahn School of Medicine at Mount Sinai·Phase 4·NCT05342532·112 enrolled

Show 2 more trials

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

Comparison of Omeprazole vs Vonoprazon in Treatment of H Pylori Infection

Not yet recruiting·RRehman Medical Institute - RMI·Phase 4·NCT07040839·128 enrolled

Antibiotic Prophylaxis4 trials

Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis

Recruiting·RRigshospitalet, Denmark·Phase 4·NCT06709196·248 enrolled

A New Antibiotic Prophylaxis Regimen to Prevent Bacteremia Following Dental Procedures

Completed·UUniversity of Santiago de Compostela·N/A·NCT02115776·266 enrolled

The Effect of Antibiotic Prophylaxis Associated With Dental Implant Surgery

Completed·MMalmö University·Phase 4·NCT03412305·474 enrolled

Show 1 more trial

Evaluation of the Effect of Antibiotic Prophylaxis (2g Amoxicillin One Hour Before Surgery) on an Inflammatory Factor (PGE2) in Salivary Samples After Third Molars Surgery

Completed·—·Phase 4·NCT06613776·18 enrolled

Efficacy and Safety4 trials

Study on The Efficacy and Safety of Berberine-containing Triple Therapy in Helicobacter Pylori First-Line Eradication

Completed·XXijing Hospital of Digestive Diseases·Phase 4·NCT05014334·300 enrolled

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

Study on The Efficacy and Safety of Vonoprazan-containing Berberine Triple Therapy in Helicobacter Pylori First-Line Eradication

Completed·XXijing Hospital of Digestive Diseases·Phase 4·NCT06514274·558 enrolled

Show 1 more trial

Study to Evaluate the Efficacy and Safety of DWP14012-based Triple Therapy in Eradication of Helicobacter Pylori

Completed· Daewoong Pharmaceutical Co. LTD. logo

Daewoong Pharmaceutical Co. LTD.·Phase 3·NCT06751121·461 enrolled

Interaction4 trials

TAK-438 Bismuth Drug Interaction Study

Completed· Takeda logo

Takeda·Phase 1·NCT02892409·30 enrolled

The PK and PD Interaction Between YH4808, Amoxicillin and Clarithromycin in Healthy Subjects

Completed·YYuhan Corporation·Phase 1·NCT01921647·95 enrolled

Pharmacokinetic Interactions of Quadruple Therapy With Anaprazole/Amoxicilin/Clarithromycin/Bismuth

Unknown status·SSihuan Pharmaceutical Holdings Group Ltd.·Phase 1·NCT04444011·32 enrolled

Show 1 more trial

Drug Interaction Study on Linaprazan Glurate Capsules

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

Antibiotic4 trials

Short Versus Standard of Care Antibiotic Duration for Children Hospitalized for CAP

Recruiting·MMedical College of Wisconsin·Phase 4·NCT06494072·236 enrolled

A Comparative, Single-Center, Pediatric Taste Test Study of Omnicef Versus Amoxicillin Antibiotic Suspension Medications

Completed·AAbbott·Phase 4·NCT00645125·154 enrolled

Alternative Antibiotic Regime in the Treatment of GAgP

Completed·KKocaeli University·Phase 4·NCT02223702·39 enrolled

Show 1 more trial

Pediatric Taste Test Study of Cefdinir (Omnicef) Versus Amoxicillin Antibiotic Suspension Medications

Completed·AAbbott·Phase 4·NCT00644891·158 enrolled

Antibiotics4 trials

Shaping the Indications for Periodontal Adjunctive Antibiotics in Dental Practice

Recruiting·RRutgers, The State University of New Jersey·Phase 3·NCT06131021·150 enrolled

Microbial, Immune, and Metabolic Perturbations by Antibiotics (MIME Study)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT02707042·108 enrolled

Accuracy and Consequences of Using Trial-of-antibiotics for TB Diagnosis (ACT-TB Study)

Completed·LLondon School of Hygiene and Tropical Medicine·Phase 3·NCT03545373·1,583 enrolled

Show 1 more trial

Antibiotics In Modic Changes

Completed·OOslo University Hospital·Phase 3·NCT02323412·180 enrolled

Sinusitis4 trials

Effectiveness and Safety of Once or Twice Daily Mometasone Nasal Spray Versus Amoxicillin Versus Placebo for Treatment of Acute Rhinosinusitis (Study P02683)

Completed·OOrganon and Co·Phase 2·NCT00750750·981 enrolled

Effectiveness and Safety of Once or Twice Daily Mometasone Nasal Spray Versus Amoxicillin Versus Placebo for Treatment of Acute Rhinosinusitis (Phase 3 Study)(Study P02692)

Completed·OOrganon and Co·Phase 3·NCT00751075·981 enrolled

Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets Versus Amoxicillin-Clavulanate for the Treatment of Acute Bacterial Sinusitis

Completed·AAbbott·Phase 3·NCT00644553·437 enrolled

Show 1 more trial

Treatment of Acute Sinusitis With High-Dose vs. Standard-Dose Amoxicillin/Clavulanate

Terminated·PPaul Sorum, MD·Phase 4·NCT03431337·157 enrolled

Complication4 trials

The Effect of Routine Antibiotic Use in the Outpatient Treatment of Severely Malnourished Children Without Complications

Completed·EEpicentre·N/A·NCT01613547·2,412 enrolled

The Effect of Systemic Antibiotics on Post-surgical Complications and Patient-centered Outcomes in Patients Undergoing Implant Surgery With Guided Bone Regeneration and Simultaneous Sinus Floor Elevation

Recruiting·MMedical University of Graz·Phase 4·NCT04552080·30 enrolled

Complications After Lower Third Molar Surgery

Completed·UUniversity of Zagreb·Phase 1/2·NCT03130933·400 enrolled

Show 1 more trial

Preoperative Dose of Co-amoxiclav for Prevention of Postoperative Complications in Dentoalveolar Surgery

Unknown status·TTaibah University·N/A·NCT03844776·135 enrolled

First-line Treatment3 trials

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

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

Efficacy and Safety of Dual Therapy as First-line Treatment for Hp Infection

Unknown status·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 4·NCT05419674·393 enrolled

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

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

Dyspepsia3 trials

Melatonin Supplementation in Postmenopausal Women With H. Pylori-associated Dyspepsia

Completed·MMedical University of Lodz·N/A·NCT04352062·152 enrolled

Helicobacter Pylori Eradication in Functional Dyspepsia

Completed·SSir Ganga Ram Hospital·N/A·NCT04697641·202 enrolled

Assessment and Management of Chronic Dyspepsia in Eastern Uganda

Completed·WWashington University School of Medicine·Phase 1·NCT04525664·376 enrolled

Treatment3 trials

PPI-amoxicillin for H. Pylori Treatment

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

Treatment of Antenatal Chlamydia Infection

Completed·OObafemi Awolowo University Teaching Hospital·Phase 2·NCT01946256·220 enrolled

Comparative Efficacy of Single-dose Doxycycline Versus Standard 5- Day Amoxicillin Treatment

Completed·IInstitut de Recherche pour le Developpement·Phase 4·NCT03765931·274 enrolled

Allergy3 trials

Penicillin Allergy De-Labelling in Elective Surgical Patients (PADLES)

Completed·TThe Leeds Teaching Hospitals NHS Trust·N/A·NCT03607734·150 enrolled

Penicillin Allergy Delabeling After a One-Dose Versus Two-Dose Graded Direct Oral Challenge

Recruiting·JJames Tarbox, MD·Phase 3·NCT06303128·380 enrolled

Oral Penicillin Challenge and Allergy De-labeling in Children

Terminated·PPhoenix Children's Hospital·Phase 4·NCT05563610·31 enrolled

Aggressive Periodontitis2 trials

Periodontal Debridement Associated With Systemic Antibiotics and Single/Repeated PDT to Treat Aggressive Periodontitis

Completed·UUniversidade Estadual Paulista Júlio de Mesquita Filho·Phase 2/3·NCT03132714·46 enrolled

Two Different Antibiotic Agents to Treat Generalized Aggressive Periodontitis

Completed·UUniversidade Estadual Paulista Júlio de Mesquita Filho·Phase 2/3·NCT02969928·46 enrolled

Helicobacter2 trials

Helicobacter Rescue Therapy With High-dose Esomeprazole and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy

Completed·XXijing Hospital of Digestive Diseases·Phase 4·NCT04678492·658 enrolled

Helicobacter Rescue Therapy With Berberine Plus Amoxicillin Quadruple Therapy Versus Tetracycline Plus Furazolidone Quadruple Therapy

Completed·XXijing Hospital of Digestive Diseases·Phase 4·NCT03609892·658 enrolled

Gut Microbiota2 trials

Effects of Phenoximethylpenicillin, Amoxicillin and Amoxicillin-clavulanic Acid on the Gut Microbiota

Completed·UUppsala University·Phase 4·NCT04084106·104 enrolled

Effects of Pre-, Pro- & Anti-biotics on Gut Microbiota

Completed·—·N/A·NCT01414010·32 enrolled

Chronic Periodontitis2 trials

Dose and Duration of Metronidazole and Amoxicillin for Treatment of Chronic Periodontitis

Unknown status·UUniversity of Guarulhos·Phase 4·NCT02735395·110 enrolled

Antibiotic and Probiotic Therapies in the Adjuvant Treatment of the Chronic Periodontitis.

Completed·UUniversidade Estadual Paulista Júlio de Mesquita Filho·N/A·NCT03692819·45 enrolled

Acute otitis media2 trials

A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media

Completed·AAbbott·Phase 4·NCT00644943·425 enrolled

Effect of Antimicrobial Treatment of Acute Otitis Media on the Intestinal Microbiome in Children

Completed·UUniversity of Oulu·Phase 4·NCT02935374·73 enrolled

Pharyngitis2 trials

Once-daily Therapy for Streptococcal Pharyngitis

Completed·—·Phase 1·NCT01310361

Treatment of Group A Beta Hemolytic Streptococcal Pharyngitis in Children in Low Resource Settings

Completed·JJohns Hopkins University·N/A·NCT01156740·558 enrolled

Pediatric2 trials

Penicillin De-labeling in the Pediatric Primary Care Setting

Completed·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT05010304·23 enrolled

Oral Challenge in the Pediatric ED

Completed·MMedical College of Wisconsin·Phase 4·NCT03404804·116 enrolled

Second-line Treatment2 trials

Long-term Follow up Helicobacter Pylori Reinfection Rate After Second-Line Treatment: Bismuth-Containing Quadruple Therapy Versus Moxifloxacin-Based Triple Therapy

Completed·SSeoul National University Bundang Hospital·Phase 4·NCT01792700·648 enrolled

Sequential Versus Quadruple Therapy in the Second-line Treatment

Unknown status·NNational Taiwan University Hospital·Phase 4·NCT03208426·240 enrolled

Tonsillitis2 trials

Evaluation of Inflammatory Symptoms Reduction With Amoxicillin + Ketoprofen in Acute Pharyngeal Tonsillitis in Pediatric Patients

Terminated· Sanofi logo

Sanofi·Phase 4·NCT00799838·106 enrolled

Efficacy Study of Pristinamycin Versus Amoxicillin to Treat Tonsillitis Induced by Streptococcus in Children

Completed· Sanofi logo

Sanofi·Phase 3·NCT00393744·395 enrolled

Randomized Controlled Trial2 trials

Tegoprazan-Based Therapies for H. Pylori Eradication: A Randomized Controlled Trial

Completed·ZZhongshan Hospital (Xiamen), Fudan University·N/A·NCT06977841·640 enrolled

Antibiotic Prophylaxis Versus Placebo in Alveolar Bone Grafting: A Randomized Controlled Trial

Not yet recruiting·AAgnaldo Rocha de Souza Junior·N/A·NCT07296302·150 enrolled

Dental Implant2 trials

Comparison of Three Antibiotic Protocols in Prevention of Infection in Dental Implant Surgery

Completed·SShiraz University of Medical Sciences·N/A·NCT04620018·450 enrolled

Comparison Between Two Different Antibiotic Regimens for the Placement of Dental Implants

Completed·UUniversité de Montréal·Phase 1·NCT01851681·42 enrolled

Lymphoma2 trials

Helicobacter - Lymphoma - Radiation Part I: Eradication, Part II: Radiation

Unknown status·TTechnische Universität Dresden·Phase 3·NCT00154440·200 enrolled

Antibiotic Therapy in Treating Patients With Low Grade Gastric Lymphoma

Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT00003151·96 enrolled

Gut Microbiome2 trials

Effect of Antibiotics on Gut Microbiome and Plasma Metabolome

Completed·FFinnish Institute for Health and Welfare·Phase 4·NCT03273296·39 enrolled

Impact of Non-surgical Periodontal Therapy on Oral and Gut Microbiome

Unknown status·UUniversity of Campinas, Brazil·Phase 4·NCT04580355·30 enrolled

Gingival Recession2 trials

Biofunctionalization of a Volume-stable Collagen Matrix (VCMX) for the Treatment of Single Gingival Recession

Unknown status·UUniversidade Estadual Paulista Júlio de Mesquita Filho·N/A·NCT05916742·75 enrolled

Use of a Novel Volume-stable Collagen Matrix (VCMX) in the Treatment of Single Gingival Recession Associated With Non-carious Cervical Lesion Partially Restored

Unknown status·UUniversidade Estadual Paulista Júlio de Mesquita Filho·N/A·NCT05916716·50 enrolled

Endocarditis1 trial

Oral Switch During Treatment of Left-sided Endocarditis Due to Multi-susceptible Streptococcus

Completed·UUniversity Hospital, Tours·Phase 3·NCT02701595·324 enrolled

Respiratory Infections1 trial

Short-course Antimicrobial Therapy for Paediatric Respiratory Infections

Completed·HHamilton Health Sciences Corporation·Phase 4·NCT02380352·281 enrolled

Rescue Therapy for Helicobacter Pylori1 trial

Rescue Therapy for Helicobacter Pylori Infection

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

Cirrhosis1 trial

Empirical vs 2nd Line Antibiotic Therapy in Health-care Associated Infections in Cirrhosis

Unknown status·UUniversity of Roma La Sapienza·Phase 4·NCT01820026·96 enrolled

Pneumonitis1 trial

Antibiotic Efficacy in Pneumonitis Following Paraffin (Kerosene) Ingestion in Children

Completed·UUniversity of Cape Town·N/A·NCT01253980·74 enrolled

Metabolism1 trial

Gut Flora and Lipid Metabolism

Completed·MMaastricht University Medical Center·N/A·NCT01566266·77 enrolled

Abscess1 trial

Systemic and Local Antimicrobials in the Management of Dental Abscess in Children

Completed·UUniversity of Malaya·Phase 2·NCT03761264·55 enrolled

Infants1 trial

Community Based Management of Fast Breathing in Infants Aged < 60 Days in Low-income Settlements of Karachi

Terminated·—·Phase 4·NCT01533818·963 enrolled

Vaginal Delivery1 trial

Necessity of Antibiotics for Prevention of Delivery-associated Infections After Spontaneous Vaginal Delivery at Term

Terminated·MMahidol University·Phase 4·NCT02131818·5 enrolled

Cleft Palate1 trial

The Role of Antibiotic Prophylaxis in Cleft Palate and Velopharyngeal Insufficiency Repair

Withdrawn·UUniversity of Florida··NCT02688634

Current Smoker1 trial

Effect of Three Periodontal Therapies in Current Smokers and Non-Smokers

Completed·TThe Forsyth Institute·Phase 2·NCT00066066·146 enrolled

Urinary Tract Infection1 trial

Interactions Between Cranberry Juice and Antibiotics Used to Treat Urinary Tract Infections

Completed·NNational Center for Complementary and Integrative Health (NCCIH)·N/A·NCT00084201·18 enrolled

MALT lymphoma1 trial

Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00002682·5 enrolled

Respiratory tract infection1 trial

Non-antibiotic Prescribing for Acute Upper Respiratory Tract Infection

Withdrawn·—·N/A·NCT01930955

High-dose Dual Therapy1 trial

The Effects of High-dose Dual Therapy With Probiotics on Gut Microbiota for Helicobacter Pylori Rescue Treatment

Completed·ZZhongshan Hospital (Xiamen), Fudan University·N/A·NCT06292546·72 enrolled

Cystic Fibrosis1 trial

Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial

Not yet recruiting·TThe University of Queensland·Phase 2·NCT07485010·300 enrolled

Hepatitis1 trial

Efficacy of Antibiotic Therapy in Severe Alcoholic Hepatitis Treated With Prednisolone

Completed·UUniversity Hospital, Lille·Phase 3·NCT02281929·297 enrolled

GastroIntestinal Bleeding1 trial

The Effect of Dual Eradication Therapy vs PPI on Gastrointestinal Bleeding in ACS Patients

Recruiting·QQilu Hospital of Shandong University·Phase 4·NCT04728516·2,600 enrolled

Peri-Implantitis1 trial

Surgical Access Combined With Systematically Administered Antibiotics in the Treatment of Peri-implantitis

Completed·UUniversity of Guarulhos·N/A·NCT05444218·89 enrolled

Bismuth Quadruple Therapy1 trial

Study on the Efficacy and Safety of Berberine, Minocycline, Esomeprazole, and Colloidal Bismuth Quadruple Therapy in the Initial Treatment of Helicobacter Pylori.

Unknown status·XXijing Hospital of Digestive Diseases·Phase 4·NCT06603688·548 enrolled

Absorption1 trial

Absorption of Paracetamol, Talinolol and Amoxicillin After Oral Administration Using Non-caloric and Caloric Water

Completed·UUniversity Medicine Greifswald·Phase 1·NCT01635608·12 enrolled

Streptococcal Infections1 trial

Amoxicillin for the Treatment of Pediatric Autoimmune Disorders Associated With Streptococcal Infections

Completed·NNational Institute of Mental Health (NIMH)·Phase 4·NCT00001658·30 enrolled

Double-blind1 trial

A Multicenter, Randomized, Double-Blind, Double-Dummy Study Of Azithromycin SR Versus Amoxicillin For The Treatment Of Strep Throat In Children

Completed· Pfizer logo

Pfizer·Phase 3·NCT00643149·693 enrolled

Biomarkers1 trial

Amoxicillin to Prevent Bacteria and Inflammatory Biomarkers After Intensive Periodontal Therapy

Unknown status·UUniversidad El Bosque, Bogotá·Phase 2·NCT03354338·90 enrolled

Tics1 trial

Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of After Administrations of DWP14012 Alone and Combinations of DWP14012, Clarithromycin and Amoxicillin in Healthy Male Subjects

Completed· Daewoong Pharmaceutical Co. LTD. logo

Daewoong Pharmaceutical Co. LTD.·Phase 1·NCT03487562·48 enrolled

MPA1 trial

Comparison of Twice- and Four-times-daily Amoxicillin Administration in 2-week Tegoprazan-based H. Pylori Eradication

Completed·SSoonchunhyang University Hospital··NCT06431737·100 enrolled

Erysipelas1 trial

Short Course of Amoxicillin for Erysipelas

Terminated·AAssistance Publique - Hôpitaux de Paris·Phase 4·NCT01059123·10 enrolled

Periodontitis1 trial

Alternative Antibiotic Regimen in Periodontitis Treatment

Completed·IIstanbul Medipol University Hospital·Phase 4·NCT04353362·74 enrolled

Bacteremia1 trial

An Oral Amoxicillin-Clavulanate Regimen to Prevent Bacteremia Following Dental Procedures

Terminated·UUniversity of Santiago de Compostela·Phase 4·NCT02783404·40 enrolled

Insulin Sensitivity1 trial

The Importance of the Gut Microbiota in Body Weight Control and Insulin Sensitivity

Completed·MMaastricht University Medical Center·N/A·NCT02241421·57 enrolled

Azithromycin1 trial

Treatment of ppROM With Erythromycin vs. Azithromycin Trial

Terminated·TThe University of Texas Medical Branch, Galveston·Phase 3·NCT03060473·21 enrolled

PK/PD1 trial

Oral Amoxicillin and Cephalexin PK/PD in Neonates

Unknown status·UUniversity of Colorado, Denver·Phase 1·NCT04916951·60 enrolled

Probiotics1 trial

Systemic Probiotics in the Periodontal Treatment

Unknown status·BBelén Retamal-Valdes·Phase 3·NCT03733379·176 enrolled

Intensive Care Unit1 trial

Amoxicillin for Enteral Nutrition Intolerance in Pediatric Intensive Care Unit

Unknown status·SSohag University·Phase 2/3·NCT05828758·90 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

Pregnancy1 trial

Phase 1 Study of the Pharmacokinetics of Amoxicillin in Pregnancy

Completed·UUniversity of Alabama at Birmingham·Phase 1·NCT05309928·13 enrolled

CAR1 trial

Primary Care Amoxicillin Challenge

Withdrawn·SState University of New York at Buffalo·Phase 4·NCT05165212

Erythema1 trial

Comparing 3 Antibiotic Regimes for Erythema Migrans in General Practice

Completed·MMorten Lindbaek·Phase 4·NCT01368341·225 enrolled

Antibiotic Resistance1 trial

Antibiotic Resistance and Microbiome in Children Aged 6-59 Months in Nouna, Burkina Faso

Completed·UUniversity of California, San Francisco·Phase 4·NCT03187834·252 enrolled

Malaria1 trial

Antimalaria Drugs Susceptibility Testing for an Effective Management of Infected Patients in Sub-Sahara Africa

Completed·—·Phase 3·NCT02974348·300 enrolled

Cognitive Development1 trial

Feeding Malnourished Children Different Types of Fatty Acids to Promote Neurocognitive Development

Completed·WWashington University School of Medicine·N/A·NCT03094247·2,897 enrolled

Infections1 trial

Immediate Versus Delayed Treatment of Odontogenic Infections

Withdrawn·—·Phase 4·NCT04057014

Efficacy1 trial

Efficacy of TAK-438, Amoxicillin and Clarithromycin in the First Line Eradication of H. Pylori

Completed· Takeda logo

Takeda·Phase 3·NCT01505127·650 enrolled

Gastrointestinal1 trial

The Effect of Amoxicillin Versus Placebo on Gastrointestinal Motility in Children

Completed·NNationwide Children's Hospital·N/A·NCT01530009·33 enrolled

PPROM1 trial

Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)

Recruiting·OOhio State University·Phase 4·NCT06396078·56 enrolled

Drug Interactions1 trial

Study to Evaluate Pharmacokinetic Drug Interactions and Safety of Clarithromycin, Amoxicillin and Ilaprazole

Completed·IIl-Yang Pharm. Co., Ltd.·Phase 1·NCT02998437·28 enrolled

Duodenal Ulcer1 trial

The Efficacy and Safety of Ilaprazole/Doxycycline-based Bismuth-containing Quadruple Therapy on Hp Infected Duodenal Ulcers

Completed·TThe Third Xiangya Hospital of Central South University·Phase 4·NCT03342456·184 enrolled

Pneumococcal Infection1 trial

A Controlled Human Pneumococcal Infection Model (PIM) Study

Completed·RRadboud University Medical Center·N/A·NCT05361499·20 enrolled

Resistance1 trial

Genotypic Resistance-guided Versus Empirical Therapy for H. Pylori Eradication.

Unknown status·—·Phase 4·NCT04090021·304 enrolled

Infection1 trial

10 vs 14 Days Triple Therapy : H.Pylori Infection Eradication

Unknown status·IIndonesia University·Phase 4·NCT03134378·73 enrolled

Hospitalized Patients1 trial

Safety and Efficacy of an Oral Penicillin Challenge in Low Risk Hospitalized Patients

Unknown status·SSaskatchewan Health Authority - Regina Area·N/A·NCT04408508·50 enrolled

Preoperative1 trial

Prevention of Dry Socket by Means of Single Preoperative Antibiotics Compared to Conventional Therapy

Completed·—·Phase 2·NCT03992144·225 enrolled

Unspecified7 trials

Banxiaxiexin Decoction Combined With Vonoprazan-Amoxicillin Dual Therapy in H. Pylori Eradication

Completed·NNanjing First Hospital, Nanjing Medical University·Phase 3·NCT06340724·104 enrolled

Study of Levofloxacin-based Concomitant Therapy for H. Pylori Eradication in Diabetic Patients

Completed·CChung-Tai Wu·Phase 4·NCT02466919·114 enrolled

Changes in Resistome After Dental Extraction and Amoxicillin.

Unknown status·TThe University of Hong Kong··NCT02830347·16 enrolled

Show 4 more trials

Head-to-head Study of Tegoprazan 50 mg BID Plus Amoxicillin 1 g TID vs. Vonoprazan 20 mg BID Plus Amoxicillin 1 g TID for H. Pylori Eradication

Recruiting·FFirst People's Hospital of Hangzhou·Phase 2/3·NCT07242456·240 enrolled

Bioequivalence of Two Commercial Amoxicillin Suspensions

Completed·UUniversity of Campinas, Brazil·Phase 4·NCT01933698·25 enrolled

Dexlansoprazole MR-Based Concomitant Quadruple Therapy

Completed·—·N/A·NCT03829150·202 enrolled

Zuojin Wan Combined with Vonoprazan-Amoxicillin Dual Therapy in H.Pylori Eradication

Not yet recruiting·NNanjing First Hospital, Nanjing Medical University·Phase 1·NCT06901375·136 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

AMOXIL

NDA NDA050542

Jan 1, 1982

AMOXIL

NDA NDA050460

Jan 1, 1982

AMOXIL

NDA NDA050459

Jul 10, 1998

AMOXIL

NDA NDA050754

Apr 15, 1999

AMOXIL

NDA NDA050761

Apr 15, 1999

AMOXIL

NDA NDA050760

Jan 23, 2008

MOXATAG

NDA NDA050813

Sources

References

[1]
ClinicalTrials.gov — 262 trial records for Amoxicillin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Amoxil drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Amoxicillin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Amoxicillin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA050813). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Amoxil. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Global Antibiotics Research and Development Partnership company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Bacterial Penicillin-Binding Protein Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: GGlobal Antibiotics Research and Development Partnership

Patent Landscape[6]

Patent Cliff

Dec 8, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8778924Dec 8, 2026

8357394Dec 8, 2026

8299052May 7, 2027