Amoxicillin-clavulanic acid

Phase 3Small molecule

Amoxicillin-clavulanic acid is one of 17 small molecule programs targeting Pleural Infection. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Pleural InfectionCompleted

Antibiotic ProphylaxisRecruiting

Pleural InfectionPreclinical

Completed

Antibiotic ProphylaxisPhase 3

Recruiting

Competition

Competitive Landscape

16 competitors in Antibiotic Prophylaxis

#DrugCompanyPhaseTrials

Cipro

Bayer

Approved

8 2

Zyvox

Pfizer

Approved

1 3

Ceftin

PPhiladelphia Eye Associates

Approved

5 4

Amoxil

GGlobal Antibiotics Research and Development Partnership

Approved

5 5

Ivadantin

PProcter and Gamble

Approved

2 6

Flagyl

DDePuy Orthopaedics

Approved

1 7

Primsol

CConrado Roberto Hoffmann Filho

Approved

1 8

Invanz

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Approved

1 9

Diflucan

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

1 10

Ancef

BBaxter Healthcare Corporation

Phase 3

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

Timeline

Expected Milestones

Q1 2027

Post-ApprovalRecruiting

Antibiotic Prophylaxis

NCT06709196

Phase 2/3Recruiting

Antibiotic Therapy

NCT07202052

Q3 2028

ApprovedRecruiting

Laparoscopic Appendectomy

NCT05761080

Clinical

Trials by Indication[1]

Antibiotic Prophylaxis2 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

eXtended Antibiotic Prophylaxis for Intermediate- and High-risk Glands After Pancreatoduodenectomy to Reduce CR-POPF

Terminated·—·Phase 2·NCT05753735·3 enrolled

Fasting Conditions2 trials

Amoxicillin-Clavulanic Acid 400 Mg-57 mg Chewable Tablets Under Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00835705·52 enrolled

Amoxicillin-Clavulanic Acid 400 Mg-57 mg Chewable Tablets Under Non-Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00836901·52 enrolled

Efficacy and Safety1 trial

A Multicentre, Randomized as a Double Blind Study, Triple Placebo, Comparative of the Efficacy and Safety of an Association Secnidazol-Ciprofloxacin Compared With Amoxicillin-Clavulanic Acid for the Treatment of Uncomplicated Episode of Diverticular Sigmoïditis Among Adults

Terminated·QQuanta Medical·Phase 3·NCT01733966·100 enrolled

Antibiotic Therapy1 trial

Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Platform Trial (RATIONAL-PT)

Recruiting·MMonash University·Phase 2/3·NCT07202052·900 enrolled

Cardiac Arrest1 trial

Prophylactic Antibiotics in Comatose Survivors of Out-of-hospital Cardiac Arrest

Completed·UUniversity Medical Centre Ljubljana·Phase 4·NCT02899507·60 enrolled

10 more indications

Gut Microbiota1 trial

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

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

Complication1 trial

Antibiotherapy During Therapeutic Hypothermia to Prevent Infectious Complications

Completed·UUniversity Hospital, Limoges·Phase 3·NCT02186951·197 enrolled

Chronic Bronchitis1 trial

Moxifloxacin Versus Amoxicillin Clavulanic Acid in Treatment of Acute Exacerbation of Chronic Bronchitis

Completed· Bayer logo

Bayer·Phase 4·NCT00656747·1,372 enrolled

Cholecystitis1 trial

Place of Antibiotics in the Postoperative Acute Lithiasic Cholecystitis

Completed·—·Phase 3·NCT01015417·414 enrolled

Critically Ill1 trial

Target Attainment and Pharmacokinetics of Antimicrobials in Non-critically Ill Surgery Patients (TAPAS)

Unknown status·UUniversitaire Ziekenhuizen KU Leuven··NCT03120663·120 enrolled

Pleural Infection1 trial

Pharmacokinetics and Pleural Fluid Penetration of Amoxicillin and Clavulanic Acid in Patients With Pleural Infections

Completed·—·N/A·NCT04350502·11 enrolled

Antibiotics1 trial

Early Antibiotics After Aspiration in ICU Patients

Terminated·UUConn Health·Phase 4·NCT05079620·5 enrolled

Diarrhea1 trial

Effect of Lactobacillus Reuteri DSM 17938 to Prevent Antibiotic-associated Diarrhea in Children

Completed·EEskisehir Osmangazi University·Phase 4·NCT02765217·1,325 enrolled

Pneumonia1 trial

Hospitalised Pneumonia With Extended Treatment (HOPE) Study

Completed·MMenzies School of Health Research·Phase 4·NCT02783859·314 enrolled

Laparoscopic Appendectomy1 trial

Evaluation of a Therapeutic Strategy to Shorten Hospital Stay in Complicated Pediatric Appendicitis: A Randomized, Parallel, Multicenter, Open-Label Clinical Trial

Recruiting·FFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau·Approved·NCT05761080·772 enrolled

Sources

References

[1]
ClinicalTrials.gov — 17 trial records for Amoxicillin-clavulanic acid. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Amoxicillin-clavulanic acid compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Amoxicillin-clavulanic acid. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Teva company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Teva

Amoxicillin-clavulanic acid

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q3 2028

Trials by Indication[1]

Antibiotic Prophylaxis2 trials

Fasting Conditions2 trials

Efficacy and Safety1 trial

Antibiotic Therapy1 trial

Cardiac Arrest1 trial

Gut Microbiota1 trial

Complication1 trial

Chronic Bronchitis1 trial

Cholecystitis1 trial

Critically Ill1 trial

Pleural Infection1 trial

Antibiotics1 trial

Diarrhea1 trial

Pneumonia1 trial

Laparoscopic Appendectomy1 trial

References

Drug Info

Quick Facts

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