amoxicillin-clavulanate

Phase 3Small molecule

IIterum Therapeutics, International Limited

amoxicillin-clavulanate is one of 28 small molecule programs targeting Anal fistula. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Anal FistulaActive, not recruiting

TonsillitisActive, not recruiting

Small Intestine Bacterial OvergrowthRecruiting

CiprofloxacinNot yet recruiting

AntibioticRecruiting

Anal FistulaPreclinical

Active, not recruiting

TonsillitisPreclinical

Active, not recruiting

Small Intestine Bacterial OvergrowthPhase 2

Recruiting

CiprofloxacinPhase 3

Not yet recruiting

AntibioticPhase 3

Recruiting

Competition

Competitive Landscape

13 competitors in Tonsillitis

#DrugCompanyPhaseTrials

Zofran

Novartis

Approved

—2

Amoxil

GGlobal Antibiotics Research and Development Partnership

Approved

2 3

Oruvail

WWyeth-Lederle Vaccines

Approved

1 4

Celebrex

PPhiladelphia Eye Associates

Tylenol

MS Contin

HHikma Pharmaceuticals LLC

Approved

—7

Versed

CConrado Roberto Hoffmann Filho

Approved

—8

Decadron

AAspen Global Incorporated

Approved

—9

Zithromax

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

Approved

—10

amoxicillin-clavulanate

IIterum Therapeutics, International Limited

Phase 3

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

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Small Intestine Bacterial Overgrowth

NCT07451171

Phase 1Recruiting

FDC

NCT06733675

Q1 2028

Phase 3Recruiting

Pneumonia

NCT02735707

Q2 2028

Post-ApprovalRecruiting

Antibiotic

NCT06494072

Q3 2028

Phase 3Not yet recruiting

Ciprofloxacin

NCT07483736

Clinical

Trials by Indication[1]

Acute otitis media5 trials

Amoxicillin-clavulanate in Treating Acute Otitis Media Evaluated by Daily Tympanometry

Completed·UUniversity of Oulu·Phase 3·NCT01244581·84 enrolled

Amoxicillin Clavulanate in Treatment of Acute Otitis Media

Unknown status·UUniversity of Turku·Phase 4·NCT00299455·320 enrolled

A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infants and Children Aged 6 to 24 Months

Completed·NNovus Therapeutics, Inc·Phase 2·NCT03818815·103 enrolled

Show 2 more trials

Acute Otitis Media (AOM) Therapy Trial in Young Children

Completed·UUniversity of Pittsburgh·Phase 4·NCT00377260·291 enrolled

Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Otitis Media)

Not yet recruiting·NNader Shaikh·Approved·NCT07730814·1,100 enrolled

Diarrhea3 trials

Mechanisms of Probiotics and Antibiotic-Associated Diarrhea

Completed·GGeorgetown University·Phase 1·NCT04414722·118 enrolled

Mechanisms of Preventing Antibiotic-Associated Diarrhea and the Role for Probiotics

Completed·GGeorgetown University·Phase 1·NCT03755765·66 enrolled

Antibiotic-Associated Diarrhea and the Role of Microorganisms in the Gut

Completed·SSingapore General Hospital·Phase 4·NCT04156555·30 enrolled

Pneumonia3 trials

A Study to Compare Different Antibiotics and Different Modes of Fluid Treatment for Children With Severe Pneumonia

Completed·UUniversity of Oxford·Phase 3·NCT04041791·4,392 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

Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia

Recruiting·UUMC Utrecht·Phase 3·NCT02735707·20,000 enrolled

Antibiotic3 trials

2-day Prophylactic Antibiotic is Effective in Transoral Endoscopic Thyroidectomy

Completed·—·N/A·NCT04268407·60 enrolled

Comparing Efficacy of Postoperative Oral Antibiotic Use in Trans-Oral Thyroidectomy

Unknown status·SSeoul National University Hospital·N/A·NCT03295955·50 enrolled

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

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

Acute Uncomplicated Diverticulitis2 trials

Non-antibiotic Management in Acute Uncomplicated Diverticulitis: Randomized Open Label-controlled Trial

Withdrawn·MMontefiore Medical Center·Approved·NCT07625267

Comparing Placebo Versus Antibiotics for Acute Uncomplicated Diverticulitis

Recruiting·VVanderbilt University Medical Center·Phase 2·NCT07492134·100 enrolled

21 more indications

Diverticulitis1 trial

Diverticulitis: Antibiotics or Close Observation?

Unknown status·—·Phase 4·NCT01111253·533 enrolled

Intra-abdominal Infection1 trial

Sulopenem Versus Ertapenem for Complicated Intra-abdominal Infection (cIAI)

Completed·IIterum Therapeutics, International Limited·Phase 3·NCT03358576·674 enrolled

Clinical Trial1 trial

Amoxicillin-clavulanate Alone or in Combination With Ciprofloxacin in Low-Risk Febrile Neutropenic Adult Patients: A Prospective, Double-blind, Randomized, Non-Inferiority Multicenter, Phase III Clinical Trial.

Withdrawn·PPoitiers University Hospital·Phase 3·NCT04698057

Orthognathic Surgery1 trial

The Efficiency of Postoperative Antibiotics in Orthognathic Surgery

Unknown status·TThe Baruch Padeh Medical Center, Poriya·N/A·NCT02740647·25 enrolled

Adult1 trial

Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Complicated UTI in Adults

Completed·IIterum Therapeutics, International Limited·Phase 3·NCT03357614·1,395 enrolled

Antibiotics1 trial

Reduction of Intravenous Antibiotics In Neonates

Completed·FFranciscus Gasthuis·Phase 4·NCT03247920·510 enrolled

Tuberculosis1 trial

The BLAST- 1 Trial - Cephalexin+Amoxicillin-clavulanate for Tuberculosis

Unknown status·WWestern Sydney Local Health District·Phase 2·NCT05664568·30 enrolled

Bacterial Pneumonia1 trial

Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Community Acquired Bacterial Pneumonia (CABP)

Completed·FForest Laboratories·Phase 2/3·NCT01530763·161 enrolled

Antibiotic Therapy1 trial

Antibiotic Therapy in Erupted Tooth Extractions

Completed·AAntonio Barone·Phase 4·NCT04082598·165 enrolled

Tonsillitis1 trial

Bacteriological Study of Acute Follicular Tonsillitis

Unknown status·—··NCT04321733·66 enrolled

Meropenem1 trial

Evaluating the EBA of Meropenem With Amoxicillin/Clavulanate and Pyrazinamide or Bedaquiline in Adults With PTB

Completed·TTASK Applied Science·Phase 2·NCT04629378·22 enrolled

Gut Microbiota1 trial

Effects of S. Boulardii and Amoxicillin/Clavulanate on Gut Microbiota

Completed·—·N/A·NCT01473368·53 enrolled

Sinusitis1 trial

Efficacy of Antibiotics in Children With Acute Sinusitis: Which Subgroups Benefit?

Completed·NNader Shaikh·Phase 3·NCT02554383·515 enrolled

Antibiotic Prophylaxis1 trial

Antibiotic PRophylAxis Based on infeCTIve Risk in Cardiac Implantable Electronic Device

Completed·UUniversity Hospital of Ferrara··NCT04736979·1,044 enrolled

Microbiota1 trial

Effect of Tebipenem on Normal Human Intestinal Microbiota

Completed·SSpero Therapeutics·Phase 1·NCT04376554·30 enrolled

Colorectal Surgery1 trial

Study the Efficacy of Topical Antibiotherapy in the Prophylaxis of Incisional Surgical Infection in Colorectal Surgery

Completed·UUniversitat Internacional de Catalunya·Phase 4·NCT03574090·268 enrolled

Infection1 trial

Fast-track Blood Test for Suspected Fever by Deficiency of a Kind of White Blood Cells As Main Defense Against Infection

Unknown status·TThe University of Hong Kong·Phase 4·NCT05393505·344 enrolled

Ciprofloxacin1 trial

Efficacy of an Empirical Treatment With Amoxicillin-clavulanate (AC) Compared to the Combination Amoxicillin-clavulanate and Ciprofloxacin (AC+C) in the Outpatient Care of Chemotherapy-induced Fever in Adult Haematology Patients.

Not yet recruiting·VVersailles Hospital·Phase 3·NCT07483736·1,526 enrolled

Anal fistula1 trial

Do Antibiotics Prevent Anal Fistulae Formation?

Completed·—·N/A·NCT01012843·151 enrolled

Small Intestine Bacterial Overgrowth1 trial

A Phase II Trial to Prevent Linear Growth Stunting and Malnutrition in Impoverished Children From a Low-Income Country by Treating Small Intestine Bacterial Overgrowth

Recruiting·UUniversity of Virginia·Phase 2·NCT07451171·60 enrolled

FDC1 trial

A Phase 1, Open-label Study to Evaluate the Safety and to Characterize the Pharmacokinetics of a Fixed-Dose Combination Formulation of Ceftibuten-Ledaborbactam Etzadroxil

Recruiting· Basilea Pharmaceutica logo

Basilea Pharmaceutica·Phase 1·NCT06733675·96 enrolled

Sources

References

[1]
ClinicalTrials.gov — 37 trial records for amoxicillin-clavulanate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — amoxicillin-clavulanate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for amoxicillin-clavulanate. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Iterum Therapeutics, International Limited company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: IIterum Therapeutics, International Limited

amoxicillin-clavulanate

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2028

Q2 2028

Q3 2028

Trials by Indication[1]

Acute otitis media5 trials

Diarrhea3 trials

Pneumonia3 trials

Antibiotic3 trials

Acute Uncomplicated Diverticulitis2 trials

Diverticulitis1 trial

Intra-abdominal Infection1 trial

Clinical Trial1 trial

Orthognathic Surgery1 trial

Adult1 trial

Antibiotics1 trial

Tuberculosis1 trial

Bacterial Pneumonia1 trial

Antibiotic Therapy1 trial

Tonsillitis1 trial

Meropenem1 trial

Gut Microbiota1 trial

Sinusitis1 trial

Antibiotic Prophylaxis1 trial

Microbiota1 trial

Colorectal Surgery1 trial

Infection1 trial

Ciprofloxacin1 trial

Anal fistula1 trial

Small Intestine Bacterial Overgrowth1 trial

FDC1 trial

References

Drug Info

Quick Facts

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