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Drug

Amoxicillin

Approved · FDA
ClassBacterial penicillin-binding protein inhibitorEmerging researchLate-stage development
Also known as AX, Amox, Amoxi Drop, Amoxi-tabs+22 more

AX, Amox, Amoxi Drop, Amoxi-tabs, Amoxicillin-Clavulanate, Amoxicot, Amoxil, Augmentin, Betacilin, Biomox, Clavamox, Dispermox, Kesium, Moxatag, Moxilin, Senox, Talicia, Trimox, Umbrellin, Wymox, Clavacillin, p-Hydroxyampicillin, Amoxicilina, Amoxicilline, Amoxycillin, Amoxicillinum.

RxNorm723ChEMBLCHEMBL1082ATCJ01CA04UNII804826J2HU
2
Research papers
26
Active clinical trials
7
Protein targets
100
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

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

Clinical trial2026-08-02Primary completion · ClinicalTrials.gov

Label change: AMOXICILLIN AND CLAVULANATE POTASSIUM (NDA050575)

Regulatory2026-07-17FDA

Label change: AMOXICILLIN AND CLAVULANATE POTASSIUM (NDA050720)

Regulatory2026-07-17FDA

Label change: AMOXICILLIN AND CLAVULANATE POTASSIUM (NDA050755)

Regulatory2026-07-17FDA

Label change: AMOXICILLIN AND CLAVULANATE POTASSIUM (NDA050785)

Regulatory2026-07-17FDA

Ozone based advanced oxidation for antibiotic amoxicillin removal from aqueous environment with kinetic and economic evaluation

Industry2026-07-14Nature — Environmental Sciences

Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis

Clinical trial2026-07-07Results expected Q4 2026 · ClinicalTrials.gov

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

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

PROMIZE: A Phase I/II Trial to Assess the Safety, Tolerability and Preliminary Anti-tumour Activity of Oral Combination Antibiotic Therapy to Modulate the Microbiome in Combination With Enzalutamide With Metastatic Castration Resistant Prostate Cancer (mCRPC).

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

Comparison 0f 03days Vs 05days Amoxicillin In Uncomplicated Community Acquired Pneumonia In Children. A Randomized Controlled Trial

Clinical trial2026-06-15Results expected Q2 2027 · ClinicalTrials.gov

Management of Helicobacter pylori infection-the Maastricht V/Florence Consensus Report.

Research2016-10-05Gut

The efficacy of prophylactic antibiotics in the management of children with kerosene-associated pneumonitis: a double-blind randomised controlled trial.

Research2015-06-26Clinical toxicology (Philadelphia, Pa.)

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Amoxicillin
Aliases & brands
AXAmoxAmoxi DropAmoxi-tabsAmoxicillin-ClavulanateAmoxicotAmoxilAugmentinBetacilinBiomoxClavamoxDispermoxKesiumMoxatagMoxilinSenoxTaliciaTrimoxUmbrellinWymoxClavacillinp-HydroxyampicillinAmoxicilinaAmoxicillineAmoxycillinAmoxicillinum
RxNorm CUI
723
ChEMBL ID
CHEMBL1082
ATC codes
J01CA04
UNII
804826J2HU
Primary mechanism
Bacterial penicillin-binding protein inhibitor
Regulatory jurisdictions
fda

Pharmacology & targets

7 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

D-alanyl-D-alanine carboxypeptidase DacB
dacB · P24228
INHIBITORBacterial penicillin-binding protein inhibitor
Peptidoglycan D,D-transpeptidase FtsI
ftsI · P0AD68
INHIBITORBacterial penicillin-binding protein inhibitor
Penicillin-binding protein 1A
mrcA · P02918
INHIBITORBacterial penicillin-binding protein inhibitor
Penicillin-binding protein 1B
mrcB · P02919
INHIBITORBacterial penicillin-binding protein inhibitor
D-alanyl-D-alanine carboxypeptidase DacA
dacA · P0AEB2
INHIBITORBacterial penicillin-binding protein inhibitor
Peptidoglycan D,D-transpeptidase MrdA
mrdA · P0AD65
INHIBITORBacterial penicillin-binding protein inhibitor
D-alanyl-D-alanine carboxypeptidase DacC
dacC · P08506
INHIBITORBacterial penicillin-binding protein inhibitor

Regulatory timeline

100 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
1984-08-06
Latest approval
2014-09-30
Authorities
FDA
Total events
100
fdaU.S. Food and Drug Administration· 100 events
2026-07-17Label change
Label change: AMOXICILLIN AND CLAVULANATE POTASSIUM (NDA050575)
Evidence ↗
2026-07-17Label change
Label change: AMOXICILLIN AND CLAVULANATE POTASSIUM (NDA050720)
Evidence ↗
2026-07-17Label change
Label change: AMOXICILLIN AND CLAVULANATE POTASSIUM (NDA050755)
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

194 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
194
registered trials across all phases
LATEST COMPLETION 2026
26
Active studies
23
Recruiting
159
Late-stage (III+)
120
Completed
48
Discontinued
PHASE DISTRIBUTIONn = 194
Early Phase 17Phase 114Phase 1 / 24Phase 210Phase 2 / 35Phase 327Phase 491Phase N / A36

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Congenital Syphilis Treatment Trial (CONSISTENT): Phase IV, Open-label, Randomized Controlled Trial of Amoxicillin vs. Benzathine in Neonates With Possible Congenital Syphilis

Not yet recruitingPH IVUniversity of Alabama at Birminghamn=3742031

Effectiveness of Short-Course Antibiotic Prophylaxis After Simple Tooth Extraction in Immunosuppressed Patients With Autoimmune Rheumatic Diseases

Not yet recruitingPH IVUniversity of Sao Paulo General Hospitaln=3522029

Azithromycin as Adjunctive Treatment for Uncomplicated Severe Acute Malnutrition: the AMOUR Trial

RecruitingPH IVKey trialUniversity of California, San Franciscon=3,0002028

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

Not yet recruitingPH IVMontefiore Medical Centern=5562028

Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis

RecruitingPH IVFundacion Clinic per a la Recerca Biomédican=3602027

Recent completions

Trials that read out recently, adding to the completed evidence base.

Efficacy and Safety of Tegoprazan-Based Dual, Triple, and Quadruple Therapies as First-Line Regimens for Helicobacter Pylori Eradication: A Prospective Randomized Controlled Trial

CompletedN/AZhongshan Hospital (Xiamen), Fudan Universityn=6402026

Drug Interaction Study on Linaprazan Glurate Capsules, Clarithromycin Tablets, Amoxicillin Capsules, and Bismuth Potassium Citrate Capsules

CompletedPH IJiangsu Sinorda Biomedicine Co., Ltdn=562025

Oral Amoxicillin and Cephalexin Pharmacokinetics/Pharmacodynamics (PK/PD) in the Neonatal Intensive Care Unit

CompletedPH IUniversity of Colorado, Denvern=722025

"Is Antibiotic Therapy Necessary for Patients Undergoing Extraction of Tooth With a Periapical Abscess? : A Randomised Controlled Clinical Study"

CompletedN/ASubbaiah Institute of Dental Sciencesn=1762025

A Rational Approach to the Identification of New Treatment Options to Prevent Congenital Syphilis: Phase 1 Study of the Pharmacokinetics of Amoxicillin in Pregnancy

CompletedPH IUniversity of Alabama at Birminghamn=132025

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

CompletedPH IVXijing Hospital of Digestive Diseasesn=5582025

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20152017
Major research themes1
Helicobacter pylori1
Journals, researchers & institutions
Top journals
  • Clinical toxicology (Philadelphia, Pa.)1
  • Gut1
Leading researchers
  • Atherton J1
  • Axon AT1
  • Balme KH1
  • Bazzoli F1
  • El-Omar EM1
  • Gasbarrini A1
  • Gisbert JP1
  • Graham DY1
Leading institutions
free-text, unnormalised
  • Erasmus University Medical Center1
  • General Infirmary Leeds1
  • Henry Dunant Hospital1
  • Hospital Universitario de La Princesa1
  • Institut für Medizinische Mikrobiologie1
  • Jichi Medical School1

Related drugs

2 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Bismuth

Studied across 4 of the same disease areas as Amoxicillin in the shared literature.

4 shared diseases1 shared paper
Clarithromycin

Studied across 4 of the same disease areas as Amoxicillin in the shared literature.

4 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.