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Ancef

(Cefazolin)

ApprovedSmall molecule

BBaxter Healthcare Corporation

Cefazolin is an antibiotic used to treat bacterial infections and to prevent infections during surgery. It works by killing bacteria that cause infections in various parts of the body.[2] Ancef is currently approved and in use across 30 indications[4].[1]

Ancef is one of 343 small molecule programs targeting Antibiotics. It is currently in Approved.

30

Indications

85

Total Trials

13

Active Trials

342

Competitors

6

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

AntibioticsTerminated

Puerperal InfectionActive, not recruiting

Bacterial DiseaseActive, not recruiting

Hepatic CystsActive, not recruiting

AppendicitisActive, not recruiting

Breast NeoplasmActive, not recruiting

Laryngeal CarcinomaApproved

Cutaneous MelanomaApproved

Cardiac ArrhythmiaApproved

CellulitisApproved

AntibioticsApproved

Terminated

Puerperal InfectionPreclinical

Active, not recruiting

Bacterial DiseaseApproved

Active, not recruiting

Hepatic CystsPreclinical

Active, not recruiting

AppendicitisPreclinical

Active, not recruiting

Breast NeoplasmPreclinical

Active, not recruiting

Laryngeal CarcinomaApproved

Approved

Cutaneous MelanomaApproved

Approved

Cardiac ArrhythmiaApproved

Approved

CellulitisApproved

Approved

Showing 10 of 28 indications

Competition

Competitive Landscape

190 competitors in Obesity

#DrugCompanyPhaseTrials

Ancef

BBaxter Healthcare Corporation

Cagrilintide

Decadron

AAspen Global Incorporated

Revlimid

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Enavogliflozin

Daewoong Pharmaceutical Co. LTD.

IBI362

Innovent Biologics (Suzhou) Co. Ltd.

Eloralintide

Elecoglipron

Aleniglipron

GGasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics

Semaglutide or Tirzepatide

NNational and Kapodistrian University of Athens

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

Timeline

Expected Milestones

Q4 2026

Colonization

NCT02996656

Q1 2027

Phase 1Active, not recruiting

Melanoma

NCT04875728

Q3 2027

Post-ApprovalRecruiting

Orthognathic Surgery

NCT05852158

Q2 2028

Phase 2Recruiting

Chronic Wounds

NCT06327113

Post-ApprovalRecruiting

Prophylaxis

NCT05447559

Clinical

Trials by Indication[1]

Antibiotic Prophylaxis8 trials

Antibiotic Prophylaxis for Revision, Clean Head and Neck Surgery

Completed·RRabin Medical Center·Phase 4·NCT01980082·53 enrolled

Trial Comparing the Optimal Timing of Antibiotic Prophylaxis at the Time of Cesarean Delivery

Completed·MMemorialCare·Phase 3·NCT00811603·50 enrolled

Antibiotic Prophylaxis in Gynecologic Laparoscopy

Completed·UUniversidade do Vale do Sapucai·N/A·NCT01991834·114 enrolled

Show 5 more trials

Antibiotic Prophylaxis in Oncological Surgery of Breast

Completed·FFabiola Soares Moreira Campos·N/A·NCT02809729·124 enrolled

Antibiotic Prophylaxis in Orthopaedic Traumatology

Completed·UUniversity of Missouri-Columbia·N/A·NCT00610987·178 enrolled

Results of Extended Versus Single Dose Antibiotic Prophylaxis In Orthopedic Revision Arthroplasty in Nijmegen.

Active, not recruiting·RRadboud University Medical Center·Phase 3·NCT06402591·751 enrolled

Antibiotic Prophylaxis in Pediatric Open Fractures

Enrolling by invitation·SSt. Louis University·Phase 4·NCT06055712·800 enrolled

Randomized Assessment of Antibiotic Prophylaxis Prior to Port Placement

Withdrawn·—·N/A·NCT05304871

Antibiotics6 trials

Antibiotics During Intrauterine Balloon Tamponade Placement

Terminated·—·Phase 4·NCT03478163·11 enrolled

Prophylactic Antibiotics Duration Towards Healing and Risk of Infection in Permanent Pacemaker (PPM) Installation

Recruiting·UUniversity of Brawijaya·Phase 2·NCT06355115·100 enrolled

Prophylactic Antibiotics in Groin Hernioplasty

Completed·SSana'a University·N/A·NCT07111702·100 enrolled

Show 3 more trials

Prophylactic Antibiotics Before RFA for HCC

Unknown status·TTaipei Veterans General Hospital, Taiwan·Phase 4·NCT02534961·600 enrolled

Antibiotics Usage in Pediatric Orthopaedic Percutaneous Surgery (APOPS)

Completed·SSumit Gupta·Phase 4·NCT03261830·160 enrolled

Postoperative Antibiotics Following Primary and Secondary Breast Augmentation

Withdrawn·UUniversity of California, Los Angeles·Phase 4·NCT04834310

Cesarean Delivery4 trials

Serum and Tissue Cefazolin Concentrations in Normal Weight Patients Undergoing Cesarean Delivery.

Withdrawn·WWest Virginia University·Phase 4·NCT01880112

Serum and Tissue Cefazolin Concentrations in Patients Undergoing Cesarean Delivery

Completed·MMichael Stitely·Phase 4·NCT01755026·23 enrolled

Increased Cefazolin During Cesarean Delivery in Obese Population

Completed·MMemorialCare Health System·Phase 4·NCT02049944·30 enrolled

Show 1 more trial

Comparing of Cefazolin Plus Azithromycin Versus Cefazolin in Prevention of Febrile Morbidity After Emergency Cesarean Delivery

Completed·DDepartment of Medical Services Ministry of Public Health of Thailand·N/A·NCT05647993·172 enrolled

Staphylococcus Aureus Bacteremia4 trials

Staphylococcus Aureus Bacteremia Antibiotic Treatment Options

Completed·HHeinrich-Heine University, Duesseldorf·Phase 3·NCT01792804·215 enrolled

Cefazolin Versus Antistaphylococcal Penicillins for Methicillin Susceptible Staphylococcus Aureus Bacteremia

Active, not recruiting·—··NCT07186894·5,000 enrolled

Non-inferiority Trial Comparing Cloxacillin vs Cefazolin in Methicillin-susceptible Staphylococcus Aureus Bacteremia

Completed·AAssistance Publique - Hôpitaux de Paris·N/A·NCT03248063·315 enrolled

Show 1 more trial

DOTS: Dalbavancin as an Option for Treatment of Staphylococcus Aureus Bacteremia

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT04775953·200 enrolled

Antibiotic3 trials

Prophylactic Antibiotic After Perineal Tear

Unknown status·MMeir Medical Center·N/A·NCT04763486·2,500 enrolled

Cefazolin-Lidocaine Combination Solution to Reduce Antibiotic Pain

Unknown status·UUniversity Health Network, Toronto·Phase 4·NCT02324166·54 enrolled

Supracondylar Pinning Antibiotic Stewardship (SPAS) Trial

Unknown status·LLegacy Health System·N/A·NCT04288206·1,200 enrolled

48 more indications

Cesarean Section3 trials

Timing of Prophylactic Antibiotics for Cesarean Sections

Completed·MMedical University of South Carolina·N/A·NCT00330278·350 enrolled

PROPHYLACTIC ANTIBIOTICS PRIOR TO CESAREAN SECTION IN OBESE WOMEN

Completed·WWomen and Infants Hospital of Rhode Island·N/A·NCT01810354·58 enrolled

Timing of Maternal Antibiotic Prophylaxis During a Cesarean Section and the Early Infant Gut Microbiome

Completed·UUniversity Medical Center Groningen·N/A·NCT06030713·33 enrolled

Cardiac Surgery3 trials

Prevention of Infections in Cardiac Surgery

Terminated·HHamilton Health Sciences Corporation·N/A·NCT02285140·5,989 enrolled

Prevention of Infections in Cardiac Surgery (PICS): a Cluster-randomized Factorial Cross-over Trial

Not yet recruiting·HHamilton Health Sciences Corporation·Phase 4·NCT06567808·38,000 enrolled

Prevention of Infections in Cardiac Surgery (PICS) Prevena Study

Completed·PPopulation Health Research Institute·Phase 4·NCT03402945·4,107 enrolled

Tics2 trials

Pharmacokinetics and Safety of Cefazolin 2g in DUPLEX

Completed·BB. Braun Medical Inc.·Phase 1·NCT01121354·24 enrolled

Cefazolin Pharmacokinetics: Elimination Clearance in Neonates

Completed·UUniversitaire Ziekenhuizen KU Leuven·Phase 4·NCT01295606·40 enrolled

Surgical Site Infection2 trials

Does a Preoperative Prophylactic Antibiotic Reduce Surgical Site Infection Following Wire-localized Lumpectomy

Completed·—·N/A·NCT04818931·326 enrolled

Antibiotic Prophylaxis in Clean Surgery. Impact on Surgical Site Infection

Completed·—·N/A·NCT03595852·138 enrolled

Prophylaxis2 trials

Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study

Recruiting·MMonash University·Phase 4·NCT05447559·9,180 enrolled

24 Vs 48 Hours of Cefazolin or Cefuroxime as Prophylaxis

Completed·SSaud Al Babtain Cardiac Center·Phase 4·NCT04303390·568 enrolled

Surgical Site Infections2 trials

Checklist to Prevent MRSA Surgical Site Infections

Completed·VVA Office of Research and Development·N/A·NCT02216227·1,794 enrolled

Prophylaxis Against Surgical Site Infections Using Local as Well as Systemic Antibiotic

Completed·LLahore General Hospital·N/A·NCT07478874·284 enrolled

Staphylococcus Aureus2 trials

A Phase 3 Telavancin Staphylococcus Aureus (S. Aureus) Bacteremia Trial

Terminated·CCumberland Pharmaceuticals·Phase 3·NCT02208063·121 enrolled

Staphylococcus Aureus Network Adaptive Platform Trial

Recruiting·UUniversity of Melbourne·Phase 4·NCT05137119·8,000 enrolled

Arrhythmia2 trials

Prevention of Arrhythmia Device Infection Trial (PADIT)

Completed·PPopulation Health Research Institute·Phase 4·NCT01613092·241 enrolled

Prevention of Arrhythmia Device Infection Trial (PADIT Pilot)

Completed·PPopulation Health Research Institute·Phase 3·NCT01002911·500 enrolled

Complication2 trials

Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term

Completed·UUniversity of Oklahoma·Phase 1·NCT03801252·186 enrolled

Does Antibiotic Prophylaxis Reduce Wound Complications After Vulvar Excision of Premalignant Lesions

Completed·WWashington University School of Medicine·Phase 2·NCT03578965·50 enrolled

Peritonitis2 trials

Peritonitis Prevention After Insertion of Peritoneal Dialysis Catheter.

Unknown status·—·Phase 3·NCT03046511·200 enrolled

Defining the Optimal Duration of Treatment for "Low-Risk" Peritoneal Dialysis-Related Peritonitis

Withdrawn·—·Phase 4·NCT03675854

Chronic Wounds1 trial

Antibiotic Tumescent For Chronic Wounds

Recruiting·UUniversity of California, Los Angeles·Phase 2·NCT06327113·60 enrolled

Hernia1 trial

The Role of Antibiotic Prophylaxis in Lowering Wound Infection Rates Post-Open Repair of Primary Elective Groin Hernias in High-Risk Patients

Recruiting·UUniversity of Aleppo·Phase 3·NCT06576154·200 enrolled

Perioperative Bleeding1 trial

The Effect of Bowel Preparation on Perioperative Bleeding

Completed·IIsfahan University of Medical Sciences·Phase 1/2·NCT02493894·105 enrolled

Pre-Term1 trial

An Open Label Study to Describe the Pharmacokinetics of Cefazolin in Preterm Neonates

Completed·PPhillip Brian Smith·Phase 1·NCT00850122·9 enrolled

Orthognathic Surgery1 trial

Antibiotics for Prevention of Infection Following Orthognathic Surgery

Recruiting·AAbdul El-Rabbany·Phase 4·NCT05852158·400 enrolled

Prostate Cancer1 trial

Antibiotic Prophylaxis for HDR Brachytherapy in the Treatment of Prostate Cancer

Terminated·CCR-CSSS Champlain-Charles-Le Moyne·Phase 3·NCT03862170·158 enrolled

Caesarean Section1 trial

Preventive Antibiotic Serum Levels During Caesarean Section

Unknown status·TTel-Aviv Sourasky Medical Center·Phase 3·NCT02838940·250 enrolled

Total Knee Replacement1 trial

The Combination of Adductor Canal Block and Periarticular Injection. A Novel Technique for Patients Undergoing Total Knee Replacement (ACB PAI)

Completed·HHospital for Special Surgery, New York·Phase 4·NCT02292082·111 enrolled

Preoperative1 trial

Preoperative Antibiotics for Carpal Tunnel Release Surgery

Completed·WWellSpan Health·Phase 4·NCT03432858·184 enrolled

Effectiveness1 trial

The Effectiveness of Vancomycin in Comarison With Cefazolin in Prevention of SSI After Craniotomy

Unknown status·IIsfahan University of Medical Sciences·Phase 1/2·NCT03466645·126 enrolled

Renal Replacement Therapy1 trial

Safety and Therapeutic Drug Monitoring of Cefazolin in Continuous Renal Replacement Therapy

Unknown status·—·Phase 1·NCT03672149·20 enrolled

Sepsis1 trial

Neonatal Suspected Sepsis Treated With Cefazolin or Vancomycin

Completed·HHospital Italiano de Buenos Aires·Phase 3·NCT01867138·109 enrolled

Prevention1 trial

Prevention of Infection in Closed Fractures: Cefazolin Versus Vancomycin

Terminated·UUniversity of Tennessee·N/A·NCT02027532·430 enrolled

Concentration1 trial

A Randomized, Controlled Trial of the Effectiveness of Perioperative Antibiotics for Reduction of Burn Wound Bacterial Concentration Following Grafting

Completed·MMedstar Health Research Institute·Phase 4·NCT04516148·32 enrolled

Preterm Premature Rupture of Membrane1 trial

Duration of Antibiotics Treatment With Cefazolin and Clarithromycin in Women With Preterm Premature Rupture of Membrane

Completed·SSamsung Medical Center·Phase 3·NCT01503606·151 enrolled

Hepatic cysts1 trial

Penetration of Cefazolin Into Hepatic Cysts

Completed·RRadboud University Medical Center·N/A·NCT02368015·8 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Prophylactic Use of an Antibiotic for Medical Thoracoscopy

Completed·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 4·NCT02446782·100 enrolled

Hysterectomy1 trial

Tinidazole Versus Cefazolin Antibiotic Prophylaxis of Vaginal and Abdominal Hysterectomy

Unknown status·UUniversity of Campinas, Brazil·N/A·NCT00787553·75 enrolled

Endometritis1 trial

Comparison Study of Cefazolin Versus Cefazolin Plus Azithromycin Prophylaxis in Post-Cesarean Endometritis

Withdrawn·UUniversity of Missouri, Kansas City·Phase 4·NCT01721616

MPA1 trial

Comparison of 2 Cefazolin Prophylactic Protocol in Laryngectomy Patients

Completed·TTehran University of Medical Sciences·Phase 3·NCT00467948·90 enrolled

Colonization1 trial

Antimicrobial Prophylaxis for Skin Colonization With Propionibacterium Acnes in Primary Open Shoulder Surgery

Recruiting·UUniversité de Montréal·N/A·NCT02996656·88 enrolled

Inguinal hernia1 trial

Effectiveness of Topical Antibiotic Prophylaxis in Inguinal Hernia Repair

Completed·—·Phase 4·NCT01273818·276 enrolled

Soft Tissue Infections1 trial

Direct Antibiotic Delivery of Cefazolin Into Soft Tissue Infections Using Subcutaneous Injection and Ultrasonic Dispersion

No longer available·SSonescence, Inc.··NCT01238276

Colorectal Surgery1 trial

Bowel Preparation in Elective Pediatric Colorectal Surgery

Unknown status·MMcMaster University·N/A·NCT03593252·81 enrolled

Pediatric1 trial

Safety of 1 g and 2 g of Cefazolin in Pediatric Subjects

Terminated·BB. Braun Medical Inc.·Phase 4·NCT03231228·61 enrolled

Adductor Canal Block1 trial

Adductor Canal Block With Periarticular Injection and IPACK (ACB/PAI/IPACK) Versus Periarticular Injection (PAI)

Completed·HHospital for Special Surgery, New York·Phase 4·NCT03094663·86 enrolled

Dialysis Patients1 trial

Is Cefazolin, Ceftazidime and Ciprofloxacin Dosing Optimal in Hemodialysis Patients?

Completed·UUniversity of Manitoba··NCT04319328·40 enrolled

Mastectomy1 trial

Bacterial Biofilms in Reconstructive Breast Prostheses Following Mastectomy

Completed·WWashington University School of Medicine·Phase 1·NCT03213249·19 enrolled

Extracorporeal Membrane Oxygenation1 trial

Pharmacokinetics of Antibiotics During Extracorporeal Membrane Oxygenation (ECMO) Support

Terminated·—··NCT03922451·4 enrolled

Shoulder Arthroplasty1 trial

Can Addition of Doxycycline Perioperatively Reduce Propionibacterium Acnes in Shoulder Arthroplasty?

Completed·RRush University Medical Center·N/A·NCT03115177·56 enrolled

Melanoma1 trial

The Impact of an Antibiotic (Cefazolin) Before Surgery on the Microbiome in Patients With Stage I-II Melanoma

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT04875728·20 enrolled

Total Knee Arthroplasty1 trial

Preoperative Antibiotic Dosing for Total Knee Arthroplasty

Withdrawn·—·Phase 4·NCT02433704

Acne1 trial

P.Acnes Colony Count Following Subdermal Cefazolin

Unknown status·UUniversity of British Columbia·Phase 1·NCT03853096·20 enrolled

Prosthetic-joint Infection1 trial

The Influence of Antibiotic Prophylaxis on Intraoperative Prosthetic Joint Infection Cultures

Completed·PParc de Salut Mar·N/A·NCT02413034·28 enrolled

Joint Infection1 trial

Randomized Open-label Active-controlled Study to Assess the Safety, Tolerability, and Efficacy of Afabicin IV/Oral in the Treatment of Patients With Bone or Joint Infection Due to Staphylococcus

Terminated·DDebiopharm International SA·Phase 2·NCT03723551·67 enrolled

Cervical Insufficiency1 trial

Evaluating Azithromycin Prophylaxis and Mycoplasma Prevalence in High-Risk Pregnancies Requiring Cerclage: A Prospective Cohort Study

Not yet recruiting·WWake Forest University Health Sciences·Approved·NCT07608562·80 enrolled

Arthropathy of Knee1 trial

Perioperative Antibiotic Prophylaxis in Patients Undergoing Elective Total Knee Arthroplasty: A Prospective, Randomized, Open-label, Controlled Multi-center Trial

Completed·DDuke University·Approved·NCT03283878·1,770 enrolled

Unspecified1 trial

Cefazolin PK Study 3g vs 2g

Completed·BBaxter Healthcare Corporation·Phase 1·NCT05309304·24 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

ANCEF

NDA NDA050461

Jun 8, 1983

ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER

NDA NDA050566

Jul 27, 2000

CEFAZOLIN AND DEXTROSE

NDA NDA050779

Feb 1, 2021

CEFAZOLIN IN DEXTROSE

NDA NDA207131

Oct 7, 2022

CEFAZOLIN SODIUM

NDA NDA216109

May 8, 2023

CEFAZOLIN SODIUM

NDA NDA211413

Sources

References

[1]
ClinicalTrials.gov — 85 trial records for Cefazolin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Ancef drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Cefazolin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Cefazolin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA211413). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Baxter Healthcare Corporation 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: BBaxter Healthcare Corporation

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