Keflex

(Cephalexin)

ApprovedSmall molecule

Keflex is a small molecule that works as a Bacterial Penicillin-Binding Protein Inhibitor.[2] It is being used across 21 indications, with its most advanced program in Approved.[1]

Keflex is one of 372 small molecule programs targeting Cellulitis. It is currently in Approved.

Indications

Total Trials

Active Trials

371

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

CellulitisActive, not recruiting

Bacterial DiseaseActive, not recruiting

ProstatitisActive, not recruiting

PyelonephritisActive, not recruiting

Skin InfectionActive, not recruiting

Respiratory Tract Infectious DisorderActive, not recruiting

Nasal CongestionApproved

Otitis MediaActive, not recruiting

Breast CancerApproved

Bladder CancerActive, not recruiting

CellulitisPreclinical

Active, not recruiting

Bacterial DiseaseApproved

Active, not recruiting

ProstatitisApproved

Active, not recruiting

PyelonephritisApproved

Active, not recruiting

Skin InfectionApproved

Active, not recruiting

Respiratory Tract Infectious DisorderApproved

Active, not recruiting

Nasal CongestionApproved

Approved

Otitis MediaApproved

Active, not recruiting

Breast CancerApproved

Approved

Bladder CancerPhase 3

Active, not recruiting

Showing 10 of 20 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Keflex

Eli Lilly

Approved

42 2

Cymbalta

Alnylam Pharmaceuticals

Preclinical

3 3

MS Contin

Merck & Co.

Preclinical

2 4

Lexiscan

Astellas

Preclinical

1 5

Blenoxane

Bristol-Myers Squibb

Preclinical

1 6

Effexor

WWyeth-Lederle Vaccines

Preclinical

2 7

Recentin

NNational Cancer Institute (NCI)

Preclinical

2 8

Avastin

Roche

Preclinical

4 9

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 10

Vfend

PPrism Pharmaceuticals

Preclinical

—

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

Timeline

Expected Milestones

Q3 2026

Post-ApprovalActive, not recruiting

Surgical Site Infection

NCT04580472

Q4 2026

Phase 2Recruiting

Implant Infection

NCT05020574

Q1 2027

Phase 2Recruiting

Eczema

NCT01631617

Clinical

Trials by Indication[1]

ART5 trials

The Effect of Losartan on Cephalexin

Recruiting·AAleksi Tornio·Phase 1·NCT07300670·12 enrolled

A Study of Cephalexin in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02100826·28 enrolled

A Study of Cephalexin Capsules in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02123446·28 enrolled

Show 2 more trials

A Study of Cephalexin Suspension in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02123459·28 enrolled

A Study of Cephalexin Liquid in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02490670·28 enrolled

Antibiotics5 trials

Strategies Using Off-Patent Antibiotics for Methicillin Resistant S. Aureus "STOP MRSA"

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2/3·NCT00729937·2,265 enrolled

Prophylactic Antibiotics After Cesarean

Completed·TThe University of Texas Medical Branch, Galveston·Phase 1·NCT03187106·321 enrolled

Postoperative Antibiotics Following Primary and Secondary Breast Augmentation

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

Show 2 more trials

Antibiotics for Prevention of SSI in Obese Women Undergoing CS

Unknown status·—·N/A·NCT03736187·280 enrolled

Role of Prophylactic Postoperative Antibiotics in HoLEP

Withdrawn·—·Phase 4·NCT05274672

Cellulitis3 trials

Study of New Antibiotic Regimen for the Treatment of Uncomplicated Cellulitis in Emergency Department Patients

Completed·—·N/A·NCT00676130·153 enrolled

High-dose vs. Standard-dose Cephalexin for Cellulitis

Completed·OOttawa Hospital Research Institute·Phase 4·NCT04471246·69 enrolled

High-dose Cephalexin for Cellulitis (HI-DOCC)

Enrolling by invitation·OOttawa Hospital Research Institute·Phase 4·NCT05852262·446 enrolled

Antibiotic Prophylaxis2 trials

Antibiotic Prophylaxis for Simple Hand Lacerations

Terminated·SState University of New York - Downstate Medical Center·N/A·NCT01155154·73 enrolled

Antibiotic Prophylaxis in Pediatric Open Fractures

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

Skin Infection2 trials

Comparison of Cephalexin Versus Clindamycin for Suspected CA-MRSA Skin Infections

Completed·AAaron Chen·Phase 4·NCT00352612·200 enrolled

A Study to Compare Cefdinir and Cephalexin for the Treatment of Mild to Moderate Uncomplicated Skin Infections

Completed·AAbbott·Phase 4·NCT00234949·380 enrolled

19 more indications

Surgical Site Infection2 trials

The Effect of Prophylactic Antibiotics on Surgical Site Infection Lower Limb Skin Excisions

Withdrawn·RRambam Health Care Campus·N/A·NCT03357419

Utility of Single-dose Oral Antibiotic Prophylaxis in Prevention of Surgical Site Infection in Dermatologic Surgery

Active, not recruiting·CCarilion Clinic·Phase 4·NCT04580472·574 enrolled

Pyelonephritis1 trial

Patient-Directed Antimicrobial Duration in Acute Uncomplicated Pyelonephritis

Completed·BBrett A Faine·Phase 4·NCT06127160·35 enrolled

Pregnancy1 trial

Treatment of Asymptomatic Bacteriuria in Pregnancy

Terminated·TTrinity Health Michigan·N/A·NCT02911662·13 enrolled

Bladder Cancer1 trial

S9809, Ciprofloxacin Compared With Cephalexin in Treating Patients With Bladder Cancer

Terminated·SSWOG Cancer Research Network·Phase 3·NCT00003824·114 enrolled

Urinary Tract Infection1 trial

The SCOUT Study: "Short Course Therapy for Urinary Tract Infections in Children"

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT01595529·717 enrolled

Clinical Trial1 trial

Antibiotics After Breast Reduction:Clinical Trial With Randomization

Completed·FFederal University of São Paulo·Phase 2·NCT02569866·124 enrolled

Staphylococcus Aureus1 trial

Antibiotic Treatment Of Staphylococcus Aureus In Stable People With CF

Unknown status·UUniversity of British Columbia·Phase 3·NCT04553419·86 enrolled

Pediatrics1 trial

A Study of Cephalexin Liquid for Pediatrics in Healthy Adults Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02123472·28 enrolled

Antibiotic1 trial

Placebo Controlled Study of Antibiotic Treatment of Soft Tissue Infection

Completed·UUniversity of California, San Francisco·N/A·NCT00187759·500 enrolled

Tuberculosis1 trial

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

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

Acute Myeloid Leukemia1 trial

Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of ASP2215 in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Completed· Astellas logo

Astellas·Phase 1/2·NCT02014558·265 enrolled

Implant Infection1 trial

Microbiome and Association With Implant Infections

Recruiting·UUniversity of California, San Francisco·Phase 2·NCT05020574·200 enrolled

PK/PD1 trial

Oral Amoxicillin and Cephalexin PK/PD in Neonates

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

Musculoskeletal1 trial

Cefadroxil and Cephalexin Drug Levels and Dosing in Pediatric Musculoskeletal Infections

Completed·UUniversity of Colorado, Denver·Phase 1·NCT03802552·17 enrolled

Mastectomy1 trial

SSI Rates in Patients Undergoing Mastectomy Without Reconstruction- A Multicenter, Double-blinded RCT.

Unknown status·—·Phase 3·NCT04577846·384 enrolled

Eczema1 trial

Effects of Treatments on the Microbiome in Healthy Volunteers and Patients With Atopic Dermatitis

Recruiting·NNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)·Phase 2·NCT01631617·130 enrolled

Infections Joint Prosthetic1 trial

Antibiotic Prophylaxis in High-Risk Arthroplasty Patients

Enrolling by invitation·MMayo Clinic·Approved·NCT04297592·4,618 enrolled

Facial Defect1 trial

The Role of Antibiotics in Full Thickness Skin Graft Survival for Facial Reconstructive Surgery

Completed·UUniversity of Michigan·Approved·NCT01912651·236 enrolled

Unspecified6 trials

Bioequivalence Study of Cephalexin Suspension 125

Completed· GSK logo

GSK·Phase 1·NCT01767532·28 enrolled

Bioequivalence Study of Cephalexin Suspension 250

Completed· GSK logo

GSK·Phase 1·NCT01767571·28 enrolled

Bioequivalence Study of Cephalexin Tablets 1g

Completed· GSK logo

GSK·Phase 1·NCT01767584·26 enrolled

Show 3 more trials

Cross-over Study to Prove Bioequivalence Between Two Brands of Cefalexin Suspension

Completed· Bayer logo

Bayer·Phase 1·NCT01073540·26 enrolled

Cross Over Study to Prove Bioequivalence Between Two Brands of Cefalexin Suspension

Completed· Bayer logo

Bayer·Phase 1·NCT01105208·26 enrolled

Cross-over Study to Prove Bioequivalence Between Two Brands of Cefalexin Capsules

Completed· Bayer logo

Bayer·Phase 1·NCT01073553·26 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

KEFLEX

NDA NDA050405

Jan 1, 1982

KEFLEX

NDA NDA050406

Jan 1, 1982

KEFLET

NDA NDA050440

Oct 29, 1987

KEFTAB

NDA NDA050614

Sources

References

[1]
ClinicalTrials.gov — 42 trial records for Cephalexin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Cephalexin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Cephalexin. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA050614). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Eli Lilly company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Bacterial Penicillin-Binding Protein Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Eli Lilly

Keflex

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q1 2027

Trials by Indication[1]

ART5 trials

Antibiotics5 trials

Cellulitis3 trials

Antibiotic Prophylaxis2 trials

Skin Infection2 trials

Surgical Site Infection2 trials

Pyelonephritis1 trial

Pregnancy1 trial

Bladder Cancer1 trial

Urinary Tract Infection1 trial

Clinical Trial1 trial

Staphylococcus Aureus1 trial

Pediatrics1 trial

Antibiotic1 trial

Tuberculosis1 trial

Acute Myeloid Leukemia1 trial

Implant Infection1 trial

PK/PD1 trial

Musculoskeletal1 trial

Mastectomy1 trial

Eczema1 trial

Infections Joint Prosthetic1 trial

Facial Defect1 trial

Unspecified6 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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