TheraRadar
Data updated: May 26, 2026

CEPHALEXIN

Infectious Disease Approved 1976-04-26

CEPHALEXIN is indicated for the treatment of Respiratory Tract Infection; Otitis Media; Skin and Skin Structure Infection; Bone Infection; Genitourinary Tract Infection.

Source: FDA Label • Teva
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How CEPHALEXIN Works

Cephalexin is a bactericidal antibiotic that inhibits bacterial cell wall synthesis. It acts by binding to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, thereby blocking the final transpeptidation step of peptidoglycan synthesis. This leads to cell wall instability and subsequent bacterial lysis.

Source: FDA Label
33
Indications
--
Phase 3 Trials
50
Years on Market

Details

Status
Discontinued
First Approved
1976-04-26
Routes
ORAL
Dosage Forms
FOR SUSPENSION, TABLET, CAPSULE

Companies

Teva VITARINE APOTHECON STEVENS J ALKEM LABS LTD IVAX SUB TEVA PHARMS FACTA FARMA Lupin Aurobindo Pharma Sun Pharma YOSHITOMI ANDA REPOSITORY CHARTWELL RX YUNG SHIN PHARM AJENAT PHARMS Hikma PUREPAC PHARM
Active Ingredient: CEPHALEXIN

CEPHALEXIN Approval History

1977
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2026
Original
New Indication
New Form
Label Update
571 FDA actions from 1976 to 2025
May 2025 SUPPL
Label · Labeling
Dec 2024 SUPPL
Mfg · Manufacturing (CMC)
Sep 2024 ORIGINAL
Update

What CEPHALEXIN Treats

5 indications

CEPHALEXIN is approved for 5 conditions since its original approval in 1976. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Respiratory Tract Infection
  • Otitis Media
  • Skin and Skin Structure Infection
  • Bone Infection
  • Genitourinary Tract Infection
Source: FDA Label

CEPHALEXIN Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

DALBAVANCIN HYDROCHLORIDE
Fresenius Kabi
2025 1 indic.
CONTEPO
MEITHEAL
2025 2 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to CEPHALEXIN

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ACTICLATE
DOXYCYCLINE HYCLATE
1 shared
CHARTWELL RX
Shared indications:
Respiratory Tract Infection
AMOXICILLIN PEDIATRIC
AMOXICILLIN
1 shared
Teva
Shared indications:
Skin and Skin Structure Infection
AMPICILLIN SODIUM
AMPICILLIN SODIUM
1 shared
WATSON LABS INC
Shared indications:
Respiratory Tract Infection
View all 20 similar drugs Pro
📋

Clinical Trial Registry

24 trials
Trial Sponsor ID Phase Status Title
NCT01631617 120159 12-AR-0159 Ph 2 recruiting Effects of Treatments on Atopic Dermatitis
NCT04580472 IRB-19-482 Ph 4 active not recruiting Utility of Single-dose Oral Antibiotic Prophylaxis in Prevention of Surgical Site Infection in Dermatologic Surgery
NCT07300670 KEFALOS T2025/25858 2025-525059-23-00 Ph 1 recruiting The Effect of Losartan on Cephalexin
NCT05020574 217510 NCI-2021-08985 Ph 2 recruiting Microbiome and Association With Implant Infections
NCT05274672 022-046 Ph 4 withdrawn Role of Prophylactic Postoperative Antibiotics in HoLEP
NCT06055712 30873 Ph 4 enrolling by invitation Antibiotic Prophylaxis in Pediatric Open Fractures
NCT05852262 HI-DOCC 20230205-01T Ph 4 enrolling by invitation High-dose Cephalexin for Cellulitis (HI-DOCC)
NCT06127160 202303721 Ph 4 completed Patient-Directed Antimicrobial Duration in Acute Uncomplicated Pyelonephritis
NCT04297592 22-001273 Ph 4 enrolling by invitation Antibiotic Prophylaxis in High-Risk Arthroplasty Patients
NCT01912651 00046677 Ph 4 recruiting The Role of Antibiotics in Full Thickness Skin Graft Survival for Facial Reconstructive Surgery
NCT04471246 results posted 20200175 Ph 4 completed High-dose vs. Standard-dose Cephalexin for Cellulitis
NCT02014558 results posted 2215-CL-0101 Ph 1, Ph 2 completed Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of ASP2215 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
NCT03187106 PACT 17-0035 Ph 1 completed Prophylactic Antibiotics After Cesarean
NCT04834310 UCLA PRS Ph 4 withdrawn Postoperative Antibiotics Following Primary and Secondary Breast Augmentation
NCT03802552 18-2142 Ph 1 completed Cefadroxil and Cephalexin Drug Levels and Dosing in Pediatric Musculoskeletal Infections
NCT01595529 results posted 09-0103 Ph 2 completed The SCOUT Study: "Short Course Therapy for Urinary Tract Infections in Children"
NCT02569866 ESG180402 Ph 2 completed Antibiotics After Breast Reduction:Clinical Trial With Randomization
NCT02490670 results posted 16062 A3Q-ME-AFBS Ph 1 completed A Study of Cephalexin Liquid in Healthy Participants
NCT02123446 results posted 15313 A3Q-ME-AFBP Ph 1 completed A Study of Cephalexin Capsules in Healthy Participants
NCT02123472 results posted 15315 A3Q-ME-AFBR Ph 1 completed A Study of Cephalexin Liquid for Pediatrics in Healthy Adults Participants
NCT02123459 results posted 15314 A3Q-ME-AFBQ Ph 1 completed A Study of Cephalexin Suspension in Healthy Participants
NCT02100826 results posted 15312 A3Q-ME-AFBO Ph 1 completed A Study of Cephalexin in Healthy Participants
NCT00729937 results posted 07-0040 Ph 2, Ph 3 completed Strategies Using Off-Patent Antibiotics for Methicillin Resistant S. Aureus "STOP MRSA"
NCT04916951 20-2877 Ph 1 completed Oral Amoxicillin and Cephalexin PK/PD in Neonates
🔬

Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

CEPHALEXIN FDA Label Details

Indications & Usage

FDA Label (PDF)

CEPHALEXIN is indicated for the treatment of Respiratory Tract Infection; Otitis Media; Skin and Skin Structure Infection; Bone Infection; Genitourinary Tract Infection.

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Data Sources

FDA Approval: ANDA062777 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.