TheraRadar
Data updated: Nov 8, 2026

KEFLEX (cephalexin) · PRAGMA

Trial Activity: Mature 9 active trials
Infectious Disease Approved 1971-01-04

KEFLEX is FDA-approved to treat 5 conditions (same as CEPHALEXIN).

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

Development Insights

Eli Lilly and Company conducting 5 trials (21%)
37 indications explored (Broad Platform)
→ surgical site infection (4 trials)
→ healthy volunteers (4 trials)
→ cellulitis (3 trials)
5
Indications
--
Phase 3 Trials
55
Years on Market

Details

Status
Discontinued
First Approved
1971-01-04
Routes
ORAL
Dosage Forms
CAPSULE, FOR SUSPENSION

Companies

PRAGMA
Active Ingredient: CEPHALEXIN

KEFLEX Approval History

1972
1973
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2026
Original
New Indication
New Form
Label Update
420 FDA actions from 1971 to 2026 · 4 indication expansions
Aug 2026 SUPPL
Label · Labeling
FDA Letter Label
Mar 2026 SUPPL
Label · Labeling
FDA Letter Label
Sep 2019 SUPPL
Label · Labeling
Label

What KEFLEX Treats

5 indications

KEFLEX is approved for 5 conditions since its original approval in 1971. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as CEPHALEXIN (same active ingredient).

Source: FDA Label
📋

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, 2025 Ph 1 completed 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NCT05274672 022-046 Ph 4 withdrawn Role of Prophylactic Postoperative Antibiotics in HoLEP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 completed High-dose Cephalexin for Cellulitis (HI-DOCC)
NCT06127160 results posted 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 completed 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

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

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.

KEFLEX FDA Label Details

Indications & Usage

FDA Label (PDF)

KEFLEX is FDA-approved to treat 5 conditions — same approved indications as CEPHALEXIN.

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Data Sources

FDA Approval: NDA050405 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment