Data updated: May 26, 2026
KEFLET (cephalexin)
Infectious Disease
Approved 1972-10-12
4
Indications
--
Phase 3 Trials
53
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1972-10-12
- Routes
- ORAL
- Dosage Forms
- TABLET
KEFLET Approval History
1973
1974
1975
1976
1977
1978
1979
1980
1981
1982
1983
1984
1985
1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
117 FDA actions from 1972 to 1992 · 1 indication expansions
Feb 1992 SUPPL
Label · Labeling
Jul 1991 SUPPL
Label · Labeling
Apr 1990 SUPPL
Label · Labeling
Jan 1987 SUPPL
Mfg
Dec 1986 ORIGINAL
Update
Jul 1986 SUPPL
Label
Nov 1985 SUPPL
Label
Sep 1985 SUPPL
Label
Sep 1984 SUPPL
Mfg
Sep 1983 SUPPL
Label
Aug 1983 SUPPL
Mfg
Feb 1983 SUPPL
Mfg
Sep 1982 SUPPL
Label
Mar 1982 SUPPL
Mfg
Sep 1981 SUPPL
Label
Feb 1981 SUPPL
Mfg
Dec 1980 SUPPL
Label
May 1980 SUPPL
Label
Mar 1980 SUPPL
Mfg
Mar 1980 SUPPL
Mfg
Nov 1979 SUPPL
Label
May 1979 SUPPL
Label
Apr 1979 SUPPL
Mfg
Jan 1979 SUPPL
Label
Nov 1978 SUPPL
Efficacy
May 1978 SUPPL
Mfg
May 1977 SUPPL
Mfg
Mar 1977 SUPPL
Mfg
Feb 1977 SUPPL
Label
Nov 1976 SUPPL
Mfg
Nov 1976 SUPPL
Label
Nov 1975 SUPPL
Label
Oct 1975 SUPPL
Mfg
Jun 1975 SUPPL
Label
Dec 1974 SUPPL
Mfg
Oct 1972 ORIGINAL
Update
What KEFLET Treats
4 FDA approvalsOriginally approved for its first indication in 1972 . Covers 4 distinct patient populations.
- Other (4)
Other
(4 approvals)- • Approved indication (Oct 1972)
- • Approved indication (Nov 1978)
- • Approved indication (Sep 1982)
- • Approved indication (Dec 1986)
📋
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| NCT05274672 | 022-046 | Ph 4 | withdrawn | Role of Prophylactic Postoperative Antibiotics in HoLEP |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 |
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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📊
Trial Timeline
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.
KEFLET FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.