cefadroxil

Trade name: duricef

Small moleculeapproved

Approved

Feb 17, 1978

Cefadroxil is a new semisynthetic cephalosporin with a broad antibacterial spectrum and a high chemotherapeutic potential when administered orally. Many studies have established the efficacy of the administration of once- or twice-daily cefadroxil in the management of infections in the respiratory tract, urinary tract, skin and soft tissues, and bones and joints. — NCATS

Clinical trial activity

11 trials · 14 clinical orgs · 15 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Jan 1, 2002 (NCT00405158)

Timeline

1970s

Feb 17, 1978
Warner Chilcott — Earliest FDA Approval
Feb 17, 1978
Warner Chilcott — NDA Secondary Org
Feb 17, 1978
Warner Chilcott — NDA Organization

1980s

Jul 30, 1980
Sandoz — Marketing Organization
Mar 3, 1987
Teva — Marketing Organization
Jan 5, 1989
Puracap Pharmaceutical — Marketing Organization
Mar 1, 1989
Ani Pharmaceuticals — Marketing Organization

1990s

Jun 22, 1999
Ranbaxy — Marketing Organization

2000s

Mar 26, 2003
Sun Pharmaceuticals — Marketing Organization
Jan 1, 2004
Teva — Earliest Phase 1 Sponsor(trial)
Sep 18, 2006
Orchid Pharma — Marketing Organization
Sep 18, 2006
Chartwell Pharmaceuticals — Marketing Organization
May 29, 2007
Lupin — Marketing Organization

2010s

Nov 28, 2012
Hikma — Marketing Organization
Apr 25, 2013
Aurobindo Pharma — Marketing Organization
Jul 28, 2017
Shijiazhuang Pharma Group (CSPC) — Marketing Organization

2020s

Jan 1, 2021
Earliest Phase 3 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Bacterial penicillin-binding proteinINHIBITOR
Bacterial penicillin-binding protein inhibitor

Approval history

approvedFeb 17, 1978

Chemistry & pharmacology

Loading structure…

SMILES

CC1=C(N2[C@H](SC1)[C@H](NC(=O)[C@H](N)C3=CC=C(O)C=C3)C2=O)C(O)=O

Mol. weight: 363.388 g/mol
Lipinski Ro5: Pass
Rule of 3: No
Chirality: Single Stereoisomer
Inorganic: No
Polymer: No
Delivery: Oral
Availability: Prescription Only

Oral

Yes

Parenteral

Topical

Sources

Also known as

baxan
baxan
bl-s578
bl-s578
cdx
cdx
cefadrops
cefadrops
cefadrox
cefadroxil
cefadroxil
cefadroxil
cefadroxil
cefadroxil
cefadroxil
cefadroxil
cefadroxil
cefadroxil
cefadroxil
cefadroxil
cefadroxil anhydrous
cefadroxil anhydrous
cefadroxil/cefadroxil hemihydrate
cefadroxil/cefadroxil hemihydrate
cefadroxil/cefadroxil hemihydrate
cefadroxil hemihydrate
cefadroxil monohydrate
cefadroxilo
cefadroxilo
cefadroxilum
cefadroxilum
cefatabs
cephadroxil
cephadroxil
cephadroxil
d-cefadroxil
d-cefadroxil
duricef
duricef
duricef
duricef
mjf-11567-3
mjf-11567-3
ultracef
ultracef

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT05977868	Phase 4	Aug 4, 2023	West Virginia University
NCT04723940	Phase 3	Jan 25, 2021	Thomas Jefferson University
NCT03802552	Phase 1	Jun 1, 2019	University of Colorado, Denver
NCT02140281	Phase 1	May 1, 2014	Ardelyx, IQVIA
NCT02446496	Phase 4	Mar 1, 2014	GlaxoSmithKline
NCT02479867	Phase 1	Mar 1, 2014	Genuine Research Center, Egypt, GlaxoSmithKline
NCT01244698	Phase 4	Nov 1, 2010	Ben Gurion University, Plastic Surgery Educational Foundation, Stony Brook University
NCT03877289	Phase 4	Oct 31, 2008	University of Calgary
NCT00834275	Phase 1	Sep 1, 2004	Biovail, Teva
NCT00835081	Phase 1	Sep 1, 2004	Biovail, Teva
NCT00405158	N/A	Jan 1, 2002	Karlstad University

Showing 11 of 11 trials

Page 1 / 1

Organizations

Research & Development (14)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Biovail	For profit	2	0	1	2004
GlaxoSmithKline	For profit	2	1	2	2014
Teva	For profit	2	2	1	2004
Ardelyx	For profit	1	1	1	2014
Ben Gurion University	Academic/Hospital	1	0	1	2010
Genuine Research Center, Egypt	For profit	1	1	1	2014
IQVIA	For profit	1	0	1	2014
Karlstad University	Academic/Hospital	1	1	1	2002
Plastic Surgery Educational Foundation	Academic/Hospital	1	0	1	2010
Stony Brook University	Academic/Hospital	1	1	1	2010
Thomas Jefferson University	Academic/Hospital	1	1	1	2021
University of Calgary	Academic/Hospital	1	1	1	2008
University of Colorado, Denver	Academic/Hospital	1	1	1	2019
West Virginia University	Academic/Hospital	1	1	1	2023

14 organizations

Page 1 / 1

Marketing (22)

Organization	Org type	Relationship	Date
Ani Pharmaceuticals	For profit	MKTG	Mar 1, 1989
Ani Pharmaceuticals	For profit	SYN	Mar 1, 1989
Apothecon	For profit	MKTG	—
Aurobindo Pharma	For profit	MKTG	Apr 25, 2013
Aurobindo Pharma	For profit	SYN	Jan 25, 2007
Bristol-Myers	For profit	MKTG	—
Chartwell Pharmaceuticals	For profit	MKTG	Sep 18, 2006
Hikma	For profit	SYN	Feb 7, 2006
Hikma	For profit	MKTG	Nov 28, 2012
Lupin	For profit	MKTG	May 29, 2007
Orchid Pharma	For profit	MKTG	Sep 18, 2006
Puracap Pharmaceutical	For profit	MKTG	Jan 5, 1989
Ranbaxy	For profit	SYN	Apr 23, 1999
Ranbaxy	For profit	MKTG	Jun 22, 1999
Sandoz	For profit	MKTG	Jul 30, 1980
Shijiazhuang Pharma Group (CSPC)	For profit	MKTG	Jul 28, 2017
Sun Pharmaceuticals	For profit	MKTG	Mar 26, 2003
Teva	For profit	MKTG	Mar 3, 1987
Teva	For profit	SYN	Feb 10, 1989
Teva	For profit	SYN	Apr 8, 1987
Warner Chilcott	For profit	NDA2	Feb 17, 1978
Warner Chilcott	For profit	NDA	Feb 17, 1978