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clarithromycin

Trade name: biaxin

Small moleculeapproved

Approved

Oct 31, 1991

Clarithromycin is an antibacterial drug which is used either in combination with lansoprazole and amoxicillin (Prevpac), in combination with omeprazole and amoxicillin (Omeclamox) or alone (Biaxin) for the treatment of broad range of infections. The drug exerts its action by binding to 23s rRNA (with nucleotides in domains II and V). The binding leads to the protein synthesis inhibition and the cell death. — NCATS

Clinical trial activity

407 trials · 423 clinical orgs · 28 marketing orgs

Phase 1
71
Phase 2
125
Phase 3
87
Phase 4
129

Earliest trial started Jan 1, 1991 (NCT00004689)

Timeline

1990s

  1. Jan 1, 1991

    Earliest Phase 2 Sponsor(trial)

  2. Oct 31, 1991

    AbbVie — Earliest FDA Approval

  3. Oct 31, 1991

    AbbVie — NDA Secondary Org

  4. Oct 31, 1991

    AbbVie — NDA Organization

  5. Jan 1, 1995

    Earliest Phase 3 Sponsor(trial)

  6. Dec 2, 1997

    Takeda — Marketing Organization

  7. Dec 2, 1997

    Takeda — NDA Secondary Org

  8. Jan 1, 1999

    Earliest Phase 1 Sponsor(trial)

2000s

  1. May 25, 2004

    West-Ward Pharmaceutical — Marketing Organization

  2. May 25, 2004

    Hikma — Marketing Organization

  3. Jun 24, 2004

    Actavis — Marketing Organization

  4. Sep 24, 2004

    Sun Pharmaceuticals — Marketing Organization

  5. Jan 26, 2005

    Ranbaxy — Marketing Organization

  6. Mar 11, 2005

    Mylan — Marketing Organization

  7. May 18, 2005

    Mayne Pharma — Marketing Organization

  8. May 18, 2005

    Dr. Reddy's Laboratories — Marketing Organization

  9. Aug 25, 2005

    Ani Pharmaceuticals — Marketing Organization

  10. Aug 25, 2005

    Novartis — Marketing Organization

  11. May 31, 2006

    Wockhardt — Marketing Organization

  12. Aug 20, 2007

    Apotex — Marketing Organization

  13. Aug 20, 2007

    Chartwell Pharmaceuticals — Marketing Organization

2010s

  1. Feb 8, 2011

    Cumberland Pharmaceuticals — Marketing Organization

  2. Feb 8, 2011

    Cumberland Pharmaceuticals — NDA Secondary Org

  3. Jul 25, 2012

    Aurobindo Pharma — Marketing Organization

  4. Jun 10, 2013

    Strides Pharma Science — Marketing Organization

  5. Aug 30, 2013

    Teva — Marketing Organization

  6. Mar 4, 2014

    Sandoz — Marketing Organization

  7. Sep 15, 2015

    Lupin — Marketing Organization

  8. Feb 29, 2016

    Allied Pharmaceutical Services — Marketing Organization

  9. Feb 29, 2016

    Nostrum Laboratories — Marketing Organization

  10. Oct 7, 2016

    Rising Pharmaceuticals — Marketing Organization

  11. Jul 9, 2018

    Sunshine Lake Pharma Co., Ltd. — Marketing Organization

  12. Apr 25, 2019

    Ajanta Pharma Ltd — Marketing Organization

2020s

  1. Jan 31, 2022

    Alembic — Marketing Organization

  2. May 3, 2022

    Phathom Pharmaceuticals, Inc. — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Combination products

  • omeclamox-pak

    with amoxicillin, omeprazole

  • prevpac (copackaged)

    with amoxicillin, lansoprazole

    Also known as lansoprazole, amoxicillin and clarithromycin (copackaged)

  • voquezna triple pak

    with amoxicillin, vonoprazan

    Also known as vonoprazan, amoxicillin, and clarithromycin, vonoprazan+amoxicillin+clarithromycin 14 days, vonoprazan+amoxicillin+clarithromycin 7 days

Approval history

  • approvedPriority reviewOct 31, 1991

Chemistry & pharmacology

Loading structure…

SMILES

CC[C@H]1OC(=O)[C@H](C)[C@@H](O[C@H]2C[C@@](C)(OC)[C@@H](O)[C@H](C)O2)[C@H](C)[C@@H](O[C@@H]3O[C@H](C)C[C@@H]([C@H]3O)N(C)C)[C@@](C)(C[C@@H](C)C(=O)[C@H](C)[C@@H](O)[C@]1(C)O)OC
Mol. weight
747.9534 g/mol
Lipinski Ro5
2 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • 6-o-methylerythromycin
  • 6-o-methylerythromycin
  • 6-o-methyl erythromycin
  • 6-o-methyl erythromycin
  • 6-o-methylerythromycin a
  • 6-o-methylerythromycin a
  • 6-o-methylerythromycin a
  • a-56268
  • a-56268
  • abbott-56268
  • abbott-56268
  • biaxin
  • biaxin
  • biaxin
  • biaxin
  • biaxin xl
  • biaxin xl
  • biaxin xl pac
  • cla
  • cla
  • clamicin
  • clarie xl
  • clarithomycin
  • clarithromycin
  • clarithromycin
  • clarithromycin
  • clarithromycin
  • clarithromycin
  • clarithromycin
  • clarithromycin
  • clarithromycin
  • clarithromycin
  • clarithromycin
  • clarithromycin
  • clarithromycina
  • clarithromycina
  • clarithromycine
  • clarithromycine
  • clarithromycin extended release
  • clarithromycin extended release
  • clarithromycinum
  • clarithromycinum
  • claritromycin
  • clarosip
  • clathromycin
  • febzin xl
  • klaricid
  • klaricid
  • klaricid
  • klaricid 500
  • klaricid adult
  • klaricid i.v.
  • klaricid paed
  • klaricid xl
  • klaricid xl
  • mycifor xl
  • prevpac
  • te-031
  • te-031
  • xetinin xl
  • zeclar
  • zeclar
  • zeclar

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07104318Phase 3Jan 1, 2026Department of Veteran Affairs
NCT07021729Phase 4Dec 31, 2025Rehman Medical Institute, Rehman Medical Institute - RMI
NCT07293910Phase 2Dec 20, 2025Tanta University
NCT07115173Phase 4Dec 1, 2025Sungkyunkwan University
NCT07179159N/ASep 9, 2025Qilu Hospital of Shandong University, Shandong University, Shandong University of Traditional Chinese Medicine, Zibo Maternal and Child Health Hospital
NCT07294846Phase 1Sep 8, 2025Sinorda Biomedicine
NCT07040839Phase 4Jul 31, 2025Rehman Medical Institute - RMI
NCT07040787Phase 1Jul 8, 2025Suzhou Suncadia Biopharmaceuticals Co., Ltd.
NCT06964334Phase 3Jun 1, 2025Assiut University
NCT07068607Phase 4Apr 1, 2025People's Liberation Army of China
NCT06959368Phase 4Mar 25, 2025Asian Institute of Gastroenterology
NCT06837259Phase 1Mar 21, 2025Pfizer
NCT07086937N/AJan 1, 2025RESnTEC, Institute of Research, Ziauddin University
NCT06514274Phase 4Oct 31, 2024People's Liberation Army of China
NCT06523764Phase 4Sep 30, 2024People's Liberation Army of China
NCT06200779Phase 4Sep 30, 2024Unilabs A/S
NCT06591494Phase 2/Phase 3 (Phase 3)Sep 15, 2024Zhejiang University
NCT06510010Phase 2Aug 31, 2024Sun Yat-Sen University
NCT06551623Phase 1Aug 26, 2024Jinlin University, TenNor Therapeutics Ltd
NCT06396078Phase 4Jul 18, 2024Ohio State University
Showing 20 of 407 trials
Page 1 / 21

Organizations

Research & Development (423)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
People's Liberation Army of ChinaGovernment181522010
Kaohsiung Medical UniversityAcademic/Hospital17742007
National Taiwan UniversityAcademic/Hospital141232006
Shandong UniversityAcademic/Hospital131322013
AbbottFor profit12551991
Seoul National UniversityAcademic/Hospital9852005
TakedaFor profit9742010
Cornell UniversityAcademic/Hospital8822004
National Institute of Allergy and Infectious Diseases (NIAID)Government8841999
Taichung Veterans General HospitalAcademic/Hospital8732007
Zhejiang UniversityAcademic/Hospital8632016
CelgeneFor profit7022004
CJ HealthCare Corp.For profit6532013
Fudan UniversityAcademic/Hospital6532014
Jiao Tong UniversityAcademic/Hospital6612012
National Cancer Institute (NCI)Government6131995
Chang Gung UniversityAcademic/Hospital5322006
Government of TaiwanGovernment5232006
Mackay Medical CollegeAcademic/Hospital5322014
RanbaxyFor profit5522002
423 organizations
Page 1 / 22

Marketing (40)

OrganizationOrg typeRelationshipDate
AbbVieFor profitNDA2Oct 31, 1991
AbbVieFor profitSYNDec 23, 1993
AbbVieFor profitNDAOct 31, 1991
ActavisFor profitMKTGJun 24, 2004
Ajanta Pharma LtdFor profitMKTGApr 25, 2019
AlembicFor profitMKTGJan 31, 2022
Allied Pharmaceutical ServicesFor profitMKTGFeb 29, 2016
Ani PharmaceuticalsFor profitMKTGAug 25, 2005
Ani PharmaceuticalsFor profitSYNAug 25, 2005
ApotexFor profitMKTGAug 20, 2007
Aurobindo PharmaFor profitMKTGJul 25, 2012
Chartwell PharmaceuticalsFor profitMKTGAug 20, 2007
Cumberland PharmaceuticalsFor profitMKTGFeb 8, 2011
Cumberland PharmaceuticalsFor profitNDA2Feb 8, 2011
Dr. Reddy's LaboratoriesFor profitMKTGMay 18, 2005
HikmaFor profitMKTGMay 25, 2004
HikmaFor profitSYNMay 25, 2004
LupinFor profitMKTGSep 15, 2015
Mayne PharmaFor profitMKTGMay 18, 2005
MylanFor profitMKTGMar 11, 2005
Nostrum LaboratoriesFor profitMKTGFeb 29, 2016
NovartisFor profitMKTGAug 25, 2005
Phathom Pharmaceuticals, Inc.For profitNDA2May 3, 2022
RanbaxyFor profitMKTGJan 26, 2005
Rising PharmaceuticalsFor profitMKTGOct 7, 2016
Rising PharmaceuticalsFor profitSYNOct 7, 2016
SandozFor profitSYNAug 25, 2005
SandozFor profitMKTGMar 4, 2014
Strides Pharma ScienceFor profitMKTGJun 10, 2013
Sun PharmaceuticalsFor profitMKTGSep 24, 2004
Sunshine Lake Pharma Co., Ltd.For profitSYNJul 9, 2018
Sunshine Lake Pharma Co., Ltd.For profitMKTGJul 9, 2018
Sunshine Lake Pharma Co., Ltd.For profitMKTGSep 28, 2015
TakedaFor profitMKTGDec 2, 1997
TakedaFor profitNDA2Dec 2, 1997
TevaFor profitSYNMay 31, 2005
TevaFor profitSYNMay 31, 2005
TevaFor profitMKTGAug 30, 2013
West-Ward PharmaceuticalFor profitMKTGMay 25, 2004
WockhardtFor profitMKTGMay 31, 2006