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azithromycin

Trade name: zithromax

Small moleculeapproved

Approved

Nov 1, 1991

Azithromycin is one of the world's best-selling antibiotics, used to treat or prevent certain bacterial infections: Acute bacterial exacerbations of chronic bronchitis in adults; acute bacterial sinusitis in adults; uncomplicated skin and skin structure infections in adults; urethritis and cervicitis in adults; genital ulcer disease in men; acute otitis media in pediatric patients; community-acquired pneumonia in adults and pediatric patients; pharyngitis/tonsillitis in adults and pediatric patients. Azithromycin should not be used in patients with pneumonia who are judged inappropriate for oral therapy because of moderate to severe illness or risk factors. A team of researchers at the Croatian pharmaceutical company Pliva, discovered azithromycin in 1980. It was patented in 1981. In 1986, Pliva and Pfizer signed a licensing agreement, which gave Pfizer exclusive rights for the sale of azithromycin in Western Europe and the United States. Pliva put its azithromycin on the market in Central and Eastern Europe under the brand name of Sumamed in 1988. Pfizer launched azithromycin under Pliva's license in other markets under the brand name Zithromax in 1991. Azithromycin is a semi-synthetic macrolide antibiotic of the azalide class. Like other macrolide antibiotics, azithromycin inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit of the bacterial 70S ribosome. Binding inhibits peptidyl transferase activity and interferes with amino acid translocation during the process of translation. Its effects may be bacteriostatic or bactericidal depending of the organism and the drug concentration. Its long half-life, which enables once daily dosing and shorter administration durations, is a property distinct from other macrolides. — NCATS

Clinical trial activity

557 trials · 576 clinical orgs · 39 marketing orgs

Phase 1
67
Phase 2
246
Phase 3
163
Phase 4
147

Earliest trial started Feb 1, 1993 (NCT00599079)

Timeline

1980s

  1. Jun 1, 1981

    Pliva — IND Organization

  2. Jun 1, 1981

    Pliva — IND Organization

1990s

  1. Nov 1, 1991

    Earliest FDA Approval

  2. Jan 1, 1998

    Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 1999

    Pfizer — Earliest Phase 1 Sponsor(trial)

  4. Jan 1, 1999

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Jun 10, 2005

    Pfizer — First NDA Organization

  2. Jun 10, 2005

    Pfizer — NDA Organization

  3. Nov 14, 2005

    Pliva — Marketing Organization

  4. Nov 14, 2005

    Novartis — Marketing Organization

  5. Nov 14, 2005

    Teva — Marketing Organization

  6. Dec 13, 2005

    Fresenius — Marketing Organization

  7. Jul 6, 2006

    Barr Laboratories — Marketing Organization

  8. Dec 19, 2006

    Teva — NDA Secondary Org

  9. Jan 8, 2007

    Mylan — Marketing Organization

  10. Jan 18, 2007

    Hikma — Marketing Organization

  11. Jan 18, 2007

    Shijiazhuang Pharma Group (CSPC) — Marketing Organization

  12. Apr 27, 2007

    Akorn, Inc. — NDA Secondary Org

  13. Apr 27, 2007

    Akorn, Inc. — Marketing Organization

  14. Apr 27, 2007

    Thea Pharma — Marketing Organization

  15. Apr 27, 2007

    Thea Pharma — NDA Secondary Org

  16. May 30, 2007

    EXTROVIS — Marketing Organization

  17. May 30, 2007

    PHARMOBEDIENT — Marketing Organization

  18. Feb 11, 2008

    Wockhardt — Marketing Organization

  19. Feb 11, 2008

    Chartwell Pharmaceuticals — Marketing Organization

  20. Jun 26, 2009

    Hospira — Marketing Organization

  21. Nov 9, 2009

    Gland Pharma Ltd — Marketing Organization

2010s

  1. Jul 13, 2011

    Apotex — Marketing Organization

  2. Apr 2, 2013

    Sun Pharmaceuticals — Marketing Organization

  3. Feb 24, 2014

    Sandoz — Marketing Organization

  4. May 15, 2015

    Lupin — Marketing Organization

  5. Jun 19, 2015

    Aurobindo Pharma — Marketing Organization

  6. Jun 19, 2015

    Eugia Pharma — Marketing Organization

  7. Aug 26, 2016

    Novel Anti-Infective Technologies, LLC — Marketing Organization

  8. Jan 26, 2017

    Rising Pharmaceuticals — Marketing Organization

  9. Apr 9, 2018

    Epic Pharma Llc — Marketing Organization

  10. Jul 19, 2018

    Amneal Pharmaceuticals — Marketing Organization

  11. Jul 31, 2018

    Zydus Discovery DMCC — Marketing Organization

  12. Oct 9, 2018

    Hainan Poly Pharm — Marketing Organization

  13. Oct 9, 2018

    SLATE RUN PHARMA — Marketing Organization

  14. Dec 6, 2018

    Sunshine Lake Pharma Co., Ltd. — Marketing Organization

  15. Dec 26, 2018

    Bionpharma Inc — Marketing Organization

  16. Dec 11, 2019

    Taro Pharmaceuticals — Marketing Organization

2020s

  1. Jan 27, 2020

    Alembic — Marketing Organization

  2. May 8, 2020

    Yung Shin Pharm. Ind. Co., Ltd. — Marketing Organization

  3. May 8, 2020

    Ionis Pharmaceuticals, Inc. — Marketing Organization

  4. Jul 12, 2022

    ACI Limited — Marketing Organization

  5. Jul 12, 2022

    Strides Pharma Science — Marketing Organization

  6. Jul 27, 2023

    ZHEJIANG POLY PHARM — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedPriority reviewNov 1, 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)(O)C[C@@H](C)CN(C)[C@H](C)[C@@H](O)[C@]1(C)O
Mol. weight
748.9845 g/mol
Lipinski Ro5
2 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • arzomicin
  • azasite
  • azasite
  • aziromycin
  • azithromcyin
  • azithromycin
  • azithromycin
  • azithromycin
  • azithromycin
  • azithromycin
  • azithromycin
  • azithromycin
  • azithromycin
  • azithromycin
  • azithromycin a
  • azithromycin anhydrous
  • azithromycin dihydrate
  • azithromycin dihydrate
  • azithromycin dihydrate
  • azithromycine
  • azithromycine
  • azithromycin hydrate
  • azithromycin monohydrate
  • azithromycinum
  • azithromycinum
  • azitromicina
  • azitromicina
  • azitromycin
  • azitromycin
  • azyter
  • azyter
  • clamelle
  • cp 62993
  • cp-62993
  • cp-62993
  • cp-62993
  • cp-62993
  • cp-62993
  • cp-62993
  • sumamed
  • sumamed
  • sunamed
  • xz-450
  • xz-450
  • zithromax
  • zithromax
  • zithromax
  • zithromax
  • zmax
  • zmax

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07306234Phase 4Mar 1, 2026Korea University
NCT06906757N/ASep 30, 2025University of Melbourne
NCT07164131Phase 4Sep 15, 2025Mayo Clinic
NCT07183462Phase 4Sep 10, 2025Tel Aviv University
NCT07052942Phase 4Aug 1, 2025Advent Health, DARTNet Institute, Icahn School of Medicine at Mount Sinai, Kelsey Research Foundation, Pennsylvania State University, RAND Corporation, Reliant Medical Group, Rutgers University, University of Colorado, Denver, University of Kansas, University of Missouri, University of North Carolina at Chapel Hill, University of Washington, Wake Forest University
NCT07084402Phase 4Jul 24, 2025Capital Medical University, MicuRx, Peking University
NCT07213765Phase 4Jul 24, 2025Anhui Medical University, Capital Medical University, Guangzhou Chest Hospital., Huazhong University of Science and Technology, Jiangxi Chest Hospital, MicuRx, Peking University
NCT06958146Phase 4May 1, 2025Government of Pakistan
NCT06921525Phase 1/Phase 2 (Phase 2)Apr 1, 2025Benha University, Tanta University
NCT06461429N/AFeb 1, 2025La Trobe University, Mater Medical Research Institute, Menzies School of Health Research, Monash University, University of Adelaide, University of Auckland, University of Melbourne, University of New South Wales, University of Sydney, University of Tasmania, University of Western Australia
NCT06715150Phase 4Jan 10, 2025University of Santiago de Compostela
NCT06325293N/AJan 1, 2025University of Zurich
NCT06605118Phase 3Nov 4, 2024George Washington University, National Institutes of Health (NIH), University of Alabama, Birmingham, University of North Carolina at Chapel Hill
NCT06618534Phase 2Oct 31, 2024Centers for Disease Control and Prevention (CDC), Emory University, State of Georgia
NCT06584474N/AOct 2, 2024Alexandria University
NCT06409299Phase 3Sep 1, 2024University of Copenhagen
NCT06349122Phase 4Aug 31, 2024Aix-University of Marseille
NCT05763693Phase 4Jul 31, 2024Centre de Recherche en Sante de Nouna, Burkina Faso, University of California, San Francisco
NCT06289647Phase 4Jul 28, 2024Government of Congo, National Eye Institute (NEI), University of California, San Francisco
NCT06488781Phase 2Jul 26, 2024Case Western Reserve University, Duke University, University of Alabama, Birmingham, University of Florida, University of Oklahoma
Showing 20 of 557 trials
Page 1 / 28

Organizations

Research & Development (576)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
PfizerFor profit625151993
University of California, San FranciscoAcademic/Hospital343032003
National Institute of Allergy and Infectious Diseases (NIAID)Government262151997
Bill and Melinda Gates FoundationAcademic/Hospital22042008
University of LondonAcademic/Hospital221242008
MerckFor profit171532004
University of WashingtonAcademic/Hospital14741998
Harvard UniversityAcademic/Hospital13452006
Johns Hopkins UniversityAcademic/Hospital12732001
University of Alabama, BirminghamAcademic/Hospital12652002
University of North Carolina at Chapel HillAcademic/Hospital11442003
Emory UniversityAcademic/Hospital10432006
International Center for Diarrheal Disease ResearchAcademic/Hospital9322002
Katholieke Universiteit LeuvenAcademic/Hospital9832005
National Heart, Lung, and Blood Institute (NHLBI)Government9241998
University of Colorado, DenverAcademic/Hospital9132006
University of OxfordAcademic/Hospital9722016
Centre de Recherche en Sante de Nouna, Burkina FasoAcademic/Hospital8012017
Laboratoires TheaFor profit8832002
SanofiFor profit8432004
576 organizations
Page 1 / 29

Marketing (60)

OrganizationOrg typeRelationshipDate
ACI LimitedFor profitMKTGJul 12, 2022
Akorn, Inc.For profitNDA2Apr 27, 2007
Akorn, Inc.For profitMKTGApr 27, 2007
AlembicFor profitMKTGJan 27, 2020
AlembicFor profitSYNJan 27, 2020
Amneal PharmaceuticalsFor profitMKTGJul 19, 2018
Amneal PharmaceuticalsFor profitSYNJul 19, 2018
ApotexFor profitMKTGJul 13, 2011
Aurobindo PharmaFor profitMKTGJun 19, 2015
Aurobindo PharmaFor profitSYNJan 8, 2007
Barr LaboratoriesFor profitMKTGJul 6, 2006
Bionpharma IncFor profitMKTGDec 26, 2018
Bionpharma IncFor profitSYNDec 26, 2018
Chartwell PharmaceuticalsFor profitMKTGFeb 11, 2008
EXTROVISFor profitMKTGMay 30, 2007
Epic Pharma LlcFor profitMKTGApr 9, 2018
Eugia PharmaFor profitMKTGJun 19, 2015
FreseniusFor profitMKTGDec 13, 2005
Gland Pharma LtdFor profitMKTGNov 9, 2009
Hainan Poly PharmFor profitMKTGOct 9, 2018
Hainan Poly PharmFor profitSYNJul 27, 2023
HikmaFor profitMKTGJan 18, 2007
HikmaFor profitSYNJan 18, 2007
HospiraFor profitMKTGJun 26, 2009
Ionis Pharmaceuticals, Inc.For profitMKTGMay 8, 2020
LupinFor profitMKTGMay 15, 2015
LupinFor profitSYNMay 15, 2015
MylanFor profitMKTGJan 8, 2007
MylanFor profitSYNMar 24, 2009
MylanFor profitSYNJan 26, 2017
NovartisFor profitMKTGNov 14, 2005
Novel Anti-Infective Technologies, LLCFor profitMKTGAug 26, 2016
PHARMOBEDIENTFor profitMKTGMay 30, 2007
PfizerFor profitSYNNov 1, 1991
PfizerFor profitNDAJun 10, 2005
PlivaFor profitMKTGNov 14, 2005
PlivaFor profitINDJun 1, 1981
Rising PharmaceuticalsFor profitMKTGJan 26, 2017
Rising PharmaceuticalsFor profitSYNJan 26, 2017
SLATE RUN PHARMAFor profitMKTGOct 9, 2018
SandozFor profitSYNNov 14, 2005
SandozFor profitMKTGFeb 24, 2014
Shijiazhuang Pharma Group (CSPC)For profitMKTGJan 18, 2007
Strides Pharma ScienceFor profitMKTGJul 12, 2022
Sun PharmaceuticalsFor profitMKTGApr 2, 2013
Sunshine Lake Pharma Co., Ltd.For profitMKTGDec 6, 2018
Sunshine Lake Pharma Co., Ltd.For profitSYNDec 6, 2018
Taro PharmaceuticalsFor profitMKTGDec 11, 2019
TevaFor profitNDA2Dec 19, 2006
TevaFor profitSYNNov 14, 2005
TevaFor profitSYNJun 24, 2008
TevaFor profitMKTGNov 14, 2005
Thea PharmaFor profitMKTGApr 27, 2007
Thea PharmaFor profitNDA2Apr 27, 2007
WockhardtFor profitMKTGFeb 11, 2008
Yung Shin Pharm. Ind. Co., Ltd.For profitMKTGMay 8, 2020
ZHEJIANG POLY PHARMFor profitMKTGJul 27, 2023
Zydus Discovery DMCCFor profitMKTGJul 31, 2018
Zydus Discovery DMCCFor profitSYNApr 7, 2023
Zydus Discovery DMCCFor profitSYNJul 31, 2018