CDEK
← All drugs Report issue

sulbactam

Trade name: unasyn

Small moleculeapproved

Approved

Dec 31, 1986

Sulbactam is a β-lactamase inhibitor given in combination with β-lactam antibiotics to inhibit β-lactamase, an enzyme produced by bacteria that destroys the antibiotics. Sulbactam in combination with semisynthetic antibiotic ampicillin sodium is indicated for the treatment of infections due to susceptible strains of the designated microorganisms: Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli etc; Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. Pneumoniae) tec; Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli, and Bacteroides spp. (including B. fragilis). — NCATS

Clinical trial activity

43 trials · 74 clinical orgs · 22 marketing orgs

Phase 1
7
Phase 2
13
Phase 3
8
Phase 4
22

Earliest trial started Feb 1, 2001 (NCT01045902)

Timeline

1980s

  1. Dec 31, 1986

    Pfizer — Earliest FDA Approval

  2. Dec 31, 1986

    Pfizer — NDA Secondary Org

  3. Dec 31, 1986

    Pfizer — NDA Organization

  4. Nov 25, 1988

    Pfizer — Marketing Organization

2000s

  1. Jan 1, 2001

    Earliest Phase 3 Sponsor(trial)

  2. Mar 19, 2002

    West-Ward Pharmaceutical — Marketing Organization

  3. Mar 19, 2002

    Hikma — Marketing Organization

  4. Nov 25, 2005

    Hanford Pharmaceuticals — Marketing Organization

  5. Nov 25, 2005

    Hq Speciality Pharma — Marketing Organization

  6. Nov 29, 2005

    Istituto Bio Ita Spa — Marketing Organization

  7. Jul 25, 2006

    Sandoz — Marketing Organization

  8. Jul 25, 2006

    Novartis — Marketing Organization

  9. Jun 29, 2007

    Pharmaceutical Associates — Marketing Organization

  10. Jun 29, 2007

    Mustafa Nevzat Pharmaceuticals — Marketing Organization

  11. Jun 29, 2007

    Medimetriks — Marketing Organization

  12. Jan 1, 2008

    Earliest Phase 1 Sponsor(trial)

  13. Jan 1, 2008

    Earliest Phase 2 Sponsor(trial)

  14. Dec 22, 2009

    ACS Dobfar — Marketing Organization

2010s

  1. Sep 20, 2010

    Aurobindo Pharma — Marketing Organization

  2. Sep 20, 2010

    Eugia Pharma — Marketing Organization

  3. Dec 21, 2011

    Hospira — Marketing Organization

  4. Apr 7, 2014

    Mylan — Marketing Organization

  5. Apr 7, 2014

    STERISCIENCE — Marketing Organization

  6. Apr 7, 2014

    ONESOURCE SPECIALTY — Marketing Organization

  7. Dec 7, 2015

    Antibiotice — Marketing Organization

  8. Jan 8, 2016

    Astral — Marketing Organization

2020s

  1. May 23, 2023

    Entasis Therapeutics — NDA Secondary Org

  2. May 23, 2023

    Innoviva — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Combination products

  • unasyn

    with procaine benzylpenicillin

    Also known as ampicillin and sulbactam

  • xacduro (copackaged)

    with durlobactam

    Also known as sulbactam, durlobactam, sulbactam-durlobactam (sul-dur)

Approval history

  • approvedDec 31, 1986

Chemistry & pharmacology

Loading structure…

SMILES

CC1(C)[C@H](C(=O)O)N2C(=O)C[C@H]2S1(=O)=O
Mol. weight
233.24 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • (2s,5r)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid 4,4-dioxide
  • (2s,5r)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid 4,4-dioxide
  • cp-45899
  • cp-45899
  • cp-458992
  • cp-458992
  • cp-45899-2
  • cp-45899-2
  • penicillanic acid 1,1-dioxide
  • penicillanic acid 1,1-dioxide
  • penicillanic acid dioxide
  • penicillanic acid sulfone
  • penicillanic acid sulfone
  • sulbactam
  • sulbactam
  • sulbactam
  • sulbactam
  • sulbactam
  • sulbactam
  • sulbactam
  • sulbactam
  • sulbactam
  • sulbactam
  • sulbactam benzathine
  • sulbactam benzathine
  • sulbactam pivoxil
  • sulbactam pivoxil
  • sulbactam pivoxil
  • sulbactam pivoxil
  • sulbactam pivoxyl
  • sulbactam pivoxyl
  • sulbactam sodium
  • sulbactam sodium
  • sulbactam sodium
  • sulbactam sodium
  • sultamicillin
  • sultamicillin
  • unasyn
  • unasyn

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06440304Phase 4Nov 30, 2024University of Zagreb
NCT06494072Phase 4Aug 22, 2024Medical College of Wisconsin
NCT06336213N/AFeb 19, 2024Petrovsky National Research Centre of Surgery
NCT05922124Phase 4Jan 31, 2024Hebrew University, Monaldi Hospital, Rutgers University, Technion University, Tel Aviv University
NCT06048692Phase 3Jan 1, 2023Beni Suef University
NCT05654090Phase 4Aug 25, 2022Yung Shin Pharm. Ind. Co., Ltd.
NCT05052619N/AJul 1, 2021Chinese Academy of Medical Sciences
NCT04290104Phase 4Mar 1, 2020Konya Training and Research Hospital
NCT04198129Phase 1Jan 1, 2020University of Texas at Houston
NCT03894046Phase 3Apr 3, 2019Entasis Therapeutics
NCT03784365Phase 3Oct 1, 2018Asian Institute of Gastroenterology
NCT03858387Phase 4Sep 1, 2018Prince of Songkla University
NCT03560232Phase 4Jul 9, 2018Mercy Health Partners, Cincinnati, MercyHealth Youngstown
NCT03445195Phase 2Jan 17, 2018Entasis Therapeutics, Medpace, Inc.
NCT03310463Phase 1Oct 3, 2017Entasis Therapeutics
NCT03303924Phase 1Aug 21, 2017Clinartis, Entasis Therapeutics
NCT02971423Phase 1Oct 1, 2016Entasis Therapeutics, Nucleus Network Ltd
NCT02493712Phase 2Jan 1, 2016Holy Stone Healthcare Co., Ltd, inVentiv, Istituto Clinico Humanitas - Rozzano (MI), Italy
NCT02980250Phase 4Nov 1, 2015Guangdong Provincial Maternal and Child Health Hospital, Guangzhou Panyu Central Hospital, Maternal and Child Health Hospital of Foshan, Shen-Zhen City Maternity and Child Healthcare Hospital, Southern Medical University
NCT04202068Phase 4Jul 3, 2015Fujian Medical University, Hangzhou Third Hospital, People's Hospital of Quzhou, People's Hospital of Shanghai Pudong New Area, Shanghai Dermatology Hospital, The Central Hospital of Shanghai Minhang District, Xiangbei Welman Pharmaceutical Co., Ltd, Yanbian University
Showing 20 of 43 trials
Page 1 / 3

Organizations

Research & Development (74)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Entasis TherapeuticsFor profit5532016
PfizerFor profit4422003
Xiangbei Welman Pharmaceutical Co., LtdFor profit4422011
Nanjing Medical UniversityAcademic/Hospital2022011
Prince of Songkla UniversityAcademic/Hospital2212014
Ajanta Hospital and Research CentreAcademic/Hospital1012014
Aligarh Muslim UniversityAcademic/Hospital1012014
All India Institute of Medical SciencesAcademic/Hospital1012014
Asian Institute of GastroenterologyAcademic/Hospital1112018
BayerFor profit1112001
Beni Suef UniversityAcademic/Hospital1112023
Boehringer IngelheimFor profit1112011
CAPNETZ StiftungAcademic/Hospital1012013
Chinese Academy of Medical SciencesAcademic/Hospital1112021
Christian Medical College, Vellore, IndiaAcademic/Hospital1012014
ClinartisFor profit1012017
Deenanath Mangeshkar Hospital & Research CentreAcademic/Hospital1012014
Fujian Medical UniversityAcademic/Hospital1012015
Gottfried Wilhelm Leibniz Universität HannoverAcademic/Hospital1112013
Guangdong Provincial Maternal and Child Health HospitalAcademic/Hospital1012015
74 organizations
Page 1 / 4

Marketing (25)

OrganizationOrg typeRelationshipDate
ACS DobfarFor profitMKTGDec 22, 2009
AntibioticeFor profitMKTGDec 7, 2015
AstralFor profitMKTGJan 8, 2016
Aurobindo PharmaFor profitMKTGSep 20, 2010
Entasis TherapeuticsFor profitNDA2May 23, 2023
Eugia PharmaFor profitMKTGSep 20, 2010
Hanford PharmaceuticalsFor profitMKTGNov 25, 2005
HikmaFor profitMKTGMar 19, 2002
HospiraFor profitMKTGDec 21, 2011
Hq Speciality PharmaFor profitMKTGNov 25, 2005
InnovivaFor profitNDA2May 23, 2023
Istituto Bio Ita SpaFor profitMKTGNov 29, 2005
MedimetriksFor profitMKTGJun 29, 2007
Mustafa Nevzat PharmaceuticalsFor profitMKTGJun 29, 2007
MylanFor profitMKTGApr 7, 2014
NovartisFor profitMKTGJul 25, 2006
ONESOURCE SPECIALTYFor profitMKTGApr 7, 2014
PfizerFor profitNDA2Dec 31, 1986
PfizerFor profitNDADec 31, 1986
PfizerFor profitMKTGNov 25, 1988
Pharmaceutical AssociatesFor profitMKTGJun 29, 2007
STERISCIENCEFor profitMKTGApr 7, 2014
STERISCIENCEFor profitSYNApr 7, 2014
SandozFor profitMKTGJul 25, 2006
West-Ward PharmaceuticalFor profitMKTGMar 19, 2002