clindamycin

Trade name: cleocin

Small moleculeapproved

Approved

Feb 22, 1970

Clindamycin phosphate is the prodrug of clindamycin with no antimicrobial activity in vitro but can be rapidly converted in vivo to the parent drug, clindamycin, by phosphatase ester hydrolysis. It is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria: Lower respiratory tract infections including pneumonia, empyema, and lung abscess caused by anaerobes; Skin and skin structure infections; Gynecological infections including endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection caused by susceptible anaerobes; Intra-abdominal infections; Septicemia; Bone and joint infections. Orally and parenterally administered clindamycin has been associated with severe colitis, which may end fatally. Abdominal pain, gastrointestinal disturbances, gram-negative folliculitis, eye pain and contact dermatitis have also been reported in association with the use of topical formulations of clindamycin. Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents — NCATS

Clinical trial activity

199 trials · 282 clinical orgs · 73 marketing orgs

Phase 1
28
Phase 2
73
Phase 3
56
Phase 4
57

Earliest trial started Nov 2, 1999 (NCT00000674)

Timeline

1970s

  1. Feb 22, 1970

    Earliest FDA Approval

  2. Feb 22, 1970

    Pharmacia & Upjohn — NDA Secondary Org

  3. Feb 22, 1970

    Pfizer — Marketing Organization

  4. Feb 22, 1970

    Pfizer — NDA Secondary Org

1980s

  1. Jul 9, 1980

    Pharmacia & Upjohn — First NDA Organization

  2. Jul 9, 1980

    Pharmacia & Upjohn — NDA Organization

  3. Feb 8, 1982

    Pharmacia & Upjohn — Marketing Organization

  4. Jul 24, 1987

    Alvogen — Marketing Organization

  5. Jul 24, 1987

    Almaject — Marketing Organization

  6. Oct 15, 1987

    West-Ward Pharmaceutical — Marketing Organization

  7. Oct 15, 1987

    Hikma — Marketing Organization

  8. May 9, 1988

    Flaga Group — Marketing Organization

  9. Sep 1, 1988

    G & W Laboratories Inc. — Marketing Organization

  10. Oct 20, 1988

    Marsam Pharmaceuticals — Marketing Organization

  11. Jan 11, 1989

    Boca Pharmacal — Marketing Organization

  12. Jun 28, 1989

    Vintage — Marketing Organization

  13. Sep 20, 1989

    Cosette — Marketing Organization

  14. Sep 20, 1989

    Teva — Marketing Organization

  15. Sep 20, 1989

    ACP Nimble — Marketing Organization

  16. Dec 22, 1989

    Abraxis — NDA Secondary Org

  17. Dec 29, 1989

    Baxalta — NDA Secondary Org

  18. Dec 29, 1989

    Baxter — NDA Secondary Org

1990s

  1. Jul 31, 1991

    Watson Pharmaceuticals — Marketing Organization

  2. Sep 30, 1992

    Paddock Laboratories — Marketing Organization

  3. Nov 30, 1995

    Perrigo — Marketing Organization

  4. Sep 27, 1996

    Novast Labs — Marketing Organization

  5. Jul 15, 1997

    Wockhardt — Marketing Organization

  6. Jul 15, 1997

    Xttrium Laboratories — Marketing Organization

  7. Jan 1, 1999

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Jan 28, 2000

    Fougera — Marketing Organization

  2. Nov 27, 2000

    PreCision Dermatology — NDA Secondary Org

  3. Nov 27, 2000

    Bausch Health Companies — NDA Secondary Org

  4. Dec 21, 2000

    Bausch Health Companies — Marketing Organization

  5. Feb 2, 2001

    Sun Pharmaceuticals — Marketing Organization

  6. Jun 29, 2001

    Abbott — Marketing Organization

  7. Jan 1, 2002

    Earliest Phase 2 Sponsor(trial)

  8. Aug 26, 2002

    Stiefel Laboratories — Marketing Organization

  9. Aug 26, 2002

    Stiefel Laboratories — NDA Secondary Org

  10. Jan 1, 2003

    Teva — Earliest Phase 1 Sponsor(trial)

  11. Mar 22, 2004

    Epic Pharma Llc — Marketing Organization

  12. Oct 22, 2004

    Mylan — NDA Secondary Org

  13. Nov 30, 2004

    Perrigo — NDA Secondary Org

  14. Nov 30, 2004

    Padagis Us — NDA Secondary Org

  15. Aug 12, 2005

    Chartwell Pharmaceuticals — Marketing Organization

  16. Aug 12, 2005

    Lannett Company, Inc. — Marketing Organization

  17. Nov 7, 2006

    Medicis — Marketing Organization

  18. Mar 29, 2007

    Fresenius — Marketing Organization

  19. Oct 23, 2008

    Dow Pharmaceutical Sciences — Marketing Organization

  20. Aug 26, 2009

    Aurobindo Pharma — Marketing Organization

2010s

  1. Mar 31, 2010

    Padagis Us — Marketing Organization

  2. Jun 17, 2010

    Akorn, Inc. — Marketing Organization

  3. Jul 16, 2010

    Almirall — Marketing Organization

  4. Jul 16, 2010

    Almirall — NDA Secondary Org

  5. Sep 30, 2011

    Sagent Pharmaceuticals, Inc. — Marketing Organization

  6. May 31, 2012

    Sandoz — Marketing Organization

  7. May 31, 2012

    Novartis — Marketing Organization

  8. Aug 28, 2012

    Lyne Laboratories — Marketing Organization

  9. Mar 13, 2014

    Amneal Pharmaceuticals — Marketing Organization

  10. May 29, 2015

    Apax Partners — Marketing Organization

  11. Jun 12, 2015

    Allergan PLC (2015) — Marketing Organization

  12. Jun 19, 2015

    Actavis — Marketing Organization

  13. Aug 25, 2016

    Tolmar Inc. — Marketing Organization

  14. Dec 30, 2016

    Pharmaceutical Associates — Marketing Organization

  15. Dec 30, 2016

    Teligent Pharmaceuticals — Marketing Organization

  16. Apr 20, 2017

    Shire — NDA Secondary Org

  17. May 5, 2017

    Alembic — Marketing Organization

  18. May 5, 2017

    Orit Labs Llc — Marketing Organization

  19. Jun 28, 2017

    Shire — Marketing Organization

  20. Oct 10, 2017

    Rising Pharmaceuticals — Marketing Organization

  21. Oct 10, 2017

    Mylan — Marketing Organization

  22. Feb 8, 2018

    Glasshouse Pharmaceuticals — Marketing Organization

  23. May 11, 2018

    Heritage Pharma — Marketing Organization

  24. May 11, 2018

    Emcure — Marketing Organization

  25. May 25, 2018

    Taro Pharmaceuticals — Marketing Organization

  26. Jul 16, 2018

    Zydus Discovery DMCC — Marketing Organization

  27. Jul 16, 2018

    Cadila Healthcare — Marketing Organization

  28. Nov 5, 2018

    Micro Labs Ltd India — Marketing Organization

  29. Jan 28, 2019

    Encube Ethicals Pvt. Ltd. — Marketing Organization

  30. Mar 14, 2019

    Glenmark Pharmaceuticals — Marketing Organization

  31. Aug 19, 2019

    ANDA Repository — Marketing Organization

2020s

  1. Jul 29, 2020

    Solaris Pharma Corp — Marketing Organization

  2. Apr 12, 2021

    AbbVie — Marketing Organization

  3. Dec 7, 2021

    Dare Bioscience — Marketing Organization

  4. Dec 7, 2021

    Dare Bioscience — NDA Secondary Org

  5. Feb 10, 2022

    Donaldson Company — Marketing Organization

Indications

Studied for

Mechanism of action

Combination products

Approval history

  • approvedFeb 22, 1970

Chemistry & pharmacology

Loading structure…

SMILES

CCCCCCCCCCCCCCCC(=O)O[C@@H]1[C@@H](O)[C@@H](O)[C@@H]([C@H](NC(=O)[C@@H]2C[C@@H](CCC)CN2C)[C@H](C)Cl)O[C@@H]1SC.Cl
Mol. weight
699.87 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

Black box warningProdrug

Sources

Also known as

  • 7-cdl
  • 7-cdl
  • 7-chloro-7-deoxylincomycin
  • 7-chloro-7-deoxylincomycin palmitate
  • 7-chlorolincomycin
  • 7-chlorolincomycin palmitate
  • 7-deoxy-7(s)-chlorolincomycin
  • 7(s)-chloro-7-deoxylincomycin
  • 7(s)-chloro-7-deoxylincomycin
  • antirobe
  • antirobe
  • benzaclin
  • benzaclin
  • chlolincocin
  • chlorodeoxylincomycin
  • chlorodeoxylincomycin
  • chlorolincomycin
  • chlorolincomycin
  • cleocin
  • cleocin
  • cleocin
  • cleocin
  • cleocin palmitate
  • cleocin phosphate
  • cleocin phosphate
  • cleocin t
  • cleocin t
  • cleocin (tn)
  • cleocin (tn)
  • clincin
  • clindagel
  • clindagel
  • clindagel
  • clindamicina
  • clindamicina
  • clindamycin
  • clindamycin
  • clindamycin
  • clindamycin
  • clindamycin
  • clindamycin
  • clindamycin
  • clindamycin
  • clindamycin 2-palmitate
  • clindamycin-2-phosphate
  • clindamycin-2-phosphate
  • clindamycine
  • clindamycine
  • clindamycin hcl
  • clindamycin hcl
  • clindamycin hcl
  • clindamycin hydrochloride
  • clindamycin hydrochloride
  • clindamycin hydrochloride
  • clindamycin hydrochloride
  • clindamycin hydrochloride hydrate
  • clindamycin hydrochloride hydrate
  • clindamycin hydrochloride hydrate
  • clindamycin hydrochloride hydrate
  • clindamycin hydrochloride hydrate
  • clindamycin hydrochloride hydrate
  • clindamycin hydrochloride monohydrate
  • clindamycin palmitate
  • clindamycin palmitate
  • clindamycin palmitate
  • clindamycin palmitate
  • clindamycin palmitate
  • clindamycin palmitate
  • clindamycin palmitate hcl
  • clindamycin palmitate hcl
  • clindamycin palmitate hcl
  • clindamycin palmitate hydrochloride
  • clindamycin palmitate hydrochloride
  • clindamycin palmitate hydrochloride
  • clindamycin palmitate hydrochloride
  • clindamycin palmitate hydrochloride
  • clindamycin palmitate hydrochloride
  • clindamycin phosphate
  • clindamycin phosphate
  • clindamycin phosphate
  • clindamycin phosphate
  • clindamycin phosphate
  • clindamycin phosphate
  • clindamycin phosphate
  • clindamycin phosphate
  • clindamycinum
  • clindamycinum
  • clindesse
  • clindesse
  • clindesse
  • clindets
  • clinimycin
  • dalacin
  • dalacin
  • dalacin c
  • dalacin c
  • dalacin c
  • dalacin c phos
  • dalacine
  • dalacin t
  • dalacin t
  • evoclin
  • evoclin
  • idp-110
  • lindamycin phosphate
  • methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-l-2-pyrrolidinecarboxamido)-1-thio-l-threo-alpha-d-galacto-octopyranoside
  • methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-l-2-pyrrolidinecarboxamido)-1-thio-l-threo-alpha-d-galacto-octopyranoside
  • onexton
  • sobelin
  • sobelin
  • sobelin
  • u-21251
  • u-21251
  • u-25179e
  • u-25179e
  • u-25179-e
  • u-25179-e
  • u-28508
  • u-28508
  • zindaclin
  • zindaclin

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07267013Phase 2Jan 15, 2026University of Nantes
NCT06702345N/AMar 1, 2025GlaxoSmithKline, Helmholtz Centre for Infection Research, Leiden University, University of Cologne, University of Oxford
NCT06841003Phase 3Feb 28, 2025Spaarne Gasthuis, ZonMw: The Netherlands Organisation for Health Research and Development
NCT06494072Phase 4Aug 22, 2024Medical College of Wisconsin
NCT05867654Phase 4Jul 31, 2024University of Louisville
NCT06422221Phase 4Jul 15, 2024Santiago de Compostela University, University of Santiago de Compostela
NCT06336824Phase 3Jun 28, 2024Clinical Research Centre, Malaysia, Government of Malaysia
NCT06787885N/AMay 1, 2024Fayoum University
NCT06120140Phase 2Mar 8, 2024
NCT05899140Phase 4Feb 1, 2024University of Munster
NCT07247851N/AJan 10, 2024Ain Shams University
NCT05846399Phase 4Sep 7, 2023University of Missouri
NCT06616168Phase 1Sep 1, 2023Lviv National Medical University
NCT05762484N/AApr 30, 2023Erasmus University Rotterdam
NCT06172010Phase 4Apr 1, 2023Alrijne Hospital, Elisabeth-TweeSteden Ziekenhuis, Erasmus University Rotterdam, Isala Clinics, Zwolle, The Netherlands, Leiden University, Medical Center Leeuwarden, Onze Lieve Vrouw Hospital, Radboud University, Reade Rheumatology Research Institute, Reinier Haga Orthopedisch Centrum, Rijnstate Hospital, Spaarne Gasthuis, Tergooi Hospital, University of Amsterdam, University of Groningen
NCT05849090Early Phase 1 (Phase 1)Mar 27, 2023University of Utah
NCT06068673N/AMar 1, 2023Damanhour University
NCT05582434Early Phase 1 (Phase 1)Jan 31, 2023Bausch Health Companies, Wake Forest University
NCT05926869Phase 2Aug 1, 2022Jinnah Postgraduate Medical Centre, University of Karachi
NCT05398679Phase 4Jun 1, 2022University of Barcelona
Showing 20 of 199 trials
Page 1 / 10

Organizations

Research & Development (282)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GlaxoSmithKlineFor profit26852004
Stiefel LaboratoriesFor profit171742004
Bausch Health CompaniesFor profit7532017
Taro PharmaceuticalsFor profit6612012
National Institute of Allergy and Infectious Diseases (NIAID)Government5531999
PfizerFor profit5242005
Leiden UniversityAcademic/Hospital4422018
PerrigoFor profit4422007
ActavisFor profit3322010
Albert Schweitzer HospitalAcademic/Hospital3222002
Cairo UniversityAcademic/Hospital3332016
Catawba Clinical ResearchFor profit3022015
Duke UniversityAcademic/Hospital3322013
Icahn School of Medicine at Mount SinaiAcademic/Hospital3322011
MedicisFor profit3122009
Miguel Hernández UniversityAcademic/Hospital3312013
Northwestern UniversityAcademic/Hospital3322010
Thomas Jefferson UniversityAcademic/Hospital3222013
University of AmsterdamAcademic/Hospital3032012
University of BarcelonaAcademic/Hospital3122010
282 organizations
Page 1 / 15

Marketing (111)

OrganizationOrg typeRelationshipDate
ACP NimbleFor profitMKTGSep 20, 1989
ANDA RepositoryFor profitMKTGAug 19, 2019
AbbVieFor profitMKTGApr 12, 2021
AbbottFor profitMKTGJun 29, 2001
AbraxisFor profitNDA2Dec 22, 1989
AbraxisFor profitMKTG
ActavisFor profitMKTGJun 19, 2015
ActavisFor profitSYNJun 12, 2015
Akorn, Inc.For profitMKTGJun 17, 2010
Akorn, Inc.For profitSYNApr 4, 2013
AlembicFor profitMKTGMay 5, 2017
Allergan PLC (2015)For profitMKTGJun 12, 2015
AlmajectFor profitMKTGJul 24, 1987
AlmirallFor profitMKTGJul 16, 2010
AlmirallFor profitNDA2Jul 16, 2010
AlvogenFor profitMKTGJul 24, 1987
AlvogenFor profitSYNJul 24, 1987
Amneal PharmaceuticalsFor profitSYNAug 5, 2022
Amneal PharmaceuticalsFor profitMKTGMar 13, 2014
Apax PartnersFor profitMKTGMay 29, 2015
Athenex, Inc.For profitMKTG
Aurobindo PharmaFor profitMKTGAug 26, 2009
Aurobindo PharmaFor profitSYNApr 30, 2013
Bausch Health CompaniesFor profitMKTGDec 21, 2000
Bausch Health CompaniesFor profitNDA2Nov 27, 2000
BaxaltaFor profitNDA2Dec 29, 1989
BaxaltaFor profitSYNApr 20, 2017
BaxterFor profitNDA2Dec 29, 1989
Bedford PharmaceuticalsFor profitMKTG
Boca PharmacalFor profitMKTGJan 11, 1989
Bristol-Myers SquibbFor profitMKTG
Cadila HealthcareFor profitMKTGJul 16, 2018
Chartwell PharmaceuticalsFor profitMKTGAug 12, 2005
Chartwell PharmaceuticalsFor profitSYNMay 5, 2017
CosetteFor profitMKTGSep 20, 1989
Dare BioscienceFor profitMKTGDec 7, 2021
Dare BioscienceFor profitNDA2Dec 7, 2021
Donaldson CompanyFor profitMKTGFeb 10, 2022
Dow Pharmaceutical SciencesFor profitMKTGOct 23, 2008
EmcureFor profitMKTGMay 11, 2018
Encube Ethicals Pvt. Ltd.For profitMKTGJan 28, 2019
Encube Ethicals Pvt. Ltd.For profitSYNMar 11, 2021
Epic Pharma LlcFor profitMKTGMar 22, 2004
Flaga GroupFor profitMKTGMay 9, 1988
FougeraFor profitMKTGJan 28, 2000
FougeraFor profitSYNJun 5, 1997
FreseniusFor profitMKTGMar 29, 2007
G & W Laboratories Inc.For profitMKTGSep 1, 1988
Glasshouse PharmaceuticalsFor profitMKTGFeb 8, 2018
Glenmark PharmaceuticalsFor profitMKTGMar 14, 2019
Glenmark PharmaceuticalsFor profitSYNFeb 10, 2021
Heritage PharmaFor profitMKTGMay 11, 2018
HikmaFor profitMKTGOct 15, 1987
Lannett Company, Inc.For profitMKTGAug 12, 2005
Lannett Company, Inc.For profitSYNAug 12, 2005
Lyne LaboratoriesFor profitMKTGAug 28, 2012
Marsam PharmaceuticalsFor profitMKTGOct 20, 1988
MedicisFor profitMKTGNov 7, 2006
Micro Labs Ltd IndiaFor profitMKTGNov 5, 2018
MylanFor profitNDA2Oct 22, 2004
MylanFor profitSYNOct 22, 2004
MylanFor profitMKTGOct 10, 2017
NovartisFor profitMKTGMay 31, 2012
Novast LabsFor profitMKTGSep 27, 1996
Orit Labs LlcFor profitMKTGMay 5, 2017
Padagis UsFor profitMKTGMar 31, 2010
Padagis UsFor profitMKTGSep 30, 1992
Padagis UsFor profitNDA2Nov 30, 2004
Paddock LaboratoriesFor profitSYNJul 7, 2010
Paddock LaboratoriesFor profitMKTGSep 30, 1992
PerrigoFor profitNDA2Nov 30, 2004
PerrigoFor profitSYNMar 31, 2010
PerrigoFor profitSYNSep 30, 1996
PerrigoFor profitSYNJun 26, 2012
PerrigoFor profitMKTGNov 30, 1995
PfizerFor profitMKTGFeb 22, 1970
PfizerFor profitNDA2Feb 22, 1970
Pharmaceutical AssociatesFor profitMKTGDec 30, 2016
Pharmacia & UpjohnFor profitNDA2Feb 22, 1970
Pharmacia & UpjohnFor profitNDAJul 9, 1980
Pharmacia & UpjohnFor profitMKTGFeb 8, 1982
PreCision DermatologyFor profitNDA2Nov 27, 2000
Rising PharmaceuticalsFor profitSYNOct 10, 2017
Rising PharmaceuticalsFor profitMKTGOct 10, 2017
SOLOPAKFor profitMKTG
Sagent Pharmaceuticals, Inc.For profitMKTGSep 30, 2011
Sagent Pharmaceuticals, Inc.For profitSYNSep 30, 2011
SandozFor profitMKTGMay 31, 2012
ShireFor profitNDA2Apr 20, 2017
ShireFor profitMKTGJun 28, 2017
Solaris Pharma CorpFor profitMKTGJul 29, 2020
Stiefel LaboratoriesFor profitMKTGAug 26, 2002
Stiefel LaboratoriesFor profitNDA2Aug 26, 2002
Sun PharmaceuticalsFor profitMKTGFeb 2, 2001
Taro PharmaceuticalsFor profitMKTGMay 25, 2018
Taro PharmaceuticalsFor profitSYNMar 31, 2004
Taro PharmaceuticalsFor profitSYNDec 15, 2017
Taro PharmaceuticalsFor profitSYNMar 11, 2020
Teligent PharmaceuticalsFor profitMKTGDec 30, 2016
Teligent PharmaceuticalsFor profitSYNDec 30, 2016
TevaFor profitMKTGSep 20, 1989
TevaFor profitSYNDec 29, 1989
Tolmar Inc.For profitMKTGAug 25, 2016
VintageFor profitMKTGJun 28, 1989
Watson PharmaceuticalsFor profitMKTGJul 31, 1991
West-Ward PharmaceuticalFor profitMKTGOct 15, 1987
WockhardtFor profitMKTGJul 15, 1997
Xttrium LaboratoriesFor profitMKTGJul 15, 1997
Zydus Discovery DMCCFor profitMKTGJul 16, 2018
Zydus Discovery DMCCFor profitSYNJan 31, 2005
Zydus Discovery DMCCFor profitSYNSep 19, 2023