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ketorolac

Trade name: acuvail

Small moleculeapproved

Approved

Nov 30, 1989

Ketorolac is a pyrrolizine carboxylic acid derivative structurally related to indomethacin. It is an NSAID and is used principally for its analgesic activity and has been shown to decrease opioid requirements in post-operative patients. It does not affect consciousness or respiration but does have effects on gastric mucosa, renal perfusion, and platelet function. Ketorolac tromethamine ophthalmic solution is sold under brand name acular LS and is indicated for the reduction of ocular pain and burning/stinging following corneal refractive surgery. Ketorolac tromethamine is a racemic mixture of [-]S- and [+]R-enantiomeric forms, with the S-form having analgesic activity. Its antiinflammatory effects are believed to be due to inhibition of both cylooxygenase-1 (COX-1) and cylooxygenase-2 (COX-2) which leads to the inhibition of prostaglandin synthesis leading to decreased formation of precursors of prostaglandins and thromboxanes from arachidonic acid. The resultant reduction in prostaglandin synthesis and activity may be at least partially responsible for many of the adverse, as well as the therapeutic, effects of these medication. Analgesia is probably produced via a peripheral action in which blockade of pain impulse generation results from decreased prostaglandin activity. — NCATS

Clinical trial activity

458 trials · 323 clinical orgs · 51 marketing orgs

Phase 1
52
Phase 2
116
Phase 3
82
Phase 4
175

Earliest trial started Jun 1, 1998 (NCT00001698)

Timeline

1980s

  1. Nov 30, 1989

    Earliest FDA Approval

  2. Nov 30, 1989

    Roche — NDA Secondary Org

1990s

  1. Nov 9, 1992

    Allergan — NDA Secondary Org

  2. Nov 9, 1992

    AbbVie — Marketing Organization

  3. Nov 9, 1992

    AbbVie — NDA Secondary Org

  4. May 16, 1997

    Teva — Marketing Organization

  5. Jun 5, 1997

    Hospira — Marketing Organization

  6. Jun 26, 1997

    Cycle Pharmaceuticals Ltd. — Marketing Organization

  7. Jun 26, 1997

    Chartwell Pharmaceuticals — Marketing Organization

  8. Sep 19, 1997

    Watson Pharmaceuticals — Marketing Organization

  9. Nov 3, 1997

    SmithKline Beecham — NDA Secondary Org

  10. Jan 1, 1998

    Earliest Phase 2 Sponsor(trial)

  11. Apr 26, 1999

    West-Ward Pharmaceutical — Marketing Organization

  12. Apr 26, 1999

    Hikma — Marketing Organization

  13. Jun 23, 1999

    Pliva — Marketing Organization

  14. Oct 25, 1999

    Bedford Pharmaceuticals — Marketing Organization

2000s

  1. Jan 1, 2000

    Earliest Phase 3 Sponsor(trial)

  2. Nov 29, 2000

    Apothecon — Marketing Organization

  3. Jun 29, 2001

    Baxalta — Marketing Organization

  4. Jul 24, 2001

    Apotex — Marketing Organization

  5. Jan 1, 2002

    Zyla Life Sciences — Earliest Phase 1 Sponsor(trial)

  6. Jan 11, 2002

    Fresenius — Marketing Organization

  7. Jul 21, 2004

    Amphastar Pharmaceuticals — Marketing Organization

  8. Jul 27, 2004

    Gland Pharma Ltd — Marketing Organization

  9. Oct 6, 2004

    Sandoz — Marketing Organization

  10. Oct 6, 2004

    Novartis — Marketing Organization

  11. Mar 27, 2007

    Atlantide Pharmaceuticals — Marketing Organization

  12. Mar 27, 2007

    Wockhardt — Marketing Organization

  13. Jul 16, 2007

    Mylan — Marketing Organization

  14. Jul 16, 2007

    STERISCIENCE — Marketing Organization

  15. Jul 16, 2007

    ONESOURCE SPECIALTY — Marketing Organization

  16. Jan 14, 2008

    Lutipold — Marketing Organization

  17. Jan 14, 2008

    Daiichi Sankyo — Marketing Organization

  18. Oct 6, 2008

    Sun Pharmaceuticals — Marketing Organization

  19. Nov 5, 2009

    Akorn, Inc. — Marketing Organization

  20. Nov 5, 2009

    Epic Pharma Llc — Marketing Organization

2010s

  1. May 14, 2010

    Zyla Life Sciences — NDA Secondary Org

  2. May 14, 2010

    Zyla Life Sciences — Marketing Organization

  3. Nov 27, 2013

    Sagent Pharmaceuticals, Inc. — Marketing Organization

  4. May 30, 2014

    Omeros Corporation — Marketing Organization

  5. May 30, 2014

    RAYNER SURGICAL — NDA Secondary Org

  6. Sep 15, 2017

    Shire — Marketing Organization

  7. Nov 15, 2018

    Aurobindo Pharma — Marketing Organization

  8. Nov 15, 2018

    Eugia Pharma — Marketing Organization

  9. Apr 5, 2019

    Micro Labs Ltd India — Marketing Organization

  10. Jul 1, 2019

    Lupin — Marketing Organization

2020s

  1. Aug 20, 2020

    Nephron Pharmaceuticals Corporation — Marketing Organization

  2. Mar 23, 2022

    Senores Pharms — Marketing Organization

  3. Aug 25, 2022

    Hetero Labs Ltd — Marketing Organization

  4. Oct 21, 2022

    Atnahs Pharmaceuticals — Marketing Organization

  5. Oct 21, 2022

    Zydus Discovery DMCC — Marketing Organization

  6. Nov 2, 2022

    Alembic — Marketing Organization

  7. Feb 23, 2023

    Bionpharma Inc — Marketing Organization

  8. Feb 23, 2023

    Leading Pharma Llc — Marketing Organization

  9. May 10, 2023

    Caplin Point Laboratories — Marketing Organization

  10. Jun 20, 2023

    Aspiro — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedPriority reviewNov 30, 1989

Chemistry & pharmacology

Loading structure…

SMILES

O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Mol. weight
255.27 g/mol
Lipinski Ro5
Pass
Rule of 3
Yes
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral, Topical
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

Yes

Black box warning

Sources

Also known as

  • (+-)-5-benzoyl-2,3-dihydro-1h-pyrrolizine-1-carboxylic acid
  • (+-)-5-benzoyl-2,3-dihydro-1h-pyrrolizine-1-carboxylic acid
  • acular
  • acular
  • acular
  • acular ls
  • acular ls
  • acuvail
  • acuvail
  • acuvail
  • keromin
  • ketolorac
  • ketoralac
  • ketoralac
  • ketorolac
  • ketorolac
  • ketorolac
  • ketorolac
  • ketorolac
  • ketorolac
  • ketorolac
  • ketorolac
  • ketorolac
  • ketorolac
  • ketorolac
  • (+-)-ketorolac
  • (+-)-ketorolac
  • (+/-)-ketorolac
  • kétorolac
  • kétorolac
  • ketorolaco
  • ketorolaco
  • ketorolac / phenylephrine
  • ketorolac trometamol
  • ketorolac tromethamine
  • ketorolac tromethamine
  • ketorolac tromethamine
  • ketorolac tromethamine
  • ketorolac tromethamine
  • ketorolacum
  • ketorolacum
  • rac-ketorolac
  • rac-ketorolac
  • sprix
  • sprix
  • toradol
  • toradol
  • toradol
  • toradol
  • trometamol ketorolac

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07276906Phase 4Jan 31, 2026University of South Alabama
NCT07305883Phase 3Dec 28, 2025University of Tehran
NCT07244757N/ANov 30, 2025Cairo University
NCT07092566Phase 3Nov 14, 2025University of North Carolina at Chapel Hill, Wake Forest University
NCT06968806Phase 3Oct 27, 2025Harbin Medical University, Henan Provincial Chest Hospital, Huai'an First People's Hospital, Nanjing University, Shandong Provincial Hospital, Shantou University
NCT07158476Phase 4Oct 21, 2025St. Louis University
NCT07185724Phase 4Oct 1, 2025University of Iowa
NCT07102641Phase 4Aug 26, 2025Thomas Jefferson University
NCT06994442Phase 3Aug 20, 2025Cornell University, National Institutes of Health (NIH)
NCT07047040Phase 2/Phase 3 (Phase 3)Aug 15, 2025Assiut University
NCT06819956Phase 3Jul 31, 2025University of Alberta
NCT06973785Phase 3Jul 15, 2025The Cleveland Clinic
NCT07064083Early Phase 1 (Phase 1)Jul 15, 2025Al Azhar University
NCT07257874Phase 3Jul 1, 2025Islamabad Medical and Dental College
NCT06853327Phase 2Apr 1, 2025University of North Carolina at Chapel Hill
NCT06447194Phase 1/Phase 2 (Phase 2)Apr 1, 2025University of Maryland
NCT06936995N/AJan 21, 2025University of Ankara
NCT06729047Phase 1/Phase 2 (Phase 2)Dec 15, 2024Assiut University
NCT06201676Phase 4Nov 30, 2024Department of Defense, Harvard University
NCT06653400Phase 1Nov 30, 2024Icahn School of Medicine at Mount Sinai
Showing 20 of 458 trials
Page 1 / 23

Organizations

Research & Development (323)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Zyla Life SciencesFor profit111132002
Cairo UniversityAcademic/Hospital101042017
AllerganFor profit9432006
Assiut UniversityAcademic/Hospital9942014
Daiichi SankyoFor profit9552006
ICONFor profit9032004
Mansoura UniversityAcademic/Hospital8832012
Case Western Reserve UniversityAcademic/Hospital7732016
Harvard UniversityAcademic/Hospital7732010
Innovative Medical Research of South Florida, IncFor profit7712006
United States ArmyGovernment7732000
University of CalgaryAcademic/Hospital7742010
Wake Forest UniversityAcademic/Hospital7732006
Azad UniversityAcademic/Hospital6522015
Henry Ford Health SystemAcademic/Hospital6642019
Orebro UniversityAcademic/Hospital6532005
The University of Texas, DallasAcademic/Hospital6522005
Yeshiva UniversityAcademic/Hospital6632009
Aarhus UniversityAcademic/Hospital5422001
Bucci Laser Vision InstituteAcademic/Hospital5312006
323 organizations
Page 1 / 17

Marketing (65)

OrganizationOrg typeRelationshipDate
AbbVieFor profitMKTGNov 9, 1992
AbbVieFor profitNDA2Nov 9, 1992
Akorn, Inc.For profitMKTGNov 5, 2009
AlembicFor profitMKTGNov 2, 2022
AllerganFor profitNDA2Nov 9, 1992
Amphastar PharmaceuticalsFor profitMKTGJul 21, 2004
ApotexFor profitMKTGJul 24, 2001
ApotexFor profitSYNMar 27, 2007
ApotheconFor profitMKTGNov 29, 2000
AspiroFor profitMKTGJun 20, 2023
Atlantide PharmaceuticalsFor profitMKTGMar 27, 2007
Atnahs PharmaceuticalsFor profitMKTGOct 21, 2022
Aurobindo PharmaFor profitMKTGNov 15, 2018
BaxaltaFor profitMKTGJun 29, 2001
Bedford PharmaceuticalsFor profitMKTGOct 25, 1999
Bionpharma IncFor profitMKTGFeb 23, 2023
Caplin Point LaboratoriesFor profitMKTGMay 10, 2023
Chartwell PharmaceuticalsFor profitMKTGJun 26, 1997
Cycle Pharmaceuticals Ltd.For profitMKTGJun 26, 1997
Cycle Pharmaceuticals Ltd.For profitSYNJun 26, 1997
Daiichi SankyoFor profitMKTGJan 14, 2008
Epic Pharma LlcFor profitMKTGNov 5, 2009
Eugia PharmaFor profitMKTGNov 15, 2018
FreseniusFor profitMKTGJan 11, 2002
Gland Pharma LtdFor profitMKTGJul 27, 2004
Gland Pharma LtdFor profitMKTGNov 1, 2016
Hetero Labs LtdFor profitMKTGAug 25, 2022
HikmaFor profitSYNApr 26, 1999
HikmaFor profitMKTGApr 26, 1999
HospiraFor profitMKTGJun 5, 1997
Leading Pharma LlcFor profitMKTGFeb 23, 2023
LupinFor profitMKTGJul 1, 2019
LupinFor profitSYNJul 1, 2019
LutipoldFor profitMKTGJan 14, 2008
Micro Labs Ltd IndiaFor profitMKTGApr 5, 2019
MylanFor profitSYNMay 16, 1997
MylanFor profitMKTGJul 16, 2007
Nephron Pharmaceuticals CorporationFor profitMKTGAug 20, 2020
NovartisFor profitMKTGOct 6, 2004
ONESOURCE SPECIALTYFor profitMKTGJul 16, 2007
Omeros CorporationFor profitMKTGMay 30, 2014
PlivaFor profitMKTGJun 23, 1999
RAYNER SURGICALFor profitNDA2May 30, 2014
RocheFor profitNDA2Nov 30, 1989
STERISCIENCEFor profitMKTGJul 16, 2007
STERISCIENCEFor profitSYNJul 16, 2007
Sagent Pharmaceuticals, Inc.For profitMKTGNov 27, 2013
Sagent Pharmaceuticals, Inc.For profitSYNNov 27, 2013
SandozFor profitMKTGOct 6, 2004
SandozFor profitSYNOct 6, 2004
Senores PharmsFor profitMKTGMar 23, 2022
ShireFor profitMKTGSep 15, 2017
SmithKline BeechamFor profitNDA2Nov 3, 1997
Sun PharmaceuticalsFor profitMKTGOct 6, 2008
Sun PharmaceuticalsFor profitSYNOct 6, 2008
SyntexFor profitNDA—
TevaFor profitMKTGMay 16, 1997
Watson PharmaceuticalsFor profitMKTGSep 19, 1997
West-Ward PharmaceuticalFor profitMKTGApr 26, 1999
WockhardtFor profitMKTGMar 27, 2007
WockhardtFor profitSYNMar 27, 2007
Zydus Discovery DMCCFor profitMKTGOct 21, 2022
Zydus Discovery DMCCFor profitSYNOct 21, 2022
Zyla Life SciencesFor profitNDA2May 14, 2010
Zyla Life SciencesFor profitMKTGMay 14, 2010