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tetracaine

Trade name: pontocaine

Small moleculeapproved

Approved

Jun 23, 2005

Tetracaine (INN, also known as amethocaine; trade name Pontocaine. Ametop and Dicaine) is a potent local anesthetic of the ester group. It is mainly used topically in ophthalmology and as an antipruritic, and it has been used in spinal anesthesia. Tetracaine blocks sodium ion channels required for the initiation and conduction of neuronal impulses thereby affecting local anesthesia. In biomedical research, tetracaine is used to alter the function of calcium release channels (ryanodine receptors) that control the release of calcium from intracellular stores. Tetracaine is an allosteric blocker of channel function. At low concentrations, tetracaine causes an initial inhibition of spontaneous calcium release events, while at high concentrations, tetracaine blocks release completely. — NCATS

Clinical trial activity

95 trials · 92 clinical orgs · 8 marketing orgs

Phase 1
9
Phase 2
40
Phase 3
19
Phase 4
22

Earliest trial started Jul 1, 2003 (NCT00267111)

Timeline

1930s

  1. Jun 1, 1930

    Evidence of US Marketing

2000s

  1. Jan 1, 2003

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2003

    Earliest Phase 3 Sponsor(trial)

  3. Jun 23, 2005

    Earliest FDA Approval

  4. Jun 23, 2005

    Galen — NDA Secondary Org

  5. Jun 23, 2005

    Warner Chilcott — NDA Secondary Org

  6. Jun 29, 2006

    Taro Pharmaceuticals — NDA Secondary Org

  7. Jan 1, 2008

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Feb 29, 2016

    Alcon — NDA Secondary Org

  2. Feb 29, 2016

    Nestle — NDA Secondary Org

  3. Jun 29, 2016

    St. Renatus, LLC — Marketing Organization

  4. Jun 29, 2016

    St. Renatus, LLC — NDA Secondary Org

  5. Mar 12, 2019

    Bausch Health Companies — Marketing Organization

  6. Mar 12, 2019

    Bausch Health Companies — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedJun 23, 2005
  • approvedJun 1, 1930

Chemistry & pharmacology

Loading structure…

SMILES

CCCCNc1ccc(C(=O)OCCN(C)C)cc1
Mol. weight
264.37 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

Yes

First in class

Sources

Also known as

  • 2-(dimethylamino)ethyl 4-(butylamino)benzoate
  • 2-(dimethylamino)ethyl 4-(butylamino)benzoate
  • 2-(dimethylamino)ethyl p-(butylamino)benzoate
  • 2-(dimethylamino)ethyl p-(butylamino)benzoate
  • amethocaine
  • amethocaine
  • amethocaine
  • amethocaine
  • amethocaine
  • amethocaine hcl
  • amethocaine hcl
  • amethocaine hcl
  • ametop
  • ametop
  • diäthylaminoäthanol ester der p-butylaminobenzösäure
  • diäthylaminoäthanol ester der p-butylaminobenzösäure
  • dicaine
  • dicaine
  • dicaine
  • kovacaine
  • kovacaine
  • laudocaine
  • lidocaine and tetracaine
  • medihaler-tetracaine
  • medihaler-tetracaine
  • medihaler-tetracaine
  • metraspray
  • metraspray
  • metraspray
  • p-(butylamino)benzoic acid β-(dimethylamino)ethyl ester
  • p-(butylamino)benzoic acid β-(dimethylamino)ethyl ester
  • p-butylaminobenzoyl-2-dimethylaminoethanol
  • p-butylaminobenzoyl-2-dimethylaminoethanol
  • pontocaine
  • pontocaine
  • pontocaine
  • pontocaine
  • pontocaine
  • pontocaine hcl
  • tetracaína
  • tetracaína
  • tetracaine
  • tetracaine
  • tetracaine
  • tetracaine
  • tetracaine
  • tetracaine
  • tetracaine
  • tetracaine
  • tetracaine
  • tétracaïne
  • tétracaïne
  • tetracaine hcl
  • tetracaine hcl
  • tetracaine hcl
  • tetracaine hcl
  • tetracaine hydrochloride
  • tetracaine hydrochloride
  • tetracaine hydrochloride
  • tetracaine hydrochloride
  • tetracaine hydrochloride
  • tetracaine monohydrochloride
  • tetracaine monohydrochloride
  • tetracaine monohydrochloride
  • tetracaine monohydrochloride
  • tetracaine monohydrochloride
  • tetracaine monohydrochloride

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07273916Phase 2Mar 31, 2026Hexsel Dermatology Clinic
NCT07294755N/ADec 20, 2025People's Liberation Army of China
NCT06874244Early Phase 1 (Phase 1)Aug 1, 2024Louisiana State University
NCT04794842Early Phase 1 (Phase 1)Aug 1, 2021Louisiana State University, Our Lady of the Lake Regional Medical Center
NCT04523961Phase 2/Phase 3 (Phase 3)Dec 1, 2020Mayo Clinic
NCT04685538Phase 3Sep 9, 2020Sintetica SA
NCT04105985Phase 2Nov 30, 2019Virginia Commonwealth University
NCT04104789Phase 2Nov 30, 2019Virginia Commonwealth University
NCT03962634Phase 2Aug 31, 2019Virginia Commonwealth University
NCT04536493Phase 4Jun 19, 2019CHOC Childrens, University of California, Irvine
NCT04102878N/AJun 4, 2019Moorgreen Hospital, Southampton
NCT03844178Phase 2Feb 10, 2019Shahid Beheshti University of Medical Sciences
NCT03749915N/ANov 20, 2018British Columbia Cancer Agency, University of British Columbia
NCT03502135Phase 4Sep 30, 2018University of North Carolina at Chapel Hill
NCT03368391Phase 4Jan 3, 2018Louisiana State University
NCT03199105N/AJul 1, 2017Sichuan University
NCT03233737Phase 2Jun 15, 2017Cetylite Industries
NCT04203225Phase 4May 22, 2017University of California, Irvine, University of California, Los Angeles
NCT02726620N/AJan 1, 2017Utrecht University, Vanderbilt University
NCT03022240Phase 4Jan 1, 2017University of Calgary
Showing 20 of 95 trials
Page 1 / 5

Organizations

Research & Development (92)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Zars Pharma Inc.For profit171642005
St. Renatus, LLCFor profit111132008
Rho, Inc.For profit10022008
Triligent InternationalFor profit8022012
Louisiana State UniversityAcademic/Hospital3222018
Nuvo Research Inc.For profit3022012
Sichuan UniversityAcademic/Hospital3312008
University of British ColumbiaAcademic/Hospital3232007
University of PittsburghAcademic/Hospital3022012
University of Texas at HoustonAcademic/Hospital3222008
Virginia Commonwealth UniversityAcademic/Hospital3312019
Analytical Bio-Chemistry Laboratories, Inc.For profit2012013
Cetylite IndustriesFor profit2212016
GaldermaFor profit2212008
Ground Zero PharmaceuticalsFor profit2012008
International Clinical Research Institute, Inc.For profit2122009
McMaster UniversityAcademic/Hospital2022009
Northwestern UniversityAcademic/Hospital2222013
University of California, IrvineAcademic/Hospital2112017
University of MiamiAcademic/Hospital2222011
92 organizations
Page 1 / 5

Marketing (12)

OrganizationOrg typeRelationshipDate
AlconFor profitNDA2Feb 29, 2016
Bausch Health CompaniesFor profitMKTGMar 12, 2019
Bausch Health CompaniesFor profitNDA2Mar 12, 2019
Bausch Health CompaniesFor profitSYNMar 12, 2019
GalenFor profitNDA2Jun 23, 2005
NestleFor profitNDA2Feb 29, 2016
St. Renatus, LLCFor profitMKTGJun 29, 2016
St. Renatus, LLCFor profitNDA2Jun 29, 2016
Sterling DrugFor profitNDA—
Taro PharmaceuticalsFor profitNDA2Jun 29, 2006
Taro PharmaceuticalsFor profitSYNJun 29, 2006
Warner ChilcottFor profitNDA2Jun 23, 2005