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benzocaine

Trade name: Orajel

Small moleculemarketed

Approved

Jun 1, 1902

Benzocaine is a local anesthetic. It acts by blocking voltage-gated sodium ion channels in nerve endings. Benzocaine is available over-the counter for local anesthesia of oral and pharyngeal mucous membranes (sore throat, cold sores, mouth ulcers, toothache, sore gums, denture irritation), otic pain, and as a local anesthetic for surgical or diagnostic procedures. As a spray, benzocaine is used for temporary relief of pain and itching associated with minor burns, sunburn, minor cuts or scrapes, insect bites, or minor skin irritations. Topical application of benzocaine to gums or mouth may cause rare, but serious and potentially fatal adverse effect methemoglobinemia. — NCATS

Clinical trial activity

47 trials · 52 clinical orgs · 0 marketing orgs

Phase 1
8
Phase 2
21
Phase 3
7
Phase 4
8

Earliest trial started Aug 1, 2004 (NCT01544842)

Timeline

1900s

  1. Jun 1, 1902

    Evidence of US Marketing

2000s

  1. Jan 1, 2005

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Jan 1, 2011

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2012

    Earliest Phase 2 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJun 1, 1902

Chemistry & pharmacology

Loading structure…

SMILES

CCOC(=O)C1=CC=C(N)C=C1
Mol. weight
165.1891 g/mol
Lipinski Ro5
Pass
Rule of 3
Yes
Chirality
Achiral Molecule
Inorganic
No
Polymer
No

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • 4-aminobenzoic acid ethyl ester
  • 4-aminobenzoic acid ethyl ester
  • 4-carbethoxyaniline
  • aezodent
  • amben ethyl ester
  • amben ethyl ester
  • americaine
  • americaine
  • americaine
  • anaesthesin
  • anaesthesin
  • anthisan plus
  • ar01
  • baby anbesol
  • baby anbesol
  • benzocaina
  • benzocaina
  • benzocaine
  • benzocaine
  • benzocaine
  • benzocaine
  • benzocaine
  • benzocaine
  • benzocaine
  • benzocaine
  • benzocaine
  • benzocaine formate
  • benzocaine hcl
  • benzocaine hydrobromide
  • benzocaine hydrochloride
  • benzocaine methanesulfonate
  • benzocainum
  • benzocainum
  • burneze
  • children's chloraseptic
  • dequacaine
  • ethyl aminobenzoate
  • ethyl aminobenzoate
  • ethyl aminobenzoate
  • ethyl aminobenzoate
  • ethyl p-aminobenzoate
  • ethyl p-aminobenzoate
  • ethyl p-aminophenylcarboxylate
  • ethyl p-aminophenylcarboxylate
  • lanacane
  • lanacane
  • medilave
  • medilave
  • nestosyl
  • nestosyl
  • norcaine
  • orajel
  • parathesin
  • p-carbethoxyaniline
  • p-carbethoxyaniline
  • p-(ethoxycarbonyl)aniline
  • p-(ethoxycarbonyl)aniline
  • p-ethoxycarboxylic aniline
  • p-ethoxycarboxylic aniline
  • tyrosolven
  • tyrozets
  • tyrozets

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06951191Phase 4Jun 23, 2025University of Missouri
NCT06691269N/AJan 31, 2025University of Maryland
NCT06804616Early Phase 1 (Phase 1)Nov 28, 2024University of Health Sciences Lahore
NCT06272903Early Phase 1 (Phase 1)Mar 31, 2024Mohammed Bin Rashid University of Medicine and Health Sciences
NCT06011005N/ASep 1, 2023Mohammed Bin Rashid University of Medicine and Health Sciences
NCT05507359N/AMar 1, 2023Cairo University
NCT05861154N/ADec 1, 2022Alexandria University
NCT05564442N/AJun 5, 2022Minia University
NCT05083975N/ADec 31, 2021Cairo University
NCT05060913Early Phase 1 (Phase 1)Nov 17, 2021Dow University of Health Sciences
NCT06165432Phase 4Mar 19, 2021B.P. Koirala Institute of Health Sciences
NCT04859738Phase 3Mar 4, 2020Erciyes University
NCT04308161Phase 2Nov 2, 2019Alexandria University
NCT04317508Phase 1/Phase 2 (Phase 2)Nov 1, 2019Alexandria University
NCT04095442Early Phase 1 (Phase 1)Oct 31, 2019Indiana University
NCT04317183Phase 2May 15, 2019Alexandria University
NCT03790540Phase 2Dec 1, 2018Alexandria University
NCT03432923Phase 3Feb 2, 2018Janssen Pharmaceutica NV, Johnson and Johnson
NCT03833570Phase 2Jan 12, 2018Alexandria University
NCT03953001N/AJan 1, 2018Imam Abdulrahman Bin Faisal University
Showing 20 of 47 trials
Page 1 / 3

Organizations

Research & Development (52)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Alexandria UniversityAcademic/Hospital6622018
Arbor PharmaceuticalsFor profit3322012
Cairo UniversityAcademic/Hospital3312016
Vanderbilt UniversityAcademic/Hospital3322012
Cetylite IndustriesFor profit2212016
Mohammed Bin Rashid University of Medicine and Health SciencesAcademic/Hospital2222023
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government2012012
University of PennsylvaniaAcademic/Hospital2122011
American Association of EndodontistsAcademic/Hospital1012013
Augusta UniversityAcademic/Hospital1012014
Azad UniversityAcademic/Hospital1112015
Beni Suef UniversityAcademic/Hospital1012016
Boehringer IngelheimFor profit1112005
B.P. Koirala Institute of Health SciencesAcademic/Hospital1112021
Carolina Ear, Nose and Throat ClinicAcademic/Hospital1012013
Church & Dwight Company, Inc.For profit1012007
Consumer Healthcare Products AssociationAcademic/Hospital1012007
Dow University of Health SciencesAcademic/Hospital1112021
EMS S/AFor profit1112012
Erciyes UniversityAcademic/Hospital1112020
52 organizations
Page 1 / 3