CDEK by Data4ThePeople
Sign in Sign up
← All drugs Report issue

chlorpheniramine

Trade name: ChlorTrimeton

Small moleculeapproved

Approved

Jan 4, 1984

Chlorphenamine (CP, CPM), also known as chlorpheniramine, is an antihistamine used to treat the symptoms of allergic conditions such as allergic rhinitis (hay fever). It is taken orally (by mouth). The medication takes effect within two hours and lasts for about 4–6 hours. It is a first-generation antihistamine and works by blocking the histamine H1 receptor. — Wikipedia

Clinical trial activity

19 trials · 26 clinical orgs · 7 marketing orgs

Phase 1
3
Phase 2
9
Phase 3
8
Phase 4
1

Earliest trial started Mar 12, 1996 (NCT03879772)

Timeline

1980s

  1. Jan 4, 1984

    UCB — Earliest FDA Approval

  2. Jan 4, 1984

    UCB — NDA Organization

  3. May 28, 1986

    Fisons — NDA Secondary Org

1990s

  1. Jan 1, 1996

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Jan 1, 2003

    Earliest Phase 1 Sponsor(trial)

  2. Jun 21, 2004

    Lannett Company, Inc. — NDA Secondary Org

  3. Sep 24, 2007

    ECR Pharmaceuticals — Marketing Organization

2010s

  1. Oct 1, 2010

    Tris Pharma, Inc. — Marketing Organization

  2. Jun 29, 2012

    Neos Therapeutics, Inc — Marketing Organization

  3. Jun 29, 2012

    AYTU BioScience — Marketing Organization

  4. Apr 30, 2015

    AYTU BioScience — NDA Secondary Org

  5. Apr 30, 2015

    Tris Pharma, Inc. — NDA Secondary Org

  6. Jan 1, 2018

    Earliest Phase 2 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Combination products

  • corsym

    with phenylpropanolamine

  • penntuss

    with codeine

    Also known as codeprex, tuzistra xr

  • tussionex pennkinetic

    with hydrocodone

    Also known as hydrocodone polistirex and chlorpheniramne polistirex, tussicaps

Approval history

  • approvedJan 4, 1984

Chemistry & pharmacology

Chirality
Racemic Mixture
Inorganic
No
Polymer
Yes
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • chlorpheniramine polistirex
  • chlorpheniramine polistirex
  • chlorpheniramine polistirex
  • chlorpheniramine polistirex
  • resfenol
  • resfenol

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06433362Phase 2Jun 1, 2024Harbin Medical University, Tianjin Medical University
NCT05858216Early Phase 1 (Phase 1)May 15, 2023Auburn University
NCT05886829Phase 2/Phase 3 (Phase 3)Jul 27, 2022Ferrer Laboratories, Hospital CEMESA Cortés, San Pedro Sula, Honduras
NCT05449405Phase 2/Phase 3 (Phase 3)Dec 7, 2021Ferrer Laboratories, Hospital CEMESA Cortés, San Pedro Sula, Honduras
NCT04937101N/AJan 1, 2021Zhejiang University
NCT04688736Phase 2Jan 1, 2021Chinese Academy of Medical Sciences
NCT04790487Phase 2/Phase 3 (Phase 3)Jul 30, 2019Larkin Community Hospital, Larkin Health System
NCT03940391N/AApr 27, 2019Seoul National University
NCT04293081N/AJan 16, 2019Ain Shams University
NCT03301454Phase 2Sep 30, 2018University of Lille
NCT03583567Phase 4Sep 5, 2018Mahidol University
NCT03332524Phase 2Jan 15, 2018Sephoris Pharmaceuticals LLC
NCT02656914Phase 3Jul 1, 2017EMS S/A
NCT02735070Phase 3Sep 1, 2016Brainfarma Industria Química e Farmacêutica S/A, Clinilive, CTD Dor Clinica de Diagnostico e Terapia da Dor Ltda, Hospital Nipo-Brasileiro, Pesquisare Saude S/S Ltda, Pharmagenix, Techtrials Pesquisa e Tecnologia Ltda
NCT01158326Phase 3Aug 1, 2010Federal University of Health Science of Porto Alegre, Federal University of Rio Grande do Sul
NCT00940836Phase 3Jun 1, 2009Federal University of Rio Grande do Sul
NCT00853190Phase 1Sep 1, 2003Mallinckrodt
NCT00853294Phase 1Sep 1, 2003Mallinckrodt
NCT03879772Phase 3Mar 12, 1996Merck
Showing 19 of 19 trials
Page 1 / 1

Organizations

Research & Development (26)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Federal University of Rio Grande do SulAcademic/Hospital2212009
Ferrer LaboratoriesFor profit2212021
Hospital CEMESA Cortés, San Pedro Sula, HondurasAcademic/Hospital2012021
MallinckrodtFor profit2212003
Ain Shams UniversityAcademic/Hospital1112019
Auburn UniversityAcademic/Hospital1112023
Brainfarma Industria Química e Farmacêutica S/AFor profit1112016
Chinese Academy of Medical SciencesAcademic/Hospital1112021
CliniliveAcademic/Hospital1012016
CTD Dor Clinica de Diagnostico e Terapia da Dor LtdaAcademic/Hospital1012016
EMS S/AFor profit1112017
Federal University of Health Science of Porto AlegreAcademic/Hospital1012010
Harbin Medical UniversityAcademic/Hospital1012024
Hospital Nipo-BrasileiroAcademic/Hospital1012016
Larkin Community HospitalAcademic/Hospital1112019
Larkin Health SystemAcademic/Hospital1012019
Mahidol UniversityAcademic/Hospital1112018
MerckFor profit1111996
Pesquisare Saude S/S LtdaAcademic/Hospital1012016
PharmagenixFor profit1012016
26 organizations
Page 1 / 2

Marketing (10)

OrganizationOrg typeRelationshipDate
AYTU BioScienceFor profitNDA2Apr 30, 2015
AYTU BioScienceFor profitMKTGJun 29, 2012
ECR PharmaceuticalsFor profitMKTGSep 24, 2007
FisonsFor profitNDA2May 28, 1986
Lannett Company, Inc.For profitNDA2Jun 21, 2004
Neos Therapeutics, IncFor profitMKTGJun 29, 2012
Neos Therapeutics, IncFor profitSYNJun 29, 2012
Tris Pharma, Inc.For profitMKTGOct 1, 2010
Tris Pharma, Inc.For profitNDA2Apr 30, 2015
UCBFor profitNDAJan 4, 1984