CDEK
← All drugs Report issue

dexchlorpheniramine maleate

Trade name: polaramine

Small moleculeapproved

Approved

Jul 13, 1949

Dexchlorpheniramine is an antihistamine with anticholinergic properties used to treat allergic conditions such as hay fever or urticaria. It is the pharmacologically active dextrorotatory isomer of chlorpheniramine. — Wikipedia

Clinical trial activity

26 trials · 25 clinical orgs · 48 marketing orgs

Phase 1
5
Phase 2
16
Phase 3
12
Phase 4
2

Earliest trial started Sep 1, 2003 (NCT00853190)

Timeline

1940s

  1. Jul 13, 1949

    Earliest FDA Approval

  2. Jul 13, 1949

    Schering — NDA Secondary Org

1950s

  1. Aug 15, 1950

    Bayer — NDA Secondary Org

  2. Jun 1, 1959

    Schering-Plough — First NDA Organization

  3. Jun 1, 1959

    Schering-Plough — NDA Organization

1970s

  1. May 9, 1972

    Teva — Marketing Organization

  2. Aug 24, 1972

    Sun Pharmaceuticals — Marketing Organization

  3. Dec 20, 1972

    Aurobindo Pharma — Marketing Organization

  4. Mar 20, 1973

    Bayer — Marketing Organization

  5. Oct 18, 1973

    West-Ward Pharmaceutical — Marketing Organization

  6. Nov 29, 1973

    Belmar Pharmacy — Marketing Organization

  7. Jun 21, 1974

    Lannett Company, Inc. — Marketing Organization

  8. Oct 18, 1974

    Watson Pharmaceuticals — Marketing Organization

  9. Feb 11, 1977

    Pharmavite — Marketing Organization

  10. Feb 9, 1979

    Newtron Pharmaceuticals — Marketing Organization

1980s

  1. Jul 14, 1981

    Schering-Plough — Marketing Organization

  2. Jul 22, 1981

    Lumara Health — Marketing Organization

  3. Nov 3, 1982

    Lederle — Marketing Organization

  4. Nov 3, 1982

    American Cyanamid — Marketing Organization

  5. Mar 23, 1984

    Pharmaceutical Associates — Marketing Organization

  6. Mar 23, 1984

    Wockhardt — Marketing Organization

  7. Jul 13, 1984

    Dow Chemical — Marketing Organization

  8. Mar 18, 1985

    Graham Dm — NDA Secondary Org

  9. Jan 17, 1986

    Ani Pharmaceuticals — Marketing Organization

  10. Mar 6, 1986

    Fisons — Marketing Organization

  11. Mar 6, 1986

    Fisons — NDA Secondary Org

  12. Aug 2, 1988

    Century Pharmaceuticals — Marketing Organization

  13. Aug 2, 1988

    Century Pharmaceuticals — NDA Secondary Org

1990s

  1. Nov 18, 1994

    Alza — NDA Secondary Org

2000s

  1. Dec 19, 2002

    Pfizer — Marketing Organization

  2. Dec 19, 2002

    GlaxoSmithKline — NDA Secondary Org

  3. Jan 1, 2003

    Earliest Phase 1 Sponsor(trial)

  4. Jan 1, 2008

    Pfizer — Earliest Phase 2 Sponsor(trial)

  5. Jan 1, 2009

    Earliest Phase 3 Sponsor(trial)

  6. May 13, 2009

    Avanthi Pharma — Marketing Organization

2010s

  1. Jun 8, 2011

    Cypress Pharmaceutical — Marketing Organization

  2. Jun 8, 2011

    Currax Pharmaceuticals — NDA Secondary Org

  3. Apr 29, 2014

    Paddock Laboratories — Marketing Organization

  4. Apr 29, 2014

    Padagis Us — Marketing Organization

  5. Nov 26, 2014

    Tris Pharma, Inc. — Marketing Organization

  6. Jun 22, 2015

    Mainpointe — Marketing Organization

  7. Jun 22, 2015

    Mainpointe — NDA Secondary Org

  8. Aug 3, 2015

    Mayne Pharma — Marketing Organization

  9. May 15, 2017

    Torrent Pharmaceuticals Limited — Marketing Organization

  10. Jun 9, 2017

    Acella Pharmaceuticals — Marketing Organization

  11. Jul 16, 2018

    Capellon Pharmaceuticals — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedJul 13, 1949

Chemistry & pharmacology

Loading structure…

SMILES

CN(C)CC[C@@H](c1ccc(Cl)cc1)c1ccccn1.O=C(O)/C=C\C(=O)O
Mol. weight
390.87 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • 1-(p-chlorophenyl)-1-(2-pyridyl)-3-dimethylaminopropane
  • 1-(p-chlorophenyl)-1-(2-pyridyl)-3-dimethylaminopropane
  • 1-(p-chlorophenyl)-1-(2-pyridyl)-3-n,n-dimethylpropylamine
  • 1-(p-chlorophenyl)-1-(2-pyridyl)-3-n,n-dimethylpropylamine
  • 2-[p-chloro-α-[2-(dimethylamino)ethyl]benzyl]pyridine
  • 2-[p-chloro-α-[2-(dimethylamino)ethyl]benzyl]pyridine
  • 3-(p-chlorophenyl)-3-(2-pyridyl)-n,n-dimethylpropylamine
  • 3-(p-chlorophenyl)-3-(2-pyridyl)-n,n-dimethylpropylamine
  • allercalm allergy relief
  • allerief
  • alunex
  • alunex
  • antagonate
  • antagonate
  • calimal
  • chloropheniramine
  • (+)-chloropheniramine
  • chlorophenylpyridamine
  • chlorophenylpyridamine
  • chlorophenylpyridamine
  • chloroprophenpyridamine
  • chlorphenamin
  • chlorphenamin
  • chlorphenamine
  • chlorphenamine
  • chlorphenamine
  • chlorphenamine
  • chlorphenamine
  • chlorphenamine
  • chlorphenamine
  • chlorphenamine
  • chlorphenamine
  • chlorphenamine maleate
  • chlorphenamine maleate
  • chlorphenaminum
  • chlorphenaminum
  • chlorpheniramine
  • chlorpheniramine
  • chlorpheniramine
  • chlorpheniramine
  • chlorpheniramine
  • chlorpheniramine
  • (+)-chlorpheniramine
  • (+)-chlorpheniramine maleate
  • (+)-chlorpheniramine maleate
  • chlorpheniramine maleate
  • chlorpheniramine maleate
  • chlorpheniramine maleate
  • chlorpheniramine maleate
  • chlorpheniramine maleate
  • chlorpheniramine maleate
  • chlorpheniramine polistirex
  • chlorpheniramine polistirex
  • chlorpheniramine tannate
  • chlorpheniraminum
  • chlorpheniraminum
  • chlorprophenpyridamine
  • chlorprophenpyridamine maleate
  • chlorprophenpyridamine maleate
  • chlor-trimeton
  • chlor-trimeton
  • chlor-trimeton
  • chlor-trimeton
  • clorfenamina
  • clorfenamina
  • clorfeniramina
  • clorfeniramina
  • d-chlorpheniramine
  • d-chlorpheniramine maleate
  • d-chlorpheniramine maleate
  • dexchlorpheniramine
  • dexchlorpheniramine
  • dexchlorpheniramine
  • dexchlorpheniramine
  • dexchlorpheniramine
  • dexchlorpheniramine
  • dexchlorpheniramine
  • dexchlorpheniramine
  • dexchlorpheniramine
  • dexchlorpheniramine, (+-)-isomer
  • dexchlorpheniramine maleate
  • dexchlorpheniramine maleate
  • dexchlorpheniramine maleate
  • dexchlorpheniramine maleate
  • dexchlorpheniramine maleate
  • dexchlorpheniramine maleate
  • dexchlorpheniramine maleate
  • dexchlorpheniramine maleate (1:1), (+-)-isomer
  • dexchlorpheniramine maleate (1:1), (r)-isomer
  • dexchlorpheniramine maleate (1:1), (s)-isomer
  • dexchlorpheniramine monohydrochloride
  • dexchlorpheniramine, monohydrochloride, (s)-isomer
  • dexchlorpheniramine, (r)-isomer
  • dexchlorpheniramine sodium maleate (1:1)
  • dexclor
  • dexclorfeniramine
  • dextrochlorpheniramine maleate
  • efidac 24 chlorpheniramine maleate
  • efidac 24 chlorpheniramine maleate
  • gamma-(4-chlorophenyl)-n,n-dimethyl-2-pyridinepropanamine
  • hayleve
  • isoclor
  • isoclor
  • kloromin
  • kloromin
  • mylaramine
  • mylaramine
  • phenetron
  • phenetron
  • piriject
  • piriton
  • piriton
  • piriton allergy
  • polaramin
  • polaramine
  • polaramine
  • polaramine
  • polaramine
  • polargen td
  • polaronil
  • pyridamal 100
  • pyridamal 100
  • rhino-syrup allergy
  • rimarin
  • s-chlorpheniramine
  • teldrin
  • teldrin
  • γ-(4-chlorophenyl)-n,n-dimethyl-2-pyridinepropanamine
  • γ-(4-chlorophenyl)-n,n-dimethyl-2-pyridinepropanamine
  • γ-(4-chlorophenyl)-γ-(2-pyridyl)propyldimethylamine
  • γ-(4-chlorophenyl)-γ-(2-pyridyl)propyldimethylamine

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT04702256Phase 3Apr 30, 2021APHP - Hôpital Necker, Assistance Publique - Hôpitaux de Paris, Claude Bernard University, Roche
NCT03805035N/AJan 24, 2019China Medical University
NCT03368664Phase 3Oct 24, 2017Genzyme, Sanofi
NCT02675374Phase 3Jun 1, 2016University of Bordeaux
NCT02722083Phase 2May 7, 2016Bayer
NCT02583594Phase 1Dec 6, 2015Genzyme, Sanofi
NCT02441894Phase 4Apr 1, 2015Sanofi
NCT02246166Phase 4Jan 1, 2015GlaxoSmithKline, Smith Kline and French
NCT01529242Phase 3Feb 1, 2014EMS S/A, University of Sao Paulo
NCT01529229Phase 3Nov 1, 2013EMS S/A, University of Sao Paulo
NCT01720485Phase 3Oct 1, 2013EMS S/A
NCT01902836Phase 2Aug 1, 2011Government of Mexico, National Polytechnic Institute, Mexico, University of Valencia
NCT01008397Phase 1Apr 1, 2011Magna Pharmaceuticals, Inc.
NCT01293201Phase 3Mar 1, 2011Magna Pharmaceuticals, Inc.
NCT01233934Phase 3Feb 1, 2011Mantecorp Industria Quimica e Farmaceutica Ltd.
NCT01209455N/AJan 1, 2011NHS Lothian, University of Edinburgh
NCT01237925Phase 3Nov 8, 2010Mantecorp Industria Quimica e Farmaceutica Ltd.
NCT01171664Phase 2Sep 1, 2010Magna Pharmaceuticals, Inc.
NCT01085851Phase 3Mar 11, 2010Mantecorp Industria Quimica e Farmaceutica Ltd., Medcin Instituto da Pele
NCT01085721Phase 3Mar 9, 2010Mantecorp Industria Quimica e Farmaceutica Ltd.
Showing 20 of 26 trials
Page 1 / 2

Organizations

Research & Development (25)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Mantecorp Industria Quimica e Farmaceutica Ltd.For profit5512009
Magna Pharmaceuticals, Inc.For profit4432009
EMS S/AFor profit3312013
SanofiFor profit3132015
GenzymeFor profit2222015
MallinckrodtFor profit2212003
University of Sao PauloAcademic/Hospital2012013
APHP - Hôpital NeckerAcademic/Hospital1012021
Assistance Publique - Hôpitaux de ParisAcademic/Hospital1112021
BayerFor profit1112016
China Medical UniversityAcademic/Hospital1112019
Claude Bernard UniversityAcademic/Hospital1012021
GlaxoSmithKlineFor profit1112015
Government of MexicoGovernment1012011
Maastricht UniversityAcademic/Hospital1112006
Medcin Instituto da PeleAcademic/Hospital1012010
National Polytechnic Institute, MexicoAcademic/Hospital1112011
NHS LothianAcademic/Hospital1012011
PfizerFor profit1112008
RocheFor profit1012021
25 organizations
Page 1 / 2

Marketing (56)

OrganizationOrg typeRelationshipDate
Acella PharmaceuticalsFor profitSYNJun 9, 2017
Acella PharmaceuticalsFor profitMKTGJun 9, 2017
AlzaFor profitNDA2Nov 18, 1994
American CyanamidFor profitMKTGNov 3, 1982
Anabolic PharmaAcademic/HospitalMKTG—
Ani PharmaceuticalsFor profitSYNJan 17, 1986
Ani PharmaceuticalsFor profitMKTGJan 17, 1986
Aurobindo PharmaFor profitMKTGDec 20, 1972
Avanthi PharmaFor profitMKTGMay 13, 2009
BELL PHARMAFor profitMKTG—
BayerFor profitMKTGMar 20, 1973
BayerFor profitNDA2Aug 15, 1950
Belmar PharmacyFor profitMKTGNov 29, 1973
Capellon PharmaceuticalsFor profitMKTGJul 16, 2018
Century PharmaceuticalsFor profitMKTGAug 2, 1988
Century PharmaceuticalsFor profitNDA2Aug 2, 1988
Currax PharmaceuticalsFor profitNDA2Jun 8, 2011
Cypress PharmaceuticalFor profitMKTGJun 8, 2011
Dow ChemicalFor profitMKTGJul 13, 1984
Elkins SinnFor profitMKTG—
FisonsFor profitMKTGMar 6, 1986
FisonsFor profitNDA2Mar 6, 1986
GlaxoSmithKlineFor profitNDA2Dec 19, 2002
Graham DmFor profitNDA2Mar 18, 1985
HalseyFor profitMKTG—
Impax LaboratoriesFor profitMKTG—
Lannett Company, Inc.For profitMKTGJun 21, 1974
LederleFor profitMKTGNov 3, 1982
Lumara HealthFor profitMKTGJul 22, 1981
MainpointeFor profitMKTGJun 22, 2015
MainpointeFor profitNDA2Jun 22, 2015
Mayne PharmaFor profitMKTGAug 3, 2015
MylanFor profitMKTG—
Newtron PharmaceuticalsFor profitMKTGFeb 9, 1979
NovartisFor profitNDA2—
Padagis UsFor profitMKTGApr 29, 2014
Paddock LaboratoriesFor profitMKTGApr 29, 2014
Paddock LaboratoriesFor profitSYNApr 29, 2014
Panray Corp.For profitMKTG—
PfizerFor profitMKTGDec 19, 2002
Pharmaceutical AssociatesFor profitMKTGMar 23, 1984
PharmaviteFor profitMKTGFeb 11, 1977
Puracap PharmaceuticalFor profitMKTG—
Roxane LaboratoriesFor profitMKTG—
ScheringFor profitNDA2Jul 13, 1949
Schering-PloughFor profitNDAJun 1, 1959
Schering-PloughFor profitMKTGJul 14, 1981
Schwarz PharmaFor profitNDA2—
Sun PharmaceuticalsFor profitMKTGAug 24, 1972
TevaFor profitMKTGMay 9, 1972
Torrent Pharmaceuticals LimitedFor profitMKTGMay 15, 2017
Tris Pharma, Inc.For profitMKTGNov 26, 2014
VitarineFor profitMKTG—
Watson PharmaceuticalsFor profitMKTGOct 18, 1974
West-Ward PharmaceuticalFor profitMKTGOct 18, 1973
WockhardtFor profitMKTGMar 23, 1984