Drugs / Dexchlorpheniramine

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) POLARAMINE 1981-07-14 fda.gov

Trials 9 · a red edge is where a trial was stopped

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 38 trials
Phase 3 NCT02735070 Sep 2016 → Mar 2017 Brainfarma Unknown No outcome recorded
Phase 3 NCT02675374 Jun 2016 → Jul 2017 University Hospital, Bordeaux Terminated No outcome recorded
Phase 3 NCT01257061 Sep 2012 → Apr 2013 atopic eczema EMS Completed No outcome recorded
Phase 3 NCT01233934 Feb → Jul 2011 insect Stings, hypersensitivity to Mantecorp Industria Quimica e Farmaceutica Ltd. Unknown No outcome recorded
Phase 3 NCT01085851 sunburn Mantecorp Industria Quimica e Farmaceutica Ltd. Unknown No outcome recorded
Phase 3 NCT00995397 insect Stings, hypersensitivity to Mantecorp Industria Quimica e Farmaceutica Ltd. Unknown No outcome recorded
Phase 3 NCT01237925 sunburn Mantecorp Industria Quimica e Farmaceutica Ltd. Unknown No outcome recorded
Phase 3 NCT01085721 viral respiratory tract infection Mantecorp Industria Quimica e Farmaceutica Ltd. Unknown No outcome recorded
Phase not applicable1 trial
NCT00846950 Dec 2006 → May 2007 Maastricht University Medical Center Completed No outcome recorded
Also used as a comparator or background therapy in 9 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT02583594 Background Dec 2015 → Mar 2016 multiple sclerosis Genzyme, a Sanofi Company Completed No outcome recorded
Phase 36 trials
Phase 3 NCT05136976 Comparator Jun 2023 → Dec 2027 expected polyneuropathy associated with IgM monoclonal gammapathy with anti-MAG University Hospital of Saint-Etienne Recruiting No outcome recorded
Phase 3 NCT04702256 Background Dec 2021 → Dec 2031 expected lupus nephritis, systemic lupus erythematosus Assistance Publique - Hôpitaux de Paris Recruiting No outcome recorded
Phase 3 NCT03368664 Background Oct 2017 → May 2021 multiple sclerosis Genzyme, a Sanofi Company Terminated No outcome recorded
Phase 3 NCT01529242 Comparator Feb 2014 → Aug 2016 hypersensitivity reaction disease EMS Terminated No outcome recorded
Phase 3 NCT01529229 Comparator Nov 2013 → Oct 2014 allergic rhinitis EMS Completed No outcome recorded
Phase 41 trial
Phase 4 NCT02441894 Background Apr 2015 → Feb 2016 prostate cancer Sanofi Completed No outcome recorded
Phase not applicable1 trial
NCT03805035 Comparator Jan → Jun 2019 China Medical University Hospital Completed No outcome recorded

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 19 sources stand behind the page.

FieldValueCited text
Known as Dexchlorpheniramine “The tablets of Coristina® d contain 400 mg acetylsalicylic acid, dexchlorpheniramine 1 mg, 10 mg phenylephrine, and 30 mg of caffeine.” NCT02735070
16

Dexchlorpheniramine maleate 10 mg/g applied 2 times / day at lesion” NCT01257061

NCT01233934

NCT01085721

NCT01529242

NCT03805035

NCT01720485

NCT02675374

NCT03368664

NCT02441894

NCT00846950

NCT04702256

NCT01237925

NCT01529229

NCT00995397

NCT02583594

NCT01085851

Known as chlorpheniramine “antihistamine(low dose) chlorpheniramine (Dexchlorpheniramine maleate)” NCT03805035
Known as DCPA “histamine H1 receptor antagonist dexchlorpheniramine (DCPA) facilitates EA analgesia in healthy human subjects.” PMID 36081814 Apr 2022
Known as Dexchlorpheniramine maleate Dexchlorpheniramine maleate 1% cream is a topical anti-histaminic formulation approved by ANVISA in Brazil for the relief of skin irritation and allergies, including the ones...” NCT00995397
6

Dexchlorpheniramine maleate 1% cream is a topical antihistamine formulation approved by ANVISA in Brazil for the relief of skin irritation and pruritus, including the ones...” NCT01085851

Dexchlorpheniramine maleate 1% cream is a topical antihistamine formulation approved by ANVISA in Brazil for the relief of skin irritation and pruritus, including the ones...” NCT01237925

“The aim of the present study is to demonstrate non-inferiority of a new pharmacological preparation of dexchlorpheniramine maleate (1% gel) with the standard preparation (1% cream)” NCT01233934

dexchlorpheniramine maleate 0,4 mg/ml + Betamethasone 0,05 mg/ml - oral solution” NCT01529242

“antihistamine(low dose) chlorpheniramine (Dexchlorpheniramine maleate)” NCT03805035

“IV Dexchlorpheniramine Maleate IV: 10 mg” NCT05136976

Action Inhibit “histamine H1 receptor antagonist dexchlorpheniramine (DCPA)” PMID 36081814 Apr 2022
Route Topical “Small amount applied over the lesion twice a day for 7 days” NCT01085851