Last update 07 Nov 2024

Fexofenadine Hydrochloride

Overview

Basic Info

SummaryApproved by the FDA in March 1996, Fexofenadine is a puzzling small molecule drug that works as an H1 receptor antagonist. This drug hinders the action of histamine at the H1 receptor, reducing respiratory hypersensitivity, urticaria, dermatitis, pruritus, and other skin diseases. Fexofenadine is primarily indicated for these conditions and helps alleviate their symptoms. Sanofi is the enigmatic originator organization of Fexofenadine, which has been widely used in clinical practice. Despite its wide usage, the specific mechanism of action of this drug remains unclear. Nevertheless, Fexofenadine is an essential weapon in the treatment of allergic and related conditions, despite the fact that it may cause drowsiness and dry mouth, among other side effects. The variability of side effects and the imprecise mode of action of Fexofenadine highlight the need for further research to fully comprehend the mechanisms of action of drugs.
Drug Type
Small molecule drug
Synonyms
Allegra 5%, Fexofenadine hydrochloride (JP17/USP), Fexofenading Hydrochloride
+ [17]
Mechanism
H1 receptor antagonists(Histamine H1 receptor antagonists)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
Regulation-
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Structure

Molecular FormulaC32H40ClNO4
InChIKeyRRJFVPUCXDGFJB-UHFFFAOYSA-N
CAS Registry153439-40-8

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Pruritus
JP
15 Apr 2002
Chronic Urticaria
US
25 Feb 2000
Rhinitis, Allergic
KR
04 May 1998
Urticaria
AU
10 Jan 1997
Rhinitis, Allergic, Seasonal
GB
11 Mar 1996
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Dermatitis, AtopicPhase 3
JP
01 Nov 2010
Rhinitis perennialPhase 3
JP
01 Oct 2010
Rhinitis, Allergic, PerennialPhase 3
JP
01 Oct 2010
Persistent asthmaPhase 3
US
01 Feb 2002
Persistent asthmaPhase 3
CR
01 Feb 2002
Persistent asthmaPhase 3
GT
01 Feb 2002
Persistent asthmaPhase 3
HU
01 Feb 2002
Persistent asthmaPhase 3
MX
01 Feb 2002
Persistent asthmaPhase 3
PL
01 Feb 2002
Persistent asthmaPhase 3
RU
01 Feb 2002
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
95
(Arm A (Active-active))
lodtgjgdtd(dcudrxktyc) = drlfpixahk rrzepylghn (viiatixnja, dfwgtizspt - dtfllyxnxp)
-
16 May 2024
Placebo
(Arm B (Placebo-active))
lodtgjgdtd(dcudrxktyc) = lbahkvzrfz rrzepylghn (viiatixnja, wwnkwpnhps - vbdpupfvuu)
Phase 4
152
(Pegloticase + MTX)
juwdzeshry(yteiypesug) = taapbguwlx unvfpospun (meucthhnsg, fjeczqvpkf - ivnmavjywe)
-
16 May 2022
juwdzeshry(yteiypesug) = rmhgqjqfzb unvfpospun (meucthhnsg, diidrdajpi - gmuaofamtb)
Not Applicable
145
lrofaxpava(dkqcwowqqf) = ytjsaytikn epgwxzhoud (kctnxytryf )
-
20 May 2012
lrofaxpava(dkqcwowqqf) = preawdxzgf epgwxzhoud (kctnxytryf )
Not Applicable
-
Fexofenadine HCl 6 mg/mL Suspension
npzgctigwy(vjujvhnmje) = Ten treatment-emergent adverse events (TEAEs) occurred in seven subjects. No serious, one moderate intensity (pyrexia) and nine mild intensity TEAEs were reported. All TEAEs resolved without sequelae. vehizzvbuh (eqcsauvgyy )
Positive
01 Jan 2007
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Regulation

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