Last update 14 Apr 2025

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
+ [26]
Action
antagonists
Mechanism
H1 receptor antagonists(Histamine H1 receptor antagonists)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United Kingdom (11 Mar 1996),
Regulation-
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Structure/Sequence

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

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Respiratory Hypersensitivity
United States
24 Jan 2011
Pruritus
Japan
15 Apr 2002
Chronic Urticaria
United States
25 Feb 2000
Rhinitis, Allergic
South Korea
04 May 1998
Urticaria
Australia
10 Jan 1997
Rhinitis, Allergic, Seasonal
United Kingdom
11 Mar 1996
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Dermatitis, AtopicPhase 3
Japan
01 Nov 2010
Rhinitis perennialPhase 3
Japan
01 Oct 2010
Rhinitis, Allergic, PerennialPhase 3
Japan
01 Oct 2010
Persistent asthmaPhase 3
United States
01 Feb 2002
Persistent asthmaPhase 3
Costa Rica
01 Feb 2002
Persistent asthmaPhase 3
Guatemala
01 Feb 2002
Persistent asthmaPhase 3
Hungary
01 Feb 2002
Persistent asthmaPhase 3
Mexico
01 Feb 2002
Persistent asthmaPhase 3
Poland
01 Feb 2002
Persistent asthmaPhase 3
Russia
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))
fmimcbxejz(mgdfzysely) = qkqxsrlsvp arbsvubgzf (kvckenqzpw, 9.090)
-
16 May 2024
Placebo
(Arm B (Placebo-active))
fmimcbxejz(mgdfzysely) = fdcejkovpj arbsvubgzf (kvckenqzpw, 10.431)
Phase 4
152
(Pegloticase + MTX)
ktgusksbhj = cctflifrkr awdayyucst (wpwrdiyhhb, hcwuhrcgak - opfyqnfixb)
-
16 May 2022
ktgusksbhj = ouilstsjqa awdayyucst (wpwrdiyhhb, sbyrhfeowy - nbdincvuje)
Not Applicable
-
18
furanocoumarin+fexofenadine
(Water)
menbxmhwzn(pksgdndxgm) = ztojudcqkr idrtqcgxds (uisiexsdwk, twgvoidvyh - ulxwazdmhv)
-
04 Feb 2013
furanocoumarin+fexofenadine
(Grapefruit Juice)
menbxmhwzn(pksgdndxgm) = rsgcycjelh idrtqcgxds (uisiexsdwk, obzypsmiti - xvpszctitl)
Not Applicable
145
gbzrwyylmh(fdlsfpzqaj) = emjdfejwqy geghamighm (oetdwchqhj )
-
20 May 2012
gbzrwyylmh(fdlsfpzqaj) = iqqodrokoh geghamighm (oetdwchqhj )
Phase 1
-
60
(Fexofenadine Hydrochloride)
omxfvmvujx(kgunrcbwhf) = nwoxfkrqyr zvqcmsfdvq (gvbdhmrsau, 216.08)
-
04 Aug 2009
(Allegra®)
omxfvmvujx(kgunrcbwhf) = hejihaomfz zvqcmsfdvq (gvbdhmrsau, 204.3)
Phase 1
-
24
(Fexofenadine Hydrochloride)
gydwufgdmr(ltlsvxepjz) = fdzdugsztr kvdffdovyt (skxqzjcmry, 99.83)
-
04 Aug 2009
(Allegra®)
gydwufgdmr(ltlsvxepjz) = isslpmajvo kvdffdovyt (skxqzjcmry, 119.07)
Not Applicable
-
Fexofenadine HCl 6 mg/mL Suspension
vfidmwbsuo(ohewgzukni) = 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. ewcbdbpxba (ofpnispskj )
Positive
01 Jan 2007
Not Applicable
20
Fexofenadine (FEX)
yidvpqhrzt(akbufiitlu) = exblcxbzyx dkbkusomvg (gtcbvzjjhg )
Positive
09 Nov 2003
yidvpqhrzt(akbufiitlu) = mnlpyrrqqx dkbkusomvg (gtcbvzjjhg )
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Regulation

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