Last update 02 Jul 2024

Fexofenadine Hydrochloride

Last update 02 Jul 2024

Overview

R&D Status

Clinical Result

Translational Medicine

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

+ [21]

Target

H1 receptor

Mechanism

H1 receptor antagonists(Histamine H1 receptor antagonists)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesCongenital Disorders+ [4]

Active Indication

Rhinitis, AllergicUrticariaChronic Urticaria+ [6]

Inactive Indication

AsthmaNon-Small Cell Lung CancerPersistent asthma+ [2]

Originator Organization

Sanofi, Inc.

Active Organization

Chongqing Zhi'en Pharmaceutical Co., Ltd.Opella Healthcare Group SAS

The University of California, San Francisco

+ [6]

Inactive Organization

Sanofi SA

Sanofi

Chattem, Inc.

+ [1]

Drug Highest PhaseApproved

First Approval Date

GB (11 Mar 1996),

Chronic UrticariaDermatitis, AtopicEczema+ [2]

Regulation-

Structure

Molecular FormulaC32H40ClNO4

InChIKeyRRJFVPUCXDGFJB-UHFFFAOYSA-N

CAS Registry153439-40-8

Clinical Trials associated with Fexofenadine Hydrochloride

TCTR20230915004 / Not yet recruitingPhase 1

A Bioequivalence study of a randomized, open-label, single dose, full replicate crossover design with four-period, two-treatment, and two-sequence of Fexofenadine 180 mg tablets relative to Telfast 180 mg tablets in healthy Thai volunteers under fasting condition.

Start Date01 Aug 2024

Sponsor / Collaborator-

NCT05720455 / Not yet recruitingPhase 4

A Phase IV, Open Label, Clinical Trial to Assess Safety and Efficacy of Fexofenadine HCL + Pseudoephedrine HCL Fixed Dose Combination in Indian Participants With Allergic Rhinitis (AR) Who Are 12 Years and Above (FAST Trial)

This is a single group, Phase IV clinical trial to assess the safety and effectiveness of Allegra® D. This study will be conducted in participants with allergic rhinitis who are 12 years of age and above. The individual study duration for each participant would be approximately 16 days (maximum of 13 days intervention + a 3-day post intervention observation). There would be 4 study visits in which the last visit can be done either telephonically or on site. Safety events would be captured for the entire study duration. In addition, the effectiveness of the study drug would be assessed using Nasal symptom score (NSS) and Total symptom score (TSS).

Start Date21 Jul 2024

Sponsor / Collaborator

Sanofi

NCT06466421 / Not yet recruitingPhase 4IIT

Clinical Study to Compare The Safety and Possible Efficacy of Fexofenadine Versus Gabapentin for Uremic Pruritus in Patients on Regular Hemodialysis

Several studies investigated the effectiveness of Gabapentin in Uremic Pruritus (UP). No previous studies investigated the use of fexofenadine in UP. The aim of this trial is to assess the safety and possible efficacy of fexofenadine in patients with UP.

Start Date01 Jul 2024

Sponsor / Collaborator

Tanta University

100 Clinical Results associated with Fexofenadine Hydrochloride

100 Translational Medicine associated with Fexofenadine Hydrochloride

100 Patents (Medical) associated with Fexofenadine Hydrochloride

160

Literatures (Medical) associated with Fexofenadine Hydrochloride

01 Feb 2024·Luminescence : the journal of biological and chemical luminescence

Eco‐friendly synchronous fluorescence spectrofluorimetric method for simultaneous determination of montelukast sodium and fexofenadine hydrochloride in their antiallergic rhinitis fixed‐dose combination tablets

Article

Author: Abdel Hamid, Mohamed A ; Michael, Mary A ; Mabrouk, Mokhtar M

Abstract:

An innovative, simple, accurate, sensitive, and eco‐friendly synchronous fluorescence spectrofluorimetric method has been developed for the simultaneous analysis of montelukast sodium (MON) and fexofenadine hydrochloride (FEX). The method relies on measuring the relative synchronous fluorescence intensity of both drugs using Δλ of 60 nm in methanol at 405 nm for MON and 288 nm for FEX. The experimental parameters influencing the developed method were investigated and optimized. The method was linear over the ranges 0.1–2.0 and 2.0–20.0 μg/ml for MON and FEX, respectively. The limits of detection were 0.018 and 0.441 μg/ml, and the limits of quantitation were 0.055 and 1.336 μg/ml for MON and FEX, respectively. The developed method was applied successfully for the determination of the two drugs in their newly released fixed‐dose combination prescribed for the treatment of allergic rhinitis. The mean per cent recoveries were found to be 100.680 ± 0.890 and 100.110 ± 0.940 for MON and FEX, respectively. Furthermore, the method was found to be eco‐friendly green as was evaluated according to the Green Analytical Procedure Index tool guidelines and analytical eco‐scale.

23 Jan 2024·Chemical & pharmaceutical bulletin

Development of Ethylcellulose Microparticles for Taste Masking of Fexofenadine

Article

Author: Shibazaki, Ikki ; Shimana, Aoi ; Yamazaki, Kurumi ; Morii, Machi ; Obata, Yasuko ; Ikeuchi-Takahashi, Yuri

For taste masking of fexofenadine hydrochloride (FXD), ethylcellulose (EC) microparticles with FXD were developed. The amounts of EC, Tween 80, and polyvinyl alcohol (PVA) in the composition had little effect on initial drug release properties. Based on the results of the drug recovery and the drug release properties, FXD(EC200) was the optimal FXD microparticle formulation. From the results of Fourier transform infrared spectroscopy spectra and X-ray diffraction patterns of FXD(EC200), FXD amorphization in the microparticles and interaction between FXD and other components were suggested, and the formation of a solid dispersion of FXD was suggested. Because the possibility of the complex of PVA and FXD on the particle surface was suggested, sodium lauryl sulfate (SLS) was added to the composition. The initial drug release from FXD microparticles with SLS was further suppressed compared with FXD(EC200). From these results, FXD microparticles with SLS can be prepared as a controlled-release formulation and are expected to be useful for masking the bitter tasting particulates.

01 Dec 2023·Clinical pharmacology in drug development

Bioequivalence of 2 Pediatric Formulations of Fexofenadine Hydrochloride Oral Suspension

Article

Author: De Fer, Beatrice Bois ; Lucio, Luiz ; Lheritier-Barrand, Michele ; Rauch, Clemence

Abstract:

Fexofenadine hydrochloride (HCl) is a second‐generation, nonsedating, histamine H1‐receptor antagonist used to manage seasonal allergic rhinitis and chronic idiopathic urticaria. A new oral pediatric suspension of fexofenadine HCl has been developed, with the preservative potassium sorbate replacing parabens. The objective of this phase 1 single‐center, open‐label, randomized, 2‐treatment, full‐replicated, 4‐period, 2‐sequence crossover study in healthy adult volunteers was to assess the bioequivalence of 30 mg of the new oral suspension of fexofenadine HCl (test) versus 30 mg of the marketed pediatric oral suspension of fexofenadine HCl (reference). The replicate design was based on the high intra‐individual variability of fexofenadine (>30% on Cmax). The study comprised 68 randomized and treated volunteers. Plasma concentrations of fexofenadine were similar following the administration of a single dose of each formulation. Cmax, AUClast, AUC, median tmax, and mean t1/2z were similar between administrations of the same fexofenadine formulation and between formulations. A high intra‐individual variability was confirmed with both formulations. Bioequivalence of the test and reference fexofenadine HCl formulations was demonstrated as the 90% confidence intervals of the geometric least squares mean ratio for Cmax, AUClast, and AUC of fexofenadine were all within the bioequivalence range of 0.80‐1.25. There were no serious adverse events (AEs) or study discontinuations due to treatment‐emergent AEs with either fexofenadine HCl formulation. The new paraben‐free fexofenadine HCl 30‐mg oral suspension and marketed fexofenadine HCl 30‐mg pediatric oral suspension are bioequivalent under fasting conditions, with no safety concerns and a safety profile consistent with the known profile of fexofenadine.

News (Medical) associated with Fexofenadine Hydrochloride

05 Mar 2024

·www.prnewswire.com

Allegra Airways Introduces Revolutionary Nationwide Mapping Tool Providing Outdoor Enthusiasts with Real-Time Routes with Less Pollen and Less Air Pollution

Boy Band Icon and Allergy Sufferer Lance Bass Raises Awareness of First-of-its-Kind Navigation Tool Helping People Breathe Cleaner Air NEW YORK, March 5, 2024 /PRNewswire/ -- Allegra, a leading brand in allergy relief, announced today the nationwide launch of Allegra Airways, a groundbreaking navigation tool designed to help outdoor enthusiasts find real-time walking, biking, and running routes with cleaner air based on hyperlocal pollen and air pollution levels on a street-by-street basis. Recent studies show that air pollution alters the pollen structure, releasing more allergens and making pollen more "aggressive." 1,2 These allergens can likely penetrate deeper into your airways, provoking more severe allergy symptoms1,2. What's more concerning is that seasonal allergy symptoms are on the rise, with an estimated 50% of the global population expected to have an allergic disease by 2050.3 "As a brand dedicated to empowering allergy sufferers to live their greatness, Allegra is thrilled to introduce Allegra Airways, a tool that goes beyond traditional solutions, and brings true innovation to the category and deepens our engagement with our consumer," said Jordana Barish, US Allegra Brand Head. "By harnessing hyperlocal data on pollen and air pollution levels, Allegra Airways guides people along cleaner routes, making an invisible problem visible and enabling people to pursue their passions outdoors with confidence." Developed in collaboration with Ambee, a renowned climate and environmental data intelligence company, Allegra Airways enables users to input their start and end destinations at and calculate the cleanest routes based on real-time pollen concentrations and air pollution data from Ambee. "We are thrilled to partner with Allegra on this cutting-edge technology that provides a real time solution for allergy sufferers across the U.S.," explained Jaideep Singh Bachher, co-founder of Ambee. To mark the national launch, Allegra is partnering with boy band legend, Lance Bass, an allergy sufferer, LA outdoor enthusiast, and parent, to raise awareness of the increase in worsening allergy symptoms and how Allegra Airways helps him. "I use Allegra Airways to navigate the cleanest routes as I go about my day in LA including my daily walks with my twins," Lance shared. "I have a lot of exciting projects coming up this year and need to stay on my game and not let my allergy symptoms get in the way." Experience Allegra Airways at SXSW Allegra Airways will debut at SXSW, a global event that sits at the intersection of innovation and culture. On March 9th and 10th, purple Allegra-branded pedicabs fitted with Allegra Airways technology will transport visitors around downtown Austin to find the cleanest route based on real-time data from Ambee where pollen concentrations and air pollution are at its lowest. Join the Allegra Airways community to learn more about how air pollution impacts pollen and how Allegra Airways can help you breathe easy. Visit to find your path to clean air. About Allegra Allegra® Allergy is an oral antihistamine available over the counter at full prescription strength to relieve indoor and outdoor allergy symptoms, including sneezing, runny nose, itchy, watery eyes, and itchy nose or throat. It provides fast, non-drowsy relief that starts in just one hour and stays strong for 24 hours. Allegra can be used by adults and children 2 years of age and older. For more information, visit . Sanofi Consumer Healthcare, US, the makers of Allegra, was recently B Corp certified. This distinction highlights the company's commitment for an inclusive and regenerative economy through its social and environmental impact. Sanofi US CHC believes that healthier people and a healthy planet go hand in hand. About Ambee Ambee is a climate and environmental intelligence technology company that provides real-time and accurate data to empower businesses, individuals and communities to make informed decisions for better outcomes. Media Contact Tia Harris [email protected] (312) 515 – 0518 Annesi-Maesano I;Maesano CN;Biagioni B;D'Amato G;Cecchi L; "Call to Action: Air Pollution, Asthma, and Allergy in the Exposome Era." The Journal of Allergy and Clinical Immunology, U.S. National Library of Medicine, pubmed.ncbi.nlm.nih.gov/34238507/. D'Amato, G.; Annesi-Maesano, I.; Biagioni, B.; Lancia, A.; Cecchi, L.; D'Ovidio, M.C.; D'Amato, M. New Developments in Climate Change, Air Pollution, Pollen Allergy, and Interaction with SARS-CoV-2. Atmosphere 2023, 14, 848. Cecchi L, D'Amato G, Annesi-Maesano I. External exposome and allergic respiratory and skin diseases. J Allergy Clin Immunol 2018;141:846-57. SOURCE Allegra

04 Jun 2023

·medcitynews.com

Ezra Earns FDA Clearance for AI Tool that Makes MRIs Faster & Cheaper

New York-based startup Ezra recently received FDA clearance for an AI tool it plans to use to launch “the world’s first 30-minute full body MRI scan.” The tool, named Ezra Flash, allows radiologists to acquire MR images at a rate much faster than normal — which results in noisier images that lack sharpness. Ezra Flash’s AI quickly removes the noise and enhances the quality of these images. This reduces the amount of time needed to complete a high-quality scan, which therefore decreases MRI costs, said CEO Emi Gal. Gal founded Ezra in 2018. The company’s name is the Hebrew word for help, which reflects the startup’s mission to help doctors detect cancer earlier, he said. “’I’m personally at high risk for cancer and lost my mother to metastatic colon cancer, so I have a very personal motivation to help people find cancer early,” Gal declared. He pointed out that screening tests exist for only about 50% of cancers — these include cancers of the breast, colon, prostate, uterus, lungs and skin. The other 50%, which include cancers in the pancreas, liver and gallbladder, lack screening procedures. This means that people really only discover they have these cancers once they’re symptomatic — when it’s generally too late. Ezra’s full body MRI screens for cancer in all the organs that radiologists can’t currently screen for. The scan is designed to look for potential cancer and 500 other diseases across 13 organs, Gal explained. “Our radiologists read Ezra Flash-powered scans similarly to the way they would read any MRI scans. The AI works in the background — as soon as an MR scan is acquired, it’s sent to the AI for enhancement. Within just a few minutes the AI returns the enhanced images to our routing system, which then passes it onto the radiologist’s reading list,” he said. The AI tool enables Ezra to create MRI scanning protocols that are “twice as fast,” without compromising on image quality, according to Gal. Ezra will now offer a 30-minute full body scan using Flash that costs $1,350 — an almost 40% reduction in price from the startup’s 60-minute scan — he pointed out. The company trained its AI tool using its proprietary longitudinal MRI dataset, which comprises hundreds of thousands of MR images taken of cancer patients and healthy subjects. “We have multiple terabytes of data across millions of MRI images from over 5,000 individuals. Roughly half of our members have come back for at least a second annual scan, and some of them are on their third or fourth,” Gal explained. This longitudinal dataset allows Ezra to find changes in the body “much earlier” than the startup would be able to by looking at a single data point. The company also continuously gathers downstream data regarding findings from its scans, as well as collects follow-up diagnostic scan and biopsy data when applicable, Gal said. Ezra isn’t the only startup working to make MRI scans quicker and cheaper, though. Last year, Prenuvo raised $70 million in Series A funds for its MRI machine that promises to scan people about three to four times faster than a regular MRI. CGToolbox, Getty Images

02 Jun 2023

·www.nsmedicaldevices.com

Ezra secures FDA 510(k) approval for AI technology that improves MRI

Ezra has created a fast MRI protocol that produces noisy images, which are later processed by Ezra Flash to enhance the image quality, and will use its AI technology to introduce the world’s first 30-minute full body MRI scan Ezra Flash AI is designed to improve MRI. (Credit: National Cancer Institute on Unsplash) Ezra has received the US Food and Drug Administration (FDA) 510(k) approval for Ezra Flash, its new Artificial Intelligence (AI) technology that improves MRI screening. Ezra Flash is designed to enhance the quality of MR images to help decrease the time required to complete a high-quality scan, thereby reducing MRI cost. The company has created a fast MRI protocol that produces noisy images, which are later processed by Ezra Flash to enhance the image quality. Ezra will use its AI technology to introduce the world’s first 30-minute full body MRI scan. Ezra founder and CEO Emi Gal said: “Over 1.9 million people are expected to be diagnosed with cancer in the U.S. in 2023 according to the American Cancer Society. “Our mission at Ezra is to detect cancer early for everyone in the world, and I’m really excited about this new AI enabling us to make our scan more affordable. “By boosting quality while reducing scan time, we’re decreasing our cost for a full body MRI by 30%, and we’re passing these cost savings to our customers.” The AI-powered solution was trained for using the company’s unique longitudinal MRI dataset that contains hundreds of thousands of MR images in patients and healthy subjects. It was trained to evaluate the elements of the MRI scan that are essential for creating a complete and accurate image, to enhance image quality in high-speed MRI scans. The company used a multi-step validation process, where panel of five radiologists analysed the performance of the AI both qualitatively and quantitatively. Ezra said that it is the world’s first company to leverage AI across all three key components of the cancer screening process, imaging, analysis, and reporting. The Ezra Flash AI enhances MR image quality, while Ezra Prostate AI aids analysis of MR images of the prostate, and Ezra Reporter AI creates an easily digestible translation of radiology reports. Sodickson added: “The FDA clearance of Ezra Flash is an important landmark – the beginning of a sea change in how medical imaging is used. Progressive increases in imaging speed over time have already resulted in myriad benefits to patients and physicians. “Ezra is using MRI as a tool for early detection of cancer prior to the development of symptoms – a safety net of proactive monitoring that has previously only been available to patients with certain well-established risk factors. “Ezra Flash will increase the accessibility of early-warning MRI, and Ezra’s dataset of repeated scans over time will help it to prevent false positives and ensure that the warnings it provides are appropriate and actionable.”

100 Deals associated with Fexofenadine Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D00671	Fexofenadine Hydrochloride	R06AX26	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Rhinitis, Allergic	KR	Handok, Inc.	04 May 1998
Urticaria	AU	Sanofi /Consumer Healthcare Brands/	10 Jan 1997
Chronic Urticaria	GB	-	11 Mar 1996
Dermatitis, Atopic	GB	-	11 Mar 1996
Eczema	GB	-	11 Mar 1996
Pruritus	GB	-	11 Mar 1996
Rhinitis, Allergic, Seasonal	GB	-	11 Mar 1996

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Rhinitis perennial	Phase 3	JP	Sanofi	01 Oct 2010
Rhinitis, Allergic, Perennial	Phase 3	JP	Sanofi	01 Oct 2010
Asthma	Phase 3	US	Sanofi	01 Feb 2002
Asthma	Phase 3	CR	Sanofi	01 Feb 2002
Asthma	Phase 3	GT	Sanofi	01 Feb 2002
Asthma	Phase 3	HU	Sanofi	01 Feb 2002
Asthma	Phase 3	MX	Sanofi	01 Feb 2002
Asthma	Phase 3	PL	Sanofi	01 Feb 2002
Asthma	Phase 3	RU	Sanofi	01 Feb 2002
Persistent asthma	Phase 3	US	Sanofi SA	01 Feb 2002

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05692154 (CTgov)	Phase 3	Rhinitis, Allergic, Seasonal	95	Fexofenadine (Arm A (Active-active))	ujmdpvwtws(gkhhmigvmv) = ryzqfsxfmr wjjdpkgydn (pdxyaaefmv, pebijknpsn - nuhwxoscie) View more	-	16 May 2024
				Placebo (Arm B (Placebo-active))	ujmdpvwtws(gkhhmigvmv) = jckibdiekh wjjdpkgydn (pdxyaaefmv, xzdtbsxuij - uhxcnkxdou) View more
ASCO2012	Not Applicable	Lung Diseases, Interstitial	145	Fexofenadine	ardlanggis(zwsfpimobo) = nshtvxptna kniqeufpwo (iubkygzson ) View more	-	20 May 2012
				No Fexofenadine	ardlanggis(zwsfpimobo) = aurhacpxht kniqeufpwo (iubkygzson ) View more
AAAAI2007	Not Applicable	Rhinitis, Allergic	-	Fexofenadine HCl 6 mg/mL Suspension	swvawjiczf(fudbsemqng) = 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. psjvjmpgts (mxgcbzjfoc ) View more	Positive	01 Jan 2007

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis