Delving into the Latest Updates on Fexofenadine Hydrochloride with Synapse

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

+ [27]

Target

H1 receptor

Action

antagonists

Mechanism

H1 receptor antagonists(Histamine H1 receptor antagonists)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesOtorhinolaryngologic Diseases+ [3]

Active Indication

Chronic UrticariaPruritusRhinitis, Allergic+ [3]

Inactive Indication

Dermatitis, AtopicPersistent asthmaRhinitis perennial+ [1]

Originator Organization

Sanofi, Inc.

Active Organization

Sanofi-Aventis Ireland Ltd.

Chongqing Zhi'en Pharmaceutical Co., Ltd.Sanofi /Consumer Healthcare Brands/

+ [10]

Inactive Organization

Sanofi

Chattem, Inc.Cellix Bio Pvt Ltd.

License Organization-

Drug Highest PhaseApproved

First Approval Date

United Kingdom (11 Mar 1996),

Rhinitis, Allergic, Seasonal

Regulation-

Login to view timeline

Structure/Sequence

Molecular FormulaC32H40ClNO4

InChIKeyRRJFVPUCXDGFJB-UHFFFAOYSA-N

CAS Registry153439-40-8

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 Date06 Jun 2025

Sponsor / Collaborator

Sanofi

CTR20251886

/ RecruitingNot Applicable

盐酸非索非那定片在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两序列、四周期、完全重复交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-sequence, four-period, fully repeated crossover bioequivalence study of fexofenadine hydrochloride tablets in Chinese healthy subjects under fasting and fed conditions

主要目的：以药代动力学参数为终点指标，比较空腹和高脂餐后给药条件下，合肥合源药业有限公司生产的盐酸非索非那定片与OPELLA HEALTHCARE FRANCE SAS为持证商的盐酸非索非那定片（规格：180mg）在健康成年人群中吸收程度和速度的差异，对两制剂的生物等效性进行评价。次要目的：评价健康受试者在空腹和高脂餐后给药条件下口服受试制剂盐酸非索非那定片和参比制剂盐酸非索非那定片的安全性。

[Translation]

Primary objective: To compare the differences in the extent and rate of absorption of fexofenadine hydrochloride tablets produced by Hefei Heyuan Pharmaceutical Co., Ltd. and fexofenadine hydrochloride tablets (specification: 180 mg) produced by OPELLA HEALTHCARE FRANCE SAS in healthy adults under fasting and high-fat meal administration conditions using pharmacokinetic parameters as endpoints, and to evaluate the bioequivalence of the two preparations. Secondary objective: To evaluate the safety of oral administration of the test preparation fexofenadine hydrochloride tablets and the reference preparation fexofenadine hydrochloride tablets to healthy subjects under fasting and high-fat meal administration conditions.

Start Date30 May 2025

Sponsor / Collaborator

Hefei Cosource Pharmaceuticals, Inc.

100 Clinical Results associated with Fexofenadine Hydrochloride

Login to view more data

100 Translational Medicine associated with Fexofenadine Hydrochloride

Login to view more data

100 Patents (Medical) associated with Fexofenadine Hydrochloride

Login to view more data

2,423

Literatures (Medical) associated with Fexofenadine Hydrochloride

01 Sep 2025·ENVIRONMENTAL POLLUTION

Validation of a large volume-solid phase extraction methodology for biotoxicity assessment of pharmaceuticals in aquatic organisms

Article

Author: Gómez-Canela, Cristian ; Moragrega-Knol, Emma ; Barata, Carlos ; Romero-Alfano, Irene

The growing scarcity of freshwater has intensified the need for alternative water sources, which often require advanced treatments to eliminate contaminants. Among emerging pollutants, pharmaceuticals have become a significant concern due to their persistence and potential impact, making their detection essential. However, analysing these contaminants is challenging due to the extremely low concentrations at which they are present. For chemical analysis, minimal or no sample enrichment is often necessary, while bioanalysis typically requires larger sample volumes and an enrichment factor to conduct comprehensive bioassays across various endpoints. Consequently, sample preconcentration techniques for large water volumes are necessary to improve the sensitivity of subsequent toxicological experiments. In this study, a novel large volume solid-phase extraction (LV-SPE) procedure was validated and evaluated for monitoring multiple pharmaceutical compounds in water samples, while maintaining the traditional solid-phase extraction (SPE) methodology using cartridges. This method proved effective extraction and preconcentration of significant amounts of water, with recoveries between 19 % and 109 % in spiked wastewaters (except for fluvoxamine, remdesivir, tamoxifen and tetracycline, with recoveries <10 %). Furthermore, the optimization of this approach covers an expansive chemical space, enabling the capture of a diverse range of pharmaceutical compounds and enhancing the validity of toxicological studies. Bioassays conducted with Daphnia magna juveniles and Danio rerio embryos validated the method's applicability regarding optimized exposure conditions, the absence of adverse effects from SPE blanks or solvent controls and sensitivity in detecting effects across field samples. Overall, the LV-SPE approach enhances sensitivity and reliability for evaluating pharmaceutical mixtures' risks under realistic conditions.

01 Aug 2025·SAUDI PHARMACEUTICAL JOURNAL

A Mechanistic Physiologically Based Pharmacokinetic (PBPK) modeling approach for fexofenadine: predictive pharmacokinetic insights in humans

Article

Author: Alqhtani, Hussain ; Saeed, Hamid ; Rasool, Muhammad Fawad ; Batool, Maryam ; Zamir, Ammara

The physiologically based pharmacokinetic (PBPK) modeling is an in-silico technique that determines drug pharmacokinetics (PK) by considering blood circulation and tissue composition within the body. Fexofenadine is an H₁ receptor antagonist drug recommended for treating seasonal allergic rhinitis and chronic idiopathic urticaria. This study aimed to build a PBPK model of fexofenadine to predict its systemic exposure in healthy, diseased, and pediatric populations. The modeling process commenced with a meticulous literature review to collect pertinent PK data on fexofenadine, which was then consolidated into the PK-Sim simulator to develop a drug-specific model in the healthy population. The model was then extrapolated to patients with chronic kidney disease (CKD) and pediatrics by employing disease and age-related physiological variations. Visual predictive checks were executed to substantiate the model's accuracy, along with the computation of observed-to-predicted ratios (R_Obs/Pre), average fold error (AFE), and absolute average fold error (AAFE). The developed PBPK model successfully predicted fexofenadine's PK with AFE values of 0.98, 0.58, and 1.21 for CL/F in healthy, diseased, and pediatric populations, which were confined within a two-fold error range. Furthermore, box-and-whisker plots were generated to critically analyze drug concentration at varying stages of CKD. The presented model offers indispensable insights that may assist clinicians in determining dosing strategies in patients with kidney disease.

01 Aug 2025·JOURNAL OF HAZARDOUS MATERIALS

Evaluation of micropollutant removal from artificially recharged water using activated carbon

Article

Author: Šváb, Marek ; Vorokhta, Maryna ; Švábová, Martina ; Pohořelý, Michael

Pilot scale micropollutant removal onto three types of granular activated carbon was tested over a period of 25 months. The columns were operated in a mode as similar as possible to the functioning of the main waterworks with the emphasis on minimizing the washing of the activated carbon layers. Sampling was performed monthly and a total of 222 micropollutants were evaluated. The columns were located at a waterworks in central Bohemia (Czech Republic). Real influent water from the river Jizera after artificial recharge and sand filtration was used. The aim of this study was to verify whether the process of micropollutant removal was suitable under the operating conditions at the waterworks. Clear seasonal patterns of micropollutant concentrations in the influent were detected. All three columns were able to effectively remove or substantially decrease the concentration of most micropollutants. The best performance was shown for the activated carbon Aquasorb 5005, which had the highest surface area and a well developed porous structure with the highest proportion of mesopores. The data were evaluated in order to identify micropollutant parameters important for their removal, and the pH-dependent octanol/water partition coefficient was identified as the key parameter. Other important parameters were charge and polar surface area of the micropollutant molecules.

13

News (Medical) associated with Fexofenadine Hydrochloride

16 Jun 2025

·www.prnewswire.com

Cortizone-10® Partners with Dylan Efron and the National Park Foundation to Help Outdoor Enthusiasts Stay Itch-Free This Summer

The brand's new Itch Relief Cooling Spray helps tackle "itchsanity" one irritation at a time. MORRISTOWN, N.J., June 16, 2025 /PRNewswire/ -- Whether it's a weekend hike, a summer camping trip, or just time spent in the backyard, skin irritations can take the fun out of outdoor activities. That's why Cortizone-10®, the #1 Doctor Recommended OTC Topical Anti-Itch Brand*, is teaming up with the National Park Foundation and outdoor advocate Dylan Efron this summer to help more people enjoy nature—without the itch. Continue Reading Dylan Efron with Cortizone-10® Itch Relief Cooling Spray | Photo Credits: brennensmedia Cortizone-10® Itchy Bear Season To enjoy nature without the not-so-great itches, we need to make sure there are outdoor spaces worth enjoying–so Cortizone-10® is partnering with the National Park Foundation, providing $475K as part of a broader brand initiative, to help protect wildlife, preserve habitats, and support conservation efforts across some of the country's most iconic and ecologically rich landscapes. To help amplify the campaign, Dylan Efron—actor, producer, and lifelong outdoor enthusiast—is partnering with Cortizone-10®, an Opella brand, to share his favorite summer adventures and how he doesn't let itches get in the way. "Ever since I was a little kid, I've always loved being outside—all day, every day," said Dylan Efron. "That's why I am so excited to partner with Cortizone-10®. I can't even count how many times I've used this stuff in a year—let alone over my lifetime. Bug bites, poison ivy, poison oak...been there, scratched that. But no itch has ever kept me from enjoying everything the outdoors has to offer." The partnership celebrates the launch of Cortizone-10® 's new Itch Relief Cooling Spray, designed to provide fast, cooling itch relief of common skin irritations that may arise from eczema and psoriasis to bug bites and poison ivy. "We're thrilled to be teaming up with Dylan Efron and the National Park Foundation for a campaign that celebrates adventuring itch-free," said Nimit Bansal, Cortizone-10® Marketing Lead. "Cortizone-10® has always been trusted itch relief for bug bites, eczema, poison ivy, and more—and now, we're making it easier than ever for people to enjoy the outdoors without the itch getting in the way." As part of its broader "Itchsanity" campaign, Cortizone-10® is launching Itchy Bear Season, a social-first series that spotlights different "itchy bear" types one might run into in the great outdoors and shares practical tips on how to stay itch-free outside. A playful nod to natural behaviors seen in the wild, the campaign reminds us that everyone itches—but with Cortizone-10®, you don't have to suffer through it. Visit @cortizone10 on Instagram to cast your vote for itchiest bear in the brand's first-ever Big Bear Itch Off competition and follow along to learn more. The new Cortizone-10® Itch Relief Cooling Spray is available now at drugstores and major retailers nationwide. Learn more at Cortizone10.com. *2024 IQVIA Study About Cortizone-10® Cortizone-10® is the #1 Doctor Recommended OTC Topical Anti-Itch Brand*, trusted for fast, effective relief from itch and irritation. Featuring the maximum strength of hydrocortisone available without a prescription, Cortizone-10® products are specially formulated to calm and soothe a wide range of itchy skin discomforts—including bug bites, poison ivy, eczema, psoriasis, and rashes caused by soaps, detergents, and cosmetics. With a variety of formats like creams, ointments, and sprays, Cortizone-10® delivers targeted, long-lasting relief to help people get back to feeling comfortable—so they can stay focused on what matters most. About Opella Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally. Our mission is to put health in people's hands by making self-care as simple as it should be for over half a billion consumers worldwide. At the core of this mission is our 100 brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and four specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of North America's most loved brands, including Allegra®, Dulcolax®, Icy Hot®, Xyzal®, Unisom® and Cortizone-10®. B Corp certified in multiple markets, we are active players in the journey towards healthier people and planet. Find out more about our mission at . SOURCE Cortizone-10® WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

30 Apr 2025

·www.fiercepharma.com

Sanofi nets €10B from Opella stake sale, eyes more 'bolt-on' deals

With Sanofi's sale of consumer health unit Opella for 10 billion euros ($11.4 billion), expect Sanofi to step up its pursuit of "bolt-on" deals, chief financial officer Francois Roger said. Six months after entering talks with U.S. private equity firm Clayton, Dubilier & Rice (CD&R), Sanofi has closed a deal to sell a 50% controlling stake of its consumer health business Opella for 10 billion euros ($11.4 billion), the French biopharma powerhouse said on Wednesday.As for Sanofi’s next move with its fresh injection of funds, don’t expect a mega-merger any time soon.In its quarterly earnings presentation last week, in addressing the company’s plan after the sale of Opella, Sanofi Chief Financial Officer Francois Roger said that it will “explore external growth opportunities for bolt-on acquisitions.”With that, Roger cited the company’s deal last month for Dren Bio’s clinical-stage bispecific antibody, DR-0201. Sanofi paid $600 million upfront for the asset and pledged another $1.3 billion attached to launch and development milestones.“We have always been very active in the M&A space,” Roger said during the company’s quarterly call in January. “We may be a bit more in the near future due to the fact that we have a strong balance sheet.”Roger said last week that Sanofi’s “primary focus” with the added funding is to drive organic growth through R&D and other internal investments. Roger said it will bolster its “dividend policy” and enhance its share repurchase program.With the Opella deal, Sanofi will retain a 48.2% stake in the consumer healthcare outfit. Public sector investor bank Bpifrance will own a 1.8% stake in Opella and gain a seat on the board. CD&R gains a company that employs more than 11,000 people in 100 countries and operates 13 manufacturing sites and four innovation development centers. Opella is the third-largest over-the-counter business in the world, selling products such as Allegra, Doliprane and Dulcolax.With the move, Sanofi becomes a “pure-play biopharma,” it said, joining other companies in its sphere that have divested to focus on developing and marketing prescription drugs.Other drugmakers have made similar moves over the last several years, including Novartis, GSK, Johnson & Johnson and Pfizer. Sanofi’s largest acquisitions over the last few decades were a 2011 purchase of rare disease specialist Genzyme for $20.1 billion and an $11.6 billion buyout of Biogen spinout Bioverativ in 2018, which bolstered the company’s presence in hemophilia.In recent years, Sanofi has settled for smaller deals such as a $3.2 billion acquisition of Translate Bio in 2021, a $2.9 billion buyout of Provention Bio in 2023 and a $1.7 billion deal for Inhibrx in January to gain a rare disease drug.

Acquisition

13 Mar 2025

·pharma.economictimes.indiatimes.com

Health dept: Scan QR codes while buying meds

Kolkata: In a move to counter fake or spurious drugs , the state health department has published a list of 300 drugs that must mandatorily carry QR codes. The move comes in the wake of increasing cases of spurious drugs being found in circulation. State health officials said this was to increase awareness about the advantage of scanning a QR code to establish the genuineness of the medicine. According to the health ministry, the 300 shortlisted drugs are termed as scheduled H2 drugs , making it mandatory for manufacturers to print the QR code. This code should encode specifics like the unique product ID, brand/generic name, manufacturer details, batch number, manufacturing/expiry dates, and licence number. Sources said that 35% of these drugs are antibiotics. The rest include medicines for diabetes, blood pressure, hypertension, skin ointment and even kits for pregnancy tests, as well as seemingly harmless products like electrolyte sachets and sprays for sports injuries. "Even these fake or spurious drugs print QR codes to make them look original. Scanning such QR codes can help consumers find out if the drug is spurious," said a state health official. The official pointed out that on scanning the QR code of spurious drugs seized from Amata in Howrah, it showed 'could not be verified'. Testing found them to be spurious. "Some of these drugs on the list are very commonly used, with many even purchasing them over the counter. When QR coding is available, consumers should take advantage of it," said pharmacology professor Subhrojyoti Bhowmick of KPC Medical College. Some of the drugs on the list include Calpol, Allegra, Pan D, Rantac, Augmentin, Telma AM, Stamlo 5 mg, Volini spray, and Prega News 6 kit. "We urge consumers to scan the QR code while buying these medicines," said Shanka Roy Choudhury, spokesperson for the Bengal Chemists and Druggists Association. Wholesalers, however, said that it could be a humongous task for them to check every strip of medicine.

100 Deals associated with Fexofenadine Hydrochloride

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
D00671	Fexofenadine Hydrochloride	R06AX26	DBSALT001227

R&D Status

Approved

10 top approved records.

Login

to view more data

Indication	Country/Location	Organization	Date
Respiratory Hypersensitivity	United States	Chattem, Inc.	24 Jan 2011
Pruritus	Japan	Sanofi KK	15 Apr 2002
Chronic Urticaria	United States	Chattem, Inc.	25 Feb 2000
Rhinitis, Allergic	South Korea	Handok, Inc.	04 May 1998
Urticaria	Australia	Sanofi /Consumer Healthcare Brands/	10 Jan 1997
Rhinitis, Allergic, Seasonal	United Kingdom	Aventis Pharma Ltd.	11 Mar 1996

Developing

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Dermatitis, Atopic	Phase 3	Japan	Sanofi	01 Nov 2010
Rhinitis perennial	Phase 3	Japan	Sanofi	01 Oct 2010
Rhinitis, Allergic, Perennial	Phase 3	Japan	Sanofi	01 Oct 2010
Persistent asthma	Phase 3	United States	Sanofi	01 Feb 2002
Persistent asthma	Phase 3	Costa Rica	Sanofi	01 Feb 2002
Persistent asthma	Phase 3	Guatemala	Sanofi	01 Feb 2002
Persistent asthma	Phase 3	Hungary	Sanofi	01 Feb 2002
Persistent asthma	Phase 3	Mexico	Sanofi	01 Feb 2002
Persistent asthma	Phase 3	Poland	Sanofi	01 Feb 2002
Persistent asthma	Phase 3	Russia	Sanofi	01 Feb 2002

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05692154 (FEXPRESAR, CTgov)	Phase 3	Rhinitis, Allergic, Seasonal	95	Fexofenadine (Arm A (Active-active))	vrdqcjhypq(ddxjkycsmc) = mqjxyxhqjf ynvoyqkkfs (shpfedrjbj, 9.090) View more	-	16 May 2024
				Placebo (Arm B (Placebo-active))	vrdqcjhypq(ddxjkycsmc) = dfvsxsmuya ynvoyqkkfs (shpfedrjbj, 10.431) View more
NCT03994731 (MIRROR RCT \| MIRROR, CTgov)	Phase 4	Gout	152	gout flare prophylaxis regimen+acetaminophen+methylprednisolone+fexofenadine+folic acid+methotrexate+Pegloticase (Pegloticase + MTX)	bjrurlkasz = egvccjurxj cdshfnytdi (bjqqknkikm, cvssrkfosl - repxyuvfhl) View more	-	16 May 2022
				placebo+acetaminophen+methylprednisolone+fexofenadine+folic acid+methotrexate+Pegloticase (Pegloticase + Placebo)	bjrurlkasz = ceokczmedq cdshfnytdi (bjqqknkikm, saspfufvga - hminkqovnc) View more
NCT01469234 (P08712, CTgov)	Phase 4	Rhinitis, Allergic, Seasonal	255	placebo to fexofenadine+loratadine (Loratadine)	cxbzzwmyhw(mpsqsvtcqk) = qnsuibcuon rqzuinrlol (sdijfnrcyv, 4.51) View more	-	22 Mar 2013
				placebo to loratadine+fexofenadine (Fexofenadine)	cxbzzwmyhw(mpsqsvtcqk) = nvapfbgstd rqzuinrlol (sdijfnrcyv, 4.86) View more
NCT01526213 (CTgov)	Not Applicable	-	18	furanocoumarin+fexofenadine (Water)	iukzgqkyth(wumjbrmzfg) = lswlkupbmn wqxodlvuws (sxmkncdqsm, zjllfbbfkj - fylzkvagrj) View more	-	04 Feb 2013
				furanocoumarin+fexofenadine (Grapefruit Juice)	iukzgqkyth(wumjbrmzfg) = yphgxssixp wqxodlvuws (sxmkncdqsm, pzecmsoycs - vttqxisobb) View more
NCT00835640 (CTgov)	Phase 1	-	24	Fexofenadine Hydrochloride (Fexofenadine Hydrochloride)	kjjfexfgti(aipkmtgsey) = zordyjbgea pbykqinqxq (awgrjyphaj, 99.83) View more	-	04 Aug 2009
				Allegra (Allegra®)	kjjfexfgti(aipkmtgsey) = kwzghiqpqa pbykqinqxq (awgrjyphaj, 119.07) View more
NCT00835276 (CTgov)	Phase 1	-	60	Fexofenadine Hydrochloride (Fexofenadine Hydrochloride)	nkqbxzxrdr(hskzvqkcph) = vymllqyzgj xzrdxdbkeg (lffcgikdqv, 216.08) View more	-	04 Aug 2009
				Allegra (Allegra®)	nkqbxzxrdr(hskzvqkcph) = nmyzgqggce xzrdxdbkeg (lffcgikdqv, 204.3) View more
AAAAI2007	Not Applicable	Rhinitis, Allergic	-	Fexofenadine HCl 6 mg/mL Suspension	nvtfncymua(uaacodldlq) = 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. acgvtlpyfh (mmzwgbcnjo ) View more	Positive	01 Jan 2007