Delving into the Latest Updates on Cetirizine Hydrochloride with Synapse

Overview

Basic Info

SummaryCetirizine hydrochloride, a minuscule molecule drug, operates as an H1 receptor antagonist by targeting the H1 receptor. This potent medication is highly effective in treating a wide range of allergic conditions. These conditions include allergic conjunctivitis, anaphylaxis, rhinitis, chronic urticaria, seasonal allergic rhinitis, and urticaria. Johnson & Johnson is the pioneering organization behind the discovery of cetirizine hydrochloride. Medical approval for this remarkable drug was granted in 1991. Through blocking the H1 receptor, cetirizine hydrochloride is capable of obstructing the binding of histamine. Histamine is the prime cause of various allergic reaction symptoms. Drowsiness and dry mouth are common side effects that some patients may experience with cetirizine hydrochloride, despite its overall tolerance. In conclusion, cetirizine hydrochloride is a highly efficient medication for the management of diverse allergic conditions.

Drug Type

Small molecule drug

Synonyms

Cetirizien Hydrochloride Drops, Cetirizine, Cetirizine Dihydrochloride

+ [46]

Target

H1 receptor

Action

antagonists

Mechanism

H1 receptor antagonists(Histamine H1 receptor antagonists)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesEye Diseases+ [3]

Active Indication

Rhinitis, Allergic, SeasonalConjunctivitis, AllergicDermatitis+ [8]

Inactive Indication

Acute conjunctivitisChronic UrticariaDermatitis, Atopic+ [2]

Originator Organization

Johnson & Johnson

Active Organization

Ocumension Therapeutics (Suzhou) co., Ltd.

Suzhou Dawnrays Pharmaceutical Co., Ltd.Pfizer Canada ULC

+ [7]

Inactive Organization

Nicox Ophthalmics, Inc.

UCB Pharma GmbH

Johnson & Johnson Holdco (NA), Inc.

+ [7]

License Organization

Apotex, Inc.ITROM Pharmaceutical Group

Santen Pharmaceutical Co., Ltd.

+ [12]

Drug Highest PhaseApproved

First Approval Date

Canada (31 Dec 1991),

Rhinitis, AllergicUrticaria

RegulationPriority Review (China)

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Structure/Sequence

Molecular FormulaC21H26Cl2N2O3

InChIKeyCUSPGNDCPOVPBA-UHFFFAOYSA-N

CAS Registry83881-52-1

The goal of this clinical trial is to learn whether a higher dose of cetirizine works better than the standard dose to relieve symptoms of acute urticaria (hives) in adults. The study also aims to learn about the safety of taking a higher dose for a short period of time.
The main questions the study aims to answer are:
Does the higher dose of cetirizine help people with acute urticaria improve faster than the standard dose? What side effects do participants experience when taking the higher dose?
Researchers will compare two groups:
one group taking the standard dose of cetirizine (10 mg per day) and another group taking a higher dose (40 mg per day). This will help researchers understand which dose works better and whether the higher dose is safe.
Participants will:
Take the assigned study medication for 7 days Record their daily symptoms, including itch and hive severity Return for follow-up visits on Day 3, Day 7, and Week 6 Have blood tests to check liver and kidney function before and after treatment
This study may help improve treatment options for people with acute urticaria and reduce the need for unnecessary steroid use.

Start Date01 Nov 2025

Sponsor / Collaborator

University of Phayao

CTRI/2025/09/095267

/ Not yet recruitingPhase 2IIT

Evaluation of comparative efficacy of Champakadi Agada versus Cetirizine in Sheetapitta (Recurrent Urticaria)-A reverse pharmacology approach. - nil

Start Date05 Oct 2025

Sponsor / Collaborator-

IRCT20130626013776N119

/ SuspendedNot Applicable

A study to compare the relative bioavailability of Loghman and GlaxoSmithKline formulations of cetirizine 10 mg tablets in 24 healthy adult volunteers under fasting conditions

Start Date23 Aug 2025

Sponsor / Collaborator-

100 Clinical Results associated with Cetirizine Hydrochloride

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100 Translational Medicine associated with Cetirizine Hydrochloride

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100 Patents (Medical) associated with Cetirizine Hydrochloride

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2,964

Literatures (Medical) associated with Cetirizine Hydrochloride

01 Nov 2025·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Handheld Spatially Offset Raman Spectroscopy for rapid non-invasive detection of ethylene glycol and diethylene glycol in medicinal syrups

Article

Author: Legge, Isabelle ; Walsby-Tickle, John ; McCullagh, James ; Stokes, Robert ; Bharucha, Tehmina ; Banerjee, Sneha ; Arman, Benediktus Yohan ; Deats, Michael ; Merchant, Hamid A ; Newton, Paul N ; Matousek, Pavel ; Mosca, Sara ; Gangadharan, Bevin ; Caillet, Céline ; Zitzmann, Nicole

We investigate the potential of Spatially Offset Raman Spectroscopy (SORS) as a rapid, non-invasive screening tool deployable in the field to detect diethylene glycol (DEG) and ethylene glycol (EG) in medicinal syrups within closed containers. Measurements were performed on neat propylene glycol (PG) and glycerol, key components of many medicinal syrups, as well as marketed medicinal syrup formulations spiked with DEG and EG at various concentration levels to assess the technique's limit of detection in real-life samples. SORS was able to detect these down to ∼0.5 % concentration level in neat PG for both DEG and EG compounds and ∼1 % concentration level for DEG and EG in neat glycerol. The DEG and EG detection thresholds for the marketed formulations measured through original bottles was ∼1 %, for Benylin (active ingredient: Glycerol) and Piriteze (active ingredient: Cetirizine Hydrochloride). For Calpol (active ingredient: Paracetamol) the detection limit was higher, ∼2 % for EG and ∼5 % for DEG. Although not reaching the International Pharmacopeial 0.1 % detection threshold currently required for purity checks for human consumption, the method can still be used to detect products where DEG or EG has been wrongly used instead of PG or glycerol or if present in large quantities. The technique could also be used for raw material identification testing to ensure no mislabelling has occurred in pre-production stages and as a screening device in distribution chains to detect major deviations from permitted content in non-diffusely scattering, clear formulations, to help prevent serious adverse outcomes, such as acute renal failure and deaths.

01 Nov 2025·NEUROPHARMACOLOGY

Histaminergic transmission potentiates post-traumatic stress-induced expression of anxiety in mice

Article

Author: Patel, Chhatrapal ; Patel, Richa ; Jain, Nishant Sudhir ; Maturkar, Vaibhav ; Vaishnav, Venu Anand Das

Post-traumatic stress is associated with an increased expression of anxiety traits and is reported to be accompanied by altered brain histamine content. However, the contribution of the central histaminergic system in the stress induced anxiety, still remains unclear. Therefore, the present study explored the plausible role of central histaminergic transmission in stress-induced anxiety measures in mice using LDB test and in the expression of CORT, CREB, or BDNF levels in the whole brain, PFC, amygdala, and hippocampus of mice. The mice were exposed to the SPS protocol and subsequently left undisturbed for 7 days. On the 8th day, non-SPS/SPS exposed mice were treated i.c.v with histaminergic agents such as histamine, or histamine precursor, l-histidine, H₁ agonist, FMPH, H₂ agonist, amthamine, H₁ antagonist, cetirizine or H₂ antagonist, ranitidine or H₃ inverse agonist, thioperamide and thereafter evaluated for changes in expression of anxiety followed by estimation of CORT, CREB and BDNF levels in brain. Results revealed that SPS-exposed mice elicit heightened anxiety-like behavior accompanied by increased levels of blood or brain histamine and CORT with reduced BDNF/CREB expression in the all-brain tissues. Administration of histaminergic enhancing agents to SPS-exposed mice potentiated the higher expression of anxiety, also further enhanced CORT, and diminished the BDNF/CREB expression in all brain regions. Conversely, central injection of the H₁ receptor antagonist, cetirizine (0.1 μg/mouse) or H₂ receptor antagonist, ranitidine (10 μg/mouse, i.c.v) to SPS mice completely alleviated all the stressed induced changes while H₃ receptor inverse agonist, thioperamide (2, 10 μg/mouse) failed to affect CORT but restored basal anxiety, CREB and BDNF expression. Thus, the blockade of central histamine H₁/H₂/H₃ receptors might mitigate SPS-induced anxiety-like manifestations by extenuating the SPS-induced CORT, CREB, and BDNF expression.

01 Oct 2025·JOURNAL OF ONCOLOGY PHARMACY PRACTICE

Evaluating the efficacy of a premedication regimen including high-dose cetirizine in reduction of hypersensitivity reactions to paclitaxel: A retrospective cohort study

Article

Author: Ingles, Lauren ; Weaver, Kelly ; Figg, Lindsay ; Volz, Lesley ; Gunaratnam, Bakeerathan ; Hutchinson, Alexander

Introduction:

Hypersensitivity reactions (HSR) are a known adverse effect of paclitaxel, occurring in approximately 10% of patients, typically during the first or second infusion of the medication. Corticosteroids, histamine-1 and histamine-2 receptor antagonists are given prior to paclitaxel infusions to reduce the incidence of HSR. There are limited data that suggest administration of cetirizine given prior to a platinum infusion as secondary prophylaxis may reduce HSR rates.

Methods:

The objective of this study was to assess the impact of a novel paclitaxel hypersensitivity prevention protocol including high-dose cetirizine administered 12 and 6 h prior to paclitaxel infusion on the rate of HSR compared to a historical control. The primary objective was the rate of HSR of any grade after the first cycle of paclitaxel. Secondary outcomes included grade of infusion reaction and incidence of severe HSR.

Results:

A total of 104 patients were included for analysis in the cetirizine group and 124 in the control group. Hypersensitivity reactions occurred in 37 (16.2%) patients in the overall population, and no statistical difference was observed between groups. (13.46% vs 18.55%; p = 0.23). Numerically more grade 3–4 HSRs occurred in the control group than the treatment group (30.77% vs 69.23; p = 0.51).

Conclusions:

The addition of cetirizine to paclitaxel infusions resulted in numerically lower rates of HSR and a reduction in severity of grade 3–4 HSRs. Future studies with more robust compliance data and a larger patient population would be needed to appropriately assess the efficacy of our novel treatment regimen.

144

News (Medical) associated with Cetirizine Hydrochloride

09 Nov 2025

·pharma.economictimes.indiatimes.com

Haryana issues public alert over cough syrup found with DEG impurity

Chandigarh: Haryana Health Minister Arti Singh Rao on Saturday said the government has issued a public health alert following the detection of diethylene glycol (DEG) impurity above permissible limits in a cough syrup formulation. The alert has been issued on the basis of an official communication received from the Central Drugs Standard Control Organisation's (CDSCO) sub-zonal office in Guwahati by the Food and Drugs Administration (FDA), Haryana. In an official statement, the minister informed that the cough syrup formulation -- "Planokuf D" syrup containing cetirizine hydrochloride, phenylephrine hydrochloride and dextromethorphan hydrobromide, and manufactured by Shreya Lifesciences Private Limited -- has been found to contain DEG impurity beyond permissible limits. The affected batch, bearing number R25053101, was manufactured in February and is set to expire in January 2027. The product has been declared adulterated and Not of Standard Quality (NSQ), the statement said. The minister said the FDA has directed all senior drugs control officers (SDCOs) and drugs control officers (DCOs) across Haryana to maintain a strict vigil on the movement of the said drug in the market. Officers have been instructed to draw samples, seize any remaining stock and initiate strict action wherever the product is found. The State Drugs Controller has ordered an immediate ban on the sale, distribution, prescription and use of the above-mentioned batch of the product throughout Haryana. Retailers, wholesalers, distributors, hospitals and medical practitioners have been strictly advised not to sell, stock, prescribe or administer the affected batch under any circumstances. DEG is a toxic chemical known to cause serious health complications, including acute poisoning, kidney failure, neurological disorders and even death, particularly among children. Rao has urged the public to remain vigilant and report any availability of the affected batch in the market to the nearest drugs control officer.>

04 Nov 2025

·www.pharmaceutical-technology.com

Kimberly-Clark buys troubled Tylenol-maker Kenvue for $48.7bn

The FDA updated the label for Tylenol in September 2025 amid pressure from the Trump administration. Credit: Kenishirotie via Shutterstock.com. Kimberly-Clark has agreed to acquire Johnson & Johnson (J&J) consumer health spinout Kenvue for $48.7bn. One of America’s largest consumer health companies, Kimberly-Clark said it would acquire all of Kenvue’s common stock, creating a conglomerate that will generate annual revenue of $32bn. According to the deal, shareholders in Kenvue – a company that J&J siphoned off in 2023 – will receive $3.50 per share, as well as 0.14625 of Kimberly-Clark shares for each Kenvue share held at closing. The total consideration to Kenvue investors is $21.01 per share. The transaction, which is expected to close in the second half of 2026, will see Kimberly-Clark shareholders own around 54% of the combined company while Kenvue shareholders will own the remaining 46%. The deal is one of the largest in the consumer sector for several years and adds to a strong mergers and acquisition (M&A) pickup across the pharmaceutical industry in 2025. However, the deal is not without its points of contention. Kenvue’s top-selling product is Tylenol (acetaminophen), the common over-the-counter (OTC) pain medication that has been under scrutiny by the US Government over safety concerns. US President Donald Trump has made claims that the medicine, known as paracetamol in most other countries, has been linked to autism when used during pregnancy. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence The US Food and Drug Administration (FDA) updated the label for Tylenol in September 2025, with a warning added for pregnant women that the drug can “increase the risk of neurological conditions such as autism and ADHD in children”. Kenvue has since filed a petition to the FDA rebuking the claims. As well as Tylenol, Kenvue is known for making Band-Aid, antihistamines Zyrtec (cetirizine) and Benadryl (budesonide), and skincare brands Neutrogena and Aveeno. Kimberly-Clark is therefore looking beyond Tylenol, stating that the transaction “brings together two iconic American companies to create a portfolio of complementary products”. When asked about the Tylenol controversy during a conference call, Kimberly-Clark’s CEO Mike Hsu said: “We reviewed this transaction in the same way that we run the business, with incredible rigor, thoughtfulness and discipline. The board carefully considered all the risks and all the opportunities. We had multiple sessions with the board with the world’s foremost scientific, medical, regulatory and legal experts. “It was definitely not opportunistic, definitely strategic.” Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now

AcquisitionDrug Approval

03 Nov 2025

·pharma.economictimes.indiatimes.com

JB Pharma, USV recall drugs in US

New Delhi: JB Chemicals and Pharmaceuticals and USV are undertaking voluntary recall of antihistamine drugs in the United States. According to the US FDA latest enforcement report, JB Pharma has ordered two separate recalls of 23,376 —’9,936 and 13,440’—bottles of Cetirizine Hydrochloride Tablets due to the imprinting of the wrong ID on the tablets. The drug was manufactured by Unique Pharmaceuticals Labs, a division of of JB Pharma and was distributed by US-based Rising Pharma Holdings, Inc. JP Pharma initiated the voluntary action on September 12 and is classed as a “class III recall,” meaning that exposure to the product is not likely to cause adverse health consequences—death, hospitalisation etc. Meanwhile, USV is recalling 8,952 bottles of Olopatadine Hydrochloride Ophthalmic Solution due to the identification of an individual unspecified impurity beyond the permissible limit. The voluntary action initiated on September 10 is classified as a “class II recall,” meaning that the products may cause temporary or medically reversible adverse health consequences. However, the probability of serious adverse health consequences is remote. Cetirizine Hydrochloride is indicated for treating symptoms caused by allergies and related conditions. Olopatadine Hydrochloride is a stabilizer used in the treatment of conjunctivitis and provides relieves from s itching, redness, tearing, and swelling. By Online Bureau ,

100 Deals associated with Cetirizine Hydrochloride

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External Link

KEGG	Wiki	ATC	Drug Bank
D00664	Cetirizine Hydrochloride	R06AE07	DB00341

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Conjunctivitis, Allergic	United States	Harrow, Inc.	30 May 2017
Dermatitis	Japan	UCB Japan Co. Ltd.	30 Jun 1998
Eczema	Japan	UCB Japan Co. Ltd.	30 Jun 1998
Pruritus	Japan	UCB Japan Co. Ltd.	30 Jun 1998
Anaphylaxis	China	Suzhou Dawnrays Pharmaceutical Co., Ltd.	01 Jan 1998
Rhinitis	China	Suzhou Dawnrays Pharmaceutical Co., Ltd.	01 Jan 1998
Chronic Urticaria	United States	Johnson & Johnson de Colombia SA	08 Dec 1995
Rhinitis, Allergic, Perennial	United States	Johnson & Johnson de Colombia SA	08 Dec 1995
Rhinitis, Allergic, Seasonal	United States	Johnson & Johnson de Colombia SA	08 Dec 1995
Rhinitis, Allergic	Canada	Pfizer Canada ULC	31 Dec 1991
Urticaria	Canada	Pfizer Canada ULC	31 Dec 1991

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Conjunctivitis	NDA/BLA	South Korea	SAMIL PHARMACEUTICAL Co., Ltd.	-
Acute urticaria	Phase 3	United States	JDP Therapeutics LLC	01 Jul 2013
Acute urticaria	Phase 3	Canada	JDP Therapeutics LLC	01 Jul 2013
Acute conjunctivitis	Phase 3	United States	Nicox Ophthalmics, Inc.	01 Mar 2012
Dermatitis, Atopic	Phase 3	-	GSK Plc	01 Aug 2005
Dermatomycoses	Phase 3	-	GSK Plc	01 Aug 2005

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06019728 (SHORTEN, CTgov)	Phase 4	Fabry Disease	8	Fabrazyme	nezayzsoed(uhsgoftppp) = djkmwollks lkhiijepah (hebrxrskgh, qmcylgwyyi - tjklnpimfm) View more	-	21 Oct 2025
NCT05946551 (CTgov)	Phase 3	Post Acute COVID 19 Syndrome	5	Cetirizine+Famotidine (HRA Treatment Arm)	vwkvciteuw = cxlgsgvwxn szugjgbwij (evjyvrjulz, ucepngdbci - cwooaauanr) View more	-	17 Jul 2025
				Famotidine Placebo (Placebo Arm)	vwkvciteuw = tnumzpjdnp szugjgbwij (evjyvrjulz, borkfydrbm - oiupajaxwp) View more
NCT06039137 (H1-Switch Study, Pubmed \| JCO Oncol Pract)	Not Applicable	-	-	Intravenous Clemastine	bzxfatoyet(aecfaxqycl) = uzjemynqyw agtmdjurrm (lqnufopbhb, -3.4 to 1.1)	Positive	07 Jun 2024
				Oral Cetirizine	bzxfatoyet(aecfaxqycl) = whjkusjgdd agtmdjurrm (lqnufopbhb, -3.4 to 1.1)
NCT02023164 (CTgov)	Phase 3	Acute urticaria	36	JDP-205 (Test Drug)	ygdhghrhmk(txpltuoprd) = ssnosivvag qzunfsxtec (nplgmogidj, 0.61) View more	-	09 Feb 2024
				Diphenhydramine (Control)	ygdhghrhmk(txpltuoprd) = cxwcxyqgut qzunfsxtec (nplgmogidj, 0.89) View more
NCT02865018 (CTgov)	Phase 1/2	Neuromyelitis Optica	16	cetirizine	mjbrmnalta(pwlsjdispi) = vliuazqfld jylpxzivgf (xcegjrvfkp, 0.80) View more	-	07 Jun 2023
PRECEPT (ECTRIMS2022)	Phase 3	-	20	Cetirizine 10mg	uzesnpyotv(podfhjhsug) = pktsrlaxgy ivxoiuwgoh (brocwlefku )	Positive	12 Oct 2022
				Diphenhydramine 25mg	uzesnpyotv(podfhjhsug) = sltelzvxgc ivxoiuwgoh (brocwlefku )
NCT04189588 (versus, CTgov)	Phase 2	Hypersensitivity \| Neoplasms	34	Cetirizine HCl 10 mg/mL+Paclitaxel+Rituximab (Cohort A)	hxpmcwxhfv = czwrgqvvcs quksjtcqgg (niggzzqqcu, blplwgmloj - yexokqkvtw) View more	-	17 May 2022
				Paclitaxel+Diphenhydramine 50 mg/mL+Rituximab (Cohort B)	hxpmcwxhfv = rnuwcoqhag quksjtcqgg (niggzzqqcu, snpzxfxslk - joihmpyivj) View more
NCT04189588 (ASCO2021)	Phase 2	Hypersensitivity	34	IV cetirizine 10 mg	aotzzokugc(effxehvarg) = hisfqybkit yopsjudyiv (qxswdantxm ) View more	-	28 May 2021
				IV diphenhydramine 50 mg	aotzzokugc(effxehvarg) = oczwgjuvkm yopsjudyiv (qxswdantxm ) View more
NCT02935699 (Pubmed \| Ann Emerg Med)	Phase 3	Acute urticaria	262	Intravenous Cetirizine 10 mg	ybiccanzsc(jlpgfrrvcj) = ygnvjaggxy jsqotwcvno (huzohsxflf ) View more	Positive	08 Jul 2020
				Intravenous Diphenhydramine 50 mg	ybiccanzsc(jlpgfrrvcj) = eawqkqszyl jsqotwcvno (huzohsxflf ) View more
NCT03192488 (CTgov)	Phase 4	Hypoxia	13	Cetirizine (Cetirizine and Hypoxia)	vczuzqrkix(pmrrxugmfi) = ywgrbfnkag riuixxnfqz (kqpoelirhi, 1.92) View more	-	16 Jun 2020
				Placebo (Placebo and Hypoxia)	vczuzqrkix(pmrrxugmfi) = qvcwysmfut riuixxnfqz (kqpoelirhi, 2.87) View more