Last update 04 Nov 2024

Cetirizine Hydrochloride

Last update 04 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

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

+ [45]

Target

H1 receptor

Mechanism

H1 receptor antagonists(Histamine H1 receptor antagonists)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesEye Diseases+ [3]

Active Indication

Conjunctivitis, AllergicEczemaPruritus+ [6]

Inactive Indication

Acute conjunctivitisChronic UrticariaDermatitis, Atopic+ [4]

Originator Organization

Johnson & Johnson

Active Organization

Harrow, Inc.

UCB Japan Co. Ltd.Ocumension Suzhou Biotech Co., Ltd.

+ [6]

Inactive Organization

GSK Plc

UCB Pharma GmbH

McNeil AB

+ [6]

Drug Highest PhaseApproved

First Approval Date

CA (31 Dec 1991),

Rhinitis, AllergicUrticaria

RegulationPriority Review (CN)

Structure

Molecular FormulaC21H26Cl2N2O3

InChIKeyCUSPGNDCPOVPBA-UHFFFAOYSA-N

CAS Registry83881-52-1

112

Clinical Trials associated with Cetirizine Hydrochloride

CTRI/2024/08/072453 / Not yet recruitingPhase 3

A Prospective, Randomized, Double-blinded, Multi-centric, Two-arm, Parallel-group, Active-Controlled, Phase III Study to Assess the Efficacyand Safety of Cetirizine Ophthalmic in Patients having ocular itching associated with allergic conjunctivitis - NIL

Start Date20 Aug 2024

Sponsor / Collaborator

Akums Drugs & Pharmaceuticals Ltd.

[+1]

CTR20233269 / RecruitingPhase 3

盐酸西替利嗪注射液治疗急性荨麻疹的有效性和安全性的随机、双盲、阳性对照、多中心III期临床研究

[Translation] A randomized, double-blind, positive-controlled, multicenter phase III clinical study on the efficacy and safety of cetirizine hydrochloride injection in the treatment of acute urticaria

评价盐酸西替利嗪注射液治疗急性荨麻疹的有效性和安全性

[Translation]

To evaluate the efficacy and safety of cetirizine hydrochloride injection in the treatment of acute urticaria

Start Date22 Apr 2024

Sponsor / Collaborator

Shandong New Time Pharmaceutical Co. Ltd.

NCT05946551 / TerminatedPhase 3IIT

Feasibility Assessment of a Decentralized Platform Adaptive Double-Blind, Randomized Controlled Trial Investigating Repurposed Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC)

The primary objective of this study is to assess the feasibility and acceptability of methods and procedures to be employed in a larger scale decentralized platform adaptive randomized clinical trial in patients with a history of a Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Polymerase Chain Reaction (PCR) positive test and/or medical records from a healthcare provider that coincides with the diagnosis of long-COVID.

Start Date08 Mar 2024

Sponsor / Collaborator

Emory University

100 Clinical Results associated with Cetirizine Hydrochloride

100 Translational Medicine associated with Cetirizine Hydrochloride

100 Patents (Medical) associated with Cetirizine Hydrochloride

1,754

Literatures (Medical) associated with Cetirizine Hydrochloride

01 Dec 2024·ARCHIVES OF TOXICOLOGY

Development of two ultra-sensitive UHPLC–QqQ-MS/MS methods for the simultaneous determination of hydroxyzine and its active metabolite (cetirizine) in human blood: applications to real cases of forensic toxicology

Article

Author: Kukula-Koch, Wirginia ; Chłopaś-Konowałek, Agnieszka ; Zawadzki, Marcin ; Szpot, Paweł ; Dudzińska, Ewa

Abstract:

Both postmortem toxicological and medical-forensic examinations are very important in the case of analyzing various types of chemical substances. Hydroxyzine (HZ) is a first-generation antihistamine drug with a sedative effect that disrupts cognitive function and affects the ability to drive motor vehicles. Enzymatic oxidation of the hydroxy-methyl group to the carboxyl group leads to the formation of its main metabolite—cetirizine (CZ). CZ is the active substance of antiallergic drugs. Because it does not cross the BBB (blood–brain barrier) easily, it is less likely to cause drowsiness or affect memory and impair cognitive function. Therefore, in criminal studies, it is often important what medication had been taken by a person involved, e.g., in a car accident, HZ or CZ. The analysis of both antihistamine drugs is challenging, as usually very low concentrations of the compound of interest need to be determined. Thus, an ultra-sensitive UHPLC–QqQ-MS/MS method was developed for simultaneous determination of HZ and CZ in biological fluid samples. The lower limit of quantification (LOQ) for HZ and CZ was calculated as 0.345 and 0.3696 ng/mL, respectively. Together with a reduced sample volume to 200 μL, it makes the developed method suitable for a sensitive multidrug forensic toxicological analysis. Samples were extracted with simple and fast liquid–liquid extraction (ethyl acetate, pH 9). The present method for the determination of HZ and CZ in human blood proved to be simple, fast, selective, and sensitive. The quantification by LC–MS/MS was successfully applied to the samples coming from 28 authentic biological fluids (blood, urine, vitreous humor, bile and stomach content), both antemortem and postmortem. The performed studies confirm that the developed method is characterized by a high extraction efficiency. Its accuracy, reproducibility, simplicity, and selectivity suggest its application in clinical, toxicological, and forensic laboratories.

01 Nov 2024·Journal of the European Academy of Dermatology and Venereology : JEADV

Treatment of acute urticaria: A systematic review

Review

Author: Badloe, Fariza M. S. ; Grosber, Martine ; Kortekaas Krohn, Inge ; Gutermuth, Jan ; Ring, Johannes

Abstract:

There are only a few clinical trials which address the treatment of acute urticaria (AU). Especially, the added value of systemic corticosteroids to antihistamines is unclear in treatment of severe AU. To review the existing evidence‐based approaches for AU treatment. A systematic electronic search was done in PubMed and Web of Science to retrieve all studies on the treatment of patients with AU. A descriptive synthesis was conducted based on the PRISMA statement. Quality assessment was independently performed by both reviewers (‘Cochrane risk‐of‐bias tool’ for RCTs). Ten randomized controlled trials (RCTs) (n = 857 participants) were included. Four studies assessed corticosteroid effectiveness added to antihistamines and six studies compared the efficacy of H1 and/ or H2‐antihistamines. The addition of corticosteroid (prednisone) to an antihistamine (levo)cetirizine did not improve symptoms of AU compared to antihistamine alone in two out of three RCTs. The combination of diphenhydramine (50 mg, IV) and ranitidine (50 mg, IV) or cimetidine (300 mg, IV) was most efficient for relief of urticaria in two out of five studies. Most frequent adverse effects were sedation and drowsiness. Recent guidelines on urticaria treatment mainly focus on chronic urticaria rather than on AU. Moreover, only few, small RCTs provide evidence for the management of AU. Thus, the state‐of‐the‐art management of this frequent condition remains unclear. The addition of corticosteroids to an antihistamine as treatment for AU needs to be further investigated. Well‐designed, high‐quality interventional trials are needed to establish evidence‐based treatment guidelines for AU.

15 Oct 2024·Farmaceuticos Comunitarios

Article

Author: Parra-Astorgano, L ; Parra-Astorgano, Lola

Case description:

Patient (29 years old) with palmo-plantar erythema, goes to the community pharmacy (FC) requesting a cream to treat atopy.

Evaluation:

The patient accessed the Pharmaceutical Indication Service (SPIF), showing that the manifestations appeared 24 hours after the start of dental treatment with amoxicillin 1g/12h and ibuprofen 600 mg/8h without any concomitant medication.

Intervention:

After explaining the possible relationship of the symptoms with their medication, patient was derived to the doctor with the referral report completed by SEFAC-eXPERT.

Results:

The patient went to the emergency where she was treated with intravenous corticosteroid and a prescription for cetirizine 10 mg. The dentist changed the beta-lactam to a macrolide (azithromycin) and the ibuprofen to paracetamol. From the FC, the evolution of the symptoms was monitored, which took 72 hours to disappear. Allergy tests suggested avoiding beta-lactams, cephalosporins, and arylpropionics without being conclusive. Months later, the patient suffered similar symptoms after inhaling a disinfectant spray and the allergy diagnosis was confirmed.

Conclusions:

The FC identified and immediately referred using SPIF a case of hypersensitivity in a patient susceptible to RNM and the SPIF helps to record the intervention and follow-up, increasing patient safety.

News (Medical) associated with Cetirizine Hydrochloride

17 Oct 2024

·www.globenewswire.com

Nicox Provides Third Quarter 2024 update and First Half 2024 Financial Results

Press Release Nicox Provides Third Quarter 2024 update and First Half 2024 Financial Results Topline results from the NCX 470 (bimatoprost grenod) Phase 3 Denali clinical trial expected in Q3 2025Cash of €19.7 million on September 30, 2024, including the estimated net proceeds of the VYZULTA royalty sale and equity investment announced on October 14, 2024The Company estimates that it is financed into Q3 2025 October 17, 2024 – release at 7:30 am CETSophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today provided the revenue and cash position for Nicox SA and its subsidiaries (the “Nicox Group”) for the third quarter of 2024 and financial results for Nicox SA (the “Company”) for the first half of 2024, as approved by the Board of Directors on October 16, 2024 and provided an update on key future milestones. As previously announced, the Company is no longer reporting consolidated accounts under IFRS standards and figures communicated for the Nicox Group are for information only. “The first 9 months of 2024 have been a period of significant strategic progress for Nicox, in which we have stabilized our financial situation with a royalty sale, optimised our cost structure to focus on our lead asset and partnerships, renewed the Board of Directors and increased our institutional shareholder base through targeted financing activities. Our development team has also continued driving the NCX 470 Denali clinical trial with the completion of recruitment in the United States in July, and the target date for topline results now advanced to Q3 2025.” said Gavin Spencer, Chief Executive Officer of Nicox. “We have also seen major progress in our partnership activity, with our Chinese licensee Ocumension Therapeutics obtaining approval for ZERVIATE in China, where we are now awaiting the commercial launch, and the signature of a new research agreement, including a pre-agreed license option, for NCX 1728 with leading ophthalmic pharmaceutical and medical technology company Glaukos. Going forward we will be focussing on the completion of the Denali trial and partnerships for the commercialisation of NCX 470 in the United States and elsewhere.” Key Future Milestones Launch of ZERVIATE in China by Nicox’s partner, Ocumension Therapeutics: Approval obtained in September 2024. Whistler Phase 3b clinical trial, initiated in December 2023, investigating NCX 470’s dual mechanism of action (nitric oxide and prostaglandin analog) in intraocular pressure lowering: results are currently expected in the first quarter of 2025. Denali Phase 3 clinical trial evaluating NCX 470 in patients with open-angle glaucoma or ocular hypertension: recruitment of the last patient in the U.S. in the Denali trial was in July when overall recruitment was approaching the 95% level, with recruitment continuing in China and topline results are expected in Q3 2025. Management ChangeEmmet Purtill, Vice President of Business Development at Nicox, has joined the Executive Committee. Emmet has been with the company since 2006 and has played a significant role in establishing our partnerships, notably the relationships with Ocumension and Kowa, and had led many of our recent deals. Emmet joins Sandrine Gestin, VP Finance and HR, Doug Hubatsch, Chief Scientific Officer and Gavin Spencer, Chief Executive Officer, who are the other Executive Committee members.Revenue, Cash Position for the Nicox Group for the Third Quarter 2024 and post-period events Due to the sale of the VYZULTA royalty, the Nicox Group received no material revenue in the third quarter of 2024 compared to €1.8 million (net revenue1 €1.1 million, entirely composed of net royalties) for the first quarter 2023.$16.5 million Royalty and Equity Financing with Soleus announced on October 14, 2024.Cash of €19.7 million at 30 September 2024 including the estimated net proceeds from the VYZULTA royalty sale and accompanying investment mentioned above, after deduction of legal, banking and other fees, compared to €7.7 million at 30 June 2024. Based on this cash position, expected milestone income from existing agreements, and accounting for the €5.2 million debt repayments by June 2025, the Company estimates that it is financed into Q3 2025. If any of the assumptions around estimated income or costs change, this may impact the cash runway of the Company. The Company cannot guarantee that it is financed to the topline results of the Denali trial, and completion of the Denali clinical trial may require additional financing.As of September 30, 2024, the Nicox Group had financial debt of €20.4 million (entirely held by Nicox SA), consisting of €19.4 million in the form of a bond financing agreement with Kreos Capital (an affiliate of BlackRock), and a €1.0 million credit agreement guaranteed by the French State, and granted in the context of the COVID-19 pandemic. Nicox will be repaying €5.2 million of the Kreos Capital debt by June 2025.The Company continues to evaluate all options for non-dilutive and dilutive financing to extend its cash runway. In particular the Company is actively exploring multiple strategic options which could facilitate the development and commercialization of its product candidate NCX 470 and the future growth of the Company. First Half 2024 Financial Results for Nicox SA Net revenue1 for the first half of 2024 was €4.9 million (including €1.7 million of net royalty payments and a license payment of €3.0 million) versus €1.7 million (consisting entirely of net royalty payments) for the first half of 2023. Operating expenses for the first half of 2024 were €10.1 million compared to €14.8 million for the first half of 2023. The decrease in operating expenses for the first half of 2024 compared with the first half of 2023 is explained by the costs related to the finalization of the Mont-Blanc study which had an impact on the first half of 2023. In addition, operating expenses for the first half of 2023 included a €3.5 million adjustment relating to the rebilling of services performed in 2022 by the U.S. subsidiary.Net loss for the six months ended June 30, 2024, was €4.4 million, compared to a net loss of €12.5 million for the same period in 2023. The reduction in the net loss for the first half of 2024 is mainly due to the increase in revenues following the signature of the agreement with Kowa for Japan for which the Company has received an initial payment of €3 million, and to the reduction in operating expenses as explained above.As of June 30, 2024, Nicox SA had cash and cash equivalents of €7.7 million as compared with €11.3 million as of December 31, 2023. Including the estimated net proceeds of the VYZULTA royalty sale and equity investment announced on October 14, 2024 and exclusively on the basis of the development of NCX 470, the Company estimates it is currently funded into Q3 2025. As of June 30, 2024, Nicox SA had financial debt of €20.5 million, consisting of (i) €19.4 million in the form of a bond financing agreement with Kreos Capital signed in January 2019 and (ii) a €1.1 million credit agreement guaranteed by the French State, and granted in August 2020 in the context of the COVID-19 pandemic.Only the figure related to the cash position and the debt of Nicox SA as of December 31, 2023, is audited; all other figures in this press release are non-audited. About NicoxNicox SA is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health. Nicox’s lead program in clinical development is NCX 470 (bimatoprost grenod), a novel nitric oxide-donating bimatoprost eye drop, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Nicox also has a preclinical research program on NCX 1728, a nitric oxide-donating phosphodiesterase-5 inhibitor, with Glaukos. Nicox’s first product, VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, is available commercially in the U.S. and over 15 other territories. Nicox generates revenue from ZERVIATE® in allergic conjunctivitis, licensed in multiple geographies, including to Harrow, Inc. in the U.S., and Ocumension Therapeutics in the Chinese and in the majority of Southeast Asian markets. . Nicox, headquartered in Sophia Antipolis, France, is listed on Euronext Growth Paris (Ticker symbol: ALCOX) and is part of the CAC Healthcare index. For more information www.nicox.comAnalyst coverageH.C. Wainwright & Co Yi Chen New York, U.S. The views expressed by analysts in their coverage of Nicox are those of the author and do not reflect the views of Nicox. Additionally, the information contained in their reports may not be correct or current. Nicox disavows any obligation to correct or to update the information contained in analyst reports.Contacts NicoxGavin SpencerChief Executive OfficerT +33 (0)4 97 24 53 00communications@nicox.com DisclaimerThe information contained in this document may be modified without prior notice. This information includes forward-looking statements. Such forward-looking statements are not guarantees of future performance. These statements are based on current expectations or beliefs of the management of Nicox S.A. and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Nicox S.A. and its affiliates, directors, officers, employees, advisers or agents, do not undertake, nor do they have any obligation, to provide updates or to revise any forward-looking statements.Risks factors which are likely to have a material effect on Nicox’s business are presented in section 3 of the “Rapport Annuel 2023” which is available on Nicox’s website (www.nicox.com).Finally, this press release may be drafted in the French and English languages. If both versions are interpreted differently, the French language version shall prevail.Nicox S.A.Sundesk Sophia Antipolis, Bâtiment C, Emerald Square, Rue Evariste Galois, 06410 Biot, FranceT +33 (0)4 97 24 53 00 Income Statement (in thousands of euros) June 30, 2024June 30, 2023Sales of services – Various re-invoicing 23Royalties for patent grants 6 0672 721REVENUE 6 0692 724Reversals of depreciation, amortization, provisions and transfers of expenses 4497Other income 10577TOTAL OPERATING INCOME 6 6232 807Other purchases and external charges (6 853)(12 049)Taxes, duties and similar payments (42)(63)Salaries and wages (1 548)(918)Social security expenses (412)(361)Amortization (9)(11)Provisions for liability and charges -(108)Other expenses (1 190)(1 189)Exchange loss on receivables and debts (57)(130)TOTAL OPERATING EXPENSES (10 111)(14 829) OPERATING PROFIT (LOSS) (3 488)(12 022)Other interest and similar income 398550Reversal of provisions, impairment losses and transfer of expenses 1339Foreign exchange gains 23110TOTAL FINANCIAL INCOME 434699Amortization, depreciation and financial provisions (311)(306)Interest and similar expenses (789)(790)Foreign exchange loss -(212)Interests on loan (28)(29)Net expense from sales of investments securities (72)(185)TOTAL FINANCIAL EXPENSES (1 200)(1 522) FINANCIAL PROFIT (LOSS) (766)(823) PRE-TAX LOSS (4 254)(12 845)Exceptional income on management operations 3-Exceptional income from previous financial year -63EXCEPTIONAL INCOME 363 EXCEPTIONAL INCOME (LOSS) (23)63Research tax credit -251NET PROFIT & LOSS (4 277)(12 531) Balance sheet June 30, 2024December 31, 2023(in thousands of euros) ASSETS Intangible fixed assets1824Tangible fixed assets1426Financial fixed assets1 7291 805 FIXED ASSETS1 7611 855 Trade receivables and related accounts3 0223 424Other receivables (1)34 98434 324Cash assets7 65411 259Prepaid expenses1 207886 CURRENT ASSETS46 86749 893 Unrealized foreign exchange losses and valuation differences – Assets713Loan redemption premiums9141 218 TOTAL REGULARISATION ACCOUNTS9211 231 TOTAL ASSETS49 54952 979 LIABILITIES Share Capital63550 170Premiums related to share capital532 068529 478Retained earnings(508 438)(537 354)Net loss for the financial year(4 277)(20 881) Total shareholders' equity19 98821 413 Provisions for liabilities713Provisions for charges256700 Total provisions for liabilities and charges263713 Loans and debts from lending institutions20 53620 895Loans and other financial debts3 1564 258Accounts payable and related accounts1 5802 498Tax and social security debts515648Deferred income1 9951 919 Total current liabilities27 78230 218 Unrealized exchange gains1 516635 TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY49 54952 979 1 Net revenue consists of revenue from collaborations less royalty payments Attachment EN_H1&Q32024_PR_FINAL

License out/inPhase 3Financial Statement

16 Oct 2024

·www.biospace.com

As Sanofi Preps Consumer Healthcare Sale, Here’s a Look Back at Similar High-Profile Deals

iStock, master1305 Sanofi looks to follow a deep history of Big Pharmas offloading their consumer healthcare businesses. When Sanofi announced last week that it plans to sell a 50% controlling stake of Opella, its consumer helath business, the disclosure echoed similar moves by other Big Pharma companies, including Johnson & Johnson, GSK, Pfizer and Novartis. Just last year, J&J split off Kenvue, creating a standalone company to house iconic brands like Tylenol and Benadryl. Novartis did the same with its generics and biosimilars unit Sandoz as well. But if you look back even further, Roche was the first Big Pharma 20 years ago to portion off its consumer work and hand it off to Bayer. Sanofi is now looking to make a similar move, selling Opella to a private equity firm. The company first set up its consumer healthcare section as a standalone global business unit in 2019, seemingly prepping it for a full spin out at some point, while streamlining down to only priority brands. Those under the Opella banner include seasonal allergy medication Allegra, topical pain relief line IcyHot and constipation drug DulcoLax. As of 2023, the unit had revenue of €5.2 billion ($5.7 billion), with a presence in 150 countries with 11,000 employees. Sanofi telegraphed the split from the consumer healthcare unit a year ago as part of its October 2023 “Play to Win Strategy.” Specifically, the company announced a plan to separate the consumer business entirely and shift its focus to innovative medicines and vaccines. The move would create two separate entities, “each better equipped to pursue its own business strategy,” according to the release, which noted that the separation could happen by the fourth quarter of 2024. And here we are, the final quarter just beginning, and Sanofi is in earnest talks with a potential buyer for Opella. As we wait for that story to unfold, BioSpace takes a look back at how this sort of transaction has gone previously. Kenvue Former parent: Johnson & Johnson New ownership: Standalone company Date of split: August 23, 2023 Brands: Tylenol, Zyrtec, Nicorette, Benadryl, Motrin 2023 revenue: $15.4 billion YOY growth: 5% Kenvue spun out of J&J in August 2023, marking a “historic moment,” according to newly-minted CEO Thibaut Mongon. J&J still has a stake in the company, but Kenvue is otherwise independent . A debt offering and the IPO raised $13.2 billion. When announcing the spin off, J&J CEO Joaquin Duato said the separation “sharpens” the healthcare company’s focus on innovation in pharma and medtech. The separate company is now the largest pure-play consumer health company by revenue, known for brands such as Tylenol, Neosporin, Johnson’s baby soap, Listerine and Neutrogena. Kenvue planned to spend 2024 investing in its brands and boosting prominence on store shelves. Mongon said during a second-quarter earnings call, “Earlier this year, I committed to you that you would see a new Kenvue, the bolder company that is moving quickly to advance our three priorities to reach more consumers effectively, invest further behind our brands, and build a culture of performance and impact.” Sandoz Former parent: Novartis New ownership: Standalone company Date of split: October 4, 2023 Brands: Generics, biosimilars 2023 revenue: $9.6 billion (reported as net sales) YOY growth: 11% Wanting to focus 100% on innovative medicines , Novartis spun off the Sandoz unit, which manufactures generics and biosmiliars, just over a year ago. This transaction was a little different from the others on this list, as Sandoz exclusively manufactures prescription medicines, but it gets lumped in with the rest when talking about major pharmaceutical companies calving off massive portions of their business to focus on innovation. In 2023, Sandoz launched biosimilars for AbbVie’s Humira and J&J’s Stelara. This year, it’s launched a generic for chemotherapy drug paclitaxel and a biosimilar of Regeneron’s Eylea, among many others. CEO Richard Saynor boasted during a second-quarter earnings call in August that Sandoz had grown for the 11th straight quarter. But he also foreshadowed changes that could impact employees, with a multiyear program underway to reduce costs by $200 million annually by 2026. “Coming out of a large pharmaceutical company with a much more complex and layered infrastructure we have plans to reduce layers across the organization and simplify our processes,” Saynor said. Haleon Former parent: GSK/Pfizer New ownership: Standalone company Date of split: July 18, 2022 Brands: Sensodyne, Advil, Voltaren, Theraflu, Centrum 2023 revenue: £11.3 billion ($14.7 billion) YOY growth: 4.1% GSK’s consumer healthcare unit was said to be worth $36 billion at the time of the demerger, which was announced in early 2022. CEO Emma Walmsley said the spin out was coming as the U.K. pharma planned “the most significant corporate change for GSK in the last 20 years.” The unit was formed through a series of M&A deals and divestments, and was partly owned by Pfizer at the time of the sale. GSK held a majority 68% interest while Pfizer had 32%. Brian McNamara, previously the chief of the consumer division at GSK, was put in place as CEO, a role he still holds. Haleon recently upped its stake in a Chinese joint venture called Tianjin TSKF Pharmaceutical, adding another 33% equity interest, and divested ChapStick and other brands, along with a handful of nicotine replacement products. “We love the portfolio we have. We don’t believe we need to do anything with the portfolio to deliver on our guidance that we have given. But that said, we want to proactively and actively manage the portfolio,” McNamara said. He promised that as certain products are offloaded, his team is keeping an eye out for bolt-on M&A opportunities. Both GSK and Pfizer have been lowering their stakes in Haleon in recent months, with Pfizer’s share dropping from 32% to 24% in March, while GSK’s has fallen to just 4.2% ownership. Consumer health business Former parent: Merck KGaA New ownership: Proctor & Gamble Date of split: December 1, 2018 Brands: Neurobion, Nasivin, Bion3 2023 revenue: N/A YOY growth: N/A Germany’s Merck KGaA sold off its consumer health unit to Proctor & Gamble in 2018, perhaps kickstarting the more recent trend we see today. The unit was purchased for €3.4 billion ($3.7 billion), netting €2.7 billion ($2.9 billion) in cash, which Merck put towards reducing debt. The unit’s key brands include Neurobion, Dolo-Neurobion, Femibion, Nasivin and Bion3, primarily sold in Europe, Latin America and Asia. P&G also took on the Merck employees from the unit. P&G has previously had a joint venture with Teva in consumer health, which was terminated with the Merck deal. Roche Consumer Health Former parent: Roche Holdings New ownership: Bayer Date of split: July 2004 Brands: Aleve, Bepanthen, Berocca, Flanax, Redoxon 2023 revenue: N/A YOY growth: N/A Roche and Bayer had been working together in a consumer health joint venture, but the Swiss pharma decided to leave the partnership in 2004. Bayer was happy to pick up the remaining shares plus a few more assets including manufacturing sites. The complex transaction was three deals in one, with the termination of the joint venture, the sale of Roche’s over-the-counter business to Bayer and the out-licensing of an anti-obesity drug called orlistat going to GSK. Consider that, 20 years later, obesity and weight loss has become all the rage in pharma, with Roche investing heavily in the GLP-1 space to keep pace with its peers. Orlistat is still manufactured and sold over-the-counter by none-other than GSK’s former consumer unit Haleon and also as a generic by others.

AcquisitionExecutive ChangeLicense out/in

18 Sep 2024

·www.globenewswire.com

Nicox Announces Approval of ZERVIATE in China

Press Release Nicox Announces Approval of ZERVIATE in China Nicox’s partner, Ocumension Therapeutics, has received approval for ZERVIATE® for ocular itching in China ZERVIATE® launch in China will add a further royalty revenue stream for Nicox September 18, 2024 – release at 7:30 am CETSophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced that its exclusive Chinese partner, Ocumension Therapeutics, has received approval of the New Drug Application (NDA) to commercialize ZERVIATE® (cetirizine ophthalmic solution), 0.24% in China for ocular itching associated with allergic conjunctivitis. “The approval of ZERVIATE for commercialization in China is an excellent achievement by our partner, Ocumension Therapeutics. We trust in their capabilities to support a quick launch and use their strong commercial presence across China to maximize market penetration. This new commercial launch will add another revenue stream to Nicox as we will receive from 5% to 9% royalties and commercial milestones on Ocumension’s net sales of ZERVIATE in China. Ocumension forecasts peak sales in excess of $100 million annually within 7 years.” said Emmet Purtill, VP Business Development of Nicox. ZERVIATE is the first and only eye drop formulation of the antihistamine cetirizine, the active ingredient in ZYRTEC®, and is currently commercialized in the U.S. for ocular itching associated with allergic conjunctivitis by Nicox’s exclusive U.S. partner, Harrow, Inc. Ocumension emphasizes that ZERVIATE is suitable for the treatment of allergic conjunctivitis in toddlers and preschoolers, which significantly fills the medical gap in this field and benefits the vast number of children in China. Ocumension plans to manufacture ZERVIATE in their new state-of-the-art purpose-built manufacturing facility located in Suzhou, China. ZERVIATE will be promoted by Ocumension’s commercial team and its extensive network of national and provincial distribution partners. The prescription market for allergic conjunctivitis products in China is expected1 to grow to almost $500 million by 2030. ZERVIATE is exclusively licensed to Ocumension for development and commercialization in the Chinese and the majority of the Southeast Asian markets. Nicox may potentially receive sales milestones of up to US$17.2 million together with royalties from 5% to 9% of net sales of ZERVIATE by Ocumension. Since Nicox’s recent successful financing, Ocumension is now its principal shareholder.About NicoxNicox SA is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health. Nicox’s lead program in clinical development is NCX 470 (bimatoprost grenod), a novel nitric oxide-donating bimatoprost eye drop, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Nicox generates revenue from VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, and ZERVIATE® in allergic conjunctivitis, licensed in multiple geographies, including to Harrow, Inc. in the U.S., and Ocumension Therapeutics in the Chinese and in the majority of Southeast Asian markets. Nicox, headquartered in Sophia Antipolis, France, is listed on Euronext Growth Paris (Ticker symbol: ALCOX) and is part of the CAC Healthcare index. For more information www.nicox.comAnalyst coverageH.C. Wainwright & Co Yi Chen New York, U.S. The views expressed by analysts in their coverage of Nicox are those of the author and do not reflect the views of Nicox. Additionally, the information contained in their reports may not be correct or current. Nicox disavows any obligation to correct or to update the information contained in analyst reports.Contacts NicoxGavin SpencerChief Executive OfficerT +33 (0)4 97 24 53 00communications@nicox.com Media / Investors Sophie Baumont Cohesion Bureau +33 6 27 74 74 49 sophie.baumont@cohesionbureau.comDisclaimerThe information contained in this document may be modified without prior notice. This information includes forward-looking statements. Such forward-looking statements are not guarantees of future performance. These statements are based on current expectations or beliefs of the management of Nicox S.A. and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Nicox S.A. and its affiliates, directors, officers, employees, advisers or agents, do not undertake, nor do they have any obligation, to provide updates or to revise any forward-looking statements.Risks factors which are likely to have a material effect on Nicox’s business are presented in section 3 of the “Rapport Annuel 2023” which is available on Nicox’s website (www.nicox.com).Finally, this press release may be drafted in the French and English languages. If both versions are interpreted differently, the French language version shall prevail.Nicox S.A.Sundesk Sophia Antipolis, Bâtiment C, Emerald Square, Rue Evariste Galois, 06410 Biot, FranceT +33 (0)4 97 24 53 00 1 Zhaoke Ophthalmology Limited IPO Prospectus, April 2021 Attachment EN_OcumensionZerviateNDAChinaApproval_PR_FINAL

Drug Approval

100 Deals associated with Cetirizine Hydrochloride

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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	US	Harrow, Inc.	30 May 2017
Eczema	JP	UCB Japan Co. Ltd.	30 Jun 1998
Pruritus	JP	UCB Japan Co. Ltd.	30 Jun 1998
Anaphylaxis	CN	Suzhou Dawnrays Pharmaceutical Co., Ltd.	01 Jan 1998
Rhinitis	CN	Suzhou Dawnrays Pharmaceutical Co., Ltd.	01 Jan 1998
Chronic Urticaria	US	Johnson & Johnson Holdco (NA), Inc.	08 Dec 1995
Rhinitis, Allergic, Perennial	US	Johnson & Johnson Holdco (NA), Inc.	08 Dec 1995
Rhinitis, Allergic, Seasonal	US	Johnson & Johnson Holdco (NA), Inc.	08 Dec 1995
Rhinitis, Allergic	CA	Pfizer Canada ULC	31 Dec 1991
Urticaria	CA	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	KR	SAMIL PHARMACEUTICAL Co., Ltd.	-
Acute urticaria	Phase 3	US	JDP Therapeutics LLC	01 Jul 2013
Acute urticaria	Phase 3	CA	JDP Therapeutics LLC	01 Jul 2013
Acute conjunctivitis	Phase 3	US	Nicox Ophthalmics, Inc.	01 Mar 2012
Dermatitis, Atopic	Phase 3	-	GSK Plc	01 Aug 2005
Dermatomycoses	Phase 3	-	GSK Plc	01 Aug 2005
Seasonal rhinitis	Phase 2	CA	UCB Pharma GmbH	01 Jan 2006
Dermatitis	Phase 1	JP	GSK Plc	18 Mar 2008

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06039137 (H1-Switch Study, Pubmed)	Not Applicable	-	-	Intravenous Clemastine	svytwozfdp(botspoxryr) = fbdmmsstvl nmnwgmnenr (wkegjuxykw, -3.4 to 1.1)	Positive	07 Jun 2024
				Oral Cetirizine	svytwozfdp(botspoxryr) = sxdjdeswdz nmnwgmnenr (wkegjuxykw, -3.4 to 1.1)
NCT02023164 (CTgov)	Phase 3	Acute urticaria	36	JDP-205 Injection (Test Drug)	izpfkcxqcb(xtcoawilvm) = eyjivblqww bmhxkybzfc (jdwautlfpf, qtshbogmlh - sgrjbknthn) View more	-	09 Feb 2024
				Diphenhydramine (Control)	izpfkcxqcb(xtcoawilvm) = rfetrdddyl bmhxkybzfc (jdwautlfpf, xpiignfzea - qggduyguon) View more
NCT02865018 (CTgov)	Phase 1/2	Neuromyelitis Optica	16	cetirizine	ebxhuxwcjs(grydunwdgw) = vnnzzdvgmw anvofdyyfx (rhutvcmiln, mdyosjpyey - afaduwvaws) View more	-	07 Jun 2023
PRECEPT (ECTRIMS2022)	Phase 3	-	20	Cetirizine 10mg	zkhzozodtm(ncczndedcy) = zzdkxcvkqe qoxxueqbbk (yuqymyubfo )	Positive	12 Oct 2022
				Diphenhydramine 25mg	zkhzozodtm(ncczndedcy) = mbzpzhcpgs qoxxueqbbk (yuqymyubfo )
NCT04189588 (versus, CTgov)	Phase 2	Hypersensitivity \| Neoplasms	34	Cetirizine HCl 10 mg/mL+Paclitaxel+Rituximab (Cohort A)	qvebuxpfov(eoiwmemlat) = iibgkjolyb lvtnjkrhze (kuochfkxgp, rjctnrfshm - glmjkjkyty) View more	-	17 May 2022
				Paclitaxel+Diphenhydramine 50 mg/mL+Rituximab (Cohort B)	qvebuxpfov(eoiwmemlat) = lpcswlufbm lvtnjkrhze (kuochfkxgp, yyhdiztflu - ydvpbslhbw) View more
NCT04189588 (ASCO2021)	Phase 2	Hypersensitivity	34	IV cetirizine 10 mg	hqobxosdap(rqafrnlsbu) = qfctcinyaj gqgqybluxy (xpnrsvzdqv ) View more	-	28 May 2021
				IV diphenhydramine 50 mg	hqobxosdap(rqafrnlsbu) = xnpkkcprdp gqgqybluxy (xpnrsvzdqv ) View more
NCT03192488 (CTgov)	Phase 4	Hypoxia	13	Cetirizine (Cetirizine and Hypoxia)	dbawunwcid(zysdcaeuqn) = dmlqlxorvs yqyjoujhkg (kddltvradk, whvzslaiau - xxjbprijlv) View more	-	16 Jun 2020
				Placebo (Placebo and Hypoxia)	dbawunwcid(zysdcaeuqn) = mjtfhoeirh yqyjoujhkg (kddltvradk, uhhbierfcs - trokawzhht) View more
NCT02935699 (CTgov)	Phase 3	Acute urticaria	262	Test Drug (JDP-205) (Test Drug)	nfhkxkydrw(gpeeibpclh) = mzlsmerman wrtayqrhfv (qgsqkpsnit, cidwnjfqth - vwgzuegzlf) View more	-	27 Nov 2019
				Active Control (Diphenhydramine) (Control)	nfhkxkydrw(gpeeibpclh) = zayntufvmx wrtayqrhfv (qgsqkpsnit, wqhqyhiqwh - hqmezqyikj) View more
NCT01825655 (CTgov)	Phase 4	Pruritus	3	Cetirizine (Cetirizine)	eybhakchrv(jurgunhxzo) = cuqunojonm gksxyothsk (sakeruxspl, gqhlbrseln - ccaebyfsdk) View more	-	11 Sep 2018
				Placebo or sugar pill (Sugar Pill)	qpwuhncktm(ekuduqemyl) = tsdbbypegl wsdlrefvjf (jcadnjuueq, rmfjnrumku - fjnrlamoqe) View more
AAAAI2018	Not Applicable	Rhinitis, Allergic, Seasonal	53	Cetirizine 5mg syrup	eahmhwqwor(aavgueirbd) = rxttqqrfwz lybelqwqzv (kpfkaxopaz )	Positive	01 Feb 2018

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