Drugs / Cetirizine
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Cetirizine

Other / unclassified targets HRH1 via inhibition

Developed for
allergic rhinitis · seasonal allergic rhinitis · perennial allergic rhinitis · COVID-19 · urticaria · androgenetic alopecia · asthma · conjunctivitis
+12 more · eye allergy · allergic disease · atopic conjunctivitis · atopic eczema · childhood onset asthma · chronic prostatitis · dermatitis · IgE responsiveness, atopic · neuromyelitis optica · rhinitis · chronic idiopathic urticaria · ureterolithiasis
Investigated by
GlaxoSmithKline · Aciex Therapeutics, Inc. · Organon and Co · Actavis Inc. · Emory University · Fraunhofer-Institute of Toxicology and Experimental Medicine
+36 more · Indiana University · JDP Therapeutics, Inc. · Mylan Pharmaceuticals Inc · UCB Pharma · Assiut University · Biogenics Research Chamber, LLC · Biolipox AB · CURE Drug Repurposing Collaboratory (CDRC) · Cairo University · California Allergy and Asthma Medical Group, Inc. · Children's Hospital Medical Center, Cincinnati · Ciusss de L'Est de l'Île de Montréal · Fujian Cancer Hospital · Guthy Jackson Charitable Foundation · Icahn School of Medicine at Mount Sinai · Idorsia Pharmaceuticals Ltd. · Johnson & Johnson Consumer and Personal Products Worldwide · Maastricht University Medical Center · Manimarane Arjunan, MD,DM (Cardiology) · McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · New York City Health and Hospitals Corporation · Nicox Ophthalmics, Inc. · Northwestern University · Novartis Pharmaceuticals · ORA, Inc. · Pengfei Qiu · Pfizer · Queen's University · Raziel Therapeutics Ltd. · Ruijin Hospital · Sandoz · Shandong New Time Pharmaceutical Co., LTD · Shionogi · UR Anoop Research Group · University of Miami

Regulatory milestones approvals, filings & regulatory actions · 4 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) CHILDREN'S ZYRTEC ALLERGY 2007-11-16 fda.gov
Label expansions (2) US (FDA) ZYRTEC 1998-05-15 – 2002-10-21 fda.gov
Approved US (FDA) ZYRTEC HIVES 1995-12-08 fda.gov

Trials 57 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT03167216 Aug 2017 → Apr 2022 chronic prostatitis Northwestern University Completed No outcome recorded
Phase 18 trials
Phase 1 NCT02173249 Jun → Aug 2014 Aciex Therapeutics, Inc. Completed No outcome recorded
Phase 1 NCT01495338 Dec 2011 Aciex Therapeutics, Inc. Completed No outcome recorded
Phase 1 NCT02447393 Mar → Apr 2008 dermatitis GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT00863902 Aug → Sep 2006 Actavis Inc. Completed No outcome recorded
Phase 1 NCT00864279 Aug → Sep 2006 Actavis Inc. Completed No outcome recorded
Phase 1 NCT00881127 Jul 2005 allergic disease Sandoz Completed No outcome recorded
Phase 1 NCT00649857 Nov → Dec 2002 Mylan Pharmaceuticals Inc Completed No outcome recorded
Phase 1 NCT00650065 Nov → Dec 2002 Mylan Pharmaceuticals Inc Completed No outcome recorded
Phase 1/23 trials
Phase 1/2 NCT06126991 Jan → Dec 2024 Ruijin Hospital Unknown No outcome recorded
Phase 1/2 NCT05476679 Sep 2022 → Jun 2023 Raziel Therapeutics Ltd. Completed No outcome recorded
Phase 1/2 NCT02865018 Apr 2014 → Feb 2016 neuromyelitis optica Icahn School of Medicine at Mount Sinai Completed No outcome recorded
Phase 27 trials
Phase 2 NCT05922358 Sep 2023 → Sep 2025 overdue digestive system neoplasm Fujian Cancer Hospital Not yet recruiting No outcome recorded
Phase 2 NCT04179461 Mar 2018 → Oct 2019 childhood onset asthma Children's Hospital Medical Center, Cincinnati Completed No outcome recorded
Phase 2 NCT01651871 Jul → Nov 2012 seasonal allergic rhinitis Shionogi Completed No outcome recorded
Phase 2 NCT01241214 Nov 2010 → Feb 2011 seasonal allergic rhinitis Idorsia Pharmaceuticals Ltd. Completed No outcome recorded
Phase 2 NCT01103050 Mar → Jul 2010 allergic rhinitis Novartis Pharmaceuticals Completed No outcome recorded
Phase 2 NCT00533637 Sep → Dec 2007 allergic rhinitis Biolipox AB Completed No outcome recorded
Phase 2 NCT00291642 Jan → Apr 2006 seasonal allergic rhinitis UCB Pharma Completed No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT04481412 Jul 2020 → Nov 2021 androgenetic alopecia Cairo University Completed No outcome recorded
Phase 2/3 NCT01332188 Apr → Jun 2011 atopic conjunctivitis Aciex Therapeutics, Inc. Completed No outcome recorded
Phase 319 trials
Phase 3 NCT07472413 Sep 2026 → Jul 2028 expected multiple sclerosis University of Miami Not yet recruiting No outcome recorded
Phase 3 NCT06819774 Apr 2024 → Aug 2025 overdue urticaria Shandong New Time Pharmaceutical Co., LTD Recruiting No outcome recorded
Phase 3 NCT05946551 Mar → Jun 2024 COVID-19 Emory University Terminated No outcome recorded
Phase 3 NCT04237090 Feb → Aug 2020 breast cancer, cervical cancer, endometrial cancer, esophageal cancer +3 Ciusss de L'Est de l'Île de Montréal Completed No outcome recorded
Phase 3 NCT02935699 Mar 2017 → Apr 2018 urticaria JDP Therapeutics, Inc. Completed No outcome recorded
Phase 3 NCT02756624 Apr → Aug 2016 Nicox Ophthalmics, Inc. Completed No outcome recorded
Phase 3 NCT02132169 May → Oct 2014 eye allergy Aciex Therapeutics, Inc. Completed No outcome recorded
Phase 3 NCT02023164 Jul 2013 → Dec 2014 urticaria JDP Therapeutics, Inc. Completed No outcome recorded
Phase 3 NCT01881113 Jun → Oct 2013 conjunctivitis Aciex Therapeutics, Inc. Completed No outcome recorded
Phase 3 NCT01685242 Sep → Nov 2012 eye allergy Aciex Therapeutics, Inc. Completed No outcome recorded
Phase 412 trials
Phase 4 NCT04836806 Aug 2021 → Jul 2022 COVID-19 Emory University Withdrawn No outcome recorded
Phase 4 NCT05095311 May 2021 → Apr 2022 Indiana University Terminated No outcome recorded
Phase 4 NCT04293822 Jun → Nov 2020 androgenetic alopecia Assiut University Unknown No outcome recorded
Phase 4 NCT03340740 May 2018 → Aug 2021 allergic rhinitis, asthma New York City Health and Hospitals Corporation Completed No outcome recorded
Phase 4 NCT03192488 Aug 2017 → Jun 2018 altitude sickness Indiana University Completed No outcome recorded
Phase 4 NCT02543346 Oct 2015 → Feb 2016 allergic rhinitis Queen's University Completed No outcome recorded
Phase 4 NCT01916226 Aug → Oct 2013 allergic rhinitis GlaxoSmithKline Completed No outcome recorded
Phase 4 NCT01781507 Jun → Dec 2011 allergic rhinitis, asthma California Allergy and Asthma Medical Group, Inc. Completed No outcome recorded
Phase 4 NCT00794846 Dec 2002 → May 2003 perennial allergic rhinitis, seasonal allergic rhinitis Organon and Co Completed No outcome recorded
Phase 4 NCT00794495 Dec 2002 → Jul 2003 perennial allergic rhinitis, seasonal allergic rhinitis Organon and Co Completed No outcome recorded
Phase not applicable5 trials
NCT06890260 Apr 2025 → Jun 2027 expected allergic rhinitis Pengfei Qiu Recruiting No outcome recorded
NCT04935515 Apr → May 2021 COVID-19 Manimarane Arjunan, MD,DM (Cardiology) Completed No outcome recorded
NCT01318681 Jan 2011 → Mar 2012 seasonal allergic rhinitis Maastricht University Medical Center Completed No outcome recorded
NCT00474890 Jun → Dec 2007 IgE responsiveness, atopic, rhinitis Fraunhofer-Institute of Toxicology and Experimental Medicine Completed No outcome recorded
NCT00334698 Jul → Sep 2006 seasonal allergic rhinitis Fraunhofer-Institute of Toxicology and Experimental Medicine Completed No outcome recorded
Also used as a comparator or background therapy in 48 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 19 trials
Phase 1 NCT04071821 Comparator May → Jul 2025 allergic disease Seattle Gummy Company Unknown No outcome recorded
Phase 1 NCT04568902 Background Sep 2020 → Oct 2025 breast cancer Eisai Inc. Completed No outcome recorded
Phase 1 NCT02665754 Background Jul 2016 → Dec 2019 allergic rhinitis Gachon University Gil Medical Center Completed No outcome recorded
Phase 1 NCT02535416 Background Sep 2015 → Aug 2016 Arrowhead Pharmaceuticals Completed No outcome recorded
Phase 1 NCT01981499 Background Jan → Apr 2014 migraine disorder Pfizer Terminated No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT04990388 Background Oct 2021 → Mar 2023 glycogen storage disease III Ultragenyx Pharmaceutical Inc Terminated No outcome recorded
Phase 211 trials
Phase 2 NCT04189588 Comparator Mar → Nov 2020 TerSera Therapeutics LLC Completed No outcome recorded
Phase 2 NCT02738008 Background Mar → Dec 2016 hepatitis B virus infection Arrowhead Pharmaceuticals Terminated No outcome recorded
Phase 2 NCT02604212 Background Nov 2015 → Dec 2016 hepatitis B virus infection Arrowhead Pharmaceuticals Terminated No outcome recorded
Phase 2 NCT02604199 Background Sep 2015 → Jan 2017 chronic hepatitis B virus infection Arrowhead Pharmaceuticals Terminated No outcome recorded
Phase 2 NCT01748344 Comparator Nov 2012 → Feb 2014 seasonal allergic rhinitis Ono Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase 38 trials
Phase 3 NCT06754410 Comparator Mar 2021 → Mar 2024 ureterolithiasis South Valley University Completed No outcome recorded
Phase 3 NCT04175834 Comparator Feb 2020 → May 2022 multiple sclerosis Providence Health & Services Completed No outcome recorded
Phase 3 NCT02613910 Background Dec 2015 → Mar 2016 pemphigus GlaxoSmithKline Terminated No outcome recorded
Phase 3 NCT01484119 Comparator Dec 2011 → Feb 2012 seasonal allergic rhinitis Idorsia Pharmaceuticals Ltd. Completed No outcome recorded
Phase 3 NCT00375713 Comparator Oct 2005 → May 2006 dermatitis UCB Pharma Completed No outcome recorded
Phase 415 trials
Phase 4 NCT06118710 Background Jun 2024 → Jun 2027 expected cancer Erasmus Medical Center Recruiting No outcome recorded
Phase 4 NCT06019728 Background Nov 2023 → Oct 2024 Fabry disease Sanofi Completed No outcome recorded
Phase 4 NCT03047278 Comparator Nov 2015 → May 2018 diabetic neuropathy, neuropathy, painful, type 2 diabetes mellitus Natalia Valadares de Moraes Completed No outcome recorded
Phase 4 NCT02205489 Background Oct 2014 → Apr 2016 relapsing-remitting multiple sclerosis Genzyme, a Sanofi Company Completed No outcome recorded
Phase 4 NCT01825655 Comparator Sep 2014 → Nov 2017 Virginia Commonwealth University Terminated No outcome recorded
Phase not applicable4 trials
NCT07236372 Comparator Nov 2025 → Jun 2026 overdue urticaria University of Phayao Recruiting No outcome recorded
NCT04706559 Background Jan → Sep 2021 atopic eczema B.P. Koirala Institute of Health Sciences Completed No outcome recorded
NCT02451579 Comparator Feb 2015 → Dec 2016 actinic keratosis Goldman, Butterwick, Fitzpatrick and Groff Completed No outcome recorded
NCT00610584 Comparator Apr 2008 → Apr 2011 seasonal allergic rhinitis Charite University, Berlin, Germany Completed No outcome recorded

Press releases naming this drug 2 releases

DateIssuerRelease
2006-07-12 Daiichi Sankyo Launch of New Formulation Zyrtec® Dry Syrup 1.25% selective H1 receptor antagonist, anti-allergic agent daiichisankyo.com
2004-09-22 Teva Branded Pharmaceutical Products R&D, Inc. Teva Announces Tentative Approval Of Cetirizine Hcl Tablets tevapharm.com

Evidence & citations 40 cited values

Every value below carries the sentence it was read from. 106 sources stand behind the page.

FieldValueCited text
Known as Cetirizine “This was a multi-center, parallel group, randomized, double-blind, active controlled, Phase III clinical trial of cetirizine injection 10 mg/mL versus diphenhydramine injection...” NCT02935699
92

“Subjects are requested to administer oral antihistamine (cetirizine) or nasal glucocorticosteroid (ciclesonide) as rescue medication for allergic rhinitis in accordance with...” NCT02665754

“A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Evaluation of the Onset and Duration of Action of Cetirizine 0.24% Ophthalmic Solution (Formula AFH-002) Compared...” NCT01551056

“A Multi-Center, Randomized, Double-Masked Evaluation of the Efficacy of Cetirizine 0.1%/Fluticasone 0.005% Ophthalmic Solution Compared to Its Components and Vehicle in a...” NCT01134328

“Patients received one of the following: Cetirizine 10 mg once per day (QD), Levocetirizine dihydrochloride 5 mg QD, Fexofenadine 60 mg twice per day or 180 mg QD, Loratadine 10...” NCT00866788

“This 6-month randomized controlled pilot study will determine whether there is some evidence that cetirizine is better tolerated than diphenhydramine without an increase in IRRs.” NCT04175834

“The antihistamine used should in general be an H1\>H2 receptor blocker and would include diphenhydramine 50 mg, cetirizine 10 mg, chlorpheniramine 8 mg or hydroxyzine 50 mg.” NCT02604212

“a combination of cetirizine (CET) and pseudoephedrine (PSE), shows an equivalent treatment effect within and outside of the grass pollen season when tested in an ECC.” PMID 21457883 Feb 2011

“would include diphenhydramine 50 mg, cetirizine 10 mg, chlorpheniramine 8 mg or hydroxyzine 50 mg.” NCT02604199

“would include diphenhydramine 50 mg, cetirizine 10 mg, chlorpheniramine 8 mg or hydroxyzine 50 mg.” NCT02738008

“All patients will be given an oral antihistamine (syrup/ tablet cetirizine 0.3mg/kg) at night.” NCT04706559

“Clemastine or Cetirizine prior to paclitaxel infusion according to local care standards” NCT06118710

“Systemic antihistamine oral drug such as fexofenadine, loratadine and cetirizine.” NCT04568902

“Take orally (cetirizine 10 mg bid, dexamethasone 8 mg bid, ranitidine 150 mg bid” NCT05922358

Cetirizine, 10mg/mL; a single 1.0 mL injection via intravenous (IV) push” NCT02023164

“Oral Azithromycin , Cetirizine, Paracetamol, Zinc, Vitamin C, Vitamin D” NCT04935515

“the marketed cetirizine oral product Zyrtec® 10 mg tablets” NCT02024152

“oral Cetirizine 0.25mg/kg, every day, for 4 weeks” NCT01902836

“Drug: CetirizineNCT01241214

cetirizineNCT04179461

cetirizineNCT04990388

NCT03340740

NCT02535416

NCT01981499

NCT00794495

NCT00794599

NCT00375713

NCT00794378

NCT00881634

NCT00334698

NCT00794794

NCT04237090

NCT00794846

NCT02865018

NCT07236372

NCT02543346

NCT04293822

NCT01651871

NCT06754410

NCT00881127

NCT01068223

NCT00649857

NCT01318681

NCT02613910

NCT06890260

NCT00561717

NCT00972504

NCT06819774

NCT04481412

NCT01916226

NCT01622283

NCT00826943

NCT00533637

NCT00650065

NCT00610584

NCT00253058

NCT01748344

NCT01103050

NCT00639587

NCT03047278

NCT01985789

NCT01781507

NCT03192488

NCT06126991

NCT05946551

NCT01127620

NCT04189588

NCT00488176

NCT00257582

NCT00257569

NCT00257595

NCT00751218

NCT00751166

NCT00974571

NCT00490204

NCT02447393

NCT06019728

NCT00851344

NCT02451579

NCT00504933

NCT02205489

NCT00291642

NCT02932774

NCT01484119

NCT00780403

NCT00420082

NCT00779116

NCT01825655

NCT00864279

NCT01940393

NCT04836806

NCT04071821

NCT07472413

Known as AC-170 ClinicalTrials.gov intervention name — accepted as the source's own label NCT01332188
6

NCT02132169

NCT01881113

NCT01685242

NCT01495338

NCT02756624

NCT02173249

Known as AFH-002 “Cetirizine 0.24% Ophthalmic Solution (Formula AFH-002)” NCT01551056
Known as Allacan ChEMBL registry synonym — accepted as the source's own label CHEMBL1000
Known as Allertek ChEMBL registry synonym — accepted as the source's own label CHEMBL1000
Known as Becoallergy ChEMBL registry synonym — accepted as the source's own label CHEMBL1000
Known as Cetec ChEMBL registry synonym — accepted as the source's own label CHEMBL1000
Known as Cetiderm ChEMBL registry synonym — accepted as the source's own label CHEMBL1000
Known as Cetirizina ChEMBL registry synonym — accepted as the source's own label CHEMBL1000
Known as Cetirizine dihydrochloride Cetirizine dihydrochloride (10 mg/ml) liposomal formulation” NCT00533637
1

cetirizine dihydrochloride (rescue medication)” NCT00610584

Known as Cetirizine HCl Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg Tablets (Sandoz, USA)” NCT00881634
3

Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg (Sandoz, USA)” NCT00881127

Cetirizine HCl Tablets 10 mg” NCT00650065

NCT05095311

Known as Cetirizine Hydrochloride “The subjects received a single dose of 1-2 ml of the injection of cetirizine hydrochloride (administered by intravenous push) and a 1 ml dose of the injection simulant of...” NCT06819774
4

Cetirizine Hydrochloride 1 MG/ML” NCT03340740

NCT00240032

NCT03167216

NCT00863902

Known as Cetirizine hydrochloride allergy ChEMBL registry synonym — accepted as the source's own label CHEMBL1000
Known as Cetirizine hydrochloride component of zyrtec-d ChEMBL registry synonym — accepted as the source's own label CHEMBL1000
Known as Cetirizine hydrochloride hives ChEMBL registry synonym — accepted as the source's own label CHEMBL1000
Known as Cetirizine hydrochloride hives relief ChEMBL registry synonym — accepted as the source's own label CHEMBL1000
Known as Cetirocol ChEMBL registry synonym — accepted as the source's own label CHEMBL1000
Known as Cetrine ChEMBL registry synonym — accepted as the source's own label CHEMBL1000
Known as Children's cetirizine hydrochloride allergy ChEMBL registry synonym — accepted as the source's own label CHEMBL1000
Known as Children's cetirizine hydrochloride hives relief ChEMBL registry synonym — accepted as the source's own label CHEMBL1000
Known as Children's zyrtec allergy ChEMBL registry synonym — accepted as the source's own label CHEMBL1000
Known as Children's zyrtec hives relief ChEMBL registry synonym — accepted as the source's own label CHEMBL1000
Known as CTZ DS “Evaluation of the Efficacy and Safety of Cetirizine Dry Syrup (CTZ DS) (2.5 mg or 5 mg Twice a Day)” NCT00490204
Known as JDP-205 “This is a multicenter, parallel group, randomized, double-blind pilot Phase III clinical study of JDP-205 (cetirizine) injection, versus diphenhydramine injection, 50 mg/mL...” NCT02023164
Known as NSC-759102 ChEMBL registry synonym — accepted as the source's own label CHEMBL1000