Drugs / Hydroxyzine

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) ATARAX 1956-04-12 fda.gov

Trials 14 · a red edge is where a trial was stopped

195519561957195819591960196119621963196419651966196719681969197019711972197319741975197619771978197919801981198219831984198519861987198819891990199119921993199419951996199719981999200020012002200320042005200620072008200920102011201220132014201520162017201820192020202120222023202420252026202720282029
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 22 trials
Phase 2 NCT00332163 Apr 2006 → Jan 2008 colorectal cancer, exanthem, toxic dermatosis Amgen Completed No outcome recorded
Phase 2 NCT01675986 ? → Nov 2014 anxiety Poitiers University Hospital Completed No outcome recorded
Phase 31 trial
Phase 3 NCT02374567 Jan 2015 → Jun 2017 anxiety disorder, dementia, depressive disorder, schizophrenia +1 Hannover Medical School Terminated No outcome recorded
Phase 48 trials
Phase 4 NCT05737511 Dec 2023 → Dec 2026 expected panic disorder Sultan Qaboos University Not yet recruiting No outcome recorded
Phase 4 NCT04184141 Dec 2019 → Jun 2020 Istanbul Medeniyet University Unknown No outcome recorded
Phase 4 NCT04188106 Jun → Dec 2019 sleep disorder Rose Research Center, LLC Completed No outcome recorded
Phase 4 NCT03324828 Nov 2017 → May 2020 anxiety Hospital San Carlos, Madrid Terminated No outcome recorded
Phase 4 NCT01372670 Jan 2012 → Apr 2013 anxiety disorder, eating disorder HealthPartners Institute Withdrawn No outcome recorded
Phase 4 NCT01250652 Mar 2011 → Feb 2013 chronic urticaria Association Asthma, Bulgaria Completed No outcome recorded
Phase 4 NCT01151696 May 2010 → Sep 2013 University Hospital, Toulouse Completed No outcome recorded
Phase 4 NCT00162786 May → Nov 2005 J. Uriach and Company Terminated No outcome recorded
Phase not applicable3 trials
NCT05492812 Jan → Dec 2021 Suleyman Demirel University Completed No outcome recorded
NCT01501591 Nov 2012 → Oct 2015 King Faisal Specialist Hospital & Research Center Completed No outcome recorded
NCT00661674 Apr → Aug 2008 substance-related disorder Stanford University Completed No outcome recorded
Also used as a comparator or background therapy in 16 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT05680584 Comparator Feb 2023 → Jan 2024 anxiety Minia University Unknown No outcome recorded
Phase 1 NCT02797522 Background Jun → Nov 2016 hepatitis B virus infection Arrowhead Pharmaceuticals Terminated No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT02858310 Background Jan 2017 → Jul 2025 cervical intraepithelial neoplasia, human papilloma virus infection, in situ carcinoma, vulvar neoplasm National Cancer Institute (NCI) Completed No outcome recorded
Phase 24 trials
Phase 2 NCT07031206 Background Jul 2025 → May 2026 overdue anxiety The University of Texas Health Science Center, Houston Not yet recruiting 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 2/31 trial
Phase 2/3 NCT00260481 Comparator Jan 2006 → Jun 2008 drug dependence, substance abuse University of California, Los Angeles Completed No outcome recorded
Phase 33 trials
Phase 3 NCT05126459 Background Feb 2022 → Apr 2023 anxiety, dental caries Loma Linda University Completed No outcome recorded
Phase 3 NCT03808805 Comparator Apr 2019 → Sep 2023 aquagenic pruritus, myeloproliferative neoplasm University Hospital, Brest Completed No outcome recorded
Phase 3 NCT03728894 Comparator Nov 2018 → Jan 2019 Latakia University Completed No outcome recorded
Phase 43 trials
Phase 4 NCT04068948 Background Jun 2019 → Dec 2022 dental caries University of Washington Completed No outcome recorded
Phase 4 NCT01496911 Comparator Apr → Oct 2012 Utrecht Institute for Pharmaceutical Sciences Completed No outcome recorded
Phase 4 NCT01055236 Comparator Aug 2007 → Oct 2008 Mahidol University Completed No outcome recorded
Phase not applicable2 trials
NCT05224167 Comparator Mar → Jun 2022 Mongi Slim Hospital Unknown No outcome recorded
NCT00570388 Comparator Mar 2007 → Sep 2008 alcohol dependence Institute of Addiction Medicine Unknown No outcome recorded

Evidence & citations 25 cited values

Every value below carries the sentence it was read from. 31 sources stand behind the page.

FieldValueCited text
Known as Hydroxyzine “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
28

“pre-treatment with hydroxyzine (50mg) followed by placebo medications administered both orally and through infusion, as well as a second dose of hydroxyzine (50mg)” NCT00260481

“Day 1-3•Hydroxyzine HCL 50 mg and multivitamins with minerals po one hour before flumazenil infusion.” NCT00570388

“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

Hydroxyzine (1.5- 2mg/kg) + Meperidine (1.5 -2 mg/kg) + Midazolam (0.5- 0.75 mg/kg)” NCT05126459

“the first received hydroxyzine (25 mg) described as hydroxyzine or placebo” PMID 27899067 Nov 2016

“topical antihistamine or oral antihistamine (hydroxyzine)” NCT00332163

hydroxyzine 50 mg PO” NCT02797522

NCT03324828

NCT05492812

NCT04068948

NCT00162786

NCT03808805

NCT03728894

NCT00661674

NCT02374567

NCT01151696

NCT01055236

NCT05680584

NCT01250652

NCT05737511

NCT04184141

NCT01675986

NCT04188106

NCT05224167

NCT01496911

NCT01372670

NCT07031206

Known as Alamon ChEMBL registry synonym — accepted as the source's own label CHEMBL896
Known as Atarax “Groups HYDROXYZINE : 75 mg d'ATARAX®” NCT01675986
1

Atarax (Hydroxyzine)” NCT01151696

Known as Atarax dihydrochloride ChEMBL registry synonym — accepted as the source's own label CHEMBL896
Known as Ataraxoid ChEMBL registry synonym — accepted as the source's own label CHEMBL896
Known as Aterax ChEMBL registry synonym — accepted as the source's own label CHEMBL896
Known as Atranine a ChEMBL registry synonym — accepted as the source's own label CHEMBL896
Known as Durrax ChEMBL registry synonym — accepted as the source's own label CHEMBL896
Known as Hidroxizina ChEMBL registry synonym — accepted as the source's own label CHEMBL896
Known as Hy-pam "25" ChEMBL registry synonym — accepted as the source's own label CHEMBL896
Known as Hydroxyzine dihydrochloride ChEMBL registry synonym — accepted as the source's own label CHEMBL896
Known as Hydroxyzine HCL “Day 1-3•Hydroxyzine HCL 50 mg and multivitamins with minerals po one hour before flumazenil infusion.” NCT00570388
1

NCT02858310

Known as HYDROXYZINE HYDROCHLORIDE ChEMBL registry synonym — accepted as the source's own label CHEMBL896
Known as Marex ChEMBL registry synonym — accepted as the source's own label CHEMBL896
Known as NSC-169188 ChEMBL registry synonym — accepted as the source's own label CHEMBL896
Known as Orgatrax ChEMBL registry synonym — accepted as the source's own label CHEMBL896
Known as Tran-q ChEMBL registry synonym — accepted as the source's own label CHEMBL896
Known as Tranquizine ChEMBL registry synonym — accepted as the source's own label CHEMBL896
Known as U.c.b-4492 ChEMBL registry synonym — accepted as the source's own label CHEMBL896
Known as Ucerax ChEMBL registry synonym — accepted as the source's own label CHEMBL896
Known as Vistaril ChEMBL registry synonym — accepted as the source's own label CHEMBL896
Action Inhibit “Histamine H1 receptor antagonist” CHEMBL896
1

“antagonizes H1 receptor” NCT01055236

Modality Small molecule CHEMBL896
Route Oral “patients will again take 50mg of hydroxyzine orally” NCT00260481
Target HRH1 “Histamine H1 receptor antagonist” CHEMBL896