Drugs / Meclizine

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (2) US (FDA) ANTIVERT — 2018-04-13 – 2019-06-28 fda.gov ↗
Approved US (FDA) ANTIVERT — 1957-02-14 fda.gov ↗

Trials 6

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT03253289 Oct 2017 → Mar 2023 hepatocellular carcinoma Tannaz Armaghnay Completed No outcome recorded
Phase 1 NCT01537471 Jan → Sep 2012 — Duke University Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT04564144 Jun → Nov 2020 — Mansoura University Unknown No outcome recorded
Phase 21 trial
Phase 2 NCT01443858 Aug 2011 → Dec 2012 — Duke University Completed No outcome recorded
Phase 31 trial
Phase 3 NCT02112578 Nov 2016 → Apr 2017 peripheral vertigo Apsen Farmaceutica S.A. Completed No outcome recorded
Phase 41 trial
Phase 4 NCT07681076 Sep → Nov 2026 expected — Karuna Therapeutics, Inc. Recruiting No outcome recorded
Comparator or background therapy5 trials
Phase 2 NCT05852730 Background Aug 2021 → Sep 2026 overdue space motion sickness Repurposed Therapeutics, Inc. Recruiting No outcome recorded
Phase 4 NCT04482985 Comparator Sep 2020 → Sep 2021 motion sickness Medical Corps, Israel Defense Force Unknown No outcome recorded
Phase 4 NCT03270839 Comparator Jun 2017 → Sep 2019 — Medical Corps, Israel Defense Force Completed No outcome recorded
— NCT02625181 Background Jul 2016 → Nov 2017 — Vanderbilt University Completed No outcome recorded
— NCT00641797 Comparator Nov 2006 → Dec 2010 benign paroxysmal positional vertigo Lehigh Valley Hospital Completed No outcome recorded

Press releases naming this drug 1 release

DateIssuerRelease
2022-08-12 Lupin Limited Lupin Receives Approval from U.S. FDA for Meclizine Hydrochloride Tablets USP lupin.com ↗

Evidence & citations 28 cited values

Every value below carries the sentence it was read from. 12 sources stand behind the page.

FieldValueCited text
Known as Meclizine “Meclizine administration - subject will take 1 tablet per os (Bonine 25Mg Chewable Tablet, Meclizine Hydrochloride 25mg, 1\*day )” NCT03270839 ↗
10

NCT02625181 ↗

NCT07681076 ↗

NCT05852730 ↗

NCT03253289 ↗

NCT01443858 ↗

NCT04482985 ↗

NCT02112578 ↗

NCT01537471 ↗

NCT00641797 ↗

NCT04564144 ↗

Known as Agyrax ChEMBL registry synonym — accepted as the source's own label CHEMBL1623 ↗
Known as Ancolan ChEMBL registry synonym — accepted as the source's own label CHEMBL1623 ↗
Known as Ancoloxin ChEMBL registry synonym — accepted as the source's own label CHEMBL1623 ↗
Known as Antivert ChEMBL registry synonym — accepted as the source's own label CHEMBL1623 ↗
Known as Bonamine ChEMBL registry synonym — accepted as the source's own label CHEMBL1623 ↗
Known as Bonine “Meclizine administration - subject will take 1 tablet per os (Bonine 25Mg Chewable Tablet, Meclizine Hydrochloride 25mg, 1\*day )” NCT03270839 ↗
Known as MECLIZINE DIHCL ChEMBL registry synonym — accepted as the source's own label CHEMBL1623 ↗
Known as Meclizine dihydrochloride monohydrate ChEMBL registry synonym — accepted as the source's own label CHEMBL1623 ↗
Known as Meclizine HCL “Meclizine HCL, an antihistamine, has been widely used for prophylactic treatment of nausea, vomiting and management of dizziness accompanying motion sickness.” NCT04564144 ↗
Known as Meclizine hydrochloride “Meclizine administration - subject will take 1 tablet per os (Bonine 25Mg Chewable Tablet, Meclizine Hydrochloride 25mg, 1\*day )” NCT03270839 ↗
3

“Meclizine hydrochloride is an antihistamine widely used for treatment of vertigo and motion sickness.” NCT03253289 ↗

“Drug: Meclizine Hydrochloride” NCT04482985 ↗

“Drug: Meclizine Hydrochloride” NCT04564144 ↗

Known as Meclizine hydrochloride anhydrous ChEMBL registry synonym — accepted as the source's own label CHEMBL1623 ↗
Known as Meclozina ChEMBL registry synonym — accepted as the source's own label CHEMBL1623 ↗
Known as Meclozine ChEMBL registry synonym — accepted as the source's own label CHEMBL1623 ↗
Known as Meclozine dihydrochloride ChEMBL registry synonym — accepted as the source's own label CHEMBL1623 ↗
Known as Meclozine hydrochloride ChEMBL registry synonym — accepted as the source's own label CHEMBL1623 ↗
Known as Meclozine hydrochloride monohydrate ChEMBL registry synonym — accepted as the source's own label CHEMBL1623 ↗
Known as NSC-169189 ChEMBL registry synonym — accepted as the source's own label CHEMBL1623 ↗
Known as NSC-28728 ChEMBL registry synonym — accepted as the source's own label CHEMBL1623 ↗
Known as NSC-757094 ChEMBL registry synonym — accepted as the source's own label CHEMBL1623 ↗
Known as Postafen ChEMBL registry synonym — accepted as the source's own label CHEMBL1623 ↗
Known as Sea-legs ChEMBL registry synonym — accepted as the source's own label CHEMBL1623 ↗
Known as Traveleeze ChEMBL registry synonym — accepted as the source's own label CHEMBL1623 ↗
Known as UCB-5062 ChEMBL registry synonym — accepted as the source's own label CHEMBL1623 ↗
Action Inhibit “Meclizine, a widely used antihistamine medication for vertigo and motion sickness, is an inverse agonist ligand of human CAR.” NCT03253289 ↗
1

“Histamine H1 receptor antagonist” CHEMBL1623 ↗