Drugs / Metolazone

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) ZAROXOLYN 1973-11-27 fda.gov

Trials 13 · a red edge is where a trial was stopped

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT00650195 Feb 2004 Mylan Pharmaceuticals Inc Completed No outcome recorded
Phase 1 NCT00649181 Oct → Nov 2003 Mylan Pharmaceuticals Inc Completed No outcome recorded
Phase 1 NCT00649051 Dec 2002 Mylan Pharmaceuticals Inc Completed No outcome recorded
Phase 22 trials
Phase 2 NCT06326112 May 2024 → Mar 2025 acute respiratory distress syndrome, critical illness polyneuropathy, infectious disease with sepsis Unity Health Toronto Unknown No outcome recorded
Phase 2 NCT04438213 Mar 2021 → Dec 2025 overdue heart failure Yale University Recruiting No outcome recorded
Phase 32 trials
Phase 3 NCT04860011 Apr 2021 → Oct 2022 heart failure NHS Greater Glasgow and Clyde Unknown No outcome recorded
Phase 3 NCT04163588 Oct 2019 → Oct 2020 heart failure Policlinico Casilino ASL RMB Unknown No outcome recorded
Phase 43 trials
Phase 4 NCT06414759 Jul → Dec 2024 overdue heart failure Cairo University Recruiting No outcome recorded
Phase 4 NCT04330300 Apr 2020 → Jul 2021 COVID-19, essential hypertension National University of Ireland, Galway, Ireland Suspended No outcome recorded
Phase 4 NCT04062760 Dec 2019 → Dec 2021 heart failure University of Parma Unknown No outcome recorded
Phase not applicable3 trials
NCT06273397 May 2024 → Mar 2027 expected symptomatic heart failure Clinica Alemana de Santiago Not yet recruiting No outcome recorded
NCT02047422 Jan 2014 → Feb 2016 congestive heart failure Yonsei University Withdrawn No outcome recorded
NCT00690521 Oct 2004 → Nov 2009 congestive heart failure University of New Mexico Completed No outcome recorded
Also used as a comparator or background therapy in 16 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT02646540 Comparator Jan 2016 → Dec 2018 cardiomyopathy, congestive heart failure Emory University Completed No outcome recorded
Phase 23 trials
Phase 2 NCT07372040 Comparator Feb 2026 → Feb 2027 expected heart failure Tanta University Recruiting No outcome recorded
Phase 2 NCT04542304 Comparator Mar 2021 → Jun 2023 end stage renal failure Stanford University Terminated No outcome recorded
Phase 2 NCT05633758 Comparator Mar 2014 → Mar 2016 heart failure Scripps Health Withdrawn No outcome recorded
Phase 31 trial
Phase 3 NCT02620384 Comparator Oct 2015 → Nov 2017 heart failure Aultman Health Foundation Terminated No outcome recorded
Phase 47 trials
Phase 4 NCT06166654 Comparator Sep 2024 → Sep 2027 expected heart failure Johannes Grand Recruiting No outcome recorded
Phase 4 NCT05986773 Comparator Oct 2023 → Dec 2024 heart failure Stadtspital Zürich Terminated No outcome recorded
Phase 4 NCT05904808 Comparator Apr → Aug 2023 congestive heart failure Rambam Health Care Campus Completed No outcome recorded
Phase 4 NCT03746002 Comparator Jan 2019 → Jan 2020 heart failure University of Maryland, Baltimore Terminated No outcome recorded
Phase 4 NCT03574857 Comparator Jun 2018 → Jan 2021 symptomatic heart failure University of Virginia Terminated No outcome recorded
Phase not applicable4 trials
NCT04572867 Comparator Jun → Jul 2021 congestive heart failure, symptomatic heart failure Ramona Gelzer Bell Withdrawn No outcome recorded
NCT01817803 Comparator Mar 2013 → Jun 2015 congestive heart failure Yonsei University Withdrawn No outcome recorded
NCT01617798 Comparator Jun 2012 → Jun 2013 respiratory failure Oregon Health and Science University Withdrawn No outcome recorded
NCT00684489 Comparator Sep 2003 → Mar 2005 essential hypertension Medical University of South Carolina Completed No outcome recorded

Press releases naming this drug 1 release

DateIssuerRelease
2004-01-06 Teva Branded Pharmaceutical Products R&D, Inc. Teva Announces Approval Of Metolazone Tablets, 2.5 Mg And 10 Mg tevapharm.com

Evidence & citations 17 cited values

Every value below carries the sentence it was read from. 30 sources stand behind the page.

FieldValueCited text
Known as Metolazone “Drugs used were hypertension medications were: chlorothiazide, hydrochlorothiazide, polythiazide indapamide, metolazoneNCT00684489
28

“Hydrochlorothiazide, metolazone, chlorthalidone, chlorothiazide, bendroflumethiazide, indapamide” NCT04330300

Metolazone may be added at 2.5mg PO 30 minutes before loop diuretic” NCT04572867

“2. metolazone at a dose based on serum creatinine value” NCT04062760

NCT00649181

NCT06273397

NCT00690521

NCT02047422

NCT06414759

NCT03574857

NCT02606253

NCT07372040

NCT01617798

NCT00650195

NCT00649051

NCT02620384

NCT04542304

NCT06326112

NCT04860011

NCT04438213

NCT00904488

NCT01817803

NCT05986773

NCT02646540

NCT03746002

NCT05904808

NCT06166654

NCT04163588

NCT05633758

Known as Diulo ChEMBL registry synonym — accepted as the source's own label CHEMBL878
Known as Metazoline ChEMBL registry synonym — accepted as the source's own label CHEMBL878
Known as Metenix ChEMBL registry synonym — accepted as the source's own label CHEMBL878
Known as Metolazona ChEMBL registry synonym — accepted as the source's own label CHEMBL878
Known as Metozalone ChEMBL registry synonym — accepted as the source's own label CHEMBL878
Known as Mykrox ChEMBL registry synonym — accepted as the source's own label CHEMBL878
Known as Normelan ChEMBL registry synonym — accepted as the source's own label CHEMBL878
Known as NSC-759581 ChEMBL registry synonym — accepted as the source's own label CHEMBL878
Known as Oldren ChEMBL registry synonym — accepted as the source's own label CHEMBL878
Known as SR 720-22 ChEMBL registry synonym — accepted as the source's own label CHEMBL878
Known as Xuret ChEMBL registry synonym — accepted as the source's own label CHEMBL878
Known as Zaroxolyn “The objective of this study was to investigate the bioequivalence of Mylan metolazone 5 mg tablets to Celltech Zaroxolyn® 5 mg tablets following a single, oral 10 mg (2 x 5 mg)...” NCT00649181
Action Inhibit “metolazone targets the distal tubule, inhibiting sodium-chloride channels” NCT06273397
1

“Thiazide-sensitive sodium-chloride cotransporter inhibitor” CHEMBL878

Modality Small molecule CHEMBL878
Route Oral “single, oral 10 mg (4 x 2.5 mg) dose administration under fasting conditions” NCT00649051
Target SLC12A3 “Thiazide-sensitive sodium-chloride cotransporter inhibitor” CHEMBL878