Drugs / Metolazone
Metolazone
also known as
Diulo · Metazoline · Metenix · Metolazona · Metozalone · Mykrox · Normelan · NSC-759581 · +4 more
Small molecule targets SLC12A3 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | ZAROXOLYN | — | 1973-11-27 | fda.gov ↗ |
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 · 1 missed | ||||||
| Phase 3 | NCT04860011 | Apr 2021 → Oct 2022 | heart failure | NHS Greater Glasgow and Clyde | Unknown | Missed primary |
| 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 Stop: Business |
| 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| — | NCT02047422 | Jan 2014 → Feb 2016 | congestive heart failure | Yonsei University | Withdrawn | No outcome recorded |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 |
| Comparator or background therapy16 trials | ||||||
| Phase 1 | NCT02646540 Comparator | Jan 2016 → Dec 2018 | cardiomyopathy, congestive heart failure | Emory University | Completed | No outcome recorded |
| 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 Stop: Enrollment |
| Phase 3 | NCT02620384 Comparator | Oct 2015 → Nov 2017 | heart failure | Aultman Health Foundation | Terminated | No outcome recorded Stop: Enrollment |
| 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 Stop: Enrollment |
| 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 Stop: Enrollment |
| Phase 4 | NCT03574857 Comparator | Jun 2018 → Jan 2021 | symptomatic heart failure | University of Virginia | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02606253 Comparator | Feb 2016 → Sep 2018 | heart failure | Vanderbilt University | Completed | Missed primary |
| Phase 4 | NCT00904488 Comparator | Oct 2008 → May 2016 | heart failure | University of North Carolina, Chapel Hill | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT04572867 Comparator | Jun → Jul 2021 | congestive heart failure, symptomatic heart failure | Ramona Gelzer Bell | Withdrawn | No outcome recorded Stop: Enrollment |
| — | 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 |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2020-12-01 | Alembic Pharmaceuticals Ltd. | Regulatory A lem bic~ - TovdtJng U- a over 1(~ ]7 alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced it· has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Metolazone Tablets USP 2.5 mg, 5 mg, and 10 mg. |
| 2004-01-06 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval Of Metolazone Tablets, 2.5 Mg And 10 Mg tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted approval of the company's ANDA for Metolazone Tablets, 2.5 mg and 10 mg. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-12-01 | Alembic Pharmaceuticals Ltd. | A lem bic~ - TovdtJng U- a over 1(~ ]7 alembicpharmaceuticals.com ↗ |
| 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.
| Field | Value | Cited text |
|---|---|---|
| Known as | metolazone | “Drugs used were hypertension medications were: chlorothiazide, hydrochlorothiazide, polythiazide indapamide, metolazone” NCT00684489 ↗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 ↗ |
| 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 ↗ |