Drugs / Hydralazine
Hydralazine
also known as
MC-1101 · Hydralazine hydrochloride · Apresoline · Apresoline (Hydralazine) · Apressinum · Dralzine · Hidralazina · Hydralazine hcl · +17 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | APRESOLINE | — | 1953-01-15 | fda.gov ↗ |
Trials 28 · a red edge is where a trial was stopped
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03423810 | Apr 2018 → Jan 2020 | polycystic kidney disease | University of Kansas Medical Center | Completed | No outcome recorded |
| Phase 15 trials | ||||||
| Phase 1 | NCT02522208 | Sep 2015 → Apr 2016 | heart failure | Arbor Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01587313 | Apr → May 2012 | — | Arbor Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01013376 | Aug 2009 | age-related macular degeneration | MacuCLEAR, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00996060 | Jul 2008 → Dec 2012 | lung cancer | New Mexico Cancer Research Alliance | Completed | No outcome recorded |
| Phase 1 | NCT00223717 | Jan 2001 → Jan 2017 | hypertensive disorder | Vanderbilt University | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00575978 | Jun 2004 → Dec 2009 | breast cancer | University of Arkansas | Withdrawn | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT01356875 | Sep 2011 → Sep 2014 | myelodysplastic syndrome | Basque Health Service | Unknown | No outcome recorded |
| Phase 2 | NCT02281838 | Aug 2011 → Nov 2021 | intracerebral hemorrhage | University of Alberta | Terminated | No outcome recorded |
| Phase 2 | NCT00404508 | Sep 2005 → Oct 2006 | refractory malignant neoplasm | National Institute of Cancerology | Completed | No outcome recorded |
| Phase 2 | NCT00395655 | Jun 2005 → Aug 2006 | female breast carcinoma | National Institute of Cancerology | Terminated | No outcome recorded |
| Phase 2 | NCT00404326 | May 2005 → Nov 2006 | cervical cancer | National Institute of Cancerology | Completed | No outcome recorded |
| Phase 2 | NCT00000499 | Sep 1980 → May 1983 | heart disorder, hypertensive disorder | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 2/34 trials | ||||||
| Phase 2/3 | NCT02127463 | Apr 2014 → Apr 2016 | dry age related macular degeneration | MacuCLEAR, Inc. | Unknown | No outcome recorded |
| Phase 2/3 | NCT01601483 | Oct 2012 → Mar 2013 | dry age related macular degeneration | MacuCLEAR, Inc. | Terminated | No outcome recorded |
| Phase 2/3 | NCT01255475 | Jan 2011 → Oct 2012 | congestive heart failure | University of Sao Paulo | Completed | No outcome recorded |
| Phase 2/3 | NCT00582777 | Nov 2007 → Dec 2008 | hypertensive nephropathy | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT02446652 | Jan 2015 → Jul 2018 | cervical cancer | National Institute of Cancerology | Withdrawn | No outcome recorded |
| Phase 3 | NCT02343393 | Jan → Dec 2015 | cardio-renal syndrome | National University Hospital, Singapore | Unknown | No outcome recorded |
| Phase 3 | NCT01538875 | Jul 2012 → Apr 2013 | hypertension, pregnancy-induced | Saint Thomas Hospital, Panama | Completed | No outcome recorded |
| Phase 3 | NCT00533299 | Aug 2007 → Dec 2009 | ovarian cancer | National Institute of Cancerology | Unknown | No outcome recorded |
| Phase 3 | NCT00532818 | Jul 2007 → Sep 2010 | cervical cancer | National Institute of Cancerology | Unknown | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT02228408 | Aug 2017 → May 2019 | end stage renal failure | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00047775 | May 2001 → Aug 2004 | congestive heart failure | Nitromed | Completed | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT07572656 | May → Oct 2024 | severe pre-eclampsia | Muhammad Aamir Latif | Completed | No outcome recorded |
| — | NCT04435210 | Aug 2018 → Feb 2019 | hypertensive disorder | Adebayo Joshua Adeniyi | Completed | No outcome recorded |
| — | NCT00599235 | Mar 2007 → May 2008 | hypertensive disorder | University of Edinburgh | Completed | No outcome recorded |
| — | NCT00204984 | May 2005 → Dec 2006 | hypertensive disorder | University of Wisconsin, Madison | Completed | No outcome recorded |
Also used as a comparator or background therapy in 23 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01922128 Comparator | Sep → Nov 2013 | dry age related macular degeneration | MacuCLEAR, Inc. | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT06360601 Comparator | Apr → Nov 2024 | severe pre-eclampsia | Tanta University | Unknown | No outcome recorded |
| Phase 1/2 | NCT00575640 Comparator | Nov 2004 → May 2008 | rectal cancer | University of Arkansas | Withdrawn | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT04484350 Background | Oct 2020 → Feb 2023 | hypertensive disorder, ischemic stroke, vascular occlusion disorder | Hamilton Health Sciences Corporation | Completed | No outcome recorded |
| Phase 2 | NCT04116112 Background | Jan 2020 → Jul 2022 | stroke disorder | University of Cincinnati | Completed | No outcome recorded |
| Phase 2 | NCT02050529 Comparator | Oct 2012 → Sep 2014 | preeclampsia | Dow University of Health Sciences | Completed | No outcome recorded |
| Phase 2 | NCT01516346 Comparator | Jan 2012 → Feb 2016 | congestive heart failure | Corporal Michael J. Crescenz VA Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT00963976 Background | Jan 2007 → Dec 2011 | intracerebral hemorrhage | University of Alberta | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT04842552 Comparator | Aug 2021 → Jun 2023 | Alzheimer disease | Shahid Sadoughi University of Medical Sciences and Health Services | Unknown | No outcome recorded |
| Phase 3 | NCT01822808 Comparator | Jan 2013 → Jan 2016 | left ventricular failure | University of Cape Town | Unknown | No outcome recorded |
| Phase 3 | NCT00000620 Background | Sep 1999 → Jun 2009 | atherosclerosis, coronary artery disorder, hyperlipoproteinemia, hypertensive disorder +1 | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 48 trials | ||||||
| Phase 4 | NCT06400784 Comparator | Mar 2022 → Feb 2024 | — | University of Abuja | Completed | No outcome recorded |
| Phase 4 | NCT06218199 Comparator | Jul 2021 → Dec 2025 overdue | congestive heart failure | Heart Center Research, LLC | Recruiting | No outcome recorded |
| Phase 4 | NCT04206865 Comparator | Nov 2019 → Sep 2020 | cardiogenic shock | The Cleveland Clinic | Withdrawn | No outcome recorded |
| Phase 4 | NCT03514108 Comparator | Mar 2018 → Dec 2025 | diabetes mellitus, heart failure | Henrik Wiggers | Completed | No outcome recorded |
| Phase 4 | NCT04217135 Comparator | Jan 2017 → Jul 2022 | mitral valve insufficiency, systolic heart failure | Kaohsiung Veterans General Hospital. | Unknown | No outcome recorded |
| Phase 4 | NCT02046395 Background | Jan 2012 → Dec 2019 | hypertensive disorder, type 2 diabetes mellitus | Tulane University School of Medicine | Completed | No outcome recorded |
| Phase 4 | NCT00661895 Background | Aug 2005 → Aug 2009 | hypertensive disorder | Creighton University | Completed | No outcome recorded |
| Phase 4 | NCT00772499 Comparator | Nov 2002 → Jul 2005 | essential hypertension | Daiichi Sankyo | Completed | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT02933593 Comparator | Aug 2016 → Jan 2017 | hypertensive disorder | St. Louis University | Withdrawn | No outcome recorded |
| — | NCT00607477 Comparator | Jan 2008 → Jan 2009 | hypertensive disorder | University of Chicago | Terminated | No outcome recorded |
| — | NCT00226096 Background | Nov 2005 → Sep 2007 | intracerebral hemorrhage | The George Institute | Completed | No outcome recorded |
| — | NCT00684489 Comparator | Sep 2003 → Mar 2005 | essential hypertension | Medical University of South Carolina | Completed | No outcome recorded |
Evidence & citations 29 cited values
Every value below carries the sentence it was read from. 52 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | hydralazine | “Fixed-dose combination of isosorbide dinitrate and hydralazine (FDC-I/H) reduced mortality by 43% and death or first hospitalization for heart failure (HF) by 37% in the...” PMID 24970468 ↗ Jun 201446“additional antihypertensive medication before bedtime [diltiazem 60-120 mg, hydralazine 25 mg, or additional ramipril 5 mg]” PMID 23172931 ↗ Nov 2012 “Isosorbide dinitrate (5mg bd) and Hydralazine (25mg bd) will be added on top of conventional heart failure medications.” NCT06400784 ↗ “BiDil XR isosorbide dinitrate 40 mg and hydralazine hydrochloride 75 mg 2 capsules 9 hours apart for one day” NCT02522208 ↗ “Alternate vasodilators will include ARBs, hydralazine and isosorbide dinitrate, and ACEi” NCT04206865 ↗ “Hydralazine 50mg tablets every 12 hours” NCT01356875 ↗ “guanfacine, hydralazine, minoxidil” NCT00684489 ↗ “hydralazine” NCT00000620 ↗ “hydralazine” NCT00000620 ↗ |
| Known as | Apresoline | ChEMBL registry synonym — accepted as the source's own label CHEMBL276832 ↗ |
| Known as | Apresoline (Hydralazine) | “Apresoline (Hydralazine)” NCT00996060 ↗ |
| Known as | Apressinum | ChEMBL registry synonym — accepted as the source's own label CHEMBL276832 ↗ |
| Known as | Dralzine | ChEMBL registry synonym — accepted as the source's own label CHEMBL276832 ↗ |
| Known as | Hidralazina | ChEMBL registry synonym — accepted as the source's own label CHEMBL276832 ↗ |
| Known as | Hydralazine hcl | ChEMBL registry synonym — accepted as the source's own label CHEMBL276832 ↗ |
| Known as | Hydralazine hydrochloride | “Hydralazine hydrochloride (25mg tablets) every eight hours (TDS)” NCT04842552 ↗ |
| Known as | Hydralazine hydrochloride component of -hydrochlorothiazide-reserpine | ChEMBL registry synonym — accepted as the source's own label CHEMBL276832 ↗ |
| Known as | Hydralazine hydrochloride component of apresazide | ChEMBL registry synonym — accepted as the source's own label CHEMBL276832 ↗ |
| Known as | Hydralazine hydrochloride component of apresoline-esidrix | ChEMBL registry synonym — accepted as the source's own label CHEMBL276832 ↗ |
| Known as | Hydralazine hydrochloride component of bidil | ChEMBL registry synonym — accepted as the source's own label CHEMBL276832 ↗ |
| Known as | Hydralazine hydrochloride component of cam-ap-es | ChEMBL registry synonym — accepted as the source's own label CHEMBL276832 ↗ |
| Known as | Hydralazine hydrochloride component of dralserp | ChEMBL registry synonym — accepted as the source's own label CHEMBL276832 ↗ |
| Known as | Hydralazine hydrochloride component of hydra-zide | ChEMBL registry synonym — accepted as the source's own label CHEMBL276832 ↗ |
| Known as | Hydralazine hydrochloride component of hydrap-es | ChEMBL registry synonym — accepted as the source's own label CHEMBL276832 ↗ |
| Known as | Hydralazine hydrochloride component of hydroserpine plus (r-h-h) | ChEMBL registry synonym — accepted as the source's own label CHEMBL276832 ↗ |
| Known as | Hydralazine hydrochloride component of ser-a-gen | ChEMBL registry synonym — accepted as the source's own label CHEMBL276832 ↗ |
| Known as | Hydralazine hydrochloride component of ser-ap-es | ChEMBL registry synonym — accepted as the source's own label CHEMBL276832 ↗ |
| Known as | Hydralazine hydrochloride component of serpasil-apresoline | ChEMBL registry synonym — accepted as the source's own label CHEMBL276832 ↗ |
| Known as | Hydralazine hydrochloride component of unipres | ChEMBL registry synonym — accepted as the source's own label CHEMBL276832 ↗ |
| Known as | Hydralazine polistirex | ChEMBL registry synonym — accepted as the source's own label CHEMBL276832 ↗ |
| Known as | Hydralazini hydrochloridum | ChEMBL registry synonym — accepted as the source's own label CHEMBL276832 ↗ |
| Known as | MC-1101 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01922128 ↗ |
| Known as | NSC-126699 | ChEMBL registry synonym — accepted as the source's own label CHEMBL276832 ↗ |
| Known as | NSC-89394 | ChEMBL registry synonym — accepted as the source's own label CHEMBL276832 ↗ |
| Action | Inhibit | “demethylating hydralazine” NCT00395655 ↗ |
| Modality | Small molecule | — CHEMBL276832 ↗ |
| Route | Oral | “oral hydralazine” NCT00204984 ↗ |