Drugs / Labetalol
Labetalol
also known as
AH 5158A · AH-5158A FREE BASE · AH-5158A HYDROCHLORIDE · Avexa · Ibidomide · Ibidomide hydrochloride · Labetalol hcl · Labetalol Hydrochloride · +16 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | NORMODYNE | — | 1984-08-01 | fda.gov ↗ |
Trials 28 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05989581 | Apr 2024 → Dec 2026 expected | hypertension, pregnancy-induced | University of Alabama at Birmingham | Recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00194974 | Jul 2004 → Mar 2005 | proteinuria, toxemia of pregnancy | Weill Medical College of Cornell University | Withdrawn | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT02997800 | Nov 2012 → Jan 2019 | hypertensive disorder | Dr. Robert Tanzola | Completed | No outcome recorded |
| Phase 2 | NCT02050529 | Oct 2012 → Sep 2014 | preeclampsia | Dow University of Health Sciences | Completed | No outcome recorded |
| Phase 2 | NCT02281838 | Aug 2011 → Nov 2021 | intracerebral hemorrhage | University of Alberta | Terminated | No outcome recorded |
| Phase 2 | NCT02327793 | Jun 2009 → Jul 2015 | ischemic stroke | University of Alberta | Completed | No outcome recorded |
| Phase 2 | NCT00000297 | Oct 1998 → Dec 2001 | nicotine dependence | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 2 | NCT00000291 | Oct 1997 → Dec 2001 | cocaine dependence | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT04298034 | Jul 2020 → Jun 2025 overdue | preeclampsia | Medical College of Wisconsin | Active not recruiting | No outcome recorded |
| Phase 413 trials | ||||||
| Phase 4 | NCT06915792 | Jun 2025 → Jul 2027 expected | hypertension, pregnancy-induced | University of California, Los Angeles | Recruiting | No outcome recorded |
| Phase 4 | NCT07034898 | Apr → Aug 2025 overdue | reactive airway disease | Ain Shams University | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT06093893 | Mar 2025 → Jan 2026 | — | Boston Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT05585125 | Feb 2024 → Jul 2026 overdue | diastolic heart failure | Weill Medical College of Cornell University | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT05019027 | Jan 2024 → Mar 2026 overdue | amyloidosis, heart disorder | Weill Medical College of Cornell University | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT04343235 | May 2020 → Jun 2022 | hypertension, pregnancy-induced | Wright State University | Terminated | No outcome recorded |
| Phase 4 | NCT03872336 | Feb 2019 → Jul 2020 | severe pre-eclampsia | Albany Medical College | Terminated | No outcome recorded |
| Phase 4 | NCT03877692 | Feb 2019 → Jul 2020 | severe pre-eclampsia | Albany Medical College | Terminated | No outcome recorded |
| Phase 4 | NCT03506724 | Sep 2017 → Apr 2019 | preeclampsia | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase 4 | NCT02299414 | Jun 2015 → Apr 2022 | hypertensive disorder | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 4 | NCT01912677 | Apr 2015 → Sep 2017 | preeclampsia | Gynuity Health Projects | Completed | No outcome recorded |
| Phase 4 | NCT01114971 | Sep 2009 → Jul 2014 | — | Cedars-Sinai Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00394537 | ? → May 2007 | — | Rabin Medical Center | Completed | No outcome recorded |
| Phase not applicable6 trials | ||||||
| — | NCT07364201 | Nov 2025 → Jan 2026 | hemorrhagic stroke, hypertensive disorder | Universitas Sumatera Utara | Completed | No outcome recorded |
| — | NCT07192081 | Jun 2025 → Jan 2026 overdue | gallbladder disorder | Dr. Waseem Ullah | Recruiting | No outcome recorded |
| — | NCT07572656 | May → Oct 2024 | severe pre-eclampsia | Muhammad Aamir Latif | Completed | No outcome recorded |
| — | NCT05310929 | Aug 2019 → Mar 2022 | severe pre-eclampsia | Ain Shams University | Completed | No outcome recorded |
| — | NCT03207100 | Dec 2017 → Feb 2021 | — | Hong Yang | Completed | No outcome recorded |
| — | NCT02168309 | Jun 2014 → Jun 2015 | hypertension, pregnancy-induced | Cedars-Sinai Medical Center | Completed | No outcome recorded |
Also used as a comparator or background therapy in 43 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT03245970 Comparator | Apr 2017 → Feb 2020 | preeclampsia | University of Tennessee Medical Center | Withdrawn | No outcome recorded |
| Phase 0 | NCT03105661 Comparator | Apr 2017 → Dec 2019 | morbid obesity, preeclampsia | University of Tennessee Graduate School of Medicine | Unknown | No outcome recorded |
| Phase 0 | NCT03059316 Comparator | Jun 2016 → Apr 2017 | — | Cairo University | Completed | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT06360601 Comparator | Apr → Nov 2024 | severe pre-eclampsia | Tanta University | Unknown | No outcome recorded |
| Phase 1/2 | NCT07296029 Background | Jul 2022 → Feb 2025 | critical illness polyneuropathy, delirium, respiratory failure | Queen's University | Completed | No outcome recorded |
| Phase 1/2 | NCT04688203 Comparator | Feb → Sep 2021 | peripheral ischemia | Zagazig University | Completed | No outcome recorded |
| Phase 1/2 | NCT01408524 Comparator | Feb 2010 → Nov 2012 | hypertensive disorder | Mahidol University | Completed | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT05955040 Comparator | Jul 2023 → May 2024 | hypertension, pregnancy-induced | Marshall University | Terminated | No outcome recorded |
| Phase 2 | NCT05670028 Background | Jun 2023 → Jan 2026 | ischemic stroke, vascular insufficiency disorder | Beijing Tiantan Hospital | Unknown | No outcome recorded |
| 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 | NCT04320589 Comparator | Jun 2019 → Aug 2021 | pheochromocytoma | National Cancer Institute, Egypt | Completed | No outcome recorded |
| Phase 2 | NCT03661346 Comparator | Mar 2017 → Mar 2018 | chronic rhinosinusitis | The University of Texas Medical Branch, Galveston | Completed | No outcome recorded |
| Phase 2 | NCT00963976 Background | Jan 2007 → Dec 2011 | intracerebral hemorrhage | University of Alberta | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT03325348 Comparator | Feb → Dec 2017 | severe pre-eclampsia | Services Institute of Medical Sciences, Pakistan | Unknown | No outcome recorded |
| Phase 2/3 | NCT00293735 Comparator | Jun 2015 → Jan 2017 | preeclampsia | Baylor College of Medicine | Withdrawn | No outcome recorded |
| Phase 2/3 | NCT03443596 Comparator | Dec 2014 → Mar 2019 | hypertensive disorder, stroke disorder | National University of Singapore | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT06677970 Comparator | Oct 2024 → Dec 2029 expected | ischemic stroke | Yonsei University | Recruiting | No outcome recorded |
| Phase 3 | NCT05551104 Comparator | May 2023 → Dec 2027 expected | hypertension, pregnancy-induced, puerperal disorder | Loma Linda University | Recruiting | No outcome recorded |
| Phase 3 | NCT02426177 Comparator | May 2015 → May 2016 | hypertensive disorder | Dow University of Health Sciences | Unknown | No outcome recorded |
| Phase 3 | NCT01538875 Comparator | Jul 2012 → Apr 2013 | hypertension, pregnancy-induced | Saint Thomas Hospital, Panama | Completed | No outcome recorded |
| Phase 413 trials | ||||||
| Phase 4 | NCT07044232 Background | Oct 2025 → Sep 2026 expected | intracerebral hemorrhage | Aarhus University Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT07277283 Comparator | Feb → Jul 2025 | hypertensive disorder, ischemic stroke | Haseki Training and Research Hospital | Completed | No outcome recorded |
| Phase 4 | NCT06752863 Comparator | Nov 2024 → Oct 2025 | otorhinolaryngologic disease | Ain Shams University | Unknown | No outcome recorded |
| Phase 4 | NCT05139238 Comparator | Jul 2022 → Aug 2025 | preeclampsia | Columbia University | Terminated | No outcome recorded |
| Phase 4 | NCT05309460 Comparator | Jun 2022 → May 2024 overdue | preeclampsia | Nebraska Methodist Health System | Recruiting | No outcome recorded |
| Phase 4 | NCT04757584 Comparator | Apr 2021 → Apr 2023 | diastolic heart failure | Weill Medical College of Cornell University | Completed | No outcome recorded |
| Phase 4 | NCT05368376 Comparator | Apr 2021 → Oct 2022 | hypotensive disorder | Damanhour Teaching Hospital | Completed | No outcome recorded |
| Phase 4 | NCT04767061 Comparator | Apr 2021 → Apr 2022 | diastolic heart failure | Weill Medical College of Cornell University | Completed | No outcome recorded |
| Phase 4 | NCT04205305 Comparator | Jun 2020 → Jul 2023 | ischemic stroke | Yonsei University | Completed | No outcome recorded |
| Phase 4 | NCT03809065 Comparator | Jan → May 2019 | hypotensive disorder | Cairo University | Completed | No outcome recorded |
| Phase 4 | NCT03449277 Comparator | Jan 2018 → Feb 2019 | preeclampsia | Hossam Ahmed Abd Ellah | Unknown | No outcome recorded |
| Phase 4 | NCT02531490 Comparator | Jan 2015 → Feb 2023 | preeclampsia | Maastricht University Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT00765648 Comparator | Oct 2008 → Jan 2010 | hypertensive urgency | The Cleveland Clinic | Completed | No outcome recorded |
| Phase not applicable9 trials | ||||||
| — | NCT07363343 Comparator | Mar 2026 → Dec 2029 expected | preeclampsia | The Cleveland Clinic | Recruiting | No outcome recorded |
| — | NCT06385600 Comparator | May 2024 → Jan 2026 | severe pre-eclampsia | Assiut University | Unknown | No outcome recorded |
| — | NCT06346561 Comparator | Mar → Aug 2024 | lacrimal duct obstruction | Sohag University | Unknown | No outcome recorded |
| — | NCT06265415 Comparator | Mar 2024 → Mar 2025 | severe pre-eclampsia | Sohag University | Unknown | No outcome recorded |
| — | NCT04539379 Comparator | Oct 2020 → Feb 2022 | — | Zagazig University | Completed | No outcome recorded |
| — | NCT02933593 Comparator | Aug 2016 → Jan 2017 | hypertensive disorder | St. Louis University | Withdrawn | No outcome recorded |
| — | NCT01041066 Comparator | Sep → Dec 2009 | — | Seoul National University Bundang Hospital | Unknown | 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 28 cited values
Every value below carries the sentence it was read from. 73 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | labetalol | “To manipulate the blood pressure within a certain range with hypotensive drugs (e.g. nifedipine, benidipine, captopril, benazepril, irbesartan, labetalol, urapidil) and/or...” NCT05670028 ↗69“Other names: acebutolol, atenolol, betaxolol, bisoprolol, carvedilol, labetalol, metoprolol, metoprolol succinate, metoprolol tartrate, nadolol, nebivolol, propranolol,...” NCT05585125 ↗ “Other Names: * acebutolol * atenolol * betaxolol * bisoprolol * carvedilol * labetalol * metoprolol succinate * metoprolol tartrate * nadolol * nebivolol * penbutolol *...” NCT05019027 ↗ “Blood pressure is raised or lowered via norepinephrine (dose range 1-10 mcg/min) and labetalol (dose range 0-2 mg/min), respectively, to match the researched blood pressure targets.” NCT07296029 ↗ “This study aimed to compare the cerebral hemodynamic effects of magnesium sulfate (MgSO4) and labetalol in pre-eclampsia patients with severe features.” PMID 37074522 ↗ Apr 2023 “Pregnancy Outcomes of Nifedipine Compared With Labetalol for Oral Treatment of Mild Chronic Hypertension.” PMID 38949541 ↗ May 2024 “Urapidil, nicardipine, and labetalol will be used in this group.” NCT03207100 ↗ “carvedilol, labetalol, benazepril, captopril, enalapril” NCT00684489 ↗ “oral labetalol tablets and oral nifedipine tablets” NCT03449277 ↗ “with intravenous Labetalol infusion” NCT03443596 ↗ “Labetalol (Trandate)200-600 mg/day” NCT04320589 ↗ “Labetalol” NCT07044232 ↗ “labetalol” NCT04757584 ↗ “labetalol” NCT04767061 ↗ |
| Known as | AH 5158A | ChEMBL registry synonym — accepted as the source's own label CHEMBL429 ↗ |
| Known as | AH-5158A FREE BASE | ChEMBL registry synonym — accepted as the source's own label CHEMBL429 ↗ |
| Known as | AH-5158A HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL429 ↗ |
| Known as | Avexa | “labetalol (Avexa)” NCT01408524 ↗ |
| Known as | Ibidomide | ChEMBL registry synonym — accepted as the source's own label CHEMBL429 ↗ |
| Known as | Ibidomide hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL429 ↗ |
| Known as | Labetalol hcl | ChEMBL registry synonym — accepted as the source's own label CHEMBL429 ↗ |
| Known as | Labetalol Hydrochloride | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00226096 ↗ |
| Known as | Labetalol hydrochloride component of normozide | ChEMBL registry synonym — accepted as the source's own label CHEMBL429 ↗ |
| Known as | Labetalol hydrochloride in dextrose | ChEMBL registry synonym — accepted as the source's own label CHEMBL429 ↗ |
| Known as | Labetalol hydrochloride in sodium chloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL429 ↗ |
| Known as | Labetalol Hydrochloride injection | “Labetalol Hydrochloride injection” NCT03325348 ↗ |
| Known as | Labetalol hydrocloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL429 ↗ |
| Known as | Labetolol | “The patients will be given intravenous infusion of labetolol (Trandate™, 5mg/ml) available in 20 ml ampoules containing 100mg labetalol (5mg/ml).” NCT04539379 ↗ |
| Known as | Labipress | “Labetalol groups: the patients will receive deliberate hypotensive anesthesia with labetalol infusion (Labipress 100mg/20ml; Al Debeiky pharma(DBK) pharmaceutical co., Cairo, Egypt)” NCT06752863 ↗ |
| Known as | Labrocol | ChEMBL registry synonym — accepted as the source's own label CHEMBL429 ↗ |
| Known as | Normodyne | ChEMBL registry synonym — accepted as the source's own label CHEMBL429 ↗ |
| Known as | Normozide | ChEMBL registry synonym — accepted as the source's own label CHEMBL429 ↗ |
| Known as | NSC-290312 | ChEMBL registry synonym — accepted as the source's own label CHEMBL429 ↗ |
| Known as | SCH 15719W | ChEMBL registry synonym — accepted as the source's own label CHEMBL429 ↗ |
| Known as | SCH-15719W FREE BASE | ChEMBL registry synonym — accepted as the source's own label CHEMBL429 ↗ |
| Known as | SCH-15719W HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL429 ↗ |
| Known as | Trandate | “Labetalol (Trandate)200-600 mg/day” NCT04320589 ↗ |
| Known as | trandate, Gsk | “Group L will recieve labetalol intravenous infusion (Trandate, Gsk) in a concentration of 10 mg/ ml, thus 50 mg/ml equals to 5 ml/hr. The starting infusion rate of the...” NCT06385600 ↗ |
| Action | Inhibit | “labetalol, an alpha and beta adrenergic blocker, will block the subjective and physiological effects of intravenously administered nicotine” NCT00000297 ↗ |
| Modality | Small molecule | — CHEMBL429 ↗ |
| Route | Oral | “a single oral dose of low (100mg) or high dose of labetalol (200mg ), or placebo will be administered.” NCT00000297 ↗ |