Drugs / Midodrine
last change Sep 2026 re-read 9 days ago

Midodrine

Small molecule

Developed for
orthostatic hypotension · cirrhosis of liver · hypotensive disorder · spinal cord injury · hepatorenal syndrome · infectious disease with sepsis · pure autonomic failure · kidney failure
+17 more · liver disorder · quadriplegia · autonomic nervous system disorder · cardiac rhythm disease · hepatobiliary disorder · hepatopulmonary syndrome · influenza · ischemic stroke · left ventricular failure · liver failure · symptomatic heart failure · vascular disorder · acute kidney injury · Alzheimer disease · hepatic encephalopathy · isoproterenol-mediated vasodilatation · syncope, familial vasovagal
Investigated by
Institute of Liver and Biliary Sciences, India · James J. Peters Veterans Affairs Medical Center · Shire · Kessler Foundation · Mylan Pharmaceuticals Inc · National Heart, Lung, and Blood Institute (NHLBI)
+36 more · University of Alberta · Vanderbilt University Medical Center · Alberta Health services · Icahn School of Medicine at Mount Sinai · Institute of Health Economics, Canada · Mayo Clinic · US Department of Veterans Affairs · University of Virginia · Ahmed talaat ahmed aly · American College of Gastroenterology · Anna Cruceta · Asian Institute of Gastroenterology, India · Hospices Civils de Lyon · Hospital Clinic of Barcelona · Hospital for Special Surgery, New York · Johns Hopkins University · National Center for Advancing Translational Sciences (NCATS) · National Center for Research Resources (NCRR) · National Hepatology & Tropical Medicine Research Institute · National Institutes of Health (NIH) · National Liver Institute, Egypt · Nimedical · Northwell Health · Novartis · Ottawa Heart Institute Research Corporation · Post Graduate Institute of Medical Education and Research, Chandigarh · Rigshospitalet, Denmark · Roberts Pharmaceutical · Satish R. Raj · Seoul National University Hospital · The Cleveland Clinic · The Craig H. Neilsen Foundation · University Hospital Foundation · University of Calgary · University of Padova · Vanderbilt University

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) PROAMATINE — 1996-09-06 fda.gov ↗

Trials 59

19961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027202820292030
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 17 trials
Phase 1 NCT03600870 Aug 2018 → Dec 2020 hepatopulmonary syndrome Mayo Clinic Completed No outcome recorded
Phase 1 NCT02897063 Sep 2016 → Sep 2026 overdue Parkinson disease, orthostatic hypotension, pure autonomic failure Vanderbilt University Medical Center Recruiting No outcome recorded
Phase 1 NCT02429557 Apr 2015 → Dec 2025 orthostatic hypotension, pure autonomic failure Vanderbilt University Medical Center Completed No outcome recorded
Phase 1 NCT00648440 Oct → Nov 2002 — Mylan Pharmaceuticals Inc Completed No outcome recorded
Phase 1 NCT00650364 Aug 2002 — Mylan Pharmaceuticals Inc Completed No outcome recorded
Phase 1 NCT00650013 Jul → Aug 2002 — Mylan Pharmaceuticals Inc Completed No outcome recorded
Phase 1 NCT00223691 Mar 2002 → Jan 2017 autonomic nervous system disorder, orthostatic hypotension Vanderbilt University Completed Mixed
Phase 1/22 trials · 1 missed
Phase 1/2 NCT03482297 Mar 2018 → Nov 2025 orthostatic hypotension, pure autonomic failure Vanderbilt University Medical Center Completed No outcome recorded
Phase 1/2 NCT00262470 Apr 1997 → Dec 2029 expected cardiac rhythm disease Satish R. Raj Active not recruiting Missed primary
Phase 210 trials
Phase 2 NCT06319248 May 2024 → May 2029 expected hypotensive disorder, infectious disease with sepsis Mayo Clinic Recruiting No outcome recorded
Phase 2 NCT04586790 Oct 2020 → Jan 2021 — Ahmed talaat ahmed aly Unknown No outcome recorded
Phase 2 NCT02893553 Dec 2016 → Dec 2021 autonomic dysreflexia, cognitive disorder, hypotensive disorder, spinal cord injury James J. Peters Veterans Affairs Medical Center Completed No outcome recorded
Phase 2 NCT01587222 Jul 2016 → Jul 2017 hepatorenal syndrome, kidney failure Anna Cruceta Withdrawn No outcome recorded
Phase 2 NCT01546506 Feb 2012 → Mar 2014 influenza Hospices Civils de Lyon Completed No outcome recorded
Phase 2 NCT00835224 May 2010 → Jun 2013 orthostatic hypotension, spinal cord injury US Department of Veterans Affairs Completed No outcome recorded
Phase 2 NCT01133795 Feb 2010 → Jun 2016 cirrhosis of liver, kidney failure Hospital Clinic of Barcelona Completed No outcome recorded
Phase 2 NCT00426842 Jan 2007 → Mar 2011 orthostatic hypotension, spinal cord injury James J. Peters Veterans Affairs Medical Center Completed No outcome recorded
Phase 2 NCT00227448 Jun 2003 → Apr 2005 ischemic stroke Johns Hopkins University Completed No outcome recorded
Phase 2 NCT00004268 Apr 2001 → ? orthostatic hypotension National Center for Research Resources (NCRR) Completed No outcome recorded
Phase 2/35 trials · 1 missed
Phase 2/3 NCT06405555 Aug 2026 → Jun 2028 expected hypotensive disorder, left ventricular failure, symptomatic heart failure Ottawa Heart Institute Research Corporation Recruiting No outcome recorded
Phase 2/3 NCT02919917 Jun 2017 → Sep 2021 autonomic dysreflexia, orthostatic hypotension, spinal cord injury James J. Peters Veterans Affairs Medical Center Completed Missed primary
Phase 2/3 NCT02173288 Jul 2013 → Mar 2016 cirrhosis of liver Post Graduate Institute of Medical Education and Research, Chandigarh Completed No outcome recorded
Phase 2/3 NCT00240045 Oct 2005 → Jul 2007 hepatorenal syndrome University of Alberta Completed No outcome recorded
Phase 2/3 NCT00742339 May 2005 → Oct 2013 cirrhosis of liver, hepatorenal syndrome University of Padova Terminated No outcome recorded
Phase 35 trials
Phase 3 NCT05240391 Feb 2021 → May 2022 — Asian Institute of Gastroenterology, India Completed No outcome recorded
Phase 3 NCT03706053 Nov 2018 → Feb 2022 infectious disease with sepsis University of Virginia Terminated No outcome recorded Stop: Business
Phase 3 NCT02990546 Mar 2017 → May 2018 infectious disease with sepsis University of Virginia Withdrawn No outcome recorded Stop: Enrollment
Phase 3 NCT02307565 Mar 2014 → Dec 2019 spinal cord injury James J. Peters Veterans Affairs Medical Center Completed No outcome recorded
Phase 3 NCT01707953 Oct 2012 → Sep 2013 orthostatic hypotension Rigshospitalet, Denmark Completed No outcome recorded
Phase 413 trials · 1 met primary · 1 missed
Phase 4 NCT05839652 Jul 2023 → Jun 2026 overdue hypotensive disorder James J. Peters Veterans Affairs Medical Center Recruiting No outcome recorded
Phase 4 NCT04489589 Mar 2021 → Jul 2022 — University of Alberta Completed No outcome recorded
Phase 4 NCT05058612 Mar 2021 → Mar 2027 expected vascular disorder University of Alberta Recruiting No outcome recorded
Phase 4 NCT02771158 Aug → Nov 2017 hypotensive disorder, infectious disease with sepsis Northwell Health Withdrawn No outcome recorded
Phase 4 NCT03080441 Nov 2016 → Apr 2017 — Nimedical Unknown No outcome recorded
Phase 4 NCT02379156 Apr 2015 → Jul 2021 cognitive impairment with or without cerebellar ataxia, quadriplegia James J. Peters Veterans Affairs Medical Center Completed Met primary
Phase 4 NCT02308124 Nov 2014 → Sep 2016 orthostatic hypotension Seoul National University Hospital Completed No outcome recorded
Phase 4 NCT01515865 May 2012 → Nov 2013 orthostatic hypotension Shire Completed Missed primary
Phase 4 NCT01822535 Jul 2011 → Oct 2015 cognitive impairment with or without cerebellar ataxia, quadriplegia James J. Peters Veterans Affairs Medical Center Completed Mixed
Phase 4 NCT00555880 Sep 2004 → Mar 2005 orthostatic hypotension Shire Completed Mixed
Phase not applicable17 trials
— NCT07465471 Mar 2026 → Sep 2027 expected cirrhosis of liver Institute of Liver and Biliary Sciences, India Not yet recruiting No outcome recorded
— NCT07422948 Feb 2026 → Aug 2027 expected liver failure Institute of Liver and Biliary Sciences, India Not yet recruiting No outcome recorded
— NCT06245590 Feb 2024 → Jan 2025 cirrhosis of liver Institute of Liver and Biliary Sciences, India Unknown No outcome recorded
— NCT05287100 Jan 2022 → May 2023 cirrhosis of liver Institute of Liver and Biliary Sciences, India Completed No outcome recorded
— NCT05084534 Nov 2021 → Feb 2023 — Institute of Liver and Biliary Sciences, India Withdrawn No outcome recorded
— NCT05060523 Sep 2021 → Sep 2022 cirrhosis of liver Institute of Liver and Biliary Sciences, India Unknown No outcome recorded
— NCT04881318 May 2021 → Dec 2026 expected postural orthostatic tachycardia syndrome University of Calgary Recruiting No outcome recorded
— NCT04816240 May 2021 → Mar 2022 cirrhosis of liver Institute of Liver and Biliary Sciences, India Unknown No outcome recorded
— NCT04474262 Jul 2020 → Mar 2021 liver disorder Institute of Liver and Biliary Sciences, India Unknown No outcome recorded
— NCT04455464 Jul 2020 → Dec 2021 liver disorder Institute of Liver and Biliary Sciences, India Completed No outcome recorded
Comparator or background therapy27 trials
Phase 0 NCT04620382 Comparator Nov 2020 → Jul 2025 Parkinson disease, orthostatic hypotension, pure autonomic failure Vanderbilt University Medical Center Completed No outcome recorded
Phase 1 NCT03129542 Comparator Aug 2017 → Apr 2020 infectious disease with sepsis Mayo Clinic Completed No outcome recorded
Phase 1/2 NCT07432997 Comparator Dec 2023 → Sep 2024 Alzheimer disease Applied Cognition Completed No outcome recorded
Phase 2 NCT05778838 Comparator Nov 2022 → Dec 2023 infectious disease with sepsis Noha Mansour Completed No outcome recorded
Phase 2 NCT04048707 Comparator Jul 2021 → Jun 2023 acute kidney injury, cirrhosis of liver, hepatorenal syndrome University of California, Los Angeles Withdrawn No outcome recorded Stop: Business

News releases announcing trial results or a regulatory action · 3

DateIssuerRelease
2021-01-01 Alembic Pharmaceuticals Ltd. Regulatory 22nd January, 2021, Vadodara, India 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) Midodrine Hydrochloride Tablets USP, 2.5 mg, 5 mg, and 10 mg.
2020-09-03 Zydus Lifesciences Limited Regulatory Zydus Cadila receives final approval from the USFDA to market Midodrine Hydrochloride Tablets zyduslife.com ↗
Zydus Cadila received final approval from the USFDA to market Midodrine Hydrochloride Tablets (US RLD- ProAmatine Tablets) in the strengths of 2.5 mg, 5 mg, and 10 mg.
2004-05-28 Impax Laboratories, LLC Regulatory IMPAX Receives Final FDA Approval for Generic PROAMATINE; Eighth ANDA Approval in 2004 amneal.com ↗
IMPAX Laboratories, Inc. (Nasdaq:IPXL) announced that the U.S. Food and Drug Administration (FDA) has granted final marketing approval to the Company's Abbreviated New Drug Application (ANDA) for its generic version of PROAMATINE(R), Midodrine Hydrochloride 2.5 and 5 mg Tablets.

All press releases naming this drug 3 releases

DateIssuerRelease

Evidence & citations 24 cited values

Every value below carries the sentence it was read from. 89 sources stand behind the page.

FieldValueCited text
Known as Midodrine “These medications include beta-blockers, midodrine, ivabradine and stimulants.” NCT04881318 ↗
80

“Albumin, midodrine and octreotide therapy (standard of care for HRS)” NCT02123576 ↗

“Midodrine 2.5 mg orally 3 times daily, 5 day-treatment.” NCT01546506 ↗

NCT00108355 ↗

NCT00227448 ↗

NCT05287100 ↗

NCT00046475 ↗

NCT06405555 ↗

NCT02173288 ↗

NCT03431194 ↗

NCT03911817 ↗

Show 70 more sources

Known as A-4020 LINZ ChEMBL registry synonym — accepted as the source's own label CHEMBL1201212 ↗
Known as Amatine ChEMBL registry synonym — accepted as the source's own label CHEMBL1201212 ↗
Known as Bramox ChEMBL registry synonym — accepted as the source's own label CHEMBL1201212 ↗
Known as Gutron ChEMBL registry synonym — accepted as the source's own label CHEMBL1201212 ↗
Known as Hipertan ChEMBL registry synonym — accepted as the source's own label CHEMBL1201212 ↗
Known as Metligine ChEMBL registry synonym — accepted as the source's own label CHEMBL1201212 ↗
Known as Midodrina ChEMBL registry synonym — accepted as the source's own label CHEMBL1201212 ↗
Known as Midodrine HCl “Midodrine HCl Tablets 5 mg” NCT00650013 ↗
3

“Midodrine HCl Tablets 5 mg” NCT00648440 ↗

“Drug: Midodrine HCl” NCT01518946 ↗

NCT01515865 ↗

Known as Midodrine Hydrochloride “The purpose of this clinical study is to evaluate the clinical effect of midodrine hydrochloride (ProAmatine®) compared to placebo in patients with orthostatic hypotension by...” NCT00555880 ↗
11

“OBJECTIVE: To compare responses to head-up tilt (HUT) in individuals with chronic tetraplegia after midodrine hydrochloride (10 mg) versus nitro-L-arginine methyl ester...” PMID 21762873 ↗ Jul 2011

“The purpose of this clinical study is to further assess the clinical effect of high dose midodrine hydrochloride (ProAmatine®), an approved treatment for orthostatic hypotension.” NCT00046163 ↗

“Midodrine hydrochloride is a short-acting pressor agent that raises blood pressure in the upright position in patients with orthostatic hypotension.” PMID 27372462 ↗ Jul 2016

“Midodrine hydrochloride is an approved medication used to treat low blood pressure.” NCT01822535 ↗

“anti-hypotensive agent Midodrine Hydrochloride (midodrine).” NCT02307565 ↗

“Midodrine hydrochloride plus standard medical treatment” NCT05084534 ↗

“Drug: Midodrine Hydrochloride” NCT05240391 ↗

NCT02919917 ↗

NCT00426842 ↗

NCT02379156 ↗

Show 1 more source

Known as Midodrine monohydrochloride ChEMBL registry synonym — accepted as the source's own label CHEMBL1201212 ↗
Known as Midodrine only “Midodrine only” NCT03350659 ↗
Known as Midon ChEMBL registry synonym — accepted as the source's own label CHEMBL1201212 ↗
Known as NSC-758429 ChEMBL registry synonym — accepted as the source's own label CHEMBL1201212 ↗
Known as Orvaten ChEMBL registry synonym — accepted as the source's own label CHEMBL1201212 ↗
Known as ProAmatine “The purpose of this clinical study is to further assess the clinical effect of high dose midodrine hydrochloride (ProAmatine®), an approved treatment for orthostatic hypotension.” NCT00046163 ↗
2

“The purpose of this clinical study is to further assess the clinical benefit of midodrine hydrochloride (ProAmatine®), an approved treatment for orthostatic hypotension.” NCT00046475 ↗

“ProAmatine® Tablets 5 mg” NCT00648440 ↗

Known as ST 1085 ChEMBL registry synonym — accepted as the source's own label CHEMBL1201212 ↗
Known as ST 1085 [AS THE BASE] ChEMBL registry synonym — accepted as the source's own label CHEMBL1201212 ↗
Known as ST 1085 HYDROCHLORIDE ChEMBL registry synonym — accepted as the source's own label CHEMBL1201212 ↗
Known as ST-1085 BASE ChEMBL registry synonym — accepted as the source's own label CHEMBL1201212 ↗
Known as ST-PETER-224 ChEMBL registry synonym — accepted as the source's own label CHEMBL1201212 ↗
Action Activate “alpha-receptor agonist midodrine” NCT00004268 ↗
Modality Small molecule — CHEMBL1201212 ↗
Route Oral “Patients receive oral midodrine three times a day” NCT00004268 ↗