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ProAmatine

(Midodrine)

ApprovedSmall molecule

Midodrine is used to treat abnormally low blood pressure, especially in people who have trouble maintaining adequate blood pressure while standing or during daily activities.[2] ProAmatine is currently approved and in use across 23 indications[4].[1]

ProAmatine is one of 522 small molecule programs targeting Cardiovascular Disease. It is currently in Approved.

23

Indications

55

Total Trials

10

Active Trials

521

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Cardiovascular DiseaseActive, not recruiting

StrokeActive, not recruiting

Vasovagal SyncopeActive, not recruiting

SyncopeActive, not recruiting

Acute Kidney InjuryActive, not recruiting

Cirrhosis of LiverActive, not recruiting

Liver TransplantActive, not recruiting

Ischemic StrokeActive, not recruiting

AscitesActive, not recruiting

Acute-on-Chronic Liver FailureActive, not recruiting

Cardiovascular DiseaseApproved

Active, not recruiting

StrokePreclinical

Active, not recruiting

Vasovagal SyncopePreclinical

Active, not recruiting

SyncopePreclinical

Active, not recruiting

Acute Kidney InjuryPreclinical

Active, not recruiting

Cirrhosis of LiverPreclinical

Active, not recruiting

Liver TransplantApproved

Active, not recruiting

Ischemic StrokePreclinical

Active, not recruiting

AscitesPreclinical

Active, not recruiting

Acute-on-Chronic Liver FailurePreclinical

Active, not recruiting

Showing 10 of 22 indications

Competition

Competitive Landscape

150 competitors in Stroke

#DrugCompanyPhaseTrials

ProAmatine

Recaticimab

SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Zometa

Savella

Repatha

Periactin

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Zantac 150

Alka-Seltzer

Haldol

DDePuy Orthopaedics

Anticoagulants

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Autonomic Failure

NCT02897063

Phase 1/2Recruiting

Orthostatic Hypotension

NCT03482297

Phase 1Recruiting

Orthostatic Hypotension

NCT02429557

Q3 2027

N/ANot yet recruiting

Acute-on-Chronic Liver Failure

NCT07422948

N/ANot yet recruiting

Cirrhosis

NCT07465471

Q1 2028

Post-ApprovalRecruiting

ESS

NCT05058612

Clinical

Trials by Indication[1]

Cirrhosis9 trials

Efficacy and Safety of Midodrine in Refractory or Recurrent Ascites in Children With Cirrhosis.

Withdrawn·IInstitute of Liver and Biliary Sciences, India·N/A·NCT05084534

Role of Midodrine and Tolvaptan in Patients With Cirrhosis With Refractory or Recurrent Ascites

Completed·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 2/3·NCT02173288·50 enrolled

Efficacy and Safety of Terlipressin With Albumin Versus Midodrine With Albumin Versus Albumin Alone in Prevention of Paracentesis Induced Circulatory Dysfunction in Cirrhosis

Completed·IInstitute of Liver and Biliary Sciences, India·N/A·NCT03144713·150 enrolled

Show 6 more trials

Carvedilol and Midodrine Versus Carvedilol Alone in Preventing Early Rebleed in Patients With Cirrhosis.

Not yet recruiting·IInstitute of Liver and Biliary Sciences, India·N/A·NCT07465471·210 enrolled

Midodrine, Octreotide and Albumin: Impact on Renal Function of Patients With Liver Cirrhosis and Renal Failure

Withdrawn·AAnna Cruceta·Phase 2·NCT01587222

Vasoconstrictors as Alternatives to Albumin After Large-Volume Paracentesis (LVP) in Cirrhosis

Completed·UUS Department of Veterans Affairs·Phase 4·NCT00108355·29 enrolled

Mechanism and the Effect of Midodrine on Portal Pressures in Patients With Cirrhosis

Withdrawn·TThe Cleveland Clinic·N/A·NCT01331785

Evaluation of Low-dose Albumin and Midodrine Versus Midodrine Alone in Outcome of Recurrent Ascites in Patients With Decompensated Cirrhosis.

Unknown status·IInstitute of Liver and Biliary Sciences, India·N/A·NCT06245590·100 enrolled

Evaluation of Albumin and Midodrine Versus Albumin Alone in Outcome of Refractory Ascites in Patients With Decompensated Cirrhosis.

Unknown status·IInstitute of Liver and Biliary Sciences, India·N/A·NCT04816240·200 enrolled

Orthostatic Hypotension7 trials

Efficacy of Midodrine for the Prevention of Orthostatic Hypotension During Early Mobilization After Fast-track Hip Arthroplasty

Completed·RRigshospitalet, Denmark·Phase 3·NCT01707953·120 enrolled

Phase II Study of Midodrine for Neurogenic Orthostatic Hypotension

Completed·NNational Center for Research Resources (NCRR)·Phase 2·NCT00004268·300 enrolled

Automated Abdominal Binder for Orthostatic Hypotension

Recruiting·VVanderbilt University Medical Center·Phase 1/2·NCT03482297·31 enrolled

Show 4 more trials

Hemodynamic Mechanisms of Abdominal Compression in the Treatment of Orthostatic Hypotension in Autonomic Failure

Recruiting·VVanderbilt University Medical Center·Phase 1·NCT02429557·29 enrolled

Treatment and Prognosis of Neurogenic Orthostatic Hypotension : A Prospective Randomized Study

Completed·SSeoul National University Hospital·Phase 4·NCT02308124·87 enrolled

An Open Label Trial to Decrease Signs and Symptoms of Orthostatic Hypotension Using Midodrine or Intravenous Fluid Bolus in Patients Following Total Hip Arthroplasty

Terminated·HHospital for Special Surgery, New York·N/A·NCT02154243·13 enrolled

Effect of Midodrine vs Abdominal Compression on Cardiovascular Risk Markers in Autonomic Failure Patients

Completed·VVanderbilt University Medical Center·Phase 1·NCT04620382·31 enrolled

Septic Shock4 trials

Impact of Midodrine Administration on the Clinical Outcome of Septic Shock Patients

Completed·—·Phase 4·NCT03911817·60 enrolled

Midodrine in the Recovery Phase of Septic Shock

Withdrawn·UUniversity of Virginia·Phase 3·NCT02990546

Midodrine Effect on the Mortality Rates in Septic Shock Patients

Completed·NNoha Mansour·Phase 2·NCT05778838·100 enrolled

Show 1 more trial

Midodrine During Recovery From Septic Shock

Withdrawn·NNorthwell Health·Phase 4·NCT02771158

Hypotension3 trials

Midodrine for the Treatment of Refractory Hypotension

Completed·MMassachusetts General Hospital·Phase 3·NCT01531959·139 enrolled

Midodrine for Prophylaxis Against Post Spinal Hypotension in Elderly Population

Completed·—·N/A·NCT05548985·58 enrolled

Minimization of Intradialytic Hypotension Using Cardiography-Guided Intervention

Unknown status·NNimedical·Phase 4·NCT03080441·35 enrolled

Ischemic stroke2 trials

Midodrine for Ischemic Stroke With Penumbra

Withdrawn·UUniversity of Utah··NCT02383121

Induced Hypertension for Acute Ischemic Stroke

Completed·JJohns Hopkins University·Phase 2·NCT00227448·60 enrolled

24 more indications

Safety and Efficacy2 trials

Safety and Efficacy of L-NAME and Midodrine to Increase MAP

Completed·UUS Department of Veterans Affairs·Phase 2·NCT00835224·34 enrolled

To Study the Safety and Efficacy of Midodrine With Albumin Versus Albumin Alone in Hepatic Hydrothorax

Completed·IInstitute of Liver and Biliary Sciences, India·N/A·NCT03645642·8 enrolled

Liver Transplant2 trials

To Assess the Efficacy of Midodrine in Prevention of Cirrhosis Related Complications in Children Awaiting Liver Transplantation.

Completed·IInstitute of Liver and Biliary Sciences, India·N/A·NCT05287100·35 enrolled

Effect of Midodrine and Albumine in the Prevention of Complications in Cirrhotic Patients Awaiting Liver Transplantation

Completed·HHospital Clinic of Barcelona·Phase 4·NCT00839358·199 enrolled

Ascites2 trials

Efficacy of Combination of Midodrine With Propranolol in Preventing First Bleed in Decompensated Cirrhotics With Severe Ascites.

Completed·IInstitute of Liver and Biliary Sciences, India·N/A·NCT04208776·140 enrolled

Midodrine and Albumin in Patients With Refractory Ascites

Unknown status·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 3·NCT04621617·114 enrolled

ESS2 trials

Midodrine for the Early Liberation of Vasopressor Support in the ICU

Completed·UUniversity of Alberta·Phase 4·NCT04489589·20 enrolled

Midodrine for the Early Liberation of Vasopressor Support in the ICU (LIBERATE Multi-Site)

Recruiting·UUniversity of Alberta·Phase 4·NCT05058612·870 enrolled

Orthostatic Intolerance2 trials

Treatment of Orthostatic Intolerance in Patients With Parkinson's Disease Using Midodrine

Unknown status·—·N/A·NCT02365012·50 enrolled

Treatment of Orthostatic Intolerance

Active, not recruiting·SSatish R. Raj·Phase 1/2·NCT00262470·150 enrolled

Spinal Cord Injury2 trials

Blood Pressure, Cerebral Blood Flow and Cognition in Spinal Cord Injury

Completed·JJames J. Peters Veterans Affairs Medical Center·Phase 3·NCT02307565·19 enrolled

Blood Pressure and Brain Blood Flow Regulation After Midodrine Administration in Those With Spinal Cord Injury

Completed·UUniversity of British Columbia··NCT01498809·22 enrolled

Cardiopulmonary Bypass1 trial

Midodrine as Novel Treatment of Post-Cardiopulmonary Bypass Vasoplegic Syndrome

Terminated·MMedstar Health Research Institute·Phase 4·NCT04668859·10 enrolled

Acute Kidney Injury1 trial

Midodrine is Effective in Management of Intradialytic Hypotension Among Critically-ill Patients With Acute Kidney Injury

Completed·—·N/A·NCT03431194·80 enrolled

Spinal Anesthesia1 trial

Midodrine for Improving Hemodynamics After Spinal Anesthesia

Completed·MMansoura University·N/A·NCT04396548·70 enrolled

Hyponatremia1 trial

To Study Effect of the Combination of Midodrine and Tolvaptan Versus Tolvaptan Alone in Patients With Severe Hyponatremia in Cirrhosis(TOLMINA Trial)

Unknown status·IInstitute of Liver and Biliary Sciences, India·N/A·NCT05060523·220 enrolled

Liver Disease1 trial

Effect of Midodrine on HVPG in Advanced Chronic Liver Disease

Completed·IInstitute of Liver and Biliary Sciences, India·N/A·NCT04455464·60 enrolled

Shock1 trial

the Effect of Oral Vasopressors for Liberation From IV Vasopressors in Spinal Shock

Unknown status·AAhmed talaat ahmed aly·Phase 2·NCT04586790·90 enrolled

Complication1 trial

Midodrine Plus Albumin Versus Midodrine Alone to Prevent Cirrhosis Related Complications in Children With Cirrhosis and Ascites

Completed·IInstitute of Liver and Biliary Sciences, India·N/A·NCT06091345·61 enrolled

Vasovagal syncope1 trial

Treatment Strategy of Vasovagal Syncope

Recruiting·CChina National Center for Cardiovascular Diseases·N/A·NCT05803148·184 enrolled

Cesarean Section1 trial

Preoperative Oral Midodrine Versus Intraoperative Intravenous Norepinephrine in Preventing Post-spinal Anesthesia Hypotension in Cesarean Section: A Prospective Double-blind Randomized Clinical Trial

Unknown status·SSohag University·N/A·NCT06213935·90 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Midodrine and Atomoxetine for Neurogenic OH

Completed·SSeoul National University Hospital·Phase 4·NCT03350659·50 enrolled

Hepatorenal Syndrome1 trial

Angiotensin 2 for Hepatorenal Syndrome

Withdrawn·UUniversity of California, Los Angeles·Phase 2·NCT04048707

Syncope1 trial

Randomized Study of Midodrine, an Alpha Adrenergic Agonist, in Patients With Neurally Mediated Syncope

Completed·IIcahn School of Medicine at Mount Sinai·N/A·NCT00004479

Acute-on-Chronic Liver Failure1 trial

Efficacy and Safety of Early Initiation of Midodrine for Control and Prevention of Ascites and Its Related Complications in Acute-on-chronic Liver Failure.

Not yet recruiting·IInstitute of Liver and Biliary Sciences, India·N/A·NCT07422948·113 enrolled

Hepatopulmonary Syndrome1 trial

Midodrine in Hepatopulmonary Syndrome

Completed·MMayo Clinic·Phase 1·NCT03600870·10 enrolled

Autonomic Failure1 trial

Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure

Recruiting·VVanderbilt University Medical Center·Phase 1·NCT02897063·34 enrolled

Efficacy1 trial

Efficacy of Albumin Plus Midodrine v/s Albumin Alone in Reducing Incidence of Paracentesis Induced Circulatory Dysfunctions in ACLF Patients.

Unknown status·IInstitute of Liver and Biliary Sciences, India·N/A·NCT04474262·150 enrolled

Heart Failure With Reduced Ejection Fraction1 trial

Midodrine in Heart Failure With Reduced Ejection Fraction With Hypotension: A Pilot, Open-label, Randomized Controlled Trial

Recruiting·OOttawa Heart Institute Research Corporation·Preclinical·NCT06405555·56 enrolled

Sepsis1 trial

MID-STEP (MIDodrine for Sepsis Treatment and Early vasoPressor Weaning) Trial

Recruiting·MMayo Clinic·Phase 2·NCT06319248·308 enrolled

Regulatory

FDA Approval Timeline[5]

Sep 6, 1996

PROAMATINE

NDA NDA019815

Sources

References

[1]
ClinicalTrials.gov — 55 trial records for Midodrine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — ProAmatine drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Midodrine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Midodrine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA019815). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Takeda company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Adrenergic Receptor Alpha-1 Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Takeda

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