Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 evaluate droxidopa across indications such as neurogenic orthostatic hypotension, Parkinson's disease, multiple system atrophy, pure autonomic failure, dopamine beta-hydroxylase deficiency, Menkes disease, and spinal cord injury-induced hypotension. Sponsored by a combination of pharmaceutical companies and academic medical centers, these evaluations encompass recruitment statuses ranging from active and completed to withdrawn or terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07398508 RECRUITING
Menkes Disease
Stephen G. Kaler
 2026-08-10 PHASE1; PHASE2
NCT06937307 RECRUITING
Acute Kidney Injury; Cirrhosis; Decompensated Cirrhosis of Liver
Giuseppe Cullaro, MD
 2025-05-27 PHASE2
NCT01370512 ENROLLING_BY_INVITATION
Orthostatic Hypotension
Mayo Clinic
 2011-11 PHASE2
NCT02897063 RECRUITING
Autonomic Failure; Pure Autonomic Failure; Multiple System Atrophy; Parkinson Disease; Orthostatic Hypotension
Vanderbilt University Medical Center
 2016-09 PHASE1
NCT04977388 COMPLETED
Menkes Disease; Occipital Horn Syndrome
Stephen G. Kaler, MD
 2021-07-12 PHASE1; PHASE2
NCT03446807 WITHDRAWN
Parkinson Disease; Multiple System Atrophy; Progressive Supranuclear Palsy
Loma Linda University
 2021-12 PHASE2
NCT02558972 TERMINATED
Postural Tachycardia Syndrome (POTS); Vasovagal Syncope (VVS); Fainting
New York Medical College
 2015-09 PHASE2
NCT02586623 COMPLETED
Symptomatic Neurogenic Orthostatic Hypotension
H. Lundbeck A/S
 2016-02-11 PHASE4
NCT03229174 COMPLETED
Parkinson Disease; Neurogenic Orthostatic Hypotension
William Ondo, MD
 2018-08-23 PHASE4
NCT03602014 COMPLETED
Hypotension, Orthostatic; Hypotension; Spinal Cord Injuries
James J. Peters Veterans Affairs Medical Center
 2018-06-01 PHASE4
NCT03446807 Withdrawn
Parkinson Disease|Multiple System Atrophy|Progressive Supranuclear Palsy
Loma Linda University|H. Lundbeck A/S
 2021-12 Phase 2
NCT04977388 Recruiting
Menkes Disease|Occipital Horn Syndrome
Stephen G. Kaler MD|Nationwide Children''s Hospital
 2021-07-12 Phase 1|Phase 2
NCT04510922 COMPLETED
Orthostatic Hypotension; Idiopathic Parkinson Disease
Alberto Espay, MD, MSc
 2019-02-11 PHASE4
NCT00581477 TERMINATED
Autonomic Nervous System Diseases; Orthostatic Hypotension; Dopamine Beta-Hydroxylase Deficiency; Orthostatic Intolerance
Vanderbilt University
 2004-01 PHASE2; PHASE3
NCT03567447 UNKNOWN
Parkinson Disease; Falls Patient
St. Joseph's Hospital and Medical Center, Phoenix
 2018-08-17 PHASE2
NCT02071459 COMPLETED
Multiple System Atrophy
University Hospital, Toulouse
 2014-01-21 PHASE2; PHASE3
NCT02624310 WITHDRAWN
HSAN Type IV
NYU Langone Health
 2016-01 PHASE2
NCT03115827 COMPLETED
Parkinson Disease
Vanderbilt University Medical Center
 2017-04-18 PHASE4
NCT03034564 TERMINATED
Parkinson Disease; Fatigue; Parkinsonism
The Cooper Health System
 2017-01 PHASE4
NCT03173781 COMPLETED
Parkinson's Disease
Colorado Springs Neurological Associates
 2016-04
NCT02066571 UNKNOWN
Parkinson's Disease; Freezing of Gait; Cognitive Ability, General
Henry Ford Health System
 2015-03 PHASE2
NCT03173781 Completed
Parkinson''s Disease
Colorado Springs Neurological Associates|H. Lundbeck A/S
 2016-04 Not Applicable
NCT01927055 TERMINATED
Symptomatic Neurogenic Orthostatic Hypotension; Parkinson's Disease; Multiple Systems Atrophy; Pure Autonomic Failure; Dopamine Beta Hydroxylase Deficiency
Chelsea Therapeutics
 2013-11 PHASE3
NCT01354158 COMPLETED
Spinal Cord Injury; Hypotension
Bronx VA Medical Center
 2011-05 PHASE1
NCT00547911 TERMINATED
Parkinson Disease; Multiple System Atrophy; Autonomic Nervous System Diseases
National Institute of Neurological Disorders and Stroke (NINDS)
 2007-10 PHASE1; PHASE2
NCT01612078 TERMINATED
Orthostatic Hypotension
TSH Biopharm Corporation Limited
 2012-06 PHASE3
NCT01132326 COMPLETED
Primary Autonomic Failure; Dopamine Beta Hydroxylase Deficiency; Non-Diabetic Neuropathy; Neurogenic Orthostatic Hypotension
Chelsea Therapeutics
 2009-01 PHASE3
NCT03070730 TERMINATED
Postural Orthostatic Tachycardia Syndrome; Orthostatic Intolerance
Beth Israel Deaconess Medical Center
 2011-08-15 PHASE1; PHASE2
NCT01331122 WITHDRAWN
Gait Disorders, Neurologic
Chelsea Therapeutics
 2012-04 PHASE1; PHASE2
NCT01468259 WITHDRAWN
Renal Disease; End Stage Renal Disease
Chelsea Therapeutics
 2012-10 PHASE1
NCT01176240 COMPLETED
Orthostatic Hypotension; Parkinson's Disease
Chelsea Therapeutics
 2010-06 PHASE3
NCT01331122 Withdrawn
Gait Disorders Neurologic
Chelsea Therapeutics
 2012-04 Phase 1|Phase 2
NCT00977171 TERMINATED
Chronic Fatigue Syndrome; Orthostatic Hypotension; Neurally Mediated Hypotension; Neurogenic Orthostatic Hypotension
Chelsea Therapeutics
 2010-07 PHASE2
NCT01323374 COMPLETED
Fibromyalgia
Chelsea Therapeutics
 2009-01 PHASE2
NCT01354158 Completed
Spinal Cord Injury|Hypotension
Bronx VA Medical Center|Chelsea Therapeutics
 2011-05 Phase 1
NCT00983814 COMPLETED
Attention Deficit Hyperactivity Disorder
Chelsea Therapeutics
 2009-10 PHASE2
NCT01327066 COMPLETED
QTc Interval
Chelsea Therapeutics
 2011-03 PHASE1
NCT01327066 Completed
QTc Interval
Chelsea Therapeutics
 2011-03 Phase 1
NCT00738062 COMPLETED
Neurogenic Orthostatic Hypotension; Non-Diabetic Autonomic Neuropathy; Multiple System Atrophy; Dopamine Beta Hydroxylase Deficiency
Chelsea Therapeutics
 2008-01 PHASE3
NCT00782340 COMPLETED
Symptomatic Neurogenic Orthostatic Hypotension (NOH); Non-diabetic Neuropathy; Primary Autonomic Failure; Dopamine Beta Hydroxylase Deficiency
Chelsea Therapeutics
 2008-09 PHASE3
NCT01149629 COMPLETED
Symptomatic Neurogenic Orthostatic Hypotension
Chelsea Therapeutics
 2010-07 PHASE1
NCT00633880 COMPLETED
Symptomatic Neurogenic Orthostatic Hypotension (NOH); Non-diabetic Neuropathy; Primary Autonomic Failure; Dopamine Beta Hydroxylase Deficiency
Chelsea Therapeutics
 2008-01 PHASE3
NCT00657046 COMPLETED
Intradialytic Hypotension
Chelsea Therapeutics
 2007-12 PHASE2
NCT00004478 COMPLETED
Shy-Drager Syndrome; Orthostatic Hypotension
Icahn School of Medicine at Mount Sinai
 1999-03

(data from https://clinicaltrials.gov, updated on 2026-07-20)

Check the Droxidopa product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Droxidopa functions as a synthetic precursor that undergoes enzymatic decarboxylation by aromatic L-amino acid decarboxylase to generate norepinephrine, which subsequently activates vascular alpha- and beta-adrenergic receptors. This receptor activation induces peripheral vasoconstriction and enhances vascular tone, thereby increasing systemic blood pressure to mitigate symptomatic neurogenic orthostatic hypotension in patients with neurodegenerative disorders such as Parkinson's disease.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Jump to

Note: Technical data last updated: Sep 1, 2026.