Northera

(Droxidopa)

ApprovedSmall molecule

Northera is a small molecule that works as Adrenergic Receptor Agonist.[2] It is being used across 9 indications, with its most advanced program in Approved.[1]

Northera is one of 194 small molecule programs targeting Cardiovascular Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

193

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Cardiovascular DiseaseActive, not recruiting

Attention Deficit Hyperactivity DisorderApproved

Orthostatic IntoleranceApproved

Orthostatic HypotensionCompleted

Parkinson DiseaseCompleted

Primary Orthostatic HypotensionActive, not recruiting

Acute Kidney InjuryRecruiting

Multiple System AtrophyActive, not recruiting

Menkes DiseaseRecruiting

Cardiovascular DiseaseApproved

Active, not recruiting

Attention Deficit Hyperactivity DisorderApproved

Approved

Orthostatic IntoleranceApproved

Approved

Orthostatic HypotensionApproved

Completed

Parkinson DiseaseApproved

Completed

Primary Orthostatic HypotensionApproved

Active, not recruiting

Acute Kidney InjuryPhase 2

Recruiting

Multiple System AtrophyApproved

Active, not recruiting

Menkes DiseasePhase 2

Recruiting

Competition

Competitive Landscape

147 competitors in Cardiovascular Disease

#DrugCompanyPhaseTrials

Northera

Lundbeck

Approved

34 2

Plavix

Pletal

1 4

Bystolic

VVitae Pharmaceuticals Inc., an Allergan affiliate

Coumadin

Samsca

Procardia

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Colcrys

1 9

Cagrilintide

Novo Nordisk

Phase 3

1 10

Pelacarsen

Novartis

Phase 3

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

Timeline

Expected Milestones

Q4 2028

Phase 2Recruiting

Acute Kidney Injury

NCT06937307

Q2 2030

PreclinicalRecruiting

Menkes Disease

NCT07398508

Clinical

Trials by Indication[1]

Orthostatic Hypotension10 trials

A Clinical Study for Patients With Neurogenic Orthostatic Hypotension (NOH) Using Droxidopa

Completed·CChelsea Therapeutics·Phase 3·NCT00782340·263 enrolled

Open-Label Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH)

Completed·CChelsea Therapeutics·Phase 3·NCT00738062·103 enrolled

Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH)

Completed·CChelsea Therapeutics·Phase 3·NCT00633880·181 enrolled

Show 7 more trials

Phase 3 Study to Evaluate the Efficacy and Safety of Droxidopa on Orthostatic Hypotension Treatment in Hemodialysis Patients

Terminated·TTSH Biopharm Corporation Limited·Phase 3·NCT01612078·25 enrolled

Sustained Effect of Droxidopa in Symptomatic Neurogenic Orthostatic Hypotension

Completed· Lundbeck logo

Lundbeck·Phase 4·NCT02586623·453 enrolled

Lundbeck TOMs Orthostatic Hypotension

Completed·—·Phase 4·NCT04510922·9 enrolled

Treatment of Orthostatic Hypotension

Terminated·VVanderbilt University·Phase 2/3·NCT00581477·8 enrolled

Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH) (Droxi-304)

Completed·CChelsea Therapeutics·Phase 3·NCT01132326·350 enrolled

Effect of L-Dihydroxyphenylserine (L-DOPS) on Falls in Patients With Neurogenic Orthostatic Hypotension (NOH)

Unknown status·SSt. Joseph's Hospital and Medical Center, Phoenix·Phase 2·NCT03567447·10 enrolled

Treatment Trial of Droxidopa and Pyridostigmine to Improve Orthostatic Hypotension Without Aggravating Supine Hypertension

Enrolling by invitation·MMayo Clinic·Phase 2·NCT01370512·30 enrolled

Parkinson's Disease5 trials

Study to Assess Droxidopa in the Treatment of Freezing Of Gait Symptoms in Patients With Parkinson's Disease

Withdrawn·CChelsea Therapeutics·Phase 1/2·NCT01331122

A Two Part Study (306A/306B) to Assess Droxidopa in Treatment of NOH in Patients With Parkinson's Disease

Completed·CChelsea Therapeutics·Phase 3·NCT01176240·225 enrolled

Study to Assess the Clinical Benefit and Safety of Droxidopa in Parkinson's Disease

Unknown status·HHenry Ford Health System·Phase 2·NCT02066571·20 enrolled

Show 2 more trials

Effects of Droxidopa When Measuring Gait Speed, Kyphosis, and Functional Reach in Parkinson's Disease

Completed·CColorado Springs Neurological Associates·N/A·NCT03173781·21 enrolled

Brain Perfusion & Oxygenation in Parkinson's Disease With NOH

Completed·WWilliam Ondo, MD·Phase 4·NCT03229174·17 enrolled

Hypotension2 trials

Safety and Benefit Study of Droxidopa to Treat Patients With Intradialytic Hypotension

Completed·CChelsea Therapeutics·Phase 2·NCT00657046·85 enrolled

Droxidopa in Treating Patients With Neurogenic Hypotension

Completed·IIcahn School of Medicine at Mount Sinai·N/A·NCT00004478

Menkes disease2 trials

NORTHERA (DROXIDOPA) for Dysautonomia in Adult Survivors of Menkes Disease and Occipital Horn Syndrome

Completed·—·Phase 1/2·NCT04977388·3 enrolled

Phase I/II Study of NORTHERA (DROXIDOPA) for Dysautonomia in Pediatric Survivors of Menkes Disease: Double-blind Placebo-controlled Randomized Crossover Clinical Trial

Recruiting·SStephen G. Kaler·Preclinical·NCT07398508·6 enrolled

CAR2 trials

Augmenting Effects of L-DOPS With Carbidopa and Entacapone

Terminated·NNational Institute of Neurological Disorders and Stroke (NINDS)·Phase 1/2·NCT00547911·14 enrolled

Electrocardiographic (ECG) Safety Study of Droxidopa at Clinical and Supratherapeutic Dose

Completed·CChelsea Therapeutics·Phase 1·NCT01327066·52 enrolled

13 more indications

Pain1 trial

A Study of Norepinephrine in Patients With Congenital Insensitivity to Pain and Anhidrosis

Withdrawn·NNYU Langone Health·Phase 2·NCT02624310

AIN1 trial

A Clinical Study of Patients With Symptomatic NOH to Assess Sustained Effects of Droxidopa Therapy

Terminated·CChelsea Therapeutics·Phase 3·NCT01927055·61 enrolled

Tics1 trial

Study of the Fed-Fast Pharmocokinetics and Bioequivalance of 300mg Capsules of Droxidopa

Completed·CChelsea Therapeutics·Phase 1·NCT01149629·24 enrolled

Hemodynamic Response1 trial

Hemodynamic Response of Neuropathic And Non-Neuropathic POTS Patients To Adrenoreceptor Agonist And Antagonist

Terminated·—·Phase 1/2·NCT03070730·8 enrolled

Spinal Cord Injury1 trial

A Dose Titration of Droxidopa in Patients With Spinal Cord Injury

Completed·—·Phase 1·NCT01354158·11 enrolled

Treatment1 trial

Long Term Treatment With L-DOPS

Approved for marketing·VVanderbilt University··NCT00889135

Fibromyalgia1 trial

Study To Assess The Clinical Benefit Of Droxidopa And Droxidopa/Carbidopa In Subjects With Fibromyalgia

Completed·CChelsea Therapeutics·Phase 2·NCT01323374·122 enrolled

Chronic Fatigue Syndrome1 trial

Study To Assess The Clinical Benefit Of Droxidopa In Subjects With Chronic Fatigue Syndrome

Terminated·CChelsea Therapeutics·Phase 2·NCT00977171·3 enrolled

Parkinson disease1 trial

Norepinephrine-targeted Therapy for Action Control in Parkinson Disease

Completed·VVanderbilt University Medical Center·Phase 4·NCT03115827·15 enrolled

Parkinsonism1 trial

Safety and Efficacy of Droxidopa for Fatigue in Patients With Parkinsonism

Withdrawn·LLoma Linda University·Phase 2·NCT03446807

Autonomic Failure1 trial

The Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure Aim 2 of RDCRN (Rare Diseases Clinical Research Network) Project 2

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

Acute Kidney Injury1 trial

Droxidopa to Increase Mean Arterial Pressure in Decompensated Cirrhosis Patients With Acute Kidney Injury

Recruiting·GGiuseppe Cullaro, MD·Phase 2·NCT06937307·75 enrolled

Unspecified1 trial

A Multi-Center, Open-Label Study

Withdrawn·CChelsea Therapeutics·Phase 1·NCT01468259

Regulatory

FDA Approval Timeline[4]

Feb 18, 2014

NORTHERA

NDA NDA203202

Feb 18, 2014

NORTHERA

NDA NDA203202

Sep 30, 2014

NORTHERA

NDA NDA203202

Nov 3, 2014

NORTHERA

NDA NDA203202

Aug 19, 2015

NORTHERA

NDA NDA203202

Aug 24, 2015

NORTHERA

NDA NDA203202

Oct 3, 2016

NORTHERA

NDA NDA203202

Feb 10, 2017

NORTHERA

NDA NDA203202

Sources

References

[1]
ClinicalTrials.gov — 34 trial records for Droxidopa. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Droxidopa compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Droxidopa. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA203202). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Lundbeck company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Adrenergic Receptor Agonist[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Lundbeck

Northera

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2028

Q2 2030

Trials by Indication[1]

Orthostatic Hypotension10 trials

Parkinson's Disease5 trials

Hypotension2 trials

Menkes disease2 trials

CAR2 trials

Pain1 trial

AIN1 trial

Tics1 trial

Hemodynamic Response1 trial

Spinal Cord Injury1 trial

Treatment1 trial

Fibromyalgia1 trial

Chronic Fatigue Syndrome1 trial

Parkinson disease1 trial

Parkinsonism1 trial

Autonomic Failure1 trial

Acute Kidney Injury1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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