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droxidopa

Trade name: northera

Small moleculeapprovedOrphan Drug FDAFast Track FDA

Approved

Feb 18, 2014

Droxidopa (Northera, Chelsea Therapeutics) is a synthetic catecholamino acid precursor of norepinephrine indicated for the treatment of orthostatic dizziness or lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension (NOH) caused by primary autonomic failure, dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. Droxidopa was approved as oral therapy in February 2014 under the FDA’s accelerated approval program. Droxidopa is directly metabolized to norepinephrine by dopadecarboxylase. The specific mechanism of action of the drug is not known completely, but it is supposed to exert the pharmacological effects through norepinephrine and not through the parent molecule or other metabolites. It increases blood flow to the brain by stimulating peripheral arterial and venous vasoconstriction. — NCATS

Clinical trial activity

39 trials · 39 clinical orgs · 24 marketing orgs

Phase 1
9
Phase 2
24
Phase 3
9
Phase 4
6

Earliest trial started Mar 1, 1999 (NCT00004478)

Timeline

2000s

  1. Jan 1, 2004

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2007

    Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2007

    Chelsea Therapeutics — Earliest Phase 2 Sponsor(trial)

  4. Jan 17, 2007

    Orphan Drug Designation

2010s

  1. Feb 18, 2014

    Chelsea Therapeutics — Earliest FDA Approval

  2. Feb 18, 2014

    Lundbeck — NDA Secondary Org

  3. Feb 18, 2014

    Chelsea Therapeutics — NDA Organization

2020s

  1. Dec 4, 2020

    Tasman Pharma — Marketing Organization

  2. Feb 18, 2021

    Zydus Discovery DMCC — Marketing Organization

  3. Feb 18, 2021

    Ajanta Pharma Ltd — Marketing Organization

  4. Feb 18, 2021

    Alkem Labs Ltd — Marketing Organization

  5. Feb 18, 2021

    Hetero Labs Ltd — Marketing Organization

  6. Feb 18, 2021

    Aurobindo Pharma — Marketing Organization

  7. Feb 18, 2021

    Hikma — Marketing Organization

  8. Feb 18, 2021

    Lupin — Marketing Organization

  9. Feb 18, 2021

    MSN Laboratories — Marketing Organization

  10. Feb 18, 2021

    Sciegen Pharmaceticals — Marketing Organization

  11. Feb 18, 2021

    Sun Pharmaceuticals — Marketing Organization

  12. Feb 18, 2021

    Teva — Marketing Organization

  13. Feb 18, 2021

    Upsher-Smith Laboratories — Marketing Organization

  14. Feb 18, 2021

    Jubilant Innovation Ltd. — Marketing Organization

  15. Apr 28, 2021

    Bionpharma Inc — Marketing Organization

  16. May 5, 2021

    Tris Pharma, Inc. — Marketing Organization

  17. May 5, 2021

    Somerset Pharmaceuticals — Marketing Organization

  18. Nov 1, 2021

    Adaptis Pharma — Marketing Organization

  19. Nov 1, 2021

    Slate Pharmaceuticals — Marketing Organization

  20. Nov 1, 2021

    SLATE RUN PHARMA — Marketing Organization

  21. May 5, 2022

    Celltrion — Marketing Organization

  22. May 5, 2022

    Chartwell Pharmaceuticals — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedFast trackFeb 18, 2014

Chemistry & pharmacology

Loading structure…

SMILES

N[C@@H]([C@H](O)C1=CC=C(O)C(O)=C1)C(O)=O
Mol. weight
213.1873 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warningFirst in classProdrug

Sources

Also known as

  • dihydroxyphenylserine
  • dihydroxyphenylserine
  • dops
  • dops
  • dops
  • droxidopa
  • droxidopa
  • droxidopa
  • droxidopa
  • droxidopa
  • droxidopa
  • droxidopa
  • droxidopa
  • droxidopa
  • l-dihydroxyphenylserine
  • l-dihydroxyphenylserine
  • l-dops
  • l-dops
  • l-dops
  • l-dops
  • l-threo
  • l-threo-3,4-dihydroxyphenylserine
  • l-threo-dihydroxyphenylserine
  • l-threo-dihydroxyphenylserine
  • l-threo dops
  • northera
  • northera
  • northera
  • northera
  • northera
  • northera
  • northera
  • northera
  • threo-dopaserine

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06937307Phase 2May 27, 2025Columbia University
NCT04977388Phase 1/Phase 2 (Phase 2)Jul 12, 2021Ohio State University
NCT04510922Phase 4Feb 11, 2019Lundbeck, University of Cincinnati
NCT03229174Phase 4Aug 23, 2018Lundbeck, Methodist Cancer Center, Houston, Texas
NCT03567447Phase 2Aug 17, 2018Arizona State University, Lundbeck, University of Arizona
NCT03602014Phase 4Jun 1, 2018Department of Veteran Affairs, State of New York
NCT03446807Phase 2Apr 30, 2018Loma Linda University, Lundbeck
NCT03115827Phase 4Apr 18, 2017American Academy of Neurology, Lundbeck, Vanderbilt University
NCT03034564Phase 4Jan 1, 2017Rowan University
NCT02897063Phase 1Sep 1, 2016Vanderbilt University
NCT02812147Phase 2May 1, 2016Arizona State University, St. Joseph's Hospital and Medical Center - Phoenix, Arizona, University of Arizona
NCT03173781N/AApr 1, 2016Colorado Springs Neurological Associates, Lundbeck
NCT02586623Phase 4Feb 1, 2016Lundbeck
NCT02624310Phase 2Jan 1, 2016New York University
NCT02558972Phase 2Sep 1, 2015Lundbeck, New York Medical College
NCT02066571Phase 2Mar 1, 2015Henry Ford Health System
NCT02071459Phase 2/Phase 3 (Phase 3)Feb 1, 2014University of Toulouse
NCT01927055Phase 3Nov 1, 2013Chelsea Therapeutics, New York University
NCT01468259Phase 1Oct 1, 2012Chelsea Therapeutics
NCT01612078Phase 3Jun 1, 2012Taipei Medical University, TSH Biopharm Corporation Limited
Showing 20 of 39 trials
Page 1 / 2

Organizations

Research & Development (39)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Chelsea TherapeuticsFor profit151432007
LundbeckFor profit8132015
New York UniversityAcademic/Hospital7131999
Vanderbilt UniversityAcademic/Hospital4442004
Mayo ClinicAcademic/Hospital3122008
University of LondonAcademic/Hospital3022008
Arizona State UniversityAcademic/Hospital2012016
Chiltern InternationalFor profit2012008
Department of Veteran AffairsGovernment2222011
Harvard UniversityAcademic/Hospital2122008
Henry Ford Health SystemAcademic/Hospital2112012
University of ArizonaAcademic/Hospital2212016
American Academy of NeurologyAcademic/Hospital1012017
Arkansas CardiologyAcademic/Hospital1012008
Bayview NephrologyAcademic/Hospital1012007
Bradenton Neurology, IncAcademic/Hospital1012008
Colorado Springs Neurological AssociatesAcademic/Hospital1112016
Columbia UniversityAcademic/Hospital1112025
Hunter-Hopkins Center, P.A.Academic/Hospital1012010
Icahn School of Medicine at Mount SinaiAcademic/Hospital1111999
39 organizations
Page 1 / 2

Marketing (27)

OrganizationOrg typeRelationshipDate
Adaptis PharmaFor profitMKTGNov 1, 2021
Ajanta Pharma LtdFor profitMKTGFeb 18, 2021
Alkem Labs LtdFor profitMKTGFeb 18, 2021
Aurobindo PharmaFor profitMKTGFeb 18, 2021
Bionpharma IncFor profitMKTGApr 28, 2021
Bionpharma IncFor profitSYNApr 28, 2021
CelltrionFor profitMKTGMay 5, 2022
Chartwell PharmaceuticalsFor profitMKTGMay 5, 2022
Chelsea TherapeuticsFor profitNDAFeb 18, 2014
Hetero Labs LtdFor profitMKTGFeb 18, 2021
HikmaFor profitMKTGFeb 18, 2021
HikmaFor profitSYNFeb 18, 2021
Jubilant Innovation Ltd.For profitMKTGFeb 18, 2021
LundbeckFor profitNDA2Feb 18, 2014
LupinFor profitMKTGFeb 18, 2021
MSN LaboratoriesFor profitMKTGFeb 18, 2021
SLATE RUN PHARMAFor profitMKTGNov 1, 2021
Sciegen PharmaceticalsFor profitMKTGFeb 18, 2021
Slate PharmaceuticalsFor profitMKTGNov 1, 2021
Somerset PharmaceuticalsFor profitMKTGMay 5, 2021
Sun PharmaceuticalsFor profitMKTGFeb 18, 2021
Tasman PharmaFor profitMKTGDec 4, 2020
TevaFor profitMKTGFeb 18, 2021
Tris Pharma, Inc.For profitMKTGMay 5, 2021
Upsher-Smith LaboratoriesFor profitMKTGFeb 18, 2021
Zydus Discovery DMCCFor profitMKTGMay 14, 2020
Zydus Discovery DMCCFor profitMKTGFeb 18, 2021