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midodrine

Trade name: proamatine

Small moleculeapprovedOrphan Drug FDA

Approved

Sep 6, 1996

Midodrine is a prodrug, i.e., the therapeutic effect of orally administered midodrine is due to the major metabolite desglymidodrine formed by deglycination of midodrine. Desglymidodrine diffuses poorly across the blood-brain barrier, and is therefore not associated with effects on the central nervous system. Administration of midodrine results in a rise in standing, sitting, and supine systolic and diastolic blood pressure in patients with orthostatic hypotension of various etiologies. Standing systolic blood pressure is elevated by approximately 15 to 30 mmHg at 1 hour after a 10-mg dose of midodrine, with some effect persisting for 2 to 3 hours. Midodrine has no clinically significant effect on standing or supine pulse rates in patients with autonomic failure. Midodrine forms an active metabolite, desglymidodrine, that is an alpha1-agonist, and exerts its actions via activation of the alpha-adrenergic receptors of the arteriolar and venous vasculature, producing an increase in vascular tone and elevation of blood pressure. Desglymidodrine does not stimulate cardiac beta-adrenergic receptors. Midodrine is used for the treatment of symptomatic orthostatic hypotension (OH). Midodrine is marketed under the brand names Amatine, ProAmatine, Gutron. — NCATS

Clinical trial activity

81 trials · 66 clinical orgs · 23 marketing orgs

Phase 1
12
Phase 2
19
Phase 3
13
Phase 4
21

Earliest trial started Apr 1, 1997 (NCT00262470)

Timeline

1980s

  1. Jun 21, 1985

    Orphan Drug Designation

1990s

  1. Sep 6, 1996

    Shire — Earliest FDA Approval

  2. Sep 6, 1996

    Shire — NDA Organization

  3. Sep 6, 1996

    Takeda — Marketing Organization

  4. Sep 6, 1996

    Takeda — NDA Secondary Org

  5. Jan 1, 1997

    Earliest Phase 1 Sponsor(trial)

2000s

  1. Jan 1, 2001

    Earliest Phase 2 Sponsor(trial)

  2. Sep 10, 2003

    Mylan — Marketing Organization

  3. Sep 11, 2003

    CASI Pharmaceuticals, Inc. — Marketing Organization

  4. Sep 11, 2003

    Chartwell Pharmaceuticals — Marketing Organization

  5. May 27, 2004

    Impax Laboratories — Marketing Organization

  6. Nov 3, 2004

    Upsher-Smith Laboratories — Marketing Organization

  7. Nov 3, 2004

    Yiling Pharmaceutical Inc. — Marketing Organization

  8. Sep 12, 2006

    Apotex — Marketing Organization

2010s

  1. Jan 1, 2012

    Earliest Phase 3 Sponsor(trial)

  2. Oct 29, 2018

    Par Pharmaceuticals — Marketing Organization

  3. Oct 29, 2018

    Bristol-Myers Squibb — Marketing Organization

  4. Oct 29, 2018

    Endo Pharmaceuticals — Marketing Organization

  5. Oct 29, 2018

    PH HEALTH — Marketing Organization

  6. Nov 2, 2018

    Unique Pharmaceuticals Ltd, India — Marketing Organization

  7. Nov 2, 2018

    THINQ Pharma CRO Ltd. — Marketing Organization

  8. Aug 19, 2019

    Rubicon Research — Marketing Organization

2020s

  1. Aug 10, 2020

    Aurobindo Pharma — Marketing Organization

  2. Sep 1, 2020

    Zydus Discovery DMCC — Marketing Organization

  3. Oct 1, 2020

    Cerovene — Marketing Organization

  4. Oct 1, 2020

    Exeltis — Marketing Organization

  5. Jan 21, 2021

    Alembic — Marketing Organization

  6. Oct 17, 2023

    SciTech Development, LLC — Marketing Organization

  7. Nov 1, 2023

    Mankind Pharma — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedSep 6, 1996

Chemistry & pharmacology

Loading structure…

SMILES

COc1ccc(OC)c(C(O)CNC(=O)CN)c1
Mol. weight
254.29 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warningProdrug

Sources

Also known as

  • 1-(2',5'-dimethoxyphenyl)-2-glycinamidoethanol
  • 1-(2',5'-dimethoxyphenyl)-2-glycinamidoethanol
  • 2-amino-n-(2,5-dimethoxy-beta-hydroxyphenethyl)acetamide
  • 2-amino-n-(2,5-dimethoxy-beta-hydroxyphenethyl)acetamide
  • (+-)-2-amino-n-(beta-hydroxy-2,5-dimethoxyphenethyl)acetamide
  • (+-)-2-amino-n-(beta-hydroxy-2,5-dimethoxyphenethyl)acetamide
  • a-4020 linz
  • a-4020 linz
  • bramox
  • dl-n1-(beta-hydroxy-2,5-dimethoxyphenethyl)glycinamid
  • dl-n1-(beta-hydroxy-2,5-dimethoxyphenethyl)glycinamid
  • gutron
  • gutron
  • midodrin
  • midodrin
  • midodrin
  • midodrina
  • midodrina
  • midodrine
  • midodrine
  • midodrine
  • midodrine
  • midodrine
  • midodrine
  • midodrine
  • midodrine
  • (+/-)-midodrine
  • midodrine hcl
  • midodrine hcl
  • midodrine hcl
  • midodrine hydrochloride
  • midodrine hydrochloride
  • midodrine hydrochloride
  • midodrine hydrochloride
  • midodrine hydrochloride
  • midodrine monohydrochloride
  • midodrine monohydrochloride
  • midodrine monohydrochloride
  • midodrine monohydrochloride
  • midodrine monohydrochloride
  • midodrine monohydrochloride
  • midodrinum
  • midodrinum
  • midon
  • midon
  • proamatine
  • proamatine
  • proamatine
  • proamatine
  • st-1085
  • st-1085
  • st-1085 [as the base]
  • st-1085 [as the base]
  • st. peter 224
  • st. peter 224

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06930235N/AMar 13, 2025Sohag University
NCT06405555Phase 2/Phase 3 (Phase 3)Aug 1, 2024University of Ottawa
NCT06319248Phase 2/Phase 3 (Phase 3)May 14, 2024Mayo Clinic
NCT06245590N/AFeb 10, 2024Institute of Liver and Biliary Sciences, India
NCT06213935N/AFeb 1, 2024Sohag University
NCT06091345N/AOct 25, 2023Institute of Liver and Biliary Sciences, India
NCT05839652Phase 4Jul 1, 2023Department of Veteran Affairs, Kessler Foundation
NCT05803148N/AApr 5, 2023Capital Medical University, Chinese Academy of Medical Sciences, Henan Provincal People's Hospital, Jiao Tong University, Ningbo No. 1 Hospital, Sun Yat-Sen University, Yeditepe University
NCT05778838Phase 4Apr 1, 2023Mansoura University
NCT05548985N/AOct 31, 2022Cairo University
NCT05287100N/AApr 4, 2022Institute of Liver and Biliary Sciences, India
NCT05084534N/ANov 1, 2021Institute of Liver and Biliary Sciences, India
NCT05060523N/ASep 19, 2021Institute of Liver and Biliary Sciences, India
NCT04816240N/AMay 15, 2021Institute of Liver and Biliary Sciences, India
NCT05058612Phase 4Mar 22, 2021Government of Canada, University of Alberta, University of Calgary
NCT05240391Phase 3Feb 20, 2021Asian Institute of Gastroenterology
NCT04782830N/AFeb 5, 2021Vanderbilt University
NCT04489589Phase 4Nov 30, 2020Government of Canada, University of Alberta, University of Calgary
NCT04621617Phase 3Nov 30, 2020Postgraduate Institute of Medical Education and Research
NCT04595942Phase 3Nov 19, 2020Ahvaz Jundishapur University of Medical Sciences, AJA University of Medical Sciences, Imam Khomeini Hospital, Isfahan University, Mahidol University, Rajaie Cardiovascular Medical and Research Center, Shahid Beheshti University of Medical Sciences, Tehran University of Medical Science, University of Tehran, Urmia University of Medical Sciences
Showing 20 of 81 trials
Page 1 / 5

Organizations

Research & Development (66)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Institute of Liver and Biliary Sciences, IndiaAcademic/Hospital111112018
Department of Veteran AffairsGovernment101042003
Vanderbilt UniversityAcademic/Hospital8641997
ShireFor profit5512002
University of CalgaryAcademic/Hospital4221997
Kendle International Inc.For profit3012002
Kessler FoundationAcademic/Hospital3032014
Mayo ClinicAcademic/Hospital3322017
MylanFor profit3312002
University of AlbertaAcademic/Hospital3322005
University of BarcelonaAcademic/Hospital3322008
University of VirginiaAcademic/Hospital3322014
Government of CanadaGovernment2012020
Icahn School of Medicine at Mount SinaiAcademic/Hospital2111999
Mansoura UniversityAcademic/Hospital2222020
National Heart, Lung, and Blood Institute (NHLBI)Government2022018
National Institutes of Health (NIH)Government2011997
Postgraduate Institute of Medical Education and ResearchAcademic/Hospital2212013
Seoul National UniversityAcademic/Hospital2212014
Sohag UniversityAcademic/Hospital2212024
66 organizations
Page 1 / 4

Marketing (29)

OrganizationOrg typeRelationshipDate
AlembicFor profitMKTGJan 21, 2021
AlembicFor profitSYNJan 21, 2021
ApotexFor profitMKTGSep 12, 2006
ApotexFor profitSYNSep 12, 2006
Aurobindo PharmaFor profitMKTGAug 10, 2020
Bristol-Myers SquibbFor profitMKTGOct 29, 2018
CASI Pharmaceuticals, Inc.For profitMKTGSep 11, 2003
CeroveneFor profitMKTGOct 1, 2020
Chartwell PharmaceuticalsFor profitMKTGSep 11, 2003
Endo PharmaceuticalsFor profitMKTGOct 29, 2018
ExeltisFor profitMKTGOct 1, 2020
Impax LaboratoriesFor profitMKTGMay 27, 2004
Mankind PharmaFor profitMKTGNov 1, 2023
MylanFor profitMKTGSep 10, 2003
PH HEALTHFor profitMKTGOct 29, 2018
Par PharmaceuticalsFor profitMKTGOct 29, 2018
Rubicon ResearchFor profitMKTGAug 19, 2019
Rubicon ResearchFor profitSYNAug 19, 2019
SciTech Development, LLCFor profitMKTGOct 17, 2023
ShireFor profitNDASep 6, 1996
THINQ Pharma CRO Ltd.For profitMKTGNov 2, 2018
TakedaFor profitMKTGSep 6, 1996
TakedaFor profitNDA2Sep 6, 1996
Unique Pharmaceuticals Ltd, IndiaFor profitMKTGNov 2, 2018
Unique Pharmaceuticals Ltd, IndiaFor profitSYNNov 2, 2018
Upsher-Smith LaboratoriesFor profitMKTGNov 3, 2004
Yiling Pharmaceutical Inc.For profitMKTGNov 3, 2004
Zydus Discovery DMCCFor profitMKTGSep 1, 2020
Zydus Discovery DMCCFor profitSYNSep 1, 2020