disopyramide

Trade name: norpace

Small moleculeapproved

Approved

Sep 1, 1977

Disopyramide is an antiarrhythmic drug indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia that are life-threatening. In man, Disopyramide at therapeutic plasma levels shortens the sinus node recovery time, lengthens the effective refractory period of the atrium, and has a minimal effect on the effective refractory period of the AV node. Little effect has been shown on AV-nodal and His-Purkinje conduction times or QRS duration. However, prolongation of conduction in accessory pathways occurs. Disopyramide is a Type 1A antiarrhythmic drug (ie, similar to procainamide and quinidine). It inhibits the fast sodium channels. In animal studies Disopyramide decreases the rate of diastolic depolarization (phase 4) in cells with augmented automaticity, decreases the upstroke velocity (phase 0) and increases the action potential duration of normal cardiac cells, decreases the disparity in refractoriness between infarcted and adjacent normally perfused myocardium, and has no effect on alpha- or beta-adrenergic receptors. It is used for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, ventricular pre-excitation and cardiac dysrhythmias. It is a Class Ia antiarrhythmic drug. — NCATS

Clinical trial activity

2 trials · 4 clinical orgs · 13 marketing orgs

Phase 1
0
Phase 2
1
Phase 3
1
Phase 4
0

Earliest trial started Mar 1, 1995 (NCT00000556)

Timeline

1970s

  1. Sep 1, 1977

    G D Searle — Earliest FDA Approval

  2. Sep 1, 1977

    G D Searle — NDA Secondary Org

  3. Sep 1, 1977

    G D Searle — NDA Organization

  4. Sep 1, 1977

    Pfizer — Marketing Organization

  5. Sep 1, 1977

    Pfizer — NDA Secondary Org

1980s

  1. Feb 22, 1985

    Teva — Marketing Organization

  2. May 31, 1985

    Mayne Pharma — Marketing Organization

  3. May 31, 1985

    Dr. Reddy's Laboratories — Marketing Organization

  4. Dec 10, 1985

    Rising Pharmaceuticals — Marketing Organization

  5. Dec 10, 1985

    Aurobindo Pharma — Marketing Organization

  6. Dec 17, 1985

    Sun Pharmaceuticals — Marketing Organization

  7. Dec 15, 1987

    Nesher Pharms — Marketing Organization

1990s

  1. Jan 1, 1995

    Earliest Phase 3 Sponsor(trial)

Indications

Mechanism of action

Approval history

  • approvedPriority reviewSep 1, 1977

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)N(CCC(C(N)=O)(c1ccccc1)c1ccccn1)C(C)C
Mol. weight
339.48 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 warning

Sources

Also known as

  • dicorantil
  • dirythmin
  • dirythmin-sa
  • disopiramida
  • disopiramida
  • disopyramide
  • disopyramide
  • disopyramide
  • disopyramide
  • disopyramide
  • disopyramide
  • disopyramide
  • disopyramide
  • disopyramide
  • disopyramide
  • disopyramide hydrochloride
  • disopyramide monohydrochloride
  • disopyramide phosphate
  • disopyramide phosphate
  • disopyramide phosphate
  • disopyramide phosphate
  • disopyramide tartrate
  • disopyramidum
  • disopyramidum
  • isomide cr
  • norpace
  • norpace
  • norpace
  • norpace cr
  • norpace cr
  • rythmodan ret
  • sc-13957
  • sc-13957
  • sc-7031
  • sc-7031

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT02294955N/AMay 1, 2008Swedish Heart Lung Foundation, Uppsala University
NCT00000556Phase 3Mar 1, 1995National Heart, Lung, and Blood Institute (NHLBI), Statistics and Epidemiology Research Corporation
Showing 2 of 2 trials
Page 1 / 1

Organizations

Research & Development (4)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Heart, Lung, and Blood Institute (NHLBI)Government1111995
Statistics and Epidemiology Research CorporationAcademic/Hospital1011995
Swedish Heart Lung FoundationAcademic/Hospital1012008
Uppsala UniversityAcademic/Hospital1112008
4 organizations
Page 1 / 1

Marketing (16)

OrganizationOrg typeRelationshipDate
Aurobindo PharmaFor profitMKTGDec 10, 1985
Dr. Reddy's LaboratoriesFor profitMKTGMay 31, 1985
G D SearleFor profitNDA2Sep 1, 1977
G D SearleFor profitNDASep 1, 1977
InterpharmFor profitMKTG
Mayne PharmaFor profitMKTGMay 31, 1985
MylanFor profitMKTG
Nesher PharmsFor profitMKTGDec 15, 1987
PfizerFor profitMKTGSep 1, 1977
PfizerFor profitNDA2Sep 1, 1977
Rising PharmaceuticalsFor profitMKTGDec 10, 1985
Sun PharmaceuticalsFor profitMKTGDec 17, 1985
SuperpharmFor profitMKTG
TevaFor profitSYNNov 18, 1985
TevaFor profitMKTGFeb 22, 1985
Watson PharmaceuticalsFor profitMKTG