disopyramide
Trade name: norpace
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
Earliest trial started Mar 1, 1995 (NCT00000556)
Timeline
1970s
- Sep 1, 1977
G D Searle — Earliest FDA Approval
- Sep 1, 1977
G D Searle — NDA Secondary Org
- Sep 1, 1977
G D Searle — NDA Organization
- Sep 1, 1977
Pfizer — Marketing Organization
- Sep 1, 1977
Pfizer — NDA Secondary Org
1980s
- Feb 22, 1985
Teva — Marketing Organization
- May 31, 1985
Mayne Pharma — Marketing Organization
- May 31, 1985
Dr. Reddy's Laboratories — Marketing Organization
- Dec 10, 1985
Rising Pharmaceuticals — Marketing Organization
- Dec 10, 1985
Aurobindo Pharma — Marketing Organization
- Dec 17, 1985
Sun Pharmaceuticals — Marketing Organization
- Dec 15, 1987
Nesher Pharms — Marketing Organization
1990s
- Jan 1, 1995
Earliest Phase 3 Sponsor(trial)
Indications
Approved for
Mechanism of action
- Sodium channel alpha subunitBLOCKER
Sodium channel alpha subunit blocker
- Sodium channel protein type 1 subunit alpha (SCN1A) ↗
- Sodium channel protein type 5 subunit alpha (SCN5A) ↗
- Sodium channel protein type 4 subunit alpha (SCN4A) ↗
- Sodium channel protein type 7 subunit alpha (SCN7A) ↗
- Sodium channel protein type 2 subunit alpha (SCN2A) ↗
- Sodium channel protein type 9 subunit alpha (SCN9A) ↗
- Sodium channel protein type 3 subunit alpha (SCN3A) ↗
- Sodium channel protein type 11 subunit alpha (SCN11A) ↗
- Sodium channel protein type 8 subunit alpha (SCN8A) ↗
- Sodium channel protein type 10 subunit alpha (SCN10A) ↗
- Sodium channel protein type I alpha subunit
- Sodium channel protein type V alpha subunit
- Sodium channel protein type IV alpha subunit
- Sodium channel protein type VII alpha subunit
- Sodium channel protein type IX alpha subunit
- Sodium channel protein type II alpha subunit
- Sodium channel protein type III alpha subunit
- Sodium channel protein type XI alpha subunit
- Sodium channel protein type VIII alpha subunit
- Sodium channel protein type X alpha subunit
- Sodium channel alpha subunits; brain (Types I, II, III)
Approval history
- approvedPriority reviewSep 1, 1977
Chemistry & pharmacology
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
Sources
- ChEMBLCHEMBL517 ↗
- WikipediaDisopyramide ↗
- NCATSGFO928U8MQ ↗
- ChEMBLCHEMBL1201020 ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT02294955 | N/A | May 1, 2008 | Swedish Heart Lung Foundation, Uppsala University |
| NCT00000556 | Phase 3 | Mar 1, 1995 | National Heart, Lung, and Blood Institute (NHLBI), Statistics and Epidemiology Research Corporation |
Organizations
Research & Development (4)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | Government | 1 | 1 | 1 | 1995 |
| Statistics and Epidemiology Research Corporation | Academic/Hospital | 1 | 0 | 1 | 1995 |
| Swedish Heart Lung Foundation | Academic/Hospital | 1 | 0 | 1 | 2008 |
| Uppsala University | Academic/Hospital | 1 | 1 | 1 | 2008 |
Marketing (16)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Aurobindo Pharma | For profit | MKTG | Dec 10, 1985 |
| Dr. Reddy's Laboratories | For profit | MKTG | May 31, 1985 |
| G D Searle | For profit | NDA2 | Sep 1, 1977 |
| G D Searle | For profit | NDA | Sep 1, 1977 |
| Interpharm | For profit | MKTG | — |
| Mayne Pharma | For profit | MKTG | May 31, 1985 |
| Mylan | For profit | MKTG | — |
| Nesher Pharms | For profit | MKTG | Dec 15, 1987 |
| Pfizer | For profit | MKTG | Sep 1, 1977 |
| Pfizer | For profit | NDA2 | Sep 1, 1977 |
| Rising Pharmaceuticals | For profit | MKTG | Dec 10, 1985 |
| Sun Pharmaceuticals | For profit | MKTG | Dec 17, 1985 |
| Superpharm | For profit | MKTG | — |
| Teva | For profit | SYN | Nov 18, 1985 |
| Teva | For profit | MKTG | Feb 22, 1985 |
| Watson Pharmaceuticals | For profit | MKTG | — |