trandolapril
Trade name: mavik
Approved
Apr 26, 1996
Trandolapril is a non-sulhydryl prodrug that belongs to the angiotensin-converting enzyme (ACE) inhibitor class of medications. It is metabolized to its biologically active diacid form, trandolaprilat, in the liver. Trandolaprilat inhibits ACE, the enzyme responsible for the conversion of angiotensin I (ATI) to angiotensin II (ATII). ATII regulates blood pressure and is a key component of the renin-angiotensin-aldosterone system (RAAS). Trandolapril may be used to treat mild to moderate hypertension, to improve survival following myocardial infarction in clinically stable patients with left ventricular dysfunction, as an adjunct treatment for congestive heart failure, and to slow the rate of progression of renal disease in hypertensive individuals with diabetes mellitus and microalbuminuria or overt nephropathy. Trandolapril is marketed by Abbott Laboratories under the brand name Mavik. — NCATS
Clinical trial activity
17 trials · 17 clinical orgs · 16 marketing orgs
Earliest trial started Mar 1, 1997 (NCT00235014)
Timeline
1990s
- Apr 26, 1996
Earliest FDA Approval
- Apr 26, 1996
AbbVie — NDA Secondary Org
2000s
- Jan 1, 2002
Earliest Phase 3 Sponsor(trial)
- Jan 1, 2004
- Dec 12, 2006
Teva — Marketing Organization
- Jun 12, 2007
Aurobindo Pharma — Marketing Organization
- Jun 12, 2007
Cipla — Marketing Organization
- Jun 12, 2007
Epic Pharma Llc — Marketing Organization
- Jun 12, 2007
Invagen Pharms — Marketing Organization
- Jun 12, 2007
Lupin — Marketing Organization
- Jun 12, 2007
Watson Pharmaceuticals — Marketing Organization
- Jun 12, 2007
Chartwell Pharmaceuticals — Marketing Organization
- Apr 28, 2008
Mylan — Marketing Organization
- Apr 28, 2008
PHARMOBEDIENT — Marketing Organization
- Aug 25, 2008
Dr. Reddy's Laboratories — Marketing Organization
- Aug 25, 2008
ANDA Repository — Marketing Organization
- Aug 25, 2008
Senores Pharms — Marketing Organization
2010s
- May 5, 2010
Glenmark Pharmaceuticals — Marketing Organization
Indications
Approved for
Studied for
- Aortic Valve Stenosis · Phase 4
- Coronary Artery Disease · Phase 4
- Diabetes Mellitus · Phase 4
- Diabetes Mellitus, Type 2 · Phase 4
- Healthy Volunteers · Phase 1
- Heart Diseases · Phase 4
- Heart Failure · Phase 4
- Hypertension · Phase 4
- Hypotension · Phase 4
- Metabolic Syndrome · Phase 4
- Obesity · Phase 3
- Proteinuria · Phase 4
- Ventricular Dysfunction, Left · Phase 4
Mechanism of action
- Angiotensin-converting enzymeINHIBITOR
ACE inhibitor
Combination products
tarka
with verapamil
Approval history
- approvedApr 26, 1996
Chemistry & pharmacology
SMILES
C[C@H](N[C@@H](CCC1=CC=CC=C1)C(O)=O)C(=O)N2[C@H]3CCCC[C@@H]3C[C@H]2C(O)=O- Mol. weight
- 402.484 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Availability
- Prescription Only
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaTrandolapril ↗
- NCATSRR6866VL0O ↗
- ChEMBLCHEMBL1519 ↗
- ChEMBLCHEMBL1201387 ↗
Also known as
- 1-(2-((1-(ethoxycarbonyl)-3-phenylpropyl)amino)-1-oxopropyl)octahydro-1h-indol-2-carboxylic acid
- abbott brand of trandolapril
- alter brand of trandolapril
- aventis brand of trandolapril
- aventis pharma brand of trandolapril
- gopten
- gopten
- gopten
- gopten
- hoechst brand of trandolapril
- indolapril
- indolapril
- knoll brand of trandolapril
- mavik
- mavik
- mavik
- mavik
- mavik
- odrik
- odrik
- odrik
- odrik
- ru44570
- ru 44570
- ru-44570
- ru-44570
- ru-44570
- trandolapril
- trandolapril
- trandolapril
- trandolapril
- trandolapril
- trandolapril
- trandolapril
- trandolapril
- trandolapril
- trandolapril
- trandolapril
- trandolaprilum
- trandolaprilum
- udrik
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT02817360 | Phase 4 | Feb 1, 2016 | Medical University of Vienna, University of Vienna |
| NCT01669434 | Phase 4 | Jun 1, 2015 | University of Nebraska |
| NCT01437371 | Phase 3 | Aug 1, 2011 | LivaNova, Servier, University Clermont Auvergne |
| NCT00887510 | Phase 4 | May 1, 2007 | National Heart, Lung, and Blood Institute (NHLBI), University of Florida |
| NCT00391846 | Phase 4 | Oct 1, 2006 | AstraZeneca, Danderyds Hospital |
| NCT01164787 | Phase 1 | Mar 1, 2006 | Dr. Reddy's Laboratories, Piramal |
| NCT01164800 | Phase 1 | Mar 1, 2006 | Dr. Reddy's Laboratories, Piramal |
| NCT00252317 | Phase 4 | Nov 1, 2005 | University of Copenhagen |
| NCT00840073 | Phase 1 | Oct 1, 2004 | Pharma Medica, Teva |
| NCT00840632 | Phase 1 | Oct 1, 2004 | Biovail, Teva |
| NCT00235001 | Phase 4 | Jun 1, 2004 | Abbott |
| NCT00233532 | Phase 4 | Mar 1, 2004 | Abbott |
| NCT00234858 | Phase 4 | Mar 1, 2004 | Abbott |
| NCT00234871 | Phase 4 | Jan 1, 2004 | Abbott |
| NCT00679653 | Phase 3 | Feb 1, 2002 | Abbott |
| NCT00133692 | Phase 4 | Sep 1, 1997 | Abbott, University of Florida |
| NCT00235014 | Phase 4 | Mar 1, 1997 | Abbott |
Organizations
Research & Development (17)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Abbott | For profit | 7 | 6 | 2 | 1997 |
| Dr. Reddy's Laboratories | For profit | 2 | 2 | 1 | 2006 |
| Piramal | For profit | 2 | 0 | 1 | 2006 |
| Teva | For profit | 2 | 2 | 1 | 2004 |
| University of Florida | Academic/Hospital | 2 | 2 | 1 | 1997 |
| AstraZeneca | For profit | 1 | 1 | 1 | 2006 |
| Biovail | For profit | 1 | 0 | 1 | 2004 |
| Danderyds Hospital | Academic/Hospital | 1 | 0 | 1 | 2006 |
| LivaNova | For profit | 1 | 0 | 1 | 2011 |
| Medical University of Vienna | Academic/Hospital | 1 | 1 | 1 | 2016 |
| National Heart, Lung, and Blood Institute (NHLBI) | Government | 1 | 0 | 1 | 2007 |
| Pharma Medica | For profit | 1 | 0 | 1 | 2004 |
| Servier | For profit | 1 | 0 | 1 | 2011 |
| University Clermont Auvergne | Academic/Hospital | 1 | 1 | 1 | 2011 |
| University of Copenhagen | Academic/Hospital | 1 | 1 | 1 | 2005 |
| University of Nebraska | Academic/Hospital | 1 | 1 | 1 | 2015 |
| University of Vienna | Academic/Hospital | 1 | 0 | 1 | 2016 |
Marketing (18)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| ANDA Repository | For profit | MKTG | Aug 25, 2008 |
| AbbVie | For profit | NDA2 | Apr 26, 1996 |
| Aurobindo Pharma | For profit | MKTG | Jun 12, 2007 |
| Chartwell Pharmaceuticals | For profit | MKTG | Jun 12, 2007 |
| Cipla | For profit | MKTG | Jun 12, 2007 |
| Dr. Reddy's Laboratories | For profit | MKTG | Aug 25, 2008 |
| Epic Pharma Llc | For profit | SYN | Jun 18, 2008 |
| Epic Pharma Llc | For profit | MKTG | Jun 12, 2007 |
| Glenmark Pharmaceuticals | For profit | MKTG | May 5, 2010 |
| Glenmark Pharmaceuticals | For profit | SYN | May 5, 2010 |
| Invagen Pharms | For profit | MKTG | Jun 12, 2007 |
| Knoll | For profit | NDA | — |
| Lupin | For profit | MKTG | Jun 12, 2007 |
| Mylan | For profit | MKTG | Apr 28, 2008 |
| PHARMOBEDIENT | For profit | MKTG | Apr 28, 2008 |
| Senores Pharms | For profit | MKTG | Aug 25, 2008 |
| Teva | For profit | MKTG | Dec 12, 2006 |
| Watson Pharmaceuticals | For profit | MKTG | Jun 12, 2007 |