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felodipine

Trade name: plendil

Small moleculeapproved

Approved

Jul 25, 1991

Felodipine is a long-acting 1,4-dihydropyridine calcium channel blocker (CCB)b. It acts primarily on vascular smooth muscle cells by stabilizing voltage-gated L-type calcium channels in their inactive conformation. By inhibiting the influx of calcium in smooth muscle cells, felodipine prevents calcium-dependent myocyte contraction and vasoconstriction. Felodipine is the most potent CCB in use and is unique in that it exhibits fluorescent activity. In addition to binding to L-type calcium channels, felodipine binds to a number of calcium-binding proteins, exhibits competitive antagonism of the mineralcorticoid receptor, inhibits the activity of calmodulin-dependent cyclic nucleotide phosphodiesterase, and blocks calcium influx through voltage-gated T-type calcium channels. Felodipine is used to treat mild to moderate essential hypertension. — NCATS

Clinical trial activity

20 trials · 26 clinical orgs · 19 marketing orgs

Phase 1
5
Phase 2
2
Phase 3
2
Phase 4
7

Earliest trial started Apr 1, 1998 (NCT01136863)

Timeline

1990s

  1. Jul 25, 1991

    Earliest FDA Approval

  2. Jul 25, 1991

    AstraZeneca — NDA Secondary Org

  3. Jan 1, 1999

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Jan 1, 2008

    AstraZeneca — Earliest Phase 1 Sponsor(trial)

  2. Apr 17, 2008

    Mylan — Marketing Organization

2010s

  1. Dec 17, 2010

    Glenmark Pharmaceuticals — Marketing Organization

  2. Oct 28, 2011

    Vintage — Marketing Organization

  3. Oct 28, 2011

    Endo Pharmaceuticals — Marketing Organization

  4. Oct 28, 2011

    Apax Partners — Marketing Organization

  5. Oct 28, 2011

    PH HEALTH — Marketing Organization

  6. Nov 28, 2011

    Torrent Pharmaceuticals Limited — Marketing Organization

  7. Aug 15, 2012

    Wockhardt — Marketing Organization

  8. Jan 17, 2013

    Aurobindo Pharma — Marketing Organization

  9. Nov 8, 2013

    Heritage Pharma — Marketing Organization

  10. Nov 8, 2013

    Emcure — Marketing Organization

  11. Dec 13, 2013

    Sun Pharmaceuticals — Marketing Organization

  12. May 21, 2015

    Orbion Pharms — Marketing Organization

  13. May 21, 2015

    Orchid Pharma — Marketing Organization

  14. Aug 19, 2016

    Jubilant Innovation Ltd. — Marketing Organization

  15. Oct 26, 2018

    Yiling Pharmaceutical Inc. — Marketing Organization

  16. Apr 29, 2019

    Yung Shin Pharm. Ind. Co., Ltd. — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedJul 25, 1991

Chemistry & pharmacology

Loading structure…

SMILES

CCOC(=O)C1=C(C)NC(C)=C(C1C2=CC=CC(Cl)=C2Cl)C(=O)OC
Mol. weight
384.254 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

Also known as

  • 3-ethyl 5-methyl 4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydro-3,5-pyridinedicarboxylate
  • 3-ethyl 5-methyl 4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydro-3,5-pyridinedicarboxylate
  • 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylic acid ethyl methyl ester
  • 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylic acid ethyl methyl ester
  • cabren
  • cardioplen xl
  • dl-felodipine
  • (+-)-ethyl methyl 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylate
  • (+-)-ethyl methyl 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylate
  • felodipina
  • felodipina
  • felodipine
  • felodipine
  • felodipine
  • felodipine
  • felodipine
  • felodipine
  • felodipine
  • felodipine
  • felodipine
  • felodipine
  • felodipine
  • (+/-)-felodipine
  • felodipinum
  • felodipinum
  • felogen xl
  • felotens xl
  • flodil
  • folpik xl
  • h 154/82
  • h 154/82
  • h-154/82
  • h-154/82
  • keloc sr
  • neofel xl
  • parmid xl
  • pinefeld xl
  • plendil
  • plendil
  • plendil
  • plendil
  • preslow
  • preslow
  • (rs)-felodipine
  • vascalpha

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05614037Phase 1Oct 28, 2022Guangzhou Kangqi Medical Technology Co., LTD, Overseas Pharmaceuticals, Ltd.
NCT02744872Phase 4Sep 1, 2013University of Copenhagen
NCT01630655Phase 1Jun 26, 2012Torrent Pharmaceuticals Limited
NCT01630902Phase 1Jun 26, 2012Torrent Pharmaceuticals Limited
NCT02232269Phase 1Feb 1, 2012University of Western Ontario
NCT01520285Phase 4Dec 1, 2011Lee's Pharmaceutical
NCT00841880Phase 4Jan 1, 2009Sanofi
NCT02311530N/AOct 1, 2008Ranbaxy
NCT00905333Phase 1Oct 1, 2008AstraZeneca, Scentryphar Clinical Research
NCT02327247N/ASep 1, 2008Ranbaxy
NCT01238705Phase 4Apr 1, 2008LanZhou University
NCT00742066N/AMar 1, 2008Maastricht University
NCT01390701N/AJan 1, 2008University of Gothenburg
NCT00507845Phase 4Jun 1, 2007Sanofi
NCT00348686Phase 4Jun 1, 2006AstraZeneca
NCT02336607N/ADec 1, 2005AstraZeneca, Peking University
NCT00861016Phase 4Oct 1, 2005AstraZeneca, BeiJing Hypertension League
NCT00679653Phase 3Feb 1, 2002Abbott
NCT00000620Phase 3Sep 1, 1999Centers for Disease Control and Prevention (CDC), Columbia University, National Eye Institute (NEI), National Heart, Lung, and Blood Institute (NHLBI), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute on Aging (NIA), Wake Forest University
NCT01136863N/AApr 1, 1998Beijing Hypertension League Insititute, Chinese Academy of Medical Sciences, Shanxi Kangbao Pharmaceutical company
Showing 20 of 20 trials
Page 1 / 1

Organizations

Research & Development (26)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AstraZenecaFor profit4432005
RanbaxyFor profit2212008
SanofiFor profit2212007
Torrent Pharmaceuticals LimitedFor profit2212012
AbbottFor profit1112002
BeiJing Hypertension LeagueAcademic/Hospital1012005
Beijing Hypertension League InsitituteAcademic/Hospital1011998
Centers for Disease Control and Prevention (CDC)Government1011999
Chinese Academy of Medical SciencesAcademic/Hospital1111998
Columbia UniversityAcademic/Hospital1011999
Guangzhou Kangqi Medical Technology Co., LTDFor profit1012022
LanZhou UniversityAcademic/Hospital1112008
Lee's PharmaceuticalFor profit1112011
Maastricht UniversityAcademic/Hospital1112008
National Eye Institute (NEI)Government1011999
National Heart, Lung, and Blood Institute (NHLBI)Government1111999
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government1011999
National Institute on Aging (NIA)Government1011999
Overseas Pharmaceuticals, Ltd.For profit1112022
Peking UniversityAcademic/Hospital1012005
26 organizations
Page 1 / 2

Marketing (26)

OrganizationOrg typeRelationshipDate
Apax PartnersFor profitMKTGOct 28, 2011
AstraZenecaFor profitNDA2Jul 25, 1991
Aurobindo PharmaFor profitMKTGJan 17, 2013
EmcureFor profitMKTGNov 8, 2013
Endo PharmaceuticalsFor profitMKTGOct 28, 2011
Glenmark PharmaceuticalsFor profitMKTGDec 17, 2010
Glenmark PharmaceuticalsFor profitSYNDec 17, 2010
Heritage PharmaFor profitMKTGNov 8, 2013
Heritage PharmaFor profitSYNNov 8, 2013
Heritage PharmaFor profitSYNNov 8, 2013
Jubilant Innovation Ltd.For profitMKTGAug 19, 2016
MerckFor profitNDA—
MylanFor profitMKTGApr 17, 2008
Orbion PharmsFor profitMKTGMay 21, 2015
Orchid PharmaFor profitMKTGMay 21, 2015
PH HEALTHFor profitMKTGOct 28, 2011
Sun PharmaceuticalsFor profitMKTGDec 13, 2013
Sun PharmaceuticalsFor profitSYNNov 2, 2004
Torrent Pharmaceuticals LimitedFor profitMKTGNov 28, 2011
VintageFor profitMKTGOct 28, 2011
WockhardtFor profitMKTGAug 15, 2012
WockhardtFor profitSYNAug 15, 2012
WockhardtFor profitSYNAug 15, 2012
Yiling Pharmaceutical Inc.For profitMKTGOct 26, 2018
Yiling Pharmaceutical Inc.For profitSYNOct 26, 2018
Yung Shin Pharm. Ind. Co., Ltd.For profitMKTGApr 29, 2019