nicardipine

Trade name: cardene

Small moleculeapproved

Approved

Dec 21, 1988

Nicardipine is a potent calcium channel blockader with marked vasodilator action used to treat high blood pressure and angina. By deforming the channel, inhibiting ion-control gating mechanisms, and/or interfering with the release of calcium from the sarcoplasmic reticulum, nicardipine inhibits the influx of extracellular calcium across the myocardial and vascular smooth muscle cell membranes The decrease in intracellular calcium inhibits the contractile processes of the myocardial smooth muscle cells, causing dilation of the coronary and systemic arteries, increased oxygen delivery to the myocardial tissue, decreased total peripheral resistance, decreased systemic blood pressure, and decreased afterload. — NCATS

Clinical trial activity

38 trials · 63 clinical orgs · 34 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Jan 1, 2004 (NCT00325793)

Timeline

1980s

Dec 21, 1988
Earliest FDA Approval
Dec 21, 1988
Chiesi — Marketing Organization
Dec 21, 1988
Chiesi — NDA Secondary Org

1990s

Jul 18, 1996
Mylan — Marketing Organization
Jul 18, 1996
PHARMOBEDIENT — Marketing Organization
Oct 28, 1996
Ani Pharmaceuticals — Marketing Organization
Oct 28, 1996
Watson Pharmaceuticals — Marketing Organization
Mar 19, 1998
Epic Pharma Llc — Marketing Organization

2000s

Jan 1, 2004
Earliest Phase 3 Sponsor(trial)
Jan 1, 2005
Earliest Phase 1 Sponsor(trial)
Jan 1, 2007
Earliest Phase 2 Sponsor(trial)
Jul 24, 2008
Hikma — Marketing Organization
Jul 24, 2008
Exela Pharma Sciences, LLC. — NDA Secondary Org
Jul 24, 2008
Hikma — NDA Secondary Org
Nov 17, 2009
Sankyo — Marketing Organization
Nov 17, 2009
Sun Pharmaceuticals — NDA Secondary Org
Nov 17, 2009
Lutipold — Marketing Organization
Nov 17, 2009
Navinta — Marketing Organization
Nov 17, 2009
Wockhardt — Marketing Organization
Nov 17, 2009
Sun Pharmaceuticals — Marketing Organization
Nov 17, 2009
Apicore — Marketing Organization
Nov 17, 2009
Daiichi Sankyo — Marketing Organization
Nov 17, 2009
Mankind Pharma — Marketing Organization
Nov 17, 2009
Somerset Pharmaceuticals — Marketing Organization
Dec 28, 2009
West-Ward Pharmaceutical — Marketing Organization

2020s

Apr 8, 2021
Aurobindo Pharma — Marketing Organization
Apr 8, 2021
Eugia Pharma — Marketing Organization
Dec 16, 2022
Glenmark Pharmaceuticals — Marketing Organization
May 3, 2023
Square Pharmaceuticals — Marketing Organization
May 3, 2023
Bionpharma Inc — Marketing Organization
Jul 7, 2023
Micro Labs Ltd India — Marketing Organization
Jul 17, 2023
Senores Pharms — Marketing Organization
Jul 17, 2023
ANDA Repository — Marketing Organization
Apr 10, 2024
Amneal Pharmaceuticals — Marketing Organization
Apr 17, 2024
Inforlife — Marketing Organization
Sep 6, 2024
CHENGDU SHUODE — Marketing Organization
Sep 24, 2024
Cipla — Marketing Organization
Aug 20, 2025
Nanjing King-Friend — Marketing Organization
Oct 22, 2025
Caplin Point Laboratories — Marketing Organization
Oct 28, 2025
Qilu Pharmaceutical Co., Ltd. — Marketing Organization

Mechanism of action

Voltage-gated L-type calcium channelBLOCKER
Voltage-gated L-type calcium channel blocker

Approval history

approvedDec 21, 1988

Chemistry & pharmacology

Loading structure…

SMILES

COC(=O)C1=C(C)NC(C)=C(C(=O)OCCN(C)Cc2ccccc2)C1c1cccc([N+](=O)[O-])c1

Mol. weight: 479.53 g/mol
Lipinski Ro5: Pass
Rule of 3: No
Chirality: Racemic Mixture
Inorganic: No
Polymer: No
Delivery: Oral, Parenteral
Availability: Prescription Only

Oral

Yes

Parenteral

Yes

Topical

Sources

Also known as

cardene
cardene
cardene
cardene
cardene sr
cardene sr
nicardipine
nicardipine
nicardipine
nicardipine
nicardipine
nicardipine
nicardipine
nicardipine
nicardipine
nicardipine
(+/-)-nicardipine
nicardipine hcl
nicardipine hcl
nicardipine hcl
nicardipine hydrochloride
nicardipine hydrochloride
nicardipine hydrochloride
nicardipine hydrochloride
nicardipine hydrochloride
nicardipino
nicardipino
nicardipinum
nicardipinum
perdipine
perdipine
perpidine
rs-69216
rs-69216
rs-69216-xx-07-0
rs-69216-xx-07-0
yc-93
yc-93

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT07246629	Phase 4	Jan 31, 2026	Advocate Healthcare, Wake Forest University
NCT07302919	Phase 2/Phase 3 (Phase 3)	Jan 15, 2026	University of Basel
NCT07044232	Phase 4	Oct 1, 2025	Aarhus University
NCT07277283	Phase 4	Feb 1, 2025	Haseki Training and Research Hospital
NCT06465719	N/A	Jan 1, 2025	Fudan University, Nanjing University, Peking University, Zhejiang University
NCT06677970	Phase 3	Dec 1, 2024	Yonsei University
NCT06329635	N/A	May 27, 2024	Guizhou Medical University
NCT06093893	Phase 4	Mar 31, 2024	Boston University
NCT05920538	N/A	Mar 13, 2023	Mahidol University
NCT05625503	Early Phase 1 (Phase 1)	Nov 14, 2022	University of Illinois at Chicago
NCT05586347	N/A	Apr 22, 2022	Nanjing Medical University, Nanjing University
NCT04538534	Phase 3	Nov 1, 2020	University of Monastir
NCT04670809	Phase 3	Jul 27, 2020	Nanjing Yoko Biomedical Co., Ltd.
NCT04269408	Phase 2	Feb 29, 2020	BIT Pharma GmbH, Data Magik Ltd, Medical University Innsbruck, NeuroScios GmbH, pharm-analyt GmbH
NCT04116112	Phase 2	Jan 1, 2020	National Institute of Neurological Disorders and Stroke (NINDS), University of Cincinnati, Vanderbilt University
NCT04205305	Phase 4	Dec 31, 2019	Yonsei University
NCT03184155	Early Phase 1 (Phase 1)	Jul 1, 2017	Thomas Jefferson University
NCT03497351	N/A	May 1, 2017	People's Liberation Army of China
NCT01996436	Phase 4	Aug 1, 2016	Geisinger Clinic, Harvard University, Lenox Hill Hospital, Mayo Clinic, Northwell Health, State University of New York, Buffalo, Temple University, Thomas Jefferson University, University of Illinois at Chicago, University of Michigan, University of Texas at Houston, Wake Forest University, Yale University
NCT02558023	Phase 3	Sep 1, 2015	University of Strasbourg

Showing 20 of 38 trials

Page 1 / 2

Organizations

Research & Development (63)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Yonsei University	Academic/Hospital	5	5	3	2010
National Institute of Neurological Disorders and Stroke (NINDS)	Government	3	0	3	2005
Nanjing Medical University	Academic/Hospital	2	2	2	2010
Nanjing University	Academic/Hospital	2	0	1	2022
National Health and Medical Research Council, Australia	Government	2	0	2	2005
Seoul National University	Academic/Hospital	2	1	2	2009
Thomas Jefferson University	Academic/Hospital	2	1	2	2016
University of Illinois at Chicago	Academic/Hospital	2	1	2	2016
University of Michigan	Academic/Hospital	2	0	2	2011
University of Minnesota	Academic/Hospital	2	2	2	2005
University of New South Wales	Academic/Hospital	2	2	2	2005
University of Strasbourg	Academic/Hospital	2	2	1	2007
University of Texas at Houston	Academic/Hospital	2	1	1	2008
Wake Forest University	Academic/Hospital	2	1	1	2016
Aarhus University	Academic/Hospital	1	1	1	2025
Advocate Healthcare	Academic/Hospital	1	0	1	2026
Astellas	For profit	1	1	1	2013
BIT Pharma GmbH	For profit	1	1	1	2020
Boston University	Academic/Hospital	1	1	1	2024
Capital Medical University	Academic/Hospital	1	0	1	2011

63 organizations

Page 1 / 4

Marketing (41)

Organization	Org type	Relationship	Date
ANDA Repository	For profit	MKTG	Jul 17, 2023
Amneal Pharmaceuticals	For profit	MKTG	Apr 10, 2024
Ani Pharmaceuticals	For profit	MKTG	Oct 28, 1996
Ani Pharmaceuticals	For profit	SYN	Oct 28, 1996
Apicore	For profit	MKTG	Nov 17, 2009
Aurobindo Pharma	For profit	MKTG	Apr 8, 2021
Bionpharma Inc	For profit	MKTG	May 3, 2023
CHENGDU SHUODE	For profit	MKTG	Sep 6, 2024
Caplin Point Laboratories	For profit	MKTG	Oct 22, 2025
Chiesi	For profit	MKTG	Dec 21, 1988
Chiesi	For profit	NDA2	Dec 21, 1988
Cipla	For profit	MKTG	Sep 24, 2024
Daiichi Sankyo	For profit	MKTG	Nov 17, 2009
Epic Pharma Llc	For profit	SYN	Mar 19, 1998
Epic Pharma Llc	For profit	MKTG	Mar 19, 1998
Eugia Pharma	For profit	MKTG	Apr 8, 2021
Exela Pharma Sciences, LLC.	For profit	NDA2	Jul 24, 2008
Glenmark Pharmaceuticals	For profit	MKTG	Dec 16, 2022
Hikma	For profit	MKTG	Jul 24, 2008
Hikma	For profit	NDA2	Jul 24, 2008
Hikma	For profit	SYN	Dec 28, 2009
Inforlife	For profit	MKTG	Apr 17, 2024
Lutipold	For profit	MKTG	Nov 17, 2009
Mankind Pharma	For profit	MKTG	Nov 17, 2009
Micro Labs Ltd India	For profit	MKTG	Jul 7, 2023
Mylan	For profit	MKTG	Jul 18, 1996
Mylan	For profit	SYN	Nov 17, 2009
Nanjing King-Friend	For profit	MKTG	Aug 20, 2025
Navinta	For profit	MKTG	Nov 17, 2009
PHARMOBEDIENT	For profit	MKTG	Jul 18, 1996
Qilu Pharmaceutical Co., Ltd.	For profit	MKTG	Oct 28, 2025
Roche	For profit	NDA	—
Sankyo	For profit	MKTG	Nov 17, 2009
Senores Pharms	For profit	MKTG	Jul 17, 2023
Somerset Pharmaceuticals	For profit	MKTG	Nov 17, 2009
Square Pharmaceuticals	For profit	MKTG	May 3, 2023
Sun Pharmaceuticals	For profit	NDA2	Nov 17, 2009
Sun Pharmaceuticals	For profit	MKTG	Nov 17, 2009
Watson Pharmaceuticals	For profit	MKTG	Oct 28, 1996
West-Ward Pharmaceutical	For profit	MKTG	Dec 28, 2009
Wockhardt	For profit	MKTG	Nov 17, 2009