nifedipine

Trade name: procardia

Small moleculeapproved

Approved

Dec 31, 1981

Nifedipine has been formulated as both a long- and short-acting 1,4-dihydropyridine calcium channel blocker. Nifedipine is sold under the brand names Adalat and Procardia among others. Nifedipine decreases arterial smooth muscle contractility and subsequent vasoconstriction by inhibiting the influx of calcium ions through L-type calcium channels. Calcium ions entering the cell through these channels bind to calmodulin. Calcium-bound calmodulin then binds to and activates myosin light chain kinase (MLCK). Activated MLCK catalyzes the phosphorylation of the regulatory light chain subunit of myosin, a key step in muscle contraction. Signal amplification is achieved by calcium-induced calcium release from the sarcoplasmic reticulum through ryanodine receptors. Inhibition of the initial influx of calcium inhibits the contractile processes of 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. The vasodilatory effects of nifedipine result in an overall decrease in blood pressure. Nifedipine is used for the management of vasospastic angina, chronic stable angina, hypertension, and Raynaud's phenomenon. May be used as a first line agent for left ventricular hypertrophy and isolated systolic hypertension (long-acting agents). — NCATS

Clinical trial activity

144 trials · 145 clinical orgs · 30 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Nov 1, 1990 (NCT00000478)

Timeline

1980s

Dec 31, 1981
Earliest FDA Approval
Dec 31, 1981
Pfizer — NDA Secondary Org
Nov 27, 1985
Bayer — NDA Secondary Org
Apr 28, 1989
Actavis — Marketing Organization
Jul 10, 1989
Chase Pharmaceuticals Corporation — Marketing Organization

1990s

Jan 1, 1990
Earliest Phase 3 Sponsor(trial)
Oct 8, 1991
Leading Pharma Llc — Marketing Organization
Feb 19, 1992
Teva — Marketing Organization
Apr 21, 1993
Norwich Eaton Company — Marketing Organization
Apr 21, 1993
Alvogen — NDA Secondary Org
Apr 21, 1993
Procter and Gamble — NDA Secondary Org
Jul 30, 1993
Intergel Pharms Inc — Marketing Organization
Jul 30, 1993
Acella Pharmaceuticals — Marketing Organization
Jan 1, 1999
Earliest Phase 1 Sponsor(trial)

2000s

Sep 27, 2000
Bausch Health Companies — Marketing Organization
Oct 26, 2001
Watson Pharmaceuticals — Marketing Organization
Mar 23, 2004
Soremartec Italia S.r.l. — Marketing Organization
Jan 1, 2005
Earliest Phase 2 Sponsor(trial)
Nov 21, 2005
Osmotica Pharmaceutical — Marketing Organization
Dec 13, 2006
Par Pharmaceuticals — Marketing Organization

2010s

Sep 13, 2010
Mylan — Marketing Organization
Sep 13, 2010
Rising Pharmaceuticals — Marketing Organization
Apr 25, 2013
Heritage Pharma — Marketing Organization
Apr 25, 2013
Emcure — Marketing Organization
Apr 3, 2014
TWi Biotechnology, Inc. — Marketing Organization
Aug 25, 2016
Novast Labs — Marketing Organization
Dec 19, 2017
Zydus Discovery DMCC — Marketing Organization
Apr 16, 2019
Sun Pharmaceuticals — Marketing Organization

2020s

Nov 18, 2020
Elite Laboratories, Inc — Marketing Organization
Jul 19, 2021
Aurobindo Pharma — Marketing Organization
Mar 29, 2022
Alkem Labs Ltd — Marketing Organization
Nov 18, 2022
Alembic — Marketing Organization
Nov 18, 2022
Pharmadax Inc — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

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

Approval history

approvedPriority reviewDec 31, 1981

Chemistry & pharmacology

Loading structure…

SMILES

CN(C)CCC=C1c2ccccc2COc2ccccc21

Mol. weight: 279.38 g/mol
Lipinski Ro5: Pass
Rule of 3: No
Chirality: Achiral Molecule
Inorganic: No
Polymer: No
Delivery: Oral, Topical
Availability: Prescription Only

Oral

Yes

Parenteral

Topical

Yes

Black box warning

Sources

Also known as

4-(2'-nitrophenyl)-2,6-dimethyl-1,4-dihydropyridin-3,5-dicarbonsaeuredimethylester
4-(2'-nitrophenyl)-2,6-dimethyl-1,4-dihydropyridin-3,5-dicarbonsaeuredimethylester
adalat
adalat
adalat a.r.
adalat cc
adalat cc
adalate lp
adalate lp
adalat ic
adalat la 20
adalat la 30
adalat la 60
adalat ret
adanif xl
adapin
adapin
adapine
adapine
adipine mr 10
adipine mr 20
adipine xl
adipine xl
afeditab cr
afeditab cr
angiopine 10
angiopine 40 la
angiopine 5
angiopine mr 10
angiopine mr 20
aponal
aponal
bay a1040
bay a1040
bay a1040
bay a1040
bay a1040
bay a1040
bay-a-1040
bay-a-1040
calanif
calchan mr 10
calchan mr 20
calcilat
calcilat
cardilate mr
cidoxepin
cidoxepin
coracten
coracten
coracten sr
coracten xl
coracten xl
coroday mr
doxepin
doxepin
doxepin
doxepin
doxepin
doxepine
fedipin
fortipine la40
genalat 10 ret
genalat 20 ret
hypolar ret 10
hypolar ret 20
hypolar xl 30
kentipine
kentipine mr 10
kentipine mr 20
nedipin
neozipine xl
nifecard
nifecard
nifecor
nifecor
nifedipine
nifedipine
nifedipine
nifedipine
nifedipine
nifedipine
nifedipine
nifedipine
nifedipine
nifedipine
nifedipine
nifedipino
nifedipino
nifedipinum
nifedipinum
nifedipres
nifedipres
nifedipress mr 10
nifedipress mr 20
nifedotard 20 mr
nifelease
nifensar xl
nifensar xl
nife-wolff
nifopress mr
nifopress ret
nimodrel mr 10
nimodrel mr 20
nimodrel xl
nivaten ret
p-3693a
p-3693a
p-3693a
p-3693a
p-3693a
p-3693a
procardia
procardia
procardia
procardia xl
procardia xl
slofedipine xl 30
slofedipine xl 60
tensipine mr 10
tensipine mr 20
unipine xl
valni 20 ret
valni xl
vasad

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT07023003	Phase 4	Jul 11, 2025	Nebraska Methodist Health System
NCT06915792	Phase 4	Apr 1, 2025	University of California, Los Angeles
NCT06859554	Phase 4	Mar 17, 2025	Lahore Medical and Dental college
NCT06220721	N/A	Sep 30, 2024	Medical College of Wisconsin, National Institutes of Health (NIH)
NCT05989581	Phase 1	Apr 24, 2024	University of Alabama, Birmingham
NCT06265415	N/A	Mar 30, 2024	Sohag University
NCT05687344	Phase 3	Sep 1, 2023	Medical College of Wisconsin
NCT05955040	Phase 2	Jul 11, 2023	Marshall University
NCT05551104	N/A	Feb 28, 2023	Loma Linda University
NCT05711810	Phase 4	Jan 2, 2023	University of Pennsylvania
NCT05520021	N/A	Sep 1, 2022	Antalya Training and Govermental Hospital, Konya Meram State Hospital
NCT05345132	N/A	Sep 1, 2022	Assiut University
NCT05343806	N/A	Sep 1, 2022	Assiut University
NCT05309460	Phase 4	Jun 6, 2022	Nebraska Methodist Health System
NCT05139238	Phase 4	Jan 31, 2022	Columbia University
NCT05049616	Phase 4	Oct 18, 2021	University of Texas at Houston
NCT04855877	Phase 4	Jul 6, 2021	University of Liege
NCT04887818	Phase 2/Phase 3 (Phase 3)	Jun 30, 2021	University of Calgary
NCT04790279	Phase 4	Apr 11, 2021	Prisma Health
NCT04392375	Phase 4	Jun 30, 2020	Ohio State University

Showing 20 of 144 trials

Page 1 / 8

Organizations

Research & Development (145)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Bayer	For profit	21	17	4	2003
Assiut University	Academic/Hospital	5	5	3	2017
RDD Pharma Ltd	For profit	4	4	2	2008
Cairo University	Academic/Hospital	3	2	3	2015
Harvard University	Academic/Hospital	3	2	2	1990
Hoosier Cancer Research Network	Academic/Hospital	3	3	1	2006
Icahn School of Medicine at Mount Sinai	Academic/Hospital	3	3	2	2010
Medical College of Wisconsin	Academic/Hospital	3	3	2	2020
Stanford University	Academic/Hospital	3	3	1	1999
Actavis	For profit	2	2	1	2005
Chongqing Medical University	Academic/Hospital	2	2	1	2007
Harbin Medical University	Academic/Hospital	2	2	1	2015
Hebrew University	Academic/Hospital	2	2	2	2014
Istituto Auxologico Italiano	Academic/Hospital	2	2	1	2012
Jiao Tong University	Academic/Hospital	2	1	1	2009
National Heart, Lung, and Blood Institute (NHLBI)	Government	2	2	1	1990
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Government	2	2	2	1993
National Institute on Drug Abuse (NIDA)	Government	2	0	1	2008
Nebraska Methodist Health System	Academic/Hospital	2	2	1	2022
Peking University	Academic/Hospital	2	2	1	2015

145 organizations

Page 1 / 8

Marketing (36)

Organization	Org type	Relationship	Date
Acella Pharmaceuticals	For profit	MKTG	Jul 30, 1993
Actavis	For profit	MKTG	Apr 28, 1989
Alembic	For profit	MKTG	Nov 18, 2022
Alkem Labs Ltd	For profit	MKTG	Mar 29, 2022
Alvogen	For profit	NDA2	Apr 21, 1993
Aurobindo Pharma	For profit	MKTG	Jun 21, 2010
Aurobindo Pharma	For profit	MKTG	Jul 19, 2021
Aurobindo Pharma	For profit	SYN	Jul 19, 2021
Bausch Health Companies	For profit	MKTG	Sep 27, 2000
Bayer	For profit	NDA2	Nov 27, 1985
Chase Pharmaceuticals Corporation	For profit	MKTG	Jul 10, 1989
Elite Laboratories, Inc	For profit	MKTG	Nov 18, 2020
Elite Laboratories, Inc	For profit	MKTG	Nov 18, 2020
Emcure	For profit	MKTG	Apr 25, 2013
Heritage Pharma	For profit	MKTG	Apr 25, 2013
Intergel Pharms Inc	For profit	MKTG	Jul 30, 1993
Leading Pharma Llc	For profit	MKTG	Oct 8, 1991
Leading Pharma Llc	For profit	SYN	Oct 8, 1991
Mylan	For profit	SYN	Dec 17, 1999
Mylan	For profit	MKTG	Sep 13, 2010
Norwich Eaton Company	For profit	MKTG	Apr 21, 1993
Novast Labs	For profit	MKTG	Aug 25, 2016
Osmotica Pharmaceutical	For profit	MKTG	Nov 21, 2005
Par Pharmaceuticals	For profit	MKTG	Dec 13, 2006
Pfizer	For profit	NDA2	Dec 31, 1981
Pharmadax Inc	For profit	MKTG	Nov 18, 2022
Procter and Gamble	For profit	NDA2	Apr 21, 1993
Rising Pharmaceuticals	For profit	MKTG	Sep 13, 2010
Roche	For profit	NDA	—
Soremartec Italia S.r.l.	For profit	MKTG	Mar 23, 2004
Sun Pharmaceuticals	For profit	MKTG	Apr 16, 2019
TWi Biotechnology, Inc.	For profit	MKTG	Apr 3, 2014
Teva	For profit	MKTG	Feb 19, 1992
Teva	For profit	SYN	Mar 10, 2000
Watson Pharmaceuticals	For profit	MKTG	Oct 26, 2001
Zydus Discovery DMCC	For profit	MKTG	Dec 19, 2017