nitroprusside

Trade name: nipride

Small moleculeapproved

Approved

May 10, 1974

Nitroprusside is a medication which is used to lower blood pressure. It is comprised of a ferrous ion complexed with five cyanide and one nitrosyl group. Upon intravenous infusion, nitroprusside interacts with oxyhemoglobin and dissociates, releasing cyanide and nitric oxide, which act as a powerful vasodilating agent. Sodium nitroprusside was approved by the FDA in 1974 and is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. Sodium Nitroprusside injection is also indicated for producing controlled hypotension in order to reduce bleeding during surgery, and for the treatment of acute congestive heart failure. — NCATS

Clinical trial activity

54 trials · 82 clinical orgs · 38 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Jan 1, 1996 (NCT00152724)

Timeline

1970s

May 10, 1974
Roche — Earliest FDA Approval
May 10, 1974
Roche — NDA Organization

1980s

Sep 8, 1981
AbbVie — NDA Secondary Org
Jul 28, 1982
Baxalta — NDA Secondary Org
Jul 28, 1982
Baxter — NDA Secondary Org
Jun 9, 1986
Hospira — Marketing Organization
Nov 16, 1987
Abbott — Marketing Organization
Aug 1, 1988
Aton — Marketing Organization

1990s

Mar 30, 1992
Teva — Marketing Organization
Jan 1, 1996
Earliest Phase 1 Sponsor(trial)

2000s

Jan 1, 2002
Earliest Phase 2 Sponsor(trial)
Jan 1, 2004
Earliest Phase 3 Sponsor(trial)

2010s

Dec 8, 2016
Sagent Pharmaceuticals, Inc. — Marketing Organization
Dec 8, 2016
Nichi-Iko Pharmaceutical Co., Ltd. — Marketing Organization
Mar 8, 2017
Exela Pharma Sciences, LLC. — NDA Secondary Org
Mar 8, 2017
Exela Pharma Sciences, LLC. — Marketing Organization
May 4, 2017
Akorn, Inc. — Marketing Organization
May 4, 2017
Epic Pharma Llc — Marketing Organization
May 25, 2017
Nexus Pharmaceuticals — Marketing Organization
Nov 7, 2017
Amneal Pharmaceuticals — Marketing Organization
Dec 8, 2017
Micro Labs Ltd India — Marketing Organization
Dec 18, 2017
Amphastar Pharmaceuticals — Marketing Organization
Apr 17, 2018
Mylan — Marketing Organization
Jun 26, 2018
ANDA Repository — Marketing Organization
Jun 26, 2018
Renaissance Pharma — Marketing Organization
Jun 26, 2018
Virtus Pharms — Marketing Organization
Jun 26, 2018
Chartwell Pharmaceuticals — Marketing Organization
Jul 16, 2018
Cipla — Marketing Organization
Aug 10, 2018
Medicure — Marketing Organization
Aug 10, 2018
PHARMOBEDIENT — Marketing Organization
Aug 17, 2018
Somerset Pharmaceuticals — Marketing Organization
Nov 26, 2018
Sun Pharmaceuticals — Marketing Organization
Apr 10, 2019
Dr. Reddy's Laboratories — Marketing Organization
Nov 29, 2019
Caplin Point Laboratories — Marketing Organization
Nov 29, 2019
Eu Yan Sang — Marketing Organization

2020s

Aug 25, 2020
Hainan Poly Pharm — Marketing Organization
Aug 25, 2020
SLATE RUN PHARMA — Marketing Organization
Nov 2, 2020
Exeltis — Marketing Organization
Dec 10, 2020
Aurobindo Pharma — Marketing Organization
Dec 10, 2020
Eugia Pharma — Marketing Organization
Jul 12, 2021
BE Pharmaceuticals — Marketing Organization
Nov 8, 2022
Avet Lifesciences — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Nitric oxide synthaseOTHER
Nitric oxide synthase

Approval history

approvedPriority reviewMay 10, 1974

Chemistry & pharmacology

Loading structure…

SMILES

[Fe++].[C-]#N.[C-]#N.[C-]#N.[C-]#N.[C-]#N.N#[O+]

Mol. weight: 215.938 g/mol
Chirality: Achiral Molecule
Inorganic: No
Polymer: No
Delivery: Parenteral
Availability: Prescription Only

Oral

Parenteral

Yes

Topical

Black box warning

Sources

Also known as

[fe(cn)5(no)](2-)
[fe(cn)5(no)](2-)
nipride
nipride
nipride
nipride
nitroferricyanide
nitroferricyanide
nitropress
nitropress
nitroprussiat
nitroprussiate
nitroprussiate
nitroprusside
nitroprusside
nitroprusside
nitroprusside
nitroprusside
nitroprusside
nitroprusside
nitroprusside sodium
nitroprusside sodium salt
sodium nitroferricyanide
sodium nitroferricyanide
sodium nitroprussiate
sodium nitroprussiate
sodium nitroprussiate
sodium nitroprusside
sodium nitroprusside
sodium nitroprusside
sodium nitroprusside
sodium nitroprusside
sodium nitroprusside hydrate
sodium nitrosylpentacyanoferrate

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT05219799	Early Phase 1 (Phase 1)	Feb 28, 2023	University of Missouri
NCT05525416	N/A	Jul 28, 2022	University of Alberta
NCT05277922	Phase 1	Apr 28, 2022	Clinical Trial Consultants AB, Vicore Pharma AB
NCT05193968	N/A	Feb 24, 2022	Mayo Clinic, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)
NCT04986072	Phase 2	Sep 1, 2021	Harvard University
NCT04928183	N/A	Jun 10, 2021	University of Alberta
NCT04001647	Early Phase 1 (Phase 1)	Jun 1, 2019	Colorado State University
NCT03953326	Phase 1/Phase 2 (Phase 2)	Apr 23, 2019	Pennsylvania State University
NCT03743103	Phase 4	Apr 18, 2019	Cristália Produtos Químicos Farmacêuticos Ltda.
NCT03972683	Early Phase 1 (Phase 1)	Apr 16, 2019	Colorado State University
NCT03738943	Early Phase 1 (Phase 1)	Feb 7, 2019	Colorado State University
NCT03446612	Phase 2	Oct 15, 2018	GlaxoSmithKline
NCT03679780	Phase 1	Oct 1, 2018	University of Texas, Arlington
NCT03680573	Phase 1	Jan 8, 2018	University of Texas, Arlington
NCT03406832	N/A	Jan 8, 2018	Anyang Regional Hospital, Henan Medical University, Henan University of Traditional Chinese Medicine, Jincheng People’s Hospital, Kaifeng Central Hospital, Lushan People’s Hospital, Nanyang Central Hospital, People's Liberation Army of China, Puyang Oil Field General Hospital, Puyang People's Hospital, Shenma Medical Group General Hospital, The First People's Hospital of Shangqiu, The First People's Hospital of Xinmi, The First People's Hospital of Zhumadian, The Peoples' Hospital of Jiaozuo City, The second people's Hospital of Jiyuan, The Second People's Hospital of Pingdingshan, Xinxiang Medical University, Xinyang Central Hospital, Yanshi People’s Hospital, Yellow River Sanmenxia hospital, Zhengzhou Cardiovascular Hospital, Zhengzhou University, Zhoukou Central Hospital, Zhumadian Central Hospital
NCT03406819	N/A	Jan 7, 2018	Anyang Regional Hospital, Henan Medical University, Henan University of Traditional Chinese Medicine, Jincheng People’s Hospital, Kaifeng Central Hospital, Lushan People’s Hospital, Nanyang Central Hospital, People's Liberation Army of China, Puyang Oil Field General Hospital, Puyang People's Hospital, Shenma Medical Group General Hospital, The First People's Hospital of Shangqiu, The First People's Hospital of Xinmi, The First People's Hospital of Zhumadian, The Peoples' Hospital of Jiaozuo City, The second people's Hospital of Jiyuan, The Second People's Hospital of Pingdingshan, Xinxiang Medical University, Xinyang Central Hospital, Yanshi People’s Hospital, Yellow River Sanmenxia hospital, Zhengzhou Cardiovascular Hospital, Zhengzhou University, Zhoukou Central Hospital, Zhumadian Central Hospital
NCT03317652	N/A	Nov 3, 2017	University of Copenhagen
NCT03102736	Phase 2	Feb 14, 2017	Icahn School of Medicine at Mount Sinai
NCT02767024	Phase 4	May 1, 2016	Yeshiva University
NCT02652065	N/A	Feb 8, 2016	University of Lyon

Showing 20 of 54 trials

Page 1 / 3

Organizations

Research & Development (82)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Colorado State University	Academic/Hospital	3	3	1	2019
National Institutes of Health (NIH)	Government	3	2	2	2005
University of Texas, Galveston	Academic/Hospital	3	3	1	2003
Anyang Regional Hospital	Academic/Hospital	2	0	1	2018
Duke University	Academic/Hospital	2	0	1	2005
Emory University	Academic/Hospital	2	2	1	2002
Harvard University	Academic/Hospital	2	2	1	2015
Henan Medical University	Academic/Hospital	2	0	1	2018
Henan University of Traditional Chinese Medicine	Academic/Hospital	2	0	1	2018
Jincheng People’s Hospital	Academic/Hospital	2	0	1	2018
Kaifeng Central Hospital	Academic/Hospital	2	0	1	2018
Lushan People’s Hospital	Academic/Hospital	2	0	1	2018
Nanyang Central Hospital	Academic/Hospital	2	0	1	2018
National Health and Medical Research Council, Australia	Government	2	0	1	2002
National Institute on Aging (NIA)	Government	2	0	1	2003
NHS Lothian	Academic/Hospital	2	0	1	2009
People's Liberation Army of China	Government	2	0	1	2018
Puyang Oil Field General Hospital	Academic/Hospital	2	0	1	2018
Puyang People's Hospital	Academic/Hospital	2	0	1	2018
Radboud University	Academic/Hospital	2	2	1	2005

82 organizations

Page 1 / 5

Marketing (45)

Organization	Org type	Relationship	Date
ANDA Repository	For profit	MKTG	Jun 26, 2018
AbbVie	For profit	NDA2	Sep 8, 1981
Abbott	For profit	MKTG	Nov 16, 1987
Abraxis	For profit	MKTG	—
Akorn, Inc.	For profit	MKTG	May 4, 2017
Amneal Pharmaceuticals	For profit	MKTG	Nov 7, 2017
Amneal Pharmaceuticals	For profit	SYN	Nov 7, 2017
Amphastar Pharmaceuticals	For profit	MKTG	Dec 18, 2017
Aton	For profit	MKTG	Aug 1, 1988
Aurobindo Pharma	For profit	MKTG	Dec 10, 2020
Avet Lifesciences	For profit	MKTG	Nov 8, 2022
BE Pharmaceuticals	For profit	MKTG	Jul 12, 2021
Baxalta	For profit	NDA2	Jul 28, 1982
Baxter	For profit	NDA2	Jul 28, 1982
Caplin Point Laboratories	For profit	MKTG	Nov 29, 2019
Chartwell Pharmaceuticals	For profit	MKTG	Jun 26, 2018
Cipla	For profit	MKTG	Jul 16, 2018
Dr. Reddy's Laboratories	For profit	SYN	Apr 10, 2019
Dr. Reddy's Laboratories	For profit	MKTG	Apr 10, 2019
Epic Pharma Llc	For profit	MKTG	May 4, 2017
Eu Yan Sang	For profit	MKTG	Nov 29, 2019
Eugia Pharma	For profit	MKTG	Dec 10, 2020
Exela Pharma Sciences, LLC.	For profit	NDA2	Mar 8, 2017
Exela Pharma Sciences, LLC.	For profit	MKTG	Mar 8, 2017
Exeltis	For profit	MKTG	Nov 2, 2020
Hainan Poly Pharm	For profit	SYN	Aug 26, 2022
Hainan Poly Pharm	For profit	MKTG	Aug 25, 2020
Hospira	For profit	MKTG	Jun 9, 1986
Medicure	For profit	MKTG	Aug 10, 2018
Micro Labs Ltd India	For profit	MKTG	Dec 8, 2017
Mylan	For profit	MKTG	Apr 17, 2018
Mylan	For profit	SYN	Aug 10, 2018
Nexus Pharmaceuticals	For profit	MKTG	May 25, 2017
Nexus Pharmaceuticals	For profit	SYN	May 25, 2017
Nichi-Iko Pharmaceutical Co., Ltd.	For profit	MKTG	Dec 8, 2016
PHARMOBEDIENT	For profit	MKTG	Aug 10, 2018
Renaissance Pharma	For profit	MKTG	Jun 26, 2018
Roche	For profit	NDA	May 10, 1974
SLATE RUN PHARMA	For profit	MKTG	Aug 25, 2020
Sagent Pharmaceuticals, Inc.	For profit	MKTG	Dec 8, 2016
Somerset Pharmaceuticals	For profit	MKTG	Aug 17, 2018
Sun Pharmaceuticals	For profit	MKTG	Nov 26, 2018
Sun Pharmaceuticals	For profit	SYN	Nov 26, 2018
Teva	For profit	MKTG	Mar 30, 1992
Virtus Pharms	For profit	MKTG	Jun 26, 2018