nimodipine

Trade name: nimotop

Small moleculeapproved

Approved

Dec 28, 1988

Nimodipine is a dihydropyridine calcium antagonist which has been shown to dilate cerebral arterioles and increase cerebral blood flow in animals and humans. It has potential in the treatment of a range of cerebrovascular disorders. Major interest to date, however, has focused on its use in the prevention and treatment of the delayed ischaemic neurological deficits that frequently occur in patients with subarachnoid haemorrhages as a result of sustained cerebral vasospasm. Nimodipine, a Ca2+ antagonist with cerebrovasodilatory and anti-ischemic effects, binds to rat, guinea pig, and human brain membranes with high affinity (less than 1 nM). Only at higher concentrations has nimodipine been reported to block the release of some neurotransmitters and hormones from neuronal tissue. — NCATS

Clinical trial activity

32 trials · 39 clinical orgs · 10 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Sep 1, 1994 (NCT00000280)

Timeline

1980s

Dec 28, 1988
Bayer — Earliest FDA Approval
Dec 28, 1988
Bayer — NDA Organization

1990s

Jan 1, 1994
Earliest Phase 1 Sponsor(trial)
Jan 1, 1998
Earliest Phase 2 Sponsor(trial)

2000s

Apr 17, 2007
Sun Pharmaceuticals — Marketing Organization
May 2, 2007
Heritage Pharma — Marketing Organization
Jan 17, 2008
Bionpharma Inc — Marketing Organization

2010s

May 10, 2013
Arbor Pharmaceuticals — NDA Secondary Org
May 10, 2013
Azurity — Marketing Organization
May 10, 2013
Azurity — NDA Secondary Org
Apr 7, 2014
Thepharmanetwork Llc — Marketing Organization
Jul 24, 2015
Sofgen Pharmaceuticals — Marketing Organization
Jan 1, 2016
Earliest Phase 3 Sponsor(trial)

2020s

Feb 21, 2023
Alkem Labs Ltd — Marketing Organization
Jul 9, 2024
Annora Pharma — Marketing Organization

Mechanism of action

Approval history

approvedPriority reviewDec 28, 1988

Chemistry & pharmacology

Loading structure…

SMILES

COCCOC(=O)C1=C(C)NC(C)=C(C1C2=CC=CC(=C2)[N+]([O-])=O)C(=O)OC(C)C

Mol. weight: 418.4403 g/mol
Lipinski Ro5: Pass
Rule of 3: No
Chirality: Racemic Mixture
Inorganic: No
Polymer: No
Delivery: Oral
Availability: Prescription Only

Oral

Yes

Parenteral

Topical

Black box warning

Sources

Also known as

2,6-dimethyl-4-(3'-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylic acid 3-β-methoxyethyl ester 5-isopropyl ester
2,6-dimethyl-4-(3'-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylic acid 3-β-methoxyethyl ester 5-isopropyl ester
bay-e-9736
bay-e-9736
isopropyl 2-methoxyethyl 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylate
isopropyl 2-methoxyethyl 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylate
isopropyl 2-methoxyethyl 1,4-dihydro-2,6-dimethyl-4-(m-nitrophenyl)-3,5-pyridinedicarboxylate
isopropyl 2-methoxyethyl 1,4-dihydro-2,6-dimethyl-4-(m-nitrophenyl)-3,5-pyridinedicarboxylate
nemotan
nimodipine
nimodipine
nimodipine
nimodipine
nimodipine
nimodipine
nimodipine
nimodipine
nimodipine
nimodipine
nimodipine
nimodipino
nimodipino
nimodipinum
nimodipinum
nimotop
nimotop
nimotop
nymalize

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT07144956	Phase 3	Dec 15, 2025	Centre Hospitalier St Anne
NCT06900998	Phase 2	Oct 1, 2025	National Institute on Alcohol Abuse and Alcoholism (NIAAA), Yale University
NCT07048522	N/A	May 19, 2025	University of Ioannina
NCT06998368	N/A	Oct 22, 2024	University of Zurich
NCT05995405	Phase 3	Oct 20, 2023	Acasti Pharma Inc.
NCT05418348	Phase 1	Aug 26, 2021	Acasti Pharma Inc.
NCT04923659	Early Phase 1 (Phase 1)	May 25, 2021	University of Toronto
NCT04801953	Phase 2	May 4, 2021	Medical University of Vienna
NCT06007573	N/A	Feb 1, 2021	Anhui Medical University
NCT05131867	Phase 2	Jul 1, 2020	Zagazig University
NCT04028596	Phase 2	Oct 31, 2019	Rijnstate Hospital, University of Amsterdam, University of Twente
NCT04100824	Phase 2	Oct 31, 2019	Assiut University
NCT03925025	Phase 3	Jul 31, 2019	Toxicology Society of Bangladesh, University of Edinburgh
NCT03671525	Early Phase 1 (Phase 1)	Sep 30, 2018	Johns Hopkins University
NCT03794843	Early Phase 1 (Phase 1)	Aug 23, 2018	Capital Medical University, Shenyang Dongxing Pharmaceutical Technology Co., Ltd.
NCT03150524	Phase 4	Jul 1, 2017	Johns Hopkins University
NCT02893826	Phase 1	Sep 1, 2016	Edge Therapeutics Inc
NCT02790632	Phase 3	Jul 1, 2016	Edge Therapeutics Inc
NCT02165644	Phase 2	Sep 1, 2015	University of Florida
NCT02537080	N/A	Sep 1, 2015	University Hospital Hradec Kralove

Showing 20 of 32 trials

Page 1 / 2

Organizations

Research & Development (39)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Edge Therapeutics Inc	For profit	3	3	3	2013
Acasti Pharma Inc.	For profit	2	2	2	2021
Capital Medical University	Academic/Hospital	2	0	2	2010
Department of Veteran Affairs	Government	2	0	2	1994
Johns Hopkins University	Academic/Hospital	2	2	2	2017
National Institute on Drug Abuse (NIDA)	Government	2	1	2	1994
University of Toronto	Academic/Hospital	2	2	2	2012
Yale University	Academic/Hospital	2	2	2	1994
Anhui Medical University	Academic/Hospital	1	1	1	2021
Assiut University	Academic/Hospital	1	1	1	2019
Boston IVF	Academic/Hospital	1	1	1	2012
Centre Hospitalier St Anne	Academic/Hospital	1	1	1	2025
China Medical University	Academic/Hospital	1	0	1	2014
Fengtian Hospital	Academic/Hospital	1	1	1	2014
Food and Drug Administration	Government	1	1	1	1995
Glaxo Wellcome	For profit	1	0	1	1999
Government of China	Government	1	1	1	2010
Harvard University	Academic/Hospital	1	0	1	2012
Johnson and Johnson	For profit	1	1	1	2008
Medical University of Vienna	Academic/Hospital	1	1	1	2021

39 organizations