Clinical Trials

Numerous clinical trials spanning Early Phase I through Phase IV evaluate nimodipine for conditions such as aneurysmal subarachnoid hemorrhage, cerebral vasospasm, delayed ischemic neurological deficits, progranulin mutation, alcohol use disorder, and infertility, with Phase III studies investigating new intravenous formulations. Sponsored by academic centers including Yale University and the University of California San Francisco alongside industry partners like Acasti Pharma Inc. and Edge Therapeutics Inc., these trials encompass completed, actively recruiting, terminated, and not yet recruiting statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06900998 NOT_YET_RECRUITING
Alcohol Use Disorder
Yale University
2026-09-01 PHASE2
NCT07681869 NOT_YET_RECRUITING
Alcohol Use Disorder
Yale University
2026-09-01 PHASE2
NCT07144956 NOT_YET_RECRUITING
Aneurysmal Subarachnoid Hemorrhage
Centre Hospitalier St Anne
2025-12-15 PHASE3
NCT06615882 NOT_YET_RECRUITING
Intracranial Vasospasm
Yonsei University
2024-09
NCT06998368 RECRUITING
Mediation of 5G Effects on Sleep
Hans-Peter Landolt
2024-10-22
NCT07048522 RECRUITING
Colectomy; Open Surgery; Pain; Pain, Postoperative; Pain, Acute
University of Ioannina
2025-05-19
NCT03925025 COMPLETED
Anticholinesterase Insecticide Poisoning; Pesticide Poisoning
University of Edinburgh
2020-06-11 PHASE3
NCT05995405 ACTIVE_NOT_RECRUITING
Aneurysmal Subarachnoid Hemorrhage (aSAH)
Grace Therapeutics Inc.
2023-10-20 PHASE3
NCT04801953 UNKNOWN
Vestibular Schwannoma
Medical University of Vienna
2021-05-04 PHASE2
NCT05995405 Recruiting
Aneurysmal Subarachnoid Hemorrhage (aSAH)
Acasti Pharma Inc.
2023-10-20 Phase 3
NCT06007573 COMPLETED
Post-stroke Dementia
Yuzhen Pan
2021-02-01
NCT04148105 TERMINATED
Aneurysmal Subarachnoid Hemorrhage
Henry Ford Health System
2019-11-01 PHASE4
NCT03671525 COMPLETED
Schizophrenia; Schizo Affective Disorder
Johns Hopkins University
2018-10-05 EARLY_PHASE1
NCT05182619 UNKNOWN
Traumatic Brain Injury
Sohag University
2022-01-01 EARLY_PHASE1
NCT04028596 COMPLETED
Epilepsy; Depression; Postictal Delirium; Electroconvulsive Therapy
Rijnstate Hospital
2019-12-05 PHASE2
NCT04100824 COMPLETED
Subarachnoid Hemorrhage
Assiut University
2020-01-11 PHASE2
NCT04923659 ACTIVE_NOT_RECRUITING
Low Intensity Focussed Ultrasound
University Health Network, Toronto
2021-05-25 EARLY_PHASE1
NCT05131867 COMPLETED
Oral Nimodipine; Milrinone; Vascular Spasm After Traumatic Subarachnoidhaemorrhage
Zagazig University
2021-11-24 PHASE2
NCT05418348 COMPLETED
Aneurysmal Subarachnoid Hemorrhage
Grace Therapeutics Inc.
2021-08-26 PHASE1
NCT04998370 Recruiting
Subarachnoid Hemorrhage Aneurysmal|Vasospasm|Delayed Cerebral Ischemia|Delayed Ischemic Neurological Deficit
University of Zurich
2021-08-18 --
NCT04649398 Recruiting
Subarachnoid Hemorrhage Aneurysmal|Delayed Cerebral Ischemia|Vasospasm Cerebral
Medical University of Vienna|University of Vienna|Austrian Science Fund (FWF)
2020-11-25 --
NCT04309708 COMPLETED
Subarachnoid Hemorrhage
B. Braun Medical International Trading Company Ltd.
2018-05-01
NCT03228498 COMPLETED
Vascular Cognitive Impairment
Azienda Ospedaliero-Universitaria Careggi
2017-05-02 PHASE2
NCT03794843 UNKNOWN
Bioavailability; Safety Issues; Ischemic Cerebrovascular Disease
Shenyang Dongxing Pharmaceutical Technology Co., Ltd.
2018-08-23 EARLY_PHASE1
NCT03150524 WITHDRAWN
Reversible Cerebral Vasoconstriction Syndrome
Johns Hopkins University
2017-07-01 PHASE4
NCT02790632 TERMINATED
Subarachnoid Hemorrhage, Aneurysmal
Edge Therapeutics Inc
2016-07 PHASE3
NCT02893826 TERMINATED
Subarachnoid Hemorrhage, Aneurysmal
Edge Therapeutics Inc
2016-09 PHASE1
NCT02537080 TERMINATED
Mild Cognitive Impairment
University Hospital Hradec Kralove
2015-09
NCT02991157 Completed
Subarachnoid Hemorrhage Aneurysmal
National Institute of Mental Health and Neuro Sciences India
2016-12 --
NCT01835665 COMPLETED
Progranulin Mutation Carriers
University of California, San Francisco
2013-03 PHASE1
NCT01893190 COMPLETED
Ruptured Cerebral Aneurysm; Ruptured Berry Aneurysm
Edge Therapeutics Inc
2013-09 PHASE1; PHASE2
NCT02248233 COMPLETED
Cerebral Infarction
Fengtian Hospital
2014-10 PHASE4
NCT02165644 WITHDRAWN
Acute Cerebrovascular Accident; Vasospasm
University of Florida
2015-09 PHASE2
NCT01551368 TERMINATED
Infertility
Mount Sinai Hospital, Canada
2012-12 PHASE2
NCT01672801 COMPLETED
Unexplained Infertility; Polycystic Ovarian Syndrome; Anovulatory
Boston IVF
2012-09
NCT01835665 Completed
Progranulin Mutation Carriers
University of California San Francisco|The Bluefield Project to Cure Frontotemporal Dementia
2013-03 Phase 1
NCT01551368 Terminated
Infertility
Mount Sinai Hospital Canada
2012-12 Phase 2
NCT01220622 UNKNOWN
Stroke; Mild Cognitive Impairment
Ministry of Science and Technology of the People´s Republic of China
2010-10 PHASE4
NCT00814658 COMPLETED
Dementia
Janssen-Cilag Farmaceutica Ltda.
2008-06 PHASE4
NCT00781326 TERMINATED
Depression
University of Pittsburgh
2008-08 PHASE4
NCT00000332 COMPLETED
Cocaine-Related Disorders
National Institute on Drug Abuse (NIDA)
1998-05 PHASE2
NCT00000280 COMPLETED
Cocaine-Related Disorders
Yale University
1994-09 PHASE1
NCT00004399 COMPLETED
Pre-eclampsia
FDA Office of Orphan Products Development
1995-09
NCT00000738 COMPLETED
AIDS Dementia Complex; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
PHASE1

(data from https://clinicaltrials.gov, updated on 2026-03-17)

Check the Nimodipine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Nimodipine selectively binds to L-type voltage-gated calcium channels in vascular smooth muscle cells, blocking the transmembrane influx of calcium ions during depolarization and preventing calcium-dependent cell contraction. This mechanism induces targeted cerebral arterial vasodilation, providing clinical therapeutic relevance for preventing vasospasm and mitigating delayed cerebral ischemia in patients affected by aneurysmal subarachnoid hemorrhage.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Note: Technical data last updated: Sep 1, 2026.