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)
Mechanism and Biochemical Profile
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>).