Drugs / Nimodipine
Nimodipine
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | NIMOTOP | — | 2000-08-22 | fda.gov ↗ |
| Approved | US (FDA) | NIMOTOP | — | 1988-12-28 | fda.gov ↗ |
Trials 21
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT04923659 | May 2021 → Jul 2022 overdue | — | University Health Network, Toronto | Active not recruiting | No outcome recorded |
| Phase 0 | NCT03671525 | Oct 2018 → May 2023 | schizoaffective disorder, schizophrenia | Johns Hopkins University | Completed | No outcome recorded |
| Phase 0 | NCT03794843 | Aug 2018 → Jun 2019 | cerebrovascular disorder | Shenyang Dongxing Pharmaceutical Technology Co., Ltd. | Unknown | No outcome recorded |
| Phase 15 trials | ||||||
| Phase 1 | NCT05418348 | Aug 2021 → Feb 2022 | acquired aneurysmal subarachnoid hemorrhage | Grace Therapeutics Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02893826 | Sep 2016 → Dec 2017 | acquired aneurysmal subarachnoid hemorrhage | Edge Therapeutics Inc | Terminated | No outcome recorded |
| Phase 1 | NCT01835665 | Mar 2013 → May 2016 | GRN-related frontotemporal lobar degeneration with Tdp43 inclusions | University of California, San Francisco | Completed | No outcome recorded |
| Phase 1 | NCT00000280 | Sep 1994 → Aug 1999 | cocaine abuse | Yale University | Completed | No outcome recorded |
| Phase 1 | NCT00000738 | ? → Jun 1994 | AIDS dementia complex, HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT07681869 | Sep 2026 → Jun 2032 expected | alcohol dependence | Yale University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06900998 | Sep 2026 → Jun 2032 expected | alcohol-related disorders | Yale University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT01551368 | Dec 2012 → Apr 2014 | infertility disorder | Mount Sinai Hospital, Canada | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00000332 | May 1998 → Jan 2000 | cocaine dependence | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT05995405 | Oct 2023 → Dec 2024 overdue | acquired aneurysmal subarachnoid hemorrhage | Grace Therapeutics Inc. | Active not recruiting | No outcome recorded |
| Phase 44 trials · 1 missed | ||||||
| Phase 4 | NCT04330300 | Apr 2020 → Jul 2021 | COVID-19, essential hypertension | National University of Ireland, Galway, Ireland | Suspended | No outcome recorded Stop: Business |
| Phase 4 | NCT02248233 | Oct 2014 → Sep 2015 | cerebral infarction | Fengtian Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00781326 | Aug 2008 → Feb 2009 | depressive disorder | University of Pittsburgh | Terminated | No outcome recorded |
| Phase 4 | NCT00814658 | Jun 2008 → Oct 2009 | dementia | Janssen-Cilag Farmaceutica Ltda. | Completed | Missed primary |
| Phase not applicable4 trials | ||||||
| — | NCT07048522 | May 2025 → Dec 2026 expected | — | University of Ioannina | Recruiting | No outcome recorded |
| — | NCT06998368 | Oct 2024 → Jun 2026 overdue | — | Hans-Peter Landolt | Recruiting | No outcome recorded |
| — | NCT02537080 | Sep 2015 → Dec 2017 | cognitive impairment with or without cerebellar ataxia | University Hospital Hradec Kralove | Terminated | No outcome recorded |
| — | NCT00004399 | Sep 1995 → Aug 2000 | preeclampsia | FDA Office of Orphan Products Development | Completed | No outcome recorded |
| Comparator or background therapy14 trials | ||||||
| Phase 1/2 | NCT01893190 Comparator | Sep 2013 → Jan 2016 | intracranial berry aneurysm | Edge Therapeutics Inc | Completed | No outcome recorded |
| Phase 2 | NCT05131867 Comparator | Nov 2021 → May 2022 | intracranial vasospasm | Zagazig University | Completed | No outcome recorded |
| Phase 2 | NCT04801953 Comparator | May 2021 → Apr 2024 | acoustic neuroma | Medical University of Vienna | Unknown | No outcome recorded |
| Phase 2 | NCT04100824 Background | Jan 2020 → Dec 2022 | subarachnoid hemorrhage | Assiut University | Completed | No outcome recorded |
| Phase 2 | NCT04028596 Comparator | Dec 2019 → Dec 2022 | delirium, epilepsy, major depressive disorder | Rijnstate Hospital | Completed | No outcome recorded |
| Phase 2 | NCT03228498 Background | May 2017 → Jul 2019 | vascular dementia | Careggi University Hospital | Completed | Missed primary |
| Phase 2 | NCT02165644 Background | Sep 2015 | intracranial vasospasm, stroke disorder | University of Florida | Withdrawn | No outcome recorded |
| Phase 3 | NCT07144956 Background | Dec 2025 → Dec 2029 expected | acquired aneurysmal subarachnoid hemorrhage | Centre Hospitalier St Anne | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT03925025 Comparator | Jun 2020 → Mar 2025 | poisoning | University of Edinburgh | Completed | No outcome recorded |
| Phase 4 | NCT07044232 Background | Oct 2025 → Sep 2026 overdue | intracerebral hemorrhage | Aarhus University Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT03150524 Comparator | Jul 2017 → May 2019 | reversible cerebral vasoconstriction syndrome | Johns Hopkins University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01220622 Comparator | Oct 2010 → Apr 2012 | cognitive impairment with or without cerebellar ataxia, ischemic stroke | Ministry of Science and Technology of the People´s Republic of China | Unknown | No outcome recorded |
| — | NCT06007573 Background | Feb 2021 → Aug 2023 | vascular dementia | Yuzhen Pan | Completed | No outcome recorded |
| — | NCT01672801 Comparator | Sep 2012 → Apr 2014 | anovulation, infertility disorder, polycystic ovary syndrome | Boston IVF | Completed | No outcome recorded |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 37 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | nimodipine | “Oral nimodipine is the only drug approved in North America for patients with aneurysmal subarachnoid hemorrhage (aSAH).” PMID 39875683 ↗ Jan 202532“Amlodipine, diltiazem, felodipine, nicardipine, nifedipine, nimodipine, nitrendipine, verapamil” NCT04330300 ↗ “Nimodipine capsules (reference formulation)” NCT05418348 ↗ “Placebo b.i.d plus Nimodipine 30 mg t.i.d” NCT03228498 ↗ |
| Known as | EG-1962 | “A sustained release microparticle formulation of nimodipine (EG-1962) was developed for treatment of patients with aneurysmal subarachnoid hemorrhage (aSAH).” PMID 32985652 ↗ Dec 2020 |
| Known as | GTX-104 | “An intravenous nimodipine formulation (GTX-104) has been developed that has bioavailability approaching 100%” PMID 39875683 ↗ Jan 2025 |
| Known as | NIM | “The effects of galantamine (GAL) on quality of life (QoL) and cognitive speed, as well its effects combined with nimodipine (NIM) in Alzheimer disease (AD) with cerebrovascular...” PMID 24964105 ↗ Jun 2014 |
| Known as | Nimotop | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04028596 ↗ |
| Known as | Nimotope | “Nimotope: Dose: 30 or 60mg x 6 orally or via feeding tube” NCT07044232 ↗ |
| Action | Inhibit | “Specifically, nimodipine blocks L-type voltage gated calcium channels” NCT01551368 ↗ |
| Modality | Small molecule | “the liposoluble dihydropyridine Ca2+ antagonist nimodipine” NCT02248233 ↗ |
| Route | Oral | “Nimodipine is administered by mouth concurrently with patients' prestudy dose of antiretroviral agent.” NCT00000738 ↗ |