Drugs / Clevidipine
Clevidipine
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed essential hypertension 1 milestone | |||||
| Filed | US (FDA) | — | essential hypertension | — | “approval submitted (US) Clevidipine butyrate injectable emulsion Nanodrug Calcium channel blocker Hypertension Application for marketing approval submitted” irasia.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | CLEVIPREX | — | 2008-08-01 | fda.gov ↗ |
Trials 27
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03719001 | Oct 2018 → Jun 2022 | vascular disorder | University of California, San Francisco | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT02011321 | Mar 2014 → Mar 2018 | brain aneurysm, intracranial vasospasm, subarachnoid hemorrhage | Henry Ford Health System | Withdrawn | No outcome recorded |
| Phase 2 | NCT00978822 | Jun 2009 → Nov 2012 | hypertensive disorder, subarachnoid hemorrhage | Henry Ford Health System | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00799604 | Nov 2008 → Oct 2009 | hypertensive disorder | The Medicines Company | Completed | No outcome recorded |
| Phase 313 trials · 3 met primary | ||||||
| Phase 3 | NCT05922436 | Jul 2023 → May 2024 | hypertensive disorder | Qilu Pharmaceutical (Hainan) Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT05783557 | May 2023 → Dec 2024 | hypertensive disorder | CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT05044364 | Oct 2021 → Apr 2022 | hypertensive disorder | Shenzhen People's Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT04670809 | Jul 2020 → Aug 2021 | hypertensive disorder | Nanjing Yoko Biomedical Co., Ltd. | Unknown | Met primary |
| Phase 3 | NCT04592380 | Aug 2014 → Feb 2016 | heart failure, hypertensive disorder | The Medicines Company | Withdrawn | No outcome recorded |
| Phase 3 | NCT00803634 | Dec 2008 → Feb 2012 | heart failure, hypertensive disorder | The Medicines Company | Completed | No outcome recorded |
| Phase 3 | NCT00666328 | Jun 2008 → Apr 2010 | hypertensive disorder, intracerebral hemorrhage | The Medicines Company | Completed | No outcome recorded |
| Phase 3 | NCT00369837 | Sep 2006 → Jan 2007 | hypertensive disorder | The Medicines Company | Completed | No outcome recorded |
| Phase 3 | NCT00093912 | Jun 2004 → Oct 2006 | hypertensive disorder | The Medicines Company | Completed | No outcome recorded |
| Phase 3 | NCT00093925 | May 2004 → Jul 2006 | hypertensive disorder | The Medicines Company | Completed | No outcome recorded |
| Phase 3 | NCT00093886 | Apr 2004 → Mar 2005 | hypertensive disorder | The Medicines Company | Completed | No outcome recorded |
| Phase 3 | NCT00093249 | Jan → Nov 2004 | hypertensive disorder | The Medicines Company | Completed | Met primary |
| Phase 3 | NCT00093262 | Dec 2003 → Oct 2004 | hypertensive disorder | The Medicines Company | Completed | Met primary |
| Phase 49 trials | ||||||
| Phase 4 | NCT06063772 | Jan → Dec 2025 overdue | hypertensive disorder | University of California, San Diego | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT03300479 | Jun 2017 → May 2021 | intracerebral hemorrhage | University of Zurich | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01938547 | Mar 2014 → Feb 2024 | — | Chiesi Farmaceutici S.p.A. | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT01526876 | Nov 2011 → Nov 2012 | hypertensive disorder | Columbia University | Withdrawn | No outcome recorded |
| Phase 4 | NCT01042574 | May → Dec 2010 | hypertensive disorder, intracerebral hemorrhage, subarachnoid hemorrhage | Methodist Healthcare - Memphis | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT01910532 | Apr 2010 → Nov 2012 | hypertensive disorder | Mario Ammirati | Withdrawn | No outcome recorded |
| Phase 4 | NCT01033370 | Nov 2009 → Aug 2012 | aortic aneurysm | Asma Zainab, M.D. | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT01121458 | Sep 2009 → Apr 2013 | pulmonary arterial hypertension | North Texas Veterans Healthcare System | Completed | No outcome recorded |
| Phase 4 | NCT00952081 | Jul → Dec 2009 | brain neoplasm, epilepsy, hypertensive disorder | NYU Langone Health | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT01480531 | Dec 2011 → Dec 2012 | aortic aneurysm | Duke University | Withdrawn | No outcome recorded Stop: Enrollment |
| Comparator or background therapy3 trials | ||||||
| Phase 2 | NCT01369147 Background | Jul 2011 → Dec 2014 | — | Emory University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2/3 | NCT01645111 Comparator | Jun 2012 → Dec 2013 | neurodevelopmental disorder with neuromuscular and skeletal abnormalities | Nationwide Children's Hospital | Completed | No outcome recorded |
| Phase 3 | NCT05175547 Comparator | Oct 2021 → Feb 2024 | hypertensive disorder, ischemic stroke | ProMedica Health System | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2026-02-02 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - CLEVIDIPINE INJECTABLE EMULSION OBTAINS DRUG REGISTRATION APPROVAL irasia.com ↗
CLEVIDIPINE INJECTABLE EMULSION OBTAINS DRUG REGISTRATION APPROVAL |
| 2023-01-09 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - CLEVIDIPINE INJECTABLE EMULSION OBTAINS CLINICAL TRIAL APPROVAL irasia.com ↗
CLEVIDIPINE INJECTABLE EMULSION OBTAINS CLINICAL TRIAL APPROVAL |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-02-02 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | VOLUNTARY ANNOUNCEMENT - CLEVIDIPINE INJECTABLE EMULSION OBTAINS DRUG REGISTRATION APPROVAL irasia.com ↗ |
| 2023-01-09 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | VOLUNTARY ANNOUNCEMENT - CLEVIDIPINE INJECTABLE EMULSION OBTAINS CLINICAL TRIAL APPROVAL irasia.com ↗ |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 35 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | clevidipine | “a Study Evaluating the Safety and Efficacy of Clevidipine for Patients Who With Hypertensive Emergency and Sub-emergency” NCT05922436 ↗27“Clevidipine infusion will be used to increase blood pressure by 20 mmHg” NCT03719001 ↗ |
| Known as | Clevidepine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1237132 ↗ |
| Known as | Clevidepine butyrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1237132 ↗ |
| Known as | Clevidipine butyrate | “Clevidipine Butyrate (Cleviprex) is a new medication approved by the FDA for the treatment of acute high blood pressure (hypertension).” NCT01526876 ↗ |
| Known as | Clevidipine Butyrate Injection | “Initiate the intravenous infusion of Clevidipine Butyrate Injection at 2 mg/hour.” NCT04670809 ↗1“original research clevidipine butyrate injection as the positive control drug” NCT05044364 ↗ |
| Known as | Clevidipine emulsion injection | “BACKGROUND: Clevidipine emulsion injection is an ultra-short-acting, intravenous calcium-channel blocker that produces a rapid and transient antihypertensive effect.” PMID 41231022 ↗ Oct 2025 |
| Known as | clevidipine, Cleviprex | “clevidipine, Cleviprex” NCT00369837 ↗3“clevidipine, Cleviprex” NCT00093886 ↗ “clevidipine, Cleviprex” NCT00093249 ↗ “clevidipine, Cleviprex” NCT00093262 ↗ |
| Known as | Clevidipino | ChEMBL registry synonym — accepted as the source's own label CHEMBL1237132 ↗ |
| Known as | Cleviprex | ChEMBL registry synonym — accepted as the source's own label CHEMBL1237132 ↗ |
| Known as | CLEVIPREX (clevidipine) | “CLEVIPREX® (clevidipine)” NCT01033370 ↗ |
| Known as | CLV | “The Evaluation of CLevidipine In the Perioperative Treatment of Hypertension Assessing Safety Events trial (ECLIPSE) was performed to compare the safety and efficacy of...” PMID 18806012 ↗ Oct 2008 |
| Known as | H-324/38 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1237132 ↗ |
| Action | Inhibit | “calcium channel blocker” PMID 17898366 ↗ Oct 2007 |
| Modality | Small molecule | “Clevidipine, an ultrashort-acting, third-generation dihydropyridine calcium channel blocker” PMID 18635468 ↗ Jul 2008 |
| Route | Intravenous | “administered intravenously” NCT00093249 ↗ |