Drugs / Clevidipine

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) CLEVIPREX 2008-08-01 fda.gov

Trials 27 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
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Mar 2014 → Mar 2018 brain aneurysm, intracranial vasospasm, subarachnoid hemorrhage Henry Ford Health System Withdrawn No outcome recorded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
Phase 2 NCT00799604 Nov 2008 → Oct 2009 hypertensive disorder The Medicines Company Completed No outcome recorded
Phase 313 trials
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 No outcome recorded
Phase 3 NCT04592380 Aug 2014 → Feb 2016 heart failure, hypertensive disorder The Medicines Company Withdrawn No outcome recorded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 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Phase 4 NCT03300479 Jun 2017 → May 2021 intracerebral hemorrhage University of Zurich Withdrawn No outcome recorded
Phase 4 NCT01938547 Mar 2014 → Feb 2024 Chiesi Farmaceutici S.p.A. Terminated No outcome recorded
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
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
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
Also used as a comparator or background therapy in 3 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 21 trial
Phase 2 NCT01369147 Background Jul 2011 → Dec 2014 Emory University Terminated No outcome recorded
Phase 2/31 trial
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 31 trial
Phase 3 NCT05175547 Comparator Oct 2021 → Feb 2024 hypertensive disorder, ischemic stroke ProMedica Health System Completed No outcome recorded

Evidence & citations 15 cited values

Every value below carries the sentence it was read from. 35 sources stand behind the page.

FieldValueCited 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

NCT00803634

NCT00666328

NCT06063772

NCT00093886

NCT00369837

NCT00799604

NCT01938547

NCT01526876

NCT00093912

NCT00093925

NCT01910532

NCT04670809

NCT01480531

NCT01369147

NCT00978822

NCT01645111

NCT02011321

NCT01042574

NCT00093249

NCT05175547

NCT03300479

NCT04592380

NCT01121458

NCT00952081

NCT01033370

NCT00093262

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
3

Clevidipine butyrate injectable emulsion” NCT00978822

NCT05044364

NCT05783557

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, CleviprexNCT00093262
3

clevidipine, CleviprexNCT00093886

clevidipine, CleviprexNCT00369837

clevidipine, CleviprexNCT00093249

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