clevidipine
Trade name: cleviprex
Approved
Aug 1, 2008
Clevidipine is a dihydropyridine calcium channel blocker. Clevidipine is marketed under the trade name Cleviprex, indicated for the reduction of blood pressure (BP) when oral therapy is not feasible or not desirable. Clevidipine is a dihydropyridine L-type calcium channel blocker. L-type calcium channels mediate the influx of calcium during depolarization in arterial smooth muscle. Experiments in anesthetized rats and dogs show that clevidipine reduces mean arterial blood pressure by decreasing systemic vascular resistance. Clevidipine does not reduce cardiac filling pressure (pre-load), confirming lack of effects on the venous capacitance vessels. — NCATS
Clinical trial activity
30 trials · 27 clinical orgs · 2 marketing orgs
Earliest trial started Dec 1, 2003 (NCT00093262)
Timeline
2000s
- Jan 1, 2003
The Medicines Company — Earliest Phase 3 Sponsor(trial)
- Jan 1, 2008
The Medicines Company — Earliest Phase 2 Sponsor(trial)
- Aug 1, 2008
Earliest FDA Approval
- Aug 1, 2008
Chiesi — Marketing Organization
- Aug 1, 2008
Chiesi — NDA Secondary Org
2010s
- Jan 1, 2018
Earliest Phase 1 Sponsor(trial)
Indications
Approved for
Studied for
- Aortic Aneurysm · Phase 4
- Aortic Diseases · Phase 4
- Blood Pressure · Phase 4
- Brain Neoplasms · Phase 4
- Critical Illness · Phase 2
- Dyspnea · Phase 3
- Epilepsy · Phase 4
- Heart Failure · Phase 3
- Hemorrhage · Phase 3
- Hypertension · Phase 4
- Hypertension, Pulmonary · Phase 4
- Intracranial Aneurysm · Phase 2
- Intracranial Hemorrhages · Phase 4
- Scoliosis · Phase 2/Phase 3
- Stroke · Phase 3
- Subarachnoid Hemorrhage · Phase 4
- Thrombosis · Phase 3
- Traumatology · Phase 4
- Vascular Diseases · Early Phase 1
- Vasospasm, Intracranial · Phase 2
Mechanism of action
Voltage-gated L-type calcium channel blocker
Approval history
- approvedAug 1, 2008
Chemistry & pharmacology
SMILES
CCCC(=O)OCOC(=O)C1=C(C)NC(C)=C(C1C2=CC=CC(Cl)=C2Cl)C(=O)OC- Mol. weight
- 456.316 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Racemic Mixture
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaClevidipine ↗
- NCATS19O2GP3B7Q ↗
- ChEMBLCHEMBL1237132 ↗
Also known as
- butyroxymethyl methyl 4-(2',3'-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate
- clevelox
- clevidipine
- clevidipine
- clevidipine
- clevidipine
- clevidipine
- clevidipine
- clevidipine
- clevidipine
- clevidipine
- clevidipine
- clevidipine
- clevidipine butyrate
- clevidipine butyrate
- clevidipine butyrate
- clevidipine butyrate
- cleviprex
- cleviprex
- cleviprex
- cleviprex
- cleviprex
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06063772 | Phase 4 | Jan 31, 2024 | University of California, San Diego |
| NCT05922436 | Phase 3 | Jul 15, 2023 | Qilu Pharmaceutical Co., Ltd., Shandong University |
| NCT05783557 | Phase 3 | May 1, 2023 | Capital Medical University, CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. |
| NCT05175547 | Phase 3 | Nov 1, 2021 | ProMedica Health System |
| NCT05044364 | Phase 3 | Oct 11, 2021 | Shenzhen University |
| NCT04670809 | Phase 3 | Jul 27, 2020 | Nanjing Yoko Biomedical Co., Ltd. |
| NCT03719001 | Early Phase 1 (Phase 1) | Oct 23, 2018 | University of California, San Francisco |
| NCT03300479 | Phase 4 | Jun 15, 2017 | University of Zurich |
| NCT04592380 | Phase 3 | Aug 31, 2014 | Baylor University, The Medicines Company |
| NCT01938547 | Phase 4 | Mar 1, 2014 | Chiesi, Ohio State University |
| NCT02011321 | Phase 2 | Mar 1, 2014 | Henry Ford Health System |
| NCT01645111 | Phase 2/Phase 3 (Phase 3) | Jun 1, 2012 | Ohio State University |
| NCT01480531 | N/A | Dec 1, 2011 | Duke University, The Medicines Company |
| NCT01526876 | Phase 4 | Nov 1, 2011 | Columbia University, The Medicines Company |
| NCT01369147 | Phase 2 | Jul 31, 2011 | Emory University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| NCT01042574 | Phase 4 | May 1, 2010 | Methodist Healthcare, The Medicines Company |
| NCT01910532 | Phase 4 | Apr 1, 2010 | Ohio State University |
| NCT01033370 | Phase 4 | Nov 1, 2009 | Methodist Cancer Center, Houston, Texas, The Medicines Company, The University of Texas, Dallas |
| NCT01121458 | Phase 4 | Sep 1, 2009 | Department of Veteran Affairs |
| NCT00978822 | Phase 2 | Sep 1, 2009 | Henry Ford Health System, The Medicines Company |
Organizations
Research & Development (27)
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Chiesi | For profit | MKTG | Aug 1, 2008 |
| Chiesi | For profit | NDA2 | Aug 1, 2008 |
| The Medicines Company | For profit | NDA | — |