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Last update 27 Jan 2026
Clevidipine
Last update 27 Jan 2026
Overview
Basic Info
Drug Type Small molecule drug |
Synonyms Clevelox, Clevidipine, Clevidipine (USAN/INN) + [5] |
Target |
Action blockers |
Mechanism L-type calcium channel blockers(Voltage-gated L-type calcium channel blockers) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (01 Aug 2008), |
Regulation- |
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Structure/Sequence
Molecular FormulaC21H23Cl2NO6 |
InChIKeyKPBZROQVTHLCDU-UHFFFAOYSA-N |
CAS Registry167221-71-8 |
Related
56
Clinical Trials associated with ClevidipineNCT06063772
Effect of Treatment of Pre-induction Hypertension on Hemodynamic Stability During Induction of General Anesthesia
NCT06402968
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
NCT05922436
A Multicentre, Randomized, Double-blind, Parallel Design Phase III Study to Evaluate the Efficacy and Safety of Intravenous QLG2071 Versus Cleviprex® for Patients With Hypertensive Emergency and Sub-emergency
100 Clinical Results associated with Clevidipine
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100 Translational Medicine associated with Clevidipine
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100 Patents (Medical) associated with Clevidipine
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205
Literatures (Medical) associated with Clevidipine01 Jan 2026JOURNAL OF HYPERTENSION
Efficacy and safety of clevidipine emulsion injection compared with nicardipine in patients with hypertensive emergencies: a randomized, single-blind, positive-parallel-controlled, phase III clinical trial
Article
Author: Liu, Min ; Li, Na ; Ma, Changsheng ; Zhang, Gaoxing ; Ouyang, Yanhong ; Wu, Yanqing ; Xu, Tie ; Wang, Xifu ; Sun, Liming ; Wang, Zhifang ; Chen, Junhong ; Yang, Ping ; Wang, Hengliang ; Zhang, Hongwei ; Zhang, Xiwen ; Zhu, Tianyi ; Liang, Zijing ; Zhao, Zhichen ; Ma, Jinxia ; Zhu, Jiaying ; Chen, Chen ; Guo, Shubin ; Liu, Xianxia ; Sun, Lei ; Du, Bo ; Lv, Qiang ; Zhao, Min ; He, Ruili ; Chen, Dexiong ; Chen, Xiaoliang ; Cao, Zhanwei ; Lin, Ling ; Gao, Feng ; Chai, Yanfen ; Zhao, Xianming ; Zhong, Yiming ; Wu, Lidong ; Li, Lipeng
Background::
Clevidipine emulsion injection is an ultra-short-acting, intravenous calcium-channel blocker that produces a rapid and transient antihypertensive effect.
Methods::
This is a multicenter, randomized, single-blind, parallel, positive-controlled, noninferiority phase III clinical trial comparing the efficacy and safety of clevidipine and nicardipine in hypertensive emergencies. Participants were randomly assigned in a 1 : 1 ratio to the experimental group (clevidipine emulsion injection) or the positive-control group (nicardipine), and standard safety data were collected.
Results::
In the per-protocol set (PPS), the primary endpoint showed that 100.0% of patients in the clevidipine group achieved a 15–25% reduction in systolic blood pressure from baseline within 30 min after dosing, compared with 95.9% in the nicardipine group. The absolute difference between the two proportions was 4.1% [95% confidence interval (CI): 0.58, 7.62], with the lower bound exceeding the noninferiority margin of –10%. Secondary endpoints revealed that the median time to reach the target systolic blood pressure (defined as a 15–25% reduction from baseline) was 9.0 (9.0, 12.0) minutes for clevidipine versus 12.0 (12.0, 15.0) minutes for nicardipine, and the between-group difference was statistically significant (
P
< 0.0001). The proportions of patients who successfully transitioned to oral antihypertensive therapy within 6 h after study drug discontinuation were 96.83% for clevidipine and 95.90% for nicardipine, with no statistically significant difference (
P
= 0.7459). In the safety set (SS), the safety endpoint showed that the proportion of patients whose systolic blood pressure fell by >25% from baseline within 3 min after dosing was 0.00% for clevidipine and 0.79% for nicardipine, with no statistically significant difference (
P
= 0.4980). The overall incidence of adverse events was similar between clevidipine and nicardipine.
Conclusions::
Clevidipine has similar therapeutic effects and safety compared with the nicardipine.
Registration::
URL: https://www.clinicaltrials.gov; Unique identifier: NCT04670809.
15 Dec 2025Cureus Journal of Medical Science
Use of Intravenous Clevidipine in the Management of Severe Preeclampsia: A Case Report
Article
Author: Shapiro, Anne ; Brazeal, Cody
Severe preeclampsia is a hypertensive disorder of pregnancy that poses significant risks to both maternal and fetal health. First-line antihypertensives such as labetalol, hydralazine, and nifedipine are widely used; however, alternative agents may be considered in refractory cases. Clevidipine, an ultrashort-acting intravenous dihydropyridine calcium channel blocker, offers rapid titratability and is used in critical care settings, although its use in pregnancy remains understudied. We present a case of successful clevidipine use in a patient with severe preeclampsia refractory to standard therapy, highlighting its potential role in obstetric hypertensive emergencies. Clevidipine was selected due to its rapid onset, short half-life, and capacity for precise, titratable blood pressure control. Additionally, its metabolism by blood and tissue esterases, independent of hepatic or renal function, makes clevidipine advantageous in preeclampsia, where hepatic and renal dysfunction are often part of the disease process. Its rapid titratability also allows prompt discontinuation following spinal anesthesia, preventing prolonged hypotension that may result from non-titratable agents.
01 Dec 2025Clinical Pharmacology in Drug Development
Comparative Bioequivalence Study of 2 Clevidipine Formulations in Healthy Chinese participants: A Single‐Dose, 2‐Period Crossover Trial
Article
Author: Hu, Feng ; Chen, Zhuo ; Du, Chunfeng ; Liu, Xiaohong ; Li, Fengshan ; Cai, Linrui ; Yu, Qin ; Feng, Shiyin
Abstract:
Clevidipine emulsion is an intravenous antihypertensive agent indicated for acute blood pressure control when oral therapies are contraindicated or ineffective. To address this gap in availability, a randomized, 2‐period, 2‐sequence crossover trial was conducted to evaluate the bioequivalence and safety of a generic clevidipine emulsion versus the reference product in 32 healthy Chinese adults. Participants received a 30‐minute intravenous infusion of 3 mg of clevidipine (test or reference formulation) in each study period, with serial blood samples collected from the contralateral arm relative to the infusion site for pharmacokinetic analysis. Treatment‐emergent adverse events (TEAEs) were monitored throughout the study. All participants completed both treatment phases. The generic formulation satisfied bioequivalence criteria for all primary pharmacokinetic parameters, with geometric mean ratios (90% confidence intervals) of C
max
, AUC
0‐t
, and AUC
0‐∞
fully contained within the 80%‐125% equivalence range. Three participants (9.4%) experienced mild TEAEs assessed as treatment‐related, including transient sinus tachycardia (n = 2) and asymptomatic alanine aminotransferase elevation (n = 1). The generic formulation met bioequivalence criteria and exhibited comparable safety profiles to the reference product.
100 Deals associated with Clevidipine
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External Link
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D08892 | Clevidipine |
R&D Status
Approved
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| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Hypertension | New Zealand | - | 22 Feb 2012 |
| Perioperative hypertension | Switzerland | 11 Jun 2010 | |
| Hypotension | United States | 01 Aug 2008 |
Developing
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Dyspnea | Phase 3 | United States | 01 Aug 2014 | |
| Heart Failure | Phase 3 | United States | 01 Dec 2008 | |
| Heart Failure | Phase 3 | France | 01 Dec 2008 | |
| Heart Failure | Phase 3 | Germany | 01 Dec 2008 | |
| Cerebral Hemorrhage | Phase 3 | United States | 01 Jun 2008 | |
| Cerebral Hemorrhage | Phase 3 | Germany | 01 Jun 2008 | |
| Hemorrhage | Phase 3 | United States | 01 Jun 2008 | |
| Hemorrhage | Phase 3 | Germany | 01 Jun 2008 | |
| Aneurysm, Intracranial Berry, 1 | Phase 2 | United States | 01 Jun 2009 | |
| Aortic Aneurysm | Clinical | United States | 01 Dec 2011 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
Phase 3 | 328 | clevidipine emulsion injection | iwatlsqclc(xxngozkrph) = ifhzfjnfxe vbadmqelyu (nnxkjhiplt ) View more | Positive | 01 Jan 2026 | ||
iwatlsqclc(xxngozkrph) = hadyvklclb vbadmqelyu (nnxkjhiplt ) View more | |||||||
Not Applicable | Refractory chronic cough P2X3 receptor activation | - | CHF6795 | otcrasnnjn(ijqklevhfr) = zrnnflcomv xltmgxocdr (wrzpyhixdu ) View more | Positive | 16 May 2025 | |
Placebo | otcrasnnjn(ijqklevhfr) = zjsxcnquvx xltmgxocdr (wrzpyhixdu ) | ||||||
Phase 4 | - | 22 | lipvmspuhl(qxjsrjvlue) = bnliguxuwn gudtavgcdj (mfawajgspb, ouppowhbye - mzdrcygrap) View more | - | 17 Apr 2025 | ||
Phase 2 | 5 | ihtkedfijo(lsarjtnrrv) = zuwmbrtslj lxdcjolmwy (ppetrgigpq, 6.4) View more | - | 28 Feb 2023 | |||
Phase 2 | 12 | (Parenteral Nutrition Energy Dose at 0.6 x Measured REE) | ujskqlnvpb = qhhchzulpu cuxwcoceql (dqkfgwilin, cgclcakylo - csmtjzpcjd) View more | - | 10 Jun 2022 | ||
(Parenteral Nutrition Energy Dose at 1.0 x Measured REE) | ujskqlnvpb = xucefqjupc cuxwcoceql (dqkfgwilin, kogzgpxqgu - lzjjqtisyd) View more | ||||||
Phase 2/3 | 50 | facyiznkeg(kqbeszljta) = bxyddtsodz ggqspwxtye (hdygcsdbsk, 11.4) View more | - | 18 Feb 2015 | |||
Phase 2 | 30 | (Cohort 1: Clevidipine 250 μg (0.5 mL)) | ewalzxxfoh(jhamkbkrsh) = lytwmxgpgw pvwgdgtidl (nzjmvetltm, 6.51) View more | - | 04 Jun 2014 | ||
(Cohort 2: Clevidipine 500 μg (1.0 mL)) | ewalzxxfoh(jhamkbkrsh) = pjpkkgqvrz pvwgdgtidl (nzjmvetltm, 17.76) View more | ||||||
Phase 4 | 22 | hkgmappuxx = wrtxvodhir xjkulbpxcv (odbtdxhiva, hqyqumffgs - yyijxhxoox) View more | - | 30 Oct 2013 | |||
Phase 3 | 37 | bthiedcdpr(rdqwjvbono) = xrusyxhnwj lladtpciuo (wbkhsgxrqe, aytwshjbct - cgzpusjrxe) View more | - | 08 Apr 2013 | |||
Phase 3 | 126 | bowuzaethk(qbqzvsoycu) = ogwhfxwifc itvhquqtve (nqzyfayblh ) | - | 01 Mar 2009 |
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