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Cleviprex

(Clevidipine)

ApprovedSmall molecule

Chiesi Farmaceutici S.p.A.

Clevidipine is used to lower high blood pressure quickly in hospitalized patients when oral medications cannot be used. It works by relaxing blood vessels to help reduce blood pressure.[2] Cleviprex is currently approved and in use across 11 indications[4].[1]

Cleviprex is one of 261 small molecule programs targeting Cardiovascular Disease. It is currently in Approved.

11

Indications

23

Total Trials

2

Active Trials

260

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

3

Patents

Pipeline

Status by Indication[4][1]

Indication

Cardiovascular DiseaseActive, not recruiting

Malignant HypertensionApproved

Spinal FusionActive, not recruiting

Aortic AneurysmActive, not recruiting

Intracerebral HemorrhageActive, not recruiting

HypertensionApproved

Heart FailureActive, not recruiting

Subarachnoid HemorrhageActive, not recruiting

ScoliosisApproved

Ischemic StrokeActive, not recruiting

Cardiovascular DiseaseApproved

Active, not recruiting

Malignant HypertensionApproved

Approved

Spinal FusionPhase 2/Phase 3

Active, not recruiting

Aortic AneurysmPreclinical

Active, not recruiting

Intracerebral HemorrhagePreclinical

Active, not recruiting

HypertensionApproved

Approved

Heart FailurePhase 3

Active, not recruiting

Subarachnoid HemorrhagePhase 2

Active, not recruiting

ScoliosisApproved

Approved

Ischemic StrokePhase 3

Active, not recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

687 competitors in Heart Failure

#DrugCompanyPhaseTrials

Cleviprex

Chiesi Farmaceutici S.p.A.

Bayer Aspirin

Brethine

Medrol

Amidate

Monoferric

PPharmacosmos A/S

Zemplar

Xylocaine

MMEDRx USA, Inc.

Tamiflu

CConrado Roberto Hoffmann Filho

Sulfonylureas

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2028

Intracerebral Hemorrhage

NCT06402968

Clinical

Trials by Indication[1]

Hypertension5 trials

Effect of Treatment of Pre-induction Hypertension on Hemodynamic Stability During Induction of General Anesthesia

Not yet recruiting·UUniversity of California, San Diego·Phase 4·NCT06063772·64 enrolled

Clevidipine in the Treatment of Patients With Severe Hypertension (VELOCITY)

Completed· Novartis logo

Novartis·Phase 3·NCT00369837·131 enrolled

Clevidipine in the Postoperative Treatment of Hypertension (ECLIPSE-NIC)

Completed· Novartis logo

Novartis·Phase 3·NCT00093925·739 enrolled

Show 2 more trials

Clevidipine in the Perioperative Treatment of Hypertension (ECLIPSE-NTG)

Completed· Novartis logo

Novartis·Phase 3·NCT00093886·629 enrolled

Clevidipine in the Perioperative Treatment of Hypertension (ECLISPE-SNP)

Completed· Novartis logo

Novartis·Phase 3·NCT00093912·739 enrolled

Cardiac Surgery3 trials

Clevidipine Bolus Administration in the Treatment of Hypertensive Patients Undergoing Cardiac Surgery (SPRINT)

Completed· Novartis logo

Novartis·Phase 2·NCT00799604·30 enrolled

Study of Clevidipine Assessing Its Preoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-1)

Completed· Novartis logo

Novartis·Phase 3·NCT00093249·105 enrolled

Study of Clevidipine Assessing Its Postoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-2)

Completed· Novartis logo

Novartis·Phase 3·NCT00093262·206 enrolled

Intracerebral Hemorrhage2 trials

Clevidipine in the Treatment of Patients With Acute Hypertension and Intracerebral Hemorrhage (ACCELERATE)

Completed· Novartis logo

Novartis·Phase 3·NCT00666328·37 enrolled

Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage

Recruiting·ZZeenat Qureshi Stroke Institute··NCT06402968·1,018 enrolled

Neurosurgical Patients1 trial

A Pilot Study to Evaluate Efficacy and Safety of Clevidipine in Neurosurgical Patients

Completed·NNYU Langone Health·Phase 4·NCT00952081·22 enrolled

Heart Failure1 trial

Clevidipine in the Treatment of Blood Pressure in Patients With Acute Heart Failure (PRONTO)

Completed· Novartis logo

Novartis·Phase 3·NCT00803634·117 enrolled

11 more indications

Aortic Aneurysm1 trial

Pre and or Post Operative Blood Pressure Control With Clevidipine (Cleviprexm Medicines Company) in Aortic Aneurysm / Dissection

Withdrawn·—·N/A·NCT01480531

Pediatric1 trial

Assessment of Efficacy, Safety and Dosing of Clevidipine in Pediatric Participants Undergoing Surgery (PIONEER)

Terminated· Chiesi Farmaceutici S.p.A. logo

Chiesi Farmaceutici S.p.A.·Phase 4·NCT01938547·22 enrolled

Ischemic stroke1 trial

Clevidipine Infusion for Blood Pressure Management After Successful Revascularization in Acute Ischemic Stroke

Completed·—·Phase 3·NCT05175547·80 enrolled

Subarachnoid Hemorrhage1 trial

Clevidipine for Vasospasm After Subarachnoid Hemorrhage (SAH)

Withdrawn·HHenry Ford Health System·Phase 2·NCT02011321

CLE1 trial

Clevidipine (Cleviprex®) Compared With Urapidil (Ebrantil®)

Withdrawn·UUniversity of Zurich·Phase 4·NCT03300479

Hypertensive1 trial

The Evaluation of Clevidipine in Patients Requiring ICP Monitoring and IV Antihypertensive Therapy

Withdrawn·MMario Ammirati·Phase 4·NCT01910532

ART1 trial

Clevidipine for Vasoreactivity Evaluation of the Pulmonary Arterial Bed

Completed·NNorth Texas Veterans Healthcare System·Phase 4·NCT01121458·12 enrolled

Safety and Efficacy1 trial

A Safety and Efficacy Study of Blood Pressure Control in Acute Aortic Emergencies - A Pilot Study (PROMPT)

Terminated·—·Phase 4·NCT01033370·5 enrolled

Spinal Fusion1 trial

An Open-label Trial of Clevidipine for Controlled Hypotension During Spinal Fusion

Completed·NNationwide Children's Hospital·Phase 2/3·NCT01645111·50 enrolled

Pilot Study1 trial

Effect of Changing Physiological Conditions on Myogenic Oscillations: Pilot Study

Completed·UUniversity of California, San Francisco·Phase 1·NCT03719001·40 enrolled

Unspecified1 trial

The Energy Dose Study

Terminated·EEmory University·Phase 2·NCT01369147·12 enrolled

Regulatory

FDA Approval Timeline[5]

Aug 1, 2008

CLEVIPREX

NDA NDA022156

Sources

References

[1]
ClinicalTrials.gov — 23 trial records for Clevidipine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Cleviprex drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Clevidipine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Clevidipine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA022156). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Cleviprex. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Chiesi Farmaceutici S.p.A. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Voltage-Gated L-Type Calcium Channel Blocker[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Chiesi Farmaceutici S.p.A.

Patent Landscape[6]

Patent Cliff

Oct 10, 2031

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8658676Oct 10, 2031

11103490Oct 10, 2031

10010537Oct 10, 2031

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