Cardizem

(Diltiazem)

ApprovedSmall molecule

Diltiazem is used to treat high blood pressure and certain types of irregular heartbeats. It helps relax blood vessels and slow down the heart rate to improve blood flow and reduce strain on the heart.[2] Cardizem is currently approved and in use across 16 indications[4].[1]

Cardizem is one of 334 small molecule programs targeting Coronary Artery Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

333

Competitors

111

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Coronary Artery DiseaseUnknown status

Metabolic SyndromeApproved

Cardiovascular DiseaseActive, not recruiting

Ischemia Reperfusion InjuryApproved

Post Operative Nausea and VomitingApproved

HemorrhoidCompleted

Anal FissureRecruiting

Acute Myocardial InfarctionCompleted

PreeclampsiaActive, not recruiting

Atrial FibrillationCompleted

Coronary Artery DiseaseApproved

Unknown status

Metabolic SyndromeApproved

Approved

Cardiovascular DiseaseApproved

Active, not recruiting

Ischemia Reperfusion InjuryApproved

Approved

Post Operative Nausea and VomitingApproved

Approved

HemorrhoidApproved

Completed

Anal FissurePhase 2

Recruiting

Acute Myocardial InfarctionApproved

Completed

PreeclampsiaPreclinical

Active, not recruiting

Atrial FibrillationApproved

Completed

Showing 10 of 14 indications

Competition

Competitive Landscape

309 competitors in COVID-19

#DrugCompanyPhaseTrials

Cardizem

BBausch Health Americas, Inc.

Approved

54 2

Stivarga

Bayer

Preclinical

1 3

Aimovig

Amgen

Preclinical

1 4

Calciferol

Activella

Tricor

1 7

Statin

Bristol-Myers Squibb

Preclinical

1 8

Achromycin V

WWyeth-Lederle Vaccines

Statins

1 10

Rayaldee

OOrganon and Co

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

Treatment

NCT06993038

Q2 2027

Phase 3Not yet recruiting

Atrial Fibrillation

NCT06276127

Clinical

Trials by Indication[1]

Atrial Fibrillation9 trials

Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM)

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00000556

RATe Control in Atrial Fibrillation

Completed·—·Phase 3·NCT00313157·80 enrolled

Comparison of Diltiazem and Metoprolol in the Management of Acute Atrial Fibrillation or Atrial Flutter

Completed·AAntonios Likourezos·Phase 4·NCT01914926·54 enrolled

Show 6 more trials

Bolus vs IVP (Intravenous Push) Diltiazem for Atrial Fibrillation or Flutter

Unknown status·MMercy Health Muskegon·Phase 4·NCT04141553·300 enrolled

Oral vs Intravenous Diltiazem for Rapid Atrial Fibrillation/Flutter Trial

Completed·VVirginia Commonwealth University·Phase 4·NCT03472495·19 enrolled

Rate Control in Atrial Fibrillation II

Completed·—·Phase 4·NCT02695992·122 enrolled

Rate Control in Atrial Fibrillation

Completed·TTehran University of Medical Sciences·Phase 4·NCT01655303·90 enrolled

Oral Bisoprolol Vs IV Diltiazem in Atrial Fibrillation or Flutter With Rapid Ventricular Rate.

Not yet recruiting·OOman Medical Speciality Board·Phase 3·NCT06276127·60 enrolled

Randomized Trial Comparing Diltiazem and Metoprolol For Atrial Fibrillation Rate Control

Terminated·CCAMC Health System·Approved·NCT02025465·69 enrolled

TIA5 trials

Adenosine vs. Diltiazem

Completed·HHaseki Training and Research Hospital·Phase 4·NCT07456423·140 enrolled

A Phase I Study to Assess PK of AZD7986 Alone & With Verapamil, Itraconazole or Diltiazem in Healthy Subjects

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT02653872·15 enrolled

Diltiazem in Jervell and Lange-Nielsen Syndrome

Completed·VVanderbilt University Medical Center·Phase 4·NCT06534671·1 enrolled

Show 2 more trials

A Clinical Study of MK-4318 and Diltiazem in Healthy People (MK-4318-003)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT06692647·19 enrolled

The Effect of Concomitant Administration of Erythromycin and Diltiazem on CYP3A Activity in Healthy Volunteers

Completed·IIndiana University School of Medicine·Phase 4·NCT00318201·7 enrolled

ART3 trials

A Study of LY2623091 in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02300259·48 enrolled

A Study to Evaluate the Effect of Co-administration of Itraconazole or Diltiazem on the Single-dose of Danicamtiv in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT05162222·30 enrolled

A Study of the Effect of Multiple Doses of Diltiazem on the Plasma Levels of MK-6916 in Healthy Participants (MK-6916-005)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT06818968·37 enrolled

Interaction3 trials

Pharmacokinetic Interaction Between Diltiazem and ACT-541468 in Healthy Subjects

Completed· Idorsia Pharmaceuticals Ltd. logo

Idorsia Pharmaceuticals Ltd.·Phase 1·NCT02526888·14 enrolled

A Drug Interaction Study of Boceprevir in Combination With Amlodipine or Diltiazem in Healthy Volunteers

Withdrawn·OOttawa Hospital Research Institute·Phase 1·NCT01549496

A Drug-Drug Interaction Study of Diltiazem and MK-1167 in Healthy Adult Participants (MK-1167-006)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT06703463·16 enrolled

Tics3 trials

Study to Determine the Effect of Repeated Administration of Diltiazem on the Pharmacokinetics of Darapladib (Sb-480848).

Completed· GSK logo

GSK·Phase 1·NCT01852565·36 enrolled

Effect of Diltiazem on Pharmacokinetics of BMS-914392

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT01211808·24 enrolled

Open Label Study, Assessing the Effect of Diltiazem or Ketoconazole on the Pharmacokinetics of AZD9742 in Healthy Volunteers

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01124760·28 enrolled

27 more indications

Single Dose2 trials

A Study of Diltiazem With a Single Dose of MK-6552 in Healthy Adult Participants (MK-6552-007)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT06662396·14 enrolled

A Study to Estimate the Effect of CYP3A4 Inhibitors (Itraconazole, Diltiazem or Verapamil) on the Pharmacokinetics of Single Dose PF- 00489791 in Healthy Volunteers

Completed· Pfizer logo

Pfizer·Phase 1·NCT02319148·22 enrolled

Anal fissure2 trials

Treatment Of Chronic Anal Fissure

Terminated·—·N/A·NCT02158013·55 enrolled

Comparative Evaluation of MEBO Ointment and Topical Diltiazem Ointment in the Treatment of Acute Anal Fissure

Recruiting·—·Phase 2·NCT04153032·183 enrolled

Hypertensive1 trial

The Effect of Nebivolol in Hypertensive Patients With Coronary Arterial Spasm

Completed·KKorea University Anam Hospital·Phase 4·NCT03930433·51 enrolled

Ischemia1 trial

Asymptomatic Cardiac Ischemia Pilot (ACIP) Study

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00000478

Intraoperative Bleeding1 trial

Efficacy of Oral Verapamil and Oral Diltiazim on Reduction of Intraoperative Bleeding During Endoscopic Sinus Surgery Under General Anesthesia

Unknown status·—·Phase 1·NCT04790331·135 enrolled

B-cell Malignancies1 trial

Interaction Study of Zanubrutinib With Moderate and Strong CYP3A Inhibitors in Participants With B-Cell Malignancies

Completed· BeiGene logo

BeiGene·Phase 1·NCT04551963·26 enrolled

Efficacy1 trial

Efficacy of Medical Therapy in Women and Men With Angina and Myocardial Bridging

Terminated·SStanford University·Phase 2·NCT04130438·5 enrolled

Thoracic Surgery1 trial

Celiprolol Versus Ditiazem for the Prevention of Postoperative Cardiac Arrythmias in Thoracic Surgery

Unknown status·—·Phase 2·NCT03752931·30 enrolled

Acute Myocardial Infarction1 trial

Effects of Different Vasodilators on Coronary No-reflow During primAry percuTaneous Coronary intErvention in Patients With Acute Myocardial Infarction

Completed·FFudan University·Phase 4·NCT00712894·102 enrolled

Blood Pressure1 trial

Control of Emergence Blood Pressure During Craniotomy for Tumor Surgery Between Labetolol and Diltiazem

Completed·MMahidol University·Phase 1/2·NCT01408524·184 enrolled

Medication1 trial

Evaluate a Medication on How Hunger and Appetite Are Influenced by Smell

Terminated·PPennington Biomedical Research Center·Phase 1·NCT01021176·12 enrolled

Methadone1 trial

Drug Discrimination in Methadone-Maintained Humans Study 1

Completed·UUniversity of Arkansas·Phase 1·NCT00593463·40 enrolled

Hypertension1 trial

Treatment of Supine Hypertension in Autonomic Failure

Completed·VVanderbilt University·Phase 1·NCT00223717·152 enrolled

Coronary Artery Disease1 trial

Randomized Trial to Examine a Differential Therapeutic Response in Symptomatic Patients With Non-obstructive Coronary Artery Disease

Unknown status·—·Phase 4·NCT05294887·132 enrolled

Treatment1 trial

Adenosine vs Diltiazem for Treatment of SVT in the ED

Recruiting·—·Phase 4·NCT06993038·20 enrolled

Hypertrophic Cardiomyopathy1 trial

Treatment of Preclinical Hypertrophic Cardiomyopathy With Diltiazem

Completed·—·Phase 2/3·NCT00319982·39 enrolled

Influenza1 trial

Efficiency of Antagonist Drugs of the Cellular Transcriptomic Signature of Influenza A Virus Infection.

Terminated·UUniversity Hospital, Lille·Phase 2·NCT03212716·85 enrolled

Heart1 trial

Heart Rate Controller in Computed Tomography Coronary Angiography

Unknown status·MMahidol University·Phase 4·NCT05261464·246 enrolled

Functional Endoscopic Sinus Surgery1 trial

Efficacy of Oral Diltiazem on the Intraoperative Bleeding in Functional Endoscopic Sinus Surgery

Unknown status·—·Phase 1·NCT03580590·40 enrolled

Midazolam1 trial

A Phase I Study in Healthy Volunteers to Assess the Effect of Cytochrome3A4 (CYP3A4) Inhibitors (Diltiazem and Itraconazole) on the Pharmacokinetics (PK) of AZD3293 and the Effects of AZD3293 on the Pharmacokinetics of Midazolam, a Cytochrome 3A4 and Cytochrome 3A5 (CYP3A4/CYP3A5) Substrate

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT02010970·56 enrolled

Drug1 trial

A Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of Single and Multiple Doses of BMS-986209 in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04154800·114 enrolled

Preeclampsia1 trial

Efficacy of Diltiazem for the Control of Blood Pressure in Puerperal Patients With Severe Preeclampsia

Completed·—·N/A·NCT04222855·42 enrolled

Surgery1 trial

Ischaemia-réperfusion During the Coronary Surgery With Beating Heart

Unknown status·UUniversity Hospital, Strasbourg, France·Phase 3·NCT01771978·120 enrolled

Hemorrhoid1 trial

Evaluation of Pain Reduction After Hemorrhoidectomy With Use of Diltiazim Ointment 2%

Completed·TTehran University of Medical Sciences·Phase 4·NCT00893100·1 enrolled

Hypertrophic Cardiomyopathy (HCM)1 trial

The Therapeutic Value of Mavacamten in Hypertrophic Cardiomyopathy With Mid-to-Apical Left Ventricular Obstruction: A Prospective, Interventional, Real-World Clinical Study.

Enrolling by invitation·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Approved·NCT07103655·132 enrolled

Coronary Artery Bypass Graft1 trial

Effect of Nicorandil, Diltiazem or Isosorbide Mononitrate for Oral Antispastic Therapy After Coronary Artery Bypass Grafting Using Radial Artery Grafts - A Pilot Randomized Controlled Trial

Completed·RRuijin Hospital·Approved·NCT04310995·150 enrolled

Unspecified3 trials

Ability of Late Sodium or Calcium Current Block to Balance the ECG Effects of Potassium Current Block

Completed·FFood and Drug Administration (FDA)·Phase 1·NCT02308748·22 enrolled

A Clinical Study to Evaluate the Plasma Pharmacokinetics of a Single Dose of MK-4082 With and Without Diltiazem Coadministration in Healthy Participants

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT07697625·28 enrolled

A Study to Evaluate the Effect of Multiple Oral Doses of Diltiazem on the Single-Dose Pharmacokinetics of Nemtabrutinib in Healthy Participants.

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT07232589·26 enrolled

Regulatory

FDA Approval Timeline[5]

Nov 5, 1982

CARDIZEM

NDA NDA018602

Mar 11, 1983

CARDIZEM

NDA NDA018602

Mar 11, 1983

CARDIZEM

NDA NDA018602

May 27, 1983

CARDIZEM

NDA NDA018602

May 27, 1983

CARDIZEM

NDA NDA018602

Sep 6, 1983

CARDIZEM

NDA NDA018602

Oct 6, 1983

CARDIZEM

NDA NDA018602

Oct 6, 1983

CARDIZEM

NDA NDA018602

Feb 28, 1984

CARDIZEM

NDA NDA018602

Jun 8, 1984

CARDIZEM

NDA NDA018602

Jun 8, 1984

CARDIZEM

NDA NDA018602

Feb 4, 1985

CARDIZEM

NDA NDA018602

Jun 20, 1985

CARDIZEM

NDA NDA018602

Jul 28, 1986

CARDIZEM

NDA NDA018602

Jul 28, 1986

CARDIZEM

NDA NDA018602

Dec 8, 1986

CARDIZEM

NDA NDA018602

Oct 29, 1987

CARDIZEM

NDA NDA018602

Nov 30, 1987

CARDIZEM

NDA NDA018602

Dec 7, 1987

CARDIZEM

NDA NDA018602

Feb 19, 1988

CARDIZEM

NDA NDA018602

Feb 19, 1988

CARDIZEM

NDA NDA018602

Aug 12, 1988

CARDIZEM

NDA NDA018602

Oct 13, 1988

CARDIZEM

NDA NDA018602

Dec 14, 1988

CARDIZEM

NDA NDA018602

Jan 23, 1989

CARDIZEM SR

NDA NDA019471

Nov 21, 1989

CARDIZEM

NDA NDA018602

Dec 18, 1989

CARDIZEM

NDA NDA018602

Apr 12, 1990

CARDIZEM

NDA NDA018602

Mar 14, 1991

CARDIZEM

NDA NDA018602

Jun 13, 1991

CARDIZEM

NDA NDA018602

Oct 24, 1991

CARDIZEM

NDA NDA020027

Dec 27, 1991

CARDIZEM CD

NDA NDA020062

May 27, 1992

CARDIZEM

NDA NDA018602

May 29, 1992

DILACOR XR

NDA NDA020092

Aug 4, 1992

CARDIZEM CD

NDA NDA020062

Aug 10, 1992

CARDIZEM CD

NDA NDA020062

Aug 10, 1992

CARDIZEM CD

NDA NDA020062

Sep 18, 1992

CARDIZEM CD

NDA NDA020062

Feb 8, 1993

CARDIZEM

NDA NDA018602

Apr 13, 1993

CARDIZEM

NDA NDA018602

Apr 28, 1993

CARDIZEM CD

NDA NDA020062

Jun 29, 1993

CARDIZEM CD

NDA NDA020062

Jul 1, 1993

CARDIZEM

NDA NDA018602

Jul 7, 1993

CARDIZEM

NDA NDA018602

Oct 6, 1993

CARDIZEM CD

NDA NDA020062

Nov 1, 1993

CARDIZEM CD

NDA NDA020062

May 5, 1994

CARDIZEM CD

NDA NDA020062

Sep 14, 1994

CARDIZEM CD

NDA NDA020062

Sep 21, 1994

CARDIZEM

NDA NDA018602

Sep 28, 1994

CARDIZEM CD

NDA NDA020062

Oct 12, 1994

CARDIZEM

NDA NDA018602

Oct 24, 1994

CARDIZEM CD

NDA NDA020062

Nov 22, 1994

CARDIZEM CD

NDA NDA020062

Nov 29, 1994

CARDIZEM

NDA NDA018602

Dec 28, 1994

CARDIZEM

NDA NDA018602

Dec 30, 1994

CARDIZEM

NDA NDA018602

Apr 3, 1995

CARDIZEM CD

NDA NDA020062

May 4, 1995

CARDIZEM CD

NDA NDA020062

May 4, 1995

CARDIZEM

NDA NDA018602

May 11, 1995

CARDIZEM CD

NDA NDA020062

Aug 29, 1995

CARDIZEM

NDA NDA018602

Sep 11, 1995

TIAZAC

NDA NDA020401

Sep 25, 1995

CARDIZEM CD

NDA NDA020062

Oct 31, 1995

CARDIZEM CD

NDA NDA020062

Apr 2, 1996

CARDIZEM CD

NDA NDA020062

Apr 2, 1996

CARDIZEM

NDA NDA018602

Apr 2, 1996

CARDIZEM

NDA NDA018602

Apr 2, 1996

CARDIZEM CD

NDA NDA020062

Aug 4, 1997

CARDIZEM

NDA NDA018602

Aug 6, 1997

CARDIZEM CD

NDA NDA020062

Sep 5, 1997

CARDIZEM

NDA NDA020792

Nov 19, 1997

CARDIZEM

NDA NDA018602

Nov 21, 1997

CARDIZEM CD

NDA NDA020062

Feb 5, 1998

CARDIZEM

NDA NDA018602

Apr 7, 1998

CARDIZEM CD

NDA NDA020062

Apr 15, 1999

CARDIZEM CD

NDA NDA020062

Apr 29, 1999

CARDIZEM CD

NDA NDA020062

Jun 18, 1999

CARDIZEM

NDA NDA018602

Aug 24, 1999

CARDIZEM CD

NDA NDA020062

Oct 19, 1999

CARDIZEM CD

NDA NDA020062

Nov 18, 1999

CARDIZEM CD

NDA NDA020062

Dec 3, 1999

CARDIZEM CD

NDA NDA020062

Jan 21, 2000

CARDIZEM CD

NDA NDA020062

Jan 28, 2000

DILTIAZEM HYDROCHLORIDE

NDA NDA020939

Jun 4, 2001

CARDIZEM

NDA NDA018602

Jun 4, 2001

CARDIZEM CD

NDA NDA020062

Feb 6, 2003

CARDIZEM LA

NDA NDA021392

Feb 6, 2003

CARDIZEM LA

NDA NDA021392

Mar 21, 2003

CARDIZEM CD

NDA NDA020062

Mar 21, 2003

CARDIZEM

NDA NDA018602

Apr 2, 2004

CARDIZEM LA

NDA NDA021392

Apr 27, 2007

CARDIZEM LA

NDA NDA021392

Nov 22, 2010

CARDIZEM CD

NDA NDA020062

Nov 23, 2010

CARDIZEM

NDA NDA018602

Nov 23, 2010

CARDIZEM LA

NDA NDA021392

Jun 24, 2014

CARDIZEM

NDA NDA018602

Nov 21, 2014

CARDIZEM

NDA NDA018602

Mar 23, 2015

CARDIZEM LA

NDA NDA021392

Jun 29, 2016

CARDIZEM CD

NDA NDA020062

Nov 18, 2016

CARDIZEM LA

NDA NDA021392

Nov 18, 2016

CARDIZEM CD

NDA NDA020062

Nov 18, 2016

CARDIZEM

NDA NDA018602

Jan 23, 2017

CARDIZEM CD

NDA NDA020062

Mar 26, 2020

CARDIZEM CD

NDA NDA020062

Jun 29, 2020

CARDIZEM

NDA NDA018602

Oct 28, 2021

DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%

NDA NDA215252

Feb 21, 2025

DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE

NDA NDA218038

Apr 16, 2025

CARDIZEM CD

NDA NDA020062

Apr 16, 2025

CARDIZEM

NDA NDA018602

Apr 16, 2025

CARDIZEM LA

NDA NDA021392

Apr 16, 2025

CARDIZEM LA

NDA NDA021392

Sources

References

[1]
ClinicalTrials.gov — 54 trial records for Diltiazem. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Cardizem drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Diltiazem compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Diltiazem. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020062). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Bausch Health Americas, Inc. 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: BBausch Health Americas, Inc.

Cardizem

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Trials by Indication[1]

Atrial Fibrillation9 trials

TIA5 trials

ART3 trials

Interaction3 trials

Tics3 trials

Single Dose2 trials

Anal fissure2 trials

Hypertensive1 trial

Ischemia1 trial

Intraoperative Bleeding1 trial

B-cell Malignancies1 trial

Efficacy1 trial

Thoracic Surgery1 trial

Acute Myocardial Infarction1 trial

Blood Pressure1 trial

Medication1 trial

Methadone1 trial

Hypertension1 trial

Coronary Artery Disease1 trial

Treatment1 trial

Hypertrophic Cardiomyopathy1 trial

Influenza1 trial

Heart1 trial

Functional Endoscopic Sinus Surgery1 trial

Midazolam1 trial

Drug1 trial

Preeclampsia1 trial

Surgery1 trial

Hemorrhoid1 trial

Hypertrophic Cardiomyopathy (HCM)1 trial

Coronary Artery Bypass Graft1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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