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 19 indications[4].[1]

Cardizem is one of 406 small molecule programs targeting Coronary Artery Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

405

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Coronary Artery DiseaseActive, not recruiting

Metabolic SyndromeApproved

Cardiovascular DiseaseActive, not recruiting

Ischemia Reperfusion InjuryApproved

Post Operative Nausea and VomitingApproved

HemorrhoidActive, not recruiting

IschemiaActive, not recruiting

Anal FissureActive, not recruiting

Acute Myocardial InfarctionActive, not recruiting

HypertensionActive, not recruiting

Coronary Artery DiseaseApproved

Active, not recruiting

Metabolic SyndromeApproved

Approved

Cardiovascular DiseaseApproved

Active, not recruiting

Ischemia Reperfusion InjuryApproved

Approved

Post Operative Nausea and VomitingApproved

Approved

HemorrhoidApproved

Active, not recruiting

IschemiaPhase 3

Active, not recruiting

Anal FissurePhase 2

Active, not recruiting

Acute Myocardial InfarctionApproved

Active, not recruiting

HypertensionPhase 1

Active, not recruiting

Showing 10 of 17 indications

Competition

Competitive Landscape

1931 competitors in COVID-19

#DrugCompanyPhaseTrials

Cardizem

BBausch Health Americas, Inc.

Approved

54 2

Spikevax

Moderna

Preclinical

21 3

Singulair

AstraZeneca

Preclinical

1 4

Calciferol

Alnylam Pharmaceuticals

Tricor

1 6

Benadryl

PParkedale

Preclinical

1 7

Glucocorticoid

AbbVie

Preclinical

1 8

Orap

Teva

Preclinical

1 9

Blood Taken

HHospices Civils de Lyon

Preclinical

1 10

Vit D

PPost Graduate Institute of Medical Education and Research, Chandigarh

Preclinical

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

Timeline

Expected Milestones

Q3 2026

Phase 1Not yet recruiting

Study completion

NCT07697625

Q4 2026

Post-ApprovalRecruiting

Treatment

NCT06993038

Q1 2027

Post-ApprovalNot yet recruiting

Hypertrophic Cardiomyopathy

NCT07103655

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

Randomized Trial Comparing Diltiazem and Metoprolol For Atrial Fibrillation Rate Control

Unknown status·—·Phase 4·NCT02025465·150 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

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

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

Show 2 more trials

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

Diltiazem in Jervell and Lange-Nielsen Syndrome

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

Interaction3 trials

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

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

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

Tics3 trials

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

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

26 more indications

Hypertrophic Cardiomyopathy2 trials

The Therapeutic Value of Mavacamten in Hypertrophic Cardiomyopathy With Mid-to-Apical Left Ventricular Obstruction

Not yet recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 4·NCT07103655·132 enrolled

Treatment of Preclinical Hypertrophic Cardiomyopathy With Diltiazem

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

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

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

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

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

Medication1 trial

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

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

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

Treatment1 trial

Adenosine vs Diltiazem for Treatment of SVT in the ED

Recruiting·—·Phase 4·NCT06993038·20 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

Heart1 trial

Heart Rate Controller in Computed Tomography Coronary Angiography

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

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

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

Not yet recruiting· Merck & Co. logo

Merck & Co.·Phase 1·NCT07697625·18 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

Jan 23, 1989

CARDIZEM SR

NDA NDA019471

Oct 24, 1991

CARDIZEM

NDA NDA020027

May 29, 1992

DILACOR XR

NDA NDA020092

Aug 10, 1992

CARDIZEM CD

NDA NDA020062

Sep 11, 1995

TIAZAC

NDA NDA020401

Sep 5, 1997

CARDIZEM

NDA NDA020792

Jan 28, 2000

DILTIAZEM HYDROCHLORIDE

NDA NDA020939

Feb 6, 2003

CARDIZEM LA

NDA NDA021392

Oct 28, 2021

DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%

NDA NDA215252

Feb 21, 2025

DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE

NDA NDA218038

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 NDA218038). 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

Q3 2026

Q4 2026

Q1 2027

Q2 2027

Trials by Indication[1]

Atrial Fibrillation9 trials

TIA5 trials

Interaction3 trials

ART3 trials

Tics3 trials

Hypertrophic Cardiomyopathy2 trials

Single Dose2 trials

Anal fissure2 trials

Preeclampsia1 trial

Surgery1 trial

Hemorrhoid1 trial

Hypertensive1 trial

Ischemia1 trial

Intraoperative Bleeding1 trial

B-cell Malignancies1 trial

Efficacy1 trial

Thoracic Surgery1 trial

Acute Myocardial Infarction1 trial

Blood Pressure1 trial

Coronary Artery Disease1 trial

Medication1 trial

Influenza1 trial

Methadone1 trial

Hypertension1 trial

Treatment1 trial

Drug1 trial

Heart1 trial

Midazolam1 trial

Functional Endoscopic Sinus Surgery1 trial

Coronary Artery Bypass Graft1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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