Cardizem Cd

(Diltiazem Hydrochloride)

Phase 3Small molecule

BBausch Health Americas, Inc.

Cardizem Cd is one of 69 small molecule programs targeting Intestinal Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Intestinal CancerNot yet recruiting

Pulmonary Arterial HypertensionActive, not recruiting

Coronary Microvascular DysfunctionActive, not recruiting

Intestinal CancerPhase 2

Not yet recruiting

Pulmonary Arterial HypertensionPreclinical

Active, not recruiting

Coronary Microvascular DysfunctionPhase 3

Active, not recruiting

Competition

Competitive Landscape

53 competitors in Pulmonary Arterial Hypertension

#DrugCompanyPhaseTrials

Letairis

Gilead

Approved

17 2

Tracleer

Johnson & Johnson

Approved

16 3

Winrevair

Merck & Co.

Approved

16 4

Opsumit

Johnson & Johnson

Approved

11 5

Remodulin

United Therapeutics

Approved

10 6

Cialis

Eli Lilly

Approved

9 7

Adempas

Bayer

Approved

7 8

Viagra

VViatris Specialty LLC

Approved

12 9

Aldactone

Pfizer

Approved

2 10

Uptravi

Johnson & Johnson

Approved

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

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Coronary Microvascular Dysfunction

NCT04777045

Q1 2030

Phase 1/2Not yet recruiting

Intestinal Cancer

NCT07456852

Clinical

Trials by Indication[1]

Intestinal Cancer1 trial

Vasodilator Therapy With Isosorbide Mononitrate or Diltiazem to Reduce Vasotoxicity in Patients With Gastrointestinal Cancer Receiving Fluoropyrimidine Therapy

Not yet recruiting·MMayo Clinic·Phase 1/2·NCT07456852·60 enrolled

Pulmonary Arterial Hypertension1 trial

Efficacy Study of Cardizem in Pulmonary Arterial Hypertension

Withdrawn·UUniversity of South Florida·N/A·NCT01645826

Coronary Microvascular Dysfunction1 trial

Efficacy of Diltiazem to Improve Coronary Microvascular Dysfunction: a Randomized Clinical Trial

Active, not recruiting·RRadboud University Medical Center·Phase 3·NCT04777045·85 enrolled

Regulatory

FDA Approval Timeline[4]

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 — 3 trial records for Diltiazem Hydrochloride. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Diltiazem Hydrochloride compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Diltiazem Hydrochloride. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA218038). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Bausch Health Americas, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: BBausch Health Americas, Inc.

Cardizem Cd

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2030

Trials by Indication[1]

Intestinal Cancer1 trial

Pulmonary Arterial Hypertension1 trial

Coronary Microvascular Dysfunction1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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