Drugs / Diltiazem
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Diltiazem

Small molecule targets CYP3A4 via inhibition

Developed for
atrial fibrillation · ulcer of anus and rectum · coronary artery disorder · COVID-19 · hypertensive disorder · coronary microvascular disorder · myocardial ischemia · acute myocardial infarction
+24 more · atrial flutter · chronic ulcer of skin · coronary vasospasm · essential hypertension · heritable pulmonary arterial hypertension · hypertensive nephropathy · hypertrophic cardiomyopathy · idiopathic pulmonary arterial hypertension · influenza · ischemic disease · Jervell and Lange-Nielsen syndrome · nonobstructive coronary artery disease · paroxysmal atrial fibrillation · preeclampsia · Prinzmetal angina · atrioventricular node disorder · cardiac rhythm disease · coronary artery intramyocardial course · hemorrhoid · metabolic syndrome X · myocardial infarction · puerperal infection · vascular ectasia · ventricular tachycardia
Investigated by
Merck Sharp & Dohme LLC · Ventrus Biosciences, Inc · Bristol-Myers Squibb · National Heart, Lung, and Blood Institute (NHLBI) · Seoul National University Hospital · Assiut University
+55 more · AstraZeneca · Mayo Clinic · Pfizer · Tehran University of Medical Sciences · University Hospital, Lille · University of Arkansas · Abbott Medical Devices · American University of Beirut Medical Center · BeiGene · Boston Children's Hospital · Boston University · Brigham and Women's Hospital · Calzada-Mendoza, Claudia, PhD · Charite University, Berlin, Germany · Chinese University of Hong Kong · Chugai Pharma China · Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK) · Duke Clinical Research Institute · Eisai Inc. · Eli Lilly and Company · Fudan University · GlaxoSmithKline · Hospices Civils de Lyon · Hospital de la Mujer · I-site University Lille North Europe · Idorsia Pharmaceuticals Ltd. · Indiana University · Kowa Research Institute, Inc. · Mahidol University · Ministry of Health, France · Mohammad Ali Nazarinia · National Institute of Allergy and Infectious Diseases (NIAID) · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · National Institute on Drug Abuse (NIDA) · National Taiwan University Hospital · National University of Ireland, Galway, Ireland · Ocharan-Hernández, Esther, MD, PhD · Oman Medical Speciality Board · Ottawa Hospital Research Institute · PRA Health Sciences · Radboud University Medical Center · Ruijin Hospital · S.L.A. Pharma AG · Shiraz University of Medical Sciences · Signia Therapeutics · Singapore General Hospital · TKL Research, Inc. · University Hospital, Strasbourg, France · University of Calgary · University of South Florida · University of Vermont · Vanderbilt University · Vanderbilt University Medical Center · Vargas-De-León, Cruz, MSc · Viatris Innovation GmbH

Regulatory milestones approvals, filings & regulatory actions · 9 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) CARDIZEM LA — 2004-04-02 fda.gov ↗
Label expansion US (FDA) TIAZAC — 1998-01-30 fda.gov ↗
Label expansion US (FDA) DILACOR XR — 1995-03-02 fda.gov ↗
Label expansions (3) US (FDA) CARDIZEM — 1986-07-28 – 1993-07-01 fda.gov ↗
Label expansions (2) US (FDA) CARDIZEM CD — 1992-08-10 – 1992-10-15 fda.gov ↗
Approved US (FDA) CARDIZEM — 1982-11-05 fda.gov ↗

Trials 67 · started per year

today
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 02 trials
Phase 0 NCT04790331 Mar 2021 → Jan 2022 — Assiut University Unknown No outcome recorded
Phase 0 NCT03580590 Sep 2018 → Nov 2019 orthostatic hypotension 2 Assiut University Unknown No outcome recorded
Phase 129 trials
Phase 1 NCT07697625 Jul → Sep 2026 overdue — Merck Sharp & Dohme LLC Not yet recruiting No outcome recorded
Phase 1 NCT07232589 Dec 2025 → May 2026 — Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 1 NCT06818968 Feb → Aug 2025 — Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 1 NCT06554639 Jul → Aug 2024 prostate neoplasm Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 1 NCT06662396 Jun → Sep 2024 — Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 1 NCT06692647 Feb → Apr 2024 — Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 1 NCT05745337 Feb → Dec 2023 atrial fibrillation, diastolic heart failure University of Vermont Unknown No outcome recorded
Phase 1 NCT05162222 Dec 2021 → Jul 2022 — Bristol-Myers Squibb Completed No outcome recorded
Phase 1 NCT04551963 Nov 2020 → Feb 2022 B-cell neoplasm BeiGene Completed Mixed
Phase 1 NCT02807909 Jul → Aug 2016 thrombotic disease Bristol-Myers Squibb Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT07456852 Apr 2026 → Apr 2028 expected digestive system cancer Mayo Clinic Recruiting No outcome recorded
Phase 24 trials
Phase 2 NCT05563168 Apr 2023 → Oct 2024 COVID-19 Hospices Civils de Lyon Withdrawn No outcome recorded
Phase 2 NCT04153032 Dec 2019 → Jan 2026 overdue — American University of Beirut Medical Center Recruiting No outcome recorded
Phase 2 NCT03212716 Dec 2017 → May 2022 influenza University Hospital, Lille Terminated No outcome recorded
Phase 2 NCT02801305 Jun 2016 → Jan 2017 chronic ulcer of skin Mohammad Ali Nazarinia Completed No outcome recorded
Phase 2/33 trials · 2 missed
Phase 2/3 NCT04887818 Jun → Dec 2021 ulcer of anus and rectum University of Calgary Unknown No outcome recorded
Phase 2/3 NCT00582777 Nov 2007 → Dec 2008 hypertensive nephropathy National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Completed Missed primary
Phase 2/3 NCT00319982 Jan 2006 → Dec 2012 hypertrophic cardiomyopathy Brigham and Women's Hospital Completed Missed primary
Phase 38 trials · 1 missed
Phase 3 NCT06276127 Apr 2025 → Apr 2027 expected atrial fibrillation, atrial flutter Oman Medical Speciality Board Not yet recruiting No outcome recorded
Phase 3 NCT04372082 May 2020 → May 2023 COVID-19 University Hospital, Lille Withdrawn No outcome recorded
Phase 3 NCT04777045 Oct 2019 → Jul 2026 overdue coronary microvascular disorder, coronary vasospasm, myocardial ischemia Radboud University Medical Center Active not recruiting Missed primary
Phase 3 NCT01690221 Oct 2012 → Dec 2013 ulcer of anus and rectum Ventrus Biosciences, Inc Completed No outcome recorded
Phase 3 NCT01217515 Oct 2010 → Mar 2012 ulcer of anus and rectum S.L.A. Pharma AG Completed No outcome recorded
Phase 3 NCT01771978 Jun 2002 → Feb 2008 ischemic disease University Hospital, Strasbourg, France Unknown No outcome recorded
Phase 3 NCT00000556 Mar 1995 → Sep 2002 atrial fibrillation National Heart, Lung, and Blood Institute (NHLBI) Completed No outcome recorded
Phase 3 NCT00000478 Nov 1990 → Jun 1997 coronary artery disorder, myocardial ischemia National Heart, Lung, and Blood Institute (NHLBI) Completed No outcome recorded
Phase 414 trials · 1 met primary
Phase 4 NCT06534671 Oct 2024 Jervell and Lange-Nielsen syndrome Vanderbilt University Medical Center Completed No outcome recorded
Phase 4 NCT05294887 Mar 2022 → Jun 2024 Prinzmetal angina, coronary microvascular disorder, nonobstructive coronary artery disease Charite University, Berlin, Germany Unknown No outcome recorded
Phase 4 NCT04234477 Dec 2021 → Jun 2022 atrial fibrillation Boston University Withdrawn No outcome recorded Stop: Enrollment
Phase 4 NCT05261464 Jan 2021 → Jun 2022 — Mahidol University Unknown No outcome recorded
Phase 4 NCT04310995 Jun 2020 → Feb 2023 coronary artery disorder Ruijin Hospital Completed No outcome recorded
Phase 4 NCT04330300 Apr 2020 → Jul 2021 COVID-19, essential hypertension National University of Ireland, Galway, Ireland Suspended No outcome recorded Stop: Business
Phase 4 NCT01162902 Sep 2013 → Jan 2015 coronary artery disorder Seoul National University Hospital Unknown No outcome recorded
Phase 4 NCT01422382 May → Jun 2011 — Kowa Research Institute, Inc. Completed No outcome recorded
Phase 4 NCT01655303 Feb → Dec 2011 atrial fibrillation Tehran University of Medical Sciences Completed No outcome recorded
Phase 4 NCT00834925 Aug 2009 atrial fibrillation Seoul National University Hospital Unknown No outcome recorded
Phase not applicable6 trials · 1 met primary
— NCT05950971 Jul 2021 → Jan 2022 paroxysmal atrial fibrillation Seoul National University Hospital Terminated No outcome recorded Stop: Enrollment
— NCT04513509 Oct 2020 → Jun 2022 atrial fibrillation National Taiwan University Hospital Completed No outcome recorded
— NCT01645826 Jul 2012 → Sep 2014 heritable pulmonary arterial hypertension, idiopathic pulmonary arterial hypertension University of South Florida Withdrawn No outcome recorded Stop: Enrollment
— NCT04222855 Jan → May 2009 preeclampsia Hospital de la Mujer Completed Met primary
— NCT00578617 Sep 2006 → Feb 2009 atrial fibrillation Mayo Clinic Completed No outcome recorded
— NCT00164801 Nov 2004 → Jan 2007 — Chinese University of Hong Kong Terminated No outcome recorded Stop: Business
Comparator or background therapy38 trials
Phase 0 NCT04017845 Comparator Apr 2015 → May 2017 adenomatous colon polyp, colorectal cancer Lewai Sharki Abdulaziz, MSc PhD Completed No outcome recorded
Phase 1 NCT06703463 Background Oct 2023 → Feb 2024 — Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 1 NCT04154800 Background Dec 2019 → Aug 2021 — Bristol-Myers Squibb Completed No outcome recorded
Phase 1 NCT03070470 Comparator Mar → Jun 2017 — Food and Drug Administration (FDA) Completed No outcome recorded
Phase 1 NCT02947711 Background Oct → Nov 2016 — Eisai Inc. Completed No outcome recorded

News releases announcing trial results or a regulatory action · 8

DateIssuerRelease
2025-11-01 Alembic Pharmaceuticals Ltd. Regulatory Press Release Diltiazem Hydrochloride Tablets alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Diltiazem Hydrochloride Tablets USP, 30 mg, 60 mg, 90 mg, and 120 mg.
2025-08-11 Zydus Lifesciences Limited Regulatory Zydus receives final approval from USFDA for Diltiazem Hydrochloride Tablets USP, 30 mg, 60 mg, 90 mg, and 120 mg zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) for Diltiazem Hydrochloride Tablets USP, 30 mg, 60 mg, 90 mg, and 120 mg (USRLD: Cardizem® Tablets, 30 mg, 60 mg, 90 mg, and 120 mg).
2024-11-01 Alembic Pharmaceuticals Ltd. Regulatory 11th November, 2024, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals announces USFDA Final Approval for Diltiazem Hydrochloride Extended-Release Capsules USP, 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg.
2021-03-23 Glenmark Pharmaceuticals Ltd. India Regulatory Glenmark Pharmaceuticals receives ANDA approval for Diltiazem Hydrochloride Extended-Release Capsules USP, 60 mg, 90 mg, and 120 mg: Granted competitive generic therapy (CGT) designation and is eligible for 180 days of CGT exclusivity glenmarkpharma.com ↗
Glenmark Pharmaceuticals receives ANDA approval for Diltiazem Hydrochloride Extended-Release Capsules USP, 60 mg, 90 mg, and 120 mg
2014-02-12 Assembly Biosciences Results Ventrus Biosciences Announces Results From Second Pivotal Phase 3 Trial of Diltiazem Cream (VEN 307) in Patients With Anal Fissure assemblybio.com ↗
The diltiazem 2% treatment arm demonstrated no significant improvement compared to placebo in the primary endpoint of average of worst anal pain associated with or following defecation.
2013-09-11 Assembly Biosciences Results Ventrus Biosciences Announces Positive Results From Clinical Dermal Safety and Pharmacokinetic Studies of Diltiazem (VEN 307) assemblybio.com ↗
Ventrus Biosciences, Inc. (Nasdaq:VTUS), a pharmaceutical company focused on developing and commercializing gastrointestinal products, today announced positive results from two clinical dermal safety studies and one pharmacokinetic (PK) study of diltiazem hydrochloride 2% cream (VEN 307).
2012-05-14 Assembly Biosciences Results Ventrus Biosciences Announces Positive Results From Pivotal Phase 3 Trial of Diltiazem (VEN 307) in Patients With Anal Fissures assemblybio.com ↗
Ventrus Biosciences, Inc. (Nasdaq:VTUS) today reported positive results from its Phase 3, randomized, double-blind, placebo-controlled clinical trial of diltiazem hydrochloride cream (VEN 307) in patients with anal fissures.
2011-10-31 Sun Pharmaceutical Industries, Inc. Regulatory Sun Pharma announces USFDA approval for generic Cardizem CD® sunpharma.com ↗
Sun Pharma announces USFDA approval for generic Cardizem CD®

All press releases naming this drug 15 releases

DateIssuerRelease

Evidence & citations 109 cited values

Every value below carries the sentence it was read from. 106 sources stand behind the page.

FieldValueCited text
Known as diltiazem “Pharmacologic therapy includes rate control with beta-blockers (e.g., bisoprolol), calcium channel blockers (e.g., diltiazem), or antiarrhythmic drugs (e.g., flecainide,...” NCT06699342 ↗
102

“In patients with structural heart disease, amiodarone is recommended, while flecainide plus diltiazem or beta-blockers are encouraged in patients without structural heart diseases.” NCT00863213 ↗

“IV beta-blockers available through the inpatient pharmacy include metoprolol or esmolol, and IV calcium channel blockers include diltiazem and verapamil.” NCT04234477 ↗

“For example, a dihydropyridine calcium channel blocker (verapamil or diltiazem) may be initiated if patient has concurrent asthma.” NCT07445334 ↗

“additional antihypertensive medication before bedtime [diltiazem 60-120 mg, hydralazine 25 mg, or additional ramipril 5 mg]” PMID 23172931 ↗ Nov 2012

“Within the former group, some were assigned randomly to receive Diltiazem and some to Verapamil.” NCT00413712 ↗

“Amlodipine, diltiazem, felodipine, nicardipine, nifedipine, nimodipine, nitrendipine, verapamil” NCT04330300 ↗

“i.e. diltiazem; dosages titrated on blood pressure, ECG, heart rate” NCT05122780 ↗

“Carvedilol 6.25-25mg, Diltiazem 180-240mg, Verapamil 180-240mg” NCT00911508 ↗

“Diltiazem: 30, 60, 120 mg oral capsule may possibly be given” NCT00733239 ↗

“* step 3: Add-on of Amlodipine 10 mg or Diltiazem LP 300 mg” NCT02364089 ↗

Show 92 more sources

Known as 2% Diltiazem “2% Diltiazem Hydrochloride Cream applied on Day 1 \& Day 8 to the perianal area (\~2.5 cm \[1 inch\]; \~8.5 mg)” NCT02080780 ↗
Known as Adizem ChEMBL registry synonym — accepted as the source's own label CHEMBL23 ↗
Known as Adizem-60 ChEMBL registry synonym — accepted as the source's own label CHEMBL23 ↗
Known as Adizem-sr ChEMBL registry synonym — accepted as the source's own label CHEMBL23 ↗
Known as Adizem-xl ChEMBL registry synonym — accepted as the source's own label CHEMBL23 ↗
Known as Altiazem ChEMBL registry synonym — accepted as the source's own label CHEMBL23 ↗
Known as Angiozem 60 ChEMBL registry synonym — accepted as the source's own label CHEMBL23 ↗
Known as Angiozem cr 120 ChEMBL registry synonym — accepted as the source's own label CHEMBL23 ↗
Known as Angiozem cr 90 ChEMBL registry synonym — accepted as the source's own label CHEMBL23 ↗
Known as Angitil sr 120 ChEMBL registry synonym — accepted as the source's own label CHEMBL23 ↗
Known as Angitil sr 180 ChEMBL registry synonym — accepted as the source's own label CHEMBL23 ↗
Known as Angitil sr 90 ChEMBL registry synonym — accepted as the source's own label CHEMBL23 ↗
Known as Angitil xl 240 ChEMBL registry synonym — accepted as the source's own label CHEMBL23 ↗
Known as Angitil xl 300 ChEMBL registry synonym — accepted as the source's own label CHEMBL23 ↗
Known as Anoheal ChEMBL registry synonym — accepted as the source's own label CHEMBL23 ↗
Known as Bi-carzem sr ChEMBL registry synonym — accepted as the source's own label CHEMBL23 ↗
Known as Bi-carzem xl ChEMBL registry synonym — accepted as the source's own label CHEMBL23 ↗
Known as Britiazim ChEMBL registry synonym — accepted as the source's own label CHEMBL23 ↗
Known as Calazem ChEMBL registry synonym — accepted as the source's own label CHEMBL23 ↗
Known as Calcicard ChEMBL registry synonym — accepted as the source's own label CHEMBL23 ↗
Known as Calcicard cr ChEMBL registry synonym — accepted as the source's own label CHEMBL23 ↗
Known as Cardizem “Diltiazem (Cardizem), a Moderate CYP3A4 Inhibitor” NCT01124760 ↗
Known as Cardizem cd ChEMBL registry synonym — accepted as the source's own label CHEMBL23 ↗
Known as Cardizem LA “Diltiazem (Cardizem LA) 240 mg QD” NCT01422382 ↗