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diltiazem

Trade name: cardizem

Small moleculeapproved

Approved

Nov 5, 1982

Diltiazem is a nondihydropyridines calcium channel blocker used in the treatment of hypertension, angina pectoris, and some types of arrhythmia. Diltiazem produces its antihypertensive effect primarily by relaxation of vascular smooth muscle and the resultant decrease in peripheral vascular resistance. — NCATS

Clinical trial activity

90 trials · 106 clinical orgs · 42 marketing orgs

Phase 1
40
Phase 2
20
Phase 3
15
Phase 4
21

Earliest trial started Nov 1, 1990 (NCT00000478)

Timeline

1980s

  1. Nov 5, 1982

    Bausch Health Companies — Earliest FDA Approval

  2. Nov 5, 1982

    Bausch Health Companies — NDA Secondary Org

  3. Nov 5, 1982

    Bausch Health Companies — NDA Organization

  4. Jan 23, 1989

    Biovail — NDA Secondary Org

1990s

  1. Jan 1, 1990

    Earliest Phase 3 Sponsor(trial)

  2. May 29, 1992

    Allergan — NDA Secondary Org

  3. May 29, 1992

    Allergan — Marketing Organization

  4. May 29, 1992

    SmithKline Beecham — NDA Secondary Org

  5. Nov 5, 1992

    Rising Pharmaceuticals — Marketing Organization

  6. Nov 5, 1992

    Chartwell Pharmaceuticals — Marketing Organization

  7. Mar 31, 1993

    Apothecon — Marketing Organization

  8. Mar 3, 1995

    Teva — Marketing Organization

  9. Feb 28, 1996

    Athenex, Inc. — Marketing Organization

  10. Feb 28, 1996

    Sagent Pharmaceuticals, Inc. — Marketing Organization

  11. Oct 4, 1996

    Merck — NDA Secondary Org

  12. Aug 26, 1997

    Dr. Reddy's Laboratories — Marketing Organization

  13. Oct 10, 1997

    Actavis — Marketing Organization

  14. Mar 18, 1998

    PHARMOBEDIENT — Marketing Organization

  15. Apr 9, 1998

    Akorn, Inc. — Marketing Organization

  16. Apr 15, 1998

    Hospira — Marketing Organization

  17. Sep 15, 1999

    Biovail — Marketing Organization

  18. Sep 30, 1999

    Mylan — Marketing Organization

  19. Dec 20, 1999

    Par Pharmaceuticals — Marketing Organization

  20. Dec 20, 1999

    PH HEALTH — Marketing Organization

  21. Dec 23, 1999

    Bausch Health Companies — Marketing Organization

2000s

  1. Jan 1, 2001

    Earliest Phase 1 Sponsor(trial)

  2. Nov 21, 2001

    International Medication — Marketing Organization

  3. Jan 1, 2006

    Earliest Phase 2 Sponsor(trial)

  4. Feb 1, 2006

    Apotex — Marketing Organization

  5. Sep 12, 2006

    Nesher Pharms — Marketing Organization

  6. Dec 17, 2008

    West-Ward Pharmaceutical — Marketing Organization

2010s

  1. Aug 9, 2012

    Hikma — Marketing Organization

  2. Sep 28, 2012

    Sandoz — Marketing Organization

  3. Sep 28, 2012

    Novartis — Marketing Organization

  4. Jun 8, 2017

    Sun Pharmaceuticals — Marketing Organization

  5. Aug 8, 2017

    Zydus Discovery DMCC — Marketing Organization

  6. May 30, 2018

    Bristol-Myers Squibb — Marketing Organization

  7. Aug 30, 2018

    TWi Biotechnology, Inc. — Marketing Organization

  8. Jun 14, 2019

    Novast Labs — Marketing Organization

  9. Nov 18, 2019

    Edenbridge Pharms — Marketing Organization

2020s

  1. Apr 28, 2020

    Accord Research — Marketing Organization

  2. Mar 22, 2021

    Glenmark Pharmaceuticals — Marketing Organization

  3. Oct 28, 2021

    Exela Pharma Sciences, LLC. — Marketing Organization

  4. Oct 28, 2021

    Exela Pharma Sciences, LLC. — NDA Secondary Org

  5. May 5, 2022

    Mayne Pharma — Marketing Organization

  6. Aug 8, 2022

    Amta — Marketing Organization

  7. Aug 8, 2022

    UTOPIC PHARMS — Marketing Organization

  8. Sep 23, 2022

    Sciegen Pharmaceticals — Marketing Organization

  9. Mar 29, 2023

    Eugia Pharma — Marketing Organization

  10. Oct 18, 2024

    Alembic — Marketing Organization

  11. Feb 21, 2025

    Hq Speciality Pharma — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedNov 5, 1982

Chemistry & pharmacology

Loading structure…

SMILES

COC1=CC=C(C=C1)[C@@H]2SC3=CC=CC=C3N(CCN(C)C)C(=O)[C@@H]2OC(C)=O
Mol. weight
414.518 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Discontinued

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • (2s,3s)-5-(2-(dimethylamino)ethyl)-2-(4-methoxyphenyl)-4-oxo-2,3,4,5-tetrahydrobenzo[b][1,4]thiazepin-3-yl acetate
  • (2s,3s)-5-(2-(dimethylamino)ethyl)-2-(4-methoxyphenyl)-4-oxo-2,3,4,5-tetrahydrobenzo[b][1,4]thiazepin-3-yl acetate
  • (2s-cis)-3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-1,5-benzothiazepin-4(5h)-one
  • (2s-cis)-3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-1,5-benzothiazepin-4(5h)-one
  • acetic acid (2s,3s)-5-(2-dimethylamino-ethyl)-2-(4-methoxy-phenyl)-4-oxo-2,3,4,5-tetrahydro-benzo[b][1,4]thiazepin-3-yl ester
  • acetic acid (2s,3s)-5-(2-dimethylamino-ethyl)-2-(4-methoxy-phenyl)-4-oxo-2,3,4,5-tetrahydro-benzo[b][1,4]thiazepin-3-yl ester
  • adizem-60
  • adizem-sr
  • adizem-xl
  • angiozem 60
  • angiozem cr 120
  • angiozem cr 90
  • angitil sr 120
  • angitil sr 180
  • angitil sr 90
  • angitil xl 240
  • angitil xl 300
  • anoheal
  • anoheal
  • bi-carzem sr
  • bi-carzem xl
  • britiazim
  • britiazim
  • calazem
  • calcicard
  • calcicard
  • calcicard cr
  • cardizem
  • cardizem
  • cardizem
  • cardizem cd
  • cardizem cd
  • cardizem la
  • cardizem la
  • cardizem sr
  • cardizem sr
  • cartia xt
  • cartia xt
  • (+)-cis-5-[2-(dimethylamino)ethyl]-2,3-dihydro-3-hydroxy-2-(p-methoxyphenyl)-1,5-benzothiazepin-4(5h)-one acetate ester
  • (+)-cis-5-[2-(dimethylamino)ethyl]-2,3-dihydro-3-hydroxy-2-(p-methoxyphenyl)-1,5-benzothiazepin-4(5h)-one acetate ester
  • d-cis-diltiazem
  • d-diltiazem
  • dilacor
  • dilacor
  • dilacor xr
  • dilacor xr
  • dilcardia sr
  • dilcardia xl
  • dilitazem
  • dilitiazem
  • dilt-cd
  • dilt-cd
  • diltiazem
  • diltiazem
  • diltiazem
  • diltiazem
  • diltiazem
  • diltiazem
  • diltiazem
  • diltiazem
  • (+)-diltiazem
  • (+)-diltiazem
  • (+)-diltiazem
  • (+)-diltiazem
  • (+)-diltiazem
  • (+)-diltiazem
  • diltiazem hcl
  • diltiazem hcl
  • diltiazem hcl
  • diltiazem hydrochloride
  • diltiazem hydrochloride
  • diltiazem hydrochloride
  • diltiazem hydrochloride
  • diltiazem hydrochloride
  • diltiazem malate
  • diltiazem malate
  • diltiazem malate
  • diltiazem malate
  • diltiazemum
  • diltiazemum
  • diltizem
  • diltzac
  • diltzac
  • dilzem
  • dilzem sr 120
  • dilzem sr 60
  • dilzem sr 90
  • dilzem xl 120
  • dilzem xl 180
  • dilzem xl 240
  • disogram sr
  • horizem sr 120
  • horizem sr 60
  • horizem sr 90
  • kentiazem
  • kenzem sr
  • mk-793
  • mk-793
  • optil
  • optil sr 120
  • optil sr 180
  • optil sr 90
  • optil xl 240
  • optil xl 300
  • retalzem 60
  • rg-83606
  • rg-83606
  • slozem
  • slozem
  • slozem 120
  • slozem 180
  • slozem 240
  • taztia xt
  • taztia xt
  • tiamate
  • tiamate
  • tiamex
  • tiazac
  • tiazac
  • tildiem
  • tildiem
  • tildiem la 200
  • tildiem la 300
  • tildiem ret 120
  • tildiem ret 90
  • uard 120xl
  • uard 180xl
  • uard 240xl
  • uard 300xl
  • viazem xl
  • viazem xl
  • zemret 180 xl
  • zemret 240 xl
  • zemret 300 xl
  • zemtard 120 xl
  • zemtard 180 xl
  • zemtard 240 xl
  • zemtard 300 xl
  • zildil sr

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07103655Phase 4Jan 1, 2026Zhejiang University
NCT07232589Phase 1Dec 8, 2025Merck
NCT06993038Phase 4Aug 1, 2025University of Iowa
NCT06818968Phase 1Feb 27, 2025Merck
NCT06534671Phase 4Oct 16, 2024Vanderbilt University
NCT06554639Phase 1Jul 11, 2024Merck
NCT06662396Phase 1Jun 13, 2024Merck
NCT06276127Phase 3Apr 30, 2024Oman Medical Board Specialty (OMSB)
NCT06692647Phase 1Feb 9, 2024Merck
NCT06703463Phase 1Oct 17, 2023Merck
NCT05563168Phase 2Oct 31, 2022Croix-Rousse Hospital, Lyon, University of Lyon
NCT05294887Phase 4Mar 4, 2022Charité University, Berlin, Germany, German Center for Cardiovascular Research e. V. (DZHK), Humboldt University, University of Zurich
NCT05162222Phase 1Dec 15, 2021Bristol-Myers Squibb
NCT05122780Phase 4Jul 1, 2021Centro Cardiologico Monzino IRCCS, Universita' Cattolica del Sacro Cuore, University of Milan
NCT05950971N/AJul 1, 2021Seoul National University
NCT04887818Phase 2/Phase 3 (Phase 3)Jun 30, 2021University of Calgary
NCT04790331Early Phase 1 (Phase 1)Mar 1, 2021Assiut University
NCT05261464Phase 4Jan 30, 2021Mahidol University
NCT04551963Phase 1Nov 15, 2020BeOne Medicines
NCT04513509N/AAug 7, 2020National Taiwan University
Showing 20 of 90 trials
Page 1 / 5

Organizations

Research & Development (106)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
MerckFor profit8622006
Ventrus Biosciences, IncFor profit5522012
AstraZenecaFor profit4412010
Bristol-Myers SquibbFor profit4412010
National Heart, Lung, and Blood Institute (NHLBI)Government4311990
Seoul National UniversityAcademic/Hospital3322009
ActelionFor profit2212015
Assiut UniversityAcademic/Hospital2212018
EisaiFor profit2212010
Food and Drug AdministrationGovernment2212014
Harvard UniversityAcademic/Hospital2111990
IQVIAFor profit2012010
Isfahan UniversityAcademic/Hospital2212007
Mahidol UniversityAcademic/Hospital2222010
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government2111999
PfizerFor profit2212010
Spaulding Clinical Research Inc.For profit2012014
University of LilleAcademic/Hospital2222017
University of OsloAcademic/Hospital2222006
University of OttawaAcademic/Hospital2121990
106 organizations
Page 1 / 6

Marketing (63)

OrganizationOrg typeRelationshipDate
Accord ResearchFor profitMKTGApr 28, 2020
ActavisFor profitSYNDec 7, 2012
ActavisFor profitMKTGOct 10, 1997
Akorn, Inc.For profitMKTGApr 9, 1998
Akorn, Inc.For profitSYNApr 9, 1998
AlembicFor profitMKTGOct 18, 2024
AllerganFor profitNDA2May 29, 1992
AllerganFor profitMKTGMay 29, 1992
AmtaFor profitMKTGAug 8, 2022
ApotexFor profitSYNAug 6, 1998
ApotexFor profitMKTGFeb 1, 2006
ApotheconFor profitMKTGMar 31, 1993
Athenex, Inc.For profitMKTGFeb 28, 1996
Bausch Health CompaniesFor profitSYNDec 23, 1999
Bausch Health CompaniesFor profitNDA2Nov 5, 1982
Bausch Health CompaniesFor profitNDANov 5, 1982
Bausch Health CompaniesFor profitMKTGDec 23, 1999
BiovailFor profitNDA2Jan 23, 1989
BiovailFor profitSYNOct 24, 1991
BiovailFor profitMKTGSep 15, 1999
Bristol-Myers SquibbFor profitMKTGMay 30, 2018
Chartwell PharmaceuticalsFor profitMKTGNov 5, 1992
Chartwell PharmaceuticalsFor profitSYNSep 28, 2012
Dr. Reddy's LaboratoriesFor profitMKTGAug 26, 1997
Dr. Reddy's LaboratoriesFor profitSYNMay 5, 2022
Edenbridge PharmsFor profitMKTGNov 18, 2019
Eugia PharmaFor profitMKTGMar 29, 2023
Exela Pharma Sciences, LLC.For profitMKTGOct 28, 2021
Exela Pharma Sciences, LLC.For profitNDA2Oct 28, 2021
Glenmark PharmaceuticalsFor profitMKTGMar 22, 2021
HikmaFor profitMKTGAug 9, 2012
HikmaFor profitSYNDec 17, 2008
HospiraFor profitMKTGApr 15, 1998
Hq Speciality PharmaFor profitMKTGFeb 21, 2025
International MedicationFor profitMKTGNov 21, 2001
Mayne PharmaFor profitMKTGMay 5, 2022
MerckFor profitNDA2Oct 4, 1996
MylanFor profitSYNNov 5, 1992
MylanFor profitMKTGSep 30, 1999
Nesher PharmsFor profitMKTGSep 12, 2006
NovartisFor profitMKTGSep 28, 2012
Novast LabsFor profitMKTGJun 14, 2019
PH HEALTHFor profitMKTGDec 20, 1999
PHARMOBEDIENTFor profitMKTGMar 18, 1998
Par PharmaceuticalsFor profitMKTGDec 20, 1999
Rising PharmaceuticalsFor profitMKTGNov 5, 1992
Rising PharmaceuticalsFor profitSYNNov 5, 1992
Sagent Pharmaceuticals, Inc.For profitMKTGFeb 28, 1996
SandozFor profitMKTGSep 28, 2012
Sciegen PharmaceticalsFor profitMKTGSep 23, 2022
SmithKline BeechamFor profitNDA2May 29, 1992
Sun PharmaceuticalsFor profitSYNNov 15, 2010
Sun PharmaceuticalsFor profitMKTGJun 8, 2017
Sun PharmaceuticalsFor profitSYNJun 8, 2017
TWi Biotechnology, Inc.For profitMKTGAug 30, 2018
TevaFor profitMKTGMar 3, 1995
TevaFor profitSYNNov 30, 1993
TevaFor profitSYNNov 5, 1992
TevaFor profitSYNAug 26, 1997
UTOPIC PHARMSFor profitMKTGAug 8, 2022
West-Ward PharmaceuticalFor profitMKTGDec 17, 2008
Zydus Discovery DMCCFor profitMKTGAug 8, 2017
Zydus Discovery DMCCFor profitSYNAug 8, 2025