CDEK
← All drugs Report issue

carvedilol

Trade name: coreg

Small moleculeapproved

Approved

Sep 14, 1995

Carvedilol competitively blocks β1, β2 and α1 receptors. The drug lacks sympathomimetic activity and has vasodilating properties that are exerted primarily through α1-blockade. Animal models indicate that carvedilol confers protection against myocardial necrosis, arrhythmia and cell damage caused by oxidising free radicals, and the drug has no adverse effects on plasma lipid profiles. COREG® (carvedilol) is a racemic mixture in which nonselective β-adrenoreceptor blocking activity is present in the S(-) enantiomer and α1-adrenergic blocking activity is present in both R(+) and S(-) enantiomers at equal potency. Carvedilol is the first drug of its kind to be approved for the treatment of congestive heart failure, and is now the standard of care for this devastating disease. Carvedilol is also confirmed as effective in the management of mild to moderate hypertension and ischaemic heart disease. — NCATS

Clinical trial activity

203 trials · 230 clinical orgs · 26 marketing orgs

Phase 1
34
Phase 2
58
Phase 3
35
Phase 4
69

Earliest trial started Sep 1, 1998 (NCT00000294)

Timeline

1990s

  1. Sep 14, 1995

    SmithKline Beecham — Earliest FDA Approval

  2. Sep 14, 1995

    SmithKline Beecham — NDA Organization

  3. Sep 14, 1995

    Woodward — Marketing Organization

  4. Sep 14, 1995

    Woodward — NDA Secondary Org

  5. Sep 14, 1995

    Waylis Therap — Marketing Organization

  6. Jan 1, 1998

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Jan 1, 2000

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2000

    Earliest Phase 3 Sponsor(trial)

  3. Sep 5, 2007

    Apotex — Marketing Organization

  4. Sep 5, 2007

    Aurobindo Pharma — Marketing Organization

  5. Sep 5, 2007

    Beximco — Marketing Organization

  6. Sep 5, 2007

    Chartwell Pharmaceuticals — Marketing Organization

  7. Sep 5, 2007

    Dr. Reddy's Laboratories — Marketing Organization

  8. Sep 5, 2007

    Glenmark Pharmaceuticals — Marketing Organization

  9. Sep 5, 2007

    Lupin — Marketing Organization

  10. Sep 5, 2007

    Mylan — Marketing Organization

  11. Sep 5, 2007

    Sandoz — Marketing Organization

  12. Sep 5, 2007

    Sun Pharmaceuticals — Marketing Organization

  13. Sep 5, 2007

    Taro Pharmaceuticals — Marketing Organization

  14. Sep 5, 2007

    Teva — Marketing Organization

  15. Sep 5, 2007

    Zydus Discovery DMCC — Marketing Organization

  16. Sep 5, 2007

    Rubicon Research — Marketing Organization

  17. Sep 5, 2007

    Novartis — Marketing Organization

  18. Sep 7, 2007

    Hikma — Marketing Organization

  19. Oct 30, 2007

    Pliva — Marketing Organization

  20. Oct 30, 2007

    Barr Laboratories — Marketing Organization

  21. Dec 22, 2009

    ACI Limited — Marketing Organization

  22. Dec 22, 2009

    Wockhardt — Marketing Organization

  23. Dec 22, 2009

    Axxelent Pharma — Marketing Organization

2010s

  1. May 7, 2018

    Impax Laboratories — Marketing Organization

  2. May 7, 2018

    Amneal Pharmaceuticals — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedSep 14, 1995

Chemistry & pharmacology

Loading structure…

SMILES

COc1ccccc1OCCNCC(O)COc1cccc2[nH]c3ccccc3c12
Mol. weight
406.48 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • (+-)-1-(carbazol-4-yloxy)-3-((2-(o-methoxyphenoxy)ethyl)amino)-2-propanol
  • (+-)-1-(carbazol-4-yloxy)-3-((2-(o-methoxyphenoxy)ethyl)amino)-2-propanol
  • bm 14190
  • bm 14,190
  • bm 14.190
  • bm 14.190
  • bm-14190
  • bm-14-190
  • bm-14-190
  • bm-14.190
  • bm-14.190
  • carvedilol
  • carvedilol
  • carvedilol
  • carvedilol
  • carvedilol
  • carvedilol
  • carvedilol
  • carvedilol
  • carvedilol
  • carvedilol
  • carvedilol
  • carvedilol, 14c-labeled
  • carvedilol hcl
  • carvedilol hydrochloride
  • carvedilol hydrochloride
  • carvedilol, (+-)-isomer
  • carvedilol phosphate
  • carvedilol phosphate
  • carvedilol phosphate
  • carvedilol phosphate
  • carvedilol phosphate
  • carvedilol phosphate hemihydrate
  • carvedilol, (r)-isomer
  • carvedilol, (s)-isomer
  • carvedilol sulfate
  • carvedilol sulfate
  • carvedilolum
  • carvedilolum
  • carvediol
  • carvediol
  • carvediol
  • coreg
  • coreg
  • coreg
  • coreg
  • coreg
  • coreg cr
  • coreg cr
  • corever
  • coropres
  • dilatrend
  • dilatrend
  • dilatrend
  • eucardic
  • eucardic 12.5
  • eucardic 25
  • eucardic 3.125
  • eucardic 6.25
  • kredex
  • querto
  • skf 105517
  • skf 105517
  • sk&f-105517-d
  • sk&f-105517-d

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07103655Phase 4Jan 1, 2026Zhejiang University
NCT06964464Phase 4Aug 17, 2025Patient-Centered Outcomes Research Institute, University of Rochester
NCT07108075N/AJun 14, 2025Institute of Liver and Biliary Sciences, India
NCT06844669Phase 2Apr 1, 2025Washington University in St. Louis
NCT06861075N/AMar 1, 2025University Clermont Auvergne
NCT06836856Phase 1/Phase 2 (Phase 2)Feb 28, 2025Mansoura University
NCT06836778N/AFeb 20, 2025Institute of Liver and Biliary Sciences, India
NCT06263816Phase 3Nov 15, 2024University Hospital, Tours, University of Angers, University of Burgundy, University of Caen-Normandie, University of Lyon, University of Montpellier, University of Nantes, University of Reims, University of Strasbourg, University of Toulouse
NCT06594744Phase 4Oct 31, 2024Taipei Veteran General hospital
NCT06594783Phase 4Oct 31, 2024Taipei Veteran General hospital
NCT06562582Phase 4Sep 1, 2024Vastra Gotaland Region
NCT06431919N/AAug 31, 2024Indian Council of Medical Research, Postgraduate Institute of Medical Education and Research
NCT06566794N/AAug 20, 2024University of Helsinki
NCT06449339Phase 4Jul 17, 2024Chinese University of Hong Kong, Jiao Tong University, Singapore General Hospital, University of Bordeaux, University of Malaya, University of Palermo
NCT06304896Phase 1May 1, 2024Arab Contractors Medical Centre
NCT05931276Phase 3Jan 1, 2024Department of Veteran Affairs
NCT06035978Phase 4Nov 30, 2023University of Ostrava
NCT06108518Early Phase 1 (Phase 1)Nov 1, 2023Tanta University
NCT06041932N/ANov 1, 2023Institute of Liver and Biliary Sciences, India
NCT06078436N/AOct 31, 2023University of Ulsan
Showing 20 of 203 trials
Page 1 / 11

Organizations

Research & Development (230)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GlaxoSmithKlineFor profit291752000
Institute of Liver and Biliary Sciences, IndiaAcademic/Hospital151512010
Chong Kun Dang PharmaceuticalFor profit7432011
Seoul National UniversityAcademic/Hospital6432011
Fudan UniversityAcademic/Hospital5312015
Jiao Tong UniversityAcademic/Hospital5012015
National Cancer Institute (NCI)Government5122010
National Institute on Drug Abuse (NIDA)Government5121998
University of MinnesotaAcademic/Hospital5321998
Department of Veteran AffairsGovernment4432001
University of CopenhagenAcademic/Hospital4432003
AstraZenecaFor profit3112000
Capital Medical UniversityAcademic/Hospital3222013
National Heart, Lung, and Blood Institute (NHLBI)Government3122000
PRACSFor profit3012001
Shanghai University of Traditional Chinese MedicineAcademic/Hospital3112015
Taipei Veteran General hospitalGovernment3222015
Tanta UniversityAcademic/Hospital3332018
The University of Texas, DallasAcademic/Hospital3322009
University of RochesterAcademic/Hospital3322011
230 organizations
Page 1 / 12

Marketing (31)

OrganizationOrg typeRelationshipDate
ACI LimitedFor profitMKTGDec 22, 2009
Amneal PharmaceuticalsFor profitMKTGMay 7, 2018
ApotexFor profitMKTGSep 5, 2007
Aurobindo PharmaFor profitMKTGSep 5, 2007
Axxelent PharmaFor profitMKTGDec 22, 2009
Barr LaboratoriesFor profitMKTGOct 30, 2007
BeximcoFor profitMKTGSep 5, 2007
Chartwell PharmaceuticalsFor profitMKTGSep 5, 2007
Dr. Reddy's LaboratoriesFor profitMKTGSep 5, 2007
Glenmark PharmaceuticalsFor profitMKTGSep 5, 2007
Glenmark PharmaceuticalsFor profitSYNSep 5, 2007
HikmaFor profitMKTGSep 7, 2007
Impax LaboratoriesFor profitMKTGMay 7, 2018
LupinFor profitMKTGSep 5, 2007
MylanFor profitMKTGSep 5, 2007
MylanFor profitSYNDec 22, 2009
NovartisFor profitMKTGSep 5, 2007
PlivaFor profitMKTGOct 30, 2007
Rubicon ResearchFor profitMKTGSep 5, 2007
SandozFor profitMKTGSep 5, 2007
SmithKline BeechamFor profitNDASep 14, 1995
Sun PharmaceuticalsFor profitMKTGSep 5, 2007
Sun PharmaceuticalsFor profitSYNSep 5, 2007
Sun PharmaceuticalsFor profitSYNOct 25, 2017
Taro PharmaceuticalsFor profitMKTGSep 5, 2007
TevaFor profitMKTGSep 5, 2007
Waylis TherapFor profitMKTGSep 14, 1995
WockhardtFor profitMKTGDec 22, 2009
WoodwardFor profitMKTGSep 14, 1995
WoodwardFor profitNDA2Sep 14, 1995
Zydus Discovery DMCCFor profitMKTGSep 5, 2007