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bromocriptine

Trade name: parlodel

Small moleculeapproved

Approved

Jun 28, 1978

Bromocriptine is an ergot derivative with potent dopamine receptor agonist activity, which activates post-synaptic dopamine receptors. Bromocriptine is indicated for the treatment of dysfunctions associated with hyperprolactinemia. Bromocriptine therapy is indicated in the treatment of acromegaly and in the treatment of the signs and symptoms of idiopathic or postencephalitic Parkinson’s disease. It is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Some commonly reported adverse reactions include nausea, fatigue, dizziness, vomiting and headache. Bromocriptine may interact with dopamine antagonists, butyrophenones and certain other agents. — NCATS

Clinical trial activity

52 trials · 81 clinical orgs · 11 marketing orgs

Phase 1
9
Phase 2
20
Phase 3
11
Phase 4
11

Earliest trial started Jun 1, 1998 (NCT02233023)

Timeline

1970s

  1. Jun 28, 1978

    Validus Pharmaceuticals — Earliest FDA Approval

  2. Jun 28, 1978

    Validus Pharmaceuticals — Marketing Organization

  3. Jun 28, 1978

    Validus Pharmaceuticals — NDA Secondary Org

  4. Jun 28, 1978

    Validus Pharmaceuticals — NDA Organization

  5. Jun 28, 1978

    ESJAY PHARMA — Marketing Organization

1990s

  1. Jan 13, 1998

    Sandoz — Marketing Organization

  2. Jan 13, 1998

    Novartis — Marketing Organization

  3. Dec 10, 1998

    Lek Pharmaceuticals — Marketing Organization

  4. Jan 1, 1999

    Earliest Phase 2 Sponsor(trial)

  5. Jan 1, 1999

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Sep 24, 2004

    Aurobindo Pharma — Marketing Organization

  2. Sep 24, 2004

    Mylan — Marketing Organization

  3. Jan 1, 2007

    Mylan — Earliest Phase 1 Sponsor(trial)

  4. Jul 30, 2008

    Zydus Discovery DMCC — Marketing Organization

  5. Oct 1, 2008

    Padagis Us — Marketing Organization

  6. Oct 1, 2008

    Paddock Laboratories — Marketing Organization

  7. May 5, 2009

    VeroScience — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewJun 28, 1978

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)C[C@H]1C(=O)N2CCC[C@H]2[C@]2(O)O[C@](NC(=O)[C@@H]3C=C4c5cccc6[nH]c(Br)c(c56)C[C@H]4N(C)C3)(C(C)C)C(=O)N12
Mol. weight
654.61 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • 2-bromo-alpha-ergocryptine
  • 2-bromo-alpha-ergocryptine
  • 2-bromo-alpha-ergokryptin
  • 2-bromo-alpha-ergokryptin
  • 2-bromo-alpha-ergokryptine
  • 2-bromo-alpha-ergokryptine
  • 2-bromoergocriptine
  • 2-bromo-α-ergocryptine
  • 2-bromo-α-ergocryptine
  • 2-bromo-α-ergokryptin
  • 2-bromo-α-ergokryptin
  • 2-bromo-α-ergokryptine
  • 2-bromo-α-ergokryptine
  • (5'alpha)-2-bromo-12'-hydroxy-2'-(1-methylethyl)-5'-(2-methylpropyl)-3',6',18-trioxoergotaman
  • (5'alpha)-2-bromo-12'-hydroxy-2'-(1-methylethyl)-5'-(2-methylpropyl)-3',6',18-trioxoergotaman
  • (5'alpha)-2-bromo-12'-hydroxy-2'-(1-methylethyl)-5'-(2-methylpropyl)ergotaman-3',6',18-trione
  • (5'alpha)-2-bromo-12'-hydroxy-2'-(1-methylethyl)-5'-(2-methylpropyl)ergotaman-3',6',18-trione
  • (5'alpha)-2-bromo-12'-hydroxy-5'-isobutyl-2'-isopropyl-3',6',18-trioxoergotaman
  • (5'alpha)-2-bromo-12'-hydroxy-5'-isobutyl-2'-isopropyl-3',6',18-trioxoergotaman
  • bromocriptin
  • bromocriptina
  • bromocriptina
  • bromocriptine
  • bromocriptine
  • bromocriptine
  • bromocriptine
  • bromocriptine
  • bromocriptine
  • bromocriptine
  • bromocriptine
  • bromocriptine
  • bromocriptine
  • bromocriptine mesilate
  • bromocriptine mesilate
  • bromocriptine mesilate
  • bromocriptine mesylate
  • bromocriptine mesylate
  • bromocriptine mesylate
  • bromocriptine mesylate
  • bromocriptine mesylate
  • bromocriptine mesylate
  • bromocriptinum
  • bromocriptinum
  • bromocryptine
  • bromocryptine
  • bromocryptine
  • bromoergocriptine
  • bromoergocriptine
  • bromoergocryptine
  • bromoergocryptine
  • cb-154
  • cb-154
  • cb-154 mesylate
  • cb-154 mesylate
  • cycloset
  • cycloset
  • ergolactin
  • parlodel
  • parlodel
  • parlodel

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06250257Phase 3Oct 21, 2024Jimma University, Ludwig Maximilians University
NCT06556186N/AOct 1, 2024Chinese Academy of Medical Sciences, Ningbo Medical Center Lihuili Eastern Hospital, Sichuan University, Wenzhou Medical University, Zhejiang University
NCT07037472N/AJan 1, 2024Chinese Academy of Medical Sciences
NCT05180773Phase 4Jul 27, 2022National Heart, Lung, and Blood Institute (NHLBI), University of Pittsburgh
NCT04674670N/AAug 16, 2021Balgrist Universitaets
NCT04413344Phase 1/Phase 2 (Phase 2)Jun 5, 2020Asakayama General Hospital, Asakayama Hospital, Kawasaki Medical School Hospital, Kyoto University, Mie University, Osaka University, Time Therapeutics, Inc., Tokushima University, Tokyo Metropolitan Geriatric Medical Center, Towa Pharmaceutical Co.,Ltd.
NCT04128683Early Phase 1 (Phase 1)Dec 31, 2019University of California, San Diego
NCT04037111N/AJul 23, 2019Xidian University, Xijing Hospital
NCT04107480Phase 4Jun 21, 2019Leiden University
NCT04038749N/AJun 16, 2019Centre of Postgraduate Medical Education, Żelazna Medical Centre, LLC
NCT04351126Phase 2Apr 1, 2019Ganin Fertility Center
NCT04181385Phase 2/Phase 3 (Phase 3)Jan 1, 2019University of Toronto
NCT03717454N/ADec 1, 2018Capital Medical University, China Medical University, Chinese Academy of Medical Sciences, Fudan University, Fujian Medical University, Jiao Tong University, People's Liberation Army of China, Wenzhou Medical University
NCT03714763N/ANov 1, 2018Capital Medical University, China Medical University, Chinese Academy of Medical Sciences, Fudan University, Fujian Medical University, Jiao Tong University, People's Liberation Army of China, Wenzhou Medical University
NCT03651674N/ASep 20, 2018Xidian University
NCT03575000Phase 4Jul 1, 2018Department of Veteran Affairs, Stanford University
NCT03496545Phase 1/Phase 2 (Phase 2)Jul 1, 2018University of California, San Francisco
NCT03525002Phase 2May 3, 2018University of Cologne, University of Lubeck, University of Tuebingen
NCT03384524Phase 1/Phase 2 (Phase 2)Mar 31, 2018Case Western Reserve University, University of Southern California
NCT05405244Phase 3Sep 19, 2017American Diabetes Association, University of North Carolina at Chapel Hill
Showing 20 of 52 trials
Page 1 / 3

Organizations

Research & Development (81)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Chinese Academy of Medical SciencesAcademic/Hospital4112018
VeroScienceFor profit4332004
Boehringer IngelheimFor profit3321998
Wenzhou Medical UniversityAcademic/Hospital3012018
Biosense Webster, Inc.For profit2212012
Capital Medical UniversityAcademic/Hospital2012018
China Medical UniversityAcademic/Hospital2012018
Federal University of Sao PauloAcademic/Hospital2222010
Fudan UniversityAcademic/Hospital2012018
Fujian Medical UniversityAcademic/Hospital2012018
Jiao Tong UniversityAcademic/Hospital2212018
MDS PharmaFor profit2012007
MylanFor profit2212007
People's Liberation Army of ChinaGovernment2012018
Sun Yat-Sen UniversityAcademic/Hospital2222016
University of AmsterdamAcademic/Hospital2212013
University of California, San FranciscoAcademic/Hospital2222013
Xidian UniversityAcademic/Hospital2112018
American Diabetes AssociationAcademic/Hospital1012017
Asakayama General HospitalAcademic/Hospital1012020
81 organizations
Page 1 / 5

Marketing (14)

OrganizationOrg typeRelationshipDate
Aurobindo PharmaFor profitMKTGSep 24, 2004
ESJAY PHARMAFor profitMKTGJun 28, 1978
Lek PharmaceuticalsFor profitMKTGDec 10, 1998
MylanFor profitMKTGSep 24, 2004
NovartisFor profitMKTGJan 13, 1998
Padagis UsFor profitMKTGOct 1, 2008
Paddock LaboratoriesFor profitMKTGOct 1, 2008
SandozFor profitSYNJan 13, 1998
SandozFor profitMKTGJan 13, 1998
Validus PharmaceuticalsFor profitMKTGJun 28, 1978
Validus PharmaceuticalsFor profitNDA2Jun 28, 1978
Validus PharmaceuticalsFor profitNDAJun 28, 1978
VeroScienceFor profitNDA2May 5, 2009
Zydus Discovery DMCCFor profitMKTGJul 30, 2008