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Bismuth Subcitrate Potassium

Trade name: Pylera

Small moleculeapproved

Approved

Sep 28, 2006

A colloid is a mixture in which one substance consisting of microscopically dispersed insoluble particles is suspended throughout another substance. Some definitions specify that the particles must be dispersed in a liquid, while others extend the definition to include substances like aerosols and gels. The term colloidal suspension refers unambiguously to the overall mixture. A colloid has a dispersed phase and a continuous phase. — Wikipedia

Clinical trial activity

87 trials · 72 clinical orgs · 6 marketing orgs

Phase 1
6
Phase 2
14
Phase 3
8
Phase 4
43

Earliest trial started Sep 1, 1997 (NCT00003151)

Timeline

1990s

  1. Jan 1, 1997

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Jan 1, 2003

    Earliest Phase 3 Sponsor(trial)

  2. Sep 28, 2006

    Earliest FDA Approval

  3. Sep 28, 2006

    Allergan — NDA Secondary Org

  4. Sep 28, 2006

    AbbVie — NDA Secondary Org

2010s

  1. Jan 1, 2010

    Earliest Phase 1 Sponsor(trial)

2020s

  1. Mar 6, 2023

    Par Pharmaceuticals — Marketing Organization

  2. Mar 6, 2023

    Bristol-Myers Squibb — Marketing Organization

  3. Jul 3, 2023

    RiconPharma — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedSep 28, 2006

Chemistry & pharmacology

Mol. weight
704.47 g/mol
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • 1001277
  • bi-citrate
  • biselic
  • bismofarma
  • bismuth citrate
  • bismuth potassium citrate
  • bismuth potassium citrate
  • bismuth potassium citrate.
  • bismuth potassium citrate.
  • bismuth subcitrate
  • bismuth subcitrate
  • bismuth subcitrate
  • bismuth subcitrate
  • bismuth subcitrate
  • bismuth subcitrate
  • bismuth subcitrate
  • bismuth subcitrate potassium
  • bismuth subcitrate potassium
  • bismuth subcitrate potassium
  • bismuth subcitrate potassium
  • bismuth subcitrate potassium
  • bismuth tripotassium dicitrate
  • bismuth tripotassium dicitrate
  • bismuth tripotassium dicitrate
  • bismuth tripotassium dicitrate
  • bismuth tripotassium dicitrate
  • colloid
  • colloid
  • colloidal bismuth subcitrate
  • colloidal bismuth subcitrate
  • colloidal bismuth subcitrate
  • denol
  • de-nol
  • de-noltab
  • gastrodenol
  • pylera
  • sucrato
  • tripotassium bismuth dicitrate
  • tripotassium dicitrate bismuthate
  • tripotassium dicitrate bismuthate
  • tripotassium dicitratobismuthate
  • tripotassium dicitratobismuthate
  • tripotassium-dicitrato bismuthate
  • ventrisol-polfa

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07294846Phase 1Sep 8, 2025Sinorda Biomedicine
NCT06523764Phase 4Sep 30, 2024People's Liberation Army of China
NCT06200779Phase 4Sep 30, 2024Unilabs A/S
NCT06510010Phase 2Aug 31, 2024Sun Yat-Sen University
NCT06561711Phase 4Aug 21, 2024Jiao Tong University
NCT06561698Phase 4Aug 21, 2024Jiao Tong University
NCT06509139Phase 4Jul 9, 2024National Cheng Kung University
NCT06349486N/ANov 28, 2023Kaohsiung Medical University
NCT05712018N/AOct 20, 2023Ningxia Medical University, The Fifth People's Hospital of Huaian
NCT05874570Phase 4Jun 20, 2023Jiao Tong University
NCT05857163Phase 3May 18, 2023TenNor Therapeutics Ltd
NCT05874544Phase 4May 16, 2023Jiao Tong University
NCT05726734Phase 4Feb 6, 2023Huazhong University of Science and Technology
NCT05431075Phase 4Jul 31, 2022Central Hospital, Zibo, Peking University, Shandong University, Taierzhuang District People's Hospital, Yuncheng Hospital of Traditional Chinese Medicine, Zhengzhou University
NCT05250050Phase 4Mar 25, 2022Fudan University
NCT05189444N/AMar 25, 2022Huazhong University of Science and Technology
NCT06143124Phase 4Mar 3, 2022University of Ljubljana
NCT05061732Phase 4Sep 30, 2021Fudan University
NCT04982016N/ASep 30, 2021Beijing Anzhen Hospital, Capital Medical University
NCT05049902Phase 4Sep 21, 2021Heze Municipal 3rd people's hospital, Maternity and Child Care Health Center of Dezhou, Nanjing Medical University, PKUcare luzhong hospital, Shandong University
Showing 20 of 87 trials
Page 1 / 5

Organizations

Research & Development (72)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Jiao Tong UniversityAcademic/Hospital161612012
Fudan UniversityAcademic/Hospital8722017
Seoul National UniversityAcademic/Hospital6622003
TakedaFor profit5522016
Huazhong University of Science and TechnologyAcademic/Hospital4322017
Shandong UniversityAcademic/Hospital4412019
Kaohsiung Medical UniversityAcademic/Hospital3322013
AxcanFor profit2012008
Forest LaboratoriesFor profit2212008
Free University of BrusselsAcademic/Hospital2222017
Heze Municipal 3rd people's hospitalAcademic/Hospital2012021
Mansoura UniversityAcademic/Hospital2212016
Maternity and Child Care Health Center of DezhouAcademic/Hospital2012021
National Cheng Kung UniversityAcademic/Hospital2212020
National Taiwan UniversityAcademic/Hospital2212015
PKUcare luzhong hospitalAcademic/Hospital2012021
The University of Hong KongAcademic/Hospital2212008
Aga Khan UniversityAcademic/Hospital1112006
American University of BeirutAcademic/Hospital1112013
AstellasFor profit1112017
72 organizations
Page 1 / 4

Marketing (6)

OrganizationOrg typeRelationshipDate
AbbVieFor profitNDA2Sep 28, 2006
AllerganFor profitNDA2Sep 28, 2006
AxcanFor profitNDA—
Bristol-Myers SquibbFor profitMKTGMar 6, 2023
Par PharmaceuticalsFor profitMKTGMar 6, 2023
RiconPharmaFor profitMKTGJul 3, 2023