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hexyl 5-aminolevulinate

Trade name: Cysview

Small moleculeapproved

Approved

May 28, 2010

Hexaminolevulinate is an optical imaging drug. In solution form, it is instilled intravesically for use with photodynamic blue light cystoscopy as an adjunct to white light cystoscopy. After bladder instillation, hexaminolevulinate enters the bladder mucosa and is proposed to enter the intracellular space of mucosal cells where it is used as a precursor in the formation of the photoactive intermediate protoporphyrin IX (PpIX) and other photoactive porphyrins (PAPs). PpIX and PAPs are reported to accumulate preferentially in neoplastic cells as compared to normal urothelium, partly due to altered enzymatic activity in the neoplastic cells. In 2010, FDA granted approval for hexaminolevulinate hydrochloride as an optical imaging agent for cystoscopic detection of non-muscle invasive papillary cancer of the bladder for patients suspected or known to have lesion(s) on the basis of a prior cystoscopy. — NCATS

Clinical trial activity

21 trials · 24 clinical orgs · 2 marketing orgs

Phase 1
6
Phase 2
16
Phase 3
8
Phase 4
2

Earliest trial started Sep 1, 2001 (NCT00052637)

Timeline

2000s

  1. Jan 1, 2001

    Photocure — Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2006

    Photocure — Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2009

    Photocure — Earliest Phase 2 Sponsor(trial)

2010s

  1. May 28, 2010

    Cato Research — Earliest FDA Approval

  2. May 28, 2010

    Photocure — NDA Secondary Org

  3. May 28, 2010

    Cato Research — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewMay 28, 2010

Chemistry & pharmacology

Loading structure…

SMILES

CCCCCCOC(=O)CCC(=O)CN
Mol. weight
215.29 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • (14c)-hexaminolevulinate
  • 4-hexyloxycarbonyl-2-oxobutylammoniumchloride
  • 4-hexyloxycarbonyl-2-oxobutylammoniumchloride
  • 5-alahe
  • 5-aminolevulinic acid hexyl ester
  • 5-aminolevulinic acid hexyl ester
  • 5-aminolevulinic acid hexyl ester
  • ala hexyl ester
  • aminolevulinic acid hexylester
  • aminolevulinic acid hexyl ester
  • cysview kit
  • cysview kit
  • hexa ala
  • hexaminolevulinate
  • hexaminolevulinate
  • hexaminolevulinate
  • hexaminolevulinate
  • hexaminolevulinate
  • hexaminolevulinate
  • hexaminolevulinate
  • hexaminolevulinate hcl
  • hexaminolevulinate hcl
  • hexaminolevulinate hydrochloride
  • hexaminolevulinate hydrochloride
  • hexaminolevulinate hydrochloride
  • hexaminolevulinate hydrochloride
  • hexaminolevulinate hydrochloride
  • hexvix
  • hexvix
  • hexyl 5-amino-4-oxopentanoate
  • hexyl 5-amino-4-oxopentanoate hydrochloride
  • hexyl 5-amino-4-oxopentanoate hydrochloride
  • hexyl(5-amino-4-oxopentanoat)-hydrochlorid
  • hexyl(5-amino-4-oxopentanoat)-hydrochlorid
  • hexyl 5-aminolevulinate
  • hexylaminolevulinate
  • hexylaminolevulinate
  • hexylaminolevulinate
  • hexyl-aminolevulinate
  • p-1026
  • p-1026
  • pentanoic acid, 5-amino-4-oxo-, hexyl ester, hydrochloride
  • pentanoic acid, 5-amino-4-oxo-, hexyl ester, hydrochloride

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06525571Phase 3Jan 4, 2025Johns Hopkins University, Photocure, Sibley Memorial Hospital
NCT05962541Phase 4Feb 29, 2024University of Roma La Sapienza
NCT05600322Phase 3Oct 31, 2022Chinese Academy of Medical Sciences, Jiangsu Asieris Pharmaceutical Technology Co., Ltd., Photocure
NCT03272659Phase 2Apr 1, 2018Karl Storz, McGill University
NCT03058705N/ANov 28, 2017University of Rochester
NCT02660190Phase 3Feb 1, 2016Aarhus University, Regional Hospital West Jutland, University of Copenhagen
NCT02560584Phase 3Oct 1, 2015Karl Storz, Photocure, University of Rochester, Yeshiva University
NCT02367547Phase 1/Phase 2 (Phase 2)Mar 1, 2015Government of Finland, University of Jyvaskyla, University of Tampere
NCT02149342Phase 1/Phase 2 (Phase 2)May 1, 2014Government of Finland, University of Helsinki
NCT01551407Phase 2Dec 1, 2011Ludwig Maximilians University, Photocure
NCT01282515Phase 2/Phase 3 (Phase 3)Aug 1, 2011Osaka University, Photocure
NCT01256424Phase 2Apr 1, 2011Gottfried Wilhelm Leibniz Universität Hannover, Photocure
NCT01050309Phase 1Nov 1, 2009Photocure
NCT01344902Phase 1/Phase 2 (Phase 2)Feb 1, 2009Photocure
NCT00708942Phase 2Jan 1, 2009Gottfried Wilhelm Leibniz Universität Hannover, Photocure
NCT00785694Phase 4Dec 1, 2008General Electric
NCT00369018Phase 1/Phase 2 (Phase 2)Aug 1, 2006Gottfried Wilhelm Leibniz Universität Hannover, Photocure
NCT00285701Phase 1/Phase 2 (Phase 2)Jul 1, 2006Karl Storz, Photocure
NCT00412971Phase 3Apr 1, 2005Photocure, University of Copenhagen
NCT00233402Phase 3Jan 1, 2005Photocure, University of Texas at Houston
Showing 20 of 21 trials
Page 1 / 2

Organizations

Research & Development (24)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
PhotocureFor profit141232001
Gottfried Wilhelm Leibniz Universität HannoverAcademic/Hospital3012006
Karl StorzFor profit3122006
Government of FinlandGovernment2212014
University of CopenhagenAcademic/Hospital2012005
University of RochesterAcademic/Hospital2122015
Aarhus UniversityAcademic/Hospital1112016
Chinese Academy of Medical SciencesAcademic/Hospital1012022
General ElectricFor profit1112008
Jiangsu Asieris Pharmaceutical Technology Co., Ltd.For profit1012022
Johns Hopkins UniversityAcademic/Hospital1112025
Ludwig Maximilians UniversityAcademic/Hospital1012011
McGill UniversityAcademic/Hospital1012018
National Cancer Institute (NCI)Government1012001
Osaka UniversityAcademic/Hospital1112011
Regional Hospital West JutlandAcademic/Hospital1012016
Sibley Memorial HospitalAcademic/Hospital1012025
University of California, Los AngelesAcademic/Hospital1012001
University of HelsinkiAcademic/Hospital1012014
University of JyvaskylaAcademic/Hospital1012015
24 organizations
Page 1 / 2

Marketing (2)

OrganizationOrg typeRelationshipDate
Cato ResearchFor profitNDAMay 28, 2010
PhotocureFor profitNDA2May 28, 2010