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sipuleucel-t

Trade name: Provenge

Vaccineapproved

Approved

Apr 29, 2010

Sipuleucel-T, sold under the brand name Provenge, developed by Dendreon Pharmaceuticals, LLC, is a cell-based cancer immunotherapy for prostate cancer (CaP). It is an autologous cellular immunotherapy. — Wikipedia

Clinical trial activity

32 trials · 26 clinical orgs · 1 marketing orgs

Phase 1
5
Phase 2
27
Phase 3
6
Phase 4
0

Earliest trial started Nov 1, 1999 (NCT00005947)

Timeline

1990s

  1. Jan 1, 1999

    Dendreon — Earliest Phase 3 Sponsor(trial)

2000s

  1. Jan 1, 2004

    Dendreon — Earliest Phase 2 Sponsor(trial)

2010s

  1. Apr 29, 2010

    Dendreon — Earliest FDA Approval

  2. Apr 29, 2010

    Dendreon — NDA Organization

  3. Jan 1, 2013

    Earliest Phase 1 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

  • Prostatic acid phosphataseBINDING AGENT

    Prostatic acid phosphatase binding agent

    Immunotherapy. Precise mechanism of action is unknown. Patient-derived antigen presenting cells are exposed to recombinant human prostatic acid phosphatase, an antigen expressed in prostate cancer tissue, linked to an immune cell activator and may help direct the immune response to cancer cells.

  • Prostatic acid phosphataseImmunity, active

    ACP3 immunity, active

    Immunotherapy. Precise mechanism of action is unknown. Patient-derived antigen presenting cells are exposed to recombinant human prostatic acid phosphatase, an antigen expressed in prostate cancer tissue, linked to an immune cell activator and may help direct the immune response to cancer cells.

Approval history

  • approvedApr 29, 2010

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No

Oral

No

Parenteral

No

Topical

No

First in class

Sources

Also known as

  • apc8015
  • apc 8015
  • apc-8015
  • apc-8015
  • apc8015f
  • provenge
  • provenge
  • provenge
  • provenge
  • sipuleucel-t
  • sipuleucel-t
  • sipuleucel-t
  • sipuleucel-t
  • sipuleucel-t

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07219147Phase 1Dec 4, 2025City of Hope National Medical Center, National Cancer Institute (NCI)
NCT06100705Phase 2Nov 30, 2023Dendreon, Yale University
NCT06134232Phase 3Nov 27, 2023Dendreon, Talosix, WCG IRB
NCT05806814Phase 1Nov 12, 2023Dendreon, Sheffield Hallam University, University of Oklahoma
NCT05751941Phase 2Feb 14, 2023Dendreon, University of South Florida
NCT03686683Phase 3Oct 31, 2018Dendreon, Pharmaceutical Research Associates, Inc. (PRA)
NCT03024216Phase 1Jan 1, 2017Dendreon, Genentech, University of Hawaii
NCT02793765Phase 2Dec 1, 2016University of Texas at Houston
NCT02793219Phase 2Dec 1, 2016University of Texas at Houston
NCT02463799Phase 2Dec 1, 2015Johns Hopkins University
NCT02159950Phase 2Jan 1, 2015Active Biotech AB, National Cancer Institute (NCI), State University of New York, Buffalo
NCT02036918Phase 1Mar 1, 2014Duke University
NCT01804465Phase 2Jan 1, 2014Bristol-Myers Squibb, Dendreon, University of California, San Francisco, University of Texas at Houston
NCT01981122Phase 2Sep 1, 2013Bausch Health Companies, Dendreon
NCT01818986Phase 2Aug 1, 2013The University of Texas, Dallas
NCT01807065Phase 2Jun 1, 2013City of Hope National Medical Center, National Cancer Institute (NCI)
NCT01706458Phase 2May 1, 2013Dendreon, University of Wisconsin
NCT01832870Phase 1Apr 1, 2013Prostate Oncology Specialists, Inc.
NCT01560923Phase 2Oct 1, 2012University of Minnesota
NCT01420965Phase 2Sep 1, 2012Augusta University
Showing 20 of 32 trials
Page 1 / 2

Organizations

Research & Development (26)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
DendreonFor profit211531999
Bausch Health CompaniesFor profit7022001
National Cancer Institute (NCI)Government3022013
University of California, San FranciscoAcademic/Hospital3121999
University of Texas at HoustonAcademic/Hospital3212014
City of Hope National Medical CenterAcademic/Hospital2222013
Devine Tidewater UrologyAcademic/Hospital2022003
Active Biotech ABFor profit1012015
Augusta UniversityAcademic/Hospital1112012
Bristol-Myers SquibbFor profit1012014
Duke UniversityAcademic/Hospital1112014
GenentechFor profit1012017
Johns Hopkins UniversityAcademic/Hospital1112015
Pharmaceutical Research Associates, Inc. (PRA)For profit1012018
Prostate Oncology Specialists, Inc.Academic/Hospital1112013
Sheffield Hallam UniversityAcademic/Hospital1012023
State University of New York, BuffaloAcademic/Hospital1112015
TalosixFor profit1012023
The University of Texas, DallasAcademic/Hospital1112013
University of HawaiiAcademic/Hospital1112017
26 organizations
Page 1 / 2

Marketing (1)

OrganizationOrg typeRelationshipDate
DendreonFor profitNDAApr 29, 2010