peanut allergen

Trade name: Palforzia

AllergenapprovedFast Track FDABreakthrough Therapy FDA

Approved

Jan 31, 2020

Clinical trial activity

32 trials · 41 clinical orgs · 1 marketing orgs

Phase 1
15
Phase 2
18
Phase 3
5
Phase 4
0

Earliest trial started Dec 1, 2007 (NCT00580606)

Timeline

2000s

  1. Jan 1, 2007

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jan 1, 2010

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2018

    Earliest Phase 3 Sponsor(trial)

2020s

  1. Jan 31, 2020

    Aimmune Therapeutics — Earliest FDA Approval

  2. Jan 31, 2020

    Aimmune Therapeutics — NDA Secondary Org

  3. Jan 31, 2020

    Aimmune Therapeutics — NDA Organization

Indications

Mechanism of action

  • PeanutImmunity, desensitized

    Peanut immunity, desensitized

Approval history

  • approvedFast trackBreakthroughJan 31, 2020

Chemistry & pharmacology

Oral

No

Parenteral

No

Topical

No

Also known as

  • arachid
  • e. coli-encapsulated, recombinant modified peanut proteins ara h 1, ara h 2, and ara h 3
  • glycerinated peanut allergenic extract
  • peanut alergen
  • peanut protein allergen

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07003919Phase 3Jun 24, 2025DBV Technologies
NCT06297083Phase 2May 31, 2024Murdoch University
NCT05923216N/AMar 24, 2023Medical University of Warsaw
NCT05741476Phase 3Mar 22, 2023DBV Technologies
NCT05621317Phase 2Dec 31, 2022Aravax Pty Ltd, Emory University
NCT05476497Phase 1Oct 31, 2022Allergy Therapeutics
NCT05440643Phase 1Sep 7, 2022ALK-Abello, S.A., Syneos Health, University of North Carolina at Chapel Hill
NCT05250856Phase 1/Phase 2 (Phase 2)Mar 14, 2022Cour Pharmaceutical Development Company, Inc., COUR Pharmaceuticals
NCT05163574N/ADec 15, 2021Medical University of Warsaw
NCT05165329N/ANov 11, 2021Chinese University of Hong Kong
NCT04872218Phase 2Nov 1, 2021St. Justine's Hospital, University of Montreal
NCT04950504Phase 1/Phase 2 (Phase 2)Jun 2, 2021Cour Pharmaceutical Development Company, Inc., COUR Pharmaceuticals
NCT04222491Phase 2Jan 31, 2020Harvard University
NCT04200989Phase 1/Phase 2 (Phase 2)Jan 1, 2020Scripps
NCT04163562Phase 1/Phase 2 (Phase 2)Dec 31, 2019Clinica Universidad de Navarra, InnoUp Farma S.L., Syntax for Science
NCT04090203Phase 1Oct 16, 2019The Cleveland Clinic
NCT03936998Phase 1/Phase 2 (Phase 2)Jun 30, 2019Harvard University, Vedanta Biosciences, Inc.
NCT04974970Phase 1/Phase 2 (Phase 2)Apr 1, 2019University of Geneva
NCT03736447Phase 3Dec 27, 2018Aimmune Therapeutics
NCT03859700Phase 3Dec 6, 2018DBV Technologies
Showing 20 of 32 trials
Page 1 / 2

Organizations

Research & Development (41)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
DBV TechnologiesFor profit6542010
Consortium of Food Allergy ResearchAcademic/Hospital3022007
Cour Pharmaceutical Development Company, Inc.For profit2212021
COUR PharmaceuticalsFor profit2012021
Harvard UniversityAcademic/Hospital2212019
Icahn School of Medicine at Mount SinaiAcademic/Hospital2022007
Imperial College LondonAcademic/Hospital2112018
Johns Hopkins UniversityAcademic/Hospital2022007
Medical University of WarsawAcademic/Hospital2212021
National Institute of Allergy and Infectious Diseases (NIAID)Government2212007
University of North Carolina at Chapel HillAcademic/Hospital2122018
Aimmune TherapeuticsFor profit1112018
ALK-Abello, S.A.For profit1112022
Allergy TherapeuticsFor profit1112022
Allertein Therapeutics, LLCFor profit1112009
Aravax Pty LtdFor profit1112022
Chinese University of Hong KongAcademic/Hospital1112021
Clinica Universidad de NavarraAcademic/Hospital1012019
Duke UniversityAcademic/Hospital1012007
Emory UniversityAcademic/Hospital1012022
41 organizations
Page 1 / 3

Marketing (2)

OrganizationOrg typeRelationshipDate
Aimmune TherapeuticsFor profitNDA2Jan 31, 2020
Aimmune TherapeuticsFor profitNDAJan 31, 2020