benzylpenicilloyl polylysine

Trade name: pre-pen

Small moleculeapproved

Approved

Jul 25, 1974

Benzylpenicilloyl Polylysine is a skin-testing reagent which used to detect immunoglobulin E antibodies in people with a history of penicillin allergy. The quantitation of in vitro IgE antibodies to the benzylpenicilloyl determinant is a useful tool for evaluating allergic subjects. A penicillin skin test predicts only the presence of IgE antibodies for the major or minor penicillin determinants at the time of application and does not predict the future development of IgE-mediated reactions during subsequent courses of penicillin. Benzylpenicilloyl polylysine reacts specifically with penicilloyl skin sensitizing antibodies (reagins) to produce immediate wheal and flare reactions which may reflect increased risk of allergic reactions to subsequent penicillin therapy. The use of benzylpenicilloyl polylysine can detect between 75-90% of all positive reactions to penicillin. Benzylpenicilloyl polylysine was FDA approved in 2009 for the assessment of sensitization to penicillin (benzylpenicillin or penicillin G) in those patients suspected of having a clinical hypersensitivity to penicillin. — NCATS

Clinical trial activity

1 trials · 8 clinical orgs · 1 marketing orgs

Phase 1
0
Phase 2
1
Phase 3
1
Phase 4
0

Earliest trial started Aug 31, 2019 (NCT04041791)

Timeline

1970s

  1. Jul 25, 1974

    AllerQuest LLC — Earliest FDA Approval

  2. Jul 25, 1974

    AllerQuest LLC — NDA Secondary Org

  3. Jul 25, 1974

    AllerQuest LLC — NDA Organization

2010s

  1. Jan 1, 2019

    Earliest Phase 3 Sponsor(trial)

Indications

Mechanism of action

Approval history

  • approvedJul 25, 1974

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • benzylpenicilloyl g polylysine
  • benzylpenicilloyl g polylysine
  • benzyl penicilloyl-polylysine
  • benzyl penicilloyl-polylysine
  • benzylpenicilloyl polylysine
  • benzylpenicilloyl polylysine
  • benzylpenicilloyl polylysine
  • benzylpenicilloyl polylysine
  • benzylpenicilloyl polylysine
  • benzylpenicilloyl polylysine
  • benzylpenicilloyl-polylysine
  • benzylpenicilloyl-polylysine
  • pre-pen

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT04041791Phase 3Aug 31, 2019Government of United Kingdom, Kenya Ministry of Health, Medical Research Council, National Institute for Health Research, United Kingdom, University of London, University of Nairobi, University of Oxford, Wellcome Trust
Showing 1 of 1 trials
Page 1 / 1

Organizations

Research & Development (8)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Government of United KingdomGovernment1012019
Kenya Ministry of HealthGovernment1012019
Medical Research CouncilGovernment1012019
National Institute for Health Research, United KingdomGovernment1012019
University of LondonAcademic/Hospital1012019
University of NairobiAcademic/Hospital1012019
University of OxfordAcademic/Hospital1112019
Wellcome TrustAcademic/Hospital1012019
8 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
AllerQuest LLCFor profitNDA2Jul 25, 1974
AllerQuest LLCFor profitNDAJul 25, 1974