benzylpenicilloyl polylysine
Trade name: pre-pen
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
Earliest trial started Aug 31, 2019 (NCT04041791)
Timeline
1970s
- Jul 25, 1974
AllerQuest LLC — Earliest FDA Approval
- Jul 25, 1974
AllerQuest LLC — NDA Secondary Org
- Jul 25, 1974
AllerQuest LLC — NDA Organization
2010s
- Jan 1, 2019
Earliest Phase 3 Sponsor(trial)
Indications
Approved for
Studied for
Mechanism of action
- Penicillin-binding protein 2bBINDING AGENT
pbpF binding agent
- Unspecified targetOTHER
Diagnostic for hypersensitivity
Approval history
- approvedJul 25, 1974
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Availability
- Prescription Only
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaBenzylpenicilloyl polylysine ↗
- NCATS76479814OY ↗
- ChEMBLCHEMBL1201779 ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT04041791 | Phase 3 | Aug 31, 2019 | Government 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 |
Organizations
Research & Development (8)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Government of United Kingdom | Government | 1 | 0 | 1 | 2019 |
| Kenya Ministry of Health | Government | 1 | 0 | 1 | 2019 |
| Medical Research Council | Government | 1 | 0 | 1 | 2019 |
| National Institute for Health Research, United Kingdom | Government | 1 | 0 | 1 | 2019 |
| University of London | Academic/Hospital | 1 | 0 | 1 | 2019 |
| University of Nairobi | Academic/Hospital | 1 | 0 | 1 | 2019 |
| University of Oxford | Academic/Hospital | 1 | 1 | 1 | 2019 |
| Wellcome Trust | Academic/Hospital | 1 | 0 | 1 | 2019 |
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| AllerQuest LLC | For profit | NDA2 | Jul 25, 1974 |
| AllerQuest LLC | For profit | NDA | Jul 25, 1974 |