Wednesday, July 8, 2026

Drug profile · INN

benzylpenicilloyl polylysine

benzylpenicilloyl polylysine (PRE-PEN) is an FDA-listed pharmaceutical active ingredient. Route of administration: injection. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 0
Pipeline programs 4
News articles 0
Drug details — benzylpenicilloyl polylysine
US status
approved
Class
Route
INJECTION
Patents
0
Programs
4
Data quality
0.84

Quick answer

benzylpenicilloyl polylysine (PRE-PEN) is an FDA-listed pharmaceutical active ingredient. Route of administration: injection. Current US regulatory status: approved.

Key facts

INN benzylpenicilloyl polylysine
Brand PRE-PEN
Route INJECTION
Formulation INJECTABLE

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. Benzyl penicillin Phase 3 · United Therapeutics Europe · Pneumonia
  2. Elective nodal irradiation (ENI) Phase 3 · Chinese Academy of · Esophageal Squamous Cell Carcinoma
  3. Pulmonary Rehabilitation (PR) Phase 2 · United Therapeutics Europe · Non-small Cell Lung Cancer Stage III
  4. MEDITOP/2025/01 Phase 1 · PARItec · Comparative bioequivalence study in healthy volunteers under

Frequently asked questions

What is benzylpenicilloyl polylysine?

benzylpenicilloyl polylysine (PRE-PEN) is an FDA-listed pharmaceutical active ingredient. Route of administration: injection. Current US regulatory status: approved.

What is the brand name for benzylpenicilloyl polylysine?

PRE-PEN is a marketed brand name for benzylpenicilloyl polylysine. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of benzylpenicilloyl polylysine?

benzylpenicilloyl polylysine has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.