Plague Pipeline

Single subcutaneous dose; reg. LP-004808

Microencapsulated recombinant F1, the capsule, plus recombinant V antigen (LcrV). One subcutaneous dose. Russian registration LP-004808, marketing authorisation in April 2024, made at the State Research Center for Applied Microbiology and Biotechnology in Obolensk. This is the only new-generation product in the set with a licence. That licence is Russian. It is not an FDA or EMA approval.

Stage chart

Preclinical

Phase 1

Phase 2

Phase 3

Licensed

Marketing authorisation. Phase 3 is empty here, as it is for every programme in the set.

Years on the record

A mark at 2024. Labelled “Apr 2024” on the briefing. Not a forecast.

Analyst card

Challenge: Marketing authorisation in Russia. The briefing does not name a bubonic, pneumonic, or septicemic challenge.
F1-negative strains: Not reported. The antigens are F1 and V. V is the usual answer to an F1-negative strain, but that strain was not part of the licence note.
Adjuvant: Microencapsulated recombinant proteins. No alum, CpG, or flagellin is named.
Route: One subcutaneous injection.
Stability: Formulation and cold-chain requirement are not stated.
Time to protection: Not reported. No time-to-protection figure is in the briefing.
Other threats: Plague only.
Survival figure: No survival figure. The evidence in this set is the Russian licence, LP-004808, April 2024.
Animal Rule: Russian authorisation, not an FDA Animal Rule approval.

Pipeline record

What is in it: Recombinant F1 capsule and recombinant V (LcrV), microencapsulated.
Dose: One subcutaneous injection.
Licence: Russian registration LP-004808. Marketing authorisation in April 2024. Not an FDA or EMA approval.
Maker: State Research Center for Applied Microbiology and Biotechnology, Obolensk.

Registries

LP-004808 · Russian state register · PMMM marketing authorisationApril 2024. One subcutaneous dose. This is a licence number, not a public trial protocol.

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Platform: Subunit
Purified pieces of the bacterium — here, usually capsule antigen F1 and the V antigen, LcrV — instead of a living organism. This is the only platform in the set with a new marketing authorisation.
Who is paying: Russia — State Res. Ctr. for Applied Microbiology
Country: Russia
What was tested: Licensed product
Stage: Marketing authorisation
Date: Apr 2024
Antigens named: F1V / LcrV