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BLB 201

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Drug Profile

BLB 201

Alternative Names: BL-200 RSV; BLB-201; CPI-RSV-F Vaccine - Blue Lake Biotechnology; Intranasal RSV vaccine - Blue Lake Biotechnology; PIV5-vectored RSV vaccine - Blue Lake Biotechnology

Latest Information Update: 11 Dec 2025

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At a glance

  • Originator Blue Lake Biotechnology
  • Class Respiratory syncytial virus vaccines; Synthetic vaccines
  • Mechanism of Action Immunostimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Phase I/II Respiratory syncytial virus infections

Most Recent Events

  • 21 Nov 2025 Blue Lake Biotechnology receives written agreement from the U.S. Food and Drug Administration to resume dosing of BLB201 in children as young as 18 months who are RSV-negative as well as those who are RSV-positive .
  • 21 Nov 2025 The US FDA placed clinical holds on BLB 201 trials to exclude the enrollment of children who tested negative for RSV exposure (RSV-negative) or who were under two years old in December 2024 .
  • 16 Sep 2025 Phase I development is ongoing in Respiratory-syncytial-virus-infections (In the elderly, Prevention, In adults) in USA (Intranasal, Spray) (Blue Lake Biotechnology pipeline, September 2025)

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