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Bayer–BlueRock’s Parkinson’s Cell Therapy Wins Japan’s Sakigake Designation

18 Dec 2025
Admin
News Article

Bayer–BlueRock’s Parkinson’s Cell Therapy Wins Japan’s Sakigake Designation

Bayer AG and its cell therapy subsidiary BlueRock Therapeutics have secured a major regulatory boost in Japan for bemdaneprocel, an investigational Parkinson’s disease treatment.

Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted Sakigake (Pioneering Regenerative Medical Product) designation, signaling strong regulatory support for the program.

What the Sakigake Designation Means?

Sakigake status is reserved for therapies with high innovation potential and urgent patient need. For bemdaneprocel, this could translate into:

Closer and more frequent interaction with Japanese regulators
Eligibility for accelerated approval pathways
Priority review, if clinical criteria are met

In short, Japan is fast-tracking the conversation.

Why This Matters for Parkinson’s Disease?

Parkinson’s disease is the world’s second most common neurodegenerative disorder.

~10 million people affected globally
~250,000 patients in Japan alone
No curative therapies available today

Current treatments manage symptoms but do not replace lost neurons. That’s the gap bemdaneprocel aims to fill.

How Bemdaneprocel Works?

Bemdaneprocel (BRT-DA01) is an investigational cell therapy designed to replace dopamine-producing neurons lost in Parkinson’s disease.

Here’s the core idea:

Dopaminergic neuron precursors are derived from human embryonic pluripotent stem cells
Cells are surgically implanted into the brain
After implantation, they mature into dopamine-producing neurons
The goal is to rebuild damaged neural networks and restore function

It’s not symptom control. It’s cellular repair.

Clinical Progress So Far

Bemdaneprocel already carries strong regulatory momentum.

FDA Fast Track Designation – 2021
FDA RMAT Designation – 2024
Sakigake Designation (Japan) – 2025

In a Phase I study with 12 patients:

Treatment was well tolerated at 36 months
No serious adverse events linked to the therapy
Encouraging trends in motor symptom improvement

The Phase III exPDite-2 Trial

BlueRock is now running exPDite-2, the first Phase III pivotal trial for an allogeneic pluripotent stem cell therapy in Parkinson’s.

Key trial details:

~102 patients enrolled
Conducted across the US, Canada, and Australia
Double-blind, sham-surgery controlled design
Primary endpoint: improvement in ON-time without troublesome dyskinesia at week 78

Secondary endpoints cover movement, non-motor symptoms, safety, daily function, and quality of life.

What Bayer and BlueRock Are Saying?

BlueRock sees Sakigake as validation of unmet need and innovation. The designation allows faster, deeper collaboration with Japanese regulators to move efficiently toward patients.

Bayer frames the milestone as part of a broader strategy to reshape Parkinson’s treatment, not just manage decline.

The Bigger Picture

Parkinson’s prevalence has doubled over the past 25 years. Symptoms worsen over time. Treatment options remain limited. If bemdaneprocel succeeds, it could redefine how Parkinson’s disease is treated—by replacing what the disease destroys, not just compensating for it. For now, Sakigake designation puts Japan at the center of that future.