IRLAB Secures Approvals for Phase Ib Study of First-in-Class Apathy Drug in Parkinson’s Disease

IRLAB Secures Approvals for Phase Ib Study of First-in-Class Apathy Drug in Parkinson’s Disease

By, Admin 27 December 2025

IRLAB, a Sweden-headquartered biotech focused on Parkinson’s disease, has received regulatory and ethical approvals to initiate a Phase Ib clinical study of IRL757, its experimental treatment for apathy in Parkinson’s patients.

The study will evaluate safety, tolerability, and early efficacy signals in patients who experience apathy, a debilitating and currently untreatable condition associated with Parkinson’s disease.

Why This Study Matters?

Apathy is not just low motivation. It is a serious neuropsychiatric symptom marked by indifference, withdrawal, and reduced emotional engagement.

For people with Parkinson’s disease:

  • Apathy significantly worsens quality of life
  • It increases disability and caregiver burden
  • No approved treatments exist today

IRLAB is aiming to change that.

About the Phase Ib Trial

The Phase Ib signal-finding study will:

  • Enroll 75 Parkinson’s patients with apathy
  • Run across 16 clinical sites
  • Cover four European countries: Germany, Bulgaria, Poland, and Spain

The trial is fully funded by IRLAB’s development partner, McQuade Center for Strategic Research and Development (MSRD), an indirect subsidiary of Otsuka Pharmaceutical.

Strong Foundation from Earlier Studies

IRL757 has already completed two Phase I studies:

  • One in healthy young adults
  • One in healthy older adults (65+)

Key takeaways:

  • Good absorption and systemic exposure after 10 days of dosing
  • No serious adverse events
  • All participants completed the studies

This safety profile supported the move into patient trials.

How IRL757 Works

IRL757 is designed to address apathy at its neurological roots.

Preclinical studies suggest the drug:

  • Improves motivation and cognitive function
  • Restores disrupted cortical to sub-cortical nerve signalling
  • Targets mechanisms believed to underlie apathy across neurodegenerative diseases

This positions IRL757 as a first-in-class therapy, not a repurposed workaround.

The Scale of the Unmet Need

The numbers are hard to ignore:

  • 20+ million people in the US and Europe live with apathy
  • 20–70% of Parkinson’s patients experience it
  • 43–59% of Alzheimer’s patients are affected

Despite this prevalence, no approved drugs exist for apathy today.

Strategic Backing from Otsuka Group

IRLAB partnered with MSRD in May 2024 to advance IRL757 through proof-of-concept trials.

The collaboration brings:

  • Financial strength
  • Development expertise
  • A clear path toward later-stage studies

According to IRLAB CEO Kristina Torfgård, the program has moved forward “very efficiently” due to this support.

What’s Next for IRLAB?

IRL757 is part of a broader Parkinson’s pipeline that includes:

  • Mesdopetam (IRL790) – completed Phase IIb, preparing for Phase III
  • Pirepemat (IRL752) – in Phase IIb for fall reduction
  • Two preclinical programs moving toward Phase I

All are built on IRLAB’s proprietary Integrative Screening Process, rooted in Nobel Prize–winning neuroscience research.

Bottom Line

IRLAB’s Phase Ib study of IRL757 marks a meaningful step toward what could become the first approved treatment for apathy in Parkinson’s disease.

If successful, it won’t just fill a gap. It could redefine care for millions of patients living with a condition long ignored by drug development.

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