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ONP-002: Breakthrough Treatment for Concussion

The First Potential FDA-Approved Treatment for Concussion

ONP-002 is a first-in-class intranasal neurosteroid designed to address the underlying biology of brain injury — not just the symptoms. With Phase 1 complete and Phase 2 trials underway, we are advancing toward a new standard of care for the 69 million people who suffer concussions each year.

69M
Concussions annually worldwide
ZERO
FDA-approved treatments
Phase 2
Trials now underway

Understanding Concussion: An Unmet Medical Crisis

A concussion is a type of mild traumatic brain injury (mTBI) caused by a sudden impact to the head or body. Despite affecting more people annually than Alzheimer’s, Parkinson’s, and MS combined, there is no FDA-approved pharmacological treatment.

  • Chemical imbalances and cellular damage in the brain
  • Disruptions in thinking, learning, behavior, and sleep
  • Symptoms ranging from headache and confusion to severe cognitive impairment
  • 30–80% of patients develop post-concussion syndrome (PCS)
  • Increased long-term risk of dementia, Alzheimer’s, Parkinson’s, and CTE
Current standard of care: “Rest, observe, wait.” — symptom management only, with no pharmacological intervention available.

Why ONP-002?

ONP-002 represents a fundamentally different approach — targeting the biology of brain injury rather than just managing symptoms.

  • First-in-Class Neurosteroid: A novel therapeutic designed specifically for traumatic brain injury
  • Targets the Biology: Reduces inflammation, oxidative stress, and brain swelling at the source
  • Direct-to-Brain Delivery: Intranasal administration bypasses the blood-brain barrier for rapid action
  • Field-Ready Design: Portable, single-use device for ER, sports sidelines, and military settings
  • Non-Sedating: Maintains cognitive function without drowsiness
  • Protected IP: Proprietary intellectual property through 2040+

How ONP-002 Works

When a concussion occurs, the brain experiences a cascade of harmful biological processes: inflammation, oxidative stress, and swelling. ONP-002 is designed to interrupt this cascade.

1
Rapid Delivery
Administered intranasally, ONP-002 travels directly to the brain via nerve pathways
2
Cellular Activation
Activates receptors in neurons and glial cells, triggering protective responses
3
Neuroprotection
Reduces inflammation, oxidative stress, and cerebral edema (swelling)
4
Debris Clearance
Activates cellular cleanup mechanisms to remove damaged material

Clinical Development

Phase 1 — Complete
  • Safe and well-tolerated across all dose levels
  • Zero serious adverse events (SAEs)
  • Minimal systemic exposure — drug goes to brain, not body
  • Quick distribution to all regions of the brain
Phase 2a — Underway (Australia)
  • 40-patient randomized, placebo-controlled trial
  • First dose within 12 hours of concussion
  • Treatment: 2x daily for 5 days post-injury
  • HREC (ethics committee) approval received
U.S. Regulatory Pathway — Planned
  • IND submission to FDA planned for 2026
  • US-based clinical trials targeted for 2027

Preclinical Foundation

  • Rapid Effects: Neuroprotective improvements within hours in animal models
  • Brain Distribution: Intranasal delivery achieved distribution to all brain regions
  • Safety Profile: Excellent tolerability with no significant toxicity concerns
  • Novel Formulation: Nanoparticle formulation enhances absorption

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