New initiative from Silo Pharma designed to align with federal actions to accelerate mental health innovation using psychedelic medicines

Silo Pharma targets unmet need in a drug market with no FDA-approved therapies that address structural or regenerative aspects of traumatic brain injury

Traumatic brain injury therapeutics market estimated to reach $6 billion by 2032

Silo Pharma (Nasdaq: SILO) (“Silo” or “the Company”), a developmental-stage biopharmaceutical company focused on novel therapeutics and drug delivery systems,  announced a strategic initiative to explore ibogaine-based therapeutics for the treatment of traumatic brain injury (TBI) and associated neuropsychiatric conditions.

Silo has filed a provisional patent application with the United States Patent and Trademark Office (USPTO) titled “Compositions and Methods for Treating Traumatic Brain Injuries and/or Disorders Associated therewith with Ibogaine.” The invention applies to the use of ibogaine and related compounds for the treatment of TBI, post-traumatic stress disorder (PTSD) and associated conditions.

Silo’s newest drug discovery initiative is in line with recently published clinical and neuroimaging findings demonstrating substantial improvements in patients with TBI following treatment with ibogaine-based protocols. Reported outcomes include significant reductions in depression and anxiety symptoms, as well as measurable structural brain changes, including increased cortical thickness, subcortical volume expansion, and reductions in predicted brain age following a single treatment.

In accordance with the Executive Order by President Trump announced on April 18, 2026, the FDA has granted Breakthrough Therapy designation to specific psychedelic drugs through a program designed to expedite the development and review of drugs intended to treat serious or life-threatening conditions. The Executive Order cites ibogaine’s potential for conditions that persist after standard therapies are completed.

“Promising clinical findings on ibogaine signify a potential paradigm shift in how we think about treating traumatic brain injury and related central nervous system (CNS) disorders,” said Eric Weisblum, CEO of Silo Pharma. “While many drugs are used off label to manage TBI symptoms like cognitive dysfunction or depression, no pharmaceutical agent has ever received FDA approval for the direct treatment of TBI. The possibility of not only addressing symptoms but also driving measurable structural brain improvements opens a compelling new frontier in neurotherapeutics.”

Silo will evaluate the potential of ibogaine and related compounds, including differentiated protocols and combination approaches, as part of its broader strategy to develop next-generation psychedelics-assisted CNS therapeutics. The Company intends to explore treatment approaches designed to promote neuroplasticity, improve functional outcomes, and address the underlying pathophysiology of TBI.

TBI remains a significant unmet medical need, particularly among military veterans and individuals with chronic neuropsychiatric symptoms. No FDA-approved treatments address structural or regenerative aspects of traumatic brain injury. Current options are limited to symptomatic support.

The global traumatic brain injury (TBI) therapeutics market is estimated to reach $6.0 billion by 2032, growing at a CAGR of 6.0% between 2025 and 2032. Key drivers of growth include. The increasing incidence of brain injuries worldwide and rapid advancements in treatment options.¹

“By expanding into ibogaine-based therapeutics, we are bolstering Silo’s position at the intersection of emerging psychedelic research and next-generation CNS drug development,” Weisblum added. “Silo’s broader strategy focuses on combining novel compounds, innovative delivery systems and measurable clinical endpoints to drive scalable therapeutic solutions.”