Indiana’s OYE Therapeutics raises $5.475 million Series A

Crown Point, Indiana’s OYE Therapeutics recently announced that it raised $5.475 million in a Series A financing to support clinical development of an intravenous, high‑concentration caffeine formulation intended for use in anesthesia recovery and to complement naloxone in opioid‑overdose care.

The clinical‑stage company plans to begin a Phase 1 trial in the first quarter of 2026 that will evaluate pharmacokinetics, safety, tolerability and preliminary efficacy of the caffeine candidate. According to OYE, the trial will enroll healthy volunteers in the initial phase and then study patients in a simulated fentanyl‑intoxication model in a subsequent part; results are expected to guide later studies and regulatory strategy aimed at a 505(b)(2) submission pathway. 

OYE’s approach is to pair a central nervous system stimulant with naloxone in suspected opioid‑overdose situations. The company argues that while naloxone rapidly reverses opioid receptor effects, a high‑concentration caffeine infusion could help maintain wakefulness and respiratory drive during recovery, potentially addressing opioid‑induced respiratory depression (OIRD). “OIRD remains a leading cause of serious adverse events in clinical and emergency care, and our approach seeks to provide clinicians with an additional tool to support respiratory function when opioids are administered,” Brett Dines, RPh, MBA, Chief Executive Officer and Founder of OYE Therapeutics said in their announcement.

As the “most widely used central nervous system (CNS) stimulant in the world” according to the National Library of Medicine, caffeine comes with well‑understood pharmacology. OYE frames the product as a complement to standard supportive care in settings where respiratory drive may be depressed by opioids or anesthetics.

“With this funding, we have the resources to complete our IND, expand our CMC activities, advance our lead candidate into the clinic, and ultimately generate our first clinical data for 505(b)(2) submission,” added Dines in the announcement.

OYE stands for “Open Your Eyes” and was founded around the concept of repurposing or reformulating overlooked or “accepted-as-intractable” clinical problems to create new solutions. 

If Phase 1 studies show a favorable safety profile and signals of efficacy in simulated intoxication, OYE could move into larger efficacy trials. Key questions for future studies may include optimal dosing, timing relative to naloxone administration, patient selection (e.g., fentanyl vs. other opioids), and monitoring for adverse cardiovascular or neuroexcitatory effects.