The FDA has approved the company’s IND application for OX640, an intranasally administered adrenaline (epinephrine) powder formulation designed for the acute treatment of anaphylaxis.

OX640 is developed using Orexo’s proprietary AmorphOX drug delivery platform and is designed to offer fast, reliable adrenaline administration without the need for injection. The product aims to address key limitations of current autoinjectors, including needle fear, use errors, and challenges related to storage and shelf life.

The IND application is based on extensive preclinical data along with positive results from completed clinical studies, which have shown rapid adrenaline absorption, a robust pharmacokinetic profile, and good tolerability. OX640 has also demonstrated strong stability across a wide temperature range, potentially offering longer shelf life than other products on the market and in development.

Orexo continues to pursue partnership opportunities to support the further development and commercialization of OX640. The company believes OX640 has the potential to become an attractive treatment option for patients at risk of severe allergic reactions.

In line with previous communications, Orexo plans to initiate the pivotal clinical development program in Q4 2026, with regulatory submission expected in 2028.

“The IND approval for OX640 is an important milestone for Orexo and a significant step in developing a new treatment option for patients at risk of anaphylaxis. While adrenaline is well established as a treatment, significant challenges remain with today’s injection-based products. With OX640, we have the opportunity to offer a needle-free, user-friendly, and temperature-stable product with the potential to improve treatment for patients worldwide,” says Nikolaj Sørensen, CEO of Orexo.