OX472
GLP-1 agonist, semaglutide
OX472 is an innovative intranasal formulation of semaglutide, a GLP-1 receptor agonist, developed using Orexo’s proprietary AmorphOX® technology. This program aims to deliver effective treatment without the need for injections, offering a needle-free alternative for patients and improving convenience and compliance.
Substance
Powder-based semaglutide
Development phase
Preclinical
Temperature stability1
≤0.1% degradation after 6 months2
Administration
Nasal powder (other delivery routes are explored)
Leverage established manufacturing processes
Spray-drying process (intranasal delivery)
Partnership
Seeking partnership for continued research and development
Demonstrating strong preclinical performance
A preclinical in-vivo study evaluated three powder-based intranasal semaglutide formulations developed with AmorphOX. These were compared to an oral semaglutide tablet (Rybelsus®) and a subcutaneous injectable (Wegovy®).3 Results demonstrated that two intranasal formulations achieved up to seven times higher median plasma concentrations than the oral tablet, with lower variability in plasma levels. As anticipated, concentrations were lower than those achieved via subcutaneous injection. Next steps include continued formulation development, assessing development pathways, and strategic partnership opportunities.
Potential to secure competitive advantage through technology
The AmorphOX technology platform provides a unique capability to stabilize peptides and enable intranasal delivery of larger molecules such as semaglutide. Unlike injectable formulations, OX472 eliminates the need for refrigeration, maintaining stability across varying temperature ranges. This differentiation not only enhances ease of use but also reduces logistical complexities. Orexo’s intellectual property portfolio protects both the AmorphOX technology and its application in GLP-1 agonists, reinforcing the company’s competitive position in this growing therapeutic area.
Expanding horizons through discovery
In parallel with OX472 development, and supported by the AmorphOX technology, the discovery work is advancing to evaluate semaglutide and other GLP-1 agonists via additional administration routes and across multiple indications. From a long-term strategic perspective, this research opens a pathway into one of the largest and fastest-growing pharmaceutical categories: GLP-1 agonists for diabetes, weight management, and potentially even CNS disorders. This positions Orexo to capture significant opportunities in a market with strong growth potential.
Preclinical PK study
Intranasal semaglutide formulated by AmorphOX vs oral forms
Findings: Semaglutide nasal powders formulated with AmorphOX demonstrated 7-times higher exposure compared to Rybelsus oral tablet (median values).4
- Chemical degradation after accelerated stability studies in 40°C/75% RH.
- Preliminary data.
- Rybelsus and Wegovy are registered trademarks of Novo Nordisk A/S.
- Exposure of AmorphOX formulations were lower than injectable reference.
