Orexo's AmorphOX technology may pave the way for intranasal GLP-1 medication
MWN-AI** Summary
Orexo AB has recently unveiled promising results from a preclinical study utilizing its proprietary AmorphOX technology to develop intranasal formulations of semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist. This technology appears to offer a novel and potentially more effective delivery method for large molecule medications. In the study, three powder-based formulations were tested against traditional oral and subcutaneous formulations of semaglutide. The results were notable, with the AmorphOX powders exhibiting significantly higher plasma concentrations and bioavailability compared to the oral tablets, achieving up to a sevenfold increase in plasma values.
This advancement could revolutionize the administration of GLP-1 medications, which currently require injections or strict regimen adherence with oral tablets. The ability to administer semaglutide nasally may allow for a more convenient, needle-free option, potentially improving patient compliance and comfort. Moreover, the AmorphOX technology overcomes some of the challenges faced with oral delivery, such as variability in bioavailability and the requirement for specific dosages relative to food intake.
Orexo's Senior Vice President Robert Rönn expressed optimism about this development, highlighting that the success of AmorphOX in formulating and stabilizing biomolecules like semaglutide signals a pivotal shift towards more efficient healthcare solutions. As Orexo seeks to establish strategic partnerships to further this technology, the implications could extend beyond semaglutide to encompass a broader range of peptides, proteins, and even vaccines.
This innovative approach not only offers a glimpse into the future of medication delivery but also aligns with the increasing demand for patient-friendly alternatives in chronic disease management solutions.
MWN-AI** Analysis
Orexo AB (publ.) has made significant advancements with its AmorphOX® technology, which may revolutionize the delivery of glucagon-like peptide-1 (GLP-1) medications, particularly through intranasal formulations. Recent preclinical pharmacokinetic studies showed that the AmorphOX intranasal semaglutide formulations achieved a remarkable sevenfold increase in plasma concentration compared to oral counterparts. This enhanced bioavailability suggests a promising direction for patients requiring needle-free options to manage type 2 diabetes and obesity.
The implications of successful intranasal delivery systems extend beyond mere convenience. Patients often struggle with the inconvenience and compliance issues associated with injectable medications that necessitate refrigeration and strict dosing schedules. AmorphOX technology, which has been validated in clinical studies for its rapid dissolution and stability, could usher in a new era of GLP-1 therapies that are both easier to use and more effective at delivering active ingredients directly into the bloodstream.
Such advancements provide essential catalysts for Orexo’s strategic partnerships, potentially accelerating the development and commercialization of innovative treatments. With the current market demand for GLP-1 receptor agonists, the prospect of a stable, effective intranasal formulation positions Orexo favorably against competitors, particularly those reliant on traditional injection-based delivery methods.
Investors should closely monitor Orexo's future studies and collaborations, focusing on any progress in regulatory approvals for their intranasal semaglutide formulation. The company's agility in leveraging its formulation technologies alongside growing market interest could translate into significant shareholder value. As the landscape of diabetes treatment evolves, Orexo's AmorphOX may not only enhance patient adherence but also capture substantial market share within a lucrative therapeutic niche.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
PR Newswire
- A preclinical pharmacokinetic in-vivo study has been conducted in which the AmorphOX® technology was used to develop three powder-based intranasal formulations with semaglutide, which were compared with an oral and an injectable formulation.
- AmorphOX formulations demonstrated significantly higher plasma concentrations and higher bioavailability than the oral tablet.
- The data further demonstrate the ability of the AmorphOX powder-based intranasal formulation technology to develop formulations for large molecules that are well absorbed through mucosal membranes.
UPPSALA, Sweden , Sept. 5, 2025 /PRNewswire/ -- Orexo AB (publ.), (STO: ORX) (OTCQX: ORXOY), today announced positive pharmacokinetic in-vivo data for a powder-based intranasal semaglutide formulation developed with the AmorphOX technology.
In the in-vivo study, three different formulations of powder semaglutide were administered intranasally. For comparison, Rybelsus®, a semaglutide tablet, was administered orally, and Wegovy®, injectable semaglutide, was administered subcutaneously.
At the median values, two of the AmorphOX powder formulations had a sevenfold increase in plasma values when compared to the oral tablet, although as expected they had lower values than the injectable. In addition to higher exposure than the oral route, the AmorphOX formulations exhibited lower variability in plasma concentration.
The data generated further supports the ability of the AmorphOX technology to formulate large molecules into powders that could be delivered intranasally. An AmorphOX-formulated intranasal semaglutide may provide needle-free delivery with improved convenience, potentially better adherence, and would not require refrigeration. Dosing schedules, depending on intranasal dosage strength and therapeutic levels achieved, may also be extended to require less frequent dosing than the oral route.
Robert Rönn, SVP and Head of R&D, comments : " It's promising that our AmorphOX powder technology successfully has managed to formulate and stabilize large peptides like semaglutide. This could pave the way for effective intranasal delivery of semaglutide and other GLP-1 receptor agonists. The study results underpin our updated AmorphOX strategy to prioritize larger molecules like peptides, proteins, and vaccines. The results will support Orexo in establishing strategic partnerships that expand and accelerate the use of this novel delivery method for more efficient treatments options."
For further information contact:
Nikolaj Sørensen, President and CEO
Lena Wange, IR & Communications Director
Robert Rönn, SVP and Head of R&D
Tel: +46 (0)18 780 88 00
E-mail: ir@orexo.com
About Orexo
Orexo is a Swedish pharmaceutical company with 30 years of experience developing improved pharmaceuticals based on proprietary formulation technologies that meet large medical needs. On the US market, Orexo provides innovative treatment solutions for patients suffering from opioid use disorder. Products targeting other therapeutic areas are developed and commercialized worldwide with leading partners. Total net sales in 2024 amounted to SEK 590 million , and the number of employees to 110. Orexo is listed on Nasdaq Stockholm's main list and is available as ADRs on OTCQX market (ORXOY) in the US.
For more information on Orexo, visit www.orexo.com . Follow Orexo on X, LinkedIn, and YouTube.
About AmorphOX®
Orexo's proprietary drug delivery platform, AmorphOX, is a powder made up of particles that are built using a unique combination of a drug, carrier materials and, optionally, other ingredients. The particles are presented as an amorphous composite of the various ingredients providing for excellent chemical and physical stability, as well as rapid dissolution. The technology works for a broad scope of active ingredients and has been validated in several human clinical studies showing rapid and extensive drug exposure.
About semaglutide
Semaglutide belongs to the class of glucagon-like peptide-1 ( GLP-1 ) receptor agonists which are available today in both oral and subcutaneous injection forms. They are primarily used for the treatment of type 2 diabetes and obesity or weight management.
Currently available GLP-1 and GLP-1 /GIP (gastric inhibitory polypeptide) receptor agonists that are FDA-approved include injectable medications that require weekly needle sticks and refrigeration. In development are oral formulations that do not require refrigeration, offer improved convenience, and potentially better adherence compared to injectable medications.
Oral bioavailability of semaglutide in humans is highly variable. Oral formulations endure enzymatic degradation in the gastrointestinal tract, impacting their bioavailability and effectiveness. Furthermore, instructions on taking oral tablets on an empty stomach with water and at least 30 minutes before a meal are restrictive.
Rybelsus ® and Wegovy® are registered trademarks of Novo Nordisk A/S.
The information was submitted for publication at 2 pm CEST on September 5, 2025 .
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https://news.cision.com/orexo/i/jela-orex-210906-763-edit-lowres,c3467294 | JELA OREX 210906-763 EDIT LOWRES |
SOURCE Orexo
FAQ**
How does Orexo AB ORXOF plan to leverage the positive pharmacokinetic data from the AmorphOX technology to establish strategic partnerships and expand its market reach for intranasal GLP-1 medications?
What specific advantages does the AmorphOX formulation provide over existing oral and injectable GLP-1 medications in terms of patient adherence and convenience for Orexo AB ORXOF?
Can you discuss the potential impact of the AmorphOX technology on the cost of GLP-1 treatments for patients and healthcare systems, particularly regarding Orexo AB ORXOF's development strategy?
What are the next steps for Orexo AB ORXOF in the clinical development of the intranasal semaglutide formulation, including any plans for future trials and regulatory submissions?
**MWN-AI FAQ is based on asking OpenAI questions about Orexo AB (OTC: ORXOF).
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