Orexo's AmorphOX technology may pave the way for intranasal GLP-1 medication
Orexo AB (OTCQX: ORXOY) has announced positive results from a preclinical pharmacokinetic study using its AmorphOX® technology to develop intranasal formulations of semaglutide. The study compared three powder-based intranasal formulations with oral (Rybelsus®) and injectable (Wegovy®) versions.
Two of the AmorphOX powder formulations demonstrated a sevenfold increase in plasma values compared to the oral tablet, with lower variability in plasma concentration. While the intranasal formulations showed lower values than injectable delivery, they offer potential advantages including needle-free administration, no refrigeration requirements, and possibly extended dosing schedules.
The successful formulation of large peptides like semaglutide supports Orexo's updated strategy to focus on larger molecules including peptides, proteins, and vaccines.
Orexo AB (OTCQX: ORXOY) ha reso noti risultati positivi da uno studio farmacocinetico preclinico che ha utilizzato la sua tecnologia AmorphOX® per sviluppare formulazioni intranasali di semaglutide. Lo studio ha confrontato tre formulazioni intranasali in polvere con le versioni orale (Rybelsus®) e iniettabile (Wegovy®).
Due delle formulazioni in polvere AmorphOX hanno mostrato un incremento di sette volte nei livelli plasmatici rispetto alla compressa orale, con una variabilità più bassa nelle concentrazioni plasmatiche. Sebbene i valori plasmatici delle formulazioni intranasali risultino inferiori rispetto alla somministrazione per iniezione, esse offrono vantaggi potenziali come la somministrazione senza ago, l'assenza di necessità di refrigerazione e la possibile estensione degli intervalli di dosaggio.
La riuscita formulazione di peptidi di grandi dimensioni come il semaglutide supporta la strategia aggiornata di Orexo, orientata su molecole più grandi come peptidi, proteine e vaccini.
Orexo AB (OTCQX: ORXOY) ha anunciado resultados positivos de un estudio farmacocinético preclínico que utilizó su tecnología AmorphOX® para desarrollar formulaciones intranasales de semaglutida. El estudio comparó tres formulaciones intranasales en polvo con las versiones oral (Rybelsus®) e inyectable (Wegovy®).
Dos de las formulaciones en polvo AmorphOX mostraron un aumento de siete veces en los valores plasmáticos en comparación con la tableta oral, con menor variabilidad en la concentración plasmática. Si bien los niveles plasmáticos de las formulaciones intranasales fueron inferiores a los de la administración inyectable, ofrecen ventajas potenciales como la administración sin aguja, la ausencia de necesidad de refrigeración y la posibilidad de ampliar los intervalos de dosificación.
La exitosa formulación de péptidos de gran tamaño como la semaglutida respalda la estrategia actualizada de Orexo de centrarse en moléculas más grandes, incluidos péptidos, proteínas y vacunas.
Orexo AB (OTCQX: ORXOY)는 자사의 AmorphOX® 기술을 이용해 세마글루타이드의 비강 투여 제형을 개발한 전임상 약동학 연구에서 긍정적인 결과를 발표했습니다. 본 연구는 분말 기반의 비강 제형 세 가지를 경구제(Rybelsus®)와 주사제(Wegovy®)와 비교했습니다.
AmorphOX 분말 제형 중 두 가지는 경구 정제에 비해 혈중 수치가 7배 증가했고, 혈중 농도의 변동성은 더 낮게 나타났습니다. 비강 제형의 혈중 수치는 주사제보다는 낮았지만, 주사 바늘이 필요 없는 투여, 냉장이 불필요한 점, 투여 간격 연장 가능성 등 잠재적 이점을 제공합니다.
세마글루타이드처럼 분자량이 큰 펩타이드의 성공적인 제형화는 펩타이드, 단백질, 백신 등 더 큰 분자에 집중하는 Orexo의 최신 전략을 뒷받침합니다.
Orexo AB (OTCQX: ORXOY) a annoncé des résultats positifs d'une étude pharmacocinétique préclinique ayant utilisé sa technologie AmorphOX® pour développer des formulations intranasales de sémaglutide. L'étude a comparé trois formulations intranasales en poudre aux versions orale (Rybelsus®) et injectable (Wegovy®).
Deux des formulations en poudre AmorphOX ont montré une augmentation par sept des valeurs plasmatiques par rapport au comprimé oral, avec une variabilité moindre des concentrations plasmatiques. Si les valeurs plasmatiques des formulations intranasales restent inférieures à celles de l'administration injectable, elles présentent des avantages potentiels tels que l'administration sans aiguille, l'absence d'exigence de réfrigération et la possibilité d'espacer davantage les doses.
La réussite de la formulation de peptides de grande taille comme le sémaglutide soutient la stratégie révisée d'Orexo, axée sur des molécules plus volumineuses, notamment les peptides, protéines et vaccins.
Orexo AB (OTCQX: ORXOY) hat positive Ergebnisse einer präklinischen pharmakokinetischen Studie veröffentlicht, in der die eigene AmorphOX®-Technologie zur Entwicklung intranasaler Semaglutid-Formulierungen eingesetzt wurde. Die Studie verglich drei pulverbasierte intranasale Formulierungen mit den oralen (Rybelsus®) und injizierbaren (Wegovy®) Versionen.
Zwei der AmorphOX-Pulverformulierungen zeigten im Vergleich zur oralen Tablette eine siebenfache Erhöhung der Plasmaspiegel bei geringerer Variabilität der Plasmakonzentration. Zwar lagen die Plasmaspiegel der intranasalen Formulierungen unter denen der Injektion, sie bieten jedoch potenzielle Vorteile wie nadel-freie Anwendung, keine Kühlkette und möglicherweise verlängerte Dosierungsintervalle.
Die erfolgreiche Formulierung großer Peptide wie Semaglutid untermauert Orexos aktualisierte Strategie, sich auf größere Moleküle wie Peptide, Proteine und Impfstoffe zu konzentrieren.
- AmorphOX formulations showed 7x higher plasma values than oral tablets
- Lower variability in plasma concentration compared to oral administration
- Technology successfully formulated and stabilized large peptides
- No refrigeration required for intranasal formulation
- Potential for extended dosing schedules compared to oral route
- Intranasal formulations showed lower plasma values than injectable delivery
- 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,
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
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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SOURCE Orexo
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