Development pipeline

Product

Indication

Technology

Partner

Exploratory
phase

Pre-clinical
phase

Clinical
development
phase

Registration

Approved/
Launched

RoW

Intranasal Rescue Medications

IZIPRY™

Naloxone, opioid overdose

–

OX640

Epinephrine, anaphylaxis

–

OX390

NCE, overdose

OX125

Nalmefene, opioid overdose

–

Other disclosed projects in pre-clinical phase

OX472

Semaglutide/GLP-1 receptor agonist

–

Others

Vaccine candidate

Development projects

IRM – Intranasal Rescue Medication

IZIPRY™ – for opioid overdose with a high dose powder-based naloxone

Izipry, former OX124, is a late-stage, high-dose nasal powder to be used in life-threatening situations where the overdose on any opioid is suspected, indicated by e.g., unconsciousness or opioid-induced respiratory depression (OIRD).

IZIPRY, Clinical data and IP

Formulations of Izipry™, former OX124, have shown more rapid absorption and higher plasma concentrations of naloxone compared to the current market leader. These properties can be critical in avoiding brain damage and saving lives as well as preventing re-intoxification during the revival process. In addition, the AmorphOX technology, which is the backbone in Izipry, contributes to improved stability of the active substance and reduces its sensitivity related to temperature changes.

Izipry is protected by patents until 2039.

OX640 – for allergic reactions with powder-based epinephrine

OX640 is a best-in-class intranasal epinephrine product that has a rapid onset to counteract suspected anaphylactic reactions in patients. The powder-based formulation is extremely stable at a wide range of very low to high temperatures, allowing patients to take the medication with them wherever they go.

Explore OX640

OX640 Clinical data and IP

In the first clinical study with OX640 the product displayed positive data from the comparative bioavailability study performed in 40 healthy volunteers assessing four investigational formulations of OX640 compared to a marketed epinephrine auto-injector. All four investigational formulations were extensively absorbed and rapidly achieved clinically relevant plasma levels of epinephrine comparable to the reference product. Furthermore, all four OX640 formulations showed concentration dependent effects on heart rate and blood pressure, a pharmacological response relevant for the treatment of allergic reactions.

Local and systemic safety findings were generally consistent with known effects of epinephrine and there were no findings that raised any safety concerns.

A second clinical study with OX640 evaluated both pharmacokinetic and pharmacodynamic effects of OX640 in individuals with and without allergic rhinitis. Data showed that OX640 treatments achieved clinically relevant plasma levels of epinephrine faster than the intramuscular reference product. In addition, absorption under conditions of allergic rhinitis was significantly faster than under normal conditions, supporting rapid onset of action even in patients with respiratory symptoms.

OX640 is protected by patents and patent applications until 2044.

OX390 – for overdoses caused by a combination of life-threatening illicit drugs

Orexo is developing a new product, OX390, a rescue medication to address the growing adulteration of potent synthetic opioids like fentanyl, complicating the management of accidental overdoses. OX390 will be a complement to naloxone or nalmefene (used in the OX124 and OX125 rescue medications) to address the growing adulteration of synthetic opioids like fentanyl, which can prevent patients intoxicated with adulterated fentanyl from responding to naloxone or nalmefene alone. We are in the pre-clinical stage developing OX390 to address this emerging threat in the Opioid Public Health Emergency and have ongoing discussions with US health authorities to collaborate in development of OX390. OX390 uses our proprietary AmorphOX^® technology.

OX125 – for opioid overdose with powder-based nalmefene

OX125 is a clinical-stage powder-based formulation of nalmefene for intranasal administration in life-threatening situations where the overdose on any opioid is suspected. Nalmefene has a prolonged half-life compared to naloxone and may potentially last longer than the majority of highly potent synthetic opioids.

OX125 Clinical data and IP

OX125, also based on the proprietary drug delivery platform AmorphOX, has shown positive results from a human pharmacokinetic study. The study was a cross-over, comparative bioavailability study in healthy volunteers to assess nalmefene absorption from three development formulations of OX125, compared to a nalmefene intramuscular injection. Data demonstrated extensive and rapid absorption across all three formulations as well as good tolerability.

OX125 is protected by patents until 2039.

Other disclosed projects in pre-clinical phase

OX472 – intranasal semaglutide/GLP-1
receptor agonist

An intranasal semaglutide/GLP-1 agonoist candidate, developed using the AmorphOX® powder-based formulation technology, demonstrated promising pharmacokinetic in-vivo data. Two of the AmorphOX formulations achieved up to sevenfold higher plasma exposure than oral semaglutide (Rybelsus®), with lower variability, though levels remained below the injectable form (Wegovy®). These results support the potential of AmorphOX to enable needle-free intranasal delivery of large molecules, such as peptides, offering improved convenience, potential adherence benefits, no refrigeration requirement, and the possibility of extended dosing intervals.

Vaccine candidate

An intranasal influenza vaccine candidate, developed with Abera Bioscience, combines the AmorphOX® powder-based formulation technology with Abera’s BERA™ vaccine platform. In-vivo proof-of-concept data in rats demonstrated robust systemic and mucosal immune responses (IgG and IgA), comparable to a liquid nasal formulation. The results support the potential of AmorphOX for developing thermostable, needle-free mucosal vaccines.