Development pipeline

 

Project

Indication

Technology

Partner

Exploratory phase 

Pre-clinical phas 

Clinical development phases

Registration

Approved and/or launched

US

EU

RoW

IZIPRY®

Naloxone, opioid overdose

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OX125

Nalmefene, opioid overdose

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OX390

NCE, overdose

  
                   

OX640

Epinephrine, allergic reactions, incl. anaphylaxis 

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Others

Multiple incl. small molecules, peptides & biologics

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Development projects

IZIPRY®- intranasal rescue medication 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).  

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.

 

OX390 - an intranasal rescue medication 
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.

 

OX640 - intranasal rescue medication 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

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.

 

OX125 - intranasal rescue medication 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, 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.

 

Partner with us

Talk to our Business Development team to explore projects of interest and discover how AmorphOX® could be applied to your APIs. 

Find out more

INSIGHTS: Synthetic opioids, such as fentanyl, increasingly poisons young Americans - OX124

Explore

Bioavailability and Stability of Epinephrine Nasal Powder Formulations for Treatment of Anaphylaxis

View Scientific Poster

Highly stable Intranasal Epinephrine Product

OX640