Development pipeline

 

Project

Indication

Technology

Partner

Exploratory phase 

Pre-clinical phas 

Clinical development phases

Registration

Approved and/or launched

US

EU

RoW

OX124

Naloxone, opioid overdose

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OX125

Nalmefene, opioid overdose

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OX640

Epinephrine, allergic reactions, incl. anaphylaxis 

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Others

Multiple incl. small molecules, peptides & biologics

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OX-MPI

Vipoglanstat, endometriosis

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Development projects

OX124 - intranasal rescue medication for  
opioid overdose with a high dose powder-based naloxone

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 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 OX124, contributes to improved stability of the active substance and reduces its sensitivity related to temperature changes.

OX124 is protected by patents until 2039.

 

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.

 

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

OX640 has shown positive data from a 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. 

 OX640 is protected by patents until 2044. 

 

Versatility of AmorphOX

Orexo has tested a wide range of APIs to be formulated with AmorphOX. The formulation of temperature-sensitive APIs such as apomorphine and cetrorelix have been successful in eliminating the cold chain requirements. Biomolecyles like a spike protein and a live attenuated virus have successfully retained activity after several months of storage at accelerated temperatures. 

Chemical degradation after accelerated stability studies at 40°C/75% RH

Small molecules

Apomorphine

0.2% after 24 months

Eletriptan

0.5% after 12 months

Loxapine

0.3% after 24 months

Naloxone

≤0.1% after 24 months

Epinephrine

0.4% after 24 months

Zavegepant

<0.1% after 6 months

Peptides

Cetrorelix

0.6% after 12 months

Biologics

Enzyme

Retained activity after 1 month

Protein (spike protein)

Retained activity after 3 months

Vaccine (Attenuated virus)

Retained titer levels, resilient to freeze thaw cycles

OX-MPI - Oral treatment for endometriosis  

Vipoglanstat for the treatment of endometriosis 

A phase II development project out-licensed to our partner Gesynta Pharma AB. OX-MPI is developed to inhibit the pro-inflammatory enzyme mPGES-1 and hence affect prostaglandine E2 that plays a vital role in the inflammatory processes in endometriosis.  

 

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