Pipeline projects
OX124
high-dose rescue medication for opioid overdose with naloxone
Project in brief
Opioid overdose is a life-threatening condition, characterized by loss of consciousness and respiratory depression. Based on the proprietary drug delivery platform AmorphOX, Orexo has developed a high-dose naloxone rescue medication, OX124, designed to reverse opioid overdoses, including those from highly potent synthetic opioids, such as illegal fentanyl.
API |
Naloxone |
Technology |
amorphOX®, nasal powder technology |
Development phase |
NDA submitted with the FDA in September 2023. The PDUFA date is set to July 15, 2024, but recent review processes in the category indicate a risk of some delay. |
In-house or partnership |
In-house |
OX125
rescue medication for opioid overdose with nalmefene
Project in brief
The widespread use of synthetic opioids also increases the need for effective and long-lasting rescue medications for use in rural areas where it takes long time for patients to reach emergency care units. With OX125, the aim is to develop an overdose rescue medication for situations where the treatment effect needs to be long-lasting while also being powerful and fast-acting. Nalmefene has a half-life of eight to eleven hours in the body versus one to two hours for naloxone.
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 OX125 formulations as well as good tolerability.
API |
Nalmefene |
Technology |
amorphOX®, nasal powder technology |
Development phase |
Finalized phase 1 |
In-house or partnership |
In-house |
OX640
epinephrine rescue medication for allergic reactions
Project in brief
The aim with OX640 is to develop a powder-based nasal epinephrine product for the emergency treatment of allergic reactions. Epinephrine is commonly used for the emergency treatment of allergic reactions, including anaphylaxis. Epinephrine is a very unstable active ingredient sensitive to chemical degradation, which is the reason why today’s commercial epinephrine products have limited shelf-life with restrictive handling and storage.
OX640 is based on AmorphOX® and its powder-based technology provides excellent chemical and physical stability. In addition to providing allergic patients with a more convenient, needle-free alternative to auto-injectors currently on the market, an epinephrine product that provides greater flexibility in relation to how it can be handled and stored should provide significant benefits to patients and healthcare systems worldwide.
OX640 is protected by granted patents both on the US and European markets. Furthermore, multiple patent applications have been filed protecting OX640 on a global basis until 2044.
API |
Epinephrine (adrenaline) |
Technology |
amorphOX®, nasal powder technology |
Development phase |
Positive data announced for phase 1 clinical study in 40 healthy volunteers assessing four investigational formulations of OX640 compared to a marketed epinephrine auto-injector. |
In-house or partnership | Partnerships are under assessment for continued development and for commercialization |
OX-MPI
vipoglanstat for the treatment of endometriosis
Project in brief
OX-MPI (GS-248) is a drug candidate in clinical development. OX-MPI inhibits the proinflammatory enzyme mPGES-1, which via its product, prostaglandin E2, plays a key role in the chronic inflammatory disease endometriosis. This disease affects approximately 10 percent of women of reproductive age. Main symptoms of endometriosis are severe pain and reduced fertility, and there is a high need for nonhormonal treatment options.
Orexo’s partner Gesynta Pharma owns all rights to the drug candidate.
API |
BI1029539 |
Technology |
- |
Development phase |
Phase 2 study |
In-house or partnership |
In partnership with |