Pipeline projects
OX124
High-dose medication for opioid overdose
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. Formulations of OX124 have shown more rapid absorption and substantially higher plasma concentrations of naloxone compared to the current market leader. All these properties can be critical in avoiding brain damage and saving lives as well as preventing re-intoxification during the revival process. OX124 has patents protecting the product until 2039.
API |
Naloxone |
Technology |
amorphOX®, nasal powder technology |
Development phase |
NDA submitted with the FDA in February 2023. Due to technical issues in the secondary packaging process of the supply chain the production site is not ready for FDA inspection. Orexo will need to resubmit an NDA with the FDA when the issues are solved and the site is ready for inspection. The resubmission is planned to take place in Q3 2023. |
In-house or partnership |
In-house |
OX125
High-dose medication for opioid overdose containing nalmefene
Project in brief
The widespread use of synthetic opioids, such as illicit fentanyl, 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 8-11 hours in the body versus 1-2 hours for naloxone.
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 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 storage conditions.
OX640 is based on amorphOX® and has shown promising chemical and physical stability data. 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.
OX640 has one granted patent protecting the product on the European market until 2041. Orexo has multiple patent applications filed in other territories and expect to continuously strengthen the patent portfolio for OX640.
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
Endometriosis, BI1029539
Project in brief
OX-MPI (vipoglanstat, 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 |