Clinical Trials
15
9 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
1995
Active, not recruiting
9
60.0%
Completed
5
33.3%
Terminated
1
6.7%
No approval data available
- The FDA has accepted Orexo's Investigational New Drug application for OX640, a nasally administered epinephrine powder for emergency treatment of anaphylaxis. - OX640 uses Orexo's AmorphOX delivery platform and has shown rapid epinephrine absorption, robust pharmacokinetics, and good tolerability in completed clinical studies. - The candidate also demonstrated strong stability across a broad temperature range, potentially enabling longer shelf life than marketed and investigational products. - Orexo plans to start the pivotal clinical program in Q4 2026, with an NDA targeted for regulatory submission in 2028, while seeking a development partner.
- Orexo AB announced positive topline results from a clinical study of OX640, a nasal rescue medication for allergic reactions, including anaphylaxis. - The study, OX640-002, demonstrated that OX640 achieved clinically relevant epinephrine plasma levels faster than intramuscular injection. - Absorption of OX640 was significantly faster under allergic rhinitis conditions, supporting rapid onset of effect in patients with airway symptoms. - The safety profile of OX640 was consistent with epinephrine's known pharmacology, with no severe adverse events reported.
