ORP-101 is a new chemical entity designed with intent to create a large stable molecule and to confer partial μ agonist and full κ-antagonist receptor pharmacology.
- ORP-101 has been shown in preclinical studies to not cross the blood-brain barrier.
- ORP-101 successfully completed Phase 1 and was granted FDA Fast Track designation in 2018.
- ORP-101 regulatory path to NDA has been agreed with the FDA.
- ORP-101 Phase 2 currently enrolling, utilizing adaptive 3-month treatment design powered for Phase 3 predictive outcomes.