ORP-101 has been granted Fast Track designation by the FDA. 

ORP-101 is a metabolically stable, peripherally active partial agonist of the μ opioid receptor and antagonist of the κ opioid receptor that is designed to mitigate colonic hypersensitivity due to intestinal hyperalgesia and associated motility dysfunction in IBS-D. In multiple clinically relevant animal models ORP-101 has repeatedly been shown to suppress general and colon-specific hyperalgesic signals without CNS penetration and without constriction of the sphincter of Oddi, which could cause acute pancreatitis. ORP-101 is a proprietary molecule fully owned by OrphoMed without any downstream royalties or associated milestone payments.