TH104

TH104 is a proprietary transmucosal buccal film formulation containing nalmefene, an opioid receptor antagonist. Developed by Tharimmune, the drug is designed for rapid absorption through the mucous membranes of the mouth, bypassing first-pass liver metabolism. Its primary mechanism involves dual antagonism of both the µ-opioid receptor and kappa opioid receptor, which are implicated in itch signaling pathways. Additionally, TH104 suppresses IL-17 inflammatory cytokine expression. The main clinical focus for TH104 is moderate-to-severe chronic pruritus associated with primary biliary cholangitis (PBC), a rare autoimmune liver disease characterized by inflammation and scarring of bile ducts leading to symptoms such as severe itching. The drug has completed Phase 1 trials demonstrating safety and bioavailability and is advancing into Phase 2 studies for PBC-related pruritus[1][3][5][4]. There are also indications that it may be explored for other liver-related or pruritogenic inflammatory conditions[5].

Other names

buccal nalmefenenalmefene buccal film