Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nalmefene · 2 trials · 3 indications
Percentage of participants with treatment-related adverse events as coded by MedDRA.
Determine the absolute bioavailability of a buccal dose of TH104
| Arm | Type | Description |
|---|---|---|
| Treatment | EXPERIMENTAL | - |
| Control | PLACEBO_COMPARATOR | - |
| Sequence 1 | EXPERIMENTAL | A buccal formulation of Nalmefene 16 mg and a 1 mg intravenous dose of nalmefene injection, with a least 7 days washout period between dose |
| Sequence 2 | EXPERIMENTAL | A 1 mg intravenous dose of nalmefene injection, and a buccal formulation of Nalmefene 16 mg with a least 7 days washout period between dose |
| Name | Type | Description |
|---|---|---|
| Nalmefene | DRUG | Th-104 Nalmefene Mucoadhesive Buccal strip |
| Placebo | DRUG | Matching placebo to TH-104 |
Inclusion Criteria: 1. Men or women aged 18 to 75 years, inclusive, at the time of signing the informed consent form. 2. Diagnosis of PBC, as demonstrated by the participant presenting with at least 2 of the following criteria at the Screening Visit: 1. history of sustained increased alkaline p...
Nalmefene is an investigational small molecule being developed by Canton Strategic Holdings, Inc. (ticker: CNTN) for the treatment of pruritus, specifically pruritus associated with primary biliary cholangitis. It is also being studied in healthy volunteers for bioavailability assessment. Nalmefene is currently in clinical development and is not approved for any indication.
Nalmefene is an opioid receptor antagonist. It works by blocking the action of opioids at their receptors, which is thought to help reduce the sensation of itching in conditions like pruritus associated with primary biliary cholangitis. The exact mechanism in this context is under investigation in clinical trials.
Nalmefene is being developed by Canton Strategic Holdings, Inc., a company traded under the ticker symbol CNTN. The company is conducting clinical trials to evaluate the drug's safety and efficacy for treating pruritus in primary biliary cholangitis and for assessing its bioavailability in healthy volunteers.
Nalmefene is in Phase 1 and Phase 2 clinical development. A Phase 1 study (NCT06198686) evaluating the absolute bioavailability of TH104 in healthy volunteers has been completed. A Phase 2 study (NCT06733519) for the treatment of pruritus in primary biliary cholangitis is not yet recruiting. Nalmefene is investigational and not FDA approved.
Nalmefene has two clinical trials. NCT06198686 is a completed Phase 1 study evaluating the absolute bioavailability of TH104 in 20 healthy volunteers in the United States. NCT06733519 is a not-yet-recruiting Phase 2 study of TH104 for the treatment of pruritus in primary biliary cholangitis, with a planned enrollment of 40 participants.
Yes, Nalmefene is also known as TH104. Clinical trials for the drug use the name TH104, including NCT06198686 and NCT06733519. Both names refer to the same investigational drug being developed by Canton Strategic Holdings, Inc.