Product Description
Nalmefene is an opiate receptor antagonist which is used to treat acute opioid overdose and to help in the management of alcohol dependence and addictive behaviors. Nalmefene has not been linked to serum enzyme elevations during therapy or to clinically apparent liver injury.
Mechanisms of Action: TLR4 Antagonist,OPRD Antagonist,OPRK Agonist,OPRM Antagonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral,Intravenous,Intramuscular
FDA Designation: Fast Track - Opioid-Related Disorders *
Approval Status: Approved
Approved Countries: Austria | Belgium | Croatia | Cyprus | Czech | Denmark | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hungary | Iceland | Ireland | Israel | Italy | Japan | Latvia | Lithuania | Luxembourg | Netherlands | Norway | Philippines | Poland | Portugal | Romania | Russia | Slovakia | Slovenia | Spain | Sweden | Switzerland | Turkey | United Kingdom | United States
Approved Indications: None
Known Adverse Events: None
Company: Lundbeck
Company Location: DENMARK G7 00000
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: United States
Active Clinical Trial Count: 4
Highest Development Phases
Phase 2: Biliary Cirrhosis|Cholangitis|Liver Cirrhosis|Pruritus
Phase 1: Depressive Disorder|Healthy Volunteers
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| TH104-108 | P2 |
Not yet recruiting |
Cholangitis|Pruritus|Biliary Cirrhosis|Liver Cirrhosis |
2026-03-01 |
|
| TH104-105 | P1 |
Active, not recruiting |
Healthy Volunteers |
2024-02-11 |
|
| NAL1004 | P1 |
Completed |
Depressive Disorder |
2022-12-23 |
|
| OPNT003-PD-001 | P1 |
Completed |
Healthy Volunteers |
2022-03-14 |
28% |