Product Description
Agomelatine is a unique melatonin analog with antidepressant properties and a large therapeutic index that improves clinical safety. It is a melatonin receptor agonist (MT1 and MT2) and a 5-HT2C receptor antagonist.Ê (Sourced from: https://pubmed.ncbi.nlm.nih.gov/34886787/)
Mechanisms of Action: 5-HT2C Antagonist, MT Agonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Not Approved
Approved Countries: Argentina | Australia | Austria | Bangladesh | Belgium | Brazil | Bulgaria | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Italy | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Thailand | Turkey | Ukraine | United Arab Emirates | United Kingdom | Uruguay | Venezuela | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Novartis
Company Location: Europe
Company CEO: Vasant Narasimhan
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, China
Active Clinical Trial Count: 4
Recent & Upcoming Milestones
Highest Development Phases
Phase 1: Depressive Disorder|Healthy Volunteers
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
CTR20223151 |
CTR20223151 | P1 |
Completed |
Depressive Disorder |
2023-04-23 |
2025-04-29 |
Patient Enrollment|Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
ACTRN12625000575437 |
ACTRN12625000575437 | P1 |
Recruiting |
Healthy Volunteers |
2026-06-30 |
2025-10-13 |
Patient Enrollment|Start Date|Trial Status |
|
ACTRN12625001137482 |
ACTRN12625001137482 | P1 |
Not yet recruiting |
Healthy Volunteers |
2026-06-30 |
2026-01-21 |
Treatments |
|
ACTRN12625000685415 |
ACTRN12625000685415 | P1 |
Recruiting |
Healthy Volunteers |
2026-06-30 |
2025-10-07 |
Patient Enrollment|Start Date|Treatments|Trial Status |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
11/12/2025 |
News Article |
Alto Neuroscience Reports Third Quarter 2025 Financial Results and Recent Business Highlights |
|
08/28/2025 |
News Article |
PureTech Health plc – Half-Year Report |
|
08/13/2025 |
News Article |
Alto Neuroscience Reports Second Quarter 2025 Financial Results and Recent Business Highlights |
|
06/03/2025 |
News Article |
Enveric Biosciences Announces Issuance of U.S. Patent Covering a Novel Family of Molecules Including Melatonin Receptor-Targeting Compounds |
|
05/06/2024 |
PubMed |
Adverse event profiles of drug-induced liver injury caused by antidepressant drugs: a disproportionality analysis. |
|
03/30/2024 |
PubMed |
Repurposed drug agomelatine is therapeutic against collagen-induced arthritis via iNOS targeting. |
|
03/20/2024 |
PubMed |
Retracted: Agomelatine Softens Depressive-Like Behavior through the Regulation of Autophagy and Apoptosis. |