Product Description
Tesomet is an investigational fixed-dose combination therapy of tesofensine (a triple monoamine reuptake inhibitor) and metoprolol (a beta-1 selective blocker). Saniona's Phase 2b trials of Tesomet in hypothalamic obesity and Prader-Willi syndrome have been voluntarily paused due to funding limitations; this pause is not related to the safety or efficacy of Tesomet. Saniona holds worldwide rights to Tesomet and is actively evaluating opportunities to advance this treatment globally. (Sourced from: https://saniona.com/pipeline/tesomet/)
Mechanisms of Action: Monoamine reuptake Inhibitor
Novel Mechanism: Yes
Modality: Small Molecule
Route of Administration: N/A
FDA Designation: Orphan Drug - ObesityOrphan Drug - Prader-Willi Syndrome *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Company: Saniona
Company Location:
Company Founding Year: None
Additional Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Recent & Upcoming Milestones
Highest Development Phases
Phase 2: Prader-Willi Syndrome|Obesity
Phase 1: Healthy Volunteers
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT03286829 |
TM003 | P1 |
Completed |
Healthy Volunteers |
2018-02-06 |
2019-03-21 |
Treatments |
|
NCT05198362 |
PWS | P2 |
Withdrawn |
Prader-Willi Syndrome |
2022-12-09 |
2022-12-14 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
|
NCT05147415 |
TM008 | P2 |
Withdrawn |
Obesity |
2022-12-09 |
2022-12-14 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
|
2021-000127-12 |
2021-000127-12 | P2 |
Terminated |
Prader-Willi Syndrome |
2022-11-08 |
2022-03-13 |
Treatments |
|
2021-000146-18 |
2021-000146-18 | P2 |
Terminated |
Obesity |
2022-11-08 |
2022-03-13 |
Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
08/20/2025 |
News Article |
Jazz Pharmaceuticals Enters Exclusive Licensing Agreement with Saniona to Develop and Commercialize SAN2355 |
|
09/29/2023 |
News Article |
Prader-Willi Syndrome (PWS) Therapeutics Market trends and dynamics, Drivers, Competitive landscape, and Future Opportunities |
|
04/25/2022 |
News Article |
Saniona Announces Refocused Strategy on Ion Channel R&D and Restructuring of Board of Directors and Executive Management Team |
|
03/29/2022 |
News Article |
Saniona Announces Strategic Program Prioritization and Restructuring to Streamline Operational Costs |