Drugs / Tesofensine
Tesofensine
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Other | — | obesity disorder | 2025-02-20 | “Medix has resubmitted the tesofensine application dossier to COFEPRIS” saniona.com ↗ |
| Filed | Other | — | obesity disorder | 2024-08-29 | “Our partner, Medix, has submitted an updated application with additional information and documentation for approval of tesofensine in Mexico.” saniona.com ↗ “Medix filed for regulatory approval of tesofensine in Mexico in May 2023” saniona.com ↗ |
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03286829 | Dec 2017 → Feb 2018 | — | Saniona | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00428415 | Mar → Dec 2007 | obesity disorder | NeuroSearch A/S | Completed | No outcome recorded |
| Phase 211 trials · 3 met primary · 1 missed | ||||||
| Phase 2 | NCT05198362 | Dec 2021 → Dec 2022 | Prader-Willi syndrome | Saniona | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT05147415 | Nov 2021 → Dec 2022 | acquired hypothalamic obesity | Saniona | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT03845075 | Feb 2019 → Oct 2020 | acquired hypothalamic obesity | Saniona | Completed | No outcome recorded |
| Phase 2 | NCT03149445 | Mar 2017 → Jul 2019 | Prader-Willi syndrome | Saniona | Completed | Missed primary |
| Phase 2 | NCT02737891 | Apr 2016 → Jan 2017 | type 2 diabetes mellitus | Saniona | Completed | Met primary |
| Phase 2 | NCT00481104 | May 2007 → Sep 2008 | obesity disorder | NeuroSearch A/S | Completed | No outcome recorded |
| Phase 2 | NCT00394667 | Sep 2006 → Sep 2007 | obesity disorder | NeuroSearch A/S | Completed | Met primary |
| Phase 2 | NCT00148486 | Jun 2003 → Mar 2005 | Parkinson disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00148512 | Mar 2003 → Feb 2005 | Parkinson disease | Boehringer Ingelheim | Completed | Met primary |
| Phase 2 | NCT00153010 | Feb 2003 → Mar 2005 | Alzheimer disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00006077 | Aug 2000 → Jul 2003 | Parkinson disease | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2025-02-20 | Saniona | Regulatory Medix has resubmitted tesofensine application to COFEPRIS saniona.com ↗
Saniona (OMX: SANION), a clinical-stage biopharmaceutical company, today announces that its partner Medix has resubmitted the tesofensine application dossier to COFEPRIS, as referenced in Saniona’s press release dated February 10. |
| 2024-11-12 | Saniona | Regulatory Update on Tesofensine Application saniona.com ↗
Saniona OMX: SANION), a clinical-stage biopharmaceutical company, today comments on Medix’s recent regulatory submission for tesofensine in obesity, following COFEPRIS’s decision to withhold approval. |
| 2024-11-06 | Saniona | Regulatory Mexican Application for Tesofensine Not Yet Approved saniona.com ↗
Saniona (OMX: SANION), a clinical-stage biopharmaceutical company, today announces that its partner, Productos Medix S.A de S.V (Medix), has not received approval from the Mexican regulatory agency (Cofepris) for tesofensine for the treatment of obesity. |
| 2024-06-17 | Saniona | Results Saniona comments on article addressing the potential mechanism of action behind tesofensine’s unique weight loss effect saniona.com ↗
The authors found that tesofensine strongly modulated lateral hypothalamus activity in obese rats and inhibited a subset of GABAergic neurons attenuating their ability to promote feeding behavior. |
| 2023-02-25 | Saniona | Regulatory Saniona’s partner Medix receives favorable opinion for tesofensine for the treatment of obesity and weight management in Mexico saniona.com ↗
COFEPRIS’ technical committee has expressed a favorable opinion on tesofensine for treatment of obesity. |
| 2015-09-21 | Saniona | Results Provides update on Tesomet and AN363 saniona.com ↗
Tesofensine reduces glycemic parameters in prediabetes individuals participating in a Phase 2 study |
All press releases naming this drug 9 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tesofensine | “1 mg tesofensine (2 tablets of 0.5 mg), 25 mg commercial IR metoprolol (1 tablet of 25 mg), 75 mg commercial ER metoprolol (1 tablet of 25 mg ER metoprolol and 1 tablet of 50...” NCT03286829 ↗10“This study will evaluate the safety and efficacy of Tesomet (tesofensine + metoprolol) in subjects with PWS.” NCT05198362 ↗ “Tesomet (tesofensine + metoprolol)” NCT05147415 ↗ “NS 2330 (Tesofensine)” NCT00153010 ↗ |
| Known as | NS 2330 | “Tesofensine (NS 2330), a monoamine reuptake inhibitor, in patients with advanced Parkinson disease and motor fluctuations: the ADVANS Study.” PMID 18474731 ↗ May 2008 |
| Known as | Tesofensina | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989690 ↗ |
| Action | Inhibit | “potent inhibitor of dopamine reuptake” NCT00006077 ↗ |
| Modality | Small molecule | — CHEMBL3989690 ↗ |
| Route | Oral | “Patients will take three pills containing NS2330 or placebo (a look-alike pill with no active ingredient) 3 days a week for up to 5 weeks” NCT00006077 ↗ |