Tesofensine (NS2330) is a serotonin-norepinephrine-dopamine reuptake inhibitor (SNDRI) that is being developed for the treatment of obesity. It was originally developed by a Danish biotechnology company, NeuroSearch, in the early 2000s.
NeuroSearch conducted a number of clinical trials of tesofensine for the treatment of obesity. The results of these trials were promising, and tesofensine was granted Fast Track status by the US Food and Drug Administration (FDA) in 2008.
However, in 2010, NeuroSearch announced that it was discontinuing development of tesofensine due to concerns about cardiovascular safety. These concerns were based on the results of a clinical trial in which tesofensine was associated with an increased risk of heart attack and stroke.
In 2014, NeuroSearch transferred the rights to tesofensine to Saniona, a Swedish biotechnology company. Saniona has since conducted additional clinical trials of tesofensine, and the results of these trials have been more positive.
In a 2017 study, published in the journal Obesity, Saniona reported that tesofensine was effective in reducing body weight and body fat in people with obesity. The study also found that tesofensine was safe and well-tolerated.
In 2020, Saniona initiated a Phase III clinical trial of tesofensine for the treatment of obesity. The results of this trial are expected to be released in 2023.
If tesofensine is approved by the FDA, it would be the first new drug for the treatment of obesity to be approved in over a decade.
Here is a timeline of the key events in the history of tesofensine:
- 2000: NeuroSearch begins development of tesofensine for the treatment of obesity.
- 2008: Tesofensine is granted Fast Track status by the FDA.
- 2010: NeuroSearch discontinues development of tesofensine due to concerns about cardiovascular safety.
- 2014: NeuroSearch transfers the rights to tesofensine to Saniona.
- 2017: Saniona publishes a study in the journal Obesity showing that tesofensine is effective and safe in people with obesity.
- 2020: Saniona initiates a Phase III clinical trial of tesofensine for the treatment of obesity.
The future of tesofensine is uncertain, but it is a promising new drug for the treatment of obesity. The results of the Phase III clinical trial are expected to be released in 2023, and if the trial is successful, tesofensine could be submitted to the FDA for approval in the same year.
It is important to note that tesofensine is not currently approved for any use, and it is not yet clear whether it will be approved for the treatment of obesity. However, the results of the clinical trials conducted to date are promising, and tesofensine has the potential to be a valuable new treatment for people with obesity.
