It's finally here! Phase 3 of TAK861 is starting!

Hello everyone, This is Masa, a patient of Narcolepsy.

Finally, it has come.

The Phase 2 clinical trial of the oral orexin receptor agonist, TAK861, has successfully concluded, and the Phase 3 trial is set to commence in the first half of 2024, as announced by Takeda on their website. In the fiscal year 2021, there was a setback during the Phase 2 trial of TAK-944, which was halted due to safety concerns, specifically liver toxicity issues with TAK-994. This news was quite disheartening for narcolepsy patients, and some expressed their desperation on international social media platforms, pleading for the drug's release despite potential liver complications.

Not only were patients disappointed, but investors also experienced significant disillusionment, resulting in a stock price decline of over 10%. This incident garnered widespread attention and discussion.

Now, the oral orexin receptor agonist is finally entering Phase 3. According to reports, there were no observed instances of liver or visual impairments, which were previously reported during the trials. Personally, having a friend who is a physician involved in this trial, I am convinced of the effevtiveness of this drug. The report also mentions that the majority of patients who completed the main trial opted to participate in the long-term continuation study, further attesting to the potential effectiveness of the medication.

My hope lies not only in its ability to promote wakefulness but also in its potential to deepen sleep by stimulating orexin production. As I've mentioned before, the daytime sleep attacks experienced by narcolepsy patients are largely attributed to insufficient sleep during the night. Many patients struggle with fragmented sleep, waking up approximately every 1 hour and 30 minutes. This is believed to be due to orexin deficiency. Orexin, as discovered by Dr. Yanagisawa of Tsukuba University, not only regulates wakefulness but also plays a crucial role in overall sleep architecture. Therefore, I have high hopes that this orexin agonist will indeed improve the quality of sleep.

I express my heartfelt gratitude to Takeda Pharmaceuticals for their sincere dedication to addressing this condition.

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