BioXcel Advances BXCL501 for Home Use Evaluation

BioXcel Therapeutics, a company that uses AI to create new medicines, is planning a new study for a drug called BXCL501. This drug is a special kind of dexmedetomidine that can melt in your mouth and might help people who are feeling very upset or agitated at home because of mental health problems like bipolar disorder or schizophrenia.

The new study, called the SERENITY At-Home Phase 3 trial, will be very careful and thorough. It will compare BXCL501 to a fake pill (placebo) to see if it really works and is safe. About 200 people who sometimes get very agitated might be in this study, and they will take the drug themselves when they need to over 12 weeks.

The main goal is to make sure the drug is safe, but they will also look at how well it works to help calm people down. There will be another smaller study with about 30 people to see if what patients or their families say about how well the drug works matches what trained doctors say.

BXCL501 is already allowed to be used in a hospital for these problems at a dose of 120 mcg, and the company is hoping that this new study will show it can also be used safely at home. The company believes that many more people could use this drug if it can be proven to work well at home, where most episodes of agitation happen.

The company also has a drug called IGALMI, which is the same as BXCL501 but is approved for use in a healthcare setting. IGALMI can cause some serious side effects, like making your blood pressure drop, changing your heart rhythm, and making you very sleepy. It's important for patients to tell their doctors about any health problems they have and any other medicines they are taking.

BioXcel Therapeutics is working hard to find new uses for drugs that are already known to be safe and effective, and they are using smart computer programs to help with this. They think BXCL501 could help many people who are dealing with agitation at home, and they are excited to start this new study to find out more.