Good afternoon, everyone, and thank you for joining us for another session of HC Wainwright's 27th Annual Global Investment Conference. My name is Eduardo Martinez, and I'm a Biotechnology Equity Research Associate at HC Wainwright. It is my pleasure to introduce Mr. Vimal Mehta, CEO and Co-Founder of BioXcel Therapeutics.
Thank you, Eduardo. Thank you, everyone, for joining us this afternoon. It's a very exciting time for the company, and I'm very happy to share our recent updates and what we plan to do in terms of the near-term milestones. As you all know, we announced our pivotal Phase 3 data last week for our Phase 3 trial, and I will be sharing some of the updates, what we are planning, what the data looks like, and what we are planning more with that data to file sNDA and everything. Let me just get first a forward-looking statement. We'll be making some forward-looking statements during this presentation. Our mission has always been to develop transformative medicines in neuroscience utilizing artificial intelligence platforms. Some of you may not be familiar with BioXcel Therapeutics. We became a public company in March of 2018.
Before everybody was talking about artificial intelligence, we chose this path to identify drugs that we can bring to the clinic at a rate that has never been experienced by the industry. I will show you what we were able to achieve and where we are with our program. Just to orient everybody, we have our first product, which is IGALMI. It's for acute treatment of agitation related to schizophrenia and bipolar disorder. There are about 16 million episodes. It's already approved, and the label says it's approved under medical supervision. What that means is that the patient can take the medication whenever there is a doctor or there is medical supervision in an emergency room or any neuropsych clinic. It's not available currently in a retail setting or in a, like, you know, they can use it in a home setting.
Once our strategy for the company was landed, we then developed our expansion strategy. IGALMI evolution happened where we were able to get the approval of the drug from first in clinical trial, which was in about 3.5 years, from first in clinical trial all the way to approval. That was very rapid, and data was very compelling in terms of both safety and efficacy, and we got the approval. We were very fortunate. IGALMI is available in the market right now. It's helping patients. It's helping caregivers. It's building the experience with the neuropsych, and we are maintaining that without much commercial support in the market to build the brand for IGALMI. Our eyes or our focus is on generating a larger value, which is going into the home setting. As I mentioned, we have recently announced the data from our pivotal Phase 3 trial.
Home setting was the next logical step to expand the market potential. Very recently, we also announced that the market opportunity that originally we thought was 23 million episodes is much bigger, 57 to 77 million episodes. I will walk you through why we think opportunity in home setting is bigger and how we have been able to triangulate the data there. What we are talking today is 16 million in the in-care setting where currently the drug is approved and will be able to expand into 57 to 77 million episodes in the home setting. In addition to that, we have another indication expansion opportunity in Alzheimer's agitation, what we call as a TRANQUILITY program. We have one positive Phase 3 trial already completed with 60 microgram dose. We have demonstrated both safety, efficacy, and tolerability for this drug.
FDA has now asked us to do another confirmatory Phase 3 trial. We have an alignment or agreement with the FDA on the protocol to initiate that trial. That's the bigger picture. It's primarily BXCL501, which I mentioned was identified using our artificial intelligence platform, and we were very fortunate to get to the approval in 3.5 years, from the first clinical trial all the way to approval. The 501 mechanism, it works through the local surveillance. We believe in the medical community. A lot of neuropsych and other leading carers believe it has a broader application. The left, what you see, is being conducted by the company. Those trials are being conducted by the company, and we are trying to maximize the value for our shareholders. What you see on the right side is being done with the investigator-sponsored trials and external funding.
We are providing our drug, but those are more or less chronic use of the drug in acute stress disorder, PTSD, and opioid use disorder. There are multiple applications wherever there is a stress-related neuropsych condition. We believe our drug can help. That's the overall potential of the drug. In terms of what we have been able to achieve, we have a very positive business momentum. We have completed our SERENITY At-Home safety trial that was announced. Just to orient everybody, why that was a safety trial? Because we were using an approved dose, lowest approved dose of IGALMI in the home setting to test that this is safe for the patients. Currently, we are working on developing or preparing our sNDA, and we had an alignment with the FDA on content and format of the sNDA in August, which was just last month.
In addition, in terms of sNDA, we have already completed the non-clinical section, and clinical and CMC sections are in progress. We are making good progress in developing our sNDA submission, and we will provide an update when this sNDA will be submitted. In addition, now we have a pretty large market, substantial market opportunity. In addition to 16 million episodes for IGALMI, we have another 57 to 77 million episodes. We are developing our commercial strategy, how we're going to bring this medicine to the patients that can be approved potentially if our sNDA is accepted and the drug is approved in 2026. We have an agreement, as I mentioned, for our Alzheimer's program with the FDA, and we have a protocol signed off, and we are currently evaluating CROs to initiate that trial.
We have strengthened our balance sheet to continue to execute on some of the milestones I have outlined over here. Agitation. Why agitation? Agitation is a very debilitating situation for both patients and threatening for healthcare providers. This is one of the largest reasons for workers' comp for healthcare providers. Once agitation happens, it's very difficult for these patients to control themselves, and they know if agitation is not treated, there will be some repercussions in terms of these patients getting hurt or someone else is getting hurt, family member or the healthcare provider. It's a very large unmet medical need. In the in-care, there are some approved therapies, but they are mostly injectables. In the home care, never an FDA-approved therapy has been approved in the home care setting. That's a very unique opportunity for us. This is the spectrum of agitation. You have a pre-agitation state.
You have an agitation initiation. Then it escalates to mild, moderate, and severe. I just want to mention agitation does not escalate like a chronic disease. It escalates very fast. It can be in minutes to hours. It could be that day to next day or that day to next week. These situations escalate very fast. Our original estimate was 23 million episodes. That was based on 1.6 million patients and 1.2 episodes per month, and that resulted in 23 million episodes. That was based on claims data. Now we have collected our data in our trial. In addition to that, we have the literature that is supportive that it's about 3 to 4 episodes per month. We have done our market research, which also says it's about 3 episodes per month.
Using 1.6 million, it becomes very clear whether you use 3 episodes per month or 4 episodes per month. It becomes a very large opportunity. In addition to patients who already end up in the hospital or institutional setting, there are about 16 million episodes. There will be some equilibrium between these episodes. If IGALMI is available in the home setting, some of the patients may not need to go to the hospital setting. Here is the current status of the program, SERENITY I and II, that were completed in 2020. The data was announced, and we are using that. We got the approval of IGALMI in April of 2022. Using that, we went to the FDA and asked them, what do we need to do to take this drug in the home setting?
They agreed that we can use the lowest approved dose of IGALMI to test it and demonstrate that the safety profile was not any different than what we have seen in the in-care setting. That was the case when we announced the data last month. Now we have announced the data, top-line data for SERENITY At-Home trial, and we continue to analyze data for other exploratory endpoints and other reasons to get ready to file, prepare our clinical study reports, as well as be able to file our sNDA. We expect sNDA to be filed in Q1 of 2026. It's a sNDA, so we are building. As I already mentioned, we have non-clinical sections completed. We will work on CSRs and CMC, and then we'll be ready to file and we'll provide more updates as we go along on our sNDA planning.
In terms of testing, there are two doses approved, 120 micrograms and 180. We agreed with the FDA to test 120 microgram dose, which is the lowest approved and marketed dose for IGALMI. I just want to mention there is real-life data because it's being used in the market. There is a pharmacovigilance that data gets collected and submitted to the FDA pretty much every quarter. There is data from the real life, and now we're going to share with you some of the data we got from our Phase 3 trial, safety trial that we announced last week. In terms of our product, it's a sublingual thin film. It's microdeposited. The drug is microdeposited on the film, and it has a very rapid onset of action. We have seen in our previous trial that it can be as fast as 20 to 30 minutes.
It has a mucoadhesive, so it cannot be spit out or swallowed. It can be given sublingual or buccal, and it's non-scheduled. The half-life is short for the product, which is designed for that purpose to treat that particular episode, and that drug clears away. Whenever there's a new episode, this drug can be used. That's what we call as IGALMI sublingual thin film of dexmedetomidine. In terms of the trial design, it was a very pragmatic trial in which we had recruited 200 patients. We ultimately ended up recruiting more to get to the 200, but the goal of the study was to evaluate 200 patients, 100 on placebo, 100 on the drug. The primary objective was safety, and the exploratory objective was patient-reported outcomes in terms of the benefit they feel when they're taking this drug over a 12-week period.
The study was designed so as many agitation episodes as patients have, they can use the drug. Either the patient was making a decision on their own, and in about 25% of the patients, we had a caregiver or their family member who was with them. The FDA wanted to make sure we get the broad label. We had both kinds of patients, those residing alone in a home or in a caregiver setting, so that we can collect the data. That was presented last week. In terms of agitation episodes, there were about 2,437 episodes or so in 208 patients which were treated. A large number of patients completed the full 12-week period. The average was about 11.7 agitation episodes, which I already mentioned, over a 12-week period, 3 to 4 episodes per month.
All patients were able to successfully self-administer the film in the home setting as well as in the in-care setting. That doesn't seem to be an issue with the agitated patient. In terms of the safety, which was the primary objective, no patient discontinued due to treatment emergent AEs in the BXCL501 arm. Adverse event profile was consistent with the approved IGALMI label. No drug-related serious adverse events were observed. No unexpected treatment emergent adverse events occurred, and no severe treatment emergent adverse events associated with BXCL501. Tolerability remained consistent with the repeated dosing throughout the trial. It was a very good outcome for the patients from this trial that we were able to show this kind of data in a home setting in an agitated patient. To my knowledge, there has never been a study conducted in an agitated patient in a home setting. This was first.
As I mentioned, there's no FDA-approved therapy for this indication. If you look at the data, SERENITY I and II, which got us the approval, single dose, and you look at the first dose, safety looks very consistent. If you look at all the doses, which is more than 2,400, data again, safety looks pretty consistent, which is mechanism-based, what you see on the left side. We were very pleased to have this data. We have done various data cuts for this safety data, and we see very consistent results. We also did exploratory assessment in terms of seeing that the drug, when given over a 12-week period, maintains its effect. These are some of the results. In essence, we saw that patients reported scales that we were using, that the drug is maintaining its effect.
That's exactly what we needed to see using the exploratory endpoints because the primary purpose for this trial was demonstrating the safety and then patients can take it in a home setting. Overall, well tolerated with repeat dosing across the trial duration. I already talked about the safety. I want to reiterate, all patients successfully self-administered the film, and we are seeing continued effect and consistent benefit with repeat dosing. All of these results, we believe, are supportive of sNDA submission and particularly having got some agreement with the FDA in August when we had planned for a pre-sNDA meeting. Our planned next steps are very clear to present this data in scientific conferences. In addition, as I mentioned, we are preparing the sNDA for submission that's expected in Q1 of 2026.
We are working very diligently to define our commercialization strategy, what our plan will be in terms of commercialization. We have a large opportunity with in-care already approved, and this is getting expanded upon approval sometime in 2026. We need to make sure we can bring this medicine to the patients. Alzheimer's agitation, it's a very interesting opportunity. This is how the distribution of the patient is. About 50% of the episodes happen in the in-care setting, even though the number of episodes may be low. There are more patients who live in the home setting, but they don't get that much agitation depending on their level of Alzheimer's. One of the biggest reasons for Alzheimer's patients to go from a home setting to the in-care setting is Alzheimer's, not their ultimate underlying disease, which is cognition.
When agitation becomes unmanageable, that's why they go to escalated cares of centers like assisted living, memory care, and nursing homes. We plan to conduct the trial in the in-care setting. It will still be, like, you know, it will be the second confirmatory Phase 3 trial so that we can expand the indication for Alzheimer's agitation beyond what we are working in the home setting for schizophrenia and bipolar. I would like to just conclude that there is a lot that has been achieved and a lot of work remaining, but it's very exciting. We are working on very exciting pieces of submission of the sNDA commercialization strategy and see when we can initiate our Alzheimer's-related agitation trial. With that, I will stop and thank you all for joining me this afternoon. Thanks.