Good morning, [inaudible]. Nice to meet you. Let me start. Today, in the first half, I'd like to talk about acquisitions and how it happened. The introduction of the company we acquired, also our strategic intent. In the second half, we will talk about TSND-201, the characteristics, the clinical data, and the characteristics. Transcend Therapeutics is a therapeutics company. It's a company listed in New York, and the company has this product, the rapid acting treatments products. This is the company to develop the rapid acting treatment product. Now, our process for acquisition is completed, and we are waiting for the clearance by the authority. Otsuka subsidiary, Otsuka America, Inc., will have another company to acquire 100% of the stakes of the company. $700 million will be upfront payments.
In addition to that, we will have the conditional milestones payments with the sales of the products up to $525 million when the product was sold at this peak. Kevin is one of the founders, and he's a venture capitalist. Blake Mandell is one of the co-founder and is a CEO today. Dr. Benjamin Kelmendi is the psychiatrist from Yale University. Dr. Benjamin is working on ketamine, and TSND-201. He works on that plus psilocybin. Ketamine, psilocybin, TSND-201. He drove to get clinical data, not just the efficacy. Why it happened, the neural circuits platforms, those are the areas of his basic research. Now we are working on the phase III TSND-201 study and NDA labeling products, prodrug for TSND-201.
Those two are substances they own, and I'd like to give you the strategic ideas with a few slides from here. The first one is our strengthening of our portfolio with the late development stage product. That is our corporate areas of the businesses. Also next generation products, especially next-gen psychiatric treatments. I would like to have a sufficient approach in that field in order to get sufficient options. After the Mindset company, we'd like to win another option for that. Third point is, in our CNS areas, psychiatry, we've been working in this area for 25 years and like to make the best out of this platform to maximize the value out of these businesses. One is the strengthening our core areas with the late-stage products together. We have REXULTI and ABILIFY MAINTENA and SYMBYAX.
We have those CNS products going on at the moment. We have a high level of the revenues out of this area. Whilst we have those revenue, we like to make sure that we have a good investment on P&L side for the upcoming late-stage products. We have centanafadine. It's already filed. We have a good collaboration with the company. Ulotaront, it's another investment for the late-stage product. At the moment, the revenue that we get today is to be invested for the next one, which now is the TSND-201, and it is a good strategic decision. In order to get this latest product be approved to have a commercial stage. Whilst we have good revenues of the ongoing products, we like to make sure that we get those profit to be invested in the next portfolio. Next generation approach.
There's a high expectation of the next generation treatment approach. It is important that we strengthen the portfolio in a strategic fashion. For us, when we say strategy or strategic, we can explain that word in three ways. One is the indication. Second is a variety of the mechanism. Third point, as I said before, continuity and the timing of the businesses.
Let me explain with the indications. PTSD in the U.S. is to come with the treatment-resistant depression, and there are many people suffering from that. There are two SSRIs, which were approved 22 years ago, only two drugs indicated for that condition, for the PTSD. Half of those patients have resistant conditions for those drugs. Because of that, as you know, REXULTI would Now completed PTSD phase III, and we are working on the conversation with the FDA responses and inquiries and so on. We actually had those processes. However, it wasn't approved, unfortunately. Those knowledge we have acquired now will be, I think, utilized for the upcoming project. Second point is the mechanism or science. When we say next generation, in a different context, probably when we say that in the psychiatry field, you would imagine a little bit differently.
Maybe the doctor's understanding may be different from that of a patient's. The high efficacy and rapid acting persistence. Basically, patients will come and then get a prescription. When they leave the office of the doctor, the doctor can say, after a week, you can get good efficacy, feeling better. The rapid action is expected. Also, the doctor could say, maybe you could stay at home for two, three months with the drug, so that if you're feeling unwell, you can come back two, three months later. Meaning that persistence of the efficacy is expected. As Dr. Benjamin researched, probably in that stage of the patients, after the prescription, there could be the neuroplasticity happening, that will probably change the pathology in a way. Then on the right-hand side.
Out of the new generation, a psychiatry portfolio, the optionality or variety of the product could be looked for. We had acquisition of the MSP-2020, MSP-2020 to 2013, and we are working on the various studies at this moment. Out of that product, we would now to get more researches for the product without the hallucination and so on. Actually, this product has a different mechanism. It is categorized as the monoamine releaser, I'll give you more information about this product in the second half. Third point, in the United States, in the 25 years till now, we have been working on the commercialization and the clinical development of various products for the schizophrenia, Alzheimer, so on. We, of course, worked on the PTSD as well, in addition to ADHD, schizophrenia, so on.
We have good experiences, like to take advantage of experiences in regulatory processes. Also for the commercialization processes, we would like to see the interventional clinics and those treatments will be provided in those clinics. Because of which you might think that our sales force could be contained in a limited arena. However, in this case, the general psychiatric specialists will be looking after those patients, not just those clinics. We have established a very broad psychiatry platform in the United States, by which we can discover patients, and it is important to be able to deliver the products to those patients.
Let me go into the overview of the [inaudible]. Next page, please. Regarding this drug, this is a monoamine releaser with MOA to promote release of monoamines such as dopamine, serotonin, noradrenaline. As you can see in the footnote, regarding the selectivity, which is high, there is no serotonin 5-HT2A agonist activity. VMAT2 inhibition is not existent, which will lead to the conditions. Other GPCR is also being screened, and we confirm there is no interaction. Biology-wise, this would promote the reorganization of the neuronal circuits in PTSD patients to induce neuroplasticity, as we have confirmed in non-clinical studies. By administering this drug in non-clinical studies, BDNF would be increased, and neuronal process number and length would be increased by two times or three times, and we are expecting the reorganization of the neuronal circuits.
We are promoting the development in PTSD in non-clinical settings, PTSD, depression, anxiety, are the three models demonstrating high effectiveness, robust effectiveness. Next page, please. As you know, PTSD patients in 2030 are expected to reach 14 million in the United States., as I said at the outset. Regardless of the time, it's twice as much compared to TRD patient population. There has been no new approved drugs for more than 20 years. Next page, please. TSND-201, phase II study is already completed. Let me talk about it. Regarding this drug, based on the phase II study results in the United States., breakthrough therapy designation was granted in the U.S. This is a clinical study. Please look at the scheme at the bottom of this page. IMPACT-1 is the name of the phase II study.
More than 60 patients were randomized 1: 1 to the active drug and the placebo. The active drug or placebo, to get the drugs, this is Friday. Patients come, for example, on Friday, and in the office, oral capsule will be obtained, 150 mg capsule would be obtained. After 90 minutes, the second capsule, 100 mg, would be obtained. In the reclining chair, there's going to be safety monitoring, and then they can go home on the same day for this treatment. This is repeated four times. That's considered one cycle. They would come back next Friday as well as the Friday the following week, and they would come again to complete this treatment cycle. After about six weeks, primary endpoint would be measured. Primary endpoint is PTSD. Primary endpoint, CAPS-5, clinical score.
In this study, at each study site, the investigators would not perform the rating. If there is a lot of interaction with the patients, a lot of information could be obtained. At central centers, monitor physicians who have not met the subjects would interview the subject to rate the CAPS-5. This is the central rater system. Also in phase III, to avoid any possible bias, we are planning to use the central rater system. The study results were published already in JAMA Psychiatry. As for the study sites, as I mentioned, it's going to be specialized centers on J&J's SPRAVATO as commercial products. Twice a week, they have to come to specialized centers. There is about two hours safety monitoring before they go home. That's continued twice a week. This is clinically applied already. Based on those results, 6,000 clinics in the United States have been launched.
In these settings already, phase III is completed for COMP360 psilocybin, which also requires monitoring, so similar clinics are going to be utilized. This is clinical data, a two, one, phase II study. Primary endpoint is CAPS-5. TSND-201 is the curve which has a declining trend. The upper curve is for the placebo. There are a few points to note. First, the timing of administration. If you look at the left bottom, there is an upper arrow for time administration with a one-week interval respectively. Without waiting for the four administrations, there is an early separation compared to the placebo. After the fourth administration, there's going to be no more treatment. But even after that, treatment effectiveness is sustained, as you can see here. Regarding this drug, in this clinical study, placebo curve behavior, REXULTI phase III successful study, and the placebo effect here is almost similar.
Next page, please. This is about safety. There was no discontinuation due to adverse events, and favorable tolerability was confirmed. Many of the adverse events were mild to moderate, and exposure period was not so long. If you look at the drug concentrations, the events were transient, and they were resolved within a short period of time. Serotonin agonist, there is no action, activity, so there is no hallucinogenic effects. We didn't capture in the study. The typical hallucinogenic effects known to be associated with psychedelic agents were observed. No hallucinogenic effect was seen, and the rationale for monitoring are based on the following symptoms: blood pressure elevation 31.3%, but it was a mild blood pressure elevation of which it was transient. Also there can be an elevation in the feelings. So we have monitoring period for phase II and phase III studies as well.
Phase III clinical study is shown on this page. As I mentioned, breakthrough therapy designation was granted. With FDA, Type B meeting was held to discuss a phase III study design already. Transcend Therapeutics clinical development team has a similar clinical development philosophy like Otsuka Pharmaceutical. If the study is successful, phase III study is implemented without changing the study design, and that's their belief. Other than the increase of the number of arms to three, phase II study design is being followed in phase III as well. One phase III study and part one will have a sample size of 300, and it's going to be randomization 1:1: 1. Four dosings will be planned as phase II. More recently, Lykos treatment received a CRL from FDA. The reason for CRL was disclosed. Lykos advisory meeting discussions occurred based on those.
Also we had a Type B meeting with FDA, and we determined the study design. Primary endpoint is going to be CAPS-5. Functional unblinding is something we are going to avoid as much as possible based on this study design. CAPS-5 demonstrated a very good response in phase II, but CAPS-5 total score, we think is very good. If you have a breakdown of CAPS-5, JAMA Psychiatry carried the breakdown there. There are four major segments in CAPS-5. One is the intrusion of the past memories which patients cannot handle on their own, that past memory would intrude. This is the intrusion category. Maybe because of that, alertness is very high. Patients are very sensitive all the time. Alert level is very high. If there is somebody knocks on the door they may be very surprised, or they may not be able to fall asleep.
This is an alertness-related segment. Number three, something can be a trigger to have the bad experiences coming into them. They try to avoid triggers. They don't go to a certain place. They try not to smell a certain odor. There is the escape intended avoidance symptom. Number four, to lose their self-esteem because of this. There are four components in CAPS-5. In particular, the intrusion is the first cluster. Memories would re-emerge in your mind. In order to avoid it, they avoid places or behaviors. Escape is a very specific symptom of PTSD, not just the total score of CAPS-5, but there is a very good response for each of the components. We judged this is a very good compound. Next page, please. This is a future plan. Now, phase III was initiated last month in March 2026.
In 2023, in June, FDA issued the psychiatric guidance, and we are referring to that. Based on the agreement with FDA, we'd like to implement an appropriate development program, phase III study. Two phase III studies would be required according to understanding. We are aiming to launch in the United States. in around 2030. Last page, please. With the acquisition of Transcend Therapeutics, we acquired a late-stage asset, TSND-201. Together with [inaudible] , we can expand the optionalities for next generation psychiatric treatment approaches. REXULTI, ABILIFY MAINTENA are using a big psychiatric business platform with which we'd like to maximize the value by leveraging the platform. That's all from me.