Paroxetine Hydrochloride

– Expands Otsuka portfolio in psychiatric and neurological fields and aims to accelerate development of Transcend's portfolio, including the TSND-201 program for post-traumatic stress disorder (PTSD) – March 27, 2026 -- Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Transcend Therapeutics, Inc. (Transcend) announce that the two companies entered into an agreement today, under which Otsuka, through its wholly owned subsidiary Otsuka America, Inc., will fully acquire Transcend. The acquisition is expected to be completed in the second quarter of 2026, subject to the fulfillment of customary closing conditions and required procedures. Under the terms of the agreement, Otsuka will pay USD 700 million to Transcend shareholders upon closing of the acquisition, and up to USD 525 million in additional contingent consideration based on future sales milestones related to assets in development, for a total potential consideration of USD $1.225 billion. Transcend, founded in 2021, is a clinical stage biotechnology company developing rapid-acting treatments for neuropsychiatric diseases. TSND-201 (methylone), which the company is developing, is a rapid-acting neuroplastogen—an agent that induces rapid and durable neural plasticity in the brain—and is being advanced as a potential treatment for post-traumatic stress disorder (PTSD) and other psychiatric conditions. In the United States, more than 13 million individuals are estimated to be affected by PTSD each year,¹ yet no new treatments have been approved for 25 years, underscoring the significant unmet medical need. Recent research has demonstrated that changes in neuroplasticity in the brain are deeply involved in both the onset and persistence of PTSD symptoms. Neuroplasticity, the brain's ability to reorganize neural circuits, supports memory formation and emotional regulation. In PTSD, alterations in fear-related pathways impair the ability to relearn safety ("overwriting fear"), driving growing interest in interventions that restore or enhance neuroplasticity.² TSND-201 (methylone) acts on monoamine transporters in the brain—including those for serotonin, norepinephrine, and dopamine. By promoting monoamine release, it increases monoamine concentrations within the synaptic cleft, resulting in rapid and sustained enhancement of neuroplasticity.3,4 Importantly, TSND-201 does not act on the serotonin 5-HT2A receptor, which mediates hallucinogenic effects, and is therefore considered a non-hallucinogenic compound.3,5 Transcend is also conducting research and development on novel prodrugs—classified as new chemical entities—to further improve the balance of efficacy, safety, and tolerability of TSND‑201. The company has selected a development candidate and is currently performing non‑clinical studies in preparation for an Investigational New Drug application to the U.S. Food and Drug Administration (FDA). TSND‑201 demonstrated favorable results in the Phase 2 clinical trial IMPACT‑1, which enrolled adults with PTSD, and study findings were published in JAMA Psychiatry in February 2026.5 Due to its rapid onset of activity and robust effects, TSND‑201 was granted Breakthrough Therapy designation by the FDA in July 2025. Transcend met with the FDA in September 2025, to discuss company plans to expedite the development of TSND-201 and confirm the design of the Phase 3 study. Patient recruitment for the Phase 3 trial is underway in the U.S. Makoto Inoue, president and representative director of Otsuka, commented, "We are very pleased to welcome Transcend Therapeutics into the Otsuka group. Although treatment options for PTSD remain limited, TSND‑201 is generating expectations as a potential paradigm‑shifting therapy in the field of psychiatry. By combining Otsuka's long‑standing expertise in the psychiatric and neurological fields with Transcend's innovative approach, we will advance the development of TSND-201 in close collaboration with regulatory authorities to bring this new treatment option to patients." Blake Mandell, CEO and co-founder at Transcend Therapeutics, noted, "We founded Transcend to bring a fundamentally new treatment to patients with PTSD–one that is rapid-acting and accessible. Otsuka's leadership and longstanding commitment in neuroscience reflect the same dedication to patients that has driven our team from day one, and we are proud to continue advancing TSND-201 together in service of that shared mission." Since the 1970s, Otsuka Pharmaceutical has focused on the psychiatric and neurological fields, working to provide new treatment options for disorders such as schizophrenia, bipolar disorder, depression and PTSD, for which therapeutic choices remain limited. In recent years, with the aim of creating next-generation therapies for psychiatric disorders, Otsuka has expanded its global network through partnerships and collaborations, as well as by the acquisition of Mindset Pharma, Inc., a company with innovative, serotonin 5-HT2A agonist discovery technology. Through these efforts, the company is actively working to broaden future treatment options. By acquiring TSND‑201—a novel investigational asset with a mechanism of action distinct from Otsuka's existing medicines and development programs—the company will further accelerate the expansion of its portfolio in the psychiatric and neurological fields. In the U.S. in particular, despite the very large number of individuals living with PTSD, treatment options remain limited to psychotherapy and antidepressants, underscoring the need for new therapeutic approaches supported by scientific evidence of efficacy and safety. By welcoming Transcend into the Otsuka group, the company aims to strengthen its position as a global leader in the psychiatric and neurological fields and to accelerate the development of next‑generation treatments, including those for PTSD, with the goal to expand future treatment options. IMPACT‑1 was a randomized, double‑blind, placebo‑controlled trial that evaluated the efficacy, safety, and tolerability of TSND‑201 in adults with PTSD. A total of 65 patients with severe PTSD, defined as having a CAPS‑5 (Clinician‑Administered PTSD Scale for DSM‑5) total severity score of 35 or higher, were enrolled across 16 sites in the U.S., the U.K., and Ireland (mean age: 43.7 years; 26 males and 39 females). Participants received blinded study drug (orally administered TSND-201 or placebo) once a week for four weeks and were followed for an additional six weeks. The IMPACT‑1 study met its primary endpoint, with the TSND‑201 group demonstrating rapid improvements in CAPS‑5 total severity scores from baseline through Day 64 compared with placebo. Notably, from Day 10 onward, the TSND‑201 group showed statistically significant greater improvement in CAPS‑5 scores relative to the placebo group. TSND‑201 was generally well tolerated. The most frequently reported treatment‑emergent adverse events included headache, decreased appetite, nausea, dizziness, increased blood pressure, dry mouth, and insomnia. These events were typically transient, occurred on the day of dosing, and resolved within one day.5,2 Post‑traumatic stress disorder is a serious mental health condition that develops after experiencing or witnessing a life‑threatening event or a deeply traumatic experience. Common symptoms include flashbacks, nightmares, severe anxiety, and uncontrollable thoughts related to the traumatic event. In the U.S., it is estimated that more than 13 million people live with PTSD each year,¹ and nearly 6 out of every 100 individuals are expected to be diagnosed with PTSD at some point in their lives. Only two medications are FDA-approved for the treatment of PTSD (sertraline and paroxetine), and novel treatments for PTSD are urgently needed. TSND-201 (methylone) is a rapid-acting neuroplastogen developed by Transcend. TSND-201 has well-characterized primary pharmacology, with its primary site of action at the monoamine transporters, and no activity at 5-HT2A receptors (i.e., not hallucinogenic). Transcend is developing TSND-201 as a rapid-acting and durable treatment for PTSD and other central nervous system (CNS) indications. TSND-201 is an investigational medication. Transcend, founded in 2021 and based in New York City, is a clinical-stage, neuroscience-focused company developing rapid-acting treatments for neuropsychiatric diseases. The company's mission is to develop new drugs for the millions of people for whom current psychiatric medicines have not worked. Otsuka Pharmaceutical Co., Ltd. is a total healthcare company that focuses on each individual's potential to enhance their well-being. Our medical-related business provides treatments and diagnostics for both physical and mental health. Our nutraceutical business supports daily health maintenance and improvement. Otsuka's unique products and services are based on scientific evidence, under the guidance of our corporate philosophy: Otsuka-people creating new products for better health worldwide. References 1. U.S. Department of Veteran Affairs. PTSD: National Center for PTSD. 2. Ressler et al., 2022, "Post-traumatic stress disorder: clinical and translational neuroscience from cells to circuits." Nat. Rev. Neurol. doi: 10.1038/s41582-022-00635-8 3. Warner-Schmidt et al., 2024, "Methylone is a rapid-acting neuroplastogen with less off-target activity than MDMA." Front. Neurosci. doi:10.3389/fnins.2024.1353131 4. Warner-Schmidt et al., 2025, "Methylone promotes neurite outgrowth and has long-lasting effects on fear extinction learning." Neuropsychopharmacology. doi:10.1038/s41386-025-02206-z 5. Jones et al., 2026, "Efficacy and safety of the neuroplastogen TSND-201 for the treatment of PTSD: A randomized clinical trial." JAMA Psychiatry. doi:10.1001/jamapsychiatry.2025.4625 The content above comes from the network. if any infringement, please contact us to modify.

RSS Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Transcend Therapeutics, Inc. (Transcend) announce that the two companies entered into an agreement today, under which Otsuka, through its wholly owned subsidiary Otsuka America, Inc., will fully acquire Transcend. The acquisition is expected to be completed in the second quarter of 2026, subject to the fulfillment of customary closing conditions and required procedures. Under the terms of the agreement, Otsuka will pay USD 700 million to Transcend shareholders upon closing of the acquisition, and up to USD 525 million in additional contingent consideration based on future sales milestones related to assets in development, for a total potential consideration of USD $1.225 billion. Transcend, founded in 2021, is a clinical stage biotechnology company developing rapid-acting treatments for neuropsychiatric diseases. TSND-201 (methylone), which the company is developing, is a rapid-acting neuroplastogen--an agent that induces rapid and durable neural plasticity in the brain--and is being advanced as a potential treatment for post-traumatic stress disorder (PTSD) and other psychiatric conditions. In the United States, more than 13 million individuals are estimated to be affected by PTSD each year,¹ yet no new treatments have been approved for 25 years, underscoring the significant unmet medical need. Recent research has demonstrated that changes in neuroplasticity in the brain are deeply involved in both the onset and persistence of PTSD symptoms. Neuroplasticity, the brain's ability to reorganize neural circuits, supports memory formation and emotional regulation. In PTSD, alterations in fear-related pathways impair the ability to relearn safety ("overwriting fear"), driving growing interest in interventions that restore or enhance neuroplasticity.² TSND-201 (methylone) acts on monoamine transporters in the brain--including those for serotonin, norepinephrine, and dopamine. By promoting monoamine release, it increases monoamine concentrations within the synaptic cleft, resulting in rapid and sustained enhancement of neuroplasticity.3,4 Importantly, TSND-201 does not act on the serotonin 5-HT2A receptor, which mediates hallucinogenic effects, and is therefore considered a non-hallucinogenic compound.3,5 Transcend is also conducting research and development on novel prodrugs--classified as new chemical entities--to further improve the balance of efficacy, safety, and tolerability of TSND‑201. The company has selected a development candidate and is currently performing non‑clinical studies in preparation for an Investigational New Drug application to the U.S. Food and Drug Administration (FDA). TSND‑201 demonstrated favorable results in the Phase 2 clinical trial IMPACT‑1, which enrolled adults with PTSD, and study findings were published in JAMA Psychiatry in February 2026.5 Due to its rapid onset of activity and robust effects, TSND‑201 was granted Breakthrough Therapy designation by the FDA in July 2025. Transcend met with the FDA in September 2025, to discuss company plans to expedite the development of TSND-201 and confirm the design of the Phase 3 study. Patient recruitment for the Phase 3 trial is underway in the U.S. Makoto Inoue, president and representative director of Otsuka, commented, "We are very pleased to welcome Transcend Therapeutics into the Otsuka group. Although treatment options for PTSD remain limited, TSND‑201 is generating expectations as a potential paradigm‑shifting therapy in the field of psychiatry. By combining Otsuka's long‑standing expertise in the psychiatric and neurological fields with Transcend's innovative approach, we will advance the development of TSND-201 in close collaboration with regulatory authorities to bring this new treatment option to patients." Blake Mandell, CEO and co-founder at Transcend Therapeutics, noted, "We founded Transcend to bring a fundamentally new treatment to patients with PTSD-one that is rapid-acting and accessible. Otsuka's leadership and longstanding commitment in neuroscience reflect the same dedication to patients that has driven our team from day one, and we are proud to continue advancing TSND-201 together in service of that shared mission." Since the 1970s, Otsuka Pharmaceutical has focused on the psychiatric and neurological fields, working to provide new treatment options for disorders such as schizophrenia, bipolar disorder, depression and PTSD, for which therapeutic choices remain limited. In recent years, with the aim of creating next-generation therapies for psychiatric disorders, Otsuka has expanded its global network through partnerships and collaborations, as well as by the acquisition of Mindset Pharma, Inc., a company with innovative, serotonin 5-HT2A agonist discovery technology. Through these efforts, the company is actively working to broaden future treatment options. By acquiring TSND‑201--a novel investigational asset with a mechanism of action distinct from Otsuka's existing medicines and development programs--the company will further accelerate the expansion of its portfolio in the psychiatric and neurological fields. In the U.S. in particular, despite the very large number of individuals living with PTSD, treatment options remain limited to psychotherapy and antidepressants, underscoring the need for new therapeutic approaches supported by scientific evidence of efficacy and safety. By welcoming Transcend into the Otsuka group, the company aims to strengthen its position as a global leader in the psychiatric and neurological fields and to accelerate the development of next‑generation treatments, including those for PTSD, with the goal to expand future treatment options.   About the Phase 2 IMPACT-1 Study IMPACT‑1 was a randomized, double‑blind, placebo‑controlled trial that evaluated the efficacy, safety, and tolerability of TSND‑201 in adults with PTSD. A total of 65 patients with severe PTSD, defined as having a CAPS‑5 (Clinician‑Administered PTSD Scale for DSM‑5) total severity score of 35 or higher, were enrolled across 16 sites in the U.S., the U.K., and Ireland (mean age: 43.7 years; 26 males and 39 females). Participants received blinded study drug (orally administered TSND-201 or placebo) once a week for four weeks and were followed for an additional six weeks. The IMPACT‑1 study met its primary endpoint, with the TSND‑201 group demonstrating rapid improvements in CAPS‑5 total severity scores from baseline through Day 64 compared with placebo. Notably, from Day 10 onward, the TSND‑201 group showed statistically significant greater improvement in CAPS‑5 scores relative to the placebo group. TSND‑201 was generally well tolerated. The most frequently reported treatment‑emergent adverse events included headache, decreased appetite, nausea, dizziness, increased blood pressure, dry mouth, and insomnia. These events were typically transient, occurred on the day of dosing, and resolved within one day.5,2   About PTSD Post‑traumatic stress disorder is a serious mental health condition that develops after experiencing or witnessing a life‑threatening event or a deeply traumatic experience. Common symptoms include flashbacks, nightmares, severe anxiety, and uncontrollable thoughts related to the traumatic event. In the U.S., it is estimated that more than 13 million people live with PTSD each year,¹ and nearly 6 out of every 100 individuals are expected to be diagnosed with PTSD at some point in their lives. Only two medications are FDA-approved for the treatment of PTSD (sertraline and paroxetine), and novel treatments for PTSD are urgently needed.   About TSND-201 TSND-201 (methylone) is a rapid-acting neuroplastogen developed by Transcend. TSND-201 has well-characterized primary pharmacology, with its primary site of action at the monoamine transporters, and no activity at 5-HT2A receptors (i.e., not hallucinogenic). Transcend is developing TSND-201 as a rapid-acting and durable treatment for PTSD and other central nervous system (CNS) indications. TSND-201 is an investigational medication.   About Transcend Therapeutics Transcend, founded in 2021 and based in New York City, is a clinical-stage, neuroscience-focused company developing rapid-acting treatments for neuropsychiatric diseases. The company's mission is to develop new drugs for the millions of people for whom current psychiatric medicines have not worked. Visit http://www.transcendtherapeutics.com for more information.   About Otsuka Otsuka Pharmaceutical Co., Ltd. is a total healthcare company that focuses on each individual's potential to enhance their well-being. Our medical-related business provides treatments and diagnostics for both physical and mental health. Our nutraceutical business supports daily health maintenance and improvement. Otsuka's unique products and services are based on scientific evidence, under the guidance of our corporate philosophy: Otsuka-people creating new products for better health worldwide. For further information, please visit www.otsuka.co.jp/en/ Reference 1. U.S. Department of Veteran Affairs. PTSD: National Center for PTSD. https://www.ptsd.va.gov/understand/common/common_adults.asp 2. Ressler et al., 2022, "Post-traumatic stress disorder: clinical and translational neuroscience from cells to circuits." Nat. Rev. Neurol. doi: 10.1038/s41582-022-00635-8 3. Warner-Schmidt et al., 2024, "Methylone is a rapid-acting neuroplastogen with less off-target activity than MDMA." Front. Neurosci. doi:10.3389/fnins.2024.1353131 4. Warner-Schmidt et al., 2025, "Methylone promotes neurite outgrowth and has long-lasting effects on fear extinction learning." Neuropsychopharmacology. doi:10.1038/s41386-025-02206-z 5, Jones et al., 2026, "Efficacy and safety of the neuroplastogen TSND-201 for the treatment of PTSD: A randomized clinical trial." JAMA Psychiatry. doi:10.1001/jamapsychiatry.2025.4625