Preeclampsia is a condition in pregnancy where a woman develops high blood pressure and other complications. Women who develop preeclampsia are 4 times more likely to have heart disease later in life. They are also more likely to have depression after pregnancy. Why they are more likely to develop these conditions is not known. It may be because their blood vessels were damaged during pregnancy. Changes in blood vessel health can predict heart disease. These changes have been recorded after pregnancy in women who had preeclampsia. These changes have also been recorded in women who have depression. In the previous phase of this award, we found that women who had preeclampsia in pregnancy had changes in blood vessel health after pregnancy. We also found that if these women were taking a medicine to treat depression, their blood vessel health was normal. This could mean that treatment for depression can also increase blood vessel health in women who had preeclampsia. In this project we will study how changes in blood vessel health are related to preeclampsia and depression in women who have had both. We will also study how medicine to treat depression can improve blood vessel health after preeclampsia. We will do this by measuring how blood vessels work in women who have had preeclampsia compared to women who did not, and in women who have depression and women who do not. This will tell us more about why risk for depression and heart disease is higher in women who have had preeclampsia. It will also help us understand if medicine for depression can reduce cardiovascular disease risk after preeclampsia.

Start Date30 Aug 2026

Sponsor / Collaborator

University of Iowa

CTIS2025-522967-13-00

/ RecruitingPhase 4IIT

A multicenter randomized, controlled, single-blind, adaptive phase IV clinical trial to evaluate the efficiency and effectiveness of a pre-emptive pharmacogenetic strategy for antidepressant selection in patients with depressive disorder: The PREDICT adaptive clinical trial.

Start Date10 Aug 2026

Sponsor / Collaborator

Fundación para la Investigación Biomédica del Hospital

NCT07669571

/ RecruitingPhase 1

A Phase I, Double-blind, Placebo-controlled Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of NS-079 in Healthy Participants

The goal of this clinical trial is evaluate the safety, pharmacokinetics, and pharmacodynamics of NS-079 with its main metabolite (NS-079-M1) in healthy participants. The main questions it aims to answer are:
* Is NS-079 safe and tolerable in heathy participants under tested dosing regimen?
* What is the pharmacokinectic profile of NS-079 in healthy participants under tested dosing regimen and the effect of paroxetine? Researchers will compare NS-079 to a placebo to see the safety and tolerability when use NS-079.

Start Date30 Jul 2026

Sponsor / Collaborator

NeuShen Therapeutics (Shanghai) Co., Ltd.

100 Clinical Results associated with Paroxetine Hydrochloride

100 Translational Medicine associated with Paroxetine Hydrochloride

100 Patents (Medical) associated with Paroxetine Hydrochloride

4,415

Literatures (Medical) associated with Paroxetine Hydrochloride

01 Nov 2025·ENVIRONMENTAL RESEARCH

Mechanisms of cellular and molecular responses in Mytilus galloprovincialis exposed to human pharmaceuticals ibuprofen, paroxetine and their mixture

Article

Author: Di Carlo, Marta ; Rovere, Giulia Dalla ; Benedetti, Maura ; Ferraresso, Serena ; Nardi, Alessandro ; Mezzelani, Marica ; Gorbi, Stefania ; Bernardini, Ilaria ; Milan, Massimo ; Regoli, Francesco ; Fattorini, Daniele ; El Idrissi, Ouafa ; d'Errico, Giuseppe ; Panni, Michela

The toxicological effects of pharmaceutical mixtures on marine ecosystems remain poorly understood, representing a significant research gap. This study investigated the interactions between ibuprofen (IBU) and paroxetine (PAR), two of the most consumed pharmaceuticals in Europe, by characterizing the molecular and cellular mechanisms behind their modes of action (MOAs) in non-target species. Mussels, Mytilus galloprovincialis were exposed to representative environmental concentrations (1 μg/L) of IBU and PAR, dosed alone and as a mixture, for 30 days, followed by a 14-days recovery period. A multidisciplinary approach was applied, combining measurements of drugs bioaccumulation, transcriptomic responses, a wide range of biochemical, cellular biomarkers, and microbiota analysis. The overall results suggested MOA of the two drugs in mussels similar to those reported for target species. PAR-driven effects were clearly observed, particularly in terms of perturbation of redox homeostasis and impairment of lipid metabolism. Remarkable competing effects were also highlighted including a lower uptake of IBU when in mixture with PAR, along with changes on biotransformation, metabolism, and excretion processes at transcriptional level. At the end of the depuration period, mussels showed an almost complete elimination of previously accumulated drugs which, however, did not reflect their capability to restore physiological homeostasis, both in terms of detrimental molecular, cellular effects and changes in bacterial communities. Overall, these findings suggest the need to consider complex environmental interactions when assessing the long-term impacts of pharmaceuticals in marine ecosystems.

01 Oct 2025·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Immobilization of human myeloperoxidase on silica gel for inhibitors assessment

Article

Author: Kauffmann, Jean-Michel ; Delporte, Cédric ; Zouaoui Boudjeltia, Karim ; Van Antwerpen, Pierre ; Parsajoo, Yalda Cobra

Myeloperoxidase (MPO), a hemo-protein present in neutrophils and monocytes, significantly contributes to immune responses against microbial pathogens. Increased MPO activity, however, promotes the production of highly reactive oxidized species in extracellular fluids that can damage host tissues causing inflammatory events. To explore the potential of MPO as a target for inhibitor screening, this study aimed to develop and evaluate a mini-reactor system based on immobilized MPO. Several immobilization strategies including physical adsorption and covalent binding, were tested using silica gel as the support material. Among them, immobilization via cyanogen bromide (CNBr) activation was selected as the optimal method based on long-term stability (> 90 % after 20 runs) and a relative activity of 60 % after immobilization. Kinetic parameters for H₂O₂ were determined to characterize the enzymatic behavior post-immobilization, including K_mapp and V_max (46 ± 4 µM and 463 ± 38 µM/min, respectively). The system was then employed to evaluate the inhibitory potency (IC₅₀) of three model compounds-salicylhydroxamic acid (SHA), paroxetine (PARO), and 4-aminobenzohydrazide (4-ABAH)-on HOCl production in the presence of 10 µM H₂O₂. 4-ABAH emerged as the most potent irreversible inhibitor (IC₅₀ = 0.30 µM), while SHA was the least effective (IC₅₀ = 27.10 µM). Those results demonstrated that immobilized-MPO preserved its activity and exhibited good stability. This mini-reactor provides a reliable platform for inhibitor studies, offering potential applications in screening therapeutic compounds to mitigate MPO-related inflammatory conditions.

01 Oct 2025·BIOCHIMICA ET BIOPHYSICA ACTA-MOLECULAR BASIS OF DISEASE

Harnessing integrated bioinformatics to identify new diagnostic and therapeutic strategies for heart failure

Article

Author: Wang, Ruilin ; Shang, Min ; Huang, Chengchen ; Sun, Shuo ; Fu, Guosheng ; Lai, Chaojie

Heart failure (HF) is a life-threatening condition that poses a significant challenge on public health, particularly among the elder populations. To develop new diagnostic and therapeutic strategies for HF, we analyzed large-scale transcriptome sequencing data from HF patients as an exploratory approach. We identified 18 HF-related genes and developed a robust scoring model for HF diagnosis, by applying two machine learning algorithms for data analysis. Meanwhile, we evaluated and compared the predictive abilities of three bioinformatics methods in identifying potential HF treatment drugs. Significantly, an unconventional network-based proximity analysis, integrating multidimensional drug target information, outperformed other methods in the assessment of predictive ability. To validate these findings, we tested several candidate drugs in a mouse model transitioning from acute myocardial infarction (MI) to chronic HF. Among the candidates, mirtazapine exhibited cardioprotective effects in both early (1-week) post-MI and chronic HF (4-week post-MI) settings, while cabergoline showed potential efficacy primarily in the early post-MI phase. Additionally, the screened triamterene, used as a positive control, exhibited protective effects in both early post-MI and chronic HF stages. Mechanistic studies revealed that growth factor receptor-bound protein 14 and Ras-related protein Rab-3A were critical to the observed cardioprotection. These findings provide valuable evidence and insights for exploring potential therapeutic agents for HF treatment.

News (Medical) associated with Paroxetine Hydrochloride

22 Apr 2026

·www.biospace.com

AtaiBeckley Announces Additional Phase 2a Results for EMP-01 (oral R-MDMA) Showing Large and Consistent Improvements in Social Anxiety Disorder

EMP-01 demonstrated a large, clinically meaningful reduction in patient-reported SAD symptoms at Day 43: placebo-adjusted LSMD -11.5 points (p=0.002) on SPIN; placebo-adjusted LSMD -15.6 points (p=0.004) on SAFE - a 38% and 32% reduction, respectively Patient-perceived global improvement: 49% PGI-C responders at Day 43 compared to 12% on placebo No severe or serious adverse events NEW YORK, April 22, 2026 (GLOBE NEWSWIRE) -- AtaiBeckley Inc. (NASDAQ: ATAI) (“AtaiBeckley” or “Company”), a clinical-stage biotechnology company on a mission to transform patient outcomes by developing rapid-acting, durable and convenient mental health treatments, today announced expanded Phase 2a results for EMP-01 (oral R-MDMA) in adults with Social Anxiety Disorder (SAD) (n=70), demonstrating clinically meaningful and consistent improvements across clinician-rated symptoms, patient-reported experience, and real-world behavioral outcomes. At Day 43, EMP‑01 achieved a 38% reduction vs 15% on placebo (Hedges’ g=0.84) on the patient-reported Social Phobia Inventory (SPIN), a 32% reduction vs 14% on placebo on the Subtle Avoidance Frequency Examination (SAFE), and a previously reported −11.9-point LS mean difference (LSMD) on the Liebowitz Social Anxiety Scale (LSAS) versus placebo (g=0.45), with 49% responder rates on both Clinical Global Impression-Improvement (CGI-I) (previously reported) and Patient Global Impressions of Change (PGI-C). EMP-01 was well tolerated, with no severe or serious adverse events. Clinical Data Summary Drug EMP-01 (oral R-MDMA) Indication Social Anxiety Disorder Trial NCT06693609: Phase 2a (Randomized 1:1, N=70). Two‑dose regimen (Days 1 and 29) with no psychotherapy; last assessment Day 43. Endpoints Primary endpoints safety and tolerability; secondary endpoint change in LSAS total score at Day 43; exploratory endpoints SPIN, SAFE, CGI‑I, PGI‑C, PK/PD, 11D‑ASC Primary Result Well tolerated; no SAEs; no severe TEAEs Secondary Results LSAS placebo-adjusted LSMD: -11.9 points, moderate effect size (g=0.45) at Day 43 (previously reported) Exploratory Results At Day 43: SPIN: -18.3 points (38% reduction from baseline vs 15% on placebo), with a large between-group effect size (Hedges’ g=0.84); post hoc MMRM placebo-adjusted LSMD -11.5 points (p=0.002) SAFE: -25.9 points (-32% reduction from baseline vs 14% on placebo); post hoc MMRM placebo-adjusted LSMD -15.6 points (p=0.004) CGI‑I responders: 49% vs 15% placebo (previously reported) PGI‑C responders: 49% vs 12% placebo Efficacy Findings EMP‑01 produced consistent and clinically meaningful improvements across all major symptom domains of SAD: LSAS: EMP-01 demonstrated a clinically meaningful LSMD of −11.9‑points vs placebo (g=0.45) at Day 43 (previously reported), with both total and subscale improvements. Improvements were observed across both fear and avoidance subscales on the clinician-rated 24-item Liebowitz Social Anxiety Scale, indicating that patients experienced fewer social situations as distressing and were more able to engage in them. This degree of change is considered clinically meaningful and reflects broad symptom improvement across core features of social anxiety disorder including fear and anxiety of social situations. SPIN: EMP-01 produced a large, clinically meaningful patient-reported improvement of -18.3-points (38% reduction vs 15% on placebo), which corresponded to a large between-group standardized effect size (g=0.84), in self-reported SAD symptoms from baseline to Day 43. Additional model-based analyses further supported treatment benefits at Day 43, showing statistically significant improvements with a placebo-adjusted LSMD of -11.5 points (95% CI: -18.5, -4.6; p=0.002) at Day 43. Patients treated with EMP-01 moved from severe baseline symptom severity to substantially lower symptom burden by Day 43. These results on the 17-item SPIN are equivalent to being able to initiate conversations, attend social events, and perform at work with substantially less fear and avoidance. SAFE: EMP-01 demonstrated a large, clinically meaningful improvement of −25.9‑points (32% reduction vs 14% on placebo) in real-world behavioral avoidance at Day 43. Additional model-based analyses further supported treatment benefits at Day 43, showing statistically significant improvements with a placebo-adjusted LSMD of -15.6 points at Day 43 (95% CI: -26.0, -5.2; p=0.004). These results on the Subtle Avoidance Frequency Examination, a 32-item questionnaire that measures safety behaviors, suggest that participants were more willing to participate in everyday activities such as social interactions without engaging in avoidant coping behaviors. Clinical impression: 49% CGI‑I responders (NNT=2.95) at Day 43 compared to 15% on placebo (previously reported). This measure reflects clinicians’ overall judgment of meaningful improvement in a patient’s condition, considering symptom severity, functioning, and overall clinical presentation. Patient perception: 49% PGI‑C responders (NNT=2.72) at Day 43 compared to 12% on placebo. This result indicates that patients themselves perceived the treatment‑associated improvements as noticeable and meaningful in their daily lives, reinforcing the clinical and functional outcomes observed on other measures. Safety & Tolerability EMP‑01 was generally safe and well tolerated: No SAEs and no severe TEAEs in any participant 97% retention, with 0% study dropouts attributed to TEAEs TEAEs were expected and consistent with the class, transient, and predominantly mild‑to‑moderate Professor Murray Stein, Distinguished Professor of Psychiatry and Public Health at the University of California San Diego (UCSD) and consultant to AtaiBeckley, said: “ I was particularly struck by the consistency of the findings across clinician-rated and patient-reported outcomes. The improvement on the SAFE is especially interesting because reductions in subtle avoidance behaviors are seen as an important goal of cognitive behavioral therapies and yet are seldom measured in medication trials for social anxiety disorder. Taken together, these findings provide strong support for continued development of EMP-01.” Management Commentary Dr Srinivas Rao, Co-Founder and Chief Executive Officer at AtaiBeckley, said: “In this Phase 2a trial of 70 patients, EMP - 01 delivered a 49% clinician - rated and patient-reported responder rate alongside significant improvements across LSAS, SPIN, and real - world avoidance behavior. Unlike current standards of care, which require daily, chronic dosing, the durability observed in this study following just two administrations suggests that EMP-01 could be a differentiated treatment option that could meaningfully improve outcomes for people living with Social Anxiety Disorder.” Dr Kevin Craig, Chief Medical Officer at AtaiBeckley said: “ Social Anxiety Disorder is a chronic and highly impairing condition for which many patients do not achieve adequate benefit from currently available treatments. The consistent improvements observed across clinician-rated symptoms, patient-reported experience, and avoidance behavior—alongside a favorable tolerability pro encouraging evidence that EMP-01 may address multiple important dimensions of this disorder.” Study Design The multi-center study enrolled 71 adults with moderate-to-severe SAD across 7 clinical sites in the UK. Participants were randomized to receive two in-clinic administrations of EMP-01 (225 mg) or placebo, given 28 days apart, with no adjunctive psychotherapy. 70 participants received at least one dose of study drug, and 69 completed the Day 43 efficacy assessments, indicating high patient acceptability and retention. All clinician-rated assessments were conducted by blinded central raters. Topline results from this study were previously reported in February 2026. Frequently Asked Questions Q1: What do the additional Phase 2a results for EMP-01 mean for patients with Social Anxiety Disorder? A1: AtaiBeckley today reported additional efficacy and safety dataset from its Phase 2a trial of EMP-01 (oral R-MDMA) in adults with Social Anxiety Disorder. The results show consistent, clinically meaningful improvements across every major symptom domain - clinician-rated anxiety (LSAS), patient-reported symptoms (SPIN), real-world avoidance behavior (SAFE), and global impression scales (CGI-I, PGI-C). Approximately 49% of EMP-01-treated patients were rated as much or very much improved by both their clinician and themselves, compared to roughly 15% and 12% on placebo, respectively. The full safety dataset also confirmed a favorable safety and tolerability pro no serious adverse events. Q2: How does EMP-01’s reduction in patient-reported social anxiety compare to standard-of-care treatments? A2: On the Social Phobia Inventory (SPIN), EMP-01 produced a placebo-adjusted LSMD of 11.5 points in a supportive post hoc MMRM analysis, with a large effect size (Hedges’ g = 0.84) and a 38% reduction from baseline after two doses over six weeks. In a cross-trial comparison, standard-of-care pharmacotherapies (venlafaxine, paroxetine) produced placebo-subtracted SPIN differences of approximately 6.7–7.8 points at comparable timepoints. On the SAFE behavioral avoidance measure, EMP-01 produced a 32% reduction (−25.9 points), exceeding the −17-point benchmark reported for cognitive behavioral therapy for SAD after 12–16 weeks. Cross-trial comparisons are inherently limited due to differences in study design, patient populations, endpoints, and duration. Q3: How does EMP-01 differ from existing pharmacotherapies for Social Anxiety Disorder? A3: Current first-line treatments for SAD - primarily SSRIs and SNRIs - require daily dosing and approximately 8–12 weeks to show meaningful effect, and roughly 50% of patients do not achieve adequate response. EMP-01 is designed as an intermittent, in-clinic oral treatment: in this trial, two administrations delivered over 28 days produced clinically meaningful improvements at Day 43, without adjunctive psychotherapy. EMP-01 is an investigational product and has not been approved by the U.S. Food and Drug Administration (FDA). Q4: What is Social Anxiety Disorder (SAD)? A4: Social Anxiety Disorder (SAD) is one of the most prevalent psychiatric conditions worldwide, affecting an estimated 400–800 million individuals with a lifetime prevalence of approximately 12%. The disorder is characterized by persistent and debilitating fear, self-consciousness, and heightened anxiety during social interactions. SAD is frequently co-morbid with major depressive disorder, generalized anxiety disorder, obsessive–compulsive disorder, attention deficit/hyperactivity disorder, bipolar disorder, and substance use disorders, contributing to substantial functional impairment and reduced quality of life. In the United States alone, roughly 30 million adults are affected by SAD; however, only about 50% of affected individuals receive treatment. Even among patients who access care, treatment adequacy remains suboptimal, and around 50% of SAD patients do not achieve adequate response to first line therapies and often deal with chronic medication side effects. Q5: What does post hoc MMRM mean A5: These were supportive statistical analyses conducted after topline results using a standard repeated-measures modelling approach. The results were consistent with the primary dataset and increase confidence in the robustness of treatment effects on SPIN and SAFE. About EMP-01 (Oral R-MDMA) EMP-01 is an oral, single-enantiomer R‑MDMA candidate being developed as a potential treatment for people living with Social Anxiety Disorder (SAD). It has been designed to elicit entactogenic and psychedelic subjective effects, with reduced dopaminergic and noradrenergic activity compared with racemic MDMA in order to support safe, scalable outpatient administration for individuals with SAD, who currently have a high unmet medical treatment need. EMP-01 is an investigational product and has not been approved by the FDA. About AtaiBeckley Inc. AtaiBeckley is a clinical-stage biotechnology company on a mission to transform patient outcomes by developing rapid-acting, durable and convenient mental health treatments. AtaiBeckley’s pipeline of novel therapies includes BPL-003 (mebufotenin benzoate nasal spray) for treatment-resistant depression (TRD), VLS-01 (DMT buccal film) for TRD and EMP-01 ((R)-MDMA HCI) for social anxiety disorder. BPL-003 is in Phase 3 planning, VLS-01 and EMP-01 are in Phase 2 clinical development. The Company is also advancing a drug discovery program to identify novel, non-hallucinogenic 5-HT2AR agonists for opioid use disorder and TRD. These programs aim to create breakthroughs in mental health through transformative interventional psychiatry therapies that can integrate seamlessly into healthcare systems. For the latest updates and to learn more about the AtaiBeckley mission, visit or follow the Company on LinkedIn and on X . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “anticipate,” “initiate,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things: our business strategy and plans; progress and results of our EMP-01 trials; the timing of further data on EMP-01; the therapeutic potential of EMP-01; and the potential benefits of EMP-01 for patients with SAD. Forward-looking statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties that could cause actual results to differ materially from those projected, including, without limitation, the important factors described in the section titled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”), as such factors may be updated from time to time in our quarterly reports and other filings with the SEC. AtaiBeckley disclaims any obligation to update or revise any forward-looking statements contained in this press release, other than to the extent required by applicable law. Contact Information: Investors: Jason Awe, PhD VP, Investor Relations IR@ataibeckley.com Media: Charlotte Chorley Associate Director, Communications PR@ataibeckley.com

Clinical ResultPhase 2Phase 3

28 Mar 2026

·www.biospace.com

Otsuka Pharmaceutical to Acquire Transcend Therapeutics

– 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.

Clinical ResultAcquisitionBreakthrough Therapy

27 Mar 2026

·www.otsuka.co.jp

Otsuka Pharmaceutical to Acquire Transcend Therapeutics - 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 (

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

Phase 2Clinical ResultBreakthrough TherapyAcquisitionPhase 3

100 Deals associated with Paroxetine Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D05374	Paroxetine Hydrochloride	N06AB05	DB00715

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Premenstrual Dysphoric Disorder	United States	Apotex, Inc.	28 Aug 2003
Panic	Japan	GlaxoSmithKline KK	22 Sep 2000
Anxiety Disorders	Brazil	Libbs Farmacêutica Ltda.	22 Dec 1999
Generalized anxiety disorder	United States	Apotex, Inc.	25 Jun 1997
Stress Disorders, Post-Traumatic	United States	Apotex, Inc.	25 Jun 1997
Depressive Disorder	China	Sino-American Tianjin SmithKline & French Lab Ltd.	01 Jan 1995
Depressive Disorder, Major	United States	Apotex, Inc.	29 Dec 1992
Obsessive-Compulsive Disorder	United States	Apotex, Inc.	29 Dec 1992
Panic Disorder	United States	Apotex, Inc.	29 Dec 1992
Phobia, Social	United States	Apotex, Inc.	29 Dec 1992

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hearing Loss	Phase 2	United Kingdom	GlaxoSmithKline Research & Development Ltd.	21 Sep 2006
Tinnitus	Phase 2	United Kingdom	GlaxoSmithKline Research & Development Ltd.	21 Sep 2006
Parkinson Disease	Phase 2	United States	GSK Plc	01 Jun 2003
Depressive Disorder, Treatment-Resistant	Clinical	United States	GSK Plc	01 Dec 2003
Neoplasms	Preclinical	China	Shanghai University of Traditional Chinese Medicine	27 Jan 2026

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


DDW2026	Not Applicable	-	443	Amitriptyline	niypbmqepr(bveljmnwdp) = hchbqgsrqi xzrueglqud (uspuqziplu ) View more	Positive	02 May 2026
NCT04404439 (CTgov)	Phase 4	Tinnitus \| Migraine Disorders	78	Nortriptyline+topiramate (Nortriptyline + Topiramate)	ncrxnthher(zqovbxxuak) = gnwyrglzrq ksrfflffoh (zahojxjunn, jwybhdtetj - mnrqwogpoe) View more	-	16 Apr 2026
				Verapamil+paroxetine (Verapamil + Paroxetine)	ncrxnthher(zqovbxxuak) = bgvknltmzc ksrfflffoh (zahojxjunn, txshuanynb - qqczmkrtzg) View more
NCT06231745 (Pubmed \| Drug Des Devel Ther)	Phase 4	Rheumatoid Arthritis	100	Paroxetine + csDMARDs	yyszmjtxkr(spfkvpohpq): P-Value = 0.005 View more	Positive	01 Dec 2025
				csDMARDs + Placebo
NCT05470465 (CTgov)	Phase 1	Hypercarbia	27	Placebo+Oxycodone (Treatment A: Placebo)	wvsytnmyvo(yvhmsqgtcg) = vlpkmtejhb wijggckchh (ecdktfqncu, fktvtcpedx - iyimteaqje) View more	-	22 May 2025
				Paroxetine+Oxycodone (Treatment B: Paroxetine)	wvsytnmyvo(yvhmsqgtcg) = oipsqqdmej wijggckchh (ecdktfqncu, xjipfodumb - okejjzcjqe) View more
AAAAI2025	Phase 1	-	18	Camlipixant	gaxchamsah(svmlsrndhc) = blrultrjxz imiqjpzeqm (sotkzwzxcv ) View more	Positive	28 Feb 2025
				Paroxetine + Camlipixant	gaxchamsah(svmlsrndhc) = zkrragscyx imiqjpzeqm (sotkzwzxcv ) View more
NCT06065735 (CTgov)	Phase 1	Anxiety Disorders	38	Paroxetine (Participants Who Received Paroxetine 20 mg)	hslxriscaj(bturweqsik) = pxofrycqot atpmkgtukl (ojvymogder, 7.37) View more	-	16 Dec 2024
				Paroxetine (Participants Who Received Paroxetine 40 mg)	hslxriscaj(bturweqsik) = xllbvlfbmf atpmkgtukl (ojvymogder, 10.82) View more
WCD2023	Not Applicable	Rosacea \| Erythema	97	Paroxetine 25 mg	drnzhsjnee(bglsvjurnb) = ntkhrcilkg lggydghbhs (gbjfrnqilg ) View more	Positive	04 Jul 2023
				Placebo	drnzhsjnee(bglsvjurnb) = usipkbzbuu lggydghbhs (gbjfrnqilg ) View more
NCT04311463 (CTgov)	Phase 1	Anxiety Disorders	38	Paroxetine (Paroxetine 20 mg (Test A))	vpqynkdczs(chpmrzvvkw) = quamfwckhz pxcutcctak (eahnylmxwh, 5.872) View more	-	20 Jan 2022
				Paroxetine (Paroxetine 20 mg (Reference B))	vpqynkdczs(chpmrzvvkw) = twfkfzenbr pxcutcctak (eahnylmxwh, 6.554) View more
NCT03274752 (Pubmed \| JAMA Cardiol)	Phase 2	Anterior Wall Myocardial Infarction	-	Paroxetine	ebyitvnxvy(lbyzmdgdui) = poucaqmjxe deilhfpkmg (tecvpiosng )	Negative	01 Oct 2021
				Placebo	ebyitvnxvy(lbyzmdgdui) = sqcuztcsku deilhfpkmg (tecvpiosng )
UEGW2018	Not Applicable	Dyspepsia	-	Fluoxetine	exmgzkhkdu(iuyanwlbms) = kteugoovcg nhuatqphnq (qxfrmhhsla )	-	01 Oct 2018
				Flupenthixol melitracen	exmgzkhkdu(iuyanwlbms) = pxayuhcitp nhuatqphnq (qxfrmhhsla )

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