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Last update 13 Oct 2026

Aripiprazole

Last update 13 Oct 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryAripiprazole, also known by its trade name Abilify Discmelt®, is an atypical antipsychotic medication that is utilized in the treatment of a diverse range of mood and psychotic disorders, including but not limited to schizophrenia, bipolar I disorder, major depressive disorder, irritability linked with autism, and Tourette's syndrome. This medication functions through its mechanism of action as both a 5-HT2A agonist and a D2 receptor agonist. Aripiprazole was first approved by the US FDA in 2002, with Otsuka Holdings as the pharmaceutical company responsible for its development. Its primary indication is for the treatment of schizophrenia.

Drug Type

Small molecule drug

Synonyms

ABILIFY MAINTENA, Abilify MyCite, Abilify Prolonged Release Aqueous Suspension

+ [36]

Target

5-HT1A receptor x 5-HT2A receptor x D2 receptor x D3 receptor

Action

agonists, antagonists

Mechanism

5-HT1A receptor agonists(Serotonin 1a (5-HT1a) receptor agonists), 5-HT2A receptor antagonists(Serotonin 2a (5-HT2a) receptor antagonists), D2 receptor agonists(Dopamine D2 receptor agonists)

Therapeutic Areas

Nervous System DiseasesCongenital DisordersOther Diseases

Active Indication

Autism Spectrum DisorderTourette SyndromeDepressive Disorder+ [9]

Inactive Indication

Acute schizophreniaAffective Disorders, PsychoticAlzheimer Disease+ [14]

Originator Organization

Otsuka Holdings Co., Ltd.

Active Organization

Otsuka Pharmaceutical Netherlands B.V.Sandoz GmbH

Otsuka Holdings Co., Ltd.

+ [11]

Inactive Organization

Otsuka Pharmaceutical Development & Commercialization, Inc.

Otsuka America Pharmaceutical, Inc.

Bristol Myers Squibb Co.

+ [7]

License Organization

Jiangsu Nhwa Pharmaceutical Co., Ltd.

Zysis Ltd.

H. Lundbeck A/S

+ [3]

Drug Highest PhaseApproved

First Approval Date

United States (15 Nov 2002),

Schizophrenia

RegulationOrphan Drug (United States), Priority Review (China)

Structure/Sequence

Molecular FormulaC23H27Cl2N3O2

InChIKeyCEUORZQYGODEFX-UHFFFAOYSA-N

CAS Registry129722-12-9

541

Clinical Trials associated with Aripiprazole

NCT07714213

/ Not yet recruitingPhase 2IIT

Prospective, Randomized, Double-blind, Placebo-controlled Phase 2a Trial of Low-dose Aripiprazole in Patients With Neuropsychiatric Impairment in Post-acute Infectious Syndrome (PAIS) Including Post-COVID-19 Condition (PCC)

Post-acute infectious syndrome (PAIS), including post-COVID-19 condition (PCC or Long COVID), can develop after an infection and may cause persistent symptoms such as fatigue, problems with memory and concentration ("brain fog"), mood changes, and reduced quality of life. In some people, these symptoms continue for months or longer and can substantially affect daily activities. Currently, there are no approved treatments that specifically target these symptoms.
Aripiprazole is a medicine that is approved to treat certain psychiatric disorders. At low doses, it may affect brain signaling and immune processes that are thought to contribute to symptoms experienced by people with PAIS. Small observational studies have suggested that low-dose aripiprazole may improve symptoms such as fatigue and cognitive impairment in people with related conditions, but its effectiveness and safety have not yet been confirmed in a randomized controlled trial.
The purpose of this study is to evaluate whether low-dose aripiprazole is safe and more effective than placebo in improving fatigue and other neuropsychiatric symptoms in adults with PAIS.
This is a phase 2b, randomized, double-blind, placebo-controlled crossover trial. Approximately 138 participants with PAIS will be enrolled. Participants will be randomly assigned to one of two treatment sequences. One group will receive low-dose aripiprazole for 8 weeks followed by placebo for 8 weeks. The other group will receive placebo first, followed by low-dose aripiprazole. The two treatment periods will be separated by a 2-week washout period. Neither the participants nor the study team will know which treatment is being given during each treatment period.
The primary objective is to determine whether low-dose aripiprazole improves fatigue after the first 8-week treatment period compared with placebo. Fatigue will be assessed using the Chalder Fatigue Questionnaire. Secondary objectives include evaluating the effects of treatment on physical functioning, quality of life, memory and cognitive performance, mood, post-exertional malaise, illness-related anxiety and distress, and fatigue in participants who meet diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Safety will be assessed throughout the study by monitoring adverse events.
The results of this study may help determine whether low-dose aripiprazole is a safe and effective treatment option for people with PAIS

Start Date01 Oct 2026

Sponsor / Collaborator

Charité - Universitätsmedizin Berlin

NCT07810738

/ Not yet recruitingPhase 2IIT

Biotype-assigned Augmentation Approach in Resistant Late-Life Depression (BAARD): a Randomized Controlled Trial

The goal of this clinical trial is to test whether a personalized approach to treatment selection improves symptoms in older adults with treatment-resistant depression.
The main questions it aims to answer is:
Will using the BAARD predictive models to select medications lead to better depression outcomes, compared to randomly selecting medications?
Researchers will use the BAARD predictive models or random assignment to choose one of two medications to add to patients' current treatment. Patients will be asked to take either aripiprazole or bupropion along with their current medication.
Participants will:
Take Aripiprazole or Bupropion in addition to their current medication for 10 weeks.
Complete follow-up assessments every 1-2 weeks for checkups.

Start Date01 Oct 2026

Sponsor / Collaborator

Washington University School of Medicine

[+1]

CTRI/2026/07/113210

/ Not yet recruitingNot ApplicableIIT

A pilot study on the efficacy of aripiprazole in children and adolescents with Oppositional defiant disorder - nil

Start Date06 Jul 2026

Sponsor / Collaborator-

100 Clinical Results associated with Aripiprazole

100 Translational Medicine associated with Aripiprazole

100 Patents (Medical) associated with Aripiprazole

5,529

Literatures (Medical) associated with Aripiprazole

01 Jan 2027·CLINICA CHIMICA ACTA

Development and validation of patient-based exponentially weighted moving average quality control models for three antipsychotic drugs and their metabolites by LC-MS/MS

Article

Author: Pu, Yungang ; Ruan, Canjun ; Guo, Guixin ; Ling, Sihai ; Zhou, Chunyan ; Guo, Qi ; Liu, Chengeng ; Liu, Xiangyi ; He, Jing

BACKGROUND:

Therapeutic drug monitoring of antipsychotics is essential for personalized dosing. Traditional internal quality control (IQC) lacks real-time capability, potentially delaying error detection. Patient-Based Real-Time Quality Control (PBRTQC) can overcome this by continuously analyzing patient data. However, its application to antipsychotic drug assays remains underexplored.

OBJECTIVE:

To develop and validate novel PBRTQC models based on the exponentially weighted moving average (EWMA) for the real-time monitoring of three first-line antipsychotics (aripiprazole, clozapine, quetiapine) and their major metabolites-addressing a critical gap in laboratory quality assurance for psychiatric pharmacotherapy.

METHODS:

Chronologically ordered concentration data were split into training and validation sets. Truncation limits were optimized via trimming and winsorization. Multiple EWMA models with different weighting factors (λ) were evaluated. Model selection was based on the false positive alarm rate (FAR) and the average number of patients before error detection (ANPed), validated using simulated constant and proportional errors.

RESULTS:

Optimal models for most analytes employed trimming at 1.5 standard deviation (SD) with λ = 0.03. The introduced PBRTQC system demonstrated high sensitivity: for a 15% analytical bias, the ANPed was <20 for quetiapine, <40 for desalkylquetiapine and aripiprazole, <50 for dehydroaripiprazole, and < 30 for clozapine/norclozapine. All ANPeds fell below 20 at a 30% bias, confirming effective error detection.

CONCLUSION:

EWMA-based PBRTQC models specifically tailored for antipsychotic drug monitoring were successfully established. The models provide a practical, real-time complement to traditional IQC, enabling the early detection of analytical shifts and enhancing the reliability of laboratory data for clinical decision-making in psychiatry.

01 Dec 2026·JOURNAL OF AFFECTIVE DISORDERS

Early metabolic and gut microbiota alterations during antipsychotic‑lithium treatment in acute bipolar mania: A prospective follow-up study

Article

Author: Sun, Chen ; Han, Wei-Jian ; Zhang, Xin ; Yi, Lei

OBJECTIVE:

To investigate early metabolic changes, gut microbiota alterations, and the correlations between key bacterial genera and metabolic indices in patients with bipolar disorder experiencing manic episodes who were treated with different antipsychotics combined with lithium carbonate.

METHODS:

This prospective observational follow-up study enrolled inpatients with bipolar disorder experiencing manic episodes who were medication-free at baseline. Participants were assigned according to treatment regimen into four groups: olanzapine combined with lithium carbonate, risperidone combined with lithium carbonate, aripiprazole combined with lithium carbonate, and lithium carbonate monotherapy. Metabolic parameters, including body weight, body mass index, waist circumference, fasting plasma glucose, triglycerides, and high-density lipoprotein cholesterol, were measured at baseline (T0), week 4 (T4), week 8 (T8), and week 12 (T12). Fecal samples were collected at T0 and T12, and gut microbiota composition was analyzed using 16S rRNA gene sequencing. Longitudinal changes in metabolic indices, α- and β-diversity of the gut microbiota, and genus-level differences in bacterial abundance were compared among groups. Spearman's rank correlation analysis was used to assess associations between changes in key bacterial genera and changes in metabolic parameters.

RESULTS:

A total of 80 patients were enrolled, and 68 completed the 12-week follow-up, with an overall dropout rate of 15.0%. From T0 to T12, changes in metabolic parameters differed significantly among the four groups (all P < 0.001). The olanzapine plus lithium carbonate group showed the most pronounced metabolic changes, followed by the risperidone plus lithium carbonate group, whereas changes were less marked in the aripiprazole plus lithium carbonate group and the lithium monotherapy group. α-diversity analysis showed that the Shannon and Simpson indices significantly increased from baseline to week 12 in the olanzapine/risperidone plus lithium carbonate group (both P < 0.05), whereas no significant changes were observed in the other two groups. β-diversity analysis indicated significant shifts in gut microbial community structure after treatment in the olanzapine and risperidone combination groups, while no significant changes were detected in the aripiprazole combination group or the lithium monotherapy group. Spearman correlation analysis showed that the change in centered log-ratio-transformed abundance of Collinsella was negatively correlated with changes in HDLC, whereas the change in Bifidobacterium abundance was positively correlated with changes in HDLC. The change in Blautia abundance was positively correlated with changes in triglycerides, while the change in Faecalibacterium abundance was negatively correlated with changes in BMI.

CONCLUSION:

Different antipsychotics combined with lithium carbonate were associated with distinct early metabolic burdens and gut microbiota alterations in patients with bipolar disorder experiencing manic episodes. Changes in gut microbiota composition were correlated with changes in metabolic indices, suggesting that the gut microbiota may be involved in the development of early antipsychotic-associated metabolic abnormalities.

01 Dec 2026·JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

A TiO2@MWCNTs-based dispersive solid-phase extraction method for mitigating matrix effects in plasma LC–MS/MS analysis

Article

Author: He, Yonghang ; Li, Yagang ; Huang, Min ; Huo, Shuyan ; Zhong, Guoping ; Zeng, Weiwei ; Wu, Wei ; Xing, Yunhui ; Jiang, Yiming

The matrix effect is a prevalent interference in LC-MS/MS bioanalysis of small-molecule drugs, with lipids as a major source of such interference in plasma matrices. Leveraging the lipid-adsorbing capability of multi-walled carbon nanotubes (MWCNTs), this study synthesized TiO₂@MWCNTs composites and developed a novel dispersive solid-phase extraction (d-SPE) method to reduce matrix effects in rat plasma. Lipid profiles were compared to characterize the lipid purification capacity of TiO₂@MWCNTs in rat plasma samples. The matrix effects of representative small-molecule drugs, including metformin, amisulpride, and aripiprazole, were compared across TiO₂@MWCNTs-based d-SPE, protein precipitation, and traditional solid-phase extraction. Method validation and sample determination were subsequently performed. The results demonstrated that TiO₂ could be successfully loaded onto MWCNTs. The responses of 72 differential lipid ions were significantly reduced by at least 2-fold after TiO₂@MWCNTs treatment, and the IS-normalized matrix factors for metformin (from 13.69-20.00% to 31.49-44.39%) and amisulpride (from 71.01-84.82% to 91.69-101.48%) as well as the accuracy for aripiprazole at low concentration were significantly improved compared with protein precipitation treatment. Method validation results confirmed excellent selectivity, accuracy, precision, and reproducibility. The validated method was also successfully applied to a pharmacokinetic study of metformin with pharmacokinetic parameters comparable to those reported previously. This study shows that the dispersive solid-phase extraction method based on TiO₂@MWCNTs could act as a simple, rapid, low-cost and reliable pretreatment strategy to mitigate matrix effects for small-molecule analytes with low lgP in rat plasma as a proof-of-concept attempt.

110

News (Medical) associated with Aripiprazole

12 Oct 2026

·www.hspharm.com

ECNP 2026 | HANSOH PHARMA ANNOUNCES PHASE 2B DATA OF OBUPRAZINE(HS-10380) IN SCHIZOPHRENIA

- Obuprazine(HS-10380) has shown promising efficacy in acute schizophrenia with marked improvements in PANSS total, positive and negative symptoms as well as cognitive factors , along with favorable overall safety and tolerability. SHANGHAI, October 12，2026— Hansoh Pharmaceutical Group Co., Ltd. (“Hansoh Pharma,” 03692.HK) today announced that the encouraging results from the phase 2b of HS-10380, in patients with schizophrenia ,were presented at the poster sessions at the 2026 European College of Neuropsychopharmacology (ECNP 2026), held on October 10 in Munich, Germany. HS-10380 is an orally administered multi-target agent acting on dopamine and 5-HT (5-hydroxytryptamine, also known as serotonin) pathways and designed to address the positive, negative and cognitive symptoms of schizophrenia. At ECNP 2026, the data were generated from a randomized controlled phase 2b study evaluating the efficacy and safety of HS-10380 in adult patients with acute schizophrenia in China. Details of the poster presentation are as follows: ● Poster Title: Efficacy and Safety of Obuprazine (HS-10380) in Patients with Schizophrenia: A Phase 2b Randomized Placebo- and Active-Controlled Trial ● Session: Poster Session 1 ● Poster No.: PS01-1227 ● Date/Time: 10 October 2026, 12:00 - 13:25 [CEST] ● Presenter: Huafang Li, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China The study results showed: A total of 363 participants were randomized to HS-10380 1.5–3 mg (n=81), HS-10380 4.5–6 mg (n=80), HS-10380 6–9 mg (n=81), aripiprazole (n=40), or placebo (n=81). Demographics and baseline characteristics were well balanced across groups. ● Promising Efficacy: Least squares mean differences (95% CI) of change from baseline in PANSS total score versus placebo at Day 42 were -16.7 (-22.5, -10.9) for HS-10380 1.5–3 mg, -13.2 (-18.9, -7.4) for HS-10380 4.5–6 mg, -14.7 (-20.5, -8.8) for HS-10380 6–9 mg, and -12.1 (-19.1, -5.1) for aripiprazole. HS-10380 also demonstrated greater improvements versus placebo and favorable efficacy trends compared to aripiprazole across positive, negative and cognitive symptom (PANSS Marder Cognitive Factors) domains. ● Favorable Safety Profile: The safety profile for HS-10380 was generally favorable, with no new significant safety concerns identified. Most TEAEs were mild to moderate in severity. The successful Ph2b results support moving this program forward into Ph3, and detailed results will be submitted for publication in a peer-reviewed journal. About HS-10380 HS-10380 is a partial agonist of D₂/D₃ and 5-HT1A receptors with potent antagonism at 5-HT₂A receptors, which may improve positive and negative symptoms, as well as cognitive symptoms of schizophrenia and reduce adverse effects. About schizophrenia Schizophrenia is a severe, chronic psychiatric disorder that ranks as the third leading cause of global disability.[1,2 ]The disorder typically emerges in late adolescence or early adulthood and is characterized by positive symptoms (hallucinations, delusions, and thought disorder), negative symptoms (apathy, social withdrawal, and diminished emotional expression), and cognitive impairments that affect multiple aspects of functioning.[3,4 ] References 1. Zhan Z, Wang J, Shen T. Results of the Global Burden of Disease study for schizophrenia: trends from 1990 to 2021 and projections to 2050. Front Psychiatry. 2025;16:1629032. doi:10.3389/fpsyt.2025.1629032 2. Charlson FJ, Ferrari AJ, Santomauro DF, et al. Global Epidemiology and Burden of Schizophrenia: Findings From the Global Burden of Disease Study 2016. Schizophr Bull. Oct 17 2018;44(6):1195–1203. doi:10.1093/schbul/sby058 3. Owen MJ, Sawa A, Mortensen PB. Schizophrenia. Lancet. Jul 2 2016;388(10039):86–97. doi:10.1016/s0140-6736(15)01121-6 4. Lim DXE, Yeo SY, Chia ZYA, Fernandis AZ, Lee J, Chua JJE. Schizophrenia: Genetics, neurological mechanisms, and therapeutic approaches. Neural Regen Res. Mar 1 2026;21(3):1089–1103. doi:10.4103/nrr.Nrr-d-24-01375 About Hansoh Pharma Hansoh Pharma is a leading innovation-driven pharmaceutical enterprise in China. With the mission of "continuous innovation for better life", the company focuses on major disease therapeutic areas such as oncology, metabolism, immunology, central nervous system (CNS) and anti-infectives. Hansoh Pharma has launched 7 innovative medicines that generate product sales in China, with the revenue from innovative medicines and collaborative products exceeding 80%, forming a rich product pipeline. The company has consistently ranked among the top 100 global pharmaceutical companies and is recognized as one of the top 3 pharmaceutical R&D enterprises in China, and is designated as a National Key High-Tech Enterprise and a National Technology Innovation Demonstration Enterprise. Hansoh Pharma was listed on the Hong Kong Stock Exchange in June 2019 (stock code: 03692.HK). Statements 1. This announcement is intended for healthcare professionals only and not for advertising purposes.2. Hansoh Pharma does not recommend the use of any unapproved drugs or off-label indications, nor does it make recommendations regarding any drug or indication.3. The information provided in this announcement is for reference only; please follow the advice or guidance of a physician or other healthcare professional. Any treatment-related decisions made by healthcare professionals should be based on the specific circumstances of the patient and should be used in accordance with the instructions for the drug.4. For more detailed information about any company products, medical treatments, or diseases, please consult a healthcare professional. Forward-Looking Statements This press release is intended to provide information about Hansoh Pharmaceutical Group Co., Ltd. and its affiliates, including their subsidiaries (collectively referred to as "Hansoh Pharma"). It does not constitute a disclosure of information about Hansoh Pharma or any investment recommendations.The information contained in this release may include forward-looking statements related to Hansoh Pharma's business and product prospects, as well as its plans, beliefs, expectations, and strategies. These statements are predictions based on speculative assumptions and are not guarantees of future performance. They are subject to risks and uncertainties, such as scientific, commercial, political, economic, financial, legal factors as well as competitive environment and social conditions, many of which are beyond Hansoh Pharma's control and difficult to predict, thus actual results may differ significantly from what is stated here, and past securities price trends should not be used as a guide for future market conditions. As such, investors should exercise caution when using this information to make investment decisions. Phrases such as "commit," "expect," "believe," "predict," "anticipate," "forecast," "intent,"“project,” “may,” “will,” “should,” “plan,” “could,” “continue,” “target,” “contemplate,” “estimate,” “guidance,” “possible,” “potential,” “pursue,”“likely,”and words and terms of similar terms substance used in connection with any discussion of future plans, actions or events indicate forward-looking statements.Hansoh Pharma does not commit to or guarantee the accuracy, timeliness, or completeness of forward-looking information and assumes no obligation to update or revise these forward-looking statements. Neither Hansoh Pharma nor any of its directors, employees, or agents will be responsible for any forward-looking statements that prove to be inaccurate or unachievable and any losses or damages incurred by users due to reliance on the information provided herein, including but not limited to direct, incidental, indirect, or punitive damages.All information in this press release is current as of the date of release. Hansoh Pharma assumes no responsibility to update or revise this information in light of new developments, future events, or other circumstances, except as required by law. Additionally, Hansoh Pharma reserves the right to make changes, corrections, or discontinuations to all or part of the content of this press release at any time without notice. For information specifically related to the listed company, investors are encouraged to refer to the announcements and financial reports of Hansoh Pharma (03692.HK).

Clinical ResultPhase 2

12 Oct 2026

·www.biospace.com

Tortugas Neuroscience Announces Positive Phase 2b Results for Obuprazine (TRTL-107) in Schizophrenia Demonstrating Broad Symptom Improvement and Rapid Onset

Trial met its primary endpoint, with each dose group showing rapid improvement in Positive and Negative Syndrome Scale (PANSS) total score and achieving statistically significant and clinically meaningful improvement versus placebo at Day 42 (p<0.0001) Secondary endpoints assessing positive symptoms, negative symptoms, and the Marder cognitive factor also demonstrated statistically significant and clinically meaningful improvements compared to placebo Obuprazine was generally well-tolerated with low rates of treatment discontinuation due to adverse events (2.5% for placebo vs. approximately 2.1% for obuprazine-treated) Results presented at the 2026 European College of Neuropsychopharmacology Congress FRAMINGHAM, Mass.--(BUSINESS WIRE)--Tortugas Neuroscience (“Tortugas”), a clinical-stage biotechnology company focused on developing transformative therapies for central nervous system (CNS) disorders, today announced positive Phase 2b trial results for obuprazine (TRTL-107), the company’s investigational treatment for schizophrenia. Results from the Phase 2b trial conducted by Tortugas’ partner, Hansoh Pharma, and presented this past weekend at the 2026 European College of Neuropsychopharmacology Congress (ECNP), demonstrated statistically significant and clinically meaningful improvements in Positive and Negative Syndrome Scale (PANSS) Total Score for each dose group, rapid onset of clinical response, broad improvements across multiple symptom domains, and a generally favorable tolerability profile. Each obuprazine dose group demonstrated statistically significant and clinically meaningful improvements versus placebo on the primary endpoint of change from baseline in PANSS Total Score at Day 42, with evidence of rapid onset of clinical response. The 1.5-3.0 mg dose group produced the largest treatment effect, with a least-squares mean change from baseline of -28.6 points compared with -11.9 points for placebo, representing a placebo-adjusted difference of -16.7 points (p<0.0001). The 4.5-6.0 mg and 6.0-9.0 mg dose groups demonstrated placebo-adjusted differences of -13.2 and -14.7 points (p<0.0001), respectively. Based on PANSS responder rates (≥50% reduction from baseline), the 1.5-3 mg and 4.5-6 mg dose groups demonstrated a notable increase in responder rates compared with both placebo and aripiprazole as early as Day 14. “These Phase 2b trial results represent one of the most compelling efficacy datasets reported in schizophrenia in recent years and provide strong evidence for the potential of obuprazine to deliver clinically meaningful efficacy across symptom domains, with an early onset of clinical response,” said Jeff Jonas, Chief Executive Officer of Tortugas Neuroscience. “We believe the consistency and breadth of these results position obuprazine as a potentially differentiated treatment option in a market with significant unmet need. These data represent a major milestone for Tortugas and strengthen our confidence as we advance the program toward the next stage of development.” The randomized, double-blind, placebo- and active-reference-controlled Phase 2b trial enrolled 363 Chinese adults with acute schizophrenia requiring hospitalization within two months prior to screening across 24 clinical centers. Patients were randomized to one of five treatment groups: 1.5–3.0 mg, 4.5–6.0 mg, 6.0–9.0 mg, aripiprazole, or placebo. The primary endpoint was change from baseline in PANSS total score at Day 42. Key Study Highlights: Each dose group achieved statistically significant and clinically meaningful improvement versus placebo. The 1.5-3.0 mg dose demonstrated a 16.7-point placebo-adjusted improvement in PANSS total score at Day 42 (p<0.0001). The 4.5-6.0 mg and 6.0-9.0 mg groups demonstrated placebo-adjusted improvements of 13.2 and 14.7 points (p<0.0001), respectively. Based on PANSS responder rates (≥50% reduction from baseline), the 1.5-3 mg and 4.5-6 mg dose groups demonstrated a notable increase in responder rates versus both placebo and aripiprazole as early as Day 14, supporting a rapid onset of clinical response. At Day 42, each obuprazine dose group demonstrated statistically significant and clinically meaningful improvement versus placebo across PANSS positive symptom subscale, negative symptom subscale, and Marder cognitive factor scores. At 1.5-3.0 mg, placebo-adjusted improvements were 5.3 points on the PANSS positive symptom subscale and 4.4 points on the PANSS negative symptom subscale (both p<0.0001). Obuprazine demonstrated numerically greater efficacy than aripiprazole across multiple endpoints, including the primary endpoint. Obuprazine was generally well tolerated, with discontinuation rates comparable to placebo (2.5% for placebo vs. approximately 2.1% for obuprazine-treated patients). “We believe that obuprazine’s differentiated pharmacology, including its functional modulation of dopamine D2, D3, and 5-HT1A receptors, coupled with potent antagonism of serotonin 5-HT2A receptors, may support broad control across multiple symptom domains while potentially addressing tolerability limitations,” said Al Robichaud, Ph.D., President and Head of Research & Development at Tortugas. “Importantly, the Phase 2b results are consistent with this pharmacologic profile, with obuprazine demonstrating robust results across multiple symptom domains and a favorable tolerability profile. We are particularly encouraged by the results observed across dose levels, which may provide physicians flexibility to optimize treatment based on individual patient needs.” The company plans to submit a U.S. Investigational New Drug (IND) application for TRTL-107. Detailed results from the Phase 2b study are expected to be submitted for publication in a peer-reviewed journal. About Obuprazine (TRTL-107) Obuprazine (or TRTL-107), Tortugas’ most advanced product candidate, is a dopamine D2/D3 receptor partial agonist, 5-HT2A receptor antagonist and 5-HT1A receptor partial agonist for the treatment of schizophrenia. Tortugas holds global commercial development rights for obuprazine, excluding Greater China. Hansoh Pharma has successfully completed multiple clinical trials for obuprazine to date, including this recent Phase 2b trial. Despite the availability of multiple antipsychotic therapies, many patients continue to experience persistent symptoms, inadequate response, treatment discontinuation, and functional impairment, underscoring the need for new treatments that can deliver broad symptom control while maintaining favorable tolerability. The efficacy and tolerability pro in this study support the potential for obuprazine to become a differentiated treatment option for patients living with schizophrenia. About Tortugas Neuroscience Tortugas Neuroscience is a clinical-stage CNS-focused biotech company dedicated to developing medicines that address diseases of the brain. With a strategic focus on clinically validated mechanisms of action with well-defined development and regulatory pathways, Tortugas Neuroscience is committed to creating therapies with meaningful impact for patients worldwide. For more information, please visit: Contacts Media Contact Rachel Ford Hutman Rachel@fordhutmanmedia.com Investor Relations investors@tortugasneuro.com

Clinical ResultPhase 2

12 Oct 2026

·healthcare-digital.com

Teva Wins FDA Approval For Schizophrenia Innovation

Weltruza is a monthly long-acting injectable requiring no monitoring period or oral supplementation. Credit: Teva Teva’s Weltruza was “developed with the patient in mind from day one,” says Chris Fox, Executive VP, as the company advances its “Pivot to Growth” strategy As World Mental Health Month draws global support for people with mental health conditions, healthcare providers are focusing on patient-centric drug innovation to provide a wider range of comfortable, accessible treatment options. The FDA approval of Weltruza, produced by leading generic pharmaceutical provider Teva, signifies a milestone within schizophrenia treatment. Teva describes Weltruza as the first once-monthly subcutaneous olanzapine formulation for adults with schizophrenia: combining the antipsychotic with long-acting injectable technology, it offers an alternative to daily oral medicines, which patients can face difficulty adhering to. “I’m incredibly proud of our R&D team and everyone across Teva who helped make this possible,” writes Eric A. Hughes, CMO and Head of R&D at Teva, on LinkedIn. “I’m especially grateful to the patients who participated in our clinical trials and the investigators who partnered with us along the way.” Eric A. Hughes, CMO and Head of R&D at Teva. Credit: LinkedIn For Teva, Weltruza’s impending rollout represents a significant strategic achievement as the pharmaceutical company pivots towards developing its pipeline of innovative medicines. Key facts - Schizophrenia An estimated 2.2 million people in the US currently live with schizophrenia, a chronic mental health condition. The National Institute of Mental Health cites an average of 28.5 potential years of life lost among people affected by the condition. Schizophrenia can affect thinking, perception, emotional expression, motivation and social functioning, and frequently co-occurs with cardiovascular disease and diabetes. The condition costs the US around US$366.8bn annually, including US$291.8bn in indirect costs, including lost productivity. The antipsychotics olanzapine, aripiprazole and risperidone constitute the main treatment pathway for schizophrenia, typically delivered through daily oral medications. A patient-friendly schizophrenia treatment For people living with schizophrenia, maintaining a treatment plan involves navigating appointments, medication routines, side effects and the practical demands of everyday life. Traditional treatment centres around daily oral doses of antipsychotic formulations to reduce symptoms, which include disruptive hallucinations and delusions. However, maintaining a consistent administration schedule can present a challenge, increasing the risk of relapse. “Adherence continues to be a major barrier to stability,” explains Christoph Correll, Clinical Professor of Psychiatry at the Zucker School of Medicine at Hofstra/Northwell. Christoph Correll, Clinical Professor of Psychiatry at the Zucker School of Medicine at Hofstra/Northwell. Credit: LinkedIn Olanzapine is also available as an intramuscular injectable, but administration requires post-injection monitoring and oral supplementation, which can prove disruptive. Weltruza is an extended-release injectable suspension, delivered once a month. The drug’s delivery platform uses SteadyTeq, a proprietary copolymer technology developed by Medincell, to enable controlled, sustained release of olanzapine. Requiring no loading doses, extended monitoring periods or additional booster medications, Teva aims to offer a lower-risk, reduced-disruption treatment option. For some patients, Weltruza could provide a more accessible treatment routine: one that fits more comfortably around work, family responsibilities and community engagement. “Weltruza was developed with the patient in mind from day one,” says Chris Fox, Executive Vice President and Head of Innovative Franchise at Teva. Chris Fox, Executive Vice President and Head of Innovative Franchise at Teva. Credit: Teva The FDA decision was supported by SOLARIS, an eight-week placebo-controlled Phase 3 trial. Teva reports that Weltruza secured improvements across three clinical measures: the Positive and Negative Syndrome Scale (PANSS), the Clinical Global Impression–Severity scale (CGI-S) and the Personal and Social Performance scale (PSP). These assess schizophrenia symptoms, overall illness severity and social functioning, respectively. “It is a powerful demonstration of what is possible when the needs of the patient guide the development of a truly innovative medicine,” Chris continues. “Pivot to Growth”: Teva’s portfolio shift For Teva, Weltruza’s approval represents more than a milestone in schizophrenia treatment; it also encompasses a milestone achievement within the company’s long-term growth strategy. As a major generic drug provider, Teva faces several growth constraints, owing to a lack of flexibility and the effects of price erosion on generic margins. In 2023, the company announced “Pivot to Growth” – its strategic shift towards innovative medicines, in order to broaden its portfolio and secure new growth opportunities. The key targets of Teva’s strategy include: Target growth through innovative medicines, in order to reduce reliance on its traditional generics pipeline. Maintain generics as a core source of cash flow, while transferring research emphasis towards complex generics, biosimilars and higher-value opportunities . Prioritise R&D and develop differentiated treatments in areas like neuroscience and immunology to invest in long-term growth. Reduce costs by US$700m by simplifying operations and improving profit margins. Secure over US$5bn in innovative medicines revenue by 2030. By scaling its existing novel medicines – including Austedo for involuntary movements and Ajovy for migraine prevention – Teva secured a 6% increase in revenues by 2024, and by 2025 its innovative portfolio constituted 30% of its core growth. The approval of Weltruza marks a significant step as the company continues to diversify its product pipeline and expand its presence in neuroscience. “This milestone truly reflects our Pivot To Growth strategy in action: accelerating our innovative pipeline through disciplined execution and translating promising science into meaningful therapies,” concludes Richard Francis, CEO of Teva, discussing Weltruza’s approval on LinkedIn. Richard Francis, President and CEO of Teva. Credit: Teva “Together, we are continuing to build momentum across our innovative medicines portfolio to deliver impact where patients need it most.” Teva’s key partners MedinCell CEO: Christophe Douat | HQ: Jacou, France Medincell is a biopharmaceutical company based in France that develops long-acting injectable medicines using proprietary technologies. Its SteadyTeq platform enables controlled, sustained drug release and underpins Weltruza. Medincell collaborates with Teva on long-acting injectable treatments, with Weltruza following UZEDY as a second US-approved medicine arising from their partnership. The Zucker School of Medicine CEO: Michael J. Dowling | HQ: Hempstead, NY The Zucker School of Medicine at Hofstra/Northwell is a medical school in New York affiliated with Northwell Health. Psychiatrist Christoph Correll, a clinical professor at the school, served as coordinating investigator for the SOLARIS clinical programme supporting Weltruza's development. The academic and clinical research setting connects the medicine's development with evidence generation in schizophrenia. Samsung Bioepis CEO: Kyung-Ah Kim | HQ: Incheon, South Korea Samsung Bioepis is a biopharmaceutical company focused on developing biosimilar medicines. Its strategic partnership with Teva covers the development and commercialisation of biosimilar candidates in agreed markets. Samsung Bioepis leads development, regulatory registration and manufacturing under the arrangement, while Teva leads commercialisation. Company portals Teva Pharmaceutical Executives Chris Fox Executive Vice President US Commercial, Head of Innovative Franchise Eric A. Hughes, MD, PhD Member Board of Directors Richard Francis President and Chief Executive Officer

Drug ApprovalPhase 3License out/in

100 Deals associated with Aripiprazole

External Link

KEGG	Wiki	ATC	Drug Bank
D01164	Aripiprazole	N05AX12	DB01238

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Autism Spectrum Disorder	Japan	Otsuka Holdings Co., Ltd.	28 Sep 2016
Tourette Syndrome	United States	Otsuka Pharmaceutical Co., Ltd.	12 Dec 2014
Tourette Syndrome	United States	Otsuka Pharmaceutical Development & Commercialization, Inc.	12 Dec 2014
Depressive Disorder	Japan	Otsuka Holdings Co., Ltd.	14 Jun 2013
Autistic Disorder	United States	Otsuka Pharmaceutical Co., Ltd.	19 Nov 2009
Irritable Mood	United States	Otsuka Pharmaceutical Co., Ltd.	19 Nov 2009
Depressive Disorder, Major	United States	Otsuka Pharmaceutical Co., Ltd.	16 Nov 2007
Depressive Disorder, Major	United States	Otsuka Pharmaceutical Development & Commercialization, Inc.	16 Nov 2007
Agitation	United States	Otsuka Pharmaceutical Co., Ltd.	29 Oct 2007
Bipolar Disorder	United States	Otsuka Pharmaceutical Development & Commercialization, Inc.	10 Dec 2004
Bipolar I disorder	Australia	Otsuka Australia Pharmaceutical Pty Ltd.	21 May 2003
Mania	Australia	Otsuka Australia Pharmaceutical Pty Ltd.	21 May 2003
Schizophrenia	United States	Otsuka Pharmaceutical Co., Ltd.	15 Nov 2002

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Depression, Postpartum	Phase 3	Canada	Bristol Myers Squibb Co.	01 Jun 2011
Bipolar and Related Disorders	Phase 3	United States	Otsuka Pharmaceutical Development & Commercialization, Inc.	01 Jul 2010
Bipolar and Related Disorders	Phase 3	Bulgaria	Otsuka Pharmaceutical Development & Commercialization, Inc.	01 Jul 2010
Bipolar and Related Disorders	Phase 3	Croatia	Otsuka Pharmaceutical Development & Commercialization, Inc.	01 Jul 2010
Bipolar and Related Disorders	Phase 3	Hungary	Otsuka Pharmaceutical Development & Commercialization, Inc.	01 Jul 2010
Bipolar and Related Disorders	Phase 3	India	Otsuka Pharmaceutical Development & Commercialization, Inc.	01 Jul 2010
Bipolar and Related Disorders	Phase 3	Malaysia	Otsuka Pharmaceutical Development & Commercialization, Inc.	01 Jul 2010
Bipolar and Related Disorders	Phase 3	Philippines	Otsuka Pharmaceutical Development & Commercialization, Inc.	01 Jul 2010
Bipolar and Related Disorders	Phase 3	Poland	Otsuka Pharmaceutical Development & Commercialization, Inc.	01 Jul 2010
Bipolar and Related Disorders	Phase 3	Romania	Otsuka Pharmaceutical Development & Commercialization, Inc.	01 Jul 2010

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02977299 (ASCERTAIN-TRD \| ASCERTAINTRD, CTgov)	Phase 4	Depressive Disorder, Treatment-Resistant	278	Aripiprazole (Aripiprazole Augmentation)	cpgvphssfp(sjiwmzhvkv) = cuvelortij qhmzkfjven (aqwxjbbwzu, 1.1) View more	-	09 Jul 2026
				Repetitive transcranial magnetic stimulation (rTMS) (rTMS Augmentation)	cpgvphssfp(sjiwmzhvkv) = secppnfwql qhmzkfjven (aqwxjbbwzu, 1.3) View more
EAN2026	Not Applicable	Tourette Syndrome	128	Aripiprazole	bqmxfevjkv(fdnctzzcis) = nwpsyrefvq snqemiljhe (cehqxdshiy ) View more	Negative	26 Jun 2026
NCT00102479 (CTgov)	Phase 1	Mania \| Schizophrenia	21	Aripiprazole (Aripiprazole 20 mg)	nzadrakhba = rqkeackalc rrmnxgypic (vsxdwnpcna, enefzahnnw - pzogvxpyik) View more	-	22 Jun 2026
				Aripiprazole (Aripiprazole 25 mg)	nzadrakhba = kuwklssiay rrmnxgypic (vsxdwnpcna, bcizbgpenv - ybuvcawlrn) View more
NCT00705783 \| NCT01663532 (Pubmed \| J Clin Psychiatry)	Phase 3	Schizophrenia	335	Aripiprazole Once-Monthly 400 mg	muavcghuzy(owslhuwrnv) = ymbztxejmd vbhsfsslwc (okmnjxlliz ) View more	Positive	13 May 2026
				Placebo	muavcghuzy(owslhuwrnv) = gaandiywgv vbhsfsslwc (okmnjxlliz ) View more
NCT01710709 (Pubmed \| J Clin Psychiatry)	Phase 4	Bipolar I disorder Maintenance	464	Aripiprazole Once-Monthly 400 mg (Black/African American)	auyngobtfz(crahmvbvdq) = changes in EPS scores were minimal in all groups cjctxvcqlf (qowhqgvdnp ) View more	Positive	09 Mar 2026
IRCT201305233930N26 (Pubmed \| BMC Psychiatry)	Phase 2	Schizophrenia	60	Aripiprazole	ncwuiqrmjm(reuclqstjo) = wsgwpukzky vgecuromko (gsdbftqjdg, 0.2) View more	Positive	18 Nov 2025
				Risperidone	ncwuiqrmjm(reuclqstjo) = didcodkovx vgecuromko (gsdbftqjdg, 0.3) View more
NCT00288353 (CTgov)	Phase 3	Bipolar Disorder \| Schizoaffective disorder \| Schizophrenia	48	Aripiprazole (Abilify (Aripiprazole (Abilify))	yppwsestnz(ffbrsbccvv) = ryblaiqmty pgztcrfuqy (lokacqmiqu, 0.7) View more	-	02 Oct 2025
				Ziprasidone (Geodon) (Ziprasidone (Geodon))	yppwsestnz(ffbrsbccvv) = oemllwvage pgztcrfuqy (lokacqmiqu, 0.6) View more
P11-6.001 (AAN2025)	Not Applicable	Tourette Syndrome First line	1,684	D2 receptor antagonists (D2RAs)	nwyyeflnik(erhhynjtme) = lzzruhwgsw wdoxhvfpzg (kmvkgvuyjy )	Negative	07 Apr 2025
NCT02918370 (CTgov)	Phase 3	Alcoholism \| Bipolar Disorder \| Bipolar I disorder	75	Aripiprazole (Aripiprazole)	gylrmvznmj(injpuddpof) = fynojmaktf xbuxiufhzx (gllyceimcu, 5.86) View more	-	19 Sep 2024
				Placebo (Placebo)	gylrmvznmj(injpuddpof) = nwmcvwaajn xbuxiufhzx (gllyceimcu, 4.23) View more
NCT06372210 (CTgov)	Not Applicable	Bipolar I disorder \| Depressive Disorder, Major \| Schizophrenia ... View more	54	Placebo (Cohort 1: D-Tect Patch + Placebo-embedded IEM)	kpdknvitam = ncxwsysjod tscwhukuqi (gkjtxorovb, jjwjkfmuwt - nkzoevqlek) View more	-	31 Jul 2024
				Aripiprazole (Cohort 2: D-Tect Patch + Abilify MyCite® (Aripiprazole-embedded IEM))	khfmtjjvjj(mquxovlgir) = xhjcgxxnvz hoxjricyre (ttjhotptcr, xdnirmjomk - ywmjgllspd) View more

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