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

Other DiseasesNervous System Diseases

Active Indication

Depressive DisorderAgitation in DementiaAgitation+ [6]

Inactive Indication

Anxiety DisordersAttention Deficit and Disruptive Behavior DisordersAttention Deficit Disorder With Hyperactivity+ [12]

Originator Organization

Otsuka Pharmaceutical Co., Ltd.

Active Organization

Hangzhou Bio-Sincerity Pharma-Tech Co., Ltd.Otsuka Pharmaceutical Development & Commercialization, Inc.

H. Lundbeck A/S

+ [30]

Inactive Organization-

License Organization

H. Lundbeck A/S

Otsuka Holdings Co., Ltd.

Drug Highest PhaseApproved

First Approval Date

United States (10 Jul 2015),

Depressive Disorder, MajorSchizophrenia

RegulationPriority Review (United States), Fast Track (United States)

Structure/Sequence

Molecular FormulaC25H27N3O2S

InChIKeyZKIAIYBUSXZPLP-UHFFFAOYSA-N

CAS Registry913611-97-9

199

Clinical Trials associated with Brexpiprazole

ChiCTR2600117345

/ Not yet recruitingNot ApplicableIIT

A Randomized Controlled Trial of Brexpiprazole versus Aripiprazole in the Treatment of Major Depressive Disorder with Psychotic Symptoms in Adolescents

Start Date01 Jan 2026

Sponsor / Collaborator-

CTR20255002

/ CompletedNot Applicable

布瑞哌唑口溶膜在健康参与者中的生物等效性试验

[Translation] Bioequivalence study of biriperazole oral disintegrating film in healthy participants

主要目的：本试验旨在研究单剂量空腹和餐后口服上海现代制药股份有限公司生产的布瑞哌唑口溶膜（2mg）的药代动力学特征，并以Otsuka Pharmaceutical Co Ltd持证的布瑞哌唑片(Rexulti ®,2mg)作为参比制剂，比较受试制剂与参比制剂的药代动力学特征，评价两种制剂在空腹或餐后给药条件下的生物等效性。次要目的：观察受试制剂和参比制剂在健康参与者中的安全性。

[Translation]

Primary Objective: This study aimed to investigate the pharmacokinetic characteristics of a single-dose oral disintegrating film (2 mg) manufactured by Shanghai Modern Pharmaceutical Co., Ltd., administered on an empty stomach and after a meal. The pharmacokinetic characteristics of the test formulation and the reference formulation were compared, and the bioequivalence of the two formulations under fasting or postprandial administration conditions was evaluated. Secondary Objective: To observe the safety of the test and reference formulations in healthy participants.

Start Date02 Dec 2025

Sponsor / Collaborator

Shanghai Shyndec Pharmaceutical Co., Ltd.

CTR20254466

/ CompletedNot Applicable

布瑞哌唑口崩片在中国健康研究参与者中餐后状态下随机、开放、单剂量、两序列、两周期、交叉生物等效性研究

[Translation] A randomized, open-label, single-dose, two-sequence, two-period, crossover bioequivalence study of birepiprazole orally disintegrating tablets in participants of the Chinese Health Study under postprandial conditions.

主要目的：健康研究参与者在餐后状态下，单次口服布瑞哌唑口崩片受试制剂（2mg，河北龙海药业有限公司）与参比制剂[2mg，大塚製薬株式会社（Otsuka Pharmaceutical Co., Ltd.）]后，比较两制剂在体内血药浓度及主要药代动力学参数，评价两制剂的生物等效性。次要目的：评价两制剂在健康研究参与者中餐后状态下的安全性。

[Translation]

Primary objective: To evaluate the bioequivalence of birepiperazole orally disintegrating tablets (2 mg, Hebei Longhai Pharmaceutical Co., Ltd.) and the reference formulation (2 mg, Otsuka Pharmaceutical Co., Ltd.) after a single oral dose in healthy study participants under postprandial conditions, comparing their plasma concentrations and major pharmacokinetic parameters. Secondary objective: To evaluate the safety of the two formulations in healthy study participants under postprandial conditions.

Start Date10 Nov 2025

Sponsor / Collaborator

Hebei Longhai Pharmaceutical Co. Ltd.

100 Clinical Results associated with Brexpiprazole

100 Translational Medicine associated with Brexpiprazole

100 Patents (Medical) associated with Brexpiprazole

598

Literatures (Medical) associated with Brexpiprazole

01 Mar 2026·Clinical Drug Investigation

Efficacy of Brexpiprazole in Participants with Agitation Associated with Dementia Due to Alzheimer’s Disease: Pooled Analysis of Randomized Controlled Trials

Article

Author: Hefting, Nanco ; Chumki, Sanjeda R ; Grossberg, George T ; Such, Pedro ; Cummings, Jeffrey L ; Brubaker, Malaak ; Wang, David ; Chang, Denise ; Zhang, Zhen

OBJECTIVE:

This analysis aimed to evaluate the efficacy of brexpiprazole 2 or 3 mg/day for the treatment of agitation associated with dementia due to Alzheimer's disease, on the basis of pooled clinical trial data.

METHODS:

Data were pooled from two similarly designed, phase 3, 12-week, multicenter, randomized, double-blind, placebo-controlled trials of fixed-dose brexpiprazole in participants in care facilities or community-based settings who had agitation associated with dementia due to Alzheimer's disease. Efficacy outcomes included Cohen-Mansfield Agitation Inventory (CMAI) total score (which measures the frequency of 29 different agitation symptoms), Clinical Global Impression-Severity of illness (CGI-S) score, CMAI factor scores (aggressive behaviors, physically nonaggressive behaviors, and verbally agitated behaviors), and response rates. A sensitivity analysis included a third trial with flexible dosing.

RESULTS:

In total, 621 participants were randomized (brexpiprazole, 368; placebo, 253), and completion rates were 320/368 (87.0%) and 225/253 (88.9%), respectively. Mean (SD) baseline CMAI total scores were: brexpiprazole 76.9 (17.2) points and placebo 75.5 (18.0) points. Over 12 weeks, CMAI total scores improved by least squares mean (SE) - 22.8 (0.8) points for brexpiprazole and - 18.3 (1.0) points for placebo, with a least squares mean difference between treatment arms of - 4.50 points (95% CI - 6.90 to - 2.10; p < 0.001; Cohen's d 0.30). CGI-S, CMAI factor, and response analyses also showed greater improvement with brexpiprazole versus placebo. The sensitivity analysis was supportive.

CONCLUSIONS:

Brexpiprazole 2 or 3 mg/day reduced agitation symptoms compared with placebo over 12 weeks in this large, pooled sample of participants with dementia due to Alzheimer's disease.

STUDY REGISTRATION:

ClinicalTrials.gov identifiers: NCT01862640, NCT03548584, and NCT01922258.

01 Mar 2026·JOURNAL OF CLINICAL PSYCHOPHARMACOLOGY

Effects of Adjunctive Brexpiprazole in Major Depressive Disorder Analyzed by Baseline Anxiety Level

Article

Author: Ward, Caroline ; Ismail, Zahinoor ; Habert, Jeffrey ; Chokka, Pratap ; Marrache, A. Marilise ; Therrien, François ; Zhang, Zhen ; McIntyre, Roger S.

Purpose/Background::

In patients with major depressive disorder (MDD), anxiety symptoms are common and associated with reduced treatment response. In an 8-week, phase 4, open-label study (ENGAGE), patients with MDD and inadequate antidepressant treatment response showed improvements in patient life engagement, depressive symptoms, and anxiety symptoms following treatment with adjunctive brexpiprazole 0.5 to 2 mg/d. This post hoc analysis of ENGAGE aimed to characterize the utility of adjunctive brexpiprazole in clinically relevant subgroups by baseline anxiety level.

Methods/Procedures::

Baseline anxiety subgroups were based on the 7-item Generalized Anxiety Disorder scale total score: no/mild (<10), moderate (10 to 14), and severe (>14). In each subgroup, changes in the 10-item Inventory of Symptomatology Self-Report (IDS-SR 10 ) Life Engagement subscale score, IDS-SR total score, and other efficacy outcomes were determined. Safety was also analyzed.

Findings/Results::

One hundred twenty patients received adjunctive brexpiprazole, of whom 30 (25.0%) had no/mild anxiety, 43 (35.8%) had moderate anxiety, and 47 (39.2%) had severe anxiety at baseline. On IDS-SR 10 Life Engagement subscale score and IDS-SR total score, improvements (nominal P <0.001) from baseline to week 8 were observed across all subgroups. Improvements were also observed on all other efficacy endpoints (nominal P <0.05 in all subgroups). Incidence of treatment-emergent adverse events was 76.7% (no/mild baseline anxiety), 72.1% (moderate baseline anxiety), and 57.4% (severe baseline anxiety). No new safety signals were observed.

Implications/Conclusions::

Over 8 weeks, adjunctive brexpiprazole was associated with improvements in patient life engagement and depressive symptoms, regardless of baseline anxiety level. This observation may assist clinical decision-making when treating patients with MDD with/without anxiety symptoms.

01 Mar 2026·Neuropsychopharmacology reports

Synergistic Effect of Combination Treatment of Brexpiprazole and Nalmefene on Ethanol Intake in Rats

Article

Author: Kakumoto, Yusuke ; Amada, Naoki ; Suzuki, Mikio ; Nakamura, Mai ; Futamura, Takashi ; Maeda, Kenji ; Ohgi, Yuta

ABSTRACT:

Aims:

Reduction of alcohol consumption is one of treatment goals to reduce harm among individuals with alcohol use disorder (AUD), a major worldwide health problem, for which nalmefene, an opioid receptor modulator, is used. In this study, the effect of nalmefene on ethanol (EtOH) intake, already reported, was evaluated in Wistar rats, as validation. In addition, effects of brexpiprazole, serotonin–dopamine activity modulator, alone and in combination with nalmefene were evaluated to investigate further treatment option for AUD.

Methods:

During the first training phase, animals had 10% EtOH as the only drinking fluid available for the first 5 days. Then, the animals had a 24‐h free choice between EtOH and water for 39 days which is named the continual access paradigm. Thereafter, the limited access paradigm, which restricted the availability of 10% EtOH to 1 h every day, was carried out for 114 days. EtOH intake (g/kg/1 h) was determined by weighing 10% EtOH bottles before and after the limited EtOH access every day. Brexpiprazole (0.01–0.1 mg/kg, orally) and nalmefene (0.04–0.4 mg/kg, subcutaneously) were daily administered to rats 1 h or 20 min before starting the limited access paradigm for consecutive 4 days, respectively. The combination effect was evaluated using each subeffective dose of brexpiprazole and nalmefene which did not significantly reduce EtOH intake. The daily and the average EtOH intake for 4 days before and during the treatment with test compounds were statistically analyzed.

Results:

Brexpiprazole (0.1 mg/kg) and nalmefene (0.4 mg/kg) alone significantly decreased EtOH intake. Moreover, the combination of subeffective doses of brexpiprazole (0.01 mg/kg) and nalmefene (0.04 mg/kg) significantly and synergistically decreased EtOH intake.

Conclusion:

These data suggest that brexpiprazole may have the potential to decrease alcohol intake in AUD patients. In addition, brexpiprazole may have a synergistic therapeutic effect with nalmefene in those patients.

162

News (Medical) associated with Brexpiprazole

08 Apr 2026

·www.fiercepharma.com

J&J's Tremfya retakes TV drug ad spending crown from AbbVie

It was a big drop for Novo Nordisk’s obesity drug Wegovy, which fell six places to ninth position. Johnson & Johnson’s immunology drug Tremfya is looking to challenge AbbVie’s dominance in 2026, securing the top spot as the biggest TV drug ad spender in March.J&J spent $50.3 million on TV ads for its drug, according to data shared with Fierce Pharma Marketing from analysts at iSpot.tv. That’s up more than $10 million from February, when it ranked second in spending.Tremfya began the year in the top spot in January and is on an early course to rival the dominance of AbbVie, which has seen one of its blockbuster drugs claim the annual crown as the top TV spender for each of the past four years.AbbVie is still in the fight, however, taking the podium spots behind J&J with its immunology duo Skyrizi and Rinvoq, spending $42.1 million and $36.3 million, respectively. Rinvoq fell two spots after taking the top position in February.J&J is back again in fourth with its atypical antipsychotic drug Caplyta, with the drug up two spots from its February ranking and a $5.5 million increase in spending month over month.Eli Lilly’s obesity drug Zepbound comes in fifth, up two spots, with its highest level of spending going to its TV ad “Watch This: Head-to-Head,” which accounted for $12.3 million in March.Lilly returns in sixth alongside partner Boehringer Ingelheim with their diabetes and kidney disease drug Jardiance, while Sanofi and Regeneron’s megablockbuster immunology drug Dupixent takes seventh place.Lundbeck and Otsuka's neurology drug missed the top 10 in February but returned to eighth place in March.It was a big drop for Novo Nordisk’s obesity drug Wegovy, which fell six places to ninth, with spending sinking from $39.5 million in February to $13.5 million last month.Bristol Myers Squibb’s schizophrenia drug snuck into the final spot after not ranking in the top 10 in February.Check out the top 10 below, as compiled from analysts at iSpot.tv.1. Tremfya Movement: Up one spotWhat is it? Johnson & Johnson’s immunology drugEst. national linear TV ad spend: $50.3 million (up from $39.8 million in February)UC/Crohn’s disease: $33 millionPsoriasis: $5 millionPsoriatic Arthritis: $12.3 millionTop TV network by spend share of voice (SOV): ABC (17.69%)Top TV program by spend SOV: Men’s college basketball (5.34%)Number of spots: 11 (three psoriasis, five UC/Crohn’s disease, three psoriatic arthritis)Biggest-ticket ad: “Relentless Weed” (est. $15.3 million) 2. Skyrizi Movement: Up two spotsWhat is it? AbbVie’s immunology drug Est. national linear TV ad spend: $42.1 million (up from $37 million in February)UC/Crohn’s disease: $21.9 millionPsoriasis: $15.8 millionPsoriatic arthritis: $4.3 millionTop TV network by spend SOV: ABC (29.96%)Top TV program by spend SOV: The Oscars (12.16%)Number of spots: Seven (two psoriatic arthritis, three psoriasis, two UC/Crohn’s disease) Biggest-ticket ad: “In the Picture: Control Is Everything” (est. $11.8 million) 3. Rinvoq Movement: Down two spotsWhat is it? AbbVie’s JAK immunology drugEst. national linear TV ad spend: $36.3 million (down from $41 million in February)Top TV network by spend SOV: ABC (22.42%)Top TV program by spend SOV: Today (5.46%) Number of spots: Five (one arthritis, one UC/Crohn’s disease, three eczema)Biggest-ticket ad: “Another Day” (est. $13 million) 4. Caplyta Movement: Up two spotsWhat is it? Johnson & Johnson’s atypical antipsychotic drugEst. national linear TV ad spend: $23.4 million (up from $17.9 million in February)MDD: $23.2 millionBipolar: $154,000Top TV network by spend SOV: NBC (15.15%)Top TV program by spend SOV: Men’s college basketball (20.33%)Number of spots: Five (two bipolar, three MDD) Biggest-ticket ad: “Let in the Lyte: More of the Lyte” (est. $9.4 million) 5. ZepboundMovement: Up two spotsWhat is it? Eli Lilly’s GIP/GLP-1 agonist for obesityEst. national linear TV ad spend: $22.9 million (up from $17.2 million in February)Top TV network by spend SOV: ABC (32.12%)Top TV program by spend SOV: Men’s college basketball (43.14%) Number of spots: SevenBiggest-ticket ad: “Watch This: Head-to-Head” (est. $12.3 million) 6. JardianceMovement: Up three spotsWhat is it? Eli Lilly and Boehringer Ingelheim’s diabetes and kidney disease drugEst. national linear TV ad spend: $20.8 million (up from $15 million in February)CKD: $13.4 millionDiabetes: $7.4 millionTop TV network by spend SOV: ABC (24.79%)Top TV program by spend SOV: ABC World News Tonight With David Muir (6.06%)Number of spots: Three (one CKD, two diabetes)Biggest-ticket ad: “Not So Fast: Garden” (est. $13.4 million) 7. DupixentMovement: Up one spotWhat is it? Sanofi and Regeneron’s immunology drugEst. national linear TV ad spend: $19.6 million (up from $15.5 million in February)Eczema: $15 millionAsthma: $4.6 millionGastrointestinal: $16,800Top TV network by spend SOV: ABC (30.44%)Top TV program by spend SOV: Men’s college basketball (39.70%) Number of spots: Eight (three asthma, four eczema, one gastrointestinal) Biggest-ticket ad: “Feel the Heal” (est. $9.6 million) 8. Rexulti (depression)Movement: Not listed last monthWhat is it? Lundbeck and Otsuka’s neurology drugEst. national linear TV ad spend: $16.5 million (up from $13 million in February)Top TV network by spend SOV: CBS (12.99%)Top TV program by spend SOV: NCIS (4.34%)Number of spots: Two Biggest-ticket ad: “Park and Arcade” (est. $14.9 million) 9. WegovyMovement: Down six spots What is it? Novo Nordisk’s obesity drug Est. national linear TV ad spend: $13.5 million (down from $39.5 million in February)Top TV network by spend SOV: ABC (38.16%)Top TV program by spend SOV: Men’s college basketball (56.05%)Number of spots: TwoBiggest-ticket ad: “A New Way” (est. $7.6 million) 10. CobenfyMovement: Not listed last monthWhat is it? Bristol Myers Squibb’s schizophrenia drugEst. national linear TV ad spend: $11.4 million (down from $12.6 million in February)Top TV network by spend SOV: CBS (25.77%)Top TV program by spend SOV: Men’s college basketball (27.69%)Number of spots: TwoBiggest-ticket ad: “Sagan’s Story” (est. $11.4 million)

02 Apr 2026

·allsci.com

Alto discontinues transdermal PDE4 inhibitor after Phase II failure in schizophrenia-linked cognitive impairment

Alto Neuroscience (NYSE: ANRO) reported that ALTO-101 did not meet its primary EEG or cognitive endpoints versus placebo in a Phase II proof-of-concept study in cognitive impairment associated with schizophrenia (CIAS), prompting the company to discontinue independent development of the asset and redirect resources toward its lead program, ALTO-207, in treatment-resistant depression. The Phase II trial (NCT06502964) was assessing ALTO-101 — a transdermal PDE4 inhibitor formulation — in adults with CIAS, enrolling 83 participants across the primary analysis set. ALTO-101 produced a near-significant effect on theta inter-trial coherence (theta-ITC), an EEG measure correlated with cognitive performance, in the full analysis set (n=83; Cohen’s d=0.34, p=0.052). In a pre-specified subgroup of more cognitively impaired patients (n=59), the effect on theta-ITC reached nominal significance (d=0.44, p=0.03). The company also noted that theta-ITC improved from day 5 to day 10 of the trial, raising the possibility that a longer treatment duration could yield larger effects, though the primary endpoints were not met and these observations remain exploratory. Tolerability was notable in one respect: nausea and vomiting rates were in line with placebo, a finding the company attributes to the pharmacokinetic profile of the transdermal formulation — a class-specific barrier that has historically constrained PDE4 inhibitor development. High rates of application site skin reactions were observed in both active and placebo arms, suggesting a formulation effect rather than a drug-specific signal. ALTO-101 belongs to the PDE4 inhibitor class, which has long been associated with pro-cognitive effects in preclinical models but has faced tolerability limitations that have restricted clinical utility. The transdermal delivery approach was designed to circumvent the gastrointestinal side effects that have limited oral PDE4 inhibitors. The near-miss on theta-ITC — a measure that the company describes as correlated with cognitive performance across datasets — suggests some pharmacodynamic engagement, but the gap between that signal and statistical significance on primary endpoints is the critical interpretive question. Cross-trial comparisons are limited, but Biogen’s AMPA receptor potentiator BIIB104, a separate CIAS-targeted program that completed Phase II, but also failed to produce sufficient efficacy in this indication. Alto has separately developed a modified-release oral formulation of ALTO-101 with an improved pharmacokinetic and tolerability profile relative to the immediate-release version. The company intends to explore partnering opportunities for this formulation, which is covered by a pending patent application, and believes it may have utility across multiple therapeutic areas beyond CIAS. Within the same press release, Alto indicated that development of ALTO-207 remains on track to begin a Phase IIb study for treatment-resistant depression (TRD) later this year, and is now the company’s top priority. ALTO-207 is a fixed-dose combination of pramipexole, a dopamine D3/D2 agonist, and ondansetron, a 5-HT3 antagonist, designed to enable rapid titration to higher pramipexole doses by suppressing the dose-limiting nausea and vomiting that have historically prevented patients from reaching therapeutically relevant exposures. The planned Phase IIb trial is a randomized, double-blind, placebo-controlled study in approximately 178 adults with TRD who have experienced two to five prior treatment failures, evaluating ALTO-207 as adjunctive therapy. The mechanistic rationale draws on the PAX-D study, published in The Lancet Psychiatry and conducted by the University of Oxford, which reported a Cohen’s d=0.87 effect size for pramipexole versus placebo at 12 weeks in depression — a figure the company characterizes as substantially larger than those seen with currently approved TRD treatments. Alto’s own Phase IIa trial of ALTO-207 met primary and secondary endpoints, and a 2025 FDA meeting is described as having positioned the company to advance toward Phase III and a potential NDA submission. The TRD landscape ALTO-207 is entering contains one truly TRD-specific intranasal therapy — esketamine (Spravato), approved in 2019 and expanded to monotherapy in January 2025 — alongside oral atypical antipsychotic augmenters such as aripiprazole, brexpiprazole, and quetiapine that carry adjunctive MDD labels rather than TRD-specific indications. Olanzapine/fluoxetine (Symbyax) holds a TRD-specific oral label but is associated with metabolic burden. The dopamine D3-preferring agonism of pramipexole is mechanistically distinct from all currently approved options, and the fixed-dose combination strategy with ondansetron addresses the primary tolerability barrier that has previously prevented pramipexole from reaching therapeutic doses in this population. Cross-trial comparisons are limited by differences in patient populations, prior treatment histories, and endpoint definitions, and the PAX-D effect size for pramipexole alone does not directly predict what ALTO-207 will produce in a rigorously controlled registrational-track study. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Phase 2Clinical ResultDrug Approval

27 Mar 2026

·www.biopharmadive.com

Otsuka picks up PTSD drug with $700M Transcend buy

One of the largest drug companies in Japan is looking to, through a $700 million buyout, take control of an experimental medicine that could be useful for treating post-traumatic stress disorder and other psychiatric conditions.On Friday, Otsuka Pharmaceutical announced that its American subsidiary plans to acquire privately held, New York-based Transcend Therapeutics. In addition to the upfront payment, Otsuka offered up to $525 million more if Transcends assets ultimately hit certain sales milestones. The companies expect to complete their deal sometime between April and the end of June.If finalized, the acquisition would hand Otsuka a drug meant to rapidly restore and improve neuroplasticity, or the brains ability to rewire and adjust the connections between neurons. Neuroplasticity impairment is a fundamental component of many psychiatric conditions including PTSD, where chronic stress and trauma can keep brain cell networks stuck in a fear-based survival mode.The active ingredient in Transcends TSND-201 is methylone, an analog of MDMA that was first synthesized three decades ago and widely used as a designer drug.TSND-201 engages with certain transporter proteins that regulate neurotransmitters like serotonin, norepinephrine and dopamine, which, according to Transcend, results in rapid and sustained enhancement of neuroplasticity.Transcend also highlights how its drug doesnt act on a key serotonin receptor that governs mood, cognition and perception. Avoiding that receptor mediates the potential hallucinogenic effects, the company says. Two years ago, Lykos Therapeutics, once a leader in psychedelic drug research, tried unsuccessfully to get the Food and Drug Administration to approve MDMA as a therapy aid for PTSD. For the FDA, a major sticking point was that, because MDMA elicits unmistakable changes to cognition and the senses, most of the participants in Lykos studies were able to decipher if they had been given the drug or a placebo.Results from a mid-stage clinical trial that tested TSND201 in adults with PTSD were published last month in the journal JAMA Psychiatry. Recruitment is now underway for the Phase 3 trial in the U.S.Although treatment options for PTSD remain limited, TSND201 is generating expectations as a potential paradigmshifting therapy in the field of psychiatry, said Makoto Inoue, president and representative director of Otsuka,in a statement Friday.Otsuka is perhaps best known for its antipsychotic medications Abilify Maintena and Rexulti. In its 2024 fiscal year, the company recorded revenue of 2.33 trillion Japanese yen or roughly $15.4 billion with 70% coming from its pharmaceutical unit. That was a more than 15% increase from the year prior, driven in large part by the performances of Abilify Maintena,Rexulti, the cancer treatment Lonsurf and the kidney therapy Jynarque.Otsuka noted in its statement that the way TSND-201 works is distinct from its existing medicines and development programs. Purchasing Transcend, therefore, should expand the company's psychiatry and neurology portfolio and strengthen its position in those fields. Otsuka made similar predictions about its rare disease and immunology research when it acquired Jnana Therapeutics for $800 million back in 2024.Transcend was co-founded in 2021 by Kevin Ryan,founder and CEO of AlleyCorp, a New York venture capital firm that specializes in technology and healthcare investing. Blake Mitchell, a AllyCorp alum himself, and Benjamin Kelmendi, an assistant professor of psychiatry at Yale, are also co-founders. The startup said it had raised around $50 million as of last May. '

AcquisitionPhase 3

100 Deals associated with Brexpiprazole

External Link

KEGG	Wiki	ATC	Drug Bank
D10309	Brexpiprazole	N05AX16	DB09128

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Depressive Disorder	Japan	Otsuka Holdings Co., Ltd.	22 Dec 2023
Agitation in Dementia	United States	Otsuka Pharmaceutical Co., Ltd.	10 May 2023
Agitation	Australia	Lundbeck Australia Pty Ltd.	19 May 2017
Alzheimer Disease	Australia	Lundbeck Australia Pty Ltd.	19 May 2017
Depressive Disorder, Major	United States	Otsuka Pharmaceutical Co., Ltd.	10 Jul 2015
Schizophrenia	United States	Otsuka Pharmaceutical Co., Ltd.	10 Jul 2015

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Psychotic Disorders	NDA/BLA	China	Shanghai Xinfeng Pharmaceutical Co. Ltd.	16 Aug 2024
Stress Disorders, Post-Traumatic	NDA/BLA	United States	Otsuka Pharmaceutical Development & Commercialization, Inc.	25 Jun 2024
Borderline Personality Disorder	Phase 3	United States	Otsuka Pharmaceutical Development & Commercialization, Inc.	13 Jan 2020
Autism Spectrum Disorder	Phase 3	United States	H. Lundbeck A/S	30 Oct 2019
Autism Spectrum Disorder	Phase 3	United States	Otsuka Pharmaceutical Development & Commercialization, Inc.	30 Oct 2019
Recurrent major depressive disorder with atypical features	Phase 3	United States	Otsuka Pharmaceutical Development & Commercialization, Inc.	13 Jul 2018
Bipolar I disorder	Phase 3	United States	Otsuka Pharmaceutical Development & Commercialization, Inc.	14 Sep 2017
Bipolar I disorder	Phase 3	United States	H. Lundbeck A/S	14 Sep 2017
Bipolar I disorder	Phase 3	Bulgaria	H. Lundbeck A/S	14 Sep 2017
Bipolar I disorder	Phase 3	Bulgaria	Otsuka Pharmaceutical Development & Commercialization, Inc.	14 Sep 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06036108 (CTgov)	Phase 1	Schizophrenia	59	Brexpiprazole (Fasting-state Administration)	mkozryhyng(hqyxaxvgqm) = nexmszmxfb enefatjauv (ipfosjagmi, 108.2) View more	-	11 Feb 2026
				Brexpiprazole (Fed-state Administration)	mkozryhyng(hqyxaxvgqm) = gjbdwridww enefatjauv (ipfosjagmi, 156.2) View more
NCT03238326 (Safety and Tolerability of Brexpiprazole in Adolescents With Schizophrenia, CTgov)	Phase 3	Schizophrenia	295	Brexpiprazole (De Novo (Conversion Period))	ajgufytjtm = bpoywtughe rtucjytfmj (vgqjjlgbmx, amymubykau - gkiengxluz) View more	-	04 Feb 2026
				Brexpiprazole (De Novo (Open-label Treatment Period))	gxepsmlppg(kvpcnozyeu) = cxstyteexo siazicackr (lbzzxjiyjc, 12.80) View more
NCT03548584 \| NCT01862640 \| NCT01922258 (Pubmed \| Clin Drug Investig)	Phase 3	Agitation in Dementia	621	Brexpiprazole 2 or 3 mg/day	ejawiwwhox(pnosldakgr): P-Value = < 0.001 View more	Positive	27 Jan 2026
				Placebo
NCT03724942 (Pubmed \| J Alzheimers Dis Rep)	Phase 3	Alzheimer Disease	183	Brexpiprazole 1mg/day	rxmsthnseq(ntpdakmipe) = rrjcueakbg sojosizzmb (cybypncyxh )	Positive	01 Dec 2025
				Brexpiprazole 2mg/day	rxmsthnseq(ntpdakmipe) = bhxggempbb sojosizzmb (cybypncyxh )
NCT03548584 \| NCT03594123 (Pubmed \| Alzheimers Dement)	Phase 3	Agitation in Dementia	390	Brexpiprazole 2 or 3 mg/day	bhgxokesnc(zsxzscpmym) = jbjcbcykiz dczmhqslim (vrdudmwlsz )	Positive	01 Dec 2025
				Placebo	bhgxokesnc(zsxzscpmym) = xonjvyculr dczmhqslim (vrdudmwlsz )
NCT03526354 (Pubmed \| J Clin Psychiatry)	Phase 2	Schizophrenia \| Substance Abuse	39	Brexpiprazole	wtvdkvhdhw(igxknlfiji) = gxmbxrkxmg lpfzgvzoli (cqsqayrwdo ) View more	Positive	13 Oct 2025
NCT03548584 \| NCT03594123 \| NCT01862640 \| NCT01922258 (Pubmed \| CNS Drugs)	Phase 3	Dementia due to Alzheimer's disease (disorder)	1,043	Brexpiprazole 0.5-3 mg/day	qviqxsmimp(xicoujlofc) = fesqyioaci punswyizoh (tknprcloes ) View more	Positive	01 Oct 2025
				Placebo	qviqxsmimp(xicoujlofc) = eaeucrrwwa punswyizoh (tknprcloes ) View more
NCT01360645 \| NCT01360632 \| NCT02196506 (Pubmed \| Int J Neuropsychopharmacol)	Phase 3	Depressive Disorder, Major	898	Antidepressant + Brexpiprazole 2-3 mg/day	ckjdbozcvj(yrohcxdjtn) = cicqqambqy tgqmhpoavt (thxdrcyjaq, 0.3) View more	Positive	01 Oct 2025
				Antidepressant + Placebo	ckjdbozcvj(yrohcxdjtn) = wggmlouswt tgqmhpoavt (thxdrcyjaq, 0.3) View more
NCT01810380 (Pubmed \| Curr Med Res Opin)	Phase 3	Schizophrenia	1,385	Brexpiprazole 2-4 mg/day	cdcqylfrzt(eeagmtlqfs): P-Value = 0.012 View more	Positive	11 Sep 2025
				Placebo
NCT04174365 (CTgov)	Phase 3	Autism Spectrum Disorder \| Irritable Mood	119	Brexpiprazole (Brexpiprazole)	ayoatsezny(kgaajzwbnv) = fmwuvxqdof qflcpmzuxd (byucfpsnaj, 1.28) View more	-	28 Aug 2025
				Placebo (Placebo)	ayoatsezny(kgaajzwbnv) = niphngnmpq qflcpmzuxd (byucfpsnaj, 1.25) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Brexpiprazole

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation