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aripiprazole (Abilify Maintena / Lu AF41155 / aripiprazole ERIS)

✓ Approved

Otsuka Holdings Co., Ltd. · DRD2 · Small Molecule

What is aripiprazole?

aripiprazole is a small molecule developed by Otsuka Holdings Co., Ltd.. It is approved for therapeutic indications via injectable (others) or intramuscular (im) injection.

Drug Profile

Brand NamesAbilify Maintena, Lu AF41155, aripiprazole ERIS
CompanyOtsuka Holdings Co., Ltd.
Drug ClassSmall Molecule
Molecular TargetDRD2, HTR1A, HTR2A
RouteInjectable (Others), Intramuscular (IM) Injection
StatusApproved
Sources: ClinicalTrials.gov, Otsuka Holdings Co., Ltd.

Mechanism of Action

Molecular Targets

aripiprazole acts on 3 molecular targets:

DRD2dopamine receptor D2 (D2DR, D2R)
HTR1A5-hydroxytryptamine receptor 1A (PFMCD, 5-HT1A)
HTR2A5-hydroxytryptamine receptor 2A (5-HT2A, HTR2)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

aripiprazole is developed for 2 unique indications across 1 therapeutic area.

Therapeutic AreaConditionPhase
Psychiatric disordersSchizophrenia✓ Approved
Psychiatric disordersBipolar disorder✓ Approved

Related Research Articles

PubMedThe AAPS journal2026-09-19

Artificial Intelligence in Pharmaceutical Regulatory Science: Opportunities, Challenges, and Emerging Frameworks.

Lucas Inês I, Sousa João J, Vitorino Carla C

Digital transformation in pharmaceutical regulatory affairs is accelerating as global submissions grow in complexity and traditional document-based workflows reach their limits. Artificial intelligence (AI), particularly natural language processing (NLP), is increasingly being explored to support regulatory data management, document preparation, and decision support activities. This review examines AI adoption across pharmaceutical regulatory science, including initiatives from major regulatory agencies, AI-supported regulatory workflows, and emerging governance and interoperability frameworks. Current applications include document classification, data extraction, Common Technical Document (CTD) support, pharmacovigilance, and predictive analytics. Key implementation challenges, including explainability, traceability, validation, data quality, interoperability, cybersecurity, and Good Practice (GxP) compliance requirements, are critically discussed. The review further examines emerging regulatory data ecosystems and governance frameworks that may support the responsible integration of AI into regulatory processes. Collectively, these developments highlight the potential of AI to support more structured, interoperable, and efficient regulatory systems while maintaining regulatory oversight and accountability. Current evidence suggests that AI implementation has progressed from conceptual research toward early operational deployment. However, robust evidence demonstrating sustained improvements in regulatory performance and long-term operational impact remains limited.

PMID 42760430
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PubMedF1000Research2026-09-19

The Beekeeping Sector of Kazakhstan and Contributions to the Pharmaceutical Industry: Promising Flavonoids with the Pharmacokinetic Properties Via the Computational Evaluations.

Kaya Şeyda Ş, Selamoglu Zeliha Z, Durna Daştan Sevgi S, Gaipov Tulkinzhon T et al.

Bee products are rich sources of bioactive flavonoids with potential applications in nutraceutical and pharmaceutical research. However, differences in the physicochemical and pharmacokinetic properties of individual flavonoids may substantially influence their drug-likeness and bioavailability. This study aimed to characterize the pharmacokinetic, physicochemical, and drug-likeness profiles of four representative flavonoids commonly associated with bee products myricetin, galangin, kaempferol, and quercetin. In silico pharmacokinetic and drug-likeness analyses were performed using the SwissADME web platform. The investigated compounds were evaluated in terms of physicochemical properties, lipophilicity, aqueous solubility, gastrointestinal absorption, blood-brain barrier (BBB) permeability, P-glycoprotein (P-gp) substrate status, and compliance with established drug-likeness rules, including Lipinski, Veber, Egan, and Muegge criteria. All four flavonoids exhibited favorable molecular properties and an identical predicted bioavailability score of 0.55. Galangin, kaempferol, and quercetin showed high predicted gastrointestinal absorption and fully complied with the Lipinski, Veber, Egan, and Muegge drug-likeness criteria. In contrast, myricetin exhibited comparatively lower predicted gastrointestinal absorption, which may be associated with its higher polarity, greater hydrogen-bonding capacity, and elevated topological polar surface area. None of the investigated flavonoids was predicted to penetrate the BBB or to act as a P-gp substrate. Variations in hydroxyl substitution were associated with marked differences in lipophilicity, aqueous solubility, membrane permeability, and overall pharmacokinetic behavior. Among the compounds evaluated, galangin displayed the most balanced physicochemical and medicinal chemistry profile, whereas kaempferol and quercetin also demonstrated favorable characteristics for oral drug development. The findings indicate that flavonoids associated with Kazakhstan bee products possess distinct but generally favorable drug-likeness and predicted pharmacokinetic profiles. In particular, galangin emerged as the most balanced candidate among the compounds examined. Integrating in silico pharmacokinetic assessment with knowledge of bee-product composition may contribute to the scientific evaluation, quality standardization, and value-added utilization of Kazakhstan's apicultural resources, while providing a basis for further experimental investigation of their nutraceutical and pharmaceutical potential.

PMID 42760912
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PubMedInfectious diseases of poverty2026-09-19

Territorial inequities in access to essential medicines for neglected tropical diseases in a decentralised European health system: a nationwide assessment in Spain.

Belhassen-García Moncef M, de la Calle-Prieto Fernando F, Del Moral Sánchez José Manuel JM, Alonso-Sardón Montserrat M et al.

Neglected tropical diseases (NTDs) represent an increasing but often overlooked challenge for European health systems owing to international mobility, migration, travel, and climate-related changes in disease ecology. Although effective treatments exist for most NTDs and many are included in the World Health Organization (WHO) Model List of Essential Medicines, their availability in decentralised high-income health systems remains poorly characterised. This study assessed the availability, accessibility, and territorial variability of essential medicines for NTDs across the autonomous communities of Spain and identified the main barriers to equitable access. A nationwide, cross-sectional study was conducted across the 17 autonomous communities of Spain. Data were collected between January and December 2025 through a structured survey of Hospital Pharmacy Services in centres with expertise in tropical medicine and infectious diseases and were complemented by expert clinical validation. Medicines were classified according to commercial status, access pathways, dispensing circuits, and regional availability. Descriptive analyses summarised inter-regional variability from a health systems and policy perspective. Data were obtained for 63 medicines and vaccines, generating 1134 records from all 17 autonomous communities. Twenty-two medicines were commercially available in Spain, whereas 39 required exceptional access mechanisms. Routine stock availability across all centres was reported in only 31.1% of valid records, while 52.8% reported no routine stock and 16.1% restricted availability to reference centres. Joint management by prescribing physicians and hospital pharmacy services was required in 72.1% of access procedures. Marked territorial variability was also observed in dispensing circuits and financing mechanisms, with 47.9% of valid records requiring full out-of-pocket payment and 47.1% involving co-payment. Access to essential medicines for NTDs in Spain remains structurally fragmented and territorially unequal. Strengthening coordinated national pharmaceutical policies is necessary to reduce reliance on exceptional access mechanisms and ensure equitable, timely, and sustainable access to essential medicines in Spain and other decentralised European health systems.

PMID 42760540
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PubMedJournal of clinical psychopharmacology2026-09-18

Low-Dose Clozapine Versus Aripiprazole in Borderline Personality Disorder: A Prospective Naturalistic Study.

D'Incalci Michele Francesco MF, Congedo Carlo Maria CM, Agostoni Giulia G, Bechi Margherita M et al.

Borderline personality disorder (BLPD) is a complex and debilitating psychiatric condition with high prevalence and clinical and psychosocial burden. Psychotherapy is the recommended first-line treatment but, in real-world clinical practice, most individuals with BLPD are prescribed psychotropic medications, including atypical antipsychotics. The literature suggests that second-generation antipsychotics may exert moderate effects on specific symptoms, but data remain limited and head-to-head comparisons are lacking. This prospective, naturalistic, follow-up study aimed to address this gap by comparing the efficacy and tolerability of low-dose clozapine versus aripiprazole in individuals with BLPD. Twenty-three patients were treated with either low-dose clozapine (n = 9) or aripiprazole (n = 14) based on clinical indication. Participants were assessed at hospital admission (T0), discharge (T1), and 3-month follow-up (T2) on emotional dysregulation, dissociative experiences, depressive symptoms, impulsivity, and quality of life. Treatment tolerability was evaluated at T1. Significant improvements in dissociation, depression, impulsivity, and quality of life were observed at both T1 and T2, independently of treatment group. Compared to aripiprazole, clozapine was associated with greater reductions in dissociative experiences at hospital discharge and in depressive symptoms at follow-up. Both treatments were safe and well tolerated. Our results suggest that low-dose clozapine is safe and may offer superior benefits for dissociative and depressive symptoms in patients with severe BLPD. Although further research is needed, these findings highlight the role of clozapine as a valuable pharmacological option in BLPD, particularly for patients with high clinical severity and inadequate response to other antipsychotics.

PMID 42757991
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PubMedPharmaceutical research2026-09-18

Amorphous Solid Dispersions in Non-Oral Drug Delivery: A Critical Review Bridging Mechanistic Advantages and Gaps in Translational Evidence.

Riccio Bruno Vincenzo Fiod BVF, Leão Aline Franciane AF, Klosowski Ana Beatriz AB, Boni Fernanda Isadora FI et al.

Non-oral drug delivery routes, including cutaneous, transdermal, pulmonary, ophthalmic, parenteral, vaginal, and rectal administration, are essential for both local and systemic therapies but impose route-specific constraints on drug dissolution, retention, permeation, clearance, and exposure. Amorphous solid dispersions (ASDs),extensively investigated for oral delivery, may improve the performance of poorly water-soluble drugs by stabilizing high-energy amorphous states, increasing apparent solubility, and promoting transient supersaturation. However, their translation into non-oral dosage forms remains fragmented and largely preclinical. This review critically examines the potential, limitations, and translational challenges of ASDs for non-oral drug delivery, with emphasis on the physicochemical, biopharmaceutical, pharmaceutical, and route-dependent determinants governing their performance. Key aspects discussed include drug-polymer interactions, molecular mobility, phase behavior, water uptake, crystallization, interactions with secondary pharmaceutical bases, and route-specific pharmacokinetic/pharmacodynamic relationships. Current evidence is examined across dermal, transdermal, pulmonary, ophthalmic, vaginal, rectal, and parenteral delivery systems. Parenteral administration is considered a special case encompassing sterile suspensions, reconstitutable systems, microneedles, implants, and depot-forming formulations. Recent technological advances, patent and industrial landscapes, and the potential extension of ASD principles to peptides, proteins, biologics, and other complex molecular entities are also addressed. ASDs are further positioned in relation to alternative and complementary solubility-enhancing technologies, including nanoparticles, nanocrystals, cocrystals, cyclodextrins, micelles, lipid-based systems, emulsions, solvents, and cosolvents. ASDs off er a promising but still underdeveloped strategy for improving non-oral delivery of poorly soluble drugs. Their successful translation will depend not only on achieving and maintaining favorable amorphousstates and supersaturation, but also on converting these physicochemical advantages into route-specific drug exposure, therapeutic benefit, formulation stability, manufacturability, and clinically meaningful outcomes.

PMID 42754781
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PubMedPCN reports : psychiatry and clinical neurosciences2026-09-18

A case of tic improvement following tipepidine administration in a boy with Tourette syndrome comorbid with attention-deficit/hyperactivity disorder and autism spectrum disorder.

Tachibana Masumi M, Sasaki Tsuyoshi T

Tourette Syndrome (TS) is defined by motor and vocal tics that begin in childhood and persist for over a year. TS causes difficulties in daily life and lowers self-esteem, yet pharmacological treatment options for TS remain limited. Tipepidine, administered in this case report, is generally used as a safe and inexpensive cough suppressant. Recent studies have suggested that tipepidine may improve symptoms of attention-deficit/hyperactivity disorder (ADHD) and depression. We report the clinical course of a boy with TS, ADHD, and autism spectrum disorder (ASD), in whom the addition of tipepidine to aripiprazole was associated with improvement in both motor and vocal tics. The patient had tried several antipsychotics before he was prescribed tipepidine. However, the effectiveness of those drugs was temporary, and the patient experienced tolerability issues such as drowsiness. The addition of tipepidine was well tolerated, and the improvement in tic symptoms was maintained during long-term follow-up. This case suggests that adjunctive tipepidine may be well tolerated and associated with sustained improvement in motor and vocal tics during long-term follow-up in a patient with TS receiving aripiprazole.

PMID 42757222
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