Risperdal Consta (risperidone depot formulation) / J&J - LARVOL DELTA

Late Diagnosed Kufor Rakeb Syndrome Presenting as Drug Induced Parkinsonism (MDS Congress 2026) - "The range of neuropsychiatric symptoms in KRS includes various combinations of irritability, agitation, aggressive outbursts, ideas of reference, persecutory delusions and multimodal hallucinations. Clinicians should exercise caution in the treatment of psychiatric symptoms in KRS."

Alzheimer's Disease • Ataxia • CNS Disorders • Dementia • Movement Disorders • Parkinson's Disease

Hydrogel-Based Depot Systems in Psychiatric Pharmacotherapy: A Narrative Review Rethinking Long-Acting Drug Delivery. (PubMed, Gels) - "Current research has primarily focused on antipsychotic delivery, where hydrogel formulations of risperidone, paliperidone, aripiprazole, olanzapine, quetiapine and the investigational peptide PAOPA show possible sustained drug release and prolonged therapeutic activity in preclinical models...Collectively, current evidence supports the technological potential of hydrogel-based systems to provide tunable drug loading, depot formation, and sustained release. However, their development as clinically meaningful next-generation LAI therapies will require long-term in vivo evaluation, robust pharmacokinetic-pharmacodynamic characterization, injection-site safety assessment, reproducible and scalable manufacturing, and well-designed clinical trials."

Journal • Review • CNS Disorders • Mental Retardation • Psychiatry

Predicting drug release from polymeric long-acting injectables using a machine learning approach to decode formulation-performance relationships. (PubMed, Drug Deliv Transl Res) - "The framework's prospective utility was examined through validation using the commercial product Risperdal Consta®, resolving method‑dependent shifts and achieving the desired outcome. Stress/exploratory testing of newly in-house prepared donepezil-loaded PLGA microspheres (intermediate release) yielded high prediction accuracy (MAE = 0.06), whereas prediction accuracy was notably challenged for slow-release formulations. Further investigation revealed that incorporating only three early-stage measurements reduced prediction error for slow-release formulations, providing a practical route for error control and offering a perspective on the use of literature-derived training models for ongoing formulation prototyping. These findings position hybrid artificial intelligence as a promising strategy for the rational development of polymeric LAIs, bridging polymer science and drug release performance while replacing empirical trial-and-error with data-driven precision."

Journal

Impact of the COVID-19 Pandemic on Catatonia: Biomarkers and Medication Reconciliation Challenges in Patients on Long-Acting Injectable Antipsychotics (APA 2026) - "Medications included haloperidol decanoate (n=6), paliperidone palmitate (n=4), and Risperdal Consta (n=2). Treatments included amantadine (n=4), benzodiazepines (n=2), bromocriptine (n=2), and combination therapies (n=2)... Monitoring serum iron may aid diagnosis and prognosis. Early identification of LAI history and improved interfacility communication may reduce adverse outcomes in catatonia patients receiving LAI antipsychotics."

Biomarker • Clinical • CNS Disorders • Infectious Disease • Novel Coronavirus Disease

Early Symptom Return During Long-Acting Injectable Antipsychotic Treatment: A Review of Oral Overlap Strategies (APA 2026) - "Risperidone injections demonstrated delayed release kinetics, with steady-state concentrations not achieved for several weeks, leading to routine recommendations for extended oral overlap during initiation...Although systematic evidence is limited and mixed, pharmacokinetic variability and delayed therapeutic exposure appear to be strong contributors. These findings highlight the need for future prospective studies to better characterize predictors of early wear-off to help identify which patients are at risk, and to standardize guidance regarding brief oral supplementation strategies."

Review • Bipolar Disorder • CNS Disorders • Mood Disorders • Schizophrenia

Risperidone redefined: A three-decade odyssey of broadening indications and evolving formulations. (PubMed, Med J Armed Forces India) - "It was the second atypical antipsychotic introduced after clozapine and its pharmacological profile was characterized by potent antagonism of dopamine D2 and serotonin 5HT2A receptors...These innovations address critical challenges in psychiatric care, particularly medication adherence, by offering flexible dosing intervals and eliminating the need for oral supplementation in newer formulations. This article provides a comprehensive review of risperidone's basic pharmacology, its evolving landscape of Food and Drug Administration-approved and off-label indications, the transformative journey from oral to long-acting injectable formulations, and the complex interplay among drug attitudes, patient perceptions, and treatment acceptance."

Journal • Autism Spectrum Disorder • Bipolar Disorder • CNS Disorders • Genetic Disorders • Mental Retardation • Mood Disorders • Psychiatry • Schizophrenia

Psychosis and Incidental Latent Toxoplasmosis: A Case Report and Key Learning Points. (PubMed, Cureus) - "Recent use of stimulants and alcohol use before admission were acknowledged. She was started on oral risperidone and then transitioned to paliperidone palmitate on account of symptom severity and concerns about adherence...Even though associations between latent Toxoplasma gondii and psychosis have been documented, the nature of this relationship remains uncertain. This case highlights the need to interpret a past Toxoplasma gondii infection with caution and the importance of considering contributing factors such as substance misuse and psychosocial stressors."

Journal • CNS Disorders • Infectious Disease • Psychiatry • Schizophrenia

Comparison of Typical and Atypical Long-Acting Antipsychotics in a Real-World Sample in terms of Treatment Adherence and Factors Influencing Treatment Choice: A One-Year Follow-Up Study. (PubMed, Noro Psikiyatr Ars) - "Adherence was particularly higher with long-acting (LA) aripiprazole and LA paliperidone compared to the other three LAIs (haloperidol, risperidone, and zuclopenthixol) (p<0.05)...Adherence to LAIs administered every four weeks was higher than those administered every two weeks (p=0.014). For patients expected to face challenges with adherence to LAIs, second-generation agents with longer administration intervals may be preferred."

Journal • Real-world evidence • Bipolar Disorder • CNS Disorders • Mental Retardation • Mood Disorders • Psychiatry • Schizophrenia

Population Pharmacokinetic-Based Strategies for Switching Patients with Schizophrenia Between Long-Acting Injectable Formulations of Risperidone: R064766 or RBP-7000 to TV-46000. (PubMed, Neurol Ther) - "These simulations revealed switching to TV-46000 4-6 weeks after the last dose of R064766 and 4 weeks after the last dose of RBP-7000 provided generally comparable PK exposures at first dose and steady state of TV-46000. Clinician discretion will determine which switching strategy is most appropriate in context based on factors such as patient preference, scheduling convenience, and concerns about tolerability."

Journal • PK/PD data • CNS Disorders • Psychiatry • Schizophrenia

6-month follow-up of adolescents at clinical high risk for psychosis (ECNP 2025) - "The patient received risperidone 2 mg, fluoxetine 20 mg and CBT...Treatment included aripiprazole 5 mg and CBT... This case series illustrates the heterogeneity of clinical trajectories among adolescents at CHR for psychosis and underscores the necessity of individualized, early intervention strategies(3). Comorbidities such as OCD and MDD are common and may influence both symptom presentation and treatment outcomes(4). The limited treatment response observed in the third case appears to align with previous findings suggesting that the severity of negative symptoms may adversely impact treatment outcomes in individuals at CHR (5).While CBT combined with low-dose antipsychotics or SSRIs can yield meaningful improvements in symptoms and functioning, outcomes vary and highlight the importance of sustained monitoring and tailored care."

Clinical • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Obsessive-Compulsive Disorder • Psychiatry • Schizophrenia

Prescribing patterns of antipsychotic monotherapy and polypharmacy in patients with psychotic disorders (ECNP 2025) - "Among monotherapy patients, olanzapine was most frequently prescribed (33.3%), followed by risperidone and haloperidol (both 18.2%), quetiapine (15.2%), aripiprazole (9.1%), and clozapine (6.1%)...Less frequently prescribed in polytherapy were aripiprazole (10.4%), risperidone (7.3%), levomepromazine and zuclopenthixol (both 6.3%), fluphenazine (4.2%), and amisulpride and sulpiride (both 1.0%)... Despite guideline recommendations that advocate for antipsychotic monotherapy whenever possible [1,3], this study found that polypharmacy remains prevalent in clinical practice. Olanzapine emerged as the most common choice in monotherapy regimens, while haloperidol and promazine were more frequently used in polytherapy. Clozapine, despite its well-established role in treatment-resistant schizophrenia, was more commonly prescribed as part of combination therapy (16.7%) than as monotherapy (6.1%)."

Clinical • Monotherapy • CNS Disorders • Psychiatry • Schizophrenia

Dissociative amnesia and brief psychotic disorder comorbidity: a long-term clinical follow-up case analysis (ECNP 2025) - "Initial treatment involved intramuscular haloperidol (10 mg/day) and biperiden (4 mg/day) for four days...Maintenance treatment included oral risperidone (6 mg/day), monthly intramuscular risperidone (Risperdal Consta 25 mg), lamotrigine (up to 400 mg/day), sertraline (100 mg/day), and lithium (1200 mg/day)...A holistic, continuous approach addressing biological, psychological, and social factors is essential to improve functioning and prevent chronic disability. Keywords: dissociative amnesia; brief psychotic disorder; psychosocial stressors; electroconvulsive therapy (ECT); long-term follow-up"

Clinical • Bipolar Disorder • CNS Disorders • Cognitive Disorders • Depression • Mood Disorders • Psychiatry

Risperidone ISM injection in the acute setting for actively psychotic patients with schizophrenia: Case reports (ECNP 2025) - "His aripiprazole was changed to oral liquid risperidone 4 mg daily administered under close supervision...Moreover, as plasma levels equivalent to the oral doses of risperidone are rapidly achieved, Risperidone ISM facilitates the transition from oral to long-acting antipsychotic treatment and is therefore likely to reduce duration of hospital admissions, a hypothesis that warrants further scrutiny. Conflict of interest: Disclosure statement: The authors have participated in an international non-interventional prospective study sponsored by ROVI that evaluated Risperidone ISM"

Case report • Clinical • CNS Disorders • Cognitive Disorders • Psychiatry • Schizophrenia

Revisiting risperidone: new formulations - new futures? (ECNP 2025) - "In clinical practice it has since been largely replaced by other atypical LAIs subsequently developed that include paliperidone (monthly, three-monthly, six-monthly), olanzapine (two-weekly, monthly) and aripiprazole (monthly, two-monthly)...These include risperidone subcutaneous monthly (Perseris) [2] risperidone subcutaneous one or two-montly (Uzedy) [3], risperidone in-situ microspheres (Okedi) [4] and risperidone extended release microspheres (Rykindo) [5]... The new formulations of risperidone LAI overall improve ease of use, increase rapidity of onset, add multiple injection site options and extend treatment duration intervals allowing for greater flexibility, simplicity and patient acceptability in clinical practice. The efficacy and safety profile of risperidone is well established and the new formulations offer the potential of use of a risperidone LAI in a broader range of clinical settings and thus, may improve the use and acceptance of LAIs in both the..."

Bipolar Disorder • CNS Disorders • Mood Disorders • Psychiatry • Schizophrenia

Shares of Lupin Ltd. gained on Wednesday, September 3, said it has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Risperidone Injectable. (CNBC-TV18) - "It said it has received USFDA's approval for Risperidone for extended-release injectable suspension, 25 mg per vial, 37.5 mg per vial, and 50 mg per vial, Single-Dose Vials....Risperidone for extended-release injectable suspension (RLD Risperdal Consta) had estimated annual sales of $190 million in the US, as per IQVIA MAT July 2025."

ANDA • Sales • Bipolar Disorder • Schizophrenia

Clinical Utility of Long-Acting Injectable Risperidone in Schizophrenia and Bipolar I Disorder: A Review of Clinical Studies. (PubMed, Psychol Res Behav Manag) - "To date, five different risperidone LAI formulations have been marketed - including a second biweekly microsphere injection (LY03004), a newer monthly intramuscular formulation using in situ microparticles (ISM) technology that does not require an oral risperidone run-in, and two subcutaneous formulations (RBP-7000 and TV-46000)...To facilitate this, healthcare providers should develop a comprehensive understanding of these formulations to select the most suitable option. While risperidone ISM, RBP-7000, and TV-46000 may enhance treatment feasibility and adherence, further research is needed to build an evidence base comparable to that available for BW-RLAI, particularly in the treatment of BD."

Journal • Review • Bipolar Disorder • CNS Disorders • Mood Disorders • Psychiatry • Schizophrenia

Diffusion dimensionality modeling of subcutaneous/intramuscular absorption of antibodies and long-acting injectables. (PubMed, J Pharmacokinet Pharmacodyn) - "The diffusion dimensionality models were challenged with previously published subcutaneous absorption data for 13 antibody drugs and insulin lispro, and the long-acting injectable antipsychotic drugs: subcutaneous Perseris™, intramuscular Invega Sustenna®, Risperdal Consta®, and olanzapine...Three antibodies (CNTO5825, ACE910 and ustekinumab) were best described by the 2-dimensional diffusion equation. The 2- and 3-dimensional diffusion equations were equivalent for ABT981, guselkumab, adalimumab, nemolizumab, omalizumab, and secukinumab. Golimumab, DX2930, AMG139, and mepolizumab were best described by the 3-dimensional diffusion equation. All the long-acting antipsychotic dosage forms except Risperdal Consta were modeled satisfactorily. Diffusion dimensionality models are a parsimonious and effective approach for modeling drug absorption profiles of subcutaneously and intramuscularly administered small molecule and protein drugs and their dosage forms."

Journal • CNS Disorders

Understanding drug release mechanisms of risperidone in situ forming implant depots in rabbits. (PubMed, J Control Release) - "To explore the in vivo drug release mechanisms, risperidone in situ forming implants with different PLGA attributes (i.e., molecular weight (MW), lactide:glycolide (L/G) ratio, blockiness, and end group) were prepared based on the reference listed drug Perseris (risperidone extended-release injectable suspension)...These results indicate that drug release in vivo may be degradation dominated and that depot degradation followed bulk erosion. This study provides an understanding of the in vivo mechanisms controlling drug release from in situ forming implant formulations."

Journal • Preclinical

Real-world outcomes and practice patterns among patients with schizophrenia when switched from oral antipsychotics to long-acting injectable formulations after hospitalization. (PubMed, Psychiatry Res) - "The most prescribed OA and LAI±OA were risperidone (26 %) and haloperidol (37 %), respectively...Prescriptions were based on clinical characteristics at discharge; those prescribed LAIs±OAs may have had less favorable prognoses. However, these results suggest that prescribing second-generation LAIs±OAs with less frequent dosing at discharge may lower rehospitalization risk for patients with schizophrenia."

Journal • Real-world evidence • CNS Disorders • Psychiatry • Schizophrenia

Retrospective cohort study of long-acting injectable (LAI) antipsychotic initiation in the inpatient setting: impact of LAI characteristics on transition and continuation of care among patients with schizophrenia in the USA. (PubMed, BMJ Open) - "Patients prescribed a combination of LAI and OA at discharge had a higher risk of rehospitalisation compared with those prescribed LAI alone. Additionally, the study findings suggest that patients are more likely to be prescribed oral risperidone, the most frequently used second-generation OA, which may support an easier transition to an LAI of the same molecule."

Journal • Retrospective data • CNS Disorders • Psychiatry • Schizophrenia

Exploring the factors and outcomes of clozapine discontinuation in India: A retrospective analysis. (PubMed, Asian J Psychiatr) - "These results align with previous studies, showing that adverse effects and inadequate response are prominent reasons for clozapine discontinuation and demonstrate the possibility of clozapine retrial in selected patients. Managing adverse effects might result in improvement, at least to a mild degree. Clozapine discontinuation can be avoided in a cohort with non-serious adverse effects, given the superiority of clozapine in resistant schizophrenia."

Journal • Retrospective data • CNS Disorders • Psychiatry • Schizophrenia

An Evaluation of the Subcutaneous Depot Release of TV-46000, A Novel Long-Acting Injectable (LAI) Formulation of Risperidone, Under Extreme Conditions in Dogs, Minipigs and Humans. (PubMed, Pharmaceutics) - "The observed similarity in findings between the animal and human studies supports the suitability of animal models for evaluation of the effect of extrinsic factors on injection sites and its translatability to clinical settings."

Journal • CNS Disorders • Psychiatry • Schizophrenia

Alkermes plc Reports Financial Results for the Fourth Quarter and Year Ended Dec. 31, 2024 and Provides Financial Expectations for 2025 (PRNewswire) - "Royalty revenues from XEPLION, INVEGA TRINZA/TREVICTA and INVEGA HAFYERA/BYANNLI for the fourth quarter were $36.5 million. VUMERITY manufacturing and royalty revenues for the fourth quarter were $35.0 million. FAMPYRA manufacturing and royalty revenues for the fourth quarter were $22.9 million. The company does not expect to record any FAMPYRA revenue going forward. RISPERDAL CONSTA manufacturing revenues for the fourth quarter were $14.7 million."

Commercial • Bipolar Disorder • CNS Disorders • Multiple Sclerosis • Schizophrenia

Real-World Effectiveness of Long-Acting Injectable and Oral Antipsychotic Agents in US Medicare Patients with Schizophrenia. (PubMed, Adv Ther) - "Efforts are needed to enhance identification of appropriate candidates for LAIs and increase their uptake, especially longer dosing interval LAIs, in the Medicare population."

Journal • Medicare • Real-world evidence • Reimbursement • US reimbursement • CNS Disorders • Psychiatry • Schizophrenia

Combination Therapy With Risperidone and High-Dose Melatonin Is Effective Despite Reversible Side Effects Including Breast Budding. (PubMed, Cureus) - "Risperidone and high-dose melatonin administration effectively reduced restlessness. Administration of risperidone and high-dose melatonin may cause breast budding; however, breast budding is reversible upon the discontinuation of melatonin, and we suggest that clinicians prescribe medication as needed to improve these symptoms."

Adverse events • Journal • CNS Disorders • Pain • Sleep Disorder