ArticleNeurology and therapy2025
Population Pharmacokinetic Modeling of TV-46000, a Risperidone Long-Acting Subcutaneous Antipsychotic for the Treatment of Patients with Schizophrenia.
Article in Neurology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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Who cites it
5 citing papers in PubMed.
- Clinical Consequences of Inadvertent Intramuscular Administration of Subcutaneous Risperidone Formulation.Case reports in psychiatry · 2026Article
- Toward adaptive therapeutic timing: integration of mechanistic pharmacology and artificial intelligence in precision dosing.Frontiers in pharmacology · 2026Review
- Rehospitalization risk in community-dwelling schizophrenia patients receiving paliperidone palmitate: a retrospective cohort study in urban China.BMC psychiatry · 2025Article
- Population Pharmacokinetic-Based Strategies for Switching Patients with Schizophrenia Between Long-Acting Injectable Formulations of Risperidone: R064766 or RBP-7000 to TV-46000.Neurology and therapy · 2025Article
- Switching Patients with Schizophrenia from Intramuscular Paliperidone Palmitate Once Monthly to TV-46000, a Long-Acting Subcutaneous Antipsychotic: Population Pharmacokinetic-Based Strategies.Advances in therapy · 2025Article
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionTV-46000 is a long-acting subcutaneous antipsychotic (LASCA) agent that combines risperidone and an innovative, copolymer-based drug delivery technology in a suspension suitable for subcutaneous administration from a prefilled syringe. The objective of the current analysis was to characterize the pharmacokinetics (PK) of TV-46000 based on pooled data from phase 1 and phase 3 studies, and to further support clinical use aspects of TV-46000.
methodsA population PK (popPK) model was developed using TV-46000 PK data obtained from three phase 1 studies (n = 267) and two phase 3 trials (n = 425). A sequential parent-metabolite model structure was used, and the total active moiety (TAM) concentration-time profiles were simulated for TV-46000 once monthly (q1m) and once every 2 months (q2m) across the range of available doses and different administration sites.
resultsThe popPK model adequately characterized the PK of risperidone and its active metabolite. TV-46000 reaches therapeutic plasma TAM concentrations (≥ 10 ng/mL) within 24 h following first dose administration. Three months after initiation of TV-46000, 86% and 88% of steady-state TAM exposure were achieved for q1m and q2m, respectively, and steady state was fully attained by 6 months (i.e., > 90% of steady-state TAM exposure). In addition, simulated D2 receptor occupancy for TV-46000 was generally within the therapeutic window of 60-80% during both dosing intervals.
conclusionsThe developed popPK model, together with corresponding simulations, supports TV-46000 as a LASCA that offers flexible dosing intervals (q1m or q2m) and administration sites (abdomen or upper arm) and does not require oral supplementation or loading dose(s).
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