micronized isotretinoin (SPJ-101CA) / Sun Pharma - LARVOL DELTA

A study of the safety, efficacy, and pharmacokinetics of SPJ-101CA as maintenance therapy for newly diagnosed high-risk neuroblastoma. (ASCO 2026) - P | "Clinical Trial Registration Number: jRCT2031220687 Background: Isotretinoin (ISO), an oral vitamin A derivative, induces differentiation of neuroblastoma (NB) cells and is used as maintenance therapy...Dinutuximab was permitted only before or after, but not during, SPJ‑101CA administration... SPJ-101CA was well-tolerated and effective as maintenance therapy following multidisciplinary treatment for high-risk NB. The PK findings were consistent with the known profile of ISO and indicated good absorption of the formulation."

Clinical • PK/PD data • Atopic Dermatitis • CNS Disorders • Dyslipidemia • Endocrine Disorders • Hypertriglyceridemia • Immunology • Mental Retardation • Metabolic Disorders • Neuroblastoma • Neutropenia • Pruritus • Solid Tumor