Drug-Induced Phospholipidosis

Di-22:6-BMP – A Proprietary non-invasive phospholipidosis assay for animal and human models

Drug-induced Phospholipidosis Brochure


Drug-induced Phospholipidosis Quantitative Assays


Drug-induced Phospholipidosis Sample Requirements


Drug-Induced Phospholipidosis


Drug-induced phospholipidosis (DIPL) is a phospholipid storage disorder characterized by an excessive accumulation of multi-lamellar bodies (myeloid bodies) in cells and tissues. Many drugs that cause DIPL are associated with clinical toxicities (myopathy, kidney injury, QT prolongation, lung injury, and hepatotoxicity). Because DIPL may be linked to unwanted toxicities, its presence during nonclinical/clinical testing can result in the delay or discontinuation of new drug development. DIPL should be carefully evaluated and interpreted on a case by case basis, especially for chronically used drugs. Read more

薬剤誘発性リン脂質症(DIPL)は、細胞や組織中に多層版構造物(ミエロイド小体)の過度の 蓄積を特徴とするリン脂質の貯蔵障害です。現在350以上の新薬候補や上市された薬剤で 、DIPLの誘発が報告されています。まだ解明されていませんが、規制当局の見解で はDIPLを有害な所見とみなしています [2]。 DIPLは望まれていない毒性とリンクしている可能 性があるので、製薬研究者や臨床医にとってこの副作用をよりよく理解し、監視し、管理する ことが重要です。Read more

Di-docosahexaenoyl (22:6)-BMP

Di-docosahexaenoyl (22:6)-BMP

The lysosomal phospholipid bis(mono)acylglycerol phosphate (BMP) is increased in the tissues of animals and humans with DIPL and the lysosomal storage disorder NPC disease. Elevated di‑docosahexaenoyl (22:6)-BMP (a unique isoform of BMP) in plasma and urine is a reliable indicator of tissue DIPL for nonclinical and clinical studies.

Bis(mono)acylglycerol phosphate (BMP)は、DIPL及びニューマンピック病C型(NPC diseaseを患う動物やヒトの組織中に増加するリソソームリン脂質です。BMPの中で 特定の物質、di-docosahexaenoyl (22:6)-BMP (di-22:6- BMP) は、ヒト及び動物の血漿/ 血清、尿、組織中でモニター可能なDIPLのバイオマーカーです。

DIPL Quantitative Assays


Nextcea specializes in DIPL bioassay services for nonclinical and clinical studies. We provide GLP validated bioanalytical
LC-MS/MS methods for measurement of di-22:6-BMP in animal and human matrices (plasma/serum, urine, tissues).

非臨床及び臨床試験での生体試料中のdi-22:6- BMP濃度の測定には、LC-MS/MSを使用するバリデートされた高感度な測定方法を用います。

  • Nonclinical and clinical studies


  • Validated LC-MS/MS Assays


  • Non-GLP, GLP Study Sample Analysis


  • Correlate DIPL with PK/PD, TK/TD


In Vitro DIPL Screening

薬剤誘発性リン脂質症In vitroスクリーニング

The in vitro analysis of di-22:6-BMP provides a sensitive and specific high throughput screening assay to rapidly identify compounds with the potential to induce DIPL early in the drug discovery process.

Di-22:6- BMPのin vitroでの分析は、探索研究フェーズでDIPLを引き起こす可能性のある化合物を迅速に特定できる、精度が高く特異的なハイスループットスクリーニングアッセイを提供します。

The patented biomarker di-docosahexaenoyl (22:6)-BMP (di-22:6-BMP) is increased in the urine, plasma/serum, and tissues of animals and humans with drug induced phospholipidosis (US Patent 8,313,949, Japanese Patent 5,702,363, and European Patent EP2419742).