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FDA Approval Timeline Novo Nordisk submitted a New Drug Application (NDA) to the FDA in December 2025 based on the REDEFINE 1 and REDEFINE 2 trial data
Change history 26 March 2024 A Correction to this paper has been published: Abbreviations AATs: Amino acid transporters AOA: Aminooxyacetic acid hemihydrochloride ASCT2: Alanine-serine-cysteine transporter 2 ATB0, + : Amino acid transporter B0, + ATP: Adenosine triphosphate CPSI: Carbamoyl phosphate synthetase I CPSII: Carbamoyl phosphate synthetase II CRC: Colorectal cancer CTLs: Cytotoxic T lymphocytes CTPS: Cytidine triphosphate synthetase DMNPN: Dual-mechanism-based nutrient partitioning nanoregulator ER + : Estrogen receptor positive FADH2: Flavin adenine dinucleotide FGAR: Formylglycinamide ribonucleotide GLS: Glutaminase GLUD: Glutamate dehydrogenase GOT: Glutamate-oxaloacetate transamininase GPT: Glutamate pyruvate transaminase GSH: Glutathione HNSCC: Head and neck squamous cell carcinoma IFN: Interferons Ig: Immunoglobulin IL: Interleukin KG: Ketoglutarate LAT1: L-amino acid transporter 1 MDSCs: Myeloid-derived suppressive cells mTOR: Mechanistic target of rapamycin NAD: Nicotinamide adenine dinucleotide NADH: Reduced nicotinamide adenine dinucleotide NF-KB: Nuclear factor-kappa B NK: Natural killer NSCLC: Non-small cell lung cancer OSC: Osmundacetone OXPHOS: Oxidative phosphorylation PD-1: Programmed cell death- 1 PD-L1: Programmed cell death- ligand 1 PMIR: PD-L1-targeted metabolism and immune regulator PPAR: Peroxisome proliferator-activated receptor PPAT: Phosphoribosyl pyrophosphate amidotransferase PPP: Pentose phosphate pathway PRA : Phosphoribosyl--amine PRPP: Phosphoribosyl--pyrophosphate RACK1: Receptor for activated C kinase 1 ROS: Reactive oxygen species RSK2: Ribosomal S6 kinase 2 SERCA: Sarcoplasmic reticulum Ca2 + -ATPase SNAT1: Sodium-coupled neutral amino acid transporter 1 TAMs: Tumor-associated macrophages TANs: Tumor-associated neutrophils TCA: Tricarboxylic acid TGF: Transforming growth factor TILs: Tumor-infiltrating lymphocytes TME: Tumor microenvironment TNBC: Triple-negative breast cancer TNF: Tumour necrosis factor Tregs: Regulatory T cells UTP: Uridine triphosphate OSC: Osmundacetone References Stine ZE, Schug ZT, Salvino JM, Dang CV
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