Ziftomenib Production Cost Reports

The report provides a detailed analysis essential for establishing a ziftomenib production plant. It encompasses all critical aspects necessary for ziftomenib production, including the cost of ziftomenib production, ziftomenib plant cost, ziftomenib production costs, and the overall ziftomenib production plant cost. Additionally, the study covers specific expenditures associated with setting up and operating a ziftomenib production plant. These encompass production processes, raw material requirements, utility requirements, infrastructure needs, machinery and technology requirements, manpower requirements, packaging requirements, transportation requirements, and more.

Ziftomenib is a medication that blocks a protein called menin to fight certain hard-to-treat blood cancers like acute myeloid leukaemia (AML). It is utilised in patients whose cancer has returned or resisted other treatments and carries specific gene changes such as NPM1 mutations. It is FDA-approved for adults with no other good options and works alone or combined with chemo, venetoclax, or other drugs. It has demonstrated tumour reduction, clearance of residual disease, and improved survival outcomes in frontline or unfit patients. It is also used in newly diagnosed people with a daily dose that's effective but needs observation for side effects. Its common side effects include infections, bleeding, diarrhoea, nausea, fatigue, swelling, muscle pain, itching, differentiation syndrome, febrile neutropenia, and abnormal liver tests.

The market for ziftomenib is fuelled by growing demand for precision oncology treatments targeting NPM1-mutated acute myeloid leukaemia (AML). Its FDA approval as the first menin inhibitor, strong Phase 2 data, and expanding Phase 3 trials in frontline intensive and non-intensive chemo combinations contribute to its market growth. The oral dosing convenience over injectables, diversification into pediatric AML and other indications, and advantage in genetically defined subsets support its market. High pricing for orphan drugs, hospital formulary inclusion based on efficacy and safety, and regulatory exclusivity influence industrial ziftomenib procurement. The bulk needs for haematology centres, competition from rival menin inhibitors, reimbursement via orphan designations, and strategic bulk affect its market dynamics.

Raw Material for Ziftomenib Production

According to the ziftomenib production plant project report, the key raw materials used in the production of ziftomenib include 4-methyl-1H-indole, phosphorus oxychloride, dimethylformamide, and 1-Boc-4-piperidone.

Production Process of Ziftomenib

The extensive ziftomenib production cost report consists of the following major industrial production process:

1. From 4-methyl-1H-indole: The production process of ziftomenib starts with formylation of 4-methyl-1H-indole using phosphorus oxychloride and dimethylformamide to obtain 4-methyl-1H-indole-5-carbaldehyde. Also, tert-butyl 4-aminopiperidine-1-carboxylate is prepared from 1-Boc-4-piperidone by reductive amination, and 6-(2,2,2-trifluoroethyl)thieno[2,3-d]pyrimidin-4-amine is synthesised from a substituted thiophene precursor via cyclisation and amination. The indole aldehyde is coupled with tert-butyl 4-aminopiperidine-1-carboxylate through reductive amination. After removal of the Boc group, the piperidine nitrogen goes through nucleophilic aromatic substitution with 6-(2,2,2-trifluoroethyl)thieno[2,3-d]pyrimidin-4-amine. The indole nitrogen is then alkylated with (S)-1-(2-(4-(methylsulfonyl)piperazin-1-yl)propyl) methanesulfonate, followed by introduction of a nitrile group at the indole 2-position and purification to get ziftomenib.

Ziftomenib has the molecular formula of C33H42F3N9O2S2 with a molecular weight of 717.9 g/mol. It is a synthetic, orally bioavailable small-molecule menin inhibitor with high lipophilicity. It has a topological polar surface area of 159 Ų with two hydrogen bond donors, 11–14 acceptors and 10–14 rotatable bonds, featuring a chiral (S)-configured propylpiperazine-indole-2-carbonitrile scaffold fused with a trifluoroethyl-thienopyrimidine core that binds potently at the menin-KMT2A interface. It appears white to off-white solid with good oral absorption, suitable for 600 mg daily capsule dosing in AML trials. It shows moderate solubility in aqueous buffers and DMSO and stability under physiological conditions for hepatic metabolism.