The report provides a detailed analysis essential for establishing a revumenib production plant. It encompasses all critical aspects necessary for revumenib production, including the cost of revumenib production, revumenib plant cost, revumenib production costs, and the overall revumenib production plant cost. Additionally, the study covers specific expenditures associated with setting up and operating a revumenib 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.
Revumenib is an oral targeted cancer drug which is classified as a Menin inhibitor that blocks the interaction between Menin and KMT2A proteins. It disrupts the growth signals in certain aggressive leukaemias. It has FDA approval as a first-in-class therapy for relapsed or refractory acute leukaemia with KMT2A gene translocations in adults and children aged 1 year and older.
It is effective in relapsed or refractory acute myeloid leukaemia (AML) when no other good treatment options exist. It is administered as tablets and shows complete remission rates in heavily pretreated patients by stopping leukaemia cell proliferation. Its common side effects of revumenib include bleeding and bruising, nausea, diarrhoea, fatigue, infections, muscle pain, differentiation syndrome, and QT prolongation.
The market for revumenib is driven by its roles as a first-in-class Menin inhibitor. Its FDA approval for KMT2A-rearranged acute leukaemia and expansions to NPM1-mutant AML contribute to its market growth. Its utilisation in relapsed and refractory settings, along with NCCN guideline inclusion, and payer-friendly budget support its market. Its effectiveness in a broad range of patient i.e. in adults and children aged 1 year and older, fuels its market.
The industrial revumenib procurement is affected by high drug purchase costs because of competitive pricing. Other factors like companion genetic testing expenses, AE management needs like differentiation syndrome monitoring, and supply from specialised manufacturers impact its sourcing strategies.
Raw Material for Revumenib Production
According to the revumenib production plant project report, the key raw materials used in the production of revumenib include methyl (1r,4r)-4-aminocyclohexane-1-carboxylate hydrochloride and ethanesulfonyl chloride.
Production Process of Revumenib
The extensive revumenib production cost report consists of the following major industrial production process:
- By Reduction: The production process for revumenib starts with the formation of a major intermediate ((1r,4r)-4-(ethylsulfonamido)cyclohexyl)methyl 4-methylbenzenesulfonate. First, sulfonamide is formed by reacting methyl (1r,4r)-4-aminocyclohexane-1-carboxylate HCl with ethanesulfonyl chloride. This is followed by the reduction of the ester to alcohol using lithium aluminium hydride. The alcohol is then activated by tosylation with p-toluenesulfonyl chloride to give the tosylate intermediate. This activated intermediate undergoes nucleophilic substitution with the appropriate heteroaryl amine fragment to install the cyclohexyl side chain. After this, functional group transformations and assembly of the heterocyclic core are carried out to get revumenib.
Revumenib has the molecular formula of C32H47FN6O4S and a molecular weight of 630.82 g/mol. It appears as a solid that is lipophilic, which contributes to its oral bioavailability. It has 10 rotatable bonds, 5 rings, and a topological polar surface area of approximately 108 Ų that influences membrane permeability. Its chemical structure centres on a benzamide core with an ethylsulfonamido-cyclohexyl group, fluoro-substituted phenyl ether, pyrimidinyl linkage, and diazaspiro nonane scaffold. It has a refractivity of around 171.88 m³·mol-¹ and polarizability of 69.55 ų. Its properties support tablet formulation for oral use in treating KMT2A-rearranged leukaemias.
