Voxelotor Production Cost Reports

The report provides a detailed analysis essential for establishing a Voxelotor production plant. It encompasses all critical aspects necessary for Voxelotor production, including the cost of Voxelotor production, Voxelotor plant cost, Voxelotor production costs, and the overall Voxelotor production plant cost. Additionally, the study covers specific expenditures associated with setting up and operating a Voxelotor 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.

Voxelotor is an oral small molecule haemoglobin modulator that is used as a disease modifying therapy in sickle cell disease (SCD). It binds reversibly to the N terminal valine of the haemoglobin α chain, stabilising the oxygenated form of haemoglobin S and thereby stopping deoxygenated HbS polymerisation, which reduces red cell sickling, haemolysis, and anaemia. It is given once daily to raise haemoglobin and improve haemolysis markers in adolescents and adults with SCD. It is also effective for those who are already on or intolerant to hydroxyurea, and can be used in combination with other SCD therapies. It provides sustained haemoglobin increases of at least 1 g/dL in many patients and long term maintenance of improved haemolysis parameters. Its common side effects include headache, diarrhoea, nausea, abdominal pain, fatigue, and rash.

The market for Voxelotor is influenced by its first in class status as an oral disease modifying therapy for sickle cell disease. The growing need for SCD, orphan drug and rare disease incentives, and payer willingness to reimburse high value therapies contribute to its market growth.

The industrial Voxelotor procurement is affected by its status as a branded, originator product under patent (single originator, no generics), and high per patient cost requiring HTA and payer negotiations (e.g., NICE and other agencies assessing cost effectiveness). Also, reliance on a limited number of GMP certified API and finished dose manufacturers and the need for robust pharmacovigilance and risk management commitments impact its sourcing.

Raw Material for Voxelotor Production

According to the Voxelotor production plant project report, the key raw materials used in the production of Voxelotor include (2,6-dihydroxybenzaldehyde, )-Potassium Carbonate, and -(3-(Chloromethyl)-2-(1-Isopropyl-1H-Pyrazol-5-yl)Pyridine Hydrochloride).

Production Process of Voxelotor

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

1. From 2,6-Dihydroxybenzaldehyde: The production process for Voxelotor involves several steps. The reaction starts by stirring 2,6-dihydroxybenzaldehyde with potassium carbonate in DMF to deprotonate the phenolic OH. Then, 3-(chloromethyl)-2-(1-isopropyl-1H-pyrazol-5-yl)pyridine hydrochloride is added, and the mixture is heated for 2 hours under inert conditions, which leads to nucleophilic substitution to form the ether linkage. After that, the mixture is filtered, concentrated, and purified to get Voxelotor as the final product.

Voxelotor is a small molecule haemoglobin S polymerisation inhibitor with the molecular formula C19H19N3O3 and a molecular weight of 337.4 g/mol. It is an achiral, non hygroscopic crystalline solid, described as white to yellow or beige, with a density of around 1.2 g/cm³. It is almost insoluble in water, has poor intrinsic aqueous solubility consistent with its classification as a BCS class II drug, and is much more soluble in organic solvents such as toluene, with slight solubility reported in chloroform and DMSO. Its logP (XLogP3) value is about 2.7, one hydrogen bond donor, three hydrogen bond acceptors, and a topological polar surface area of roughly 70–75 Ų. It has several rotatable bonds, supporting good membrane permeability but solubility limited oral absorption. It is a substituted benzaldehyde bearing a phenolic hydroxyl, a methoxy linker to a 3 pyridyl ring, and a 1 isopropyl 1H pyrazol 5 yl moiety.