Desidustat Production Cost Reports

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

Desidustat is a small-molecule hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitor developed by Zydus Lifesciences to treat anaemia associated with chronic kidney disease (CKD) in adults. It stabilises HIF to boost endogenous erythropoietin production, enhance iron utilisation, reduce hepcidin levels, and improve haemoglobin, red blood cell counts, and haematocrit.

It has shown efficacy in clinical trials comparable to darbepoetin, with oral dosing every other day effectively reversing anaemia from nephrectomy, inflammation, or chemotherapy in preclinical rodent models. It also demonstrates potential in reducing inflammation, oxidative stress, and complement pathways for conditions like chemotherapy-induced anaemia, sickle cell disease, acute kidney injury, and even EPO-resistant cases.

Desidustat's market growth is driven by the rising prevalence of chronic kidney disease (CKD)-associated anaemia, along with global erythropoietin drugs market expansion. Its status as an innovative oral HIF-PH inhibitor offering advantages over injectable ESAs, like better patient compliance, comparable efficacy to darbepoetin, and potential in dialysis/non-dialysis CKD patients, boosts its market growth. Additionally, strategic partnerships and robust clinical trial data from DREAM-ND/DREAM-D studies further boost adoption. Furthermore, the fluctuations in the cost and availability of the major raw materials utilized in the production process, such as 2-iodobenzoic acid and ethanol/H2SO4, impacts industrial desidustat procurement.

Raw Material for Desidustat Production

According to the desidustat production plant project report, the various raw materials for desidustat production include 2-iodobenzoic acid and ethanol/H2SO4.

Production Process of Desidustat

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

1. Production via chemical synthesis: The production process of desidustat occurs through a seven-step process starting from 2-iodobenzoic acid. The process involves esterification with ethanol/H2SO4 to form ethyl 2-iodobenzoate, followed by copper(I) iodide-catalysed N-arylation with tert-butyl (cyclopropylmethoxy)carbamate and glycine. The next step involves Boc deprotection with methanolic HCl, acylation with ethyl hydrogen malonate using POCl3/pyridine, and base-mediated (NaOMe) cyclisation to form the quinolone-3-carboxylate core. The final steps involve selective amide coupling of the ester with glycine ethyl ester·HCl/DIPEA in THF, followed by saponification with NaOH, followed by acidification to produce desidustat.

Properties of Desidustat

Desidustat is a small-molecule pharmaceutical with the chemical name Glycine, N-[[1-(cyclopropylmethoxy)-1,2-dihydro-4-hydroxy-2-oxo-3-quinolinyl]carbonyl], also known as ZYAN1. It has a molecular formula of C16H16N2O6 and a molecular weight of 332.31 g/mol. It appears as a white to off-white crystalline solid or powder, formulated into uncoated biconvex tablets (25 mg or 50 mg strengths with excipients like microcrystalline cellulose, lactose, and magnesium stearate), and exhibits good stability (≥4 years at -20 °C, processed stability up to 97h at RT in blood). It is sparingly soluble in aqueous buffers but highly soluble in organic solvents such as ethanol (~1 mg/mL), DMSO, and DMF (~3 mg/mL), with computed descriptors including XLogP3-AA (lipophilicity measure). It consists of a hydrogen donor count of 3, an acceptor count of 6, a polar surface area of 116.17 Ų, rotatable bonds of 6, and three rings.