Ivosidenib Production Cost Reports

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

Ivosidenib, marketed as Tibsovo, is a targeted IDH1 inhibitor. It is utilised in pharmaceutical applications to treat cancers harbouring susceptible IDH1 mutations, such as newly diagnosed acute myeloid leukaemia (AML) in adults aged 75 or older, or those with comorbidities precluding intensive chemotherapy, either as monotherapy or combined with azacitidine.

It is also approved for relapsed or refractory AML, relapsed or refractory myelodysplastic syndromes (MDS), and previously treated locally advanced or metastatic cholangiocarcinoma in adults. Additionally, by inhibiting the mutant IDH1 enzyme, ivosidenib reduces oncogenic 2-hydroxyglutarate levels, restoring normal cellular differentiation and epigenetic regulation in affected haematological and solid tumours.

Ivosidenib (Tibsovo) market growth is driven by the rising prevalence of IDH1-mutated cancers like acute myeloid leukaemia (AML), unmet needs in relapsed/refractory cases, and expanding FDA approvals for AML, cholangiocarcinoma, and myelodysplastic syndromes. Precision oncology advancements, such as companion diagnostics and targeted therapies, boost adoption alongside favourable clinical outcomes, safety profiles, and label expansions into combination regimens like azacitidine.

Additionally, rising R&D investments, strategic pharma partnerships, supportive reimbursement policies, and global penetration contribute to the demand. Industrial ivosidenib procurement is impacted by its orphan drug status and FDA approvals tied to specific IDH1-mutated indications (AML, cholangiocarcinoma, MDS), mandating companion diagnostics for patient selection and limiting bulk sourcing to verified GMP suppliers. Furthermore, high synthesis 

Raw Material for Ivosidenib Production

According to the Ivosidenib production plant project report, the various raw materials for Ivosidenib production include 1-(difluoromethyl)cyclobutan-1-amine hydrochloride, ethyl formate, and triethylamine.

Production Process of Ivosidenib

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

1. Production via chemical synthesis: The production process of ivosidenib begins with converting 1-(difluoromethyl)cyclobutan-1-amine hydrochloride to its formamide using ethyl formate and triethylamine. The reaction is followed by partial solvent evaporation and dehydration with POCl3 and Et3N to yield crude isonitrile in trifluoroethanol. The resulting compound undergoes a key Ugi reaction with preformed imine (from aniline and aldehyde) and acid compound, producing a diastereomer mixture that is resolved via acid/base extraction, piperidine treatment, and crystallisation to isolate the desired diastereomer intermediate. The final steps involve Buchwald-Hartwig coupling of the intermediate with 2-chloroisonicotinonitrile, followed by crystallisation from EtOAc and n-heptane to afford ivosidenib.

Properties of Ivosidenib

Ivosidenib (C28H22ClF3N6O3) is a small-molecule IDH1 inhibitor with a molecular weight of 582.97 g/mol (monoisotopic 582.1394008), featuring two chiral centres in the (2S,1'S) configuration, low aqueous solubility, and sparse hygroscopicity as a crystalline white to light yellow solid. It has 92-96% plasma protein binding, primarily metabolised by CYP3A4 via oxidation (with minor N-dealkylation and hydrolysis), and acts as a targeted inhibitor of mutant IDH1 enzyme (EC 1.1.1.42) in cancers. The compound includes functional groups such as amide, nitrile, and difluorocyclobutyl moieties.