Selumetinib API is a small-molecule active pharmaceutical ingredient belonging to the benzimidazole class and functioning as a selective inhibitor of mitogen-activated protein kinase kinase 1 and 2 (MEK1 and MEK2). Selumetinib is chemically identified as 5-[(4-bromo-2-chlorophenyl)amino]-4-fluoro-N-(2-hydroxyethoxy)-1-methyl-1H-benzimidazole-6-carboxamide and is associated with development codes including AZD6244, AZD-6244, ARRY-142886 and ARRY-886.
Selumetinib has the molecular formula C₁₇H₁₅BrClFN₄O₃ and a molecular weight of approximately 457.68 g/mol. The primary CAS Number is 606143-52-6. FDA's substance database identifies Selumetinib under UNII 6UH91I579U.
Swapnroop Drugs and Pharmaceuticals provides Selumetinib API for pharmaceutical development and manufacturing requirements, supported by quality-focused analytical testing, technical documentation and controlled pharmaceutical handling.
Selumetinib is a targeted small-molecule MEK inhibitor that acts on MEK1 and MEK2, components of the RAF-MEK-ERK signaling pathway. By inhibiting MEK signaling, selumetinib can interfere with downstream signaling involved in cellular proliferation.
Selumetinib is an important pharmaceutical compound within targeted therapy research and has an established clinical and regulatory history. FDA currently identifies selumetinib as a kinase inhibitor and its approved use includes adult and pediatric patients one year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas.
Selumetinib contains a substituted benzimidazole core incorporating fluorine, bromine and chlorine-containing aromatic functionality together with a hydroxyethoxycarboxamide group.
The chemical identity of Selumetinib is represented by the molecular formula C₁₇H₁₅BrClFN₄O₃, while its molecular weight is approximately 457.7 g/mol. PubChem reports an XLogP3-AA value of 3.6, topological polar surface area of 88.4 Ų, six hydrogen-bond acceptors, three hydrogen-bond donors and six rotatable bonds.
FDA GSRS and PubChem independently identify these core chemical characteristics.
Selumetinib is used as the active pharmaceutical ingredient in targeted pharmaceutical products designed around MEK inhibition.
The FDA-approved product KOSELUGO contains selumetinib and is indicated for adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). The FDA expanded the indication to adults in November 2025, following earlier pediatric approvals.
Selumetinib API may therefore be relevant to:
The pharmaceutical application of the API should always be determined according to the applicable regulatory approval, intended use and customer-specific requirements.
Selumetinib is a MEK1 and MEK2 inhibitor. MEK1 and MEK2 are components of the RAF-MEK-ERK signaling pathway, which plays an important role in cellular proliferation and signaling.
By inhibiting MEK1/2 activity, selumetinib reduces downstream pathway signaling. This pharmacological activity forms the basis for its use in NF1-associated symptomatic, inoperable plexiform neurofibromas. FDA describes selumetinib as a kinase inhibitor, and the current prescribing information identifies its mechanism and clinical use within this indication.
Quality control of Selumetinib API should be performed using validated analytical methods appropriate for the substance and the applicable approved specification.
Typical analytical evaluation may include:
Analytical acceptance criteria should be established according to the applicable product specification and validated analytical procedure.
For Selumetinib, universal numerical limits should not be invented where an authoritative pharmacopeial or regulatory specification does not establish them. Customer-specific and manufacturer-approved specifications should be used for release testing.
Swapnroop Drugs and Pharmaceuticals supports pharmaceutical customers requiring Selumetinib API for research, formulation development and manufacturing applications.
Our approach to API quality focuses on controlled manufacturing processes, raw-material control, analytical characterization, impurity monitoring, appropriate packaging and documentation.
Selumetinib API documentation may include, subject to product and customer requirements:
Selumetinib API should be packaged in suitable pharmaceutical-grade containers that provide appropriate protection against environmental exposure, including moisture and light where required by the approved storage specification.
Storage conditions for bulk API should be based on validated stability data and the applicable manufacturer specification.
The storage conditions for a finished Selumetinib drug product should not automatically be treated as the storage specification for bulk API. For example, the current FDA/DailyMed labeling for KOSELUGO capsules specifies storage at 20°C to 25°C, with permitted excursions to 15°C to 30°C, and protection from light and moisture in the original bottle. These conditions relate to the finished drug product.
Swapnroop can support pharmaceutical requirements with appropriate product and quality documentation, depending on the applicable commercial and regulatory requirements.
Typical documentation may include:
Swapnroop Drugs and Pharmaceuticals focuses on pharmaceutical API solutions with emphasis on chemical identity, analytical quality, documentation and controlled product handling.
Key advantages include:
For Selumetinib API requirements, contact Swapnroop Drugs and Pharmaceuticals for product specifications, documentation, availability and commercial information.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |