Blog Date 29 March, 2023

Ruxolitinib

Ruxolitinib phosphate is a kinase inhibitor with the chemical name (R)-3-(4-(7H-pyrrolo[2,3d] pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphate and a molecular weight of 404.36 g/mol.

Ruxolitinib phosphate is a white to off-white to light pink powder and is soluble in aqueous buffers across a pH range of 1 to 8.Ruxolitinib is a medication approved in the US in 2011 for the treatment of intermediate or high-risk myelofibrosis a type of myeloproliferative disorder that affects the bone marrow. Myelofibrosis is a life-threatening bone marrow problem, which is manifested by the following symptoms: Enlarged spleen (splenomegaly), severe itching, fever, night sweats, weight loss, bone pain, or unusual tiredness or weakness.

Ruxolitinib was first approved for the treatment of adult patients with myelofibrosis by the FDA in 2011, followed by EMA's approval in 2012. In 2014, it was approved for the treatment of polycythemia in adults who have an inadequate response to or are intolerant of hydroxyurea.The topical formulation of

Ruxolitinib is used to treat atopic dermatitis and vitiligo. 

Ruxolitinib has been investigated to treat patients with coronavirus disease 2019 (COVID-19) accompanied by severe systemic hyper inflammation. In phase II clinical trials, ruxolitinib improved chest computed tomography and improved recovery in patients with lymphopenia.

Ruxolitinib is a type of targeted cancer drug called a cancer growth blocker. A cancer growth blocker blocks the growth factors that trigger the cancer cells to divide and grow. Ruxolitinib works by blocking a gene that is important in the production of blood cells. This gene is called JAK2.You have a blood test to check for the JAK2 gene change before you start treatment.

Ruxolitinib used in the treatment of Vitiligo

Ruxolitinib is the first medication that can restore pigment in patients with no segmental vitiligo. The FDA approved ruxolitinib cream for adults and children ages 12 and up

Vitiligo is a chronic autoimmune condition that causes patches of skin to lose pigment and turn milky white. The most prevalent form is nonsegmental (also known as generalized) vitiligo, in which white patches appear symmetrically on both sides of the body, such as on both hands or both knees, often covering large areas. Vitiligo can occur at any age, but most people experience the initial symptoms before age 30. 

 Some of the known (Pharmacopeial) and unknown impurities (non-pharmacopeial) of Ruxolitinib are tabulated below.

CatLog Number

Product Name

Cas No.

 R650000

(R)-RuxolitinibAPI 

941678-49-5

 R650004

Ruxolitinib M18 metabolite

 1315607-85-2

 R650006

Ruxolitinib Amide Impurity

1911644-32-0

 R650007

Ruxolitinib Pyrazole deazapurine

941685-27-4

 R650008

Ruxolitinib Acrylo pyrimidine Impurity

941685-39-8

 R650012

Ruxolitinib Impurity 5

2102675-40-9

 

For more details, visit www.simsonpharma.com

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