Available EU DMF/CEP
EU DMF
CEP
API Status
Commercial
Pipeline
Therapeutic Category
Alimentary tract & metabolism
Anti-infectives for systemic use
Antipyretic, analgesic and anti-inflammatory
Antineoplastic & immunomodulating agents
Blood & blood forming organs
Cardiovascular system
Genito-urinary system & sex hormones
Injectable forms
Musculo-skeletal system
Nervous system
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Available US DMF
US DMF
Available Japanese/Chinese DMF
Japanese DMF
Chinese DMF
Korean DMF

Baricitinib

CAS No.

1187594-09-7

Innovator/marketer

Olumiant

Polymorphic form

Form I

Therapeutic Area

Antineoplastic & immunomodulating agents

Status

Pipeline

EU DMF readiness

Q2 2019

US DMF readiness

Q2 2019

Drug description:

Baricitinib belongs to antineoplastic and immunomodulating agents; is a selective immunosuppressant.
Baricitinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs. Baricitinib may be used as monotherapy or in combination with methotrexate.
It is formulated as film-coated tablets for oral route of administration.

Mechanism of action:

Baricitinib is a selective and reversible inhibitor of Janus kinase 1 (JAK1) and Janus kinase 2 (JAK2).
Janus kinases (JAKs) are enzymes that transduce intracellular signals from cell surface receptors for a number of cytokines and growth factors involved in hematopoiesis, inflammation and immune function. Within the intracellular signaling pathway, JAKs phosphorylate and activate signal transducers and activators of transcription (STATs), which activate gene expression within the cell. Baricitinib modulates these signaling pathways by partially inhibiting JAK1 and JAK2 enzymatic activity, thereby reducing the phosphorylation and activation of STATs.

DISCLAIMER
The above product is presented solely for informational purposes and does not constitute an offer in any sense. Products under patent (SPC) protection in Poland and/or other countries are not offered until expiration of the corresponding IP right.

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