Baricitinib
Status | Pipeline |
Development phase | |
Therapeutic cat. | Other |
Polymorphic form | Form I |
CAS No. | 1187594-09-7 |
Reference Product | |
Injectable Form | |
EU DMF readiness | |
CEP | |
CHINESE DMF | |
JAPANESE DMF | |
KOREAN DMF | |
CANADIAN DMF | |
CADIFA | |
US DMF readiness | |
OEB No. | |
Samples |
Drug description
Baricitinib (brand name Olumiant) is used to treat rheumatoid arthritis, severe alopecia areata (hair loss), and COVID-19 in certain patients. These conditions may be caused by an overactive immune system causing inflammation. Baricitinib works by blocking a specific protein (Janus kinase) that causes inflammation to help relieve the symptoms of these conditions. Baricitinib is classified as a Janus kinase inhibitor (JAK inhibitor). In rheumatoid arthritis, the immune system attacks healthy joint tissues causing the joint to be inflamed. Baricitinib reduces inflammation in RA to help relieve pain, swelling, and tenderness of the joints.In alopecia areata (AA), hair loss is caused by the immune system attacking the hair follicles, causing inflammation that interrupts hair growth. Baricitinib's mechanism of action means it blocks inflammation, which allows hair to regrow. Baricitinib treats symptoms of alopecia areata, but it is not a cure, and if you stop taking the tablets, then your hair may fall out again. When used to treat COVID-19, baricitinib is associated with an improvement in COVID-19 symptoms and a reduced need for ventilators. While generally well-tolerated, some patients developed elevated liver enzymes as a side effect. Baricitinib gained FDA approval on May 31, 2018, under the brand name Olumiant. A generic version of Olumiant was FDA-approved on July 22, 2024, and is sold under the name baricitinib.
Polpharma API
- Stable product of very high quality
- Tailor-made PSD
- Optimized use of solvents to limit impact on the environment
Disclaimer
Products protected by patents (SPC) in Poland are developed solely for the purpose of Regulatory Submissions or R&D purposes intended to support Regulatory Submissions. These products are not offered for sale or made available in countries where such products are subject to patent (SPC) protection and where the offer for sale or any related activity constitutes patent infringement. It is within the buyer’s responsibility and liability to check the patent situation of the product in the import market(s). Based on exemption under art. 5(2) of the Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products Apixaban, Dapagliflozin (amorphous), Linagliptin, Rivaroxaban and Ticagrelor, which are protected by SPCs in Poland, can be manufactured and offered only for the purpose of export to non-EU countries, provided all requirements of the Regulationare met.