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Search results for "LiverTox|Immunomodulatory|Rheumatic Disease" in comments (approximate match)
Showing 1 - 9 of 9 results
Status:
US Approved Rx
(2020)
Source:
NDA213082
(2020)
Source URL:
First approved in 2012
Source:
NDA203214
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Tofacitinib is an orally available inhibitor of Janus kinases (JAK), with immunomodulatory and anti-inflammatory activities. Upon administration, tofacitinib binds to JAK and prevents the activation of the JAK-signal transducers and activators of transcription (STAT) signaling pathway. This may decrease the production of pro-inflammatory cytokines, such as interleukin (IL)-6, -7, -15, -21, interferon-alpha and -beta, and may prevent both an inflammatory response and the inflammation-induced damage caused by certain immunological diseases. JAK kinases are intracellular enzymes involved in signaling pathways affecting hematopoiesis, immunity and inflammation. Tofacitinib was discovered and developed by the National Institutes of Health and Pfizer. Besides rheumatoid arthritis, tofacitinib has also been studied in clinical trials for the prevention of organ transplant rejection, and the treatment of psoriasis and ulcerative colitis. Patients treated with tofacitinib (XELJANZ) are at increased risk for developing serious infections that may lead to hospitalization or death and adverse reactions. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Status:
US Approved Rx
(2013)
Source:
BLA125472
(2013)
Source URL:
First approved in 2010
Source:
BLA125276
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2013)
Source:
BLA125433
(2013)
Source URL:
First approved in 2009
Source:
BLA125289
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2005)
Source:
BLA125118
(2005)
Source URL:
First approved in 2005
Source:
BLA125118
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2021)
Source:
BLA761216
(2021)
Source URL:
First approved in 2002
Source:
BLA125057
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2001)
Source:
BLA103950
(2001)
Source URL:
First approved in 2001
Source:
BLA103950
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2019)
Source:
BLA761086
(2019)
Source URL:
First approved in 1998
Source:
BLA103772
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(1998)
Source:
BLA103795
(1998)
Source URL:
First approved in 1998
Source:
BLA103795
Source URL:
Class:
PROTEIN
Status:
Possibly Marketed Outside US
Source:
NCT02132234: Phase 4 Interventional Unknown status Rheumatoid Arthritis
(2013)
Source URL:
Class:
PROTEIN