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Restrict the search for
riboflavin phosphate
to a specific field?
Status:
First approved in 2004
Source:
21 CFR 352
Source URL:
Class:
STRUCTURALLY DIVERSE
Status:
Other
Class:
G1 SPECIFIED SUBSTANCE
Status:
Possibly Marketed Outside US
Source:
BLA125812
(2024)
Source URL:
First approved in 2024
Source:
BLA125812
Source URL:
Class:
G1 SPECIFIED SUBSTANCE
Status:
Investigational
Source:
NCT01414153: Phase 2 Interventional Completed Exudative Age-related Macular Degeneration
(2012)
Source URL:
Class:
CONCEPT
Status:
Other
Class:
CONCEPT
Status:
Other
Class:
CONCEPT
Status:
Possibly Marketed Outside US
Source:
M022
(2024)
Source URL:
First approved in 2024
Source:
M022
Source URL:
Class:
CONCEPT
Status:
US Approved Rx
(2024)
Source:
NDA217900
(2024)
Source URL:
First approved in 2024
Source:
NDA217900
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Status:
US Approved Rx
(2023)
Source:
NDA216956
(2023)
Source URL:
First approved in 2023
Source:
NDA216956
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
APD-334 (Etrasimod) was discovered as part of our internal effort to identify potent, centrally available, functional antagonists of the S1P1 receptor for use as next generation therapeutics for treating multiple sclerosis (MS) and other autoimmune diseases. APD334 is a potent functional antagonist of S1P1 and has a favorable PK/PD profile, producing robust lymphocyte lowering at relatively low plasma concentrations in several preclinical species. This new agent was efficacious in a mouse experimental autoimmune encephalomyelitis (EAE) model of MS and a rat collagen induced arthritis (CIA) model and was found to have appreciable central exposure. APD-334 has therapeutic potential in immune and inflammatory-mediated diseases such as ulcerative colitis, Crohn’s disease, and atopic dermatitis.
Status:
US Approved Rx
(2023)
Source:
NDA217759
(2023)
Source URL:
First approved in 2023
Source:
NDA217759
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Leniolisib (JOENJA®) is an oral selective phosphoinositide 3-kinase-delta (PI3Kdelta) inhibitor being developed by Pharming Group NV in-licensed from Novartis for the treatment of immunodeficiency disorders. Leniolisib inhibits PI3K-delta by blocking the active binding site of PI3K-delta. In cell-free isolated enzyme assays, leniolisib was selective for PI3K-delta over PI3K-alpha (28-fold), PI3K-beta (43-fold), and PI3K-gamma (257-fold), as well as the broader kinome. In cell-based assays, leniolisib reduced pAKT pathway activity and inhibited proliferation and activation of B and T cell subsets. Gain-of-function variants in the gene encoding the p110-delta catalytic subunit or loss of function variants in the gene encoding the p85-alpha regulatory subunit each cause hyperactivity of PI3K-delta. Leniolisib inhibits the signalling pathways that lead to increased production of PIP3, hyperactivity of the downstream mTOR/AKT pathway, and to the dysregulation of B and T cells. In March 2023, leniolisib received its first approval for the treatment of activated PI3Kdelta syndrome (APDS) in adult and paediatric patients 12 years of age and older. Leniolisib is also under regulatory review in European Union for the treatment of APDS. Development of leniolisib for the treatment of Sjögren's syndrome has been discontinued.
