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Search results for fludarabine root_notes_note in Note (approximate match)
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2011)
Source URL:
First approved in 2011
Source:
21 CFR 352
Source URL:
Class:
POLYMER
Status:
Possibly Marketed Outside US
Source:
21 CFR 333E
(2021)
Source URL:
First approved in 2009
Source:
21 CFR 333D
Source URL:
Class:
POLYMER
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2017)
Source URL:
First approved in 2007
Source:
21 CFR 352
Source URL:
Class:
POLYMER
Status:
Possibly Marketed Outside US
Source:
M020
(2022)
Source URL:
First approved in 1993
Source:
21 CFR 352
Source URL:
Class:
POLYMER
Status:
Possibly Marketed Outside US
Source:
M020
(2015)
Source URL:
First approved in 2015
Source:
M020
Source URL:
Class:
STRUCTURALLY DIVERSE
Status:
Other
Class:
G1 SPECIFIED SUBSTANCE
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:
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.
Status:
US Approved Rx
(2021)
Source:
NDA214900
(2021)
Source URL:
First approved in 2021
Source:
NDA214900
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Ibrexafungerp (BREXAFEMME®) is an orally active triterpenoid antifungal drug being developed by SCYNEXIS, Inc. for the treatment of fungal infections. The inhibition of β-1,3-D glucan synthetase by ibrexafungerp compromises the integrity of fungal cell walls. Ibrexafungerp has been recently approved for the treatment of vulvovaginal candidiasis (VVC), and it is the first novel antifungal drug class to be approved in more than 20 years. Food and Drug Administration's decision was based on positive results from two pivotal phase III studies in which oral ibrexafungerp proved both safe and effective in patients with vulvovaginal candidiasis. Development for the treatment of recurrent VVC and invasive fungal infections is ongoing.
