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Status:
US Previously Marketed
Source:
UKONIQ by TG THERAPS
(2021)
Source URL:
First approved in 2021
Source:
UKONIQ by TG THERAPS
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Umbralisib (Ukoniq, TG Therapeutics) is an orally available PI3K delta inhibitor, targeting the delta isoform with nanomolar potency and several fold selectivity over the alpha, beta, and gamma isoforms of PI3K. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B-cell lymphocytes. On February 5, 2021, the Food and Drug Administration granted accelerated approval to umbralisib for the following indications: adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen; adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy. However, on June 1, 2022, the FDA withdrew its approval for the cancer medicine Ukoniq due to safety concerns.
Status:
US Previously Marketed
Source:
TRUSELTIQ by HELSINN HLTHCARE
(2021)
Source URL:
First approved in 2021
Source:
TRUSELTIQ by HELSINN HLTHCARE
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Infigratinib (BGJ398), a potent, orally bioavailable, small-molecule pan-FGFR kinase inhibitor. FGFR genetic alterations are the most significant predictors for BGJ398 sensitivity. It is currently in phase 2 trials for Cholangiocarcinoma, Glioblastoma and Solid tumors. Detected adverse events were hyperphosphatemia, fatigue, constipation, cough and nausea. Other adverse events were generally mild and included stomatitis, hair loss, decreased appetite, and fatigue.
Status:
US Previously Marketed
Source:
TRUSELTIQ by HELSINN HLTHCARE
(2021)
Source URL:
First approved in 2021
Source:
TRUSELTIQ by HELSINN HLTHCARE
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Infigratinib (BGJ398), a potent, orally bioavailable, small-molecule pan-FGFR kinase inhibitor. FGFR genetic alterations are the most significant predictors for BGJ398 sensitivity. It is currently in phase 2 trials for Cholangiocarcinoma, Glioblastoma and Solid tumors. Detected adverse events were hyperphosphatemia, fatigue, constipation, cough and nausea. Other adverse events were generally mild and included stomatitis, hair loss, decreased appetite, and fatigue.
Status:
US Previously Marketed
Source:
TRUSELTIQ by HELSINN HLTHCARE
(2021)
Source URL:
First approved in 2021
Source:
TRUSELTIQ by HELSINN HLTHCARE
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Infigratinib (BGJ398), a potent, orally bioavailable, small-molecule pan-FGFR kinase inhibitor. FGFR genetic alterations are the most significant predictors for BGJ398 sensitivity. It is currently in phase 2 trials for Cholangiocarcinoma, Glioblastoma and Solid tumors. Detected adverse events were hyperphosphatemia, fatigue, constipation, cough and nausea. Other adverse events were generally mild and included stomatitis, hair loss, decreased appetite, and fatigue.
Status:
US Previously Marketed
Source:
TRUSELTIQ by HELSINN HLTHCARE
(2021)
Source URL:
First approved in 2021
Source:
TRUSELTIQ by HELSINN HLTHCARE
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Infigratinib (BGJ398), a potent, orally bioavailable, small-molecule pan-FGFR kinase inhibitor. FGFR genetic alterations are the most significant predictors for BGJ398 sensitivity. It is currently in phase 2 trials for Cholangiocarcinoma, Glioblastoma and Solid tumors. Detected adverse events were hyperphosphatemia, fatigue, constipation, cough and nausea. Other adverse events were generally mild and included stomatitis, hair loss, decreased appetite, and fatigue.
Status:
US Previously Marketed
Source:
TRUSELTIQ by HELSINN HLTHCARE
(2021)
Source URL:
First approved in 2021
Source:
TRUSELTIQ by HELSINN HLTHCARE
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Infigratinib (BGJ398), a potent, orally bioavailable, small-molecule pan-FGFR kinase inhibitor. FGFR genetic alterations are the most significant predictors for BGJ398 sensitivity. It is currently in phase 2 trials for Cholangiocarcinoma, Glioblastoma and Solid tumors. Detected adverse events were hyperphosphatemia, fatigue, constipation, cough and nausea. Other adverse events were generally mild and included stomatitis, hair loss, decreased appetite, and fatigue.
Status:
Possibly Marketed Outside US
Source:
M017
(2021)
Source URL:
First approved in 2021
Source:
M017
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
LAURALKONIUM is an antiseptic.
Status:
Possibly Marketed Outside US
Source:
M020
(2022)
Source URL:
First approved in 2021
Source:
M020
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Status:
Possibly Marketed Outside US
Source:
21 CFR 349
(2021)
Source URL:
First approved in 2021
Source:
21 CFR 349
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Dextromethorphan D6 is a weak uncompetitive antagonist of the NMDA receptor. Dextromethorphan is also acts at nicotinic receptors, sigma-1 rcptor and serotonin and norepinephrine transporters. The incorporation of deuterium serves to reduce dextromethorphan first-pass liver metabolism. AVP-786 is an oral formulation of a combination of deuterated (d6)-dextromethorphan and an ultra-low dose of quinidine. Avanir Pharmaceuticals launched a phase III development program of AVP-786 for the treatment of agitation in patients with Alzheimer's disease.
Status:
Possibly Marketed Outside US
Source:
21 CFR 348
(2021)
Source URL:
First approved in 2021
Source:
21 CFR 348
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)