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Status:
US Approved Rx
(2020)
Source:
NDA209510
(2020)
Source URL:
First approved in 2020
Source:
NDA209510
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Conditions:
Amisulpride, a benzamide derivative, shows a unique therapeutic profile being atypical antipsychotic. At low doses, it enhances dopaminergic neurotransmission by preferentially blocking presynaptic dopamine D2/D3 autoreceptors. At higher doses, amisupride antagonises postsynaptic dopamine D2 and D3 receptors, preferentially in the limbic system rather than the striatum, thereby reducing dopaminergic transmission. In addition its antagonism at serotonin 5-HT7 receptors likely underlies the antidepressant actions. Amisulpride is approved for clinical use in treating schizophrenia in a number of European countries and also for treating dysthymia, a mild form of depression, in Italy.
Status:
US Approved Rx
(2020)
Source:
NDA212950
(2020)
Source URL:
First approved in 2020
Source:
NDA212950
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Fostemsavir (BMS-663068) is an investigational attachment inhibitor with a unique mechanism of action. It is a prodrug of temsavir, which binds to HIV envelope glycoprotein 120 (gp120), thereby preventing viral attachment to the host CD4 cell surface receptor. In the absence of effective binding of HIV gp120 with the host CD4 receptor, HIV does not enter the host cell. Because fostemsavir has a novel mechanism of action, the drug should have full activity against HIV strains that have developed resistance to other classes of antiretroviral medications. In a phase 2b study of treatment-experienced individuals, fostemsavir appeared to be well tolerated. Phase 3 studies are ongoing.
Status:
US Approved Rx
(2020)
Source:
NDA212950
(2020)
Source URL:
First approved in 2020
Source:
NDA212950
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Fostemsavir (BMS-663068) is an investigational attachment inhibitor with a unique mechanism of action. It is a prodrug of temsavir, which binds to HIV envelope glycoprotein 120 (gp120), thereby preventing viral attachment to the host CD4 cell surface receptor. In the absence of effective binding of HIV gp120 with the host CD4 receptor, HIV does not enter the host cell. Because fostemsavir has a novel mechanism of action, the drug should have full activity against HIV strains that have developed resistance to other classes of antiretroviral medications. In a phase 2b study of treatment-experienced individuals, fostemsavir appeared to be well tolerated. Phase 3 studies are ongoing.
Status:
US Approved Rx
(2020)
Source:
NDA212950
(2020)
Source URL:
First approved in 2020
Source:
NDA212950
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Fostemsavir (BMS-663068) is an investigational attachment inhibitor with a unique mechanism of action. It is a prodrug of temsavir, which binds to HIV envelope glycoprotein 120 (gp120), thereby preventing viral attachment to the host CD4 cell surface receptor. In the absence of effective binding of HIV gp120 with the host CD4 receptor, HIV does not enter the host cell. Because fostemsavir has a novel mechanism of action, the drug should have full activity against HIV strains that have developed resistance to other classes of antiretroviral medications. In a phase 2b study of treatment-experienced individuals, fostemsavir appeared to be well tolerated. Phase 3 studies are ongoing.
Status:
US Approved Rx
(2020)
Source:
NDA212950
(2020)
Source URL:
First approved in 2020
Source:
NDA212950
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Fostemsavir (BMS-663068) is an investigational attachment inhibitor with a unique mechanism of action. It is a prodrug of temsavir, which binds to HIV envelope glycoprotein 120 (gp120), thereby preventing viral attachment to the host CD4 cell surface receptor. In the absence of effective binding of HIV gp120 with the host CD4 receptor, HIV does not enter the host cell. Because fostemsavir has a novel mechanism of action, the drug should have full activity against HIV strains that have developed resistance to other classes of antiretroviral medications. In a phase 2b study of treatment-experienced individuals, fostemsavir appeared to be well tolerated. Phase 3 studies are ongoing.
Status:
US Approved Rx
(2020)
Source:
NDA213756
(2020)
Source URL:
First approved in 2020
Source:
NDA213756
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Selumetinib (AZD6244 or ARRY-142886) is a potent, selective, and ATP-uncompetitive inhibitor of Ras-Raf-mitogen-activated protein kinase kinase (MEK1/2). This inhibition can prevent ERK activation, disrupt downstream signal transduction, and inhibit cancer cell proliferation and survival. Selumetinib has shown tumour suppressive activity in multiple rodent models of human cancer including melanoma, pancreatic, colon, lung, and breast cancers. AstraZeneca is responsible for development and commercialization of selumetinib.
Status:
US Approved Rx
(2019)
Source:
NDA211280
(2019)
Source URL:
First approved in 2019
Source:
NDA211280
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
LASMIDITAN is a serotonin (5-HT) receptor agonist without vasoconstrictor activity, which selectively binds to the 5-HT(1F) receptor subtype. It is under development for the treatment of migraine.
Status:
US Approved Rx
(2019)
Source:
NDA212327
(2019)
Source URL:
First approved in 2019
Source:
NDA212327
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Fedratinib (SAR-302503, TG-101348) is a selective small-molecule inhibitor of Janus kinase-2. Fedratinib demonstrated therapeutic efficacy in a murine model of myeloproliferative disease. Sanofi was developing Fedratinib for the treatment of myeloproliferative diseases and solid tumors.
The clinical development of fedratinib was terminated after reports of Wernicke's encephalopathy in myelofibrosis patients.
Status:
US Approved Rx
(2023)
Source:
NDA213931
(2023)
Source URL:
First approved in 2019
Source:
NDA211801
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Tenapanor is an inhibitor of the sodium-proton (Na(+)/H(+)) exchanger NHE3 and reduces sodium absorption in the GI tract, thus increasing intestinal fluid. Ardelyx has completed Phase 3 development of tenapanor for the treatment of irritable bowel syndrome with constipation (IBS-C) and submitted a new drug application to the U.S. Food and Drug Administration for the treatment of patients with IBS-C. In addition, tenapanor successfully completed phase III clinical trial for the treatment of hyperphosphatemia in people with end-stage renal disease who are on dialysis and RDX013, a potassium secretagogue program for the potential treatment of high potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease.
Status:
US Approved Rx
(2019)
Source:
NDA211672
(2019)
Source URL:
First approved in 2019
Source:
NDA211672
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
LEFAMULIN is a pleuromutilin antibiotic under development for the treatment of community-acquired bacterial pneumonia, as well as acute bacterial skin and skin structure infections. It inhibits bacterial protein synthesis by binding to the peptidyl transferase center of the 50S ribosome, resulting in the cessation of bacterial growth.