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Restrict the search for
icosapent ethyl
to a specific field?
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:
NDA210730
(2020)
Source URL:
First approved in 2020
Source:
NDA210730
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Status:
US Approved Rx
(2020)
Source:
NDA214701
(2020)
Source URL:
First approved in 2020
Source:
NDA214701
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Status:
US Approved Rx
(2020)
Source:
NDA213736
(2020)
Source URL:
First approved in 2020
Source:
NDA213736
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Pemigatinib, an oral kinases inhibitor, was approved under the brand name PEMAZYRE for the treatment of adults with previously treated, unresectable locally advanced, or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion. The FDA-approved indication for pemigatinib was granted under accelerated approval based on the overall response rate and duration of response in pre-marketing clinical trials. The drug inhibited FGFR1-3 phosphorylation and signaling and decreased cell viability in cancer cell lines with activating FGFR amplification and fusions that resulted in constitutive activation of FGFR signaling.
Status:
US Approved Rx
(2020)
Source:
NDA213973
(2020)
Source URL:
First approved in 2020
Source:
NDA213973
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
US Approved Rx
(2020)
Source:
NDA211723
(2020)
Source URL:
First approved in 2020
Source:
NDA211723
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Tazemetostat (EPZ-6438) is a selective inhibitor of histone-lysine N-methyltransferase EZH2. The drug is under clinical development (phase II) for the treatment of Diffuse Large B Cell Lymphoma, Malignant Mesothelioma and Synovial Sarcoma.
Status:
US Approved Rx
(2021)
Source:
NDA214032
(2021)
Source URL:
First approved in 2020
Source:
NDA212643
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Prostamedix is a 68Ga-labeled ligand of the prostate-specific membrane antigen (PSMA) for Prostate Cancer PET imaging. Because of the increased expression of PSMA in Prostate Cancer and its metastases, Prostamedix was reported to exhibit a favorable lesion-to-background ratio with high detection rates. Further studies evaluating Prostamedix showed substantially higher detection rates in patients with recurrent PC than reported for other imaging modalities, especially at low PSA values. The chelator HBED-CC (N,N'-bis-[2-hydroxy-5-(carboxyethyl)benzyl]ethylenediamine-N,N'-diacetic acid), represents a hitherto rarely used acyclic complexing agent especially allowing efficient radiolabelling with 68Ga even at ambient temperature. By combining HBED-CC with the PSMA inhibitor Glu-urea-Lys, a favorable aromatic part is introduced into the radiotracer which was found to be a necessary requirement for sustainable interaction with the PSMA receptor, putatively with the accessory hydrophobic pocket of the PSMA
Status:
US Approved Rx
(2019)
Source:
NDA209445
(2019)
Source URL:
First approved in 2019
Source:
NDA209445
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Status:
US Approved Rx
(2021)
Source:
NDA216157
(2021)
Source URL:
First approved in 2019
Source:
NDA213137
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
GBT440 (previously GTx011) is a potent and direct drug for sickle cell treatment. In sickle cell anemia, abnormal hemoglobin molecules are formed, which causes problems for the flow of blood and oxygen through the body. GBT440 can selectively bind to hemoglobin, thereby increasing its affinity for oxygen. By inhibiting hemoglobin polymerization, it also prevents deformation of the red blood cells. GBT440, renamed Voxelotor, is thought to help prevent sickle cells blocking blood vessels, and therefore reduces pain (sickle cell crisis) experienced by patients. GBT440 is well absorbed following intravenous and oral administration, and quickly partitions into the red blood cell with a small part re‐distributed into the plasma. GBT440 was well tolerated in a randomized, placebo‐controlled, double blind, parallel group phase I/II study in healthy volunteers and sickle cell disease patients. Headache is the most reported adverse event related to the use of this drug, and no serious adverse events are known. A phase 3 clinical trial examining the efficacy and safety of the drug (compared to placebo) is planned to be completed in 2019. Voxelotor was also studied as a potential therapy for treatment of low oxygen levels in the blood of idiopathic pulmonary fibrosis patients, but this program was discontinued because of a lack of clinical benefits.
Status:
US Approved Rx
(2019)
Source:
NDA211675
(2019)
Source URL:
First approved in 2019
Source:
NDA211675
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Upadacitinib (ABT-494) is a Janus kinase 1 (JAK1) inhibitor currently being developed by AbbVie for the treatment of rheumatoid arthritis (RA), Crohn’s disease, ulcerative colitis, atopic dermatitis, and psoriatic arthritis. It is also being investigated as a potential treatment for people with active ankylosing spondylitis (AS). Currently, upadacitinib is being evaluatedin six global phase III studies in RA and twophase III studies in psoriatic arthritis (PsA), inaddition to phase II studies in Crohn’s disease and atopicdermatitis and a combined phase II/III study inulcerative colitis. Upadacitinib is a potent and selective Janus kinase (JAK) 1 inhibitor with an IC50 of 43 nM.
