{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
Restrict the search for
alpha-tocopherol acetate
to a specific field?
Status:
US Approved Rx
(2021)
Source:
NDA213716
(2021)
Source URL:
First approved in 2021
Source:
NDA213716
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Voclosporin (Lupkynis™) is an oral calcineurin inhibitor immunosuppressant that is being developed by Aurinia Pharmaceuticals. Voclosporin is an analogue of cyclosporine with a modification at the amino acid-1 position. The drug has been designed to show improved potency against calcineurin inhibition and better metabolic stability than cyclosporine. Although the exact mechanism of voclosporin is not yet clear, it inhibits calcineurin, thereby blocking lymphocyte proliferation and T-cell mediated immune responses, as well as increasing podocyte integrity in the kidney. In January 2021, based on positive results from the pivotal phases II and III trials, oral voclosporin received its first approval in the USA for use in combination with a background immunosuppressive therapy regimen for adults with active lupus nephritis. Voclosporin is also being explored for the novel coronavirus disease 2019 (COVID-19) in kidney transplant recipients. Clinical evaluation of voclosporin for plaque psoriasis, coronary artery restenosis and rheumatoid arthritis has been discontinued and no recent development for prevention of renal transplant rejection has been identified since 2015.
Status:
US Approved Rx
(2021)
Source:
NDA214916
(2021)
Source URL:
First approved in 2021
Source:
NDA214916
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Difelikefalin (Korsuva™) is a synthetic peptide agonist of the kappa opioid receptor being developed by Cara Therapeutics for the treatment of pruritus. In August 2021, intravenous difelikefalin was approved in the USA for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD) in adults undergoing haemodialysis. Difelikefalin selectively acts on kappa opioid receptors in peripheral tissues, which contribute to pruritis and nociception. The activation of opioid receptors in peripheral neurons and keratinocytes reduces afferent (sensory) impulses towards the central nervous system, decreasing pain signals. Activating kappa opioid receptors on immune cells, including monocytes and T lymphocytes, decreases the release of pro-inflammatory chemicals such as prostaglandins.
Status:
US Approved Rx
(2021)
Source:
NDA214377
(2021)
Source URL:
First approved in 2021
Source:
NDA214377
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Vericiguat, discovered at Bayer, is the first soluble guanylate cyclase (sGC) stimulator. Vericiguat is currently being studied in a Phase III clinical program for the treatment of heart failure with reduced ejection fraction (HFrEF).
Status:
US Approved Rx
(2021)
Source:
NDA214907
(2021)
Source URL:
First approved in 2021
Source:
NDA214907
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
OTL-38 (OTL-0038, Pafolacianine), a fluorescent-labelled folate receptor-α (FRα) targeted imaging agent that accumulates in vivo in tumor cells expressing FR. In 2014, the OTL-38 molecule was granted orphan drug status which can be given to the maker of a drug that treats rare conditions or diseases and offers protection from competition for a period of time. OTL-38 under the brand name Cytalux was approved by the U.S. Food and Drug Administration (FDA) on 29 November 2021, as an additional approach that can be used to identify malignant lesions and to ensure the total resection of the tumors in ovarian cancer patients. Cytalux is a fluorescent drug that targets folate receptor which may be overexpressed in ovarian cancer. Pafolacianine binds to FR-expressing cancer cells with ~1 nM affinity, internalizes via
receptor mediated endocytosis, and concentrates in FR-positive cancer tissues. Pafolacianine absorbs light in the near-infrared region within a range of 760 nm to 785 nm with peak absorption of 776 nm and emits fluorescence within a range of 790 nm to 815 nm with a peak emission of 796 nm.
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:
NDA213433
(2020)
Source URL:
First approved in 2020
Source:
NDA213433
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Cortexolone 17α-propionate (WINLEVI, BREEZULA) is a steroid belonging to the family of cortexolone derivatives. It is a topical and peripherally selective androgen antagonist. WINLEVI is used for the treatment of acne and has completed Phase II clinical trials and Phase III trials. BREEZULA is used for the treatment of androgenic alopecia and is currently undergoing a Phase II trial in the US.
Status:
US Approved Rx
(2020)
Source:
NDA213793
(2020)
Source URL:
First approved in 2020
Source:
NDA213793
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Setmelanotide (IMCIVREE™) is a melanocortin-4 (MC4) receptor agonist developed by Rhythm Pharmaceuticals (Rhythm) for the treatment of ultrarare genetic disorders of
obesity. Setmelanotide was approved on 27 November 2020 in the
USA as a subcutaneous (SC) injectable formulation for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS). Rhythm are also developing the drug
for the treatment of obesity associated with other rare genetic
disorders including Bardet–Biedl Syndrome, Alström Syndrome, POMC and other MC4R pathway heterozygous defciency obesities, and POMC epigenetic disorders.
Status:
US Approved Rx
(2020)
Source:
NDA213973
(2020)
Source URL:
First approved in 2020
Source:
NDA213973
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Ripretinib (DCC-2618) is an investigational, orally available switch control kinase inhibitor being developed for the treatment of gastrointestinal stromal tumors (GIST), advanced systemic mastocytosis (ASM), gliomas, and other solid tumors driven by tyrosine-protein kinase KIT (KIT) or platelet-derived growth factor alpha (PDGFRα) kinase. Ripretinib acts by forcing the activation loop (or activation "switch") of kinases into an inactive conformation and is a type II kinase inhibitor demonstrated to broadly inhibit activation loop mutations in KIT and PDGFRA, previously thought only achievable with type I inhibitor. Ripretinib is developed by the company Deciphera and is being investigated in phase 3 clinical trials for the treatment of GIST, ASM and other tumors.
Status:
US Approved Rx
(2020)
Source:
NDA212608
(2020)
Source URL:
First approved in 2020
Source:
NDA212608
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
AVAPRITINIB (Blu-285) is a potent and selective inhibitor for hematologic malignancies with KIT Exon 17 Mutations. BLU-285 has demonstrated biochemical in vitro activity on the KIT exon-17 mutant enzyme, KIT D816V. Cellular activity of BLU-285 on KIT D816 mutants was measured by autophosphorylation in the human mast cell leukemia cell line HMC1.2, and the P815 mouse mastocytoma cell line with IC50= 4 and 22 nM, respectively. In vivo BLU-285 was well tolerated and has demonstrated dose-dependent antitumor efficacy. Complete tumor growth inhibition and ≥ 75% KIT kinase inhibition was observed with 10 mg/kg once daily, oral dosing of BLU-285 in the aggressive KIT exon 17 mutant driven P815 mastocytoma model grown as a solid tumor allograft as well as in a disseminated model of the disease. BLU-285 was also well tolerated in this in vivo model and had no adverse effects on body weight at either dose.
Status:
US Approved Rx
(2020)
Source:
NDA212155
(2020)
Source URL:
First approved in 2020
Source:
NDA212155
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Fluoroestradiol F-18 is a derivative of estradiol. where hydrogen at position 16 is replaced by radioactive fluorine. Fluoroestradiol F-18 is taken up by tumor cells, expression estrogen receptor, and it is clinically evaluated for PET imaging to detect and stage breast cancer, ovarian cancer, and cancer of uterine endometrium and myometrium.
