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Restrict the search for
nonoxynol-9
to a specific field?
Status:
US Approved Rx
(2021)
Source:
NDA214783
(2021)
Source URL:
First approved in 2021
Source:
NDA214783
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
KD025 is an orally available, selective small molecule inhibitor of ROCK2 (Rho-associated coiled-coil kinase 2), a molecular target in multiple autoimmune, fibrotic and neurodegenerative diseases. KD025 is the only ROCK2-specific inhibitor in the clinical trials. KD025 down-regulates the IL-17 and IL-21 secretion in human PBMCs, and leads to down-regulation of STAT3 phosphorylation, IRF4, and RORγt expression in CD4+ T cells. Kadmon Pharmaceuticals initiated phase II clinical trials of KD025 for the treatment of Graft-versus-host disease; Idiopathic pulmonary fibrosis; Plaque psoriasis.
Status:
US Approved Rx
(2021)
Source:
NDA214429
(2021)
Source URL:
First approved in 2021
Source:
NDA214429
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Fexinidazole is an antiparasitic drug, which is in the phase III of clinical trial for the treatment of Human African Trypanosomiasis, and in the phase II for the treatment Disease, Chagas and Visceral Leishmaniosis. However, for the Visceral Leishmaniosis, studies were terminated, due to lack of efficacy. Fexinidazole rapidly metabolized to two active metabolites, a sulfone and a sulfoxide, which prolong the pharmacological action of parent drug. These metabolites retaine trypanocidal activity but are less effective in nifurtimox-resistant lines, which can lead to the potential danger in the use of fexinidazole as a monotherapy.
Status:
US Approved Rx
(2020)
Source:
NDA214787
(2020)
Source URL:
First approved in 2020
Source:
NDA214787
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Status:
US Approved Rx
(2020)
Source:
NDA212728
(2020)
Source URL:
First approved in 2020
Source:
NDA212728
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Bristol-Myers Squibb developed Rimegepant, also known as BMS-927711. Rimegepant is a potent, selective, competitive and orally active calcitonin gene-related peptide (CGRP) antagonist in clinical trials for treating migraine. Rimegepant has shown in vivo efficacy without vasoconstrictor effect; it is superior to placebo at several different doses (75 mg, 150 mg, and 300 mg) and has an excellent tolerability profile.
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:
NDA212576
(2020)
Source URL:
First approved in 2020
Source:
NDA212576
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Cedazuridine is a specific cytidine deaminase (CDA) inhibitor that was approved in combination with decitabine for the treatment of variable forms of myelodysplastic syndrome (MDS). It is known that decitabine is rapidly metabolized by CDA prior to reaching systemic circulation when administered orally. Thus, cedazuridine by inhibition of CDA increases systemic exposure of decitabine.
Status:
US Approved Rx
(2020)
Source:
NDA213411
(2020)
Source URL:
First approved in 2020
Source:
NDA213411
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
TUCATINIB (ONT-380 or ARRY-380) is an orally active, reversible and selective small-molecule HER2 inhibitor invented by Array and licensed to Cascadian Therapeutics (previously named Oncothyreon) for development, manufacturing and commercialization. HER2, a growth factor receptor that is over-expressed in multiple cancers, including breast, ovarian, and stomach cancer. HER2 mediates cell growth, differentiation and survival, and tumors that overexpress HER2 are more aggressive and historically have been associated with poorer overall survival compared with HER2-negative cancers. ONT-380 is highly active as a single agent and in combination with both chemotherapy and Herceptin® (trastuzumab) in xenograft models of HER2+ breast cancer, including models of CNS metastases that were refractory to Tykerb® (lapatinib) or neratinib treatment. In a Phase 1 single agent clinical study, ONT-380 administered orally twice a day was well tolerated and demonstrated anti-tumor activity in heavily pre-treated HER2+ breast cancer patients with metastatic disease. Based on the strength of these preclinical and clinical trials, ONT-380 is advancing in one Phase 2 and three Phase 1b combination trials in patients with metastatic breast cancer. A second study reported the CNS activity of ONT-380 in combination with either T-DM1 or trastuzumab or capecitabine. Patients with brain metastases assessable for response were included in the combined analysis. Responses and clinical benefit in the CNS were reported with the three combinations tested, supporting future development of the drug for this particular indication.
Status:
US Approved Rx
(2020)
Source:
NDA212643
(2020)
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
(2020)
Source:
NDA213036
(2020)
Source URL:
First approved in 2020
Source:
NDA213036
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Artenimol (dihydroartemisinin) is a derivate of antimalarial compound artemisinin. Artenimol (dihydroartemisinin) is able to reach high concentrations within the parasitized erythrocytes. Its endoperoxide bridge is thought to be essential for its antimalarial activity, causing free-radical damage to parasite membrane systems including:
• Inhibition of falciparum sarcoplasmic-endoplasmic reticulum calcium ATPase, • Interference with mitochondrial electron transport • Interference with parasite transport proteins • Disruption of parasite mitochondrial function. Dihydroartemisinin in combination with piperaquine tetraphosphate (Eurartesim, EMA-approved in 2011) is indicated for the treatment of uncomplicated Plasmodium falciparum malaria. The formulation meets WHO recommendations, which advise combination treatment for Plasmodium falciparum malaria to reduce the risk of resistance development, with artemisinin-based preparations regarded as the ‘policy standard’. However, experimental testing demonstrates that, due to its intrinsic chemical instability, dihydroartemisinin is not suitable to be used in pharmaceutical formulations. In addition, data show that the currently available dihydroartemisinin preparations fail to meet the internationally accepted stability requirements.
Status:
US Approved Rx
(2020)
Source:
NDA213702
(2020)
Source URL:
First approved in 2020
Source:
NDA213702
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Lurbinectedin (PM-01183) - is a synthetic tetrahydropyrrolo [4, 3, 2-de]quinolin-8(1H)-one alkaloid analogue with potential antineoplastic activity. Lurbinectedin covalently binds to residues lying in the minor groove of DNA, which may result in delayed progression through S phase, cell cycle arrest in the G2/M phase and cell death. Lurbinectedin is a novel anticancer agent currently undergoing late-stage (Phase II /III) clinical evaluation in platinum-resistant ovarian, BRCA1/2-mutated breast and small-cell lung cancer. Lurbinectedin is structurally related to trabectedin and it inhibits active transcription and the DNA repair machinery in tumour cells.
