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Restrict the search for
nonoxynol-9
to a specific field?
Status:
US Approved Rx
(2024)
Source:
NDA217347
(2024)
Source URL:
First approved in 2024
Source:
NDA217347
Source URL:
Class (Stereo):
CHEMICAL (EPIMERIC)
Status:
US Approved Rx
(2024)
Source:
NDA218820
(2024)
Source URL:
First approved in 2024
Source:
NDA218820
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
SSR-125543 is a potent, selective, and orally active corticotropin-releasing factor 1 receptor (CRF1) antagonist (Ki value of 2nM). SSR-125543 attenuates long-term cognitive deficit induced by acute inescapable stress in mice, independently from the hypothalamic pituitary adrenal axis. SSR-125543 prevents stress-induced cognitive deficit associated with hippocampal dysfunction. SSR-125543 had been in phase II clinical trials by Sanofi for the treatment of Post-traumatic stress disorder. It is also in phase I trials for the treatment of anxiety. The compound had also been in phase II clinical trials for the treatment of major depression. However, in 2011, the research was discontinued.
Status:
US Approved Rx
(2024)
Source:
NDA217686
(2024)
Source URL:
First approved in 2024
Source:
NDA217686
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
ACT-132577 is the major and pharmacologically active metabolite of macitentan (ACT-064992), which is dual ETA/ETB endothelin (ET) receptor antagonist designed for tissue targeting.
Status:
US Approved Rx
(2024)
Source:
NDA217785
(2024)
Source URL:
First approved in 2024
Source:
NDA217785
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
MGL-3196 is a first-in-class, orally administered, small-molecule, liver-directed, THR β-selective agonist. Preclinical, toxicology and Phase 1 clinical data suggest MGL-3196 has an attractive, differentiated profile as a potential treatment for non-alcoholic steatohepatitis (NASH) and dyslipidemias. THR-β selectivity also enhances the safety profile of MGL-3196, compared to non-selective agents. MGL-3196 has shown no suppression of the central thyroid axis, no THR-α effects on heart rate or bone, and no elevation of liver enzymes. These characteristics make MGL-3196 among the most promising molecules in development in this therapeutic area. MGL-3196 is in a Phase 2 clinical trial for the treatment of non-alcoholic steatohepatitis (NASH).
Status:
US Approved Rx
(2024)
Source:
NDA215168
(2024)
Source URL:
First approved in 2024
Source:
NDA215168
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Flurpiridaz F-18, a fluorine 18-labeled agent was developed by Lantheus Medical Imaging for the diagnosis of coronary artery disease (CAD), the most common form of heart disease, which affects an estimated 15.5 million Americans 20 years of age or older. Flurpiridaz F 18 is an investigational positron emission tomography (PET) myocardial perfusion imaging (MPI) agent. GE Healthcare has launched a second Phase III clinical trial for the use of Flurpiridaz 18F Injection in PET myocardial perfusion imaging (MPI) to detect CAD.
Status:
US Approved Rx
(2024)
Source:
NDA218860
(2024)
Source URL:
First approved in 2024
Source:
NDA218860
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Elafibranor (GFT505) is an agonist of the peroxisome proliferator-activated receptor-α and peroxisome proliferator-activated receptor-δ. GFT505 has an active
metabolite, GFT1007, and both have potent agonist activity
for PPAR-a and to a lesser extent for PPAR-d. Elafibranor improves insulin sensitivity, glucose homeostasis, and lipid metabolism and reduces inflammation. Elafibranor (GFT505) reverses nonalcoholic steatohepatitis (NASH) to prevent fibrosis progression. With an outstanding safety and tolerance profile, elafibranor provides NASH patients with needed cardio-protective benefits. Elafibranor is currently being evaluated in the clinical Phase 3 study RESOLVE-IT. The safety profile of GFT505 from the completed clinical
trials appears satisfactory with no indication of PPAR-g agonist
effects such as edema or body weight gain.
Status:
US Approved Rx
(2024)
Source:
NDA215192
(2024)
Source URL:
First approved in 2024
Source:
NDA215192
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Vadadustat is an Hypoxia-inducible factor (HIF) prolyl hydroxylase (PH) enzyme inhibitor. Patients with chronic kidney disease (CKD) have reduced levels of erythropoietin (EPO) and iron in the body, which can result in decreased number of oxygen-carrying red blood cells (RBCs) (anemia). The deficiency in RBCs causes inadequate oxygen delivery to cells and tissues. Vadadustat simulates the hypoxia response pathway by stabilizing key regulatory proteins called HIFs. Under normal conditions, when sufficient oxygen is present, HIF proteins are targeted for degradation by HIF-PH to maintain homeostasis in RBC production. Under conditions of hypoxia, HIF-PH activity is reduced, resulting in HIF stabilization. Stable HIF moves to the nucleus, where it activates target genes that increase EPO synthesis, resulting in the production of new RBCs, and suppression of hepcidin to promote iron absorption and mobilization. Vadadustat is currently in the phase 3 stage of development for the treatment of anemia secondary to CKD.
Status:
US Approved Rx
(2024)
Source:
NDA217779
(2024)
Source URL:
First approved in 2024
Source:
NDA217779
Source URL:
Class (Stereo):
CHEMICAL (MIXED)
Status:
US Approved Rx
(2023)
Source:
NDA215830
(2023)
Source URL:
First approved in 2023
Source:
NDA215830
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Ritlecitinib is an orally administered, covalent small-molecule selective dual inhibitor of JAK3 and the TEC kinase family. In vitro studies showed ritlecitinib covalently binds to JAK3 and is more than 10 000 times more potent against JAK3 than against JAK1, JAK2, and tyrosine kinase. Ritlecitinib also inhibits the five members of the TEC kinase family. Ritlecitinib irreversibly inhibits Janus kinase 3 (JAK3) and TEC kinase family by blocking the adenosine triphosphate (ATP) binding site. In cellular settings, ritlecitinib inhibits cytokine induced STAT phosphorylation mediated by JAK3-dependent receptors.
Additionally, ritlecitinib inhibits signaling of immune receptors dependent on TEC kinase family members.The FDA has approved ritlecitinib (LITFULO; Pfizer Inc), a once daily oral treatment, for individuals aged 12 years and older with severe alopecia areata. This makes ritlecitinib, in the 50 mg dosage, the first and only treatment approved by the FDA for adolescents with severe alopecia areata. The approval was based on the results of the ALLEGRO phase 2b/3 trial (NCT03732807), which included 718 individuals who had 50% or more scalp hair loss measured by the Severity of Alopecia Tool. Investigators of the study evaluated the safety and efficacy of ritlecitinib at 118 different sites in 18 different countries. Regulatory applications for LITFULO in alopecia areata have been submitted to countries around the world for review, including China, the European Union, Japan, and the United Kingdom. The European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for ritlecitinib with a decision anticipated in the third quarter of 2023. LITFULO is also being evaluated for vitiligo, Crohn’s disease, and ulcerative colitis.
Status:
US Approved Rx
(2023)
Source:
NDA216023
(2023)
Source URL:
First approved in 2023
Source:
NDA216023
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
