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Restrict the search for
m nalidixic acid
to a specific field?
Status:
US Approved Rx
(2021)
Source:
NDA214154
(2021)
Source URL:
First approved in 2021
Source:
NDA214154
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Estetrol is the natural human fetal selective estrogen receptor modulator. It is synthesized exclusively by the human fetal liver during pregnancy. Estetrol has a moderate affinity for human estrogen A receptor (ERa) and estrogen B receptor (ERb). Estetrol may be suitable as a potential drug for human use in applications such as hormone replacement therapy (vaginal atrophy, hot flushes), contraception and osteoporosis. The most common drug-related adverse events were lower abdominal pain, nausea, headache, dysmenorrhoea, breast enlargement and acne. Estetrol had been in clinical trials for the treatment of breast and prostate cancers.
Status:
US Approved Rx
(2021)
Source:
NDA214916
(2021)
Source URL:
First approved in 2021
Source:
NDA214916
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Difelikefalin is an orally bioavailable second-generation peptide. It is an investigational peripheral kappa opioid receptor agonist. Difelikefalin significantly reduced moderate to severe chronic itching while achieving across-the-board clinically meaningful improvements in quality of life measures in patients with hemodialysis-associated pruritus in a phase 2 study. In a phase 2 clinical investigation, difelikefalin was safe, well tolerated and showed robust analgesic activity for postoperative pain in female patients undergoing laparoscopy, with a significant reduction in post-operative morphine consumption and opioid-related side effects. Now difelikefalin is in phase III clinical trials for the treatment of post-operative pain and pruritus.
Status:
US Approved Rx
(2021)
Source:
NDA215310
(2021)
Source URL:
First approved in 2021
Source:
NDA215310
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
US Approved Rx
(2021)
Source:
NDA214662
(2021)
Source URL:
First approved in 2021
Source:
NDA214662
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Maralixibat (SHP625; formerly LUM001 or lopixibat) is a potent, apical, sodium‐dependent, bile acid transporter competitive inhibitor with minimal systemic absorption. Maralixibat works by reducing systemic levels of bile acids. In animal models of cholestasis, maralixibat blocked reabsorption of bile acids in the terminal ileum, thereby reducing enterohepatic recirculation to the liver and increasing fecal excretion of bile acids. Maralixibat is being evaluated as a treatment for children with rare cholestatic liver diseases, including Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC).
Status:
US Approved Rx
(2021)
Source:
NDA214900
(2021)
Source URL:
First approved in 2021
Source:
NDA214900
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
MK-3118 is an orally active inhibitor of fungal β-(1,3)-glucan synthase patented by Merck Sharp & Dohme Corp for the treatment of fungal infections. MK-3118 demonstrated enhanced efficacy for most C. albicans and C. glabrata ER isolates relative to caspofungin. MK-3118 showed no or poor activity against Mucoromycotina and Fusarium spp. However, MK-3118 was highly active against Paecilomyces variotii and was the only compound displaying some activity against notoriously pan-resistant Scedosporium prolificans.
Status:
US Approved Rx
(2021)
Source:
NDA215341
(2021)
Source URL:
First approved in 2021
Source:
NDA215341
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
FINERENONE is a potent and selective nonsteroidal mineralocorticoid receptor antagonist. Results in preclinical studies showed that lower doses of FINERENONE were needed to achieve similar cardiorenal protective effects compared to both spironolactone and eplerenone. It is in phase III clinical trials for the treatment of diabetic kidney disease.
Status:
US Approved Rx
(2021)
Source:
NDA214793
(2021)
Source URL:
First approved in 2021
Source:
NDA214793
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
DCFPYL F-18 is an urea-based radiotracer composed of the prostate-specific membrane antigen (PSMA)-targeting agent DCFPyL and labeled with the positron-emitting isotope, fluorine F 18, that can potentially be used for positron-emitting tomography (PET) imaging. Upon administration of fluorine F 18 DCFPyL, the DCFPyL moiety binds to PSMA expressed on tumor cells. The fluorine F 18 moiety facilitates PET imaging of PSMA-expressing tumor cells. DCFPYL F-18 is investigated in a number of clinical trials in patients with prostate cancer and neuroendocrine tumors.
Status:
US Approved Rx
(2021)
Source:
NDA212888
(2021)
Source URL:
First approved in 2021
Source:
NDA212888
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Cabotegravir is an investigational drug that is being studied for the treatment and prevention of HIV infection. Cabotegravir belongs to a class (group) of HIV drugs called integrase inhibitors. Integrase inhibitors block an HIV enzyme called integrase. (An enzyme is a protein that starts or increases the speed of a chemical reaction.) By blocking integrase, integrase inhibitors prevent HIV from multiplying and can reduce the amount of HIV in the body. Cabotegravir does not require boosting with an additional drug. Two forms of cabotegravir are being studied: tablets that are taken by mouth (known as oral cabotegravir or oral CAB) and a long-acting injectable form that is injected into the muscle (known as cabotegravir LA or CAB LA; LA stands for "long-acting"). (A long-acting drug formulation works over a long period of time. Using this type of drug might mean that the drug could be taken less often, making a treatment or prevention regimen simpler to take.) Cabotegravir is in Phase-III clinical trials for HIV infections.
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:
NDA213716
(2021)
Source URL:
First approved in 2021
Source:
NDA213716
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Voclosporin (trans-ISA247) is a Cyclosporin A derivative and immunosuppressive compound currently being investigated for the treatment of psoriasis, lupus nephritis and for the prevention of organ rejection in kidney transplant patients. An animal study showed that a lower blood level of Voclosporin was able to produce a greater or similar inhibition of lymphocyte proliferation, expression of T-cell activation surface antigens, and T-cell cytokine production compared to Cyclosporin A. Voclosporin has been shown to be an efficacious and safe immunosuppressant in phase IIb and phase III trials in renal transplant recipients and in plaque psoriasis patients. In clinical trials, Voclosporin added to standard-of-care induction therapy for lupus nephritis increases complete renal remission (CRR) rates, but higher rates of adverse events including death were observed.
