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Restrict the search for
sildenafil
to a specific field?
Status:
Possibly Marketed Outside US
Source:
21 CFR 356
(2020)
Source URL:
First approved in 2020
Source:
21 CFR 356
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Imidazole is a planer five-member heterocyclic ring with 3C and 2N atom and in ring N is present in 1st and 3rd positions. The imidazole ring is a constituent of several important natural products, including purine, histamine, histidine and nucleic acid. Being a polar and ionisable aromatic compound, it improves pharmacokinetic characteristics of lead molecules and thus used as a remedy to optimize solubility and bioavailability parameters of proposed poorly soluble lead molecules. The imidazole derivatives possess extensive spectrum of biological activities such as antibacterial, anticancer, antitubercular, antifungal, analgesic, and anti-HIV activities. The organic compound is used in the chemical industry as an intermediate in the production of pharmaceuticals,
pesticides, dye intermediates, auxiliaries for textile dyeing and finishing, photographic chemicals and corrosion inhibitors. The chemical possesses properties (corrosivity to skin, irreversible damage to eyes, teratogenic effects) indicating a
hazard for human health. Humans are exposed by consumer products (chemical concentrations up to 10%) and at the workplace. Therefore, the chemical is a candidate for further work. An exposure assessment and if indicated a risk assessment is recommended.
Status:
Possibly Marketed Outside US
Source:
NDA019157
(2018)
Source URL:
First approved in 2018
Source:
NDA019157
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Udenafil is a new phosphodiesterase type 5 (PDE5) inhibitor used to treat erectile dysfunction. Udenafil inhibits the cyclic GMP specific phosphodiesterase type 5 (PDE5) which is responsible for degradation of Cyclic GMP in the corpus cavernosum located around the penis. Cyclic GMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum. So the inhibition of phosphodiesterase type 5 (PDE5) by Udenafil enhances erectile function by increasing the amount of Cyclic GMP. Udenafil has proven to have high efficacy and a favorable safety profile for a broad spectrum of erectile dysfunction patients, which are comparable to those of other PDE5Is. Due to the clinical properties of relatively rapid onset and long duration of action, Udenafil may be a better option for erectile dysfunction treatment according to patient-specific sex-life patterns. Udenafil is as effective in the treatment of diabetes mellitus-associated erectile dysfunction as other PDE5Is. Recent data suggest that the concomitant use of anti-hypertensive drugs does not significantly affect the efficacy and safety profile. Also, due to its clinical properties, Udenafil can be a daily-dosing option for the treatment of erectile dysfunction, as suggested by its favorable efficacy and safety profile. Udenafil has been approved in South Korea and will be marketed under the brand name Zydena.
