U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

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Showing 11761 - 11770 of 13362 results

Status:
Possibly Marketed Outside US
Source:
ORAPENEM by Wyeth
Source URL:

Class (Stereo):
CHEMICAL (ABSOLUTE)



Tebipenem pivoxil is an oral carbapenem prodrug that was originated by Wyeth (now Pfizer). It was approved by Pharmaceuticals and Medical Devices Agency of Japan (PMDA) on Apr 22, 2009. It was developed and marketed as Orapenem® by Meiji Seika in Japan. Tebipenem pivoxil is a broad-spectrum orally-administered antibiotic, from the carbapenem subgroup of β-lactam antibiotics. Carbapenems are a class of beta-lactam antibiotics, which act by inhibiting the synthesis of the peptidoglycan layer of bacterial cell walls. It is used to treat otorhinolaryngological infection, otitis media and bacterial pneumonia. Orapenem® is available as granules for oral use, containing 100 mg Tebipenem pivoxil/g granules. According to the weight of children, 4 mg/kg, and twice a day after dinner.
Status:
Possibly Marketed Outside US

Class (Stereo):
CHEMICAL (ABSOLUTE)

FEXAPOTIDE is a protein drug that is under development for the treatment of benign prostatic hyperplasia (prostate enlargement, BPH) and for low grade localized prostate cancer. It safely targets prostate glandular cells that have proliferated in BPH. FEXAPOTIDE works by a mechanism of inducing apoptosis.
Status:
Possibly Marketed Outside US

Class (Stereo):
CHEMICAL (ABSOLUTE)

Vapreotide (Sanvar) is cyclic octapeptide analog of somatostatin with higher metabolic stability than the parent hormone and developed by Debiopharm Group for the treatment of esophageal variceal bleeding in patients with cirrhotic liver disease and AIDS-related diarrhea. Somatostatin inhibits the secretion of vasodilatory peptides from the gastrointestinal tract, including glucagon, which has been shown to contribute to the maintenance of portal hypertension. While natural somatostatin has a very short half-life (3 min), the elimination half-life of vapreotide is reported to be approximately 10 times longer than that of its parent compound. Pharmacodynamic studies of healthy volunteers demonstrated suppression of gastric acid secretion and inhibition of the secretion of pancreatic enzyme, which is similar to somatostatin. Vapreotide has demonstrated efficacy in the early management of acute variceal hemorrhage but only based on combined primary endpoints of hemostasis and survival after 5 days. In addition, vapreotide’s efficacy is limited to only one major study performed in Europe and not yet in the United States. Although it did not show a significant reduction in mortality, vapreotide’s observed the effect on hemostasis, as well as its favorable safety profile. Adverse effects that occurred in the vapreotide trials were generally mild and primarily included gastrointestinal symptoms and alterations of the gastrointestinal hormonal system. Vapreotide not recommended for approval by an FDA Advisory Panel due to Insufficient evidence that the drug provided a benefit in the treatment for acute esophageal variceal bleeding.
Status:
Possibly Marketed Outside US
Source:
NCT04054479: Phase 4 Interventional Completed PONV
(2019)
Source URL:

Class (Stereo):
CHEMICAL (MIXED)

Penequinine (penehyclidine) is a selective M1/M2 receptor antagonist. Due to anticholinergic effects, penequinine is used in Chine for the treatment of organophosphorus and soman poisoning. In addition, penequinine is a negative regulator of TLR4 and NF-kB signaling and is investigated as a potential treatment in clinical trials for the treatment of acute lung injury and acute cerebral ischemia-reperfusion injury.
Status:
Possibly Marketed Outside US
Source:
Mvix by SK Chemicals
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)



The inhibition of cyclic nucleotide Phosphodiesterase type 5 (PDE5) has been clinically validated as an effective treatment for erectile dysfunction. One of them is mirodenafil (formerly known as SK-3530) approved only in Korea. This drug was developed by SK Chemicals and marketed under the trade name Mvix.
Status:
Possibly Marketed Outside US
Source:
NCT03151707: Phase 4 Interventional Terminated Healthy
(2017)
Source URL:

Class (Stereo):
CHEMICAL (ABSOLUTE)


Nimorazole is an antimicrobial with activity against anaerobic bacteria and protozoa. Its actions and properties are similar to metronidazole. It has also been used in trials studying the treatment of Hypoxia, Radiotherapy, Hypoxic Modification, Gene Profile, Gene Signature, and Head and Neck Squamous Cell Carcinoma, among others. Azanta is developing, nimorazole, as an oral hypoxic radio-sensitiser for the treatment of patients with head and neck cancer who are undergoing radiotherapy. Previously, nimorazole has been approved for use as an anti-protozoal agent and has been launched worldwide. Nimorazole, for the treatment of head and neck cancer patients undergoing radiotherapy received orphan designation by EMA in 2011.
Dibrompropamidine isetionate is an antiseptic. Ointment containing dibrompropamidine isetionate is used to treat minor eye or eyelid infections, such as conjunctivitis and blepharitis.
Status:
Possibly Marketed Outside US
Source:
Canada:POTASSIUM PERMANGANATE
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)

Status:
Possibly Marketed Outside US
Source:
DALVANCE by Vicuron Pharmaceuticals
Source URL:

Class (Stereo):
CHEMICAL (ABSOLUTE)



Dalbavancin is a mixture of five closely related active homologs (A0, A1, B0, B1, and B2); the component B0 is the major component of dalbavancin. The predominant component of dalbavancin is Factor B0, which accounts for >75% of the whole complex. Dalbavancin is a second-generation lipoglycopeptide antibiotic that was designed to improve on the natural glycopeptides currently available, such as vancomycin and teicoplanin. Modifications from these older glycoprotein classes allowed a similar mechanism of action with increased activity and once weekly dosing. Its use is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by the following gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), S. pyogenes, S. agalactiae, and S. anginosus group (including S. anginosus, S. intermedius, and S. constellatus). Under the brand name DALVANCE Dalbavancin is indicated for acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram-positive microorganisms. The bactericidal action of dalbavancin results primarily from inhibition of cell-wall biosynthesis. Specifically, dalbavancin prevents incorporation of N-acetylmuramic acid (NAM)- and N-acetylglucosamine (NAG)-peptide subunits from being incorporated into the peptidoglycan matrix; which forms the major structural component of Gram-positive cell walls. The large hydrophilic molecule is able to form hydrogen bond interactions with the terminal D-alanyl-D-alanine moieties of the NAM/NAG-peptides, which is normally a five-point interaction. Binding of dalbavancin to the D-Ala-D-Ala prevents the incorporation of the NAM/NAG-peptide subunits into the peptidoglycan matrix. In addition, dalbavancin alters bacterial-cell-membrane permeability and RNA synthesis.

Showing 11761 - 11770 of 13362 results