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Status:
US Approved Rx
(2010)
Source:
ANDA065362
(2010)
Source URL:
First approved in 1981
Source:
PIPRACIL by WYETH PHARMS INC
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Piperacillin is a semisynthetic, broad-spectrum, ampicillin derived ureidopenicillin antibiotic which exerts bactericidal activity by inhibiting septum formation and cell wall synthesis of susceptible bacteria. Piperacillin sodium salt is used in combination with the β-lactamase inhibitor tazobactam sodium (ZOSYN®) for the treatment of patients with moderate to severe infections caused by susceptible bacteria.
Status:
US Previously Marketed
Source:
XEPI by FERRER INTERNACIONAL
(2017)
Source URL:
First approved in 2017
Source:
XEPI by FERRER INTERNACIONAL
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Ozenoxacin is an experimental quinolone antibiotic being developed for the treatment of impetigo and other dermatological bacterial infections. Ozenoxacin is active against some bacteria that have developed resistance to currently used quinolone and fluoroquinolone antibiotics. In two phase 3 studies, Ozenoxacin cream, 1%, applied topically twice daily for 5 days vs. placebo, demonstrated superiority on both clinical and bacteriological endpoints, according to the release. Superior bacteriological cure of Ozenoxacin compared to placebo was demonstrated as early as day 4. In both adults and a pediatric population aged 2 months and older, Ozenoxacin treatment was reported to be safe and well tolerated.
Status:
US Previously Marketed
Source:
CEFOBID by PFIZER
(1995)
Source URL:
First approved in 1982
Source:
CEFOBID by PFIZER
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Cefoperazone (marketed under the name Cefobid) is a third-generation cephalosporin antibiotic. Cefoperazone has a broad spectrum of activity: Respiratory Tract Infections caused by S. pneumoniae, H. influenzae, S. aureus (penicillinase and non-penicillinase producing strains), S. pyogenes (Group A beta-hemolytic streptococci), P. aeruginosa, Klebsiella pneumoniae, E. coli, Proteus mirabilis, and Enterobacter species. Peritonitis and Other Intra-abdominal Infections caused by E. coli, P. aeruginosa, and anaerobic gram-negative bacilli (including Bacteroides fragilis). Bacterial Septicemia caused by S. pneumoniae, S. agalactiae, S. aureus, Pseudomonas aeruginosa, E. coli, Klebsiella spp., Klebsiella pneumoniae, Proteus species (indole-positive and indole-negative), Clostridium spp. and anaerobic gram-positive cocci. Infections of the Skin and Skin Structures caused by S. aureus (penicillinase and non-penicillinase producing strains), S. pyogenes, and P. aeruginosa. Pelvic Inflammatory Disease, Endometritis, and Other Infections of the Female Genital Tract caused by N. gonorrhoeae, S. epidermidis, S. agalactiae, E. coli, Clostridium spp., Bacteroides species (including Bacteroides fragilis), and anaerobic gram-positive cocci. Cefobid has no activity against Chlamydia trachomatis. Therefore, when Cefobid is used in the treatment of patients with pelvic inflammatory disease and C. trachomatis is one of the suspected pathogens, appropriate anti-chlamydial coverage should be added. Urinary Tract Infections caused by Escherichia coli and Pseudomonas aeruginosa. Cefoperazone, a third-generation cephalosporin, interferes with cell wall synthesis by binding to the penicillin-binding proteins (PBPs), thus preventing cross-linking of nascent peptidoglycan. Cefoperazone is stable to penicillinases and has a high degree of stability to many beta-lactamases produced by gram-negative bacteria. When tested in vitro, cefoperazone has demonstrated synergistic interactions with aminoglycosides against gram-negative bacilli. As with all cephalosporins, hypersensitivity manifested by skin reactions or drug fever. Reversible neutropenia may occur with prolonged administration. Diarrhea or loose stools has been reported also.
Status:
Possibly Marketed Outside US
Source:
GARENOXACIN MESYLATE by Toyama
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Garenoxacin is an antibacterial agent active against a range of aerobic Gram-positive and Gram-negative bacteria. It exerts its action by inhibiting bacterial DNA gyrase and topoisomerase IV. The drug was withdrawn from the market in Europe and was never approved in the USA. Garenoxacin is still marketed in Japan under the name Geninax.
Status:
Possibly Marketed Outside US
Source:
NCT04359615: Phase 4 Interventional Unknown status COVID-19
(2020)
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Favipiravir (originally known as T-705) is an orally administered novel anti-viral compound with a unique mechanism of action that is active against a wide range of RNA-based viruses in laboratory tests. Favipiravir has recently being approved in Japan under the brand name Avigan. Avigan is an experimental antiviral drug being developed by Toyama Chemical of Japan. It is a viral RNA polymerase inhibitor with a new mechanism of action, inhibiting viral gene replication within infected cells to prevent the propagation. Favipiravir is
phosphoribosylated by cellular enzymes to its active form, favipiravir-ribofuranosyl-5′- triphosphate (RTP). Favipiravir is active against a broad range of influenza viruses, including
A(H1N1)pdm09, A(H5N1) and the recently emerged A(H7N9) avian virus. It also inhibits
influenza strains resistant to current antiviral drugs, and shows a synergistic effect in combination
with oseltamivir, thereby expanding influenza treatment options. A Phase III clinical evaluation of
favipiravir for influenza therapy has been completed in Japan and two Phase II studies have been
completed in the United States. In addition to its anti-influenza activity, favipiravir blocks the
replication of many other RNA viruses, including arenaviruses (Junin, Machupo and Pichinde);
phleboviruses (Rift Valley fever, sandfly fever and Punta Toro); hantaviruses (Maporal, Dobrava,
and Prospect Hill); flaviviruses (yellow fever and West Nile); enteroviruses (polio- and
rhinoviruses); an alphavirus, Western equine encephalitis virus; a paramyxovirus, respiratory
syncytial virus; and noroviruses.
Status:
Possibly Marketed Outside US
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Cefteram is a semisynthetic cephalosporin formulated for oral administration as the prodrug ester, cefteram pivoxil. The mechanism of action of cefteram is inhibition of bacterial cell wall synthesis. Cefteram exerts its bactericidal activity by strongly binding to penicillin-binding protein (PBP) 3, 1A, and 1Bs. The drug is available in Japan and is used for the treatment of bacterial infections.
Status:
Possibly Marketed Outside US
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Osutidine (T-593) is a H2 receptor antagonist which was undergoing development by Toyama Chemical for the treatment of peptic/gastric and duodenal ulcers. It is a beta-hydroxyphenethylamine derivative with both antisecretory and cytoprotective properties. Osutidine inhibited the histamine-induced cAMP generation in a concentration-dependent manner. Osutidine suppressed the maximal response of the histamine-induced positive chronotropic response, indicating that the compound is unsurmountable H2-antagonists. The metabolism of Osutidine in humans may not differ from that of rodents and dogs. No clinically relevant accumulation occurred following repeated dosage. In the single oral and subcutaneous dose toxicity studies in rats, there were no dead animals. The oral LD50 value was greater than 5 g/kg for both sexes, and there was no abnormality in general signs. An oral formulation of the drug was in phase III clinical trials in Japan, however Toyama has dropped it from clinical development.
Status:
Possibly Marketed Outside US
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
Aclatonium (also known as aclatonium napadisilate) is a cholinergic agonist that has been developed and used in Asia as an activator of gastrointestinal motility.
Status:
Possibly Marketed Outside US
Source:
NCT03855007: Phase 4 Interventional Completed Arthritis, Rheumatoid
(2016)
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Iguratimod, a methanesulfonanilide, is an anti-inflammatory drug for the treatment of rheumatoid arthritis that has been developed exclusively in Japan and China. It inhibits the production of immunoglobulins and various inflammatory cytokines (interleukin-1, -6 and -8 and TNF), and exerts anabolic effects on bone metabolism by stimulating osteoblastic differentiation and inhibiting osteoclastogenesis. On the molecular level, it inhibits the nuclear transcription factor NF-κB but not its inhibitor, IκBα. In addition to these immunomodulatory and other long-lasting effects, iguratimod inhibits cyclooxygenase-2, which provides a synergistic short-term action against pain and inflammation. Efficacy and tolerability are comparable to salazosulfapyridine, and probably also to methotrexate. Combination with methotrexate is synergistic in patients with insufficient response to methotrexate and does not significantly increase adverse events.
Status:
Possibly Marketed Outside US
Source:
Ozex by Toyama
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Tosufloxacin is a fluoroquinolone antibacterial agent. Tosufloxacin is an inhibitor of bacterial DNA gyrase and topoisomerase IV. Tosufloxacin is indicated for the treatment of various infections such as skin, respiratory, urinary, gynecologic, ophthalmologic, otolaryngologic, dental infections. Fluoroquinolones including tosufloxacin have a potential risk of inducing cartilage and joint toxicity in children. It is also associated with severe thrombocytopenia and nephritis, and hepatotoxicity.