Garenoxacin: Difference between revisions

Browse history interactively← Previous editContent deleted Content addedVisual Wikitext

Revision as of 01:52, 10 August 2011 editCheMoBot (talk \| contribs)Bots141,565 edits Updating {{drugbox}} (no changed fields - added verified revid - updated 'ChemSpiderID_Ref', 'ChEMBL_Ref', 'ChEBI_Ref', 'StdInChI_Ref', 'StdInChIKey_Ref', 'ChEBI_Ref') per Chem/Drugbox validation ← Previous edit		Latest revision as of 15:22, 9 December 2024 edit undoCitation bot (talk \| contribs)Bots5,429,452 edits Added date. \| Use this bot. Report bugs. \| Suggested by Dominic3203 \| Linked from User:Marbletan/sandbox \| #UCB_webform_linked 61/2664
(42 intermediate revisions by 29 users not shown)
Line 1:		Line 1:
			{{Short description\|Chemical compound}}
	{{drugbox
			{{Drugbox
			\| Verifiedfields = changed
			\| Watchedfields = changed
		⚫	\| verifiedrevid = 443977394
		⚫	\| IUPAC_name = 1-Cyclopropyl-8-(difluoromethoxy)-7--4-oxo-1,4-dihydroquinoline-3-carboxylic acid
		⚫	\| image = Garenoxacin.svg

			<!--Clinical data-->
			\| tradename =
		⚫	\| pregnancy_category =
		⚫	\| legal_status =
		⚫	\| routes_of_administration = Oral

			<!--Pharmacokinetic data-->
		⚫	\| bioavailability =
			\| protein_bound =
		⚫	\| metabolism =
		⚫	\| elimination_half-life =
		⚫	\| excretion =

			<!--Identifiers-->
			\| CAS_number_Ref = {{cascite\|changed\|??}}
		⚫	\| CAS_number = 194804-75-6
		⚫	\| ATC_prefix = J01
		⚫	\| ATC_suffix = MA19
		⚫	\| PubChem = 124093
		⚫	\| DrugBank_Ref = {{drugbankcite\|correct\|drugbank}}
		⚫	\| DrugBank =
	\| UNII_Ref = {{fdacite\|correct\|FDA}}		\| UNII_Ref = {{fdacite\|correct\|FDA}}
	\| UNII = V72H9867WB		\| UNII = V72H9867WB
⚫	\| verifiedrevid = ~~443450244~~
⚫	\| IUPAC_name = 1-~~cyclopropyl~~-8-(difluoromethoxy)-7--4-oxo-1,4-dihydroquinoline-3-carboxylic acid
⚫	\| image = Garenoxacin.svg
⚫	\| CAS_number = ~~91421~~-42-0
⚫	\| ATC_prefix = J01
⚫	\| ATC_suffix = MA19
⚫	\| PubChem = 124093
⚫	\| DrugBank_Ref = {{drugbankcite\|correct\|drugbank}}
⚫	\| DrugBank =
	\| KEGG_Ref = {{keggcite\|correct\|kegg}}		\| KEGG_Ref = {{keggcite\|correct\|kegg}}
	\| KEGG = D04031		\| KEGG = D04031
			\| ChEBI_Ref = {{ebicite\|changed\|EBI}}
⚫	\| C = 23 \|H = 20 \|F = 2 \|N = 2 \|O = 4
			\| ChEBI = 131716
	\| molecular_weight = 426.412 ]/]
			\| ChemSpiderID_Ref = {{chemspidercite\|changed\|chemspider}}
⚫	\| bioavailability =
	\| ~~protein_bound~~ =		\| ChemSpiderID = 110579
			\| smiles = FC(F)Oc1c(ccc2c1N(/C=C(\C2=O)C(=O)O)C3CC3)c4ccc5c(c4)CN5C
⚫	\| metabolism =
			\| StdInChI_Ref = {{stdinchicite\|changed\|chemspider}}
⚫	\| elimination_half-life =
			\| StdInChI = 1S/C23H20F2N2O4/c1-11-15-5-2-12(8-13(15)9-26-11)16-6-7-17-19(21(16)31-23(24)25)27(14-3-4-14)10-18(20(17)28)22(29)30/h2,5-8,10-11,14,23,26H,3-4,9H2,1H3,(H,29,30)/t11-/m1/s1
⚫	\| excretion =
			\| StdInChIKey_Ref = {{stdinchicite\|changed\|chemspider}}
⚫	\| pregnancy_category =
			\| StdInChIKey = NJDRXTDGYFKORP-LLVKDONJSA-N
⚫	\| legal_status =

⚫	\| routes_of_administration = Oral
			<!--Chemical data-->
		⚫	\| C=23 \| H=20 \| F=2 \| N=2 \| O=4
	}}		}}

	'''Garenoxacin''' (]) is a quinolone antibiotic for the treatment of ~~gram~~-positive and ~~gram~~-negative bacterial infections.		'''Garenoxacin''' (]) is a ] ] for the treatment of ] and ] bacterial infections.<ref name="pmid18790608">{{cite journal \| vauthors = Takagi H, Tanaka K, Tsuda H, Kobayashi H \| title = Clinical studies of garenoxacin \| journal = International Journal of Antimicrobial Agents \| volume = 32 \| issue = 6 \| pages = 468–74 \| date = December 2008 \| pmid = 18790608 \| doi = 10.1016/j.ijantimicag.2008.06.032 \| doi-access = free }}</ref>

	It was discovered by Toyama Chemical Co., Ltd. of Tokyo, Japan, and is currently being marketed in ] under the tradename Geninax. ] holds worldwide rights for garenoxacin, except for Japan, ], and ].		Garenoxacin was discovered by Toyama Chemical Co., Ltd. of Tokyo, Japan, and is currently being marketed in ] under the tradename Geninax. ] holds worldwide rights for garenoxacin, except for Japan, ], and ].{{cn\|date=January 2023}}

	On February 13, 2006, Schering-Plough announced that the ] ] ~~has~~ accepted the New Drug Application (NDA) for garenoxacin, and ~~has~~ been granted a 10-month review.<ref>{{cite web \|url=~~http~~://www.drugs.com/nda/garenoxacin_060213.html \|title=Drugs.com, Schering-Plough Reports Garenoxacin NDA Accepted for FDA Review \|~~accessdate~~=2008-03-25 ~~\|format= \|work=~~ }}</ref>		On February 13, 2006, ] announced that the ] ] had accepted the New Drug Application (NDA) for garenoxacin, and had been granted a 10-month review.<ref>{{cite web \|url=https://www.drugs.com/nda/garenoxacin_060213.html \|title=Drugs.com, Schering-Plough Reports Garenoxacin NDA Accepted for FDA Review \|access-date=2008-03-25 }}</ref> As of 2015, however, it has not been approved in the US.{{cn\|date=January 2023}}

	Schering-Plough later withdrew its application to the United States Food and Drug Administration, FDA, (August 20, 2006) for approval of the antibiotic Garenoxacin.<ref>http://www.fiercebiotech.com/story/schering-plough-pulls-its-garenoxacin-app/2006-08-21</ref>		Schering-Plough later withdrew its application to the United States Food and Drug Administration, FDA, (August 20, 2006) for approval of the antibiotic Garenoxacin.<ref>{{Cite web \| url=http://www.fiercebiotech.com/story/schering-plough-pulls-its-garenoxacin-app/2006-08-21 \| title=Schering-Plough pulls its garenoxacin app\| date=20 August 2006}}</ref>

			The ] (EMA) had also been formally notified by Schering-Plough Europe (July 25, 2007) of its decision to withdraw the application for a centralized marketing authorization for garenoxacin as well.<ref>{{Cite web \|url=http://www.medicalnewstoday.com/articles/78052.php \|title=Schering-Plough Europe Withdraws Its Marketing Authorisation Application For Garenoxacin Mesylate \|access-date=2009-05-30 \|archive-date=2007-08-08 \|archive-url=https://web.archive.org/web/20070808183432/http://www.medicalnewstoday.com/articles/78052.php \|url-status=dead \| publisher = MediLexicon International Ltd \| date = 28 July 2007 }}</ref><ref>{{cite web \| title=Garenoxacin mesylate: Withdrawn application \| website=] (EMA) \| date=17 September 2018 \| url= https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/garenoxacin-mesylate \| access-date=13 July 2020}}</ref><ref>{{cite press release \| title=Schering-Plough Europe withdraws its marketing authorisation applicationfor Garenoxacin mesylate \| website=] (EMA) \| url=https://www.ema.europa.eu/en/news/schering-plough-europe-withdraws-its-marketing-authorisation-applicationfor-garenoxacin-mesylate \| access-date=13 July 2020}}</ref> Based on the CHMP review of the data regarding safety and efficacy (risk/benefit), the CHMP considered the application for garenoxacin to be unapprovable.<ref>{{cite web \| title = Withdrawal Assessment report for Garenoxacin Mesylate (garenoxacin) \| url = https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-garenoxacin-mesylate_en.pdf \| publisher = European Medicines Agency \| date = 18 October 2007 }}</ref>
	The European Medicines Agency (EMEA) had also been formally notified by Schering-Plough Europe (July 28 2007) of its decision to withdraw the application for a centralized marketing authorization for Garenoxacin as well.
	<ref>http://www.medicalnewstoday.com/articles/78052.php</ref><ref>http://www.emea.europa.eu/humandocs/PDFs/EPAR/garenoxacinmesylate/34117407en.pdf</ref><ref>http://www.emea.europa.eu/humandocs/PDFs/EPAR/garenoxacinmesylate/H-747-WAR.pdf</ref>

	Based on the CHMP review of the data regarding safety and efficacy, (risk/benefit) the CHMP considered the application for Garenoxacin to be unapprovable. <ref> http://www.emea.europa.eu/humandocs/PDFs/EPAR/garenoxacinmesylate/H-747-WAR.pdf</ref>

	==See also==
	*]
	*]

	==References==		==References==
Line 47:		Line 61:
	{{QuinoloneAntiBiotics}}		{{QuinoloneAntiBiotics}}

	]		]
	]		]
	]		]
	]		]
			]


	{{antibiotic-stub}}		{{antibiotic-stub}}

	]
	]