Doripenem

also known as [14C]-DORIPENEM · Doribax · Doripenem (Doribax) · Doripenem hydrate · DORIPENEM MONOHYDRATE · Dripenem hydrate · Finibax · S-4661

Small molecule

Developed for: bacterial infectious disease · nosocomial infection · appendicitis · bacterial pneumonia · peritonitis · pneumonia · urinary tract infection · abscess
+7 more
· cholecystitis · infectious disease with sepsis · pancreatitis · pyelonephritis · intestinal perforation · acute pyelonephritis · neutropenia
Investigated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Janssen Research & Development, LLC · Peninsula Pharmaceuticals, Inc. · Changi General Hospital · Emory University · Janssen-Cilag Ltd.,Thailand
+12 more
· Johnson & Johnson (Hong Kong) Ltd. · Keith A. Rodvold · Medical University of Vienna · National University Hospital, Singapore · Ortho-McNeil Janssen Scientific Affairs, LLC · PriCara, Unit of Ortho-McNeil, Inc. · Prince of Songkla University · Pulmonary Associates, PA · Singapore General Hospital · Sutep Jaruratanasirikul · Tan Tock Seng Hospital · University Hospital, Montpellier

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Withdrawn	EU (EMA)	Doribax	—	2014-07-31	europa.eu ↗
Approved	EU (EMA)	Doribax	—	2008-07-25	europa.eu ↗
Approved	US (FDA)	DORIBAX	—	2007-10-12	fda.gov ↗

Trials 22

today

US approved 2007

EU approved 2008

NCT02134106 · Ph 2/3 NCT01366651 · Ph 1 NCT01517815 · not/applicable NCT01110408 · Ph 3 NCT01110382 · Ph 3 NCT01110421 · Ph 3 NCT01467648 · Ph 4 NCT01311141 · Ph 4 NCT01027897 · Ph 4 NCT01381848 · Ph 1 NCT00986102 · Ph 4 NCT00925392 · Ph 1 NCT00965848 · Ph 4 NCT00589693 · Ph 3 NCT00515034 · Ph 2 NCT00502801 · Ph 2 NCT00211016 · Ph 3 NCT00211003 · Ph 3 NCT00210990 · Ph 3 NCT00229060 · Ph 3 NCT00210938 · Ph 3 NCT00229021 · Ph 3

200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 13 trials
Phase 1	NCT01366651	Mar → May 2012	meningitis	Janssen Research & Development, LLC	Terminated	No outcome recorded Stop: Business
Phase 1	NCT01381848	Oct 2009 → Apr 2012	bacterial infectious disease	Janssen Research & Development, LLC	Completed	No outcome recorded
Phase 1	NCT00925392	Jun 2009 → Jan 2010	—	Keith A. Rodvold	Completed	No outcome recorded
Phase 22 trials
Phase 2	NCT00515034	Oct 2007 → Nov 2008	abscess, bacterial pneumonia	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Completed	No outcome recorded
Phase 2	NCT00502801	Aug 2007 → Nov 2008	bacterial pneumonia, nosocomial infection	PriCara, Unit of Ortho-McNeil, Inc.	Completed	No outcome recorded
Phase 2/31 trial
Phase 2/3	NCT02134106	Jan → Oct 2015	bacterial infectious disease, nosocomial infection	Tan Tock Seng Hospital	Withdrawn	No outcome recorded
Phase 310 trials · 2 met primary
Phase 3	NCT01110408	Dec 2010 → Jun 2013	urinary tract infection	Janssen Research & Development, LLC	Terminated	No outcome recorded Stop: Business
Phase 3	NCT01110382	Dec 2010 → Sep 2013	abscess, appendicitis, ileus, intestinal perforation +1	Janssen Research & Development, LLC	Terminated	No outcome recorded Stop: Business
Phase 3	NCT01110421	Dec 2010 → Mar 2012	bacterial pneumonia, nosocomial infection	Janssen Research & Development, LLC	Terminated	No outcome recorded Stop: Business
Phase 3	NCT00589693	Apr 2008 → Jun 2011	—	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Terminated	No outcome recorded
Phase 3	NCT00211016	Aug 2004 → Oct 2006	pneumonia	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Completed	Met primary
Phase 3	NCT00211003	May 2004 → Oct 2006	pneumonia	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Completed	Met primary
Phase 3	NCT00210990	Mar 2004 → Apr 2006	pyelonephritis	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Completed	No outcome recorded
Phase 3	NCT00229060	Mar 2004 → Mar 2006	appendicitis, bacterial infectious disease, cholecystitis, pancreatitis +1	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Completed	No outcome recorded
Phase 3	NCT00210938	Mar 2004 → Jan 2006	appendicitis, bacterial infectious disease, cholecystitis, pancreatitis +1	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Completed	No outcome recorded
Phase 3	NCT00229021	Dec 2003 → Mar 2006	pyelonephritis	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Completed	No outcome recorded
Phase 45 trials
Phase 4	NCT01467648	Oct 2010 → Oct 2011	—	Sutep Jaruratanasirikul	Completed	No outcome recorded
Phase 4	NCT01311141	Aug 2010 → Mar 2011	—	Medical University of Vienna	Completed	No outcome recorded
Phase 4	NCT01027897	Apr 2010 → Dec 2011	infectious disease with sepsis	Emory University	Completed	No outcome recorded
Phase 4	NCT00986102	Jul 2009 → Sep 2011	pneumonia, urinary tract infection	Janssen Research & Development, LLC	Completed	No outcome recorded
Phase 4	NCT00965848	Jun 2009 → Jul 2010	bacterial infectious disease, nosocomial infection, urinary tract infection	Janssen-Cilag Ltd.,Thailand	Completed	No outcome recorded
Phase not applicable1 trial
—	NCT01517815	Feb 2012 → Jun 2013	infectious disease with sepsis	University Hospital, Montpellier	Completed	No outcome recorded
Comparator or background therapy4 trials
Phase 2	NCT01281462 Comparator	Dec 2010 → Mar 2012	urinary tract infection	Forest Laboratories	Completed	No outcome recorded
Phase 3	NCT01595438 Comparator	Oct 2012 → Aug 2014	acute pyelonephritis	Pfizer	Completed	Met primary
Phase 3	NCT01599806 Comparator	Oct 2012 → Aug 2014	acute pyelonephritis	Pfizer	Completed	Met primary
Phase 4	NCT01401010 Comparator	Aug 2010 → Feb 2012	neutropenia	Gary E. Stein, Pharm.D.	Completed	No outcome recorded

Evidence & citations 11 cited values

Every value below carries the sentence it was read from. 28 sources stand behind the page.

Field	Value	Cited text
Known as	Doripenem	“Doripenem was evaluated in adults with complicated urinary tract infections and pyelonephritis in two phase 3 studies.” PMID 21303745 ↗ Dec 2010 25 NCT00589693 ↗ NCT01110408 ↗ NCT01381848 ↗ NCT00515034 ↗ NCT00965848 ↗ NCT01311141 ↗ NCT00986102 ↗ NCT01595438 ↗ NCT01517815 ↗ NCT01366651 ↗ Show 15 more sources
Known as	[14C]-DORIPENEM	ChEMBL registry synonym — accepted as the source's own label CHEMBL491571 ↗
Known as	Doribax	ChEMBL registry synonym — accepted as the source's own label CHEMBL491571 ↗
Known as	Doripenem (Doribax)	“Doripenem (Doribax)” NCT01467648 ↗
Known as	Doripenem hydrate	ChEMBL registry synonym — accepted as the source's own label CHEMBL491571 ↗
Known as	DORIPENEM MONOHYDRATE	ChEMBL registry synonym — accepted as the source's own label CHEMBL491571 ↗
Known as	Dripenem hydrate	ChEMBL registry synonym — accepted as the source's own label CHEMBL491571 ↗
Known as	Finibax	ChEMBL registry synonym — accepted as the source's own label CHEMBL491571 ↗
Known as	S-4661	ChEMBL registry synonym — accepted as the source's own label CHEMBL491571 ↗
Modality	Small molecule	“Doripenem is a new carbapenem, recently approved in the US for the treatment of adults with complicated urinary tract infections (cUTI) or complicated intra-abdominal infections (cIAI)” PMID 19670912 ↗ 2009
Route	Intravenous	“intravenous doripenem versus a comparator antibiotic” NCT00210938 ↗