Drugs / laropiprant

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Withdrawn EU (EMA) Trevaclyn 2013-04-10 europa.eu
Approved EU (EMA) Trevaclyn 2008-07-03 europa.eu

Trials 30 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 15 trials
Phase 1 NCT01583647 Jun → Dec 2012 familial hypercholesterolemia Merck Sharp & Dohme LLC Terminated No outcome recorded
Phase 1 NCT01451619 Nov 2011 → Apr 2012 rosacea Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 1 NCT01012219 Nov 2009 → Mar 2010 hyperlipidemia, combined, 2, hyperlipoproteinemia Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 1 NCT00769132 Aug → Oct 2007 hyperlipoproteinemia Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 1 NCT00618995 Aug → Dec 2007 type 2 diabetes mellitus Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 25 trials
Phase 2 NCT00111891 Jun → Aug 2005 hyperlipidemia Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 2 NCT00533312 Apr → Jul 2005 hyperlipidemia Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 2 NCT00783601 Oct 2004 → May 2005 asthma Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 2 NCT00536237 Aug 2004 → Feb 2005 flushing of ears and somnolence Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 2 NCT00533208 Jul → Oct 2003 seasonal allergic rhinitis Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 314 trials
Phase 3 NCT01414166 Sep 2011 → Feb 2013 hyperlipidemia Merck Sharp & Dohme LLC Terminated No outcome recorded
Phase 3 NCT01335997 May 2011 → Jan 2012 hyperlipidemia, combined, 2, hyperlipoproteinemia Merck Sharp & Dohme LLC Terminated No outcome recorded
Phase 3 NCT01274559 Mar 2011 → Feb 2013 hyperlipidemia, combined, 2, hyperlipoproteinemia Merck Sharp & Dohme LLC Terminated No outcome recorded
Phase 3 NCT01294683 Feb 2011 → Jan 2012 hyperlipidemia, hyperlipoproteinemia Merck Sharp & Dohme LLC Terminated No outcome recorded
Phase 3 NCT00961636 Oct 2009 → Jan 2011 hyperlipidemia Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 3 NCT00664287 Sep 2008 → Nov 2009 hyperlipidemia Merck Sharp & Dohme LLC Withdrawn No outcome recorded
Phase 3 NCT00485758 Jul 2007 → Aug 2008 type 2 diabetes mellitus Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 3 NCT00479388 Jul 2007 → Jul 2008 hyperlipidemia, combined, 2, hyperlipoproteinemia Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 3 NCT00536510 Apr 2007 → Mar 2008 hyperlipidemia Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 3 NCT00461630 Jan 2007 → Oct 2012 coronary artery disorder, diabetes mellitus, peripheral arterial disease University of Oxford Completed No outcome recorded
Phase 46 trials
Phase 4 NCT01942291 Mar → Dec 2012 hypoalphalipoproteinemia University of Campinas, Brazil Completed No outcome recorded
Phase 4 NCT01308203 Oct 2011 → Jan 2013 coronary artery disorder, hyperlipidemia Daniel A. Siniawski Terminated No outcome recorded
Phase 4 NCT01321034 Oct 2011 → Aug 2012 hyperlipoproteinemia Aragon Health Sciences Institute Completed No outcome recorded
Phase 4 NCT01239992 Jun 2011 → Jan 2013 hyperlipoproteinemia, metabolic syndrome X Ludwig-Maximilians - University of Munich Terminated No outcome recorded
Phase 4 NCT01054508 Jun 2010 → Jan 2012 hyperlipidemia Manchester University NHS Foundation Trust Completed No outcome recorded
Phase 4 NCT02153879 Feb 2009 → Dec 2011 hyperlipidemia, type 2 diabetes mellitus Institut Investigacio Sanitaria Pere Virgili Completed No outcome recorded
Also used as a comparator or background therapy in 8 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 31 trial
Phase 3 NCT01071525 Comparator Apr → Aug 2010 hyperlipidemia Rambam Health Care Campus Unknown No outcome recorded
Phase 46 trials
Phase 4 NCT01683656 Comparator Aug 2012 → Jul 2014 HIV infectious disease, atherosclerosis Calmy Alexandra Terminated No outcome recorded
Phase 4 NCT01450410 Comparator Jul 2012 → Mar 2013 hyperlipidemia Xavier Pinto Sala Terminated No outcome recorded
Phase 4 NCT01126073 Comparator Sep 2010 → Oct 2011 coronary artery disorder University Medical Centre Ljubljana Completed No outcome recorded
Phase 4 NCT01052311 Comparator Jul 2010 → Jan 2013 coronary artery disorder, hyperlipidemia Sheba Medical Center Terminated No outcome recorded
Phase 4 NCT01118598 Comparator Jun 2010 → May 2012 polycystic ovary syndrome Hull University Teaching Hospitals NHS Trust Completed No outcome recorded
Phase not applicable1 trial
NCT01391377 Comparator Jul 2011 → Dec 2014 peripheral arterial disease Bayside Health Terminated No outcome recorded

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 44 sources stand behind the page.

FieldValueCited text
Known as laropiprant “The purpose of this study is to determine the pharmacokinetics of laropiprant following administration of a single dose of 1 (Panel A) and 2 (Panel B) combination tablets of...” NCT01583647
36

“ERN/LRPT combination tablets (each containing 1 g of extended release niacin and 20 mg of laropiprant), orally, one tablet once per day for 4 weeks, then 2 tablets once per day...” NCT01414166

“Clinical studies of the DP1 antagonist laropiprant in asthma and allergic rhinitis.” PMID 19748656 Sep 2009

“Nicotinic acid / laropiprant (Tredaptive 1000 mg/20 mg modified-release tablets).” NCT01450410

“the prostaglandin D2 receptor antagonist laropiprantPMID 24768191 Apr 2014

NCT00384293

NCT00269217

NCT01052311

NCT00269204

NCT01391377

NCT02153879

NCT00961636

NCT01683656

NCT00111891

NCT00479388

NCT01010516

NCT01294683

NCT00618995

NCT01335997

NCT00461630

NCT01308203

NCT00769132

NCT01239992

NCT00485758

NCT01071525

NCT00378833

NCT01274559

NCT01012219

NCT01126073

NCT00536510

NCT00533312

NCT00664287

NCT01118598

NCT01451619

NCT01321034

NCT01054508

NCT00536237

Known as Cordaptive ChEMBL registry synonym — accepted as the source's own label CHEMBL426559
Known as LRP “Laropiprant (LRP; Merck \& Co., Inc, Whitehouse Station, NJ, USA) is a potent, once-daily, highly selective PGD2-receptor (DP1) antagonist.” NCT01052311
Known as LRPT “Laropiprant (LRPT), a PGD(2) receptor (DP1) antagonist that mitigates niacin-induced flushing, has been combined with extended-release niacin (ERN) into a fixed-dose tablet...” PMID 21291812 May 2009
4

“Laropiprant (LRPT), a selective prostaglandin D(2) receptor-1 antagonist, decreases flushing associated with extended-release niacin (ERN).” PMID 19576324 Jul 2009

“add-on-statin extended release nicotinic acid (ER-NA)/laropiprant (LRPT) or to add-on-statin micronized fenofibrate” PMID 23600368 Apr 2013

“Laropiprant (LRPT) reduces NIF; however, its effects on chronic flushing (>6 months) have not been studied.” PMID 22683042 Jun 2012

“ER niacin/laropiprant (ERN/LRPT)” NCT01335997

Known as MK0524 ClinicalTrials.gov intervention name — accepted as the source's own label NCT00783601
Action Inhibit “selective prostaglandin D2 receptor subtype 1 inhibitor laropiprant” PMID 24854458 May 2014
1

“Prostanoid DP receptor antagonist” CHEMBL426559

Modality Small molecule CHEMBL426559
Route Oral “niacin (+) laropiprant (2 g) po qd.” NCT00384293
Target PTGDR “Prostanoid DP receptor antagonist” CHEMBL426559