Drugs / laropiprant
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Trevaclyn | — | 2013-04-10 | europa.eu ↗ |
| Approved | EU (EMA) | Trevaclyn | — | 2008-07-03 | europa.eu ↗ |
Trials 30
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials · 2 missed | ||||||
| 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 | Missed primary |
| Phase 1 | NCT01012219 | Nov 2009 → Mar 2010 | hyperlipidemia, combined, 2, hyperlipoproteinemia | Merck Sharp & Dohme LLC | Completed | Missed primary |
| 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 · 2 missed | ||||||
| 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 | Missed primary |
| 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 | Missed primary |
| Phase 314 trials · 4 met primary · 1 missed | ||||||
| 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 Stop: Business |
| 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 | Met primary |
| 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 | Met primary |
| Phase 3 | NCT00479388 | Jul 2007 → Jul 2008 | hyperlipidemia, combined, 2, hyperlipoproteinemia | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT00536510 | Apr 2007 → Mar 2008 | hyperlipidemia | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT00461630 | Jan 2007 → Oct 2012 | coronary artery disorder, diabetes mellitus, peripheral arterial disease | University of Oxford | Completed | Missed primary |
| Phase 3 | NCT00384293 | Sep 2006 → Aug 2008 | familial hypercholesterolemia | Merck Sharp & Dohme LLC | Terminated | No outcome recorded |
| Phase 3 | NCT00378833 | Jul 2006 → Mar 2007 | hyperlipidemia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00269217 | Jan 2006 → Jan 2007 | hyperlipidemia, combined, 2, hyperlipoproteinemia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00269204 | Dec 2005 → Dec 2006 | hyperlipidemia, hyperlipoproteinemia | Merck Sharp & Dohme LLC | 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 |
| Comparator or background therapy8 trials | ||||||
| Phase 3 | NCT01071525 Comparator | Apr → Aug 2010 | hyperlipidemia | Rambam Health Care Campus | Unknown | No outcome recorded |
| 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 4 | NCT01010516 Comparator | Oct 2009 → Dec 2011 | hyperlipidemia | University of Ioannina | Unknown | No outcome recorded |
| — | NCT01391377 Comparator | Jul 2011 → Dec 2014 | peripheral arterial disease | Bayside Health | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2013-03-09 | Merck Sharp & Dohme LLC | Results Results from HPS2-THRIVE Study of TREDAPTIVE™ (extended-release niacin/laropiprant) Presented at American College of Cardiology Scientific Sessions merck.com ↗
Adding TREDAPTIVE to statin therapy did not significantly further reduce the risk of major vascular events compared to statin therapy in patients at high risk of cardiovascular events. |
| 2013-01-11 | Merck Sharp & Dohme LLC | Regulatory Merck Provides Update on Next Steps for TREDAPTIVE™ (extended-release niacin/laropiprant) merck.com ↗
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the company is taking steps to suspend the availability of TREDAPTIVE ™ (extended-release niacin/laropiprant) tablets worldwide. |
| 2012-12-20 | Merck Sharp & Dohme LLC | Results Merck Announces HPS2-THRIVE Study of TREDAPTIVE™ (Extended-Release Niacin/Laropiprant) Did Not Achieve Primary Endpoint merck.com ↗
In the study, adding the combination of extended-release niacin and laropiprant to statin therapy did not significantly further reduce the risk of the combination of coronary deaths, non-fatal heart attacks, strokes or revascularizations compared to statin therapy. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2013-03-09 | Merck Sharp & Dohme LLC | Results from HPS2-THRIVE Study of TREDAPTIVE™ (extended-release niacin/laropiprant) Presented at American College of Cardiology Scientific Sessions merck.com ↗ |
| 2013-01-11 | Merck Sharp & Dohme LLC | Merck Provides Update on Next Steps for TREDAPTIVE™ (extended-release niacin/laropiprant) merck.com ↗ |
| 2012-12-20 | Merck Sharp & Dohme LLC | Merck Announces HPS2-THRIVE Study of TREDAPTIVE™ (Extended-Release Niacin/Laropiprant) Did Not Achieve Primary Endpoint merck.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 44 sources stand behind the page.
| Field | Value | Cited 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 laropiprant” PMID 24768191 ↗ Apr 2014 |
| 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 20094“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 20141“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 ↗ |