Niacin

also known as nicotinic acid · Niaspan · ERN · ER Niacin · Extended Release Niacin · vitamin B3 · niacin ER · B3 vitamin · +7 more

Small molecule

Developed for: hyperlipidemia · coronary artery disorder · hyperlipoproteinemia · atherosclerosis · type 2 diabetes mellitus · hyperlipidemia, combined, 2 · myocardial ischemia · coronary atherosclerosis
+43 more
· HIV infectious disease · metabolic syndrome X · obesity disorder · peripheral arterial disease · carotid artery disorder · hypertriglyceridemia · myocardial infarction · arterial occlusion · familial hypercholesterolemia · hyperphosphatemia · hypoalphalipoproteinemia · intermittent vascular claudication · stroke disorder · Alzheimer disease · aortic valve stenosis · bladder transitional cell carcinoma · cardiomyopathy · central retinal vein occlusion · congestive heart failure · end stage renal failure · hand-foot syndrome · hypertriglyceridemia 2 · hypolipoproteinemia · IDH-wildtype glioblastoma · inborn errors of metabolism · intracranial arteriosclerosis · ischemic stroke · metabolic disease · NAFLD1 · occlusion of tributary of retinal vein · persian gulf syndrome · psychotic disorder · retinal vein occlusion · rheumatoid arthritis · sickle cell disease · systolic heart failure · traumatic brain injury · tuberculosis · chronic kidney disease · metabolic dysfunction-associated steatohepatitis · polycystic ovary syndrome · prediabetes syndrome · sexual disorder
Investigated by: Merck Sharp & Dohme LLC · National Heart, Lung, and Blood Institute (NHLBI) · Kos Pharmaceuticals · Abbott · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · University of Sherbrooke
+93 more
· National Institute of Allergy and Infectious Diseases (NIAID) · University of Pennsylvania · University of Washington · Albert Einstein College of Medicine · Baylor College of Medicine · GlaxoSmithKline · Heidelberg University · Ludwig-Maximilians - University of Munich · Mayo Clinic · McGill University Health Centre/Research Institute of the McGill University Health Centre · National Institutes of Health (NIH) · Palo Alto Medical Foundation · United States Department of Defense · University of Oxford · AHS Cancer Control Alberta · Acura Pharmaceuticals Inc. · Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Aegerion Pharmaceuticals, Inc. · Al-Azhar University · Alzheimer's Association · American Diabetes Association · Antengene Therapeutics Limited · Aragon Health Sciences Institute · Assiut University · Axio Research. LLC · Brigham and Women's Hospital · Buck Institute for Research on Aging · CIHR Canadian HIV Trials Network · Cedars-Sinai Medical Center · Centre de Recherche en Nutrition Humaine Rhone-Alpe · Centre de recherche du Centre hospitalier universitaire de Sherbrooke · Craigavon Area Hospital · Daiichi Sankyo · Daniel A. Siniawski · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · First People's Hospital of Hangzhou · Foundation Research, Florida · French National Institute of Health and Medical Research · General Clinical Research Center (GCRC) · George Thanassoulis · Hannover Medical School · Heart and Stroke Foundation of Ontario · Henry Ford Health System · Hoskinson Health and Wellness Clinic · Hospital Miguel Servet · In His Image · Indiana University · Institut Investigacio Sanitaria Pere Virgili · Institut universitaire de cardiologie et de pneumologie de Québec, University Laval · Jewish General Hospital · Jiujiang No.1 People's Hospital · Johns Hopkins University · KRL Hospital, Islamabad · Karyopharm Therapeutics Inc · King Pharmaceuticals is now a wholly owned subsidiary of Pfizer · Laval University · Legacy Community Health Center · Manchester University NHS Foundation Trust · Merck KGaA, Darmstadt, Germany · Monash University · NYU Langone Health · National Institute on Aging (NIA) · North Texas Veterans Healthcare System · Nova Scotia Health Authority · Peking University People's Hospital · Pfizer · Phoenix VA Health Care System · Quebec Heart Institute · Rutgers University · Severna Park Health and Wellness Center · Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Sydney Local Health District · The Dana Foundation · all 99 on the full record

Regulatory milestones approvals, filings & regulatory actions · 6 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 ↗
Label expansions (3)	US (FDA)	NIASPAN TITRATION STARTER PACK	—	1999-09-13 – 2003-01-31	fda.gov ↗
Approved	US (FDA)	WAMPOCAP	—	1957-07-24	fda.gov ↗

Trials 112 · started per year

today

US approved 1957

EU approved 2008

19561957195819591960196119621963196419651966196719681969197019711972197319741975197619771978197919801981198219831984198519861987198819891990199119921993199419951996199719981999200020012002200320042005200620072008200920102011201220132014201520162017201820192020202120222023202420252026202720282029

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 05 trials
Phase 0	NCT06175403	Jan 2024 → May 2027 expected	—	Mayo Clinic	Recruiting	No outcome recorded
Phase 0	NCT06242535	Jul 2023 → May 2024	cognitive disorder, depressive disorder, hyperlipidemia, hypertensive disorder +1	Hoskinson Health and Wellness Clinic	Completed	No outcome recorded
Phase 0	NCT03867500	Nov 2018 → Dec 2021	obesity disorder, type 2 diabetes mellitus	Mayo Clinic	Completed	No outcome recorded
Phase 0	NCT02109614	May 2014 → Jan 2017	aortic valve stenosis	George Thanassoulis	Withdrawn	No outcome recorded
Phase 0	NCT00957359	Feb 2009 → Sep 2018	cancer	NYU Langone Health	Completed	No outcome recorded
Phase 112 trials
Phase 1	NCT07119996	Aug 2025 → Feb 2026 overdue	bladder transitional cell carcinoma	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Recruiting	No outcome recorded
Phase 1	NCT06378125	Dec 2022 → Nov 2024	—	University Hospital Schleswig-Holstein	Completed	No outcome recorded
Phase 1	NCT04281420	Apr 2020 → Oct 2023	non-Hodgkin lymphoma	Antengene Therapeutics Limited	Terminated	No outcome recorded
Phase 1	NCT02702492	Jun 2016 → Jan 2021	cancer, non-Hodgkin lymphoma	Karyopharm Therapeutics Inc	Terminated	No outcome recorded
Phase 1	NCT01583647	Jun → Dec 2012	familial hypercholesterolemia	Merck Sharp & Dohme LLC	Terminated	No outcome recorded
Phase 1	NCT01071291	Feb → Aug 2010	hyperlipidemia	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	NCT01104519	Mar → Jul 2008	hyperlipidemia	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 1	NCT01258491	May → Nov 2005	—	Heidelberg University	Completed	No outcome recorded
Phase 1	NCT00176020	—	—	Heidelberg University	Unknown	No outcome recorded

Phase 1/23 trials
Phase 1/2	NCT06582706	Dec 2024 → Dec 2026 expected	Alzheimer disease	Indiana University	Recruiting	No outcome recorded
Phase 1/2	NCT04677049	Mar 2021 → Dec 2026	IDH-wildtype glioblastoma	AHS Cancer Control Alberta	Suspended	No outcome recorded
Phase 1/2	NCT01237041	Jul 2011 → Oct 2017	isolated short stature, obesity disorder	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Terminated	No outcome recorded
Phase 220 trials
Phase 2	NCT07004725	May 2025 → Jan 2027 expected	rheumatoid arthritis	Peking University People's Hospital	Not yet recruiting	No outcome recorded
Phase 2	NCT05709353	Sep 2023 → May 2026	alcohol dependence, post-traumatic stress disorder	University of Sydney	Unknown	No outcome recorded
Phase 2	NCT04703361	Feb → Sep 2021	systolic heart failure	University of Aarhus	Completed	No outcome recorded
Phase 2	NCT04242927	Mar 2020 → Mar 2021	hand-foot syndrome	First People's Hospital of Hangzhou	Unknown	No outcome recorded
Phase 2	NCT03685773	Apr 2019 → Apr 2023	hyperglycemia, type 2 diabetes mellitus	Albert Einstein College of Medicine	Withdrawn	No outcome recorded
Phase 2	NCT03540758	Aug 2018 → Apr 2027 expected	diabetes mellitus	Albert Einstein College of Medicine	Recruiting	No outcome recorded
Phase 2	NCT02018965	Nov 2011 → Jun 2017	HIV infectious disease	McGill University Health Centre/Research Institute of the McGill University Health Centre	Completed	No outcome recorded
Phase 2	NCT01426438	Nov 2011 → Oct 2013	HIV infectious disease	Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections	Completed	No outcome recorded
Phase 2	NCT01221402	Oct 2010 → Oct 2014	coronary atherosclerosis	North Texas Veterans Healthcare System	Completed	No outcome recorded
Phase 2	NCT01672710	Apr 2010 → Aug 2015	persian gulf syndrome	University at Albany	Completed	No outcome recorded
Phase 2	NCT01030406	Jan → Feb 2010	opioid abuse	Acura Pharmaceuticals Inc.	Completed	No outcome recorded
Phase 2	NCT00796887	Apr 2009 → Aug 2012	ischemic stroke	Henry Ford Health System	Completed	No outcome recorded
Phase 2	NCT00804843	Apr 2009 → Oct 2010	atherosclerosis	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 2	NCT00508989	Jul 2007 → Dec 2010	sickle cell disease	National Heart, Lung, and Blood Institute (NHLBI)	Completed	No outcome recorded
Phase 2	NCT00431145	Oct 2006 → ?	coronary artery disorder	Ludwig-Maximilians - University of Munich	Unknown	No outcome recorded
Phase 2	NCT00359281	Mar 2006 → Nov 2007	—	Aegerion Pharmaceuticals, Inc.	Completed	No outcome recorded
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	NCT00536237	Aug 2004 → Feb 2005	flushing of ears and somnolence	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 2	NCT00000461	Dec 1986 → Nov 1992	coronary artery disorder, myocardial ischemia	National Heart, Lung, and Blood Institute (NHLBI)	Completed	No outcome recorded

Phase 2/33 trials
Phase 2/3	NCT06406140	Mar 2024 → Jan 2026 overdue	end stage renal failure	Al-Azhar University	Enrolling by invitation	No outcome recorded
Phase 2/3	NCT00500045	Feb 2007 → Oct 2016	central retinal vein occlusion, occlusion of tributary of retinal vein	Palo Alto Medical Foundation	Terminated	No outcome recorded
Phase 2/3	NCT00493064	Oct 2006 → Oct 2016	retinal vein occlusion	Palo Alto Medical Foundation	Completed	No outcome recorded
Phase 332 trials
Phase 3	NCT05958277	Jun 2021 → Jan 2023	traumatic brain injury	KRL Hospital, Islamabad	Completed	No outcome recorded
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	NCT01720095	Oct 2009 → Dec 2014	psychotic disorder	Nova Scotia Health Authority	Completed	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	NCT00626392	Feb → Apr 2008	hyperlipidemia	Abbott	Completed	No outcome recorded
Phase 3	NCT00630877	Feb → Jun 2008	hyperlipidemia	Abbott	Completed	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	NCT00465088	Apr 2007 → Feb 2008	hyperlipidemia, combined, 2	Abbott	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 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 3	NCT00150722	Sep 2005 → Aug 2008	atherosclerosis	University of Calgary	Completed	No outcome recorded
Phase 3	NCT00120289	Sep 2005 → Sep 2012	atherosclerosis, coronary artery disorder, myocardial infarction, stroke disorder	Axio Research. LLC	Terminated	No outcome recorded
Phase 3	NCT00080275	Mar 2004 → ?	hyperlipidemia	Kos Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT00071266	Oct 2003 → ?	intermittent vascular claudication	Kos Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT00127218	Sep 2003 → Dec 2008	atherosclerosis	Johns Hopkins University	Completed	No outcome recorded
Phase 3	NCT00062556	Jan 2003 → Mar 2006	intermittent vascular claudication, peripheral arterial disease	Kos Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT00170404	Jun 2000 → Oct 2005	tuberculosis	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 3	NCT00000553	Sep 1994 → Feb 2001	coronary artery disorder, myocardial ischemia	University of Washington	Completed	No outcome recorded
Phase 3	NCT00000539	Sep 1992 → Mar 1999	arterial occlusion, diabetes mellitus, heart disorder	National Heart, Lung, and Blood Institute (NHLBI)	Completed	No outcome recorded
Phase 3	NCT00000512	Jan 1984 → Aug 1989	coronary atherosclerosis, myocardial ischemia	University of Washington	Completed	No outcome recorded
Phase 3	NCT00000599	Jun 1980 → Nov 1994	arterial occlusion, carotid artery disorder, coronary atherosclerosis, intracranial arteriosclerosis +1	National Heart, Lung, and Blood Institute (NHLBI)	Completed	No outcome recorded
Phase 3	NCT00000482	Apr 1965 → Mar 1985	coronary artery disorder, myocardial infarction, myocardial ischemia	National Heart, Lung, and Blood Institute (NHLBI)	Completed	No outcome recorded
Phase 3	NCT00082251	—	hyperlipidemia	Kos Pharmaceuticals	Completed	No outcome recorded

Phase 421 trials
Phase 4	NCT07592897	Jun → Nov 2026 expected	—	University of Sao Paulo	Not yet recruiting	No outcome recorded
Phase 4	NCT03163576	Jun 2017 → Jun 2019	hyperphosphatemia	Assiut University	Unknown	No outcome recorded
Phase 4	NCT02836184	Jul → Sep 2016	hyperphosphatemia	Jiujiang No.1 People's Hospital	Unknown	No outcome recorded
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	NCT01122355	Feb 2009 → Jan 2010	metabolic disease	Yonsei University	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
Phase 4	NCT00286234	Oct 2007 → Aug 2008	hypertriglyceridemia, metabolic syndrome X	University of South Dakota	Completed	No outcome recorded
Phase 4	NCT00346970	Jul 2006 → Jul 2007	metabolic syndrome X	Hannover Medical School	Completed	No outcome recorded
Phase 4	NCT00298909	Mar 2006 → Jun 2009	coronary artery disorder, hypolipoproteinemia	University of Leipzig	Completed	No outcome recorded
Phase 4	NCT00238004	Nov 2005 → ?	coronary atherosclerosis, lipoprotein types--Lt system	Craigavon Area Hospital	Unknown	No outcome recorded
Phase 4	NCT00687076	Apr 2004 → Dec 2010	peripheral arterial disease	Baylor College of Medicine	Completed	No outcome recorded
Phase 4	NCT00079638	Apr 2004 → May 2005	atherosclerosis, coronary artery disorder, diabetes mellitus, hyperlipidemia +1	Kos Pharmaceuticals	Completed	No outcome recorded
Phase 4	NCT00345657	Jul 2003 → May 2004	hyperlipidemia, combined, 2	In His Image	Completed	No outcome recorded
Phase 4	NCT00590629	Jun 2002 → Nov 2005	coronary artery disorder	Cedars-Sinai Medical Center	Completed	No outcome recorded
Phase 4	NCT00715273	May 2001 → Dec 2018	atherosclerosis, carotid artery disorder, coronary artery disorder	University of Washington	Completed	No outcome recorded
Phase 4	NCT00304993	Jan 2001 → Feb 2005	metabolic syndrome X	Foundation Research, Florida	Completed	No outcome recorded
Phase 4	NCT00307307	Jan 2000 → Sep 2005	atherosclerosis	University of Pennsylvania	Completed	No outcome recorded

Phase not applicable16 trials
—	NCT05934409	Nov 2023 → Jan 2028 expected	type 2 diabetes mellitus	University of Sherbrooke	Recruiting	No outcome recorded
—	NCT05553184	Jul 2022 → May 2023	obesity disorder, type 2 diabetes mellitus	University of Sherbrooke	Completed	No outcome recorded
—	NCT05092945	May 2021 → Feb 2022	type 2 diabetes mellitus	University of Sherbrooke	Completed	No outcome recorded
—	NCT02808182	Jan 2017 → Dec 2020	glucose intolerance	University of Sherbrooke	Completed	No outcome recorded
—	NCT02003638	Mar 2012 → Jan 2013	carotid artery disorder, coronary artery disorder, peripheral arterial disease	University of Pennsylvania	Completed	No outcome recorded
—	NCT01159054	Jul 2010 → Dec 2014	atherosclerosis	Brigham and Women's Hospital	Terminated	No outcome recorded
—	NCT01474486	Apr 2010 → Feb 2016	cardiomyopathy, congestive heart failure	Phoenix VA Health Care System	Completed	No outcome recorded
—	NCT00986986	Nov 2007 → Apr 2010	HIV infectious disease, hyperlipidemia	University of Hawaii	Completed	No outcome recorded
—	NCT00953667	Jun 2007 → Feb 2011	—	University of Pennsylvania	Completed	No outcome recorded
—	NCT00458055	Nov 2006 → Sep 2007	coronary atherosclerosis, hypoalphalipoproteinemia, inborn errors of metabolism	McGill University Health Centre/Research Institute of the McGill University Health Centre	Completed	No outcome recorded
—	NCT01216956	Sep 2006 → Jun 2009	hypertriglyceridemia 2, lipoprotein types--Lt system	Centre de Recherche en Nutrition Humaine Rhone-Alpe	Completed	No outcome recorded
—	NCT00262964	Oct 2004 → Dec 2008	NAFLD1	Washington University School of Medicine	Completed	No outcome recorded
—	NCT00232531	Sep 2004 → Feb 2009	atherosclerosis	University of Oxford	Unknown	No outcome recorded
—	NCT00246376	Jan 2004 → Sep 2009	HIV infectious disease, atherosclerosis, heart disorder, hyperlipidemia +1	Baylor College of Medicine	Completed	No outcome recorded
—	NCT00000483	Jun 1981 → Mar 1985	coronary artery disorder, myocardial infarction, myocardial ischemia	National Heart, Lung, and Blood Institute (NHLBI)	Completed	No outcome recorded
—	NCT00046267	? → Dec 2006	HIV infectious disease, diabetes mellitus, hyperlipoproteinemia, hypertriglyceridemia	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded

Also used as a comparator or background therapy in 40 trials

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 14 trials
Phase 1	NCT01809301 Comparator	Mar → May 2013	—	Cortria Corporation	Completed	No outcome recorded
Phase 1	NCT01984073 Comparator	Dec 2012 → Dec 2019	hyperlipidemia	University of Pennsylvania	Completed	No outcome recorded
Phase 1	NCT00608699 Background	Dec 2007 → Apr 2008	hyperlipidemia	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT00652431 Comparator	May → Jul 2007	hyperlipidemia	Organon and Co	Completed	No outcome recorded
Phase 29 trials
Phase 2	NCT07286747 Comparator	Mar 2026 → May 2028 expected	prediabetes syndrome	University Hospital Schleswig-Holstein	Recruiting	No outcome recorded
Phase 2	NCT06444243 Comparator	Sep 2024 → Jul 2025	alcohol dependence, anxiety, depressive disorder	University of Sydney	Unknown	No outcome recorded
Phase 2	NCT05452772 Comparator	Nov 2023 → Dec 2026 expected	nicotine dependence	Johns Hopkins University	Recruiting	No outcome recorded
Phase 2	NCT05846373 Comparator	Nov 2022 → Jan 2024	—	Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh	Completed	No outcome recorded
Phase 2	NCT02890992 Background	Sep 2016 → Sep 2018	familial hypercholesterolemia	Sanofi	Completed	No outcome recorded
Phase 2	NCT01083329 Comparator	Jan → Jun 2010	obesity disorder	University Hospital, Toulouse	Completed	No outcome recorded
Phase 2	NCT00903617 Comparator	Jun 2009 → Feb 2010	hyperlipidemia	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT00728910 Comparator	Jun 2008 → Aug 2009	hyperlipidemia	University of Pennsylvania	Completed	No outcome recorded
Phase 2	NCT00699010 Comparator	Mar → Aug 2008	opioid abuse	Acura Pharmaceuticals Inc.	Completed	No outcome recorded

Phase 39 trials
Phase 3	NCT03510715 Background	Aug 2018 → Feb 2020	hyperlipidemia	Sanofi	Completed	No outcome recorded
Phase 3	NCT03510884 Background	May 2018 → Jan 2021	hyperlipidemia	Sanofi	Completed	No outcome recorded
Phase 3	NCT01071525 Comparator	Apr → Aug 2010	hyperlipidemia	Rambam Health Care Campus	Unknown	No outcome recorded
Phase 3	NCT00633698 Comparator	Jan 2008 → Dec 2009	hyperlipoproteinemia	Charite University, Berlin, Germany	Unknown	No outcome recorded
Phase 3	NCT00654069 Comparator	Sep 2007 → Feb 2008	—	Acura Pharmaceuticals Inc.	Completed	No outcome recorded
Phase 3	NCT00533611 Background	Apr → Aug 2007	flushing of ears and somnolence	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 3	NCT00376584 Comparator	Jul 2006 → Jan 2007	hyperlipidemia	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 3	NCT00271817 Comparator	Dec 2005 → Feb 2008	hyperlipoproteinemia	Organon and Co	Completed	No outcome recorded
Phase 3	NCT00108485 Comparator	Apr 2005 → Dec 2012	chronic kidney disease, hyperlipidemia, type 2 diabetes mellitus	University of Miami	Terminated	No outcome recorded

Phase 413 trials
Phase 4	NCT02642159 Comparator	Mar 2016 → Mar 2017	hyperlipidemia	Sanofi	Completed	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
Phase 4	NCT00852969 Comparator	Aug 2008 → Apr 2012	chronic kidney disease	Tufts Medical Center	Completed	No outcome recorded
Phase 4	NCT00712049 Comparator	Jun 2008 → ?	atherosclerosis, hyperlipidemia	Medical University of Vienna	Unknown	No outcome recorded
Phase 4	NCT00397657 Comparator	Nov 2006 → Aug 2009	atherosclerosis	Walter Reed Army Medical Center	Terminated	No outcome recorded
Phase 4	NCT00203476 Comparator	May 2005 → Jan 2008	hyperlipidemia, hyperlipoproteinemia	Tuscaloosa Research & Education Advancement Corporation	Completed	No outcome recorded
Phase 4	NCT00194402 Comparator	Aug 2003 → Jan 2006	hyperlipidemia	University of Washington	Completed	No outcome recorded
Phase 4	NCT01921010 Comparator	Jun 2003 → Jun 2005	—	Cedars-Sinai Medical Center	Completed	No outcome recorded

Phase not applicable5 trials
—	NCT06843148 Comparator	Jun 2026 → Mar 2030 expected	metabolic dysfunction-associated steatohepatitis	University of Sherbrooke	Recruiting	No outcome recorded
—	NCT01391377 Comparator	Jul 2011 → Dec 2014	peripheral arterial disease	Bayside Health	Terminated	No outcome recorded
—	NCT01250990 Comparator	Nov 2010 → May 2011	hyperlipidemia	University of Pennsylvania	Completed	No outcome recorded
—	NCT01085981 Comparator	Apr → Jun 2010	sexual disorder	East Suburban Ob Gyn	Unknown	No outcome recorded
—	NCT01275300 Comparator	Jul 2007 → Jan 2012	hyperlipidemia	University of Pennsylvania	Completed	No outcome recorded

Press releases naming this drug 1 release

Date	Issuer	Release
2013-09-20	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces Exclusive Launch of Generic NIASPAN® in the United States tevapharm.com ↗

Evidence & citations 19 cited values

Every value below carries the sentence it was read from. 162 sources stand behind the page.

Field	Value	Cited text
Known as	niacin	“OBJECTIVE: To evaluate the efficacy and safety of two dose strengths of oxycodone hydrochloride (HCl)/niacin tablets * for the treatment of moderate-to-severe postoperative...” PMID 21231862 ↗ Jan 2011 115 “To Determine if the Cardiovascular Risk Indices Including Postprandial Hypertriglyceridaemia Are Modified Favourably by Nicotinic Acid (Niacin) in Patients With Polycystic...” NCT01118598 ↗ “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 ↗ “Each capsule is a combination of vitamins and natural products: Vitamin B1 (100mg); Vitamin B6 (50mg); Niacin (200mg); Alpha Lipoic Acid (150mg); and Piperine (15mg).” NCT06242535 ↗ “Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg” NCT00957359 ↗ “An ER formulation of niacin (Niaspan - Kos) will be available in Canada in 2005 and has been shown to be efficacious and safe.” NCT00150722 ↗ “Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine” NCT01474486 ↗ “Nicotinic acid (niacin) has the ability to lower LDL levels and raise HDL levels thus reducing the incidence of CVD.” NCT01054508 ↗ “niacin 500 mg po for 4 weeks, niacin 1000 mg po for 4 weeks, niacin 1500 mg po for 8 weeks” NCT01122355 ↗ “Nicotinic acid (Niacin) has been used for many years for the treatment of dyslipidemia.” NCT01216956 ↗ “8x Oxycodone/Niacin 5/30mg tablets All arms taken with a 48 hour washout between doses” NCT01030406 ↗ “between extended-release niacin and ezetimibe/simvastatin and their major metabolites” PMID 21120461 ↗ Dec 2010 “Flexible Doses of Niacin (NIASPAN) as an Adjunct to Antipsychotic Medication” NCT01720095 ↗ “Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg” NCT01583647 ↗ “Niacin (91% niacinamide, 9% niacin) - 100 mg” NCT07592897 ↗ “immediate release nicotinic acid (niacin)” NCT00238004 ↗ “Acurox (Oxycodone HCl and Niacin) Tablets” NCT00699010 ↗ “1000 mg ER niacin and AEGR-733 10 mg” NCT00359281 ↗ “Nicotinic acid (niacin)” NCT00633698 ↗ NCT00536237 ↗ NCT01071525 ↗ NCT00269204 ↗ NCT01942291 ↗ NCT01672710 ↗ NCT00271817 ↗ NCT00852969 ↗ NCT02003638 ↗ NCT01321034 ↗ NCT06582706 ↗ NCT00000483 ↗ NCT00536510 ↗ NCT00378833 ↗ NCT00953667 ↗ NCT00461630 ↗ NCT00082251 ↗ NCT01126073 ↗ NCT01274559 ↗ NCT04281420 ↗ NCT02018965 ↗ NCT01391377 ↗ NCT01221402 ↗ NCT00465088 ↗ NCT01085981 ↗ NCT02109614 ↗ NCT00804843 ↗ NCT00769132 ↗ NCT00664287 ↗ NCT00000512 ↗ NCT00000539 ↗ NCT00304993 ↗ NCT01275300 ↗ NCT00715273 ↗ NCT01294683 ↗ NCT00262964 ↗ NCT01984073 ↗ NCT00046267 ↗ NCT04677049 ↗ NCT00345657 ↗ NCT00120289 ↗ NCT01239992 ↗ NCT07004725 ↗ NCT04703361 ↗ NCT01012219 ↗ NCT00062556 ↗ NCT00127218 ↗ NCT05452772 ↗ NCT02702492 ↗ NCT00626392 ↗ NCT03867500 ↗ NCT01237041 ↗ NCT00608699 ↗ NCT06406140 ↗ NCT01335997 ↗ NCT00533611 ↗ NCT01683656 ↗ NCT00080275 ↗ NCT03163576 ↗ NCT00203476 ↗ NCT00269217 ↗ NCT06175403 ↗ NCT06843148 ↗ NCT00508989 ↗ NCT00618995 ↗ NCT00111891 ↗ NCT00397657 ↗ NCT00376584 ↗ NCT00079638 ↗ NCT01250990 ↗ NCT06444243 ↗ NCT00431145 ↗ NCT00000461 ↗ NCT00485758 ↗ NCT00479388 ↗ NCT02153879 ↗ NCT00533312 ↗ NCT00796887 ↗ NCT00170404 ↗ NCT00071266 ↗ NCT00286234 ↗ NCT05709353 ↗ NCT00298909 ↗ NCT00630877 ↗ NCT01426438 ↗ NCT01308203 ↗ NCT00458055 ↗ NCT00346970 ↗ NCT00961636 ↗ NCT00000482 ↗ NCT00307307 ↗ NCT00986986 ↗ NCT01010516 ↗ NCT00384293 ↗ NCT00246376 ↗ NCT01052311 ↗ NCT00000553 ↗ NCT00000599 ↗
Known as	B3 vitamin	“B3 vitamin, Niacin” NCT04703361 ↗
Known as	ER Niacin	“One tablet of ER niacin/laropiprant (1g); advancing to ER niacin/laropiprant (2g) at Week 4 for the remainder of the study 36 Weeks.” NCT00485758 ↗ 4 “Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.” NCT01274559 ↗ “ER niacin 1 g/laropiprant 20 mg oral tablet taken once daily” NCT01335997 ↗ “Drug: ER Niacin” NCT00376584 ↗ NCT00728910 ↗
Known as	ERN	“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 6 “addition of extended-release niacin (ERN) to simvastatin in participants with established cardiovascular disease, low high-density lipoprotein cholesterol, and high...” PMID 23881958 ↗ Jul 2013 “Extended-release nicotinic acid (ERN) was shown to reduce plasma triacylglycerols and total cholesterol but also to markedly increase high-density lipoprotein-cholesterol (HDL-C).” PMID 28752209 ↗ Jun 2017 “Prescription omega-3 acid ethyl esters (P-OM3) and extended release niacin (ERN) both have beneficial effects on plasma lipids and lipoproteins.” PMID 25932792 ↗ Apr 2015 “Extended-release niacin (ERN) improves multiple lipid parameters but is underused owing to niacin-induced flushing (NIF).” PMID 22683042 ↗ Jun 2012 “1 g of extended release niacin (ERN) and 20 mg of laropiprant, highly selective PGD2-receptor (DP1) antagonist” NCT01126073 ↗ “ER niacin/laropiprant (ERN/LRPT)” NCT01335997 ↗
Known as	Extended Release Niacin	“A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Study to Evaluate the Efficacy of MK0524 to Improve Tolerability of Extended Release Niacin” NCT00376584 ↗ 3 “The patients were randomly assigned to receive extended-release niacin (target dose, 2000 mg per day) or ezetimibe (10 mg per day).” PMID 19915217 ↗ Nov 2009 “Drug: Extended Release Niacin” NCT06582706 ↗ NCT00108485 ↗
Known as	NER	“Niacin extended-release (NER) is safe and effective for treatment of dyslipidemia.” PMID 19331435 ↗ 2009
Known as	niacin ER	“The OCEANS study (Open-label evaluation of the safety and efficacy of a Combination of niacin ER and simvAstatin in patieNts with dySlipidemia; ClinicalTrials.gov identifier:...” PMID 18422390 ↗ 2008 1 “Drug: Niacin ER” NCT02702492 ↗
Known as	niacinamide	“Niacin (91% niacinamide, 9% niacin) - 100 mg” NCT07592897 ↗
Known as	Niacor(R)	“Treatment A: 500 mg nicotinic acid (Niacor(R))” NCT00176020 ↗
Known as	Nialor	“The first form is called Nialor, and is sometimes called immediate-release niacin because it is absorbed into the bloodstream quickly.” NCT01984073 ↗
Known as	Niaspan	“The purpose of this study is to evaluate the effectiveness of first-line treatment using Niaspan (an extended release version of niacin) and statins versus other drugs that...” NCT00079638 ↗ 15 “This study will evaluate whether chronic dosing with Niaspan™ increases reverse cholesterol transport, high-density lipoprotein cholesterol (HDL-C) levels, and fecal excretion...” NCT01071291 ↗ “The second form is called Niaspan, and is sometimes called extended-release niacin because it is a time-released spansule that takes longer to get into the bloodstream.” NCT01984073 ↗ “Both Niaspan and lovastatin (Mevacor®) are approved by the United States Food and Drug Administration (FDA) to treat high cholesterol.” NCT00071266 ↗ “An ER formulation of niacin (Niaspan - Kos) will be available in Canada in 2005 and has been shown to be efficacious and safe.” NCT00150722 ↗ “gradually titrated niacin extended-release (N-ER; given as NIASPAN, trademark of Kos Life Sciences LLC)” PMID 19576324 ↗ Jul 2009 “Flexible Doses of Niacin (NIASPAN) as an Adjunct to Antipsychotic Medication” NCT01720095 ↗ “extended-release niacin (Niaspan)” NCT01221402 ↗ NCT01104519 ↗ NCT00903617 ↗ NCT01071291 ↗ NCT00232531 ↗ NCT00687076 ↗ NCT01809301 ↗ NCT01921010 ↗ NCT00590629 ↗
Known as	nicotinic acid	“Niacin (generic name of nicotinic acid), also known as vitamin B3, is a naturally occurring water-soluble vitamin” NCT06406140 ↗ 30 “Niacin/nicotinic acid is obtained principally through diet and can cross the blood brain barrier.” NCT06582706 ↗ “Niacin (nicotinic acid) reduces cardiovascular events in patients with dyslipidemia.” PMID 17392721 ↗ Mar 2007 “both nicotinamide and niacin (nicotinic acid) are forms of vitamin B3 .” NCT03163576 ↗ NCT01083329 ↗ NCT01450410 ↗ NCT05934409 ↗ NCT05553184 ↗ NCT01258491 ↗ NCT01118598 ↗ NCT00712049 ↗ NCT04242927 ↗ NCT00238004 ↗ NCT02642159 ↗ NCT00633698 ↗ NCT03510715 ↗ NCT03510884 ↗ NCT01216956 ↗ NCT03685773 ↗ NCT02808182 ↗ NCT01159054 ↗ NCT00176020 ↗ NCT05846373 ↗ NCT00500045 ↗ NCT07286747 ↗ NCT01054508 ↗ NCT03540758 ↗ NCT06378125 ↗ NCT00493064 ↗ NCT05092945 ↗ NCT02890992 ↗
Known as	Nicotinic Acids	ClinicalTrials.gov intervention name — accepted as the source's own label NCT02836184 ↗
Known as	Slo-Niacin	ClinicalTrials.gov intervention name — accepted as the source's own label NCT00194402 ↗
Known as	Slo-Niacin (R) (time-release niacin	“Slo-Niacin (R) (time-release niacin” NCT00194402 ↗
Known as	vitamin B3	“Niacin (generic name of nicotinic acid), also known as vitamin B3, is a naturally occurring water-soluble vitamin” NCT06406140 ↗ 3 “Niacin, vitamin B3, has been used as a treatment for dyslipidemia.” NCT04703361 ↗ NCT07119996 ↗ NCT05958277 ↗
Action	Inhibit	“inhibits lipolysis and lowers circulating FFA concentrations” NCT01237041 ↗
Modality	Small molecule	“Niacin is a nicotinic acid derivative” NCT01237041 ↗
Route	Oral	“Single Oral Repeated Dose” NCT00176020 ↗