Drugs / Nicotinic acid
Nicotinic acid
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| Withdrawn | EU (EMA) | Trevaclyn | — | 2013-04-10 | europa.eu ↗ |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 16
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT06378125 | Dec 2022 → Nov 2024 | — | University Hospital Schleswig-Holstein | 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 23 trials | ||||||
| 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2 | NCT03685773 | Apr 2019 → Apr 2023 | hyperglycemia, type 2 diabetes mellitus | Albert Einstein College of Medicine | Withdrawn | No outcome recorded |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 2/32 trials | ||||||
| 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 42 trials | ||||||
| Phase 4 | NCT01054508 | Jun 2010 → Jan 2012 | hyperlipidemia | Manchester University NHS Foundation Trust | Completed | No outcome recorded |
| Phase 4 | NCT00238004 | Nov 2005 → ? | coronary atherosclerosis, lipoprotein types--Lt system | Craigavon Area Hospital | Unknown | No outcome recorded |
| Phase not applicable6 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 |
| — | NCT01159054 | Jul 2010 → Dec 2014 | atherosclerosis | Brigham and Women's Hospital | Terminated | No outcome recorded Stop: Business |
| — | NCT01216956 | Sep 2006 → Jun 2009 | hypertriglyceridemia 2, lipoprotein types--Lt system | Centre de Recherche en Nutrition Humaine Rhone-Alpe | Completed | No outcome recorded |
| Comparator or background therapy11 trials | ||||||
| Phase 2 | NCT07286747 Comparator | Mar 2026 → May 2028 expected | prediabetes syndrome | University Hospital Schleswig-Holstein | 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 3 | NCT03510715 Background | Aug 2018 → Feb 2020 | hyperlipidemia | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT03510884 Background | May 2018 → Jan 2021 | hyperlipidemia | Sanofi | Completed | Met primary |
| Phase 3 | NCT00633698 Comparator | Jan 2008 → Dec 2009 | hyperlipoproteinemia | Charite University, Berlin, Germany | Unknown | No outcome recorded |
| Phase 4 | NCT02642159 Comparator | Mar 2016 → Mar 2017 | hyperlipidemia | Sanofi | Completed | Met primary |
| Phase 4 | NCT01450410 Comparator | Jul 2012 → Mar 2013 | hyperlipidemia | Xavier Pinto Sala | 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 | NCT00712049 Comparator | Jun 2008 → ? | atherosclerosis, hyperlipidemia | Medical University of Vienna | Unknown | No outcome recorded |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 29 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Nicotinic acid | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03540758 ↗ |
| Known as | ERN | “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 |
| Known as | niacin | “To Determine if the Cardiovascular Risk Indices Including Postprandial Hypertriglyceridaemia Are Modified Favourably by Nicotinic Acid (Niacin) in Patients With Polycystic...” NCT01118598 ↗4“Nicotinic acid (niacin) has the ability to lower LDL levels and raise HDL levels thus reducing the incidence of CVD.” NCT01054508 ↗ “Nicotinic acid (Niacin) has been used for many years for the treatment of dyslipidemia.” NCT01216956 ↗ “immediate release nicotinic acid (niacin)” NCT00238004 ↗ “Nicotinic acid (niacin)” NCT00633698 ↗ |
| Known as | Niacor(R) | “Treatment A: 500 mg nicotinic acid (Niacor(R))” NCT00176020 ↗ |
| Action | Inhibit | “pharmacological inhibition of postprandial AT intracellular lipolysis using short-acting nicotinic acid (NA)” PMID 40157702 ↗ Mar 2025 |
| Route | Oral | “Single Oral Repeated Dose” NCT00176020 ↗ |