Niacin
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | NIASPAN TITRATION STARTER PACK | — | 1999-09-13 – 2003-01-31 | fda.gov ↗ |
| Approved | US (FDA) | WAMPOCAP | — | 1957-07-24 | fda.gov ↗ |
Trials 95 · started per year
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2025-04-30 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from USFDA for Niacin Extended-Release Tablets zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Niacin Extended-Release Tablets USP, 500 mg, 750 mg, and 1,000 mg (Niaspan ® Extended-Release Tablets, 500 mg, 750 mg, and 1,000 mg). |
| 2017-06-19 | Lannett Company, Inc. | Regulatory Lannett Receives Approval For Niacin Extended-Release Tablets USP, 500 Mg And 1000 Mg investorroom.com ↗
today announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Niacin Extended-Release Tablets USP, 500 mg and 1000 mg |
| 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 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-04-30 | Zydus Lifesciences Limited | Zydus receives final approval from USFDA for Niacin Extended-Release Tablets zyduslife.com ↗ |
| 2017-06-19 | Lannett Company, Inc. | Lannett Receives Approval For Niacin Extended-Release Tablets USP, 500 Mg And 1000 Mg investorroom.com ↗ |
| 2013-09-20 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Exclusive Launch of Generic NIASPAN® in the United States tevapharm.com ↗ |
| 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 15 cited values
Every value below carries the sentence it was read from. 130 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 2011110“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 ↗ “niacin 500 mg po for 4 weeks, niacin 1000 mg po for 4 weeks, niacin 1500 mg po for 8 weeks” NCT01122355 ↗ “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 ↗ |
| 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 ↗3“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 ↗ |
| 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 20095“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 “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 ↗2“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 ↗ |
| 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 ↗ 20081“Drug: Niacin ER” NCT02702492 ↗ |
| Known as | niacinamide | “Niacin (91% niacinamide, 9% niacin) - 100 mg” NCT07592897 ↗ |
| 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 ↗ |
| Known as | nicotinic acid | “Niacin (generic name of nicotinic acid), also known as vitamin B3, is a naturally occurring water-soluble vitamin” NCT06406140 ↗3“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 ↗ |
| 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 ↗ |
| Action | Inhibit | “inhibits lipolysis and lowers circulating FFA concentrations” NCT01237041 ↗ |
| Modality | Small molecule | “Niacin is a nicotinic acid derivative” NCT01237041 ↗ |
| Route | Oral | “niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be \~24 weeks” NCT00271817 ↗ |