niacin extended-release formulation / Generic mfg. - LARVOL DELTA

Effect of Nicotinic Acid as Add on Therapy in Patients Receiving β Blocker for Prophylaxis of Moderate to Severe Migraine (clinicaltrials.gov) - P2 | N=58 | Completed | Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Recruiting ➔ Completed

Trial completion • CNS Disorders • Migraine • Pain

Management of Acute Pancreatitis Due to Hypertriglyceridemia in Pregnancy (ACG 2025) - "Plasmapheresis was considered due to the severity and risk to the pregnancy, but ultimately, the patient was treated supportively and improved clinically with bowel rest, insulin drip, fenofibrate, Niaspan, and Lovaza. In conclusion, patients with suspected familial hypertriglyceridemia should be counseled on triglyceride management before pregnancy to prevent this complication. Furthermore, in the event of developing hypertriglyceridemia-induced acute pancreatitis in pregnancy, plasmapheresis can be considered for treatment."

Diabetes • Dyslipidemia • Gastroenterology • Hepatology • Hypertriglyceridemia • Metabolic Disorders • Pancreatitis • Type 2 Diabetes Mellitus

Zydus receives approval from the US drug authority to produce cholesterol-lowering tablets (The Tribune) - "Indian multinational pharmaceutical company, Zydus Lifesciences Limited, has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Niacin Extended-Release Tablets. Niacin is indicated to reduce elevated total cholesterol (TC), LDL cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides (TG), and to increase HDL cholesterol (HDL-C) in patients with primary hyperlipidaemia and mixed dyslipidaemia....Niacin-Extended-Release tablets had annual sales of USD 5.5 million in the United States (IQVIA MAT, February 2025), as reported by the company in its filings to the exchanges."

ANDA • Sales • Dyslipidemia

THERAPEUTIC POTENTIAL OF NIACIN IN PS19 TAUOPATHY MICE (ADPD 2025) - "Our results indicate that hipp ocampal HCAR2 expression is increased in 9 -month-old PS19 mice. Moreover, treatment with Niaspan® improved motor coordination but did not affect the clasping reflex nor inflammatory markers. These results indicate that niacin may be acting via microglial H CAR2 to attenuate disease severity."

Preclinical • CLSPN,

Effects of Niacin Therapy on Lipoprotein Composition and Function (clinicaltrials.gov) - P=N/A | N=22 | Completed | Sponsor: National Heart, Lung, and Blood Institute (NHLBI) | Phase classification: P2 ➔ P=N/A

Phase classification • Cardiovascular

Niacin ameliorates Charcot-Marie-Tooth 4B1 neuropathy without interfering with nerve regeneration. (PubMed, Brain Commun) - "Niacin, nicotinic acid, is a vitamin used for many decades as anti-dyslipidaemic and anti-cholesterol drug product under the commercial name of Niaspan®, the extended-release formulation of niacin...We also sought to determine whether this strategy might interfere with nerve regeneration, which is dependent on Neuregulin type I signalling. Surprisingly, we found that the Mtmr2 knockout mice, a model of CMT4B1, have a defect in nerve regeneration and that niacin-based treatment is not detrimental to nerve regeneration."

Journal • Genetic Disorders • Inflammation • Pain • MTMR2 • TNFA

Nicotinic Acid for the Treatment of Alzheimer's Disease (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: Indiana University | Not yet recruiting ➔ Recruiting

Enrollment open • Alzheimer's Disease • CNS Disorders

Nicotinic Acid for the Treatment of Alzheimer's Disease (clinicaltrials.gov) - P1/2 | N=30 | Not yet recruiting | Sponsor: Indiana University | Trial completion date: Aug 2026 ➔ Feb 2026

Trial completion date • Alzheimer's Disease • CNS Disorders

TEACH: A Study of Evaluating Dual Inhibitor of PAK4 and NAMPT ATG-019 in Advanced Solid Tumors or Non-Hodgkin's Lymphoma (clinicaltrials.gov) - P1 | N=20 | Terminated | Sponsor: Antengene Therapeutics Limited | N=70 ➔ 20 | Recruiting ➔ Terminated; Because the sponsor modified the study-product development strategy.

Enrollment change • Metastases • Trial termination • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Effects of niacin and omega-3 fatty acids on HDL-apolipoprotein A-I exchange in subjects with metabolic syndrome. (PubMed, PLoS One) - "This study investigates whether niacin and omega-3 fatty acids induce measurable changes in HAE using a cohort of fifty-six subjects with metabolic syndrome (MetS) who were previously recruited to a double-blind trial where they were randomized to 16 weeks of treatment with dual placebo, extended-release niacin (ERN, 2g/day), prescription omega-3 ethyl esters (P-OM3, 4g/day), or the combination. However the combination had no statistically significant effect, 10% (-9, 31 CI, P = 0.39). With regard to P-OM3 therapy in particular, the HAE assay detected an increase in this property in the absence of a concomitant rise in HDL-C and apoA-I levels, suggesting that the assay can detect functional changes in HDL that occur in the absence of traditional biomarkers."

Journal • Metabolic Disorders • APOA1

NICOTINIC ACID RECEPTOR HCAR2 AFFECTS MICROGLIA RESPONSE AND AMYLOID PATHOLOGY AT EARLY- AND LATE-STAGE DISEASE (ADPD 2024) - "To examine if activation of HCAR2 exerted beneficial effects, 2-month-old 5xFAD mice were provided with high doses of nicotinic acid through food pellets for 4 months and 8-month-old mice were treated with an FDA-approved formulation of nicotinic acid (Niaspan®) by daily oral gavage for 30 days... These preliminary data demonstrate that HCAR2 impacts amyloid pathology and microglia response throughout the course of amyloid pathology, highlighting an important role of this receptor in disease and its potential as a therapeutic target. Our findings with nicotinic acid-treated mice further support the therapeutic potential of HCAR2 in Alzheimer's disease."

Alzheimer's Disease • CNS Disorders • Dementia

THERAPEUTIC POTENTIAL OF NICOTINIC ACID IN PS19 TAUOPATHY MICE. (ADPD 2024) - "Our results indicate that in 9-month-old PS19 mice, there was an increase in hippocampal HCAR2 expression. Moreover, treatment with Niaspan® improved motor coordination but did not affect the clasping reflex nor inflammatory markers. These results indicate that niacin may be acting via microglial HCAR2, attenuating disease severity."

Preclinical • Alzheimer's Disease • CNS Disorders • Dementia • CLSPN,

Cholestatic Drug-Induced Liver Injury in a Patient Taking High-Dose Niacin for Hyperlipidemia. (PubMed, J Investig Med High Impact Case Rep) - "Although mode of liver injury remains unknown, the use of extended-release niacin formulations and prolonged high-dose supplementation is associated with enhanced hepatotoxicity. Careful review and counseling of commonly available supplements remains an important task of both hospital and primary care physicians."

Journal • Dyslipidemia • Fibrosis • Gastroenterology • Hepatology • Immunology • Liver Failure • Metabolic Disorders • Primary Biliary Cholangitis

Benefits of Trimetazidine in MAFLD Pateints (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: October 6 University

Trial completion date • Trial primary completion date • Hepatology • Non-alcoholic Fatty Liver Disease

Effects of Niacin on apolipoprotein A1 and B levels: A systematic review and meta-analysis of Randomised Controlled Trials. (PubMed, Br J Nutr) - "Subgroup analyses revealed that the beneficial effects of Niacin on Apo A1 were observed at a dosage of >1500 mg/day (p < 0.001), and Extended-Release Niacin was more effective compared to other forms (p < 0.001)...This meta-analysis highlights Niacin's potential role in improving lipid profiles and cardiovascular health. Further well-designed clinical trials are needed to elucidate and confirm optimal dosages and durations of Niacin interventions for influencing Apolipoproteins A1 and B."

Journal • Retrospective data • Review • Cardiovascular • Metabolic Disorders • APOA1 • APOB

Benefits of Trimetazidine in MAFLD Pateints (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: October 6 University

New P2 trial • Hepatology • Non-alcoholic Fatty Liver Disease

Cholestatic Drug-Induced Liver Injury in a Patient Taking High-Dose Niacin for Hyperlipidemia (ACG 2023) - "Although mode of liver injury remains unknown, use of extended-release niacin formulations and prolonged high-dose supplementation is associated with enhanced hepatotoxicity...Periodic acid–Schiff (PAS)-positive intra- and extra-cellular globular accumulation are seen (black arrow: hematoxylin & eosin stain, red arrow: PAS stain). Genetic testing for Alpha-1-Antitrypsin is negative (normal phenotype - MM)."

Clinical • Cholestasis • Coronary Artery Disease • Dyslipidemia • Fibrosis • Hepatology • Immunology • Liver Failure

EAVaLL: Early Aortic Valve Lipoprotein(a) Lowering Trial (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: George Thanassoulis | N=238 ➔ 0 | Unknown status ➔ Withdrawn

Enrollment change • Trial withdrawal • Cardiovascular • Congestive Heart Failure

Effect of Nicotinic Acid as Add on Therapy in Patients Receiving β Blocker for Prophylaxis of Moderate to Severe Migraine (clinicaltrials.gov) - P2 | N=66 | Recruiting | Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

New P2 trial • CNS Disorders • Migraine

"Niaspan / Niacin SR ? Rosy face blush?" (@MikeyDCA2018)

"You’re the quack who thinks flush niacin is extended release niacin lol" (@NiacinGlutamine)

Magnetic Resonance Imaging of Intraplaque Hemorrhage and Plaque Lipid Content With Continued Lipid-Lowering Therapy: Results of a Magnetic Resonance Imaging Substudy in AIM-HIGH. (PubMed, Circ Cardiovasc Imaging) - P=N/A | "Carotid plaques under continued intensive lipid-lowering therapy moved toward stabilization. However, plaques with IPH showed greater increases in lipid content and greater decreases in lumen area than plaques without IPH."

Journal • MRI • Atherosclerosis • Cardiovascular • Dyslipidemia • Hematological Disorders • Hypertriglyceridemia • Metabolic Disorders • Thrombosis • APOA1 • APOB

"They used extended release flush niacin instead of immediate release? I thought immediate release was better." (@KevCTNC)

Lipid-lowering drugs. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal

Comparison table: Some lipid-lowering drugs. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal