TheraRadar
Data updated: May 26, 2026

NIACOR (niacin)

Trial Activity: Stable 3 active trials
Metabolic Approved 2000-05-03

NIACOR is indicated for the treatment of Atherosclerotic Vascular Disease; Hypercholesterolemia; Hyperlipidemia; Pancreatitis.

Source: FDA Label • AVONDALE PHARMS
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

Development Insights

University of Sydney conducting 2 trials (15%)
20 indications explored (Broad Platform)
→ alcohol use disorder (2 trials)
→ alcohol dependence (2 trials)
→ depression (2 trials)
1
Indication
--
Phase 3 Trials
26
Years on Market

Details

Status
Prescription
First Approved
2000-05-03
Routes
ORAL
Dosage Forms
TABLET

Companies

AVONDALE PHARMS
Active Ingredient: NIACIN

NIACOR Approval History

2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2000 to 2002
Dec 2002 SUPPL
Mfg · Manufacturing (CMC)
Jan 2002 SUPPL
Label · Labeling
May 2000 ORIGINAL
Update
FDA Letter Label

What NIACOR Treats

4 indications

NIACOR is approved for 4 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Atherosclerotic Vascular Disease
  • Hypercholesterolemia
  • Hyperlipidemia
  • Pancreatitis
Source: FDA Label

NIACOR Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

LEROCHOL
LIB THERAPEUTICS,
2025 2 indic.
PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE
Dr. Reddy's
2024 4 indic.
Unlock 8 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to NIACOR

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

CHOLESTYRAMINE
CHOLESTYRAMINE
2 shared
ALKEM LABS LTD
Shared indications:
HypercholesterolemiaAtherosclerotic Vascular Disease
CHOLESTYRAMINE LIGHT
CHOLESTYRAMINE
2 shared
PHARMOBEDIENT CNSLTG
Shared indications:
HypercholesterolemiaAtherosclerotic Vascular Disease
COLESTID
COLESTIPOL HYDROCHLORIDE
2 shared
Pfizer
Shared indications:
HypercholesterolemiaAtherosclerotic Vascular Disease
View all 20 similar drugs Pro
📋

Clinical Trial Registry

12 trials
Trial Sponsor ID Phase Status Title
NCT03866174 results posted PSIL201 Ph 2 completed A Study of Psilocybin for Major Depressive Disorder (MDD)
NCT05452772 IRB00326148 U01DA052174 Ph 2 recruiting 5-HT2A Agonist Psilocybin in the Treatment of Tobacco Use Disorder
NCT04424225 results posted PSYCH-2019-28235 Ph 1 terminated Visual Surround Suppression and Perceptual Expectation Under Psilocybin
NCT06444243 X23-0055 Ph 2 not yet recruiting Psilocybin-assisted Therapy for Alcohol Use Disorder
NCT03752918 2000020348 Ph 1 withdrawn The Effects of MDMA on Prefrontal and Amygdala Activation in PTSD.
NCT04630964 PSIPET 2020-002790-94 Ph 2 completed The Effect of Psilocybin on MDD Symptom Severity and Synaptic Density
NCT05709353 MPATHY X22-0121 Ph 2 recruiting MDMA-assisted Prolonged Exposure Therapy for Comorbid Alcohol Use Disorder and Post-traumatic Stress Disorder
NCT04703361 KETO-COX 1010 Ph 2 completed Effects of Ketones and Niacin in Heart Failure Patients
NCT02018965 CTN006 Ph 2 completed Niacin on Immune Activation : a Proof-of-concept Study
NCT01426438 results posted ACTG A5293 1U01AI068636 Ph 2 completed Endothelial Function, Lipoproteins, and Inflammation With Low HDL Cholesterol in HIV: ER Niacin Versus Fenofibrate
NCT00852969 results posted 5R21DK077368 5R21DK077368-02 Ph 4 completed Niacin and Endothelial Function in Early CKD
NCT01942291 Unicamp845/2011 Ph 4 completed Short-term Effect of Extended-release Niacin on Endothelial Function.
🔬

Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

NIACOR FDA Label Details

Indications & Usage

FDA Label (PDF)

NIACOR is indicated for the treatment of Atherosclerotic Vascular Disease; Hypercholesterolemia; Hyperlipidemia; Pancreatitis.

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Data Sources

FDA Approval: ANDA040378 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment