Wednesday, July 8, 2026

Drug profile · INN

niacin

niacin (NIACIN) is an FDA-listed pharmaceutical active ingredient. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 1
Pipeline programs 6
News articles 0
Drug details — niacin
US status
approved
Class
Route
ORAL
Patents
1
Programs
6
Data quality
0.89

Quick answer

niacin (NIACIN) is an FDA-listed pharmaceutical active ingredient. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN niacin
Brand NIACIN
Route ORAL
Formulation TABLET, EXTENDED RELEASE

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. 747-308 Phase 3 · Anaxis Pharma · Biliary Atresia, Post-hepatoportoenterostomy
  2. IAC regimen Phase 3 · First People's Hospital · Acute Myeloid Leukemia
  3. OCA 5MG IR +BZF 400 MG SR Phase 3 · Anaxis Pharma · Primary Biliary Cholangitis (PBC)
  4. Start antiplatelet monotherapy Phase 3 · Chinese Academy of · Intracerebral Hemorrhage
  5. GW093066 Phase 2 · United Therapeutics Europe · Gulf War Illness
  6. extended release niacin Unknown · United Therapeutics Europe · HIV Infections
  1. US 9072732

    Indication for use of niacin (nicotinic acid) for treatment and reversal of fatty liver disease

    Expires Mon Jul 02 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is niacin?

niacin (NIACIN) is an FDA-listed pharmaceutical active ingredient. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for niacin?

NIACIN is a marketed brand name for niacin. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of niacin?

niacin has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.