Drug

Niacin

As of the edition of 20 October 2026, Niacin is a small molecule: marketed, first approved in 1979 (CA); acts on HCAR2.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Marketed; latest approval 1982
Kind
Small molecule
Brand name
Wampocap
First approved
31 December 1979 (CA)
Approvals on record
16 in 2 regions
Holder of the most recent approval
AbbVie; 3 holders in all
Withdrawn from market
10 April 2013 (in some regions)
Registered trials
117, 16 stopped early
Disease areas
Nutrition and metabolism; Heart and blood vessels; Hormones; Nervous system; Inherited and neonatal; Cancer

US protection

No US approval on record.

With no US approval on record there are no listed US patents or exclusivities.

This is the US only.

Target

GeneProteinUniProt
HCAR2Hydroxycarboxylic acid receptor 2Q8TDS4

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated221632
Phase 1211144
Phase 2211242
Phase 3352806
Phase 4181302
All trials117

Who has held its approvals

CompanyRoleYears
AbbottLater holder and Lead sponsor of trials1997 to now
Medpointe Pharmaceuticals Medpointe HealthcareAcquired holder2003 to now
AbbVieAcquired holder2012 to now