Last reviewed 2026-04-22 · How we verify

Acid Nicotinique

French Cardiology Society · Phase 3 active Small molecule

Acid Nicotinique is a Nicotinic acid derivative / Lipid-modifying agent Small molecule drug developed by French Cardiology Society. It is currently in Phase 3 development for Dyslipidemia / mixed hyperlipidemia, Cardiovascular risk reduction in patients with elevated triglycerides and low HDL.

Nicotinic acid (niacin) reduces triglycerides and LDL cholesterol while raising HDL cholesterol through inhibition of hepatic VLDL production and increased lipolysis.

Nicotinic acid (niacin) reduces triglycerides and LDL cholesterol while raising HDL cholesterol through inhibition of hepatic VLDL production and increased lipolysis. Used for Dyslipidemia / mixed hyperlipidemia, Cardiovascular risk reduction in patients with elevated triglycerides and low HDL.

Likelihood of approval

56.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Cardiovascular Phase 3 risk -2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Acid Nicotinique
Sponsor	French Cardiology Society
Drug class	Nicotinic acid derivative / Lipid-modifying agent
Target	GPR109A (HCA2 receptor)
Modality	Small molecule
Therapeutic area	Cardiovascular
Phase	Phase 3

Mechanism of action

Nicotinic acid is a B vitamin that acts as a ligand for GPR109A (hydroxycarboxylic acid receptor 2) on adipocytes and immune cells, suppressing free fatty acid release and hepatic triglyceride synthesis. This leads to decreased VLDL production and improved lipid profiles. It also has anti-inflammatory properties relevant to cardiovascular disease.

Approved indications

Dyslipidemia / mixed hyperlipidemia
Cardiovascular risk reduction in patients with elevated triglycerides and low HDL

Common side effects

Flushing
Pruritus
Gastrointestinal upset
Hyperglycemia
Hyperuricemia

Key clinical trials

Assessment of Endothelial Vasomotricity After Treatment by Nicotinic Acid in Acute Coronary Syndrome (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Acid Nicotinique CI brief — competitive landscape report
Acid Nicotinique updates RSS · CI watch RSS
French Cardiology Society portfolio CI

Frequently asked questions about Acid Nicotinique

What is Acid Nicotinique?

Acid Nicotinique is a Nicotinic acid derivative / Lipid-modifying agent drug developed by French Cardiology Society, indicated for Dyslipidemia / mixed hyperlipidemia, Cardiovascular risk reduction in patients with elevated triglycerides and low HDL.

How does Acid Nicotinique work?

Nicotinic acid (niacin) reduces triglycerides and LDL cholesterol while raising HDL cholesterol through inhibition of hepatic VLDL production and increased lipolysis.

What is Acid Nicotinique used for?

Acid Nicotinique is indicated for Dyslipidemia / mixed hyperlipidemia, Cardiovascular risk reduction in patients with elevated triglycerides and low HDL.

Who makes Acid Nicotinique?

Acid Nicotinique is developed by French Cardiology Society (see full French Cardiology Society pipeline at /company/french-cardiology-society).

What drug class is Acid Nicotinique in?

Acid Nicotinique belongs to the Nicotinic acid derivative / Lipid-modifying agent class. See all Nicotinic acid derivative / Lipid-modifying agent drugs at /class/nicotinic-acid-derivative-lipid-modifying-agent.

What development phase is Acid Nicotinique in?

Acid Nicotinique is in Phase 3.

What are the side effects of Acid Nicotinique?

Common side effects of Acid Nicotinique include Flushing, Pruritus, Gastrointestinal upset, Hyperglycemia, Hyperuricemia.

What does Acid Nicotinique target?

Acid Nicotinique targets GPR109A (HCA2 receptor) and is a Nicotinic acid derivative / Lipid-modifying agent.

Drug class: All Nicotinic acid derivative / Lipid-modifying agent drugs
Target: All drugs targeting GPR109A (HCA2 receptor)
Manufacturer: French Cardiology Society — full pipeline
Therapeutic area: All drugs in Cardiovascular
Indication: Drugs for Dyslipidemia / mixed hyperlipidemia
Indication: Drugs for Cardiovascular risk reduction in patients with elevated triglycerides and low HDL

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing