Last reviewed 2026-04-20 · How we verify

Cholexamin (NICOMOL)

Phase 2 active Small molecule

Cholexamin (generic name: NICOMOL) is a nicomol drug. It is currently in Phase 2 development for Hyperlipidemia.

Cholexamin works by inhibiting the enzyme responsible for cholesterol synthesis.

Cholexamin (NICOMOL) is a small molecule nicomol drug used to treat Hyperlipidemia. Its exact target is unknown, but it is believed to work by inhibiting the synthesis of cholesterol. Cholexamin is a patented drug, but its commercial status as a generic product is unknown. Key safety considerations include unknown half-life and bioavailability. Further research is needed to fully understand its pharmacokinetics and potential side effects.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	NICOMOL
Drug class	nicomol
Modality	Small molecule
Therapeutic area	Metabolic
Phase	Phase 2

Mechanism of action

Think of cholesterol as a building block for your body's cells. Cholexamin helps slow down the production of new cholesterol by blocking the enzyme that makes it. This can help lower the amount of cholesterol in your blood, which can reduce your risk of heart disease.

Approved indications

Hyperlipidemia

Common side effects

No common side effects on file.

Competitive intelligence

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

Cholexamin CI brief — competitive landscape report
Cholexamin updates RSS · CI watch RSS

Frequently asked questions about Cholexamin

What is Cholexamin?

Cholexamin (NICOMOL) is a nicomol drug, indicated for Hyperlipidemia.

How does Cholexamin work?

Cholexamin works by inhibiting the enzyme responsible for cholesterol synthesis.

What is Cholexamin used for?

Cholexamin is indicated for Hyperlipidemia.

What is the generic name of Cholexamin?

NICOMOL is the generic (nonproprietary) name of Cholexamin.

What drug class is Cholexamin in?

Cholexamin belongs to the nicomol class. See all nicomol drugs at /class/nicomol.

What development phase is Cholexamin in?

Cholexamin is in Phase 2.

Drug class: All nicomol drugs
Therapeutic area: All drugs in Metabolic
Indication: Drugs for Hyperlipidemia

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