Last reviewed 2026-05-22 · How we verify

Niamine (NIKETHAMIDE)

Phase 2 active Small molecule

Niamine (generic name: NIKETHAMIDE) is a nikethamide drug. It is currently in Phase 2 development.

Niamine works by stimulating the central nervous system, which can help increase alertness and wakefulness.

Niamine, also known as nikethamide, is a small molecule drug in the nikethamide class. Its exact target is unknown, but it is believed to work by stimulating the central nervous system. Niamine is not FDA-approved for any indications, and its commercial status is unclear. As a result, there is limited information available on its safety profile. Further research is needed to fully understand its effects and potential uses.

Likelihood of approval

12.3% 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).
CNS / neurology attrition -3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).

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	NIKETHAMIDE
Drug class	nikethamide
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Think of it like a wake-up call for your brain. Niamine helps increase the activity of certain chemicals in the brain that help you feel more alert and awake. This can be helpful in situations where you need to stay awake and focused, such as during long periods of work or study.

Approved indications

No approved indications tracked.

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:

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

Frequently asked questions about Niamine

What is Niamine?

Niamine (NIKETHAMIDE) is a nikethamide drug.

How does Niamine work?

Niamine works by stimulating the central nervous system, which can help increase alertness and wakefulness.

What is the generic name of Niamine?

NIKETHAMIDE is the generic (nonproprietary) name of Niamine.

What drug class is Niamine in?

Niamine belongs to the nikethamide class. See all nikethamide drugs at /class/nikethamide.

What development phase is Niamine in?

Niamine is in Phase 2.

Drug class: All nikethamide drugs
Therapeutic area: All drugs in Neuroscience

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