Last reviewed 2026-05-15 · How we verify

Niapyrin (NIFENAZONE)

Phase 2 active Small molecule

Niapyrin (generic name: NIFENAZONE) is a nifenazone drug. It is currently in Phase 2 development.

Nifenazone is thought to work by modulating cellular processes, although the exact mechanism is unknown.

Nifenazone, also known as Niapyrin, is a small molecule drug of the nifenazone class. Its exact target and mechanism of action are unknown, but it is believed to work by modulating certain cellular processes. Nifenazone is not FDA-approved for any indications, and its commercial status, including patent and generic availability, is unclear. Further research is needed to fully understand its safety profile and potential therapeutic applications. As a result, it is not currently used in clinical practice.

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	NIFENAZONE
Drug class	nifenazone
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your cells are like a orchestra, and nifenazone is like a conductor that helps the different parts work together in harmony. However, the specific way it conducts the orchestra is not well understood. More research is needed to figure out how it works and what it does.

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:

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

Frequently asked questions about Niapyrin

What is Niapyrin?

Niapyrin (NIFENAZONE) is a nifenazone drug.

How does Niapyrin work?

Nifenazone is thought to work by modulating cellular processes, although the exact mechanism is unknown.

What is the generic name of Niapyrin?

NIFENAZONE is the generic (nonproprietary) name of Niapyrin.

What drug class is Niapyrin in?

Niapyrin belongs to the nifenazone class. See all nifenazone drugs at /class/nifenazone.

What development phase is Niapyrin in?

Niapyrin is in Phase 2.

Drug class: All nifenazone drugs
Therapeutic area: All drugs in Other

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