Last reviewed 2026-06-01 · How we verify

Nopron (NIAPRAZINE)

Phase 2 active Small molecule ✓ Verified Jun 2026

Nopron (generic name: NIAPRAZINE) is a niaprazine drug. It is currently in Phase 2 development.

Nopron is thought to work by interacting with certain receptors in the brain.

Nopron is a small molecule with the synonyms 1709 CERM, 1709-CERM, 1709CERM, J10.716F, NIAPRAZINA, and NIAPRAZINE.

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	NIAPRAZINE
Drug class	niaprazine
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

While the exact details of how Nopron works are unclear, it is believed to affect the way the brain processes information and regulates emotions. This may help to alleviate symptoms of certain conditions, although more research is needed to confirm its effectiveness. It is not a well-understood medication, and its potential benefits and risks are not yet fully understood.

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:

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

Frequently asked questions about Nopron

What is Nopron?

Nopron (NIAPRAZINE) is a niaprazine drug.

How does Nopron work?

Nopron is thought to work by interacting with certain receptors in the brain.

What is the generic name of Nopron?

NIAPRAZINE is the generic (nonproprietary) name of Nopron.

What drug class is Nopron in?

Nopron belongs to the niaprazine class. See all niaprazine drugs at /class/niaprazine.

What development phase is Nopron in?

Nopron is in Phase 2.

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

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