Last reviewed 2026-04-19 · How we verify

Neu2000KWL Low-does group

GNT Pharma · Phase 2 active Small molecule

Neu2000KWL Low-does group is a Small molecule drug developed by GNT Pharma. It is currently in Phase 2 development. Also known as: Neu2000KWL is produced by GNT Pharma Pharmaceutical company.

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	Neu2000KWL Low-does group
Also known as	Neu2000KWL is produced by GNT Pharma Pharmaceutical company
Sponsor	GNT Pharma
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Safety and Optimal Neuroprotection of neu2000 in Ischemic Stroke With Endovascular reCanalizion (SONIC) (PHASE2)

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:

Neu2000KWL Low-does group CI brief — competitive landscape report
Neu2000KWL Low-does group updates RSS · CI watch RSS
GNT Pharma portfolio CI

Frequently asked questions about Neu2000KWL Low-does group

What is Neu2000KWL Low-does group?

Neu2000KWL Low-does group is a Small molecule drug developed by GNT Pharma.

Who makes Neu2000KWL Low-does group?

Neu2000KWL Low-does group is developed by GNT Pharma (see full GNT Pharma pipeline at /company/gnt-pharma).

Is Neu2000KWL Low-does group also known as anything else?

Neu2000KWL Low-does group is also known as Neu2000KWL is produced by GNT Pharma Pharmaceutical company.

What development phase is Neu2000KWL Low-does group in?

Neu2000KWL Low-does group is in Phase 2.

Manufacturer: GNT Pharma — full pipeline
Also known as: Neu2000KWL is produced by GNT Pharma Pharmaceutical company

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