Last reviewed 2026-05-30 · How we verify

N-IP-00001 inhalation solution

NeoTrials Pty Ltd · Phase 1 active Small molecule ✓ Verified May 2026

N-IP-00001 inhalation solution is a Small molecule drug developed by NeoTrials Pty Ltd. It is currently in Phase 1 development.

N-IP-00001 inhalation solution is being studied in a Phase I safety trial to determine its tolerability and safety in healthy volunteers. The trial is a randomized, double-blind, placebo-controlled, dose-escalation study comparing N-IP-00001 to 0.9% NaCl isotonic saline solution.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% 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	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+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	N-IP-00001 inhalation solution
Sponsor	NeoTrials Pty Ltd
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Phase I Safety Study of Inhaled N-IP-00001 to Determine Tolerability and Safety in Healthy Volunteers. (PHASE1)

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:

N-IP-00001 inhalation solution CI brief — competitive landscape report
N-IP-00001 inhalation solution updates RSS · CI watch RSS
NeoTrials Pty Ltd portfolio CI

Frequently asked questions about N-IP-00001 inhalation solution

What is N-IP-00001 inhalation solution?

N-IP-00001 inhalation solution is a Small molecule drug developed by NeoTrials Pty Ltd.

Who makes N-IP-00001 inhalation solution?

N-IP-00001 inhalation solution is developed by NeoTrials Pty Ltd (see full NeoTrials Pty Ltd pipeline at /company/neotrials-pty-ltd).

What development phase is N-IP-00001 inhalation solution in?

N-IP-00001 inhalation solution is in Phase 1.

Manufacturer: NeoTrials Pty Ltd — full pipeline

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