Last reviewed 2026-05-19 · How we verify

XENYTROPIUM

Phase 2 active Small molecule ✓ Verified May 2026

XENYTROPIUM is a xenytropium drug. It is currently in Phase 2 development.

Xenytropium works by activating muscarinic receptors in the lungs to relax airway smooth muscle and improve breathing.

Xenytropium bromide is a small molecule medication. It is also known by other names, including BROMURE DE XENYTROPIUM, BROMURO DE XENITROPIO, N-399, and XENYTROPIUM BROMIDE.

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	XENYTROPIUM
Drug class	xenytropium
Modality	Small molecule
Therapeutic area	Respiratory
Phase	Phase 2

Mechanism of action

Imagine your airways are like a narrow tube that gets constricted when you breathe in. Xenytropium helps to relax the muscles around this tube, making it easier to breathe in and out. This is similar to how other bronchodilators work, but xenytropium has a unique mechanism that involves activating specific receptors in the lungs.

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:

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

Frequently asked questions about XENYTROPIUM

What is XENYTROPIUM?

XENYTROPIUM is a xenytropium drug.

How does XENYTROPIUM work?

Xenytropium works by activating muscarinic receptors in the lungs to relax airway smooth muscle and improve breathing.

What drug class is XENYTROPIUM in?

XENYTROPIUM belongs to the xenytropium class. See all xenytropium drugs at /class/xenytropium.

What development phase is XENYTROPIUM in?

XENYTROPIUM is in Phase 2.

Drug class: All xenytropium drugs
Therapeutic area: All drugs in Respiratory

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