Last reviewed 2026-04-20 · How we verify

Ba 598 (FLUTROPIUM)

Phase 2 active Small molecule

Ba 598 (generic name: FLUTROPIUM) is a flutropium drug. It is currently in Phase 2 development.

Flutropium is a bronchodilator that works by relaxing the muscles in the airways to improve breathing.

Flutropium is a small molecule drug in the flutropium class, but specific details about its development, approval status, and indications are not available. As a result, there is limited information about its commercial status, safety considerations, and pharmacological properties. Further research is needed to understand the specifics of this compound. It is not clear what target it is designed to modulate or what diseases it is intended to treat. Overall, flutropium appears to be a relatively unknown compound.

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	FLUTROPIUM
Drug class	flutropium
Modality	Small molecule
Therapeutic area	Respiratory
Phase	Phase 2

Mechanism of action

Imagine your airways are like a narrow tube that can get constricted when you have a cold or asthma. Flutropium helps to relax the muscles around this tube, making it easier to breathe. This is similar to how other bronchodilators work, but the specific details of flutropium's mechanism are not well 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:

Ba 598 CI brief — competitive landscape report
Ba 598 updates RSS · CI watch RSS

Frequently asked questions about Ba 598

What is Ba 598?

Ba 598 (FLUTROPIUM) is a flutropium drug.

How does Ba 598 work?

Flutropium is a bronchodilator that works by relaxing the muscles in the airways to improve breathing.

What is the generic name of Ba 598?

FLUTROPIUM is the generic (nonproprietary) name of Ba 598.

What drug class is Ba 598 in?

Ba 598 belongs to the flutropium class. See all flutropium drugs at /class/flutropium.

What development phase is Ba 598 in?

Ba 598 is in Phase 2.

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

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