Last reviewed 2026-04-19 · How we verify

CARBUTEROL

Phase 2 active Small molecule

CARBUTEROL is a carbuterol drug. It is currently in Phase 2 development.

Carbuterol works by stimulating the beta-2 adrenergic receptors in the lungs to relax airway smooth muscle and improve breathing.

Carbuterol is a small molecule drug in the carbuterol class, but specific details about its development, approval status, and commercial status are not available. It is intended to treat a specific condition, but the target and approved indications are unknown. As a small molecule, carbuterol works by interacting with specific biological targets to produce a therapeutic effect. The safety considerations and pharmacokinetic properties of carbuterol are also not well-documented. Further research is needed to fully understand the properties and potential uses of this drug.

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	CARBUTEROL
Drug class	carbuterol
Modality	Small molecule
Therapeutic area	Respiratory
Phase	Phase 2

Mechanism of action

Imagine your airways are like a narrow road that gets congested when you're sick. Carbuterol helps to relax the muscles around the road, making it easier to breathe by widening the airway.

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:

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

Frequently asked questions about CARBUTEROL

What is CARBUTEROL?

CARBUTEROL is a carbuterol drug.

How does CARBUTEROL work?

Carbuterol works by stimulating the beta-2 adrenergic receptors in the lungs to relax airway smooth muscle and improve breathing.

What drug class is CARBUTEROL in?

CARBUTEROL belongs to the carbuterol class. See all carbuterol drugs at /class/carbuterol.

What development phase is CARBUTEROL in?

CARBUTEROL is in Phase 2.

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

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