Last reviewed 2026-05-23 · How we verify

TOBUTEROL

Phase 2 active Small molecule ✓ Verified May 2026

TOBUTEROL is a tobuterol drug. It is currently in Phase 2 development.

Tobutamone works by interacting with the body's beta-2 adrenergic receptors to produce a bronchodilating effect.

Tobuterol is a small molecule. Its exact function and clinical uses are not specified in the provided information.

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	TOBUTEROL
Drug class	tobuterol
Modality	Small molecule
Therapeutic area	Respiratory
Phase	Phase 2

Mechanism of action

Imagine your airways are like a narrow road that gets congested. Tobutamone helps to relax the muscles around the airways, making it easier to breathe by widening the road.

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:

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

Frequently asked questions about TOBUTEROL

What is TOBUTEROL?

TOBUTEROL is a tobuterol drug.

How does TOBUTEROL work?

Tobutamone works by interacting with the body's beta-2 adrenergic receptors to produce a bronchodilating effect.

What drug class is TOBUTEROL in?

TOBUTEROL belongs to the tobuterol class. See all tobuterol drugs at /class/tobuterol.

What development phase is TOBUTEROL in?

TOBUTEROL is in Phase 2.

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

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