Last reviewed 2026-04-20 · How we verify

Ambuterol (MABUTEROL)

Phase 2 active Small molecule

Ambuterol (generic name: MABUTEROL) is a mabuterol drug. It is currently in Phase 2 development.

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

Ambuterol, also known as Mabuterol, is a small molecule drug of the mabuterol class. Its target and exact mechanism of action are unknown. It is not FDA-approved for any indications. The commercial status of Ambuterol is unclear, and it may be patented or generic. Key safety considerations are also unknown.

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	MABUTEROL
Drug class	mabuterol
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 have asthma or COPD. Ambuterol helps to relax the muscles around this tube, making it easier to breathe. This is similar to how a bronchodilator inhaler works, but Ambuterol is a small molecule that can be taken orally or inhaled.

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:

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

Frequently asked questions about Ambuterol

What is Ambuterol?

Ambuterol (MABUTEROL) is a mabuterol drug.

How does Ambuterol work?

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

What is the generic name of Ambuterol?

MABUTEROL is the generic (nonproprietary) name of Ambuterol.

What drug class is Ambuterol in?

Ambuterol belongs to the mabuterol class. See all mabuterol drugs at /class/mabuterol.

What development phase is Ambuterol in?

Ambuterol is in Phase 2.

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

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