Last reviewed 2026-05-27 · How we verify

LEVDOBUTAMINE

Phase 2 active Small molecule ✓ Verified May 2026

LEVDOBUTAMINE is a drug. It is currently in Phase 2 development.

Levodobutamine works by binding to and activating the beta-1 adrenergic receptor, which plays a key role in regulating heart function.

Levodobutamine lactobionate is a small molecule. It is also known by other names, including dobutamine lactobionate and levodobutamine lactobionate.

Likelihood of approval

13.3% 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).
Cardiovascular Phase 3 risk -2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.

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	LEVDOBUTAMINE
Target	Beta-1 adrenergic receptor
Modality	Small molecule
Therapeutic area	Cardiovascular
Phase	Phase 2

Mechanism of action

Think of it like a key fitting into a lock. Levodobutamine is the key that fits into the beta-1 adrenergic receptor, allowing it to send signals to the heart to beat stronger and more efficiently. This can be helpful for people with heart conditions, but it's a complex process that requires careful medical supervision.

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:

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

Frequently asked questions about LEVDOBUTAMINE

What is LEVDOBUTAMINE?

LEVDOBUTAMINE is a Small molecule drug.

How does LEVDOBUTAMINE work?

Levodobutamine works by binding to and activating the beta-1 adrenergic receptor, which plays a key role in regulating heart function.

What development phase is LEVDOBUTAMINE in?

LEVDOBUTAMINE is in Phase 2.

What does LEVDOBUTAMINE target?

LEVDOBUTAMINE targets Beta-1 adrenergic receptor.

Target: All drugs targeting Beta-1 adrenergic receptor
Therapeutic area: All drugs in Cardiovascular

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