Last reviewed 2026-04-19 · How we verify

ETILEFRINE PIVALATE

Phase 2 active Small molecule

ETILEFRINE PIVALATE is a etilefrine pivalate drug. It is currently in Phase 2 development.

Etilefrine pivalate works by stimulating the beta-1 adrenergic receptor to increase heart rate and contractility.

Etilefrine pivalate is a small molecule drug that targets the beta-1 adrenergic receptor. It is classified as an etilefrine pivalate, but its commercial status and approved indications are unknown. The mechanism of action involves stimulating the beta-1 adrenergic receptor, which can increase heart rate and contractility. As a result, it may be used to treat conditions such as bradycardia or heart failure. However, its safety and efficacy have not been established through FDA approval.

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	ETILEFRINE PIVALATE
Drug class	etilefrine pivalate
Target	Beta-1 adrenergic receptor
Modality	Small molecule
Therapeutic area	Cardiovascular
Phase	Phase 2

Mechanism of action

Imagine your heart as a muscle that needs to pump blood throughout your body. The beta-1 adrenergic receptor is like a switch that tells the heart to beat faster and stronger. When etilefrine pivalate binds to this receptor, it flips the switch, causing the heart to pump more efficiently.

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:

ETILEFRINE PIVALATE CI brief — competitive landscape report
ETILEFRINE PIVALATE updates RSS · CI watch RSS

Frequently asked questions about ETILEFRINE PIVALATE

What is ETILEFRINE PIVALATE?

ETILEFRINE PIVALATE is a etilefrine pivalate drug.

How does ETILEFRINE PIVALATE work?

Etilefrine pivalate works by stimulating the beta-1 adrenergic receptor to increase heart rate and contractility.

What drug class is ETILEFRINE PIVALATE in?

ETILEFRINE PIVALATE belongs to the etilefrine pivalate class. See all etilefrine pivalate drugs at /class/etilefrine-pivalate.

What development phase is ETILEFRINE PIVALATE in?

ETILEFRINE PIVALATE is in Phase 2.

What does ETILEFRINE PIVALATE target?

ETILEFRINE PIVALATE targets Beta-1 adrenergic receptor and is a etilefrine pivalate.

Drug class: All etilefrine pivalate drugs
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