Last reviewed 2026-06-02 · How we verify

OXILOFRINE

Phase 2 active Small molecule ✓ Verified Jun 2026 Quality 19/100

OXILOFRINE is a oxilofrine drug. It is currently in Phase 2 development.

Oxilofrine is thought to work by stimulating the body's sympathetic nervous system, which can increase heart rate and blood pressure.

Oxilofrine is a small molecule with the synonyms 4-Hydroxyephedrine, Carnigen, Edornat, J5.704E, Methylsympatol, and Methylsynephrin.

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	OXILOFRINE
Drug class	oxilofrine
Modality	Small molecule
Therapeutic area	Cardiovascular
Phase	Phase 2

Mechanism of action

Imagine your body's nervous system as a car's accelerator and brakes. Oxilofrine is like pressing the accelerator, making your heart beat faster and your blood vessels constrict, which can increase blood pressure. This can be helpful in certain situations, but it's also important to be careful not to overdo it, as it can lead to problems like high blood pressure or heart palpitations.

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:

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

Frequently asked questions about OXILOFRINE

What is OXILOFRINE?

OXILOFRINE is a oxilofrine drug.

How does OXILOFRINE work?

Oxilofrine is thought to work by stimulating the body's sympathetic nervous system, which can increase heart rate and blood pressure.

What drug class is OXILOFRINE in?

OXILOFRINE belongs to the oxilofrine class. See all oxilofrine drugs at /class/oxilofrine.

What development phase is OXILOFRINE in?

OXILOFRINE is in Phase 2.

Drug class: All oxilofrine drugs
Therapeutic area: All drugs in Cardiovascular

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