Last reviewed 2026-04-20 · How we verify

Bethoxycaine (BETOXYCAINE)

Phase 2 active Small molecule

Bethoxycaine (generic name: BETOXYCAINE) is a betoxycaine drug. It is currently in Phase 2 development.

Bethoxycaine is a local anesthetic that works by blocking nerve signals to prevent pain.

Bethoxycaine, also known as BETOXYCAINE, is a small molecule drug in the betoxycaine class. Unfortunately, there is limited information available on this compound, including its target, approved indications, and pharmacokinetic properties. As a result, its clinical use and safety profile are not well established. Further research is needed to determine the potential benefits and risks of this medication. Currently, there is no information available on its commercial status or patent status.

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	BETOXYCAINE
Drug class	betoxycaine
Modality	Small molecule
Therapeutic area	Pain
Phase	Phase 2

Mechanism of action

Imagine your nerves are like messengers that send signals to your brain when you're hurt. Bethoxycaine blocks these messengers, so your brain doesn't receive the pain signal. This helps to numb the area and reduce pain.

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:

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

Frequently asked questions about Bethoxycaine

What is Bethoxycaine?

Bethoxycaine (BETOXYCAINE) is a betoxycaine drug.

How does Bethoxycaine work?

Bethoxycaine is a local anesthetic that works by blocking nerve signals to prevent pain.

What is the generic name of Bethoxycaine?

BETOXYCAINE is the generic (nonproprietary) name of Bethoxycaine.

What drug class is Bethoxycaine in?

Bethoxycaine belongs to the betoxycaine class. See all betoxycaine drugs at /class/betoxycaine.

What development phase is Bethoxycaine in?

Bethoxycaine is in Phase 2.

Drug class: All betoxycaine drugs
Therapeutic area: All drugs in Pain

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