Last reviewed 2026-05-25 · How we verify

Oracaine (MEPRYLCAINE)

Phase 2 active Small molecule

Oracaine (generic name: MEPRYLCAINE) is a meprylcaine drug. It is currently in Phase 2 development.

Oracaine works by blocking sodium channels in the brain to prevent the transmission of nerve impulses.

Oracaine, also known as meprylcaine, is a small molecule drug that targets sodium channel alpha subunits in the brain. It is classified as a meprylcaine and works by blocking the sodium channels, which are responsible for transmitting nerve impulses. However, due to the lack of available information, its approved indications, half-life, bioavailability, generic manufacturers, and commercial status are unknown. As a result, its clinical use and safety profile cannot be fully assessed. Further research is needed to determine its potential as a therapeutic agent.

Likelihood of approval

12.3% 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).
CNS / neurology attrition -3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).

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	MEPRYLCAINE
Drug class	meprylcaine
Target	Sodium channel alpha subunits; brain (Types I, II, III)
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Imagine your nerves are like electrical wires that carry messages to and from your brain. Sodium channels are like the switches that turn these wires on and off. Oracaine blocks these switches, which can help reduce pain and other symptoms by preventing the transmission of painful signals to the brain.

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:

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

Frequently asked questions about Oracaine

What is Oracaine?

Oracaine (MEPRYLCAINE) is a meprylcaine drug.

How does Oracaine work?

Oracaine works by blocking sodium channels in the brain to prevent the transmission of nerve impulses.

What is the generic name of Oracaine?

MEPRYLCAINE is the generic (nonproprietary) name of Oracaine.

What drug class is Oracaine in?

Oracaine belongs to the meprylcaine class. See all meprylcaine drugs at /class/meprylcaine.

What development phase is Oracaine in?

Oracaine is in Phase 2.

What does Oracaine target?

Oracaine targets Sodium channel alpha subunits; brain (Types I, II, III) and is a meprylcaine.

Drug class: All meprylcaine drugs
Target: All drugs targeting Sodium channel alpha subunits; brain (Types I, II, III)
Therapeutic area: All drugs in Neuroscience

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