Last reviewed 2026-04-20 · How we verify

Topocaine (CYCLOMETHYCAINE)

Phase 2 active Small molecule

Topocaine (generic name: CYCLOMETHYCAINE) is a cyclomethycaine drug. It is currently in Phase 2 development.

Topocaine blocks sodium channels in the brain to prevent pain signals from being transmitted.

Topocaine (CYCLOMETHYCAINE) is a cyclomethycaine, a small molecule that targets sodium channel alpha subunits in the brain. It is believed to work by blocking these channels, which are responsible for transmitting pain signals. However, due to a lack of FDA approval information, its approved indications and commercial status are unknown. As a result, key safety considerations and pharmacokinetic properties, such as half-life and bioavailability, are also unclear. Further research is needed to fully understand this medication.

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	CYCLOMETHYCAINE
Drug class	cyclomethycaine
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 send signals to your brain. Sodium channels are like the switches that turn these signals on and off. Topocaine works by flipping these switches to the 'off' position, which can help relieve 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:

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

Frequently asked questions about Topocaine

What is Topocaine?

Topocaine (CYCLOMETHYCAINE) is a cyclomethycaine drug.

How does Topocaine work?

Topocaine blocks sodium channels in the brain to prevent pain signals from being transmitted.

What is the generic name of Topocaine?

CYCLOMETHYCAINE is the generic (nonproprietary) name of Topocaine.

What drug class is Topocaine in?

Topocaine belongs to the cyclomethycaine class. See all cyclomethycaine drugs at /class/cyclomethycaine.

What development phase is Topocaine in?

Topocaine is in Phase 2.

What does Topocaine target?

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

Drug class: All cyclomethycaine 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