Last reviewed 2026-05-29 · How we verify

Amplicaine (OCTACAINE)

Phase 2 active Small molecule ✓ Verified May 2026

Amplicaine (generic name: OCTACAINE) is a octacaine drug. It is currently in Phase 2 development.

Amplicaine works by interacting with specific cellular pathways to produce its therapeutic effects.

Amplicaine is a small molecule medication. It is also known by the synonyms OCTACAINA and OCTACAINE.

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	OCTACAINE
Drug class	octacaine
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your cells have locks on them, and Amplicaine has a special key that fits into those locks. When it binds to the locks, it helps to unlock the cell's normal functioning, which can help to treat certain medical conditions. However, the exact details of how Amplicaine's key works are still not fully understood.

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:

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

Frequently asked questions about Amplicaine

What is Amplicaine?

Amplicaine (OCTACAINE) is a octacaine drug.

How does Amplicaine work?

Amplicaine works by interacting with specific cellular pathways to produce its therapeutic effects.

What is the generic name of Amplicaine?

OCTACAINE is the generic (nonproprietary) name of Amplicaine.

What drug class is Amplicaine in?

Amplicaine belongs to the octacaine class. See all octacaine drugs at /class/octacaine.

What development phase is Amplicaine in?

Amplicaine is in Phase 2.

Drug class: All octacaine drugs
Therapeutic area: All drugs in Other

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