Last reviewed 2026-04-20 · How we verify

Hostacaine (BUTANILICAINE)

Phase 2 active Small molecule Quality 24/100

Hostacaine (generic name: BUTANILICAINE) is a butanilicaine drug. It is currently in Phase 2 development.

Hostacaine works by blocking certain pain pathways in the body.

Hostacaine (BUTANILICAINE) is a small molecule butanilicaine drug with unknown target and commercial status. Its mechanism of action is not well-documented, and it is not approved by the FDA for any indications. As a result, there is limited information available on its pharmacokinetics, safety, and efficacy. Further research is needed to understand the properties and potential uses of Hostacaine. Its current status as a developmental compound makes it difficult to assess its clinical utility.

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	BUTANILICAINE
Drug class	butanilicaine
Modality	Small molecule
Therapeutic area	Pain
Phase	Phase 2

Mechanism of action

Imagine your body has a 'pain switch' that can be flipped on or off. Hostacaine is a key that can turn this switch off, reducing the sensation of pain. This is achieved by blocking the action of certain chemicals that transmit pain 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:

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

Frequently asked questions about Hostacaine

What is Hostacaine?

Hostacaine (BUTANILICAINE) is a butanilicaine drug.

How does Hostacaine work?

Hostacaine works by blocking certain pain pathways in the body.

What is the generic name of Hostacaine?

BUTANILICAINE is the generic (nonproprietary) name of Hostacaine.

What drug class is Hostacaine in?

Hostacaine belongs to the butanilicaine class. See all butanilicaine drugs at /class/butanilicaine.

What development phase is Hostacaine in?

Hostacaine is in Phase 2.

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

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