Last reviewed 2026-05-27 · How we verify

Salicain (HYDROXYTETRACAINE)

Phase 2 active Small molecule ✓ Verified May 2026 Quality 19/100

Salicain (generic name: HYDROXYTETRACAINE) is a hydroxytetracaine drug. It is currently in Phase 2 development.

Salicain works by blocking sodium channels in nerve cells to numb pain and reduce inflammation.

Salicain is a small molecule with synonyms HIDROXITETRACAINA and HYDROXYTETRACAINE.

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	HYDROXYTETRACAINE
Drug class	hydroxytetracaine
Modality	Small molecule
Therapeutic area	Pain
Phase	Phase 2

Mechanism of action

Imagine your nerve cells are like electrical wires that send signals to your brain. Salicain blocks these signals, making it harder for pain and inflammation to reach your brain. This helps to reduce discomfort and swelling in the affected area.

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:

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

Frequently asked questions about Salicain

What is Salicain?

Salicain (HYDROXYTETRACAINE) is a hydroxytetracaine drug.

How does Salicain work?

Salicain works by blocking sodium channels in nerve cells to numb pain and reduce inflammation.

What is the generic name of Salicain?

HYDROXYTETRACAINE is the generic (nonproprietary) name of Salicain.

What drug class is Salicain in?

Salicain belongs to the hydroxytetracaine class. See all hydroxytetracaine drugs at /class/hydroxytetracaine.

What development phase is Salicain in?

Salicain is in Phase 2.

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

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