Last reviewed 2026-05-25 · How we verify

SKL11197

SK Life Science, Inc. · Phase 2 active Small molecule ✓ Verified May 2026

SKL11197 is a Small molecule drug developed by SK Life Science, Inc.. It is currently in Phase 2 development.

SKL11197 is a treatment being studied for Painful Diabetic Neuropathy in a Phase 2 clinical trial. The trial is a randomized, double-blind, placebo-controlled study comparing the efficacy of SKL11197 to a placebo.

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	SKL11197
Sponsor	SK Life Science, Inc.
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study for the Pain of Diabetic Peripheral Neuropathy (PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

SKL11197 CI brief — competitive landscape report
SKL11197 updates RSS · CI watch RSS
SK Life Science, Inc. portfolio CI

Frequently asked questions about SKL11197

What is SKL11197?

SKL11197 is a Small molecule drug developed by SK Life Science, Inc..

Who makes SKL11197?

SKL11197 is developed by SK Life Science, Inc. (see full SK Life Science, Inc. pipeline at /company/sk-life-science-inc).

What development phase is SKL11197 in?

SKL11197 is in Phase 2.

Manufacturer: SK Life Science, Inc. — full pipeline

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