Last reviewed 2026-06-02 · How we verify

SKL15508

SK Life Science, Inc. · Phase 1 active Small molecule ✓ Verified Jun 2026

SKL15508 is a Small molecule drug developed by SK Life Science, Inc.. It is currently in Phase 1 development.

SKL15508 is an oral medication being studied for its safety and tolerability in individuals with stable schizophrenia. The study, NCT02205099, is a randomized, double-blind, flexible-dosage trial comparing SKL15508 to a placebo.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% 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	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+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	SKL15508
Sponsor	SK Life Science, Inc.
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Safety, Tolerability, PK and PD Study of Multiple Oral Doses of SKL15508 in Subjects With Stable Schizophrenia (PHASE1, 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:

SKL15508 CI brief — competitive landscape report
SKL15508 updates RSS · CI watch RSS
SK Life Science, Inc. portfolio CI

Frequently asked questions about SKL15508

What is SKL15508?

SKL15508 is a Small molecule drug developed by SK Life Science, Inc..

Who makes SKL15508?

SKL15508 is developed by SK Life Science, Inc. (see full SK Life Science, Inc. pipeline at /company/sk-life-science-inc).

What development phase is SKL15508 in?

SKL15508 is in Phase 1.

Manufacturer: SK Life Science, Inc. — full pipeline

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