Last reviewed 2026-05-19 · How we verify

LC350189 200 mg

LG Chem · Phase 1 active Small molecule ✓ Verified May 2026 Quality 0/100

LC350189 200 mg is a Small molecule drug developed by LG Chem. It is currently in Phase 1 development.

LC350189, also known as MG-S-2525, is a small molecule being studied for its effects on cardiac repolarization and potential treatment of conditions such as hyperuricemia and gout. It was evaluated in a thorough QT study using a single dose of 200mg in healthy male and female subjects.

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	LC350189 200 mg
Sponsor	LG Chem
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

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:

LC350189 200 mg CI brief — competitive landscape report
LC350189 200 mg updates RSS · CI watch RSS
LG Chem portfolio CI

Frequently asked questions about LC350189 200 mg

What is LC350189 200 mg?

LC350189 200 mg is a Small molecule drug developed by LG Chem.

Who makes LC350189 200 mg?

LC350189 200 mg is developed by LG Chem (see full LG Chem pipeline at /company/lg-chem).

What development phase is LC350189 200 mg in?

LC350189 200 mg is in Phase 1.

Manufacturer: LG Chem — full pipeline

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