Last reviewed 2026-05-29 · How we verify

SP-8203 Low dose

Shin Poong Pharmaceutical Co. Ltd. · Phase 2 active Small molecule ✓ Verified May 2026

SP-8203 Low dose is a Small molecule drug developed by Shin Poong Pharmaceutical Co. Ltd.. It is currently in Phase 2 development. Also known as: SP-8203 is produced by Shin Poong Pharmaceutical company.

SP-8203 is a treatment being studied for ischemic stroke, with a clinical trial (NCT02787278) comparing its low dose, high dose, and placebo in patients requiring rtPA. The trial is a prospective, randomized, double-blinded Phase IIa study to investigate the safety and efficacy of SP-8203 in this patient population.

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	SP-8203 Low dose
Also known as	SP-8203 is produced by Shin Poong Pharmaceutical company
Sponsor	Shin Poong Pharmaceutical Co. Ltd.
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Safety and Efficacy of Two Doses of SP-8203 in Patients With Ischemic Stroke Requiring rtPA (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:

SP-8203 Low dose CI brief — competitive landscape report
SP-8203 Low dose updates RSS · CI watch RSS
Shin Poong Pharmaceutical Co. Ltd. portfolio CI

Frequently asked questions about SP-8203 Low dose

What is SP-8203 Low dose?

SP-8203 Low dose is a Small molecule drug developed by Shin Poong Pharmaceutical Co. Ltd..

Who makes SP-8203 Low dose?

SP-8203 Low dose is developed by Shin Poong Pharmaceutical Co. Ltd. (see full Shin Poong Pharmaceutical Co. Ltd. pipeline at /company/shin-poong-pharmaceutical-co-ltd).

Is SP-8203 Low dose also known as anything else?

SP-8203 Low dose is also known as SP-8203 is produced by Shin Poong Pharmaceutical company.

What development phase is SP-8203 Low dose in?

SP-8203 Low dose is in Phase 2.

Manufacturer: Shin Poong Pharmaceutical Co. Ltd. — full pipeline
Also known as: SP-8203 is produced by Shin Poong Pharmaceutical company

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