Last reviewed 2026-05-20 · How we verify

S-531011

Shionogi · Phase 1 active Small molecule ✓ Verified May 2026

S-531011 is a Small molecule drug developed by Shionogi. It is currently in Phase 1 development.

S-531011 is a small molecule used in a clinical trial for the treatment of metastatic colorectal neoplasms, microsatellite stable/proficient mismatch repair colorectal cancer, and solid tumors. It is being evaluated in a multicenter, Phase Ib/II clinical trial in combination with other treatments, including Fruquintinib and Pembrolizumab.

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	S-531011
Sponsor	Shionogi
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Advanced or Metastatic Solid Tumors (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:

S-531011 CI brief — competitive landscape report
S-531011 updates RSS · CI watch RSS
Shionogi portfolio CI

Frequently asked questions about S-531011

What is S-531011?

S-531011 is a Small molecule drug developed by Shionogi.

Who makes S-531011?

S-531011 is developed by Shionogi (see full Shionogi pipeline at /company/shionogi).

What development phase is S-531011 in?

S-531011 is in Phase 1.

Manufacturer: Shionogi — full pipeline

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