Last reviewed 2026-05-24 · How we verify

Lerotinib

Sunshine Lake Pharma Co., Ltd. · Phase 3 active Small molecule ✓ Verified May 2026 Quality 0/100

Lerotinib is a Small molecule drug developed by Sunshine Lake Pharma Co., Ltd.. It is currently in Phase 3 development. Also known as: Z650.

Lerotinib is being studied as a treatment for unresectable advanced or recurrent esophageal cancer. It is being compared to investigator's choice single-agent chemotherapy, specifically Irinotecan/Tegafur, in a clinical trial.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+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	Lerotinib
Also known as	Z650
Sponsor	Sunshine Lake Pharma Co., Ltd.
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 3

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Study of Larotinib in Unresectable Advanced or Recurrent Esophageal Cancer (PHASE3)

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:

Lerotinib CI brief — competitive landscape report
Lerotinib updates RSS · CI watch RSS
Sunshine Lake Pharma Co., Ltd. portfolio CI

Frequently asked questions about Lerotinib

What is Lerotinib?

Lerotinib is a Small molecule drug developed by Sunshine Lake Pharma Co., Ltd..

Who makes Lerotinib?

Lerotinib is developed by Sunshine Lake Pharma Co., Ltd. (see full Sunshine Lake Pharma Co., Ltd. pipeline at /company/sunshine-lake-pharma-co-ltd).

Is Lerotinib also known as anything else?

Lerotinib is also known as Z650.

What development phase is Lerotinib in?

Lerotinib is in Phase 3.

Manufacturer: Sunshine Lake Pharma Co., Ltd. — full pipeline
Therapeutic area: All drugs in Other
Also known as: Z650

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