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Larotinib
Larotinib is a Small molecule drug developed by Sunshine Lake Pharma Co., Ltd.. It is currently in Phase 1 development. Also known as: Z650.
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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).
| 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 | Larotinib |
|---|---|
| Also known as | Z650 |
| Sponsor | Sunshine Lake Pharma Co., Ltd. |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Pharmacokinetics Study of Larotinib in Subjects With Impaired Hepatic Function (PHASE1)
- Study of Larotinib in Unresectable Advanced or Recurrent Esophageal Cancer (PHASE3)
- A Study to Evaluate Drug-Drug Interaction of Larotinib With Itraconazole and Rifampin in Healthy Adult Participants (PHASE1)
- Z650 in Advanced Esophageal Squamous Cell Carcinoma With EGFR Over Expression or Gene Amplification (PHASE1, PHASE2)
- ADME Study of [14C]- Larotinib in Healthy Male Subjects (PHASE1)
- Gemcitabine and Z650 in Treating Patients With Metastatic or Recurrent Pancreatic Cancer (PHASE1)
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:
- Larotinib CI brief — competitive landscape report
- Larotinib updates RSS · CI watch RSS
- Sunshine Lake Pharma Co., Ltd. portfolio CI
Frequently asked questions about Larotinib
What is Larotinib?
Who makes Larotinib?
Is Larotinib also known as anything else?
What development phase is Larotinib in?
Related
- 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