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AL3818 Capsule
AL3818 Capsule is a Multi-targeted tyrosine kinase inhibitor Small molecule drug developed by Advenchen Laboratories Nanjing Ltd.. It is currently in Phase 3 development for Advanced or metastatic solid tumors (Phase 3 development). Also known as: Anlotinib hydrochloride, Catequentenib, Anlotinib, Anlotinib Hydrochloride.
AL3818 is a tyrosine kinase inhibitor that targets multiple receptor tyrosine kinases involved in tumor growth and angiogenesis.
AL3818 is a tyrosine kinase inhibitor that targets multiple receptor tyrosine kinases involved in tumor growth and angiogenesis. Used for Advanced or metastatic solid tumors (Phase 3 development).
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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). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| 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 | AL3818 Capsule |
|---|---|
| Also known as | Anlotinib hydrochloride, Catequentenib, Anlotinib, Anlotinib Hydrochloride, Catequentinib |
| Sponsor | Advenchen Laboratories Nanjing Ltd. |
| Drug class | Multi-targeted tyrosine kinase inhibitor |
| Target | FGFR, VEGFR, and other receptor tyrosine kinases |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
AL3818 inhibits several key kinases including FGFR, VEGFR, and other receptor tyrosine kinases that drive tumor cell proliferation and promote new blood vessel formation. By blocking these pathways, the drug aims to suppress tumor growth and limit the blood supply to cancer cells. This multi-targeted approach is designed to provide anti-tumor and anti-angiogenic activity.
Approved indications
- Advanced or metastatic solid tumors (Phase 3 development)
Common side effects
- Diarrhea
- Fatigue
- Nausea
- Hypertension
- Anorexia
Key clinical trials
- Carboplatin/Cisplatin + Etoposide + Benmelstobart Sequential Benmelstobart Combined With Anlotinib Versus Carboplatin/Cisplatin + Etoposide + Tislelizumab Sequential Tislelizumab in the Treatment of Extensive Stage Small Cell Lung Cancer (PHASE2)
- A Phase III Study of First-line Anlotinib Combined With Benmelstobart in Patients With Advanced Esophageal Squamous Cell Carcinoma (PHASE3)
- Catequentinib Hydrochloride (AL3818) Drug-Drug Interaction Study in Healthy Volunteers (PHASE1)
- Phase III Trial of Anlotinib, Catequentinib in Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma, Synovial Sarcoma (APROMISS) (PHASE3)
- Anlotinib Capsules in the Treatment for IPF/PF-ILDs (PHASE2, PHASE3)
- Safety and Efficacy Analysis of Oral Etoposide Combined With Anlotinib and Envafolimab in First-line Treatment of Elderly Patients With Small Cell Lung Cancer/ Open-label, Single-arm, Exploratory Phase II Clinical Study (PHASE2)
- Anlotinib Plus Immunotherapy and Chemoradiotherapy for High-Risk Nasopharyngeal Carcinoma (PHASE3)
- A Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy as First-line Treatment in Subjects With RAS/BRAF Wild Metastatic Colorectal 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:
- AL3818 Capsule CI brief — competitive landscape report
- AL3818 Capsule updates RSS · CI watch RSS
- Advenchen Laboratories Nanjing Ltd. portfolio CI
Frequently asked questions about AL3818 Capsule
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Related
- Drug class: All Multi-targeted tyrosine kinase inhibitor drugs
- Target: All drugs targeting FGFR, VEGFR, and other receptor tyrosine kinases
- Manufacturer: Advenchen Laboratories Nanjing Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Advanced or metastatic solid tumors (Phase 3 development)
- Also known as: Anlotinib hydrochloride, Catequentenib, Anlotinib, Anlotinib Hydrochloride, Catequentinib