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Enzastaurin HCL
Enzastaurin HCL is a Small molecule drug developed by Eli Lilly and Company. It is currently in Phase 2 development. Also known as: LY317615.
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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). -
Big-pharma sponsor
+3.0pp
Eli Lilly and Company is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | Enzastaurin HCL |
|---|---|
| Also known as | LY317615 |
| Sponsor | Eli Lilly and Company |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Study to Assess Enzastaurin + R-CHOP in Subjects With DLBCL With the Genomic Biomarker DGM1™ (PHASE3)
- A Trial of Enzastaurin Plus Temozolomide During and Following Radiation Therapy in Patients With Newly Diagnosed Glioblastoma With or Without the Novel Genomic Biomarker, DGM1 (PHASE3)
- A Study of Enzastaurin and Erlotinib in Participants With Solid Tumors and Lung Cancer (PHASE1, PHASE2)
- First Line Chemotherapy Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) (PHASE2)
- A Study of Enzastaurin in Chinese Patients With Advanced and/or Metastatic Solid Tumors or Lymphoma (PHASE1)
- A Trial of Placebo Versus Enzastaurin for Lung Cancer Prevention in Former Smokers (PHASE2)
- A Study for Patients That Have Been Previously Been Treated in Waldenstrom's Macroglobulinemia or Multiple Myeloma (PHASE2)
- Enzastaurin for Patients With Metastatic Colorectal Cancer (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:
- Enzastaurin HCL CI brief — competitive landscape report
- Enzastaurin HCL updates RSS · CI watch RSS
- Eli Lilly and Company portfolio CI
Frequently asked questions about Enzastaurin HCL
What is Enzastaurin HCL?
Who makes Enzastaurin HCL?
Is Enzastaurin HCL also known as anything else?
What development phase is Enzastaurin HCL in?
Related
- Manufacturer: Eli Lilly and Company — full pipeline
- Also known as: LY317615
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing