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LOXO-292
LOXO-292 is a Small molecule drug developed by Eli Lilly and Company. It is currently in Phase 1 development. Also known as: Selpercatinib, LY3527723.
LOXO-292 is a small molecule inhibitor of the neurotrophic tyrosine kinase receptor. It is being studied in clinical trials for various types of cancer, including hematopoietic and lymphatic system neoplasms, recurrent ependymoma, recurrent Ewing sarcoma, recurrent hepatoblastoma, and recurrent histiocytic and dendritic cell neoplasm.
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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). -
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 | 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 | LOXO-292 |
|---|---|
| Also known as | Selpercatinib, LY3527723 |
| Sponsor | Eli Lilly and Company |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Targeted Treatment for RET Fusion-Positive Advanced Non-Small Cell Lung Cancer (A LUNG-MAP Treatment Trial) (PHASE2)
- A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer (PHASE3)
- A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC) (PHASE3)
- Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) (PHASE2)
- A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors (PHASE1, PHASE2)
- A Study of Effects of Selpercatinib (LY3527723) on Repaglinide in Healthy Participants (PHASE1)
- Selpercatinib for the Treatment of Advanced Solid Tumors, Lymphomas, or Histiocytic Disorders With Activating RET Gene Alterations, a Pediatric MATCH Treatment Trial (PHASE2)
- Selpercatinib Before Surgery for the Treatment of RET-Altered Thyroid 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:
- LOXO-292 CI brief — competitive landscape report
- LOXO-292 updates RSS · CI watch RSS
- Eli Lilly and Company portfolio CI
Frequently asked questions about LOXO-292
What is LOXO-292?
Who makes LOXO-292?
Is LOXO-292 also known as anything else?
What development phase is LOXO-292 in?
Related
- Manufacturer: Eli Lilly and Company — full pipeline
- Also known as: Selpercatinib, LY3527723
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing