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[14C]-Selpercatinib

Eli Lilly and Company · Phase 1 active Small molecule ✓ Verified May 2026

[14C]-Selpercatinib is a Small molecule drug developed by Eli Lilly and Company. It is currently in Phase 1 development. Also known as: LY3527723, LOXO-292.

Selpercatinib is a small molecule inhibitor that targets the Proto-oncogene tyrosine-protein kinase receptor Ret. It works by inhibiting the tyrosine-protein kinase receptor RET.

Likelihood of approval
12.6% vs 9.6% industry baseline
If approved by FDA: likely 2033–2036
Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • 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.
Predicted approval windows by jurisdiction (conditional on FDA approval)
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[14C]-Selpercatinib
Also known asLY3527723, LOXO-292
SponsorEli Lilly and Company
ModalitySmall molecule
PhasePhase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Frequently asked questions about [14C]-Selpercatinib

What is [14C]-Selpercatinib?

[14C]-Selpercatinib is a Small molecule drug developed by Eli Lilly and Company.

Who makes [14C]-Selpercatinib?

[14C]-Selpercatinib is developed by Eli Lilly and Company (see full Eli Lilly and Company pipeline at /company/eli-lilly).

Is [14C]-Selpercatinib also known as anything else?

[14C]-Selpercatinib is also known as LY3527723, LOXO-292.

What development phase is [14C]-Selpercatinib in?

[14C]-Selpercatinib is in Phase 1.

Related

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