TheraRadar
Data updated: May 26, 2026

RETEVMO (selpercatinib)

Rearranged during Transfection (RET) Inhibitors Genetically Validated Trial Activity: Stable 13 active trials
Orphan Drug Breakthrough Therapy Priority Review Accelerated Approval
Oncology Approved 2020-05-08

RETEVMO is indicated for the treatment of Non-Small Cell Lung Cancer; Medullary Thyroid Cancer; Thyroid Cancer; Solid Tumors.

Source: FDA Label • Eli Lilly • Kinase Inhibitor

How RETEVMO Works

Selpercatinib functions as a kinase inhibitor that targets wild-type and multiple mutated isoforms of the RET protein. In certain cancers, RET gene fusions or point mutations create constitutively active proteins that drive tumor cell proliferation. By inhibiting these proteins, selpercatinib demonstrates anti-tumor activity across various models of RET-driven disease. The drug also inhibits other targets, including VEGFR and FGFR, at clinically achievable concentrations.

Development Insights

Eli Lilly and Company conducting 15 trials (52%)
90 indications explored (Broad Platform)
healthy (15 trials)
medullary thyroid cancer (3 trials)
recurrent ependymoma (2 trials)
7
Indications
--
Phase 3 Trials
4
Priority Reviews
6
Years on Market

Details

Status
Prescription
First Approved
2020-05-08
Patent Cliff
2039

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
CAPSULE, TABLET

Companies

Active Ingredient: SELPERCATINIB

RETEVMO Approval History

2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
66 FDA actions from 2020 to 2025 · 5 indication expansions
Nov 2025 SUPPL Priority
Efficacy
Dec 2024 SUPPL
Label · Labeling
Sep 2024 SUPPL Priority
Efficacy

What RETEVMO Treats

4 indications

RETEVMO is approved for 4 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Non-Small Cell Lung Cancer
  • Medullary Thyroid Cancer
  • Thyroid Cancer
  • Solid Tumors
Source: FDA Label

RETEVMO Target & Pathway

Pro

Target

FGFR (Fibroblast Growth Factor Receptor) Receptor Tyrosine Kinase

RETEVMO Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to RETEVMO

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

AUGTYRO
REPOTRECTINIB
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Shared indications:
MEKINIST
TRAMETINIB
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Novartis
Shared indications:
TAFINLAR
DABRAFENIB MESYLATE
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Shared indications:
📋

Clinical Trial Registry

29 trials
Trial Sponsor ID Phase Status Title
NCT03155620 results posted NCI-2017-01251 NCI-2017-01251, APEC1621SC Ph 2 active not recruiting 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)
NCT04320888 results posted NCI-2020-01756 NCI-2020-01756, APEC1621N Ph 2 active not recruiting Selpercatinib for the Treatment of Advanced Solid Tumors, Lymphomas, or Histiocytic Disorders With Activating RET Gene Alterations, a Pediatric MATCH Treatment Trial
NCT04280081 LIBRETTO-321 results posted 17492 J2G-GH-JZJK Ph 2 active not recruiting A Study of Selpercatinib (LY3527723) in Participants With Advanced Solid Tumors Including RET Fusion-positive Solid Tumors, Medullary Thyroid Cancer and Other Tumors With RET Activation
NCT04268550 S1900B NCI-2019-08097, S1900B Ph 2 active not recruiting Targeted Treatment for RET Fusion-Positive Advanced Non-Small Cell Lung Cancer (A LUNG-MAP Treatment Trial)
NCT04211337 LIBRETTO-531 results posted 17478 J2G-MC-JZJB, 2019-001978-28 Ph 3 active not recruiting A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer
NCT04819100 LIBRETTO-432 18126 J2G-MC-JZJX, 2020-005191-35 Ph 3 active not recruiting A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC)
NCT03899792 LIBRETTO-121 results posted 17493 J2G-OX-JZJJ, LOXO-RET-18036 Ph 1, Ph 2 active not recruiting A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors
NCT05469113 results posted 17754 J2G-OX-JZJS, LOXO-RET-18026 Ph 1 completed A Study of Effects of Selpercatinib (LY3527723) on Repaglinide in Healthy Participants
NCT04759911 2020-0570 NCI-2021-00535, 2020-0570 Ph 2 active not recruiting Selpercatinib Before Surgery for the Treatment of RET-Altered Thyroid Cancer
NCT04194944 LIBRETTO-431 results posted 17479 J2G-MC-JZJC, 2019-001979-36 Ph 3 active not recruiting A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
NCT05338476 results posted 17753 J2G-OX-JZJR, LOXO-RET-18017 Ph 1 completed A Study of Effects of Selpercatinib (LY3527723) on Midazolam in Healthy Participants
NCT05338489 results posted 17751 J2G-OX-JZJP, LOXO-RET-18014 Ph 1 completed A Study of Effects of Itraconazole and Rifampin on Selpercatinib (LY3527723) in Healthy Participants
NCT05468164 results posted 17752 J2G-MC-JZJQ, LOXO-RET-18015 Ph 1 completed A Study of Effect of Food and a Proton Pump Inhibitor on Selpercatinib (LY3527723) in Healthy Participants
NCT05630274 results posted 17486 J2G-OX-JZJG, LOXO-RET-18032 Ph 1 completed A Study of Effect of Selpercatinib (LY3527723) on Corrected QT (QTc) Interval in Healthy Participants
NCT05469100 results posted 17484 J2G-OX-JZJE, LOXO-RET-18023 Ph 1 completed A Study of Effect of Selpercatinib (LY3527723) in Participants With Normal and Impaired Renal Function
NCT05906836 results posted 18727 J2G-MC-JZPB Ph 1 completed A Drug Drug Interaction (DDI) Study of Selpercatinib (LY3527723) and Rosuvastatin in Healthy Participants
NCT07010393 Real-Neo Ph 4 not yet recruiting Genotype-Driven Neoadjuvant Therapy for Locally Advanced Thyroid Cancer: A Real-World Cohort Study
NCT05338515 results posted 17485 J2G-OX-JZJF, LOXO-RET-18057 Ph 1 completed A Study of Selpercatinib (LY3527723) in Healthy Participants
NCT05630287 results posted 17768 J2G-OX-JZJT, LOXO-RET-18016 Ph 1 completed A Study of Absorption, Metabolism, Excretion, and Absolute Bioavailability of Carbon-14-Labelled [14C] Selpercatinib (LY3527723) in Healthy Male Participants
NCT05436912 results posted 17483 J2G-OX-JZJD, LOXO-RET-18022 Ph 1 completed A Study of Effects of Selpercatinib in Hepatically Impaired Participants and Healthy Participants
NCT05324124 results posted 18178 J2G-MC-JZPA Ph 1 completed A Study of the Effect of Food on Selpercatinib (LY3527723) in Healthy Participants
NCT05089019 results posted 18177 J2G-MC-JZJZ Ph 1 completed A Study Comparing Two Formulations of Selpercatinib (LY3527723) in Healthy Participants
NCT05136404 results posted 17821 J2G-MC-JZJU Ph 1 completed A Relative Bioavailability Study of Selpercatinib (LY3527723) in Healthy Participants
NCT03944772 ORCHARD D6186C00001 2023-504624-25-00, 2018-003974-29 Ph 2 active not recruiting Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD)
NCT05668962 22-018 Ph 2 recruiting Restor. I-131 Upt. + Selpercatinib in RET F-P RAI-R TC
NCT05338502 results posted 17574 J2G-OX-JZJL, LOXO-RET-19075 Ph 1 completed Study of H2 Antagonist and a Proton Pump Inhibitor of Selpercatinib in Healthy Participants
NCT05364645 S1900F NCI-2022-02517, S1900F Ph 2 withdrawn Testing the Use of Targeted Treatment for RET Positive Advanced Non-small Cell Lung Cancer
NCT04782076 results posted 17972 J2G-MC-JZJV Ph 1 completed A Drug Drug Interaction (DDI) Study of Selpercatinib and Dabigatran in Healthy Participants
NCT02925234 DRUP M15DRU Ph 2 recruiting The Drug Rediscovery Protocol (DRUP Trial)
🔬

Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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📊

Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

RETEVMO FDA Label Details

Indications & Usage

FDA Label (PDF)

RETEVMO is indicated for the treatment of Non-Small Cell Lung Cancer; Medullary Thyroid Cancer; Thyroid Cancer; Solid Tumors.

View full patent landscape →
12 OB patents · 3 families · 142 international docs across 42 countries

RETEVMO Patents & Exclusivity

Latest Patent: Apr 2039
Exclusivity: Nov 2031

Patents (12 active)

US12138250*PED Expires Apr 10, 2039
US10786489*PED Expires Apr 10, 2039
US10584124*PED Expires Apr 10, 2039
US12138250 Expires Oct 10, 2038
US10584124 Expires Oct 10, 2038
US10786489 Expires Oct 10, 2038
US10112942*PED Expires Apr 10, 2038
US10137124*PED Expires Apr 10, 2038
US10172851*PED Expires Apr 10, 2038
US10172851 Expires Oct 10, 2037
US10137124 Expires Oct 10, 2037
US10112942 Expires Oct 10, 2037

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Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for RETEVMO

Revenue Insights

  • Quarterly revenue tracking
  • Historical trend analysis

Patent Timeline

  • Cliff: 2039
  • 516 active patents

Trial Analysis

  • 29 total trials
  • Stage: Stable

Competitive Landscape

  • 20 similar drugs
  • Same target/indication analysis
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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment