RETEVMO (selpercatinib)
RETEVMO is indicated for the treatment of Non-Small Cell Lung Cancer; Medullary Thyroid Cancer; Thyroid Cancer; Solid Tumors.
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
Details
- Status
- Prescription
- First Approved
- 2020-05-08
- Patent Cliff
- 2039
- Routes
- ORAL
- Dosage Forms
- CAPSULE, TABLET
RETEVMO Approval History
What RETEVMO Treats
4 indicationsRETEVMO 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
RETEVMO Target & Pathway
ProTarget
RETEVMO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in RETEVMO's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications RETEVMO treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to RETEVMO
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
RETEVMO Patents & Exclusivity
Patents (12 active)
Exclusivity
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
Full approval history • All patents • Revenue trends • Competitor analysis
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