Retevmo

(Selpercatinib)

ApprovedSmall molecule

Retevmo is a small molecule that works as a RET Inhibitor.[2] It is being used across 17 indications, with its most advanced program in Approved.[1]

Retevmo is one of 420 small molecule programs targeting Pancreatic Neoplasm. It is currently in Approved.

Indications

Total Trials

Active Trials

419

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Pancreatic NeoplasmActive, not recruiting

Thyroid NeoplasmActive, not recruiting

Erectile DysfunctionActive, not recruiting

Lung CancerActive, not recruiting

Tic DisorderActive, not recruiting

Colon CarcinomaActive, not recruiting

Malignant Colon NeoplasmActive, not recruiting

Malignant Pancreatic NeoplasmActive, not recruiting

Liver DiseaseApproved

Medullary Thyroid Gland CarcinomaActive, not recruiting

Pancreatic NeoplasmApproved

Active, not recruiting

Thyroid NeoplasmApproved

Active, not recruiting

Erectile DysfunctionPreclinical

Active, not recruiting

Lung CancerPhase 2

Active, not recruiting

Tic DisorderPhase 2

Active, not recruiting

Colon CarcinomaApproved

Active, not recruiting

Malignant Colon NeoplasmApproved

Active, not recruiting

Malignant Pancreatic NeoplasmApproved

Active, not recruiting

Liver DiseaseApproved

Approved

Medullary Thyroid Gland CarcinomaApproved

Active, not recruiting

Showing 10 of 17 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Retevmo

Eli Lilly

Approved

34 2

Lexiscan

Astellas

Preclinical

1 3

Adenocard

Astellas

Preclinical

1 4

Motexafin Gadolinium

PPharmacyclics LLC.

Preclinical

1 5

Conventional Chemotherapy

SShanghai Jiao Tong University School of Medicine

Preclinical

1 6

Naltrexone/bupropion

Novo Nordisk

Preclinical

1 7

Iniparib

Sanofi

Preclinical

6 8

Ibrance

Pfizer

Preclinical

2 9

Fluorothymidine F-18

MM.D. Anderson Cancer Center

Preclinical

1 10

Docetaxel-Carboplatin

NNational University Hospital, Singapore

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Recruiting

Erectile Dysfunction

NCT06532149

Q4 2026

Phase 2Active, not recruiting

Non-Small Cell Lung Cancer

NCT04268550

Q1 2027

Phase 2Active, not recruiting

Tic Disorder

NCT03155620

Q4 2027

Phase 2Active, not recruiting

Thyroid Cancer

NCT04280081

Phase 3Active, not recruiting

Thyroid Cancer

NCT04211337

Phase 2Active, not recruiting

Thyroid Cancer

NCT04759911

Clinical

Trials by Indication[1]

ART10 trials

A Study of Effects of Selpercatinib (LY3527723) on Repaglinide in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05469113·16 enrolled

A Study of the Effect of Food on Selpercatinib (LY3527723) in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05324124·46 enrolled

A Study Comparing Two Formulations of Selpercatinib (LY3527723) in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05089019·224 enrolled

Show 7 more trials

A Relative Bioavailability Study of Selpercatinib (LY3527723) in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05136404·42 enrolled

A Study of Effects of Selpercatinib in Hepatically Impaired Participants and Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05436912·36 enrolled

A Study of Effect of Selpercatinib (LY3527723) on Corrected QT (QTc) Interval in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05630274·32 enrolled

A Study of Selpercatinib (LY3527723) in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05338515·18 enrolled

A Study of Effects of Itraconazole and Rifampin on Selpercatinib (LY3527723) in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05338489·24 enrolled

A Study of Effect of Food and a Proton Pump Inhibitor on Selpercatinib (LY3527723) in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05468164·20 enrolled

Study of H2 Antagonist and a Proton Pump Inhibitor of Selpercatinib in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05338502·20 enrolled

Thyroid Cancer5 trials

Selpercatinib Pre-RAI in Patients With RET Fusion Thyroid Cancer (RAISE)

Recruiting·—·Phase 2·NCT06458036·13 enrolled

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

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 2·NCT04280081·77 enrolled

A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT04211337·291 enrolled

Show 2 more trials

Selpercatinib Before Surgery for the Treatment of RET-Altered Thyroid Cancer

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04759911·30 enrolled

Genotype-Driven Neoadjuvant Therapy for Locally Advanced Thyroid Cancer: A Real-World Cohort Study

Not yet recruiting·FFujian Medical University·Phase 4·NCT07010393·335 enrolled

Non-Small Cell Lung Cancer4 trials

Targeted Treatment for RET Fusion-Positive Advanced Non-Small Cell Lung Cancer (A LUNG-MAP Treatment Trial)

Active, not recruiting·SSWOG Cancer Research Network·Phase 2·NCT04268550·124 enrolled

A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT04194944·261 enrolled

A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC)

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT04819100·152 enrolled

Show 1 more trial

Testing the Use of Targeted Treatment for RET Positive Advanced Non-small Cell Lung Cancer

Withdrawn·SSWOG Cancer Research Network·Phase 2·NCT05364645

Interaction2 trials

A Drug Drug Interaction (DDI) Study of Selpercatinib and Dabigatran in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT04782076·36 enrolled

A Drug Drug Interaction (DDI) Study of Selpercatinib (LY3527723) and Rosuvastatin in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05906836·28 enrolled

Tic Disorder2 trials

Selpercatinib for the Treatment of Advanced Solid Tumors, Lymphomas, or Histiocytic Disorders With Activating RET Gene Alterations, a Pediatric MATCH Treatment Trial

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04320888·1 enrolled

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)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03155620·1,376 enrolled

10 more indications

Immunotherapy1 trial

The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy

Unknown status·FFondazione per la Medicina Personalizzata·Phase 2·NCT04591431·400 enrolled

Central Nervous System (CNS) Tumors1 trial

A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 1/2·NCT03899792·36 enrolled

Midazolam1 trial

A Study of Effects of Selpercatinib (LY3527723) on Midazolam in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05338476·16 enrolled

Trial1 trial

The Drug Rediscovery Protocol (DRUP Trial)

Recruiting·TThe Netherlands Cancer Institute·Phase 2·NCT02925234·1,550 enrolled

Treatment1 trial

Expanded Access for the Treatment of Cancers With Rearranged During Transfection (RET) Activation

Approved for marketing· Eli Lilly logo

Eli Lilly··NCT03906331

Erectile Dysfunction1 trial

ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer

Recruiting·FFondazione Policlinico Universitario Agostino Gemelli IRCCS··NCT06532149·80 enrolled

Absorption1 trial

A Study of Absorption, Metabolism, Excretion, and Absolute Bioavailability of Carbon-14-Labelled [14C] Selpercatinib (LY3527723) in Healthy Male Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05630287·12 enrolled

Lung Cancer1 trial

Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT03944772·247 enrolled

Impaired Renal Function1 trial

A Study of Effect of Selpercatinib (LY3527723) in Participants With Normal and Impaired Renal Function

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05469100·37 enrolled

Unspecified2 trials

Feasibility Study for Repurposing RET Inhibitors

Not yet recruiting·UUniversity of Oklahoma·Phase 1·NCT07146893·7 enrolled

Restor. I-131 Upt. + Selpercatinib in RET F-P RAI-R TC

Recruiting·MMassachusetts General Hospital·Phase 2·NCT05668962·30 enrolled

Regulatory

FDA Approval Timeline[4]

May 8, 2020

RETEVMO

NDA NDA213246

Apr 10, 2024

RETEVMO

NDA NDA218160

Sources

References

[1]
ClinicalTrials.gov — 34 trial records for Selpercatinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Selpercatinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Selpercatinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA218160). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Retevmo. U.S. Food & Drug Administration.
[6]
PubMed — 1 publication indexed for Selpercatinib. U.S. National Library of Medicine.
[7]
SEC EDGAR — Eli Lilly company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: RET Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Eli Lilly

Patent Landscape[5]

Patent Cliff

Oct 10, 2037

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10172851Oct 10, 2037

10112942Oct 10, 2037

10137124Oct 10, 2037

10137124*PEDApr 10, 2038

10172851*PEDApr 10, 2038

7 more patents

10112942*PEDApr 10, 2038

10584124Oct 10, 2038

12138250Oct 10, 2038

10786489Oct 10, 2038

10584124*PEDApr 10, 2039

12138250*PEDApr 10, 2039

10786489*PEDApr 10, 2039

Key Publications[6]

Selpercatinib in RET Fusion-Positive NSCLC: LIBRETTO-001 Updated

N Engl J MedAug 22, 2023DOI: 10.1056/NEJMoa2305276

Retevmo

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q1 2027

Q4 2027

Trials by Indication[1]

ART10 trials

Thyroid Cancer5 trials

Non-Small Cell Lung Cancer4 trials

Interaction2 trials

Tic Disorder2 trials

Immunotherapy1 trial

Central Nervous System (CNS) Tumors1 trial

Midazolam1 trial

Trial1 trial

Treatment1 trial

Erectile Dysfunction1 trial

Absorption1 trial

Lung Cancer1 trial

Impaired Renal Function1 trial

Unspecified2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

Key Publications[6]

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