RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (Australia), Conditional marketing approval (China), Priority Review (China), Breakthrough Therapy (United States)

Structure/Sequence

Molecular FormulaC29H31N7O3

InChIKeyXIIOFHFUYBLOLW-UHFFFAOYSA-N

CAS Registry2152628-33-4

Clinical Trials associated with Selpercatinib

NCT07146893

/ Not yet recruitingEarly Phase 1IIT

Feasibility Study for Repurposing RET Inhibitors for Treating Cancer Cachexia

The purpose of this study is to assess the effects of selpercatinib on cachexia and anorexia in patients diagnosed with NSCLC, colorectal cancer, or pancreatic cancer.

Start Date26 Feb 2026

Sponsor / Collaborator

University of Oklahoma

[+1]

NCT07010393

/ Not yet recruitingPhase 4IIT

A Multicenter Prospective-Retrospective Real-World Study Evaluating Conversion-to-Surgery and Survival After Genotype-Matched Neoadjuvant Systemic Therapy in Locally Advanced Thyroid Carcinoma

This multicenter registry tests whether genomically matched neoadjuvant therapy (1-4 cycles tailored to BRAF V600E, RET fusion/mutation, isolated TERT mutation, triple-negative BRAF/RET/TERT, or ICI ± TKI) can render locally advanced, initially unresectable-or high-morbidity-thyroid cancers operable. The primary endpoint is conversion-to-surgery; key secondaries are R0/1 margin rate and 12-month event-free survival, with propensity-score weighting correcting cohort imbalances. Findings aim to define a precision-guided neoadjuvant standard for down-staging advanced thyroid tumors.

Start Date01 Jul 2025

Sponsor / Collaborator

Fujian Medical University

NCT06532149

/ RecruitingNot ApplicableIIT

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

Although many phase III clinical trials evaluate the quality of life as a secondary endpoint, male sexuality remains a neglected topic in oncology research. In light of the long-term efficacy of new-generation anticancer treatments for ANSCLC (i.e. targeted therapies and immunotherapy), there is a paucity of data about any detrimental effect on fertility and sexuality that could complicate the therapy proposal, especially in young patients.
The aim of this trial is to assess incidence of endocrine toxicity and sexual dysfuction in male patients receiving active treatment for ANSCLC

Start Date05 Aug 2024

Sponsor / Collaborator-

100 Clinical Results associated with Selpercatinib

100 Translational Medicine associated with Selpercatinib

100 Patents (Medical) associated with Selpercatinib

435

Literatures (Medical) associated with Selpercatinib

01 Feb 2026·PATHOLOGY INTERNATIONAL

Medullary Thyroid Carcinoma That Progressed From Low‐ to High‐Grade During Treatment: A Case Report

Article

Author: Ohashi, Ryuji ; Sugitani, Iwao ; Shintani‐Domoto, Yukako ; Abe, Takeshi ; Saito, Marie ; Fujii, Takenori ; Kazusaka, Hiroko ; Nagaoka, Ryuta ; Sakanushi, Atsuko ; Jikuzono, Tomoo ; Sen, Masaomi ; Ito, Ryo ; Matsui, Mami

ABSTRACT:

Medullary thyroid carcinoma (MTC) with high proliferative potential or tumor necrosis is classified as high‐grade MTC. Progression from low‐ to high‐grade MTC has rarely been documented. We report a case in which a sporadic MTC transitioned from low‐ to high‐grade after the initial therapy. A 62‐year‐old man with low‐grade MTC underwent total thyroidectomy and bilateral neck dissection. Recurrence was identified postoperatively, and the surgical specimen of the lymph node revealed metastatic MTC with high‐grade features. Treatment was initiated with vandetanib followed by selpercatinib, with no significant efficacy. Debulking surgery was performed for five recurrent lesions. Surgical specimens of the tumor after chemotherapy showed increased aggression, characterized by high Ki‐67 index and decreased calcitonin expression. The patient eventually died due to brain metastasis. This case highlights the potential for MTC to progress from low‐ to high‐grade and underscores the importance of ongoing evaluations for recurrent disease.

17 Jan 2026·ONCOLOGIST

A phase 2 study of GI-6207 in patients with recurrent medullary thyroid cancer

Article

Author: Bilusic, Marijo ; Gramza, Ann ; Del Rivero, Jaydira ; Cordes, Lisa ; Gulley, James L ; Marte, Jennifer L ; Karzai, Fatima ; Madan, Ravi A ; Schlom, Jeffery ; Donahue, Renee N

Abstract:

Background:

Medullary thyroid cancer (MTC) accounts for approximately 4% of thyroid carcinomas. Patients with unresectable, metastatic disease are candidates for approved agent-targeted therapies such as vandetanib, cabozantinib, or selpercatinib, but toxicity is often an issue. Preclinical data supported the potential use of immunotherapy targeting carcinoembryonic antigen (CEA) in this indolent disease.

Methods:

Patients with advanced/recurrent MTC were randomly assigned in a 1:1 ratio to receive a Saccharomyces cerevisiae (yeast)-based immunotherapy (GI-6207) targeting CEA starting at the time of enrollment or 6 months after surveillance. The primary endpoint was to compare the calcitonin growth rate in the GI-6207 arm at 6 months with patients in the surveillance arm at 6 months.

Results:

Between March 2013 and May 2018, 34 patients were randomly assigned to receive the yeast-CEA vaccine (GI-6207) starting at the time of enrollment or 6 months after surveillance. The mean age was 51 years, and 82% of patients were diagnosed with sporadic MTC. There was no significant change in the calcitonin growth rates at 6 months when the immunotherapy group was compared with the surveillance group (−2.490042 vs −2.526385; P = .3760). Treatment with GI-6207 was associated with increased peripheral CEA-specific CD4 and/or CD8 T cells, with 15/26 (58%) patients displaying increases after 3 months of treatment. One patient had a significant inflammatory event 17 months after the last vaccine at a known lymph node, perhaps related to a delayed immune response. There were no grade 3 or 4 adverse events. Grade 1 injection site reactions were most common.

Conclusion:

The immunotherapy was well tolerated but did not have an impact on tumor growth rate at 6 months as measured by calcitonin kinetics.

Clinical Trial Identification:

NCT01856920

02 Jan 2026·JOURNAL OF CHEMOTHERAPY

An acquired CCDC6:: RET gene fusion as resistance mechanism for Osimertinib in exon 21 EGFR(L858R) -mutated non-small cell lung cancer and its successful management with Osimertinib and Selpercatinib: a case report and review of literature

Review

Author: Van Haecke, Peter ; Demedts, Ingel ; Lormans, Maud

Background: Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) are the recommended front-line therapy for treatment-naïve patients with advanced stage EGFR mutated Non-Small Cell Lung Cancer (NSCLC), with better tolerance and outcomes compared to chemotherapy. However, patients inevitably develop resistance to EGFR-TKI. The extent of progression free survival depends on intrinsic or acquired on-target/off-target mechanisms of EGFR-TKI resistance. Overcoming these acquired rearrangements remains challenging in modern precision medicine. In case of disease progression during treatment with an EGFR-TKI, rebiopsy is recommended to search for a potential resistance mechanism. However, the therapeutic potential of these resistance mechanisms represents an unmet need in thoracic oncology. Case Presentation: We present a case of a 78-year-old woman with stage IVB EGFR-mutated NSCLC in whom an acquired RET Gene Fusion was identified as the EGFR-independent resistance mechanism. Additionally, a combined therapy of Osimertinib and Selpercatinib showed a durable oncological response with 14 months of progression free survival in the absence of adverse events. Conclusion: Addition of Selpercatinib to Osimertinib in an EGFR-mutated NSCLC patient with an acquired RET fusion was well tolerated and created a clinical benefit. Further prospective investigation into these novel combination strategies is needed as resistance mechanisms could serve as possible targets for new therapy approaches.

223

News (Medical) associated with Selpercatinib

24 Feb 2026

·www.prnewswire.com

Oncology Market Set to Nearly Triple: Here Are Five Companies Leading the Charge

Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Feb. 24, 2026 /PRNewswire/ -- USA News Group News Commentary, The global oncology market is on track to nearly triple in value over the next decade, growing from $279.98 billion in 2026 to an estimated $748.17 billion by 2035[1]. Cancer drug revenues alone are projected to reach $335.2 billion by 2033, driven by a surge in targeted therapies and immunotherapy adoption[2]. Five companies advancing novel approaches in the oncology sector include Oncolytics Biotech (NASDAQ: ONCY), Exelixis (NASDAQ: EXEL), Eli Lilly (NYSE: LLY), Merck (NYSE: MRK), and Gilead Sciences (NASDAQ: GILD). The immunotherapy drugs market is experiencing significant growth as rising cancer prevalence accelerates demand for targeted treatments and combination therapies[3]. The immuno-oncology segment specifically is forecast to expand from $65.22 billion in 2025 to $170.19 billion by 2032, representing a compound annual growth rate of 14.9%[4]. Oncolytics Biotech Inc. (NASDAQ: ONCY) recently announced its decision to focus on registrational programs in anal and colorectal cancer, concluding enrollment in the GOBLET gastrointestinal study after generating sufficient clinical and translational data to chart a clear path toward FDA approval. The promising efficacy signal in GOBLET Cohort 4 has defined a clear registrational path for pelareorep in second-line and later squamous cell anal cancer, a setting where available therapies offer only limited benefit to patients. Oncolytics expects to meet with the FDA in mid-April to align on study design, and believes a clinical trial of well under 100 subjects will be sufficient to secure approval in this rare cancer indication. With sufficient cash on hand to execute near-term milestones, the company expects to avoid immediate material dilution, redirecting capital from the GOBLET cohorts toward its highest-conviction registration programs. "GOBLET has done its job successfully. We now know where pelareorep can make the greatest impact for patients and where we can pursue approval most efficiently," said Jared Kelly, CEO of Oncolytics Biotech. "Our disciplined strategy is to run registrational or registration-enabling studies with ruthless efficiency that can create maximum shareholder value without unnecessary dilution." The registration push builds on pelareorep's recent Fast Track Designation from the FDA for second-line KRAS-mutant microsatellite-stable (MSS) metastatic colorectal cancer. Clinical data showed pelareorep combined with standard chemotherapy and Avastin® achieved a 33% response rate versus roughly 10% with chemotherapy and Avastin®, while median overall survival reached 27 months versus 11.2 months with standard treatment. KRAS-mutant MSS colorectal cancer represents one of the hardest-to-treat populations, with limited options after first-line treatment fails. The global market for second-line treatment in this patient group runs between $3 billion and $5 billion annually. The company plans to launch a controlled study with the first clinical site activating in March and interim data expected by year-end 2026. Pelareorep is also delivering strong results in anal cancer, where third-line patients achieved a 29% response rate with the median duration of response lasting around 17 months in a setting with no FDA-approved treatments. In second-line or later patients, the 30% response rate more than doubled the benchmark for the FDA-approved immunotherapy. The company continues strengthening its leadership, having recently appointed John McAdory as EVP of Strategy and Operations and Yujun Wu as Head of Biostatistics. Kelly and Chief Business Officer Andrew Aromando both joined from Ambrx Biopharma, which sold to Johnson & Johnson for $2 billion in 2024. CONTINUED… Read this and more news for Oncolytics Biotech at: In other industry developments: Exelixis (NASDAQ: EXEL) reported strong results for fiscal year 2025, with U.S. net product revenues from its cabozantinib franchise reaching $2.1 billion. The FDA accepted the company's New Drug Application for zanzalintinib in combination with atezolizumab for previously treated metastatic colorectal cancer. "The team is highly motivated to build a second Exelixis oncology franchise with zanzalintinib and is working diligently to advance a first potential indication in metastatic colorectal cancer, following the recent acceptance of our New Drug Application by U.S. regulatory authorities," said Michael M. Morrissey, Ph.D., President and CEO of Exelixis. The company has a target FDA action date of December 2026 for zanzalintinib, which could establish a second major oncology franchise. Eli Lilly (NYSE: LLY) announced positive results from its Phase 3 LIBRETTO-432 trial, showing that Retevmo delivered a highly statistically significant improvement in event-free survival as adjuvant therapy in early-stage RET fusion-positive non-small cell lung cancer. The trial is the first randomized Phase 3 study to evaluate a selective RET kinase inhibitor in this population. "We have consistently observed that cancer medicines can deliver their greatest impact when administered early in the course of a patient's treatment journey," said Jacob Van Naarden, executive vice president and president of Lilly Oncology. The company plans to present detailed results at an upcoming medical congress and discuss findings with global health authorities. Merck (NYSE: MRK) received FDA approval for KEYTRUDA and its subcutaneous formulation KEYTRUDA QLEX plus paclitaxel for adults with PD-L1-positive platinum-resistant ovarian cancer. KEYTRUDA is the first PD-1 inhibitor approved for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. "For many patients with ovarian cancer, the disease can become platinum-resistant, at which point recurrence is not just a setback, it's when options can become limited, and the reality patients face can change very quickly," said Dr. Bradley Monk, gynecologic oncologist at Florida Cancer Specialists and Research Institute. The KEYNOTE-B96 trial demonstrated a 28% reduction in the risk of disease progression or death and a 24% reduction in the risk of death compared to placebo. Gilead Sciences (NASDAQ: GILD) received an updated label for its Kite subsidiary's Yescarta CAR T-cell therapy, with the FDA removing previous limitations of use in relapsed or refractory primary central nervous system lymphoma. Yescarta is now the only CAR T-cell therapy approved for large B-cell lymphoma with this designation. "This update to the axi-cel prescribing information provides clinicians with important evidence for patients who have historically had very limited treatment options," said Lakshmi Nayak, MD, Director of the Center for CNS Lymphoma at Dana-Farber Cancer Institute. Article Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SOURCES: Logo - 21% more press release views with Request a Demo

Clinical ResultPhase 3ImmunotherapyExecutive ChangeFast Track

18 Feb 2026

·www.prnewswire.com

Lilly's Retevmo (selpercatinib) delivers substantial event-free survival benefit as an adjuvant therapy in early-stage RET fusion-positive lung cancer

Selpercatinib demonstrated a highly statistically significant and clinically meaningful improvement in reducing the risk of disease recurrence or death Results from the LIBRETTO-432 trial build on previous results for selpercatinib in advanced NSCLC and reinforce the value of genomic testing at diagnosis and across all stages of disease Feb. 16, 2026 -- Eli Lilly and Company (NYSE: LLY) today announced positive topline results from the Phase 3 LIBRETTO-432 clinical trial of Retevmo (selpercatinib) as adjuvant therapy versus placebo. The study met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in investigator-assessed event-free survival (EFS) in patients with early-stage (II-IIIA) rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC). Overall survival results trended in favor of selpercatinib, but were immature at the time of this analysis with few events observed. The overall safety profile of selpercatinib in LIBRETTO-432 was generally consistent with previously reported trials in the selpercatinib development program. Detailed results will be presented at an upcoming medical congress, submitted to a peer-reviewed journal, and discussed with health authorities globally. "We have consistently observed that cancer medicines can deliver their greatest impact when administered early in the course of a patient's treatment journey. The LIBRETTO-432 results support this observation, demonstrating an effect size in line with the most striking data for targeted adjuvant therapy in lung cancer," said Jacob Van Naarden, executive vice president and president of Lilly Oncology. "Building on the adoption of targeted therapies for early-stage patients with EGFR- and ALK-driven lung cancer, we hope these results further accelerate the use of genomic testing for all people diagnosed with early-stage disease." LIBRETTO-432 is the first and only randomized Phase 3 study to evaluate the safety and efficacy of a selective RET kinase inhibitor as adjuvant therapy in this population. NSCLC accounts for about 85 percent of all lung cancer diagnoses in the U.S., and around 30 percent of patients with NSCLC present with stage IB-IIIA disease.1,2 Approximately 50 percent of people with NSCLC have actionable biomarkers, and RET fusions have been identified in one to two percent of all NSCLC cases.3,4 LIBRETTO-432 is a Phase 3, global, multicenter, randomized, double-blind, controlled clinical trial of selpercatinib versus placebo in patients with RET fusion-positive NSCLC following completion of definitive radiotherapy or surgery with curative intent, and other adjuvant therapy, if indicated. The trial enrolled 151 patients who were randomized 1:1 to receive either selpercatinib or placebo as adjuvant therapy for RET fusion-positive NSCLC. The primary endpoint is EFS as assessed by investigator in the primary analysis population, which was comprised of patients with stage II-IIIA RET fusion-positive NSCLC. Secondary endpoints include EFS as assessed by investigator in the overall population, overall survival (OS), EFS as assessed by blinded independent central review (BICR), time to distant disease recurrence in the central nervous system (CNS) as assessed by investigator and BICR, progression-free survival on the next line of treatment (PFS2), positive predictive value (PPV) of RET tests from investigator-identified laboratories with respect to the Lilly-designated RET test, safety and tolerability. Retevmo (selpercatinib, formerly known as LOXO-292) (pronounced reh-TEHV-moh) is a highly selective and potent RET kinase inhibitor with central nervous system (CNS) activity. Retevmo may affect both tumor cells and healthy cells, which can result in side effects. RET-driver alterations are predominantly mutually exclusive from other oncogenic drivers. Retevmo is a U.S. FDA-approved oral prescription medicine, 120 mg or 160 mg dependent on weight (<50 kg or ≥50 kg, respectively), taken twice daily until disease progression or unacceptable toxicity.5 Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. Endnotes & References American Cancer Society. What is Lung Cancer? January 2024. https://www.cancer.org/cancer/types/lung-cancer/about/what-is.html Goldman, JW, Sands, J, Hallqvist, A, et al. LIBRETTO-432: A phase 3 study of adjuvant selpercatinib or placebo in stage IB-IIIA RET fusion-positive (RET+) NSCLC. J Clinc Oncol 2024;42:16. Published 2024 May 29. doi:10.1200/JCO.2024.42.16_suppl.TPS811 Huang RSP, et al. Landscape of Biomarkers in Non-small Cell Lung Cancer Using Comprehensive Genomic Profiling and PD-L1 Immunohistochemistry. Pathol Oncol Res. 2021;27:592997. Published 2021 Mar 11. doi:10.3389/pore.2021.592997 Wang R, Hu H, Pan Y, et al. RET fusions define a unique molecular and clinicopathologic subtype of non-small-cell lung cancer. J Clin Oncol 2012;30:4352-4359. The content above comes from the network. if any infringement, please contact us to modify.

Clinical Result

17 Feb 2026

·www.fiercepharma.com

Lilly's rare cancer drug Retevmo looks to broaden reach with adjuvant trial win

Eli Lilly has reported the success of a phase 3 trial of Retevmo, showing improvement in event free survival in patients with RET fusion-positive NSCLC who have had surgery or radiation therapy. Some six years after the FDA approved Eli Lilly’s Retevmo to treat lung and thyroid cancers that have a mutation or fusion to the RET gene, the Indianapolis drugmaker is laying groundwork to move the treatment into the adjuvant setting.Lilly has reported a successful phase 3 trial in which Retevmo demonstrated “highly statistically significant and clinically meaningful” improvement in event-free survival in patients with early-stage (II-IIIA) RET fusion-positive non-small cell lung cancer (NSCLC). The twice-daily oral medication was tested against placebo in patients who have had surgery or radiation therapy. Lilly isn’t declaring complete victory in the study yet, however. As a secondary endpoint, overall survival trended positively in Retevmo's favor, but the data were immature with few events observed at the time of the drugmaker's analysis. Lilly said it will present detailed results from the trial at an upcoming medical conference and discuss them with global regulators. “We have consistently observed that cancer medicines can deliver their greatest impact when administered early in the course of a patient’s treatment journey,” Jacob Van Naarden, Lilly’s oncology chief, said in a release, adding that the results show “an effect size in line with the most striking data for targeted adjuvant therapy in lung cancer.”The trial, which enrolled 151 participants, is the first randomized phase 3 study to evaluate the safety and efficacy of a selective RET kinase inhibitor as adjuvant therapy in the patient population, Lilly said.NSCLC accounts for about 85% of all lung cancer diagnoses in the U.S., with half of those having actionable biomarkers, Lilly said, including 1% to 2% with RET fusions. “Building on the adoption of targeted therapies for early-stage patients with EGFR- and ALK-driven lung cancer, we hope these results further accelerate the use of genomic testing for all people diagnosed with early-stage disease,” Van Naarden added. Two years after the FDA originally approved Retevmo on an accelerated basis, the U.S. regulator signed off on the RET inhibitor to treat all tumor types that bear the relevant biomarker. The nod covered patients with locally advanced or metastatic solid tumors who have tried prior systemic treatment, as well as those with no other treatment alternatives. The approval was based on Retevmo showing that it shrunk various tumor types by 44% and provided benefits for a median of 24.5 months. Retevmo generated sales of $364 million in 2024 and $456 million last year. Lilly acquired Retevmo in its $8 billion buyout of Loxo Oncology in 2019. Two years ago, the company scrapped a next-generation RET inhibitor gained in the buyout which was designed to overcome acquired resistance to Retevmo. The only other RET inhibitor on the market, Rigel’s Gavreto, has struggled to gain traction, achieving sales of $32 million in the first three quarters of 2025. The FDA originally approved Gavreto in 2020, four months after signing off on Retevmo. It was developed by Blueprint, with Roche paying $675 million upfront to become commercial partner on the drug in 2020. The Swiss pharma giant exited the collaboration three years later, and Rigel picked up the product from Blueprint in early 2024.

Clinical ResultPhase 3Drug ApprovalAcquisition

100 Deals associated with Selpercatinib

External Link

KEGG	Wiki	ATC	Drug Bank
D11713	Selpercatinib	L01XE	DB15685

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
RET fusion-positive Solid Tumors	United States	Eli Lilly & Co.	10 Apr 2024
metastatic non-small cell lung cancer	United States	Eli Lilly & Co.	21 Sep 2022
Metastatic Solid Tumor	United States	Eli Lilly & Co.	21 Sep 2022
Thyroid Cancer, Medullary	United States	Eli Lilly & Co.	21 Sep 2022
RET fusion-positive Non-Small Cell Lung Cancer	European Union	Eli Lilly Nederland BV	11 Feb 2021
RET fusion-positive Non-Small Cell Lung Cancer	Iceland	Eli Lilly Nederland BV	11 Feb 2021
RET fusion-positive Non-Small Cell Lung Cancer	Liechtenstein	Eli Lilly Nederland BV	11 Feb 2021
RET fusion-positive Non-Small Cell Lung Cancer	Norway	Eli Lilly Nederland BV	11 Feb 2021
RET fusion-positive Thyroid Cancer	European Union	Eli Lilly Nederland BV	11 Feb 2021
RET fusion-positive Thyroid Cancer	Iceland	Eli Lilly Nederland BV	11 Feb 2021
RET fusion-positive Thyroid Cancer	Liechtenstein	Eli Lilly Nederland BV	11 Feb 2021
RET fusion-positive Thyroid Cancer	Norway	Eli Lilly Nederland BV	11 Feb 2021
Non-Small Cell Lung Cancer	United States	Eli Lilly & Co.	08 May 2020
RET Mutation-Positive Medullary Thyroid Cancer	United States	Eli Lilly & Co.	08 May 2020
Thyroid Cancer	United States	Eli Lilly & Co.	08 May 2020

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
RET fusion-positive Adenocarcinoma of Lung	Phase 3	United States	Eli Lilly & Co.	19 Jan 2021
RET fusion-positive Adenocarcinoma of Lung	Phase 3	China	Eli Lilly & Co.	19 Jan 2021
RET fusion-positive Adenocarcinoma of Lung	Phase 3	Japan	Eli Lilly & Co.	19 Jan 2021
RET fusion-positive Adenocarcinoma of Lung	Phase 3	Australia	Eli Lilly & Co.	19 Jan 2021
RET fusion-positive Adenocarcinoma of Lung	Phase 3	Austria	Eli Lilly & Co.	19 Jan 2021
RET fusion-positive Adenocarcinoma of Lung	Phase 3	Belgium	Eli Lilly & Co.	19 Jan 2021
RET fusion-positive Adenocarcinoma of Lung	Phase 3	Brazil	Eli Lilly & Co.	19 Jan 2021
RET fusion-positive Adenocarcinoma of Lung	Phase 3	Canada	Eli Lilly & Co.	19 Jan 2021
RET fusion-positive Adenocarcinoma of Lung	Phase 3	Czechia	Eli Lilly & Co.	19 Jan 2021
RET fusion-positive Adenocarcinoma of Lung	Phase 3	Denmark	Eli Lilly & Co.	19 Jan 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03899792 (LIBRETTO-121, CTgov)	Phase 1/2	RET mutation Solid Tumors \| Papillary thyroid cancer \| Central Nervous System Neoplasms ... View more	36	Selpercatinib	inhtfomigb(osqznspjxd) = vyfbgrrece bkugwkywvg (cxkavphbsj, yoiruadira - bxxrimgjsj) View more	-	06 Jan 2026
NCT05469113 (CTgov)	Phase 1	-	16	Repaglinide (Period 1: Repaglinide)	xaouksjdqy(rssupmhhlp) = nxygcutfxc pbjugoanrf (hqncslivue, 57.1) View more	-	11 Dec 2025
				Selpercatinib+Repaglinide (Period 2: Selpercatinib + Repaglinide)	xaouksjdqy(rssupmhhlp) = soahdhzles pbjugoanrf (hqncslivue, 53.2) View more
NCT04320888 (CTgov)	Phase 2	Refractory Soft Tissue Sarcoma \| Ependymoma \| Relapsed Solid Neoplasm ... View more	1	Computed Tomography+Selpercatinib	pvlnzxhsgx = bpleehkget skgjlwyajz (zjnerjzycc, cmsrqnemdp - dmzmxqnzsq) View more	-	06 Nov 2025
NCT05338476 (CTgov)	Phase 1	-	16	Midazolam	lkmnooqtmq(xnjtlzbwtr) = rtsdhbooof yenhzgvufz (vkzrfvpito, 38.4) View more	-	20 Oct 2025
NCT05338489 (CTgov)	Phase 1	-	24	Selpercatinib (Part 1 Period 1: 160 mg Selpercatinib)	ythbdskags(xyuargmrlv) = oqztyhzwzs zmutarwvju (dsaighmixg, 31.8) View more	-	19 Sep 2025
				Itraconazole+Selpercatinib (Part 1 Period 2: 160 mg Selpercatinib + 200 mg Itraconazole)	ythbdskags(xyuargmrlv) = tfeglcabzg zmutarwvju (dsaighmixg, 41.9) View more
NCT05468164 (CTgov)	Phase 1	-	20	Selpercatinib (Treatment A: 160 mg Selpercatinib (Fasted))	sitinxmntf(hojjkbyzbf) = eitijexnan rwjzrnwigo (ycegawqxhy, 38.9) View more	-	19 Sep 2025
				Selpercatinib (Treatment B: 160 mg Selpercatinib (Fed))	sitinxmntf(hojjkbyzbf) = gkbaogzqdn rwjzrnwigo (ycegawqxhy, 20.4) View more
NCT05630274 (CTgov)	Phase 1	-	32	Selpercatinib (320 mg Selpercatinib (Treatment A))	pgyiftbblz(opqhrkpetb) = xnplbyqgiw zrkplvxigx (yenslsrldl, nrxsabizwi - ypbiqqadoz) View more	-	18 Sep 2025
				Selpercatnib (640 mg Selpercatnib (Treatment B))	pgyiftbblz(opqhrkpetb) = wqahcmsioa zrkplvxigx (yenslsrldl, hrufzagrfe - lrcxgpsxxn) View more
NCT05469100 (CTgov)	Phase 1	Renal Insufficiency	37	Selpercatinib (Selpercatinib (Control; Normal Renal Function))	htkvyjkppr(suimzmjmqg) = nnaltdfenk rizzenmrzh (ysgplxwzcj, 52.1) View more	-	18 Sep 2025
				Selpercatinib (Selpercatinib (Mild Renal Impairment))	htkvyjkppr(suimzmjmqg) = uehgjumcgl rizzenmrzh (ysgplxwzcj, 36.0) View more
NCT05906836 (CTgov)	Phase 1	-	28	Rosuvastatin+Selpercatinib	mapzhqltyr(fgrebftmju) = jsiyviekze aeuvfywmpx (lhoeqcxthv, 38) View more	-	16 Sep 2025
GEMINI (ASCO2025)	Not Applicable	Non-Small Cell Lung Cancer \| Chylothorax \| Pericarditis First line RET fusion-positive	103	Selpercatinib	ifxqhhmmny(vaqyibizmc) = We identified chylous effusion as an AE following RETi exposure in 12% of pts in our cohort, including 2 cases of chylopericardium. These adverse events can occur with either selpercatinib or pralsetinib, and making a differential diagnosis, including ruling out disease progression, is crucial for effective management. uvjewphrlc (yuhnhpeacd ) View more	Positive	30 May 2025
				Pralsetinib

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