Selpercatinib clinical trials
Selpercatinib is named as an intervention in 15 current clinical trials in our China, Australia, Spain, Italy, Canada, Japan, South Korea, UK, USA, Germany, France, Netherlands, Denmark, Israel, India, Belgium, Poland, Czechia, Brazil, Mexico, Taiwan, Singapore, Sweden, Norway, Turkey, Austria and Switzerland registers. 3 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Eli Lilly and Company (6). The most-studied condition is Medullary Thyroid Cancer. The EU clinical trials register (CTIS) separately lists 2 authorised or ongoing trials.
Where Selpercatinib is approved
All regulators →Of the three regulators tracked here, the first to approve Selpercatinib was the US, on 8 May 2020. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Selpercatinib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Selpercatinib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 6 listed patents; the last listed expires 10 Apr 2039 (US 12138250, including a 6-month paediatric extension).
- Latest patent on the drug substance itself: 10 Apr 2039 (US 10584124, with paediatric extension).
- Exclusivity PED: Pediatric exclusivity, until 29 Nov 2031.
- Exclusivity ODE-484: Orphan drug exclusivity: treatment of pediatric patients 2 years of age to less than 12 years of age with advanced or metastatic medullary …, until 29 May 2031.
- Exclusivity ODE-485: Orphan drug exclusivity: treatment of pediatric patients 2 years of age to less than 12 years of age with advanced or metastatic thyroid ca…, until 29 May 2031.
- Exclusivity ODE-487: Orphan drug exclusivity: treatment of pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a r…, until 29 May 2031.
- Exclusivity ODE*: FDA has not recognized orphan-drug exclusivity (ode) for this drug, but it contains the same active moiety or moieties as another drug(s) t…, until 29 May 2031.
- Exclusivity PED: Pediatric exclusivity, until 21 Mar 2030.
- 6 further exclusivities are listed.
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Selpercatinib
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Selpercatinib works
All drug targets →- Tyrosine-protein kinase receptor RET inhibitor InhibitorTarget: RET ret proto-oncogene✓ In ChEMBL and the Guide to Pharmacology
- Kinesin-1 heavy chain/ Tyrosine-protein kinase receptor RET inhibitor InhibitorTarget: Kinesin-1 heavy chain/ Tyrosine-protein kinase receptor RET✓ In ChEMBL and the Guide to Pharmacology
- Coiled-coil domain-containing protein 6/Tyrosine-protein kinase receptor RET inhibitor InhibitorTarget: Coiled-coil domain-containing protein 6/Tyrosine-protein kinase receptor RET✓ In ChEMBL and the Guide to Pharmacology
- Breast cancerPhase 2
- Differentiated thyroid carcinomaPhase 2
- Digestive system neoplasmPhase 2
- LymphomaPhase 2
- Non-Hodgkin lymphomaPhase 2
- Plasma cell myelomaPhase 2
- Thyroid gland carcinomaPhase 2
- Thyroid gland papillary carcinomaPhase 2
- Thyroid gland undifferentiated (anaplastic) carcinomaPhase 2
- Colon carcinomaPhase 1/2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4559134, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 10318, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Selpercatinib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 6 technology appraisals of Selpercatinib. 5 are current, and 3 of these recommend it for at least some patients. 1 older appraisal was replaced or withdrawn.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Selpercatinib for previously treated RET fusion-positive advanced non-small-cell lung cancer NICE TA1042 | Optimised | 19 Feb 2025 | Current |
| Selpercatinib for advanced thyroid cancer with RET alterations after treatment with a targeted cancer drug in people 12 years and over NICE TA1038 | Optimised | 12 Feb 2025 | Current |
| Selpercatinib for advanced thyroid cancer with RET alterations untreated with a targeted cancer drug in people 12 years and over NICE TA1039 | Recommended | 12 Feb 2025 | Current |
| Selpercatinib for untreated RET fusion-positive advanced non-small-cell lung cancer NICE TA911 | Optimised (Cancer Drugs Fund) | 26 Jul 2023 | Current |
| Selpercatinib for previously treated RET fusion-positive advanced non-small-cell lung cancer NICE TA760 | Recommended (Cancer Drugs Fund) | 12 Jan 2022 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Selpercatinib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 6 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: RetsevmoEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Trials by status
Trials by phase
Clinical trials of Selpercatinib
15 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Selpercatinib in the EU trials register (CTIS)
2 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Selpercatinib. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
DYNAMIC ” IDentifY the best therapeutic sequeNcing strAtegy in oncogene addICted NSCLC:”
“A multi-arms prospective, randomized phase II study to evaluate the best sequential
therapeutic strategis in patients with metastatic non-small cell lung cancer harboring
targetable genomic driver alterations”
2026-525268-16-00 · CTIS ↗ · Neoplasms
|
Phase 3 | Authorised | Universita' Degli Studi Di Torino | Italy |
|
TAILOR-PANC: Molecularly Tailored Therapy versus Standard Care in Advanced Pancreatic Cancer (DPCG-02)
2025-522431-34-00 · CTIS ↗ · Neoplasms
|
Phase 2 | Authorised | Region Hovedstaden | Denmark |
Selpercatinib across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
6 single-substance products containing Selpercatinib on the HPRA medicines list.
- Retsevmo 120 mg film-coated tabletsEli Lilly Nederland B.V. · EU/1/20/1527/018-020
- Retsevmo 160 mg film-coated tabletsEli Lilly Nederland B.V. · EU/1/20/1527/021-023
- Retsevmo 40 mg film-coated tabletsEli Lilly Nederland B.V. · EU/1/20/1527/012-014
- Retsevmo 40 mg hard capsulesEli Lilly Nederland B.V. · EU/1/20/1527/001
- Retsevmo 80 mg film-coated tabletsEli Lilly Nederland B.V. · EU/1/20/1527/015-017
Supply shortages
No entry for Selpercatinib in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Selpercatinib
28 conditionsAll 28 conditions
| Condition (as registered) | Trials |
|---|---|
| Medullary Thyroid Cancer | 4 |
| Non-Small Cell Lung Cancer | 3 |
| Thyroid Neoplasms | 3 |
| Carcinoma, Non-Small-Cell Lung | 2 |
| Infantile Myofibromatosis | 1 |
| Infantile Fibrosarcoma | 1 |
| Papillary Thyroid Cancer | 1 |
| Colon Cancer | 1 |
| Any Solid Tumor | 1 |
| Advanced Thyroid Cancer Patients Who Received Target Therapy | 1 |
| Thyroid Cancer | 1 |
| Solid Tumor | 1 |
| Cancer | 1 |
| Tumors | 1 |
| Neoplasm | 1 |
| Neoplasia | 1 |
| Advanced Malignant Solid Neoplasm | 1 |
| Ann Arbor Stage III Non-Hodgkin Lymphoma | 1 |
| Ann Arbor Stage IV Non-Hodgkin Lymphoma | 1 |
| Histiocytic Sarcoma | 1 |
| Recurrent Lung Non-Small Cell Carcinoma | 1 |
| Stage IV Lung Cancer AJCC v8 | 1 |
| Stage IVA Lung Cancer AJCC v8 | 1 |
| Stage IVB Lung Cancer AJCC v8 | 1 |
| Hematopoietic and Lymphatic System Neoplasm | 1 |
| Recurrent Ependymoma | 1 |
| Recurrent Ewing Sarcoma | 1 |
| Recurrent Hepatoblastoma | 1 |
Sponsors
lead sponsor per trialBy country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Selpercatinib trials
How many clinical trials are testing Selpercatinib?
15 current trials in our China, Australia, Spain, Italy, Canada, Japan, South Korea, UK, USA, Germany, France, Netherlands, Denmark, Israel, India, Belgium, Poland, Czechia, Brazil, Mexico, Taiwan, Singapore, Sweden, Norway, Turkey, Austria and Switzerland registers name Selpercatinib (also registered as LY3527723) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Selpercatinib trials recruiting patients?
Yes. 3 of the 15 trials are recruiting: 2 with sites in China and 1 with sites in Netherlands. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Selpercatinib clinical trials?
Eli Lilly and Company (6), Fujian Medical University (2), National Cancer Institute (NCI) (2) and Loxo Oncology, Inc (1), among 8 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Selpercatinib licensed in Ireland?
Yes. The HPRA medicines list includes 6 single-substance products containing Selpercatinib, for example Retsevmo 120 mg film-coated tablets (Eli Lilly Nederland B.V.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Selpercatinib shortage?
Not in the lists we track: Selpercatinib has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Selpercatinib works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Selpercatinib works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Selpercatinib (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.