Pralsetinib clinical trials
Pralsetinib is named as an intervention in 9 current clinical trials in our China, USA, Spain, South Korea, UK, Germany, France, Italy, Belgium, Denmark, Poland, Switzerland, Portugal, Canada, Brazil, Mexico, Japan, Taiwan, Singapore, Australia, Israel and Egypt registers. 6 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Fujian Medical University (2). The most-studied condition is Thyroid Cancer.
Where Pralsetinib is approved
All regulators →Of the three regulators tracked here, the first to approve Pralsetinib was the US, on 4 Sep 2020. It is approved in 3 of the 3 regulators tracked here.
- 1 EU safety letter (DHPC), latest: adverse event;post-authorisation measure for Gavreto, 16 Jun 2023
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.
Pralsetinib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Pralsetinib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 8 listed patents; the last listed expires 19 Apr 2043 (US 12692251).
- Latest patent on the drug substance itself: 7 Jul 2042 (US 12448366).
- Exclusivity ODE-340: Orphan drug exclusivity: treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic ret-mutant medulla…, until 1 Dec 2027.
- Exclusivity ODE-341: Orphan drug exclusivity: treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic ret fusion-positiv…, until 1 Dec 2027.
- Exclusivity ODE-318: Orphan drug exclusivity: treatment of adult patients with metastatic ret fusion-positive non-small cell lung cancer (NSCLC) as detected by …, until 4 Sep 2027.
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 Pralsetinib
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 Pralsetinib works
All drug targets →- Tyrosine-protein kinase receptor RET inhibitor InhibitorTarget: RET ret proto-oncogene✓ 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
- 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
- Breast cancerPhase 2
- Central nervous system cancerPhase 2
- Central nervous system neoplasmPhase 2
- Digestive system neoplasmPhase 2
- Poorly differentiated thyroid gland carcinomaPhase 2
- Thyroid cancerPhase 2
- Thyroid gland follicular carcinomaPhase 2
- Thyroid gland papillary carcinomaPhase 2
- Thyroid gland undifferentiated (anaplastic) carcinomaPhase 2
- CancerPhase 1/2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4582651, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 10033, 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 Pralsetinib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Pralsetinib. 1 is current.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Pralsetinib for treating RET fusion-positive advanced non-small-cell lung cancer NICE TA812 | Not recommended | 3 Aug 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 Pralsetinib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- 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 Pralsetinib
9 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.
Conditions studied with Pralsetinib
14 conditionsAll 14 conditions
| Condition (as registered) | Trials |
|---|---|
| Thyroid Cancer | 2 |
| Thyroid Neoplasms | 2 |
| Solid Tumors | 1 |
| Non-small Cell Lung Cancer | 1 |
| Lung Cancer Stage III | 1 |
| Mutation | 1 |
| Advanced Thyroid Cancer Patients Who Received Target Therapy | 1 |
| Locally Advanced Thyroid Gland Carcinoma | 1 |
| NSCLC (Non-small Cell Lung Cancer) | 1 |
| Solid Tumor Malignancies | 1 |
| Advanced Malignancies | 1 |
| Solid Tumor | 1 |
| Advanced Solid Tumor | 1 |
| Metastatic Cancer | 1 |
Sponsors
lead sponsor per trialBy country register
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Pralsetinib trials
How many clinical trials are testing Pralsetinib?
9 current trials in our China, USA, Spain, South Korea, UK, Germany, France, Italy, Belgium, Denmark, Poland, Switzerland, Portugal, Canada, Brazil, Mexico, Japan, Taiwan, Singapore, Australia, Israel and Egypt registers name Pralsetinib as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Pralsetinib trials recruiting patients?
Yes. 6 of the 9 trials are recruiting: 4 with sites in China, 1 with sites in USA and 1 with sites in Spain. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Pralsetinib clinical trials?
Fujian Medical University (2), Hoffmann-La Roche (1), Genentech, Inc (1) and Sun Yat-sen University (1), among 8 lead sponsors in total. The number in brackets is how many trials each organisation leads.
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 Pralsetinib 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 Pralsetinib 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 Pralsetinib (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.