Neladalkib clinical trials
Neladalkib is named as an intervention in 2 current clinical trials in our UK, USA, Germany, France, Spain, Italy, Netherlands, Belgium, Switzerland, Canada, Japan, South Korea, Taiwan, Singapore, Australia, Denmark, Poland, Austria, Czechia, Portugal, Brazil and Mexico registers. 2 are recruiting patients now. The most common phase is Phase 3. The lead sponsor is Nuvalent Inc. The most-studied condition is Non-small Cell Lung Cancer.
How Neladalkib works
All drug targets →- Non-small cell lung carcinomaPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL6068023, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 13214, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Neladalkib
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 Neladalkib
2 trials| Study | Phase | Status | Lead sponsor | Registers |
|---|---|---|---|---|
|
Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC
NCT06765109 · Non-small Cell Lung Cancer, Anaplastic Lymphoma Kinase-positive
|
Phase 3 | Recruiting | Nuvalent Inc | UK, USA, Germany, France, Spain, Italy, Netherlands, Belgium, Denmark, Poland, Switzerland, Austria, Czechia, Portugal, Canada, Brazil, Mexico, Japan, South Korea, Taiwan, Singapore, Australia |
|
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
NCT05384626 · Locally Advanced Solid Tumor, Metastatic Solid Tumor
|
Phase 1/2 | Recruiting | Nuvalent Inc | UK, USA, Germany, France, Spain, Italy, Netherlands, Belgium, Switzerland, Canada, Japan, South Korea, Taiwan, Singapore, Australia |
Registers 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 Neladalkib
4 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Nuvalent Inc | 2 |
By country register
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Neladalkib trials
How many clinical trials are testing Neladalkib?
2 current trials in our UK, USA, Germany, France, Spain, Italy, Netherlands, Belgium, Switzerland, Canada, Japan, South Korea, Taiwan, Singapore, Australia, Denmark, Poland, Austria, Czechia, Portugal, Brazil and Mexico registers name Neladalkib (also registered as NVL-655) as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Neladalkib trials recruiting patients?
Yes. 2 of the 2 trials are recruiting: 2 with sites in UK, 2 with sites in USA, 2 with sites in Germany, 2 with sites in France, 2 with sites in Spain, 2 with sites in Italy, 2 with sites in Netherlands, 2 with sites in Belgium, 2 with sites in Switzerland, 2 with sites in Canada, 2 with sites in Japan, 2 with sites in South Korea, 2 with sites in Taiwan, 2 with sites in Singapore, 2 with sites in Australia, 1 with sites in Denmark, 1 with sites in Poland, 1 with sites in Austria, 1 with sites in Czechia, 1 with sites in Portugal, 1 with sites in Brazil and 1 with sites in Mexico. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Neladalkib clinical trials?
The lead sponsor is Nuvalent Inc. 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 Neladalkib 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 Neladalkib 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 Neladalkib (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 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.