Neratinib is named as an intervention in 7 current clinical trials in our Canada, Mexico, France, Belgium, Spain, Israel and Egypt registers. 5 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is University Health Network, Toronto (2). The most-studied condition is Biliary Tract Neoplasms.
Neratinib was first approved in the US on 17 Jul 2017. 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.
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.
The same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
1 single-substance product containing Neratinib on the HPRA medicines list.
No entry for Neratinib in the EMA, FDA or German BfArM shortage lists we track.
| Condition (as registered) | Trials |
|---|---|
| Biliary Tract Neoplasms | 1 |
| Early-stage Breast Cancer | 1 |
| HER2 Positive Breast Cancer | 1 |
| Hormone Receptor Positive | 1 |
| Solid Tumor | 1 |
| Central Nervous System Tumor | 1 |
| Lymphoma | 1 |
| Leukemia | 1 |
| Pancreatic Ductal Carcinoma | 1 |
| Advanced Cancer | 1 |
| Epithelial Tumor | 1 |
| Breast Cancer | 1 |
| HER2-positive Breast Cancer | 1 |
| Advanced Malignant Solid Neoplasm | 1 |
| Anatomic Stage III Breast Cancer AJCC v8 | 1 |
| Anatomic Stage IV Breast Cancer AJCC v8 | 1 |
| Locally Advanced Malignant Solid Neoplasm | 1 |
| Malignant Female Reproductive System Neoplasm | 1 |
| Malignant Solid Neoplasm | 1 |
| Recurrent Malignant Female Reproductive System Neoplasm | 1 |
| Recurrent Malignant Solid Neoplasm | 1 |
| Lead sponsor | Trials |
|---|---|
| University Health Network, Toronto | 2 |
| National Cancer Institute (NCI) | 2 |
| UNICANCER | 1 |
| Spanish Breast Cancer Research Group | 1 |
| Memorial Sloan Kettering Cancer Center | 1 |
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in Canada | 3 | 2 |
| Clinical trials in Mexico | 2 | 2 |
| Clinical trials in France | 1 | 1 |
| Clinical trials in Belgium | 1 | 1 |
| Clinical trials in Spain | 1 | 0 |
| Clinical trials in Israel | 1 | 1 |
| Clinical trials in Egypt | 1 | 1 |
A trial with sites in more than one country appears in each of those registers.
7 current trials in our Canada, Mexico, France, Belgium, Spain, Israel and Egypt registers name Neratinib (also registered as 2-Butenamide) as a drug or biological intervention, as of the registry sync on 27 September 2026. Completed and withdrawn studies are not counted.
Yes. 5 of the 7 trials are recruiting: 2 with sites in Canada, 2 with sites in Mexico, 1 with sites in France, 1 with sites in Belgium, 1 with sites in Israel and 1 with sites in Egypt. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
University Health Network, Toronto (2), National Cancer Institute (NCI) (2), UNICANCER (1) and Spanish Breast Cancer Research Group (1), among 5 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Yes. The HPRA medicines list includes 1 single-substance product containing Neratinib, for example Nerlynx 40 mg Film-coated tablet (Pierre Fabre Medicament). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Not in the lists we track: Neratinib has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Neratinib works or whether it is effective, and it is not medical advice.
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Neratinib works or whether it is effective. Each trial links to its own record so you can check it yourself.
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Neratinib (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 27 Sep 2026.