Apalutamide clinical trials
Apalutamide is named as an intervention in 30 current clinical trials in our USA, Canada, Australia, France, Spain, China, UK, Germany, Mexico, Poland, Japan, Brazil, Italy, Netherlands, Belgium, Sweden, South Korea, Israel, Czechia, Taiwan, Turkey, Austria, Norway, Switzerland, Denmark, India and Portugal registers. 12 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Aragon Pharmaceuticals, Inc (6). The most-studied condition is Prostatic Neoplasms. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Apalutamide is approved
All regulators →Of the three regulators tracked here, the first to approve Apalutamide was the US, on 14 Feb 2018. 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.
Apalutamide patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Apalutamide, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 14 listed patents; the last listed expires 14 Jan 2041 (US 11723898).
- Latest patent on the drug substance itself: 4 Jun 2033 (US 9481663).
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 Apalutamide
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 Apalutamide works
All drug targets →- Androgen Receptor antagonist AntagonistTarget: AR androgen receptor✓ In ChEMBL and the Guide to Pharmacology
- CancerPhase 3
- Metastatic prostate carcinomaPhase 3
- Progression free survivalPhase 2
- Prostate adenocarcinomaPhase 2
- Salivary gland carcinomaPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL3183409, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 9043, 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 Apalutamide
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 2 technology appraisals of Apalutamide. 2 are current, and 2 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Apalutamide with androgen deprivation therapy for treating high-risk hormone-relapsed non-metastatic prostate cancer NICE TA740 | Recommended | 28 Oct 2021 | Current |
| Apalutamide with androgen deprivation therapy for treating hormone-sensitive metastatic prostate cancer NICE TA741 | Optimised | 28 Oct 2021 | 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 Apalutamide
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 2 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: ErleadaEMA 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.
Reference identifiers for Apalutamide
- ATC code
- L02BB05
- ChEMBL
- CHEMBL3183409
- DrugBank
- DB11901
- PubChem CID
- 24872560
- CAS number
- 956104-40-8
- FDA UNII
- 4T36H88UA7
- Wikidata
- Q21098975
- Wikipedia
- Apalutamide
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Apalutamide
30 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.
Apalutamide in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Apalutamide. 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 |
|---|---|---|---|---|
|
Phase III Randomized, International, Open-Label Clinical Trial of Treatment Intensification with Docetaxel plus Apalutamide in Patients with Metastatic Hormone-Sensitive Prostate Cancer Who Did Not Achieve a Deep PSA Response After Initial Treatment with Apalutamide: REINFORCE Trial
2025-524408-30-01 · CTIS ↗ · Neoplasms
|
Phase 3 | Ongoing | Alianza Multidisciplinar Para La Investigacion De Los Tumores Genitourinarios Guard | Spain, Germany, France + 2 more |
Apalutamide 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)
2 single-substance products containing Apalutamide on the HPRA medicines list.
- Erleada 240 mg film-coated tabletsJanssen-Cilag International NV · EU/1/18/1342/004-006
- Erleada 60 mg film-coated tabletsJanssen-Cilag International NV · EU/1/18/1342/001-003
Supply shortages
No entry for Apalutamide in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Apalutamide
36 conditionsAll 36 conditions
| Condition (as registered) | Trials |
|---|---|
| Prostatic Neoplasms | 9 |
| Prostate Cancer | 4 |
| Metastatic Prostate Cancer | 3 |
| Prostate Cancer (Adenocarcinoma) | 2 |
| High Risk Prostate Cancer | 2 |
| Prostate Adenocarcinoma | 2 |
| Stage III Prostate Cancer AJCC v8 | 2 |
| Metastatic Castration-resistant Prostate Cancer | 1 |
| Metastatic Castrate-sensitive Prostate Cancer | 1 |
| Metastatic Castration-resistant Prostate Neoplasms | 1 |
| Metastatic Hormone-sensitive Prostate Cancer | 1 |
| Metastatic Hormone-Sensitive Prostate Cancer | 1 |
| Castration-Resistant Prostate Cancer (CRPC) | 1 |
| Castration-Resistant Prostate Cancer | 1 |
| Metastatic Cancer | 1 |
| Neoplasm, Prostate | 1 |
| Castrate-sensitive | 1 |
| Castrate-sensitive Prostate Cancer | 1 |
| Neoadjuvant Therapy | 1 |
| Locally Advanced Prostate Cancer | 1 |
| Intense Endocrine Therapy | 1 |
| Castration-Sensitive Prostate Cancer | 1 |
| Hormone Sensitive Prostate Cancer | 1 |
| Metastatic Tumor | 1 |
| Metastatic Castration-resistant Prostate Cancer (mCRPC) | 1 |
| Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) | 1 |
| Metastatic Castrate-Resistant Prostate Cancer (mCRPC) | 1 |
| Recurrent Prostate Carcinoma | 1 |
| Stage III Prostate Adenocarcinoma AJCC v7 | 1 |
| Stage IV Prostate Adenocarcinoma AJCC v7 | 1 |
| Stage I Prostate Cancer AJCC v8 | 1 |
| Stage II Prostate Cancer AJCC v8 | 1 |
| Stage IVA Prostate Cancer AJCC v8 | 1 |
| Salivary Gland Neoplasms | 1 |
| Metastatic Castration-Resistant Prostate Cancer | 1 |
| Prostatic Neoplasms, Castration-Resistant | 1 |
Sponsors
lead sponsor per trial+ 2 more sponsors in the trial list above.
By 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 Apalutamide trials
How many clinical trials are testing Apalutamide?
30 current trials in our USA, Canada, Australia, France, Spain, China, UK, Germany, Mexico, Poland, Japan, Brazil, Italy, Netherlands, Belgium, Sweden, South Korea, Israel, Czechia, Taiwan, Turkey, Austria, Norway, Switzerland, Denmark, India and Portugal registers name Apalutamide (also registered as JNJ-56021927) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Apalutamide trials recruiting patients?
Yes. 12 of the 30 trials are recruiting: 6 with sites in USA, 2 with sites in Canada, 3 with sites in Australia, 2 with sites in France, 2 with sites in Spain, 3 with sites in China, 1 with sites in UK, 1 with sites in Germany, 1 with sites in Mexico, 1 with sites in Poland, 2 with sites in Japan, 1 with sites in Brazil, 3 with sites in Italy, 1 with sites in Netherlands, 2 with sites in Belgium, 2 with sites in Sweden, 1 with sites in South Korea, 1 with sites in Israel, 1 with sites in Taiwan, 1 with sites in Turkey, 1 with sites in Austria, 1 with sites in Norway, 3 with sites in Switzerland and 1 with sites in India. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Apalutamide clinical trials?
Aragon Pharmaceuticals, Inc (6), Janssen Research & Development, LLC (6), NRG Oncology (3) and AstraZeneca (2), among 17 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Apalutamide licensed in Ireland?
Yes. The HPRA medicines list includes 2 single-substance products containing Apalutamide, for example Erleada 240 mg film-coated tablets (Janssen-Cilag International NV). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Apalutamide shortage?
Not in the lists we track: Apalutamide 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 Apalutamide 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 Apalutamide 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 Apalutamide (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.