Darolutamide clinical trials
Darolutamide is named as an intervention in 58 current clinical trials in our China, USA, Spain, France, Canada, Australia, Italy, Belgium, Germany, UK, Japan, Brazil, Sweden, Switzerland, Netherlands, Poland, Austria, South Korea, Taiwan, Israel, India, Turkey, Mexico, Ireland, Portugal, Norway, Denmark, Czechia and Singapore registers. 36 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Bayer (12). The most-studied condition is Prostate Cancer. The EU clinical trials register (CTIS) separately lists 2 authorised or ongoing trials.
Where Darolutamide is approved
All regulators →Of the three regulators tracked here, the first to approve Darolutamide was the US, on 30 Jul 2019. 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.
Darolutamide patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Darolutamide, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 10 listed patents; the last listed expires 17 Jun 2042 (US 12329742).
- Latest patent on the drug substance itself: 27 Feb 2038 (US 11168058).
- Exclusivity I-971: New indication: darolutamide as a single agent for treatment of adult patients with metastatic castration-sensitive prostate cancer (mcspc), until 3 Jun 2028.
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 Darolutamide
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 Darolutamide works
All drug targets →- Androgen Receptor antagonist AntagonistTarget: AR androgen receptor✓ In ChEMBL and the Guide to Pharmacology
- Breast cancerPhase 2
- CancerPhase 2
- Metastatic prostate carcinomaPhase 2
- Ovarian granulosa tumourPhase 2
- Prostate adenocarcinomaPhase 2
- Salivary gland cancerPhase 2
- Salivary gland carcinomaPhase 2
- Triple-negative breast carcinomaPhase 2
- Non-small cell lung carcinomaPhase 1/2
- Hematopoietic and lymphoid cell neoplasmPhase 1
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4297185, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 10439, 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 Darolutamide
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 3 technology appraisals of Darolutamide. 3 are current, and 3 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Darolutamide with androgen deprivation therapy for treating hormone-sensitive metastatic prostate cancer NICE TA1109 | Recommended | 12 Nov 2025 | Current |
| Darolutamide with androgen deprivation therapy and docetaxel for treating hormone-sensitive metastatic prostate cancer NICE TA903 | Recommended | 21 Jun 2023 | Current |
| Darolutamide with androgen deprivation therapy for treating hormone-relapsed non-metastatic prostate cancer NICE TA660 | Recommended | 25 Nov 2020 | 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 Darolutamide
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 1 product on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: NubeqaEMA 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 Darolutamide
58 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.
Darolutamide in the EU trials register (CTIS)
2 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Darolutamide. 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 |
|---|---|---|---|---|
|
A Randomised, Double‑Blind, Placebo‑Controlled, 2‑Cohort, Phase III Study of Saruparib Combined with Physician’s Choice of Androgen Receptor Pathway Inhibitor in Patients With Metastatic Hormone‑Sensitive Prostate Cancer, Previously Treated With Docetaxel or PSMA‑directed 177Lutetium‑Containing Therapy Without Disease Progression, and With Prostate‑Specific Antigen ≥ 0.2 ng/mL: EvoPAR Prostate‑05
2026-526275-38-00 · CTIS ↗ · Male Urogenital Diseases
|
Phase 3 | Authorised | AstraZeneca AB | Poland, Hungary, France + 4 more |
|
Clinical Application of the Androgen Receptor Inhibitor Darolutamide to Upregulate the Prostate-Specific Membrane Antigen (PSMA) Protein Expression in Patients with Hormone Sensitive Prostate Cancer.
- The DARO-flare Trial -
2025-520482-52-03 · CTIS ↗ · Diagnosis
|
Phase 1 | Authorised | Amsterdam UMC Stichting | Netherlands |
Darolutamide 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)
1 single-substance product containing Darolutamide on the HPRA medicines list.
- NUBEQA 300 mg film-coated tabletsBayer AG · EU/1/20/1432/001
Supply shortages
No entry for Darolutamide in the EMA, FDA or German BfArM shortage lists we track.
Recent approvals
- NubeqaFDA · 30 Jul 2019 · New Drug (NDA) · Bayer Healthcare
Conditions studied with Darolutamide
47 conditionsAll 47 conditions
| Condition (as registered) | Trials |
|---|---|
| Prostate Cancer | 17 |
| Metastatic Castration-resistant Prostate Cancer | 6 |
| Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) | 5 |
| Metastatic Prostate Cancer | 3 |
| Metastatic Hormone-sensitive Prostate Cancer (mHSPC) | 3 |
| Non-metastatic Castration-resistant Prostate Cancer | 3 |
| Metastatic Hormone-Sensitive Prostate Cancer | 2 |
| Metastatic Hormone-sensitive Prostate Cancer | 2 |
| Hormone Sensitive Prostate Cancer | 2 |
| Prostate Cancer (Adenocarcinoma) | 2 |
| Prostate Cancer Metastatic | 1 |
| Metastatic Castration-Sensitive Prostate Cancer | 1 |
| mCRPC (Metastatic Castration-resistant Prostate Cancer) | 1 |
| Genital Diseases, Male | 1 |
| Urogenital Diseases, Male | 1 |
| Prostatic Disease | 1 |
| Biochemically Recurrent Prostate Cancer | 1 |
| Cancer | 1 |
| Advanced Solid Tumor | 1 |
| Metastatic Castration Resistant Prostate Cancer | 1 |
| Metastatic Castration-resistant Prostate Neoplasms | 1 |
| Prostatic Neoplasms | 1 |
| Metastatic Castration-Resistant Prostate Cancer Patients | 1 |
| Metastatic Castration-resistant Prostate Cancer, mCRPC | 1 |
| mCRPC | 1 |
| Castration Resistant Prostatic Cancer | 1 |
| Metastatic Castration Sensitive Prostate Cancer (mCSPC) | 1 |
| Prostate Cancer (CRPC) | 1 |
| Refractory or Relapsed Solid Tumors | 1 |
| High-risk Localized Prostate Cancer | 1 |
| mHSPC | 1 |
| Prostate Cancer Patients | 1 |
| Intermitent Anti-androgen Therapy | 1 |
| High Risk Prostate Carcinoma | 1 |
| Prostatic Cancer, Castration-Resistant | 1 |
| Metastatic Hormone-Sensitive Prostate Cance | 1 |
| Genitourinary Cancers | 1 |
| Metastatic Tumor | 1 |
| Metastatic Castration-resistant Prostate Cancer (mCRPC) | 1 |
| Castration-resistant Prostate Cancer | 1 |
| Prostate Adenocarcinoma | 1 |
| Low-volume Metastasis | 1 |
| Advanced Prostate Carcinoma | 1 |
| Cancer of Prostate | 1 |
| PSA | 1 |
| Castrate Resistant Prostate Cancer | 1 |
| Advanced Prostate Cancer | 1 |
Sponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Bayer | 12 |
| AstraZeneca | 4 |
| UNICANCER | 3 |
| Canadian Cancer Trials Group | 2 |
| Daiichi Sankyo | 1 |
| University of Sydney | 1 |
| Celcuity Inc | 1 |
| Novartis Pharmaceuticals | 1 |
| ParVation Therapeutics, Inc | 1 |
| ORIC Pharmaceuticals | 1 |
| Janssen Research & Development, LLC | 1 |
| Amgen | 1 |
| K36 Therapeutics, Inc | 1 |
| Janux Therapeutics | 1 |
| Pfizer | 1 |
+ 26 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 Darolutamide trials
How many clinical trials are testing Darolutamide?
58 current trials in our China, USA, Spain, France, Canada, Australia, Italy, Belgium, Germany, UK, Japan, Brazil, Sweden, Switzerland, Netherlands, Poland, Austria, South Korea, Taiwan, Israel, India, Turkey, Mexico, Ireland, Portugal, Norway, Denmark, Czechia and Singapore registers name Darolutamide (also registered as BAY 1841788) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Darolutamide trials recruiting patients?
Yes. 36 of the 58 trials are recruiting: 11 with sites in China, 12 with sites in USA, 11 with sites in Spain, 11 with sites in France, 5 with sites in Canada, 7 with sites in Australia, 7 with sites in Italy, 6 with sites in Belgium, 6 with sites in Germany, 5 with sites in UK, 4 with sites in Japan, 3 with sites in Brazil, 5 with sites in Sweden, 7 with sites in Switzerland, 3 with sites in Netherlands, 3 with sites in Poland, 2 with sites in Austria, 4 with sites in South Korea, 2 with sites in Taiwan, 2 with sites in Israel, 3 with sites in India, 3 with sites in Turkey, 1 with sites in Mexico, 2 with sites in Ireland, 1 with sites in Portugal and 2 with sites in Norway. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Darolutamide clinical trials?
Bayer (12), AstraZeneca (4), UNICANCER (3) and Canadian Cancer Trials Group (2), among 41 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Darolutamide clinical trials in Ireland?
Yes. 3 trials in our Ireland register (ClinicalTrials.gov). Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.
Is Darolutamide licensed in Ireland?
Yes. The HPRA medicines list includes 1 single-substance product containing Darolutamide, for example NUBEQA 300 mg film-coated tablets (Bayer AG). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Darolutamide shortage?
Not in the lists we track: Darolutamide 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 Darolutamide 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 Darolutamide 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 Darolutamide (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.