DAROSTEP: Evaluating Step Counts as a Biomarker and Its Relationship on Treatment Outcomes in Vulnerable Patients With Metastatic Hormone-Sensitive Prostate Cancer on Darolutamide and Androgen Deprivation Therapy

This prospective clinical trial aims to investigate the impact of darolutamide in combination with standard-of-care androgen deprivation on physical activity, specifically step count, and its correlation with important markers of safety in vulnerable adults who screen positive by a brief geriatric assessment (GA) and metastatic hormone-sensitive prostate cancer.

Start Date01 Nov 2025

Sponsor / Collaborator

The University of Chicago

NCT07016399

/ Not yet recruitingPhase 2IIT

A Phase II Neoadjuvant Clinical Trial of the Androgen Receptor Inhibitor Darolutamide in Early-Stage Androgen Receptor Positive (AR+) Triple-Negative Breast Cancer

This phase II trial compares the effect of adding darolutamide to standard therapy versus standard therapy alone before surgery for the treatment of patients with stage II-IIIA androgen receptor positive triple-negative breast carcinoma. Standard therapy before surgery for triple-negative breast cancer typically consists of a combination of chemotherapy and immunotherapy drugs. Chemotherapy drugs, such as carboplatin, paclitaxel, doxorubicin and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Darolutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Giving darolutamide in combination with standard therapy before surgery may make the tumor smaller and may reduce the amount of normal tissue that needs to be removed.

Start Date01 Sep 2025

Sponsor / Collaborator

The Vanderbilt-Ingram Cancer Center

[+1]

NCT07027124

/ Not yet recruitingPhase 2IIT

Neoadjuvant ADT and Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in NCCN High-risk and Molecularly Stratified Prostate Cancer Patients

This is a single-arm, phase II study of neoadjuvant combination therapy of Androgen Deprivation Therapy (ADT), [Gonadotropin-Releasing Hormone (GnRH) agonist Leuprolide], androgen receptor (AR)-antagonist Darolutamide and Pembrolizumab in a stratified high-risk localized prostate cancer cohort, followed by adjuvant treatment with Pembrolizumab (12 cycles) post-radical prostatectomy (RP).
Patients with National Comprehensive Cancer Network (NCCN) high-risk non-metastatic prostate cancer (localized or locally advanced) (defined as Gleason ≥8, disease stage >=cT3a, or PSA l >20 ng/mL) will be risk-stratified at a biopsy using Decipher, a commercial standard-of-care diagnostic assay. Patients satisfying all three criteria of high-risk genomic characteristics listed below as per the Decipher grid results will be enrolled in the study:
1. Decipher Genomic classifier, GC>0.6
2. AR activity score/AR-output gene signature (ARoS)>11.0
3. High Luminal B score/ PAM50 subtype signature

Start Date01 Jun 2025

Sponsor / Collaborator

Icahn School of Medicine at Mount Sinai

[+2]

100 Clinical Results associated with Darolutamide

100 Translational Medicine associated with Darolutamide

100 Patents (Medical) associated with Darolutamide

506

Literatures (Medical) associated with Darolutamide

01 Jul 2025·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Discovery of novel tetrahydroquinoline derivatives as potent, selective, and orally Available AR antagonists

Article

Author: Qin, Yiyang ; Hou, Tingjun ; Zhang, Minkui ; Yuan, Leer ; Sheng, Rong ; Li, Dan ; Cai, Lvtao ; Liao, Jinbiao ; Liao, Jianing

Androgen receptor (AR) antagonists are the first-line medicine for the treatment of prostate cancer (PCa) in clinic. In our previous work, the tetrahydroquinoline derivative AT2 was identified as a novel scaffold AR antagonist via virtual screening and structural modifications, while its poor pharmacokinetic properties hindered further development. Herein, we report the systematic structural optimizations of AT2 and discover a novel tetrahydroquinoline derivative C2 as potent AR antagonist with an IC₅₀ value of 0.019 μM, accompanied with excellent selectivity over other nuclear receptors (PR, GR, MR). Further biological assays revealed that C2 significantly inhibited LNCaP cell proliferation, and efficiently reduced PSA protein expression. Especially, C2 showed superior efficacy against AR^F877L/T878A mutants compared to darolutamide and enzalutamide. Furthermore, C2 demonstrated excellent oral bioavailability, indicating the potential to enhance in vivo efficacy and to serve as a promising therapeutic option for PCa treatment.

01 Jul 2025·Genes & Diseases

GATA2 up-regulation restores androgen receptor chromatin association and advances darolutamide resistance in prostate cancer

Article

Author: Yu, Chengtai ; Zhou, Tianyi ; Han, Yali ; Feng, Qin ; He, Bin

01 Jul 2025·BIOCHEMICAL AND BIOPHYSICAL RESEARCH COMMUNICATIONS

Gnetin C sensitizes darolutamide-resistant prostate cancer cells by targeting NAD+ and energy metabolism

Article

Author: Endo, Satoshi ; Abe, Naohito ; Honda, Ryo ; Kashiwagi, Hirohito ; Nomura, Teiko Komori ; Kudo, Yudai ; Saka, Tomofumi ; Kawano, Shinya ; Oyama, Masayoshi ; Ikari, Akira ; Kawai, Mina ; Yoshino, Yuta

Resistance to androgen receptor-targeted therapies, including darolutamide (Dar), remains a major challenge in treating castration-resistant prostate cancer (CRPC). Metabolic adaptations, particularly involving dysregulated NAD⁺ metabolism and altered energy pathways, have been implicated in therapeutic resistance. In this study, we investigated whether Gnetin C-a resveratrol dimer derived from Gnetum gnemon-could overcome Dar resistance in prostate cancer cells. A recently established Dar-resistant 22Rv1 cell line (Dar-R) exhibited a metabolically quiescent phenotype, characterized by suppressed NAD⁺ metabolism, a decreased NAD⁺/NADH ratio, and simultaneous inhibition of both glycolysis and oxidative phosphorylation. Gnetin C demonstrated strong anticancer activity in both parental and Dar-R cells. In Dar-R cells, it downregulated NMNAT2, resulting in intracellular NAD⁺ depletion, and suppressed key mitochondrial proteins, leading to mitochondrial dysfunction. Gnetin C also downregulated Drp1 and upregulated Mitofusin-2, indicating a role in mitochondrial dynamics, and further inhibited glycolytic enzymes and glycolytic activity. These combined effects contributed to its potent anticancer activity by impairing both mitochondrial and glycolytic energy metabolism. Notably, Gnetin C significantly enhanced Dar sensitivity in Dar-R cells, accompanied by increased production of total and mitochondrial reactive oxygen species and the induction of apoptosis. These findings identify Gnetin C as a promising candidate for overcoming drug resistance in CRPC through metabolic disruption.

203

News (Medical) associated with Darolutamide

20 Jun 2025

·www.fiercepharma.com

Europe's CHMP gives thumbs up to ExCellThera's blood cancer cell therapy Zemcelpro

Europe’s Committee for Medicinal Products for Human Use has recommended marketing authorization for ExCellThera’s novel cell therapy Zemcelpro in certain blood cancer patients. In a first for the bloc, Europe’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for a new type of stem cell transplant therapy for certain blood cancer patients. The marketing endorsement was awarded to ExCellThera’s Zemcelpro and covers a recommended approval in adults with blood cancers that require an allogeneic hematopoietic stem cell transplantation (HSCT) following myeloablative conditioning for whom no other type of suitable donor cells is available.Zemcelpro contains stem cells from a donor’s umbilical cord blood, some of which have been grown and multiplied, the European Medicines Agency (EMA) said in a press release on the decision. By boosting the number of cells, Zemcelpro makes the stem cells from a small cord blood unit more effective, the European regulator explained. For several blood cancers—including leukemias, which are detected in the blood; lymphomas, which are found in the lymph nodes; and myelodysplastic syndrome and myelomas, which are diagnosed in the bone marrow—the only current curative treatment option is allogeneic HSCT. This type of transplant involves using donated stem cells to replace the patient’s bone marrow cells to form new marrow that produces healthy blood cells. The CHMP based its Zemcelpro recommendation on pooled analysis of two single-arm trials that included 25 patients. The studies found that 84% of patients who received Zemcelpro achieved neutrophil engraftment, when donor stem cells establish themselves in the recipient’s bone marrow and produce the white blood cells known as neutrophils within a median span of 20 days.Some 10,000 new blood cancer cases requiring bone marrow transplant crop up in Europe each year, ExCellThera estimates. Many of these patients do not have access to suitable donor cells largely because of the unavailability of matched donors, the company explained. ExCellThera said it expects to gain marketing authorization from the EMA in roughly two months' time. After winning an endorsement from the CHMP, prospective medicines must go before the European Commission for a final approval verdict.ExCellThera also plans to file for approval of Zemcelpro in the U.S., U.K. and other countries. Madrigal’s Rezdiffra among others gaining CHMP nodsThe committee has also given a thumbs up to Madrigal’s Rezdiffra for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), a disease where fat cells accumulate in the liver causing chronic inflammation. If the drug gains marketing authorization, it would become the first treatment in the EU for the condition. Fifteen months ago, Rezdiffra became the first drug approved for MASH in the U.S. Also making the grade this month was Teva blockbuster Austedo for patients with moderate-to-severe tardive dyskinesia. The FDA approved the treatment in the indication eight years ago. Tardive dyskinesia is an irreversible movement disorder characterized by repetitive and uncontrollable movements of the tongue, lips, face, trunk and extremities and can be caused by medications used to treat mental health or gastrointestinal conditions.Meanwhile, Pfizer spinout SpringWorks Therapeutics has picked up a CHMP nod for Ogsiveo in adults with progressing desmoid tumors, which are marked by noncancerous soft tissue growths in the limbs and abdomen that often cause severe pain and disfigurement. The FDA approved Ogsiveo in the same indication in 2023.Also gaining a positive recommendation from the CHMP was Partner Therapeutics’ Imreplys for the treatment of patients exposed to myelosuppressive doses of radiation with hematopoietic sub-syndrome of acute radiation syndrome. The medicine is known as Leukine in the U.S. where it was approved in 2018. CHMP signs off on label expansions for 6 drugsAside from new approval recommendations, the CHMP has also endorsed labeled expansions for a half-dozen established medicines. The committee gave a thumbs up to Ipsen’s Cabometyx as a second-line treatment for patients with unresectable or metastatic, well differentiated extra-pancreatic (epNET) and pancreatic (pNET) neuroendocrine tumors. The FDA signed off Cabometyx in the indication three months ago. The treatment, which has been on the market since 2016, brought home sales of $1.8 billion last year.Also winning CHMP recommendations were Johnson & Johnson blockbusters Darzalex, for smoldering multiple myeloma, and Imbruvica, for patients with previously treated mantle cell lymphoma who would be eligible for autologous stem cell transplant. AbbVie partners with J&J on Imbruvica.The committee further signed off on expansions for GSK’s lupus treatment Benlysta, Bayer’s prostate cancer drug Nubeqa and Sanofi’s multiple myeloma medicine Sarclisa. CHMP opens re-examination of Lilly’s KisunlaElsewhere, fifteen months after giving a thumbs down to Eli Lilly’s Alzheimer’s disease treatment Kisunla in March of last year, the CHMP will give the medication a second look. The regulator said that it re-opened its examination of Kisunla on June 2. The FDA signed off on Kisunla in July of last year, opening up competition with Eisai and Biogen’s Alzheimer's rival Leqembi.

Drug ApprovalCell TherapyClinical Result

20 Jun 2025

·www.globenewswire.com

CHMP recommends third indication for darolutamide for patients with advanced prostate cancer

ORION CORPORATION PRESS RELEASE 20 JUNE 2025 at 13.30 EEST CHMP recommends third indication for darolutamide for patients with advanced prostate cancer CHMP adopts positive opinion for the marketing authorisation of darolutamide in combination with androgen deprivation therapy (ADT) for patients with metastatic hormone-sensitive prostate cancer (mHSPC) in the European Union.Positive opinion is based on results from the pivotal Phase III ARANOTE trial.Pending approval, this broadened indication would give doctors the option to use darolutamide plus ADT, with or without chemotherapy (docetaxel), offering greater flexibility to tailor treatment plans to meet mHSPC patients’ needs. Orion’s collaboration partner Bayer announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended darolutamide, an oral androgen receptor inhibitor (ARi), plus androgen deprivation therapy (ADT) for marketing authorisation in the European Union (EU) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). The CHMP recommendation is based on positive results from the pivotal Phase III ARANOTE trial which showed that darolutamide plus ADT significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54; 95% CI 0.41–0.71; P<0.0001) in patients with mHSPC. A final decision on marketing authorisation from the European Commission is anticipated in the coming months. The U.S. Food and Drug Administration (FDA) recently approved darolutamide in combination with ADT for mHSPC in June 2025, making it the first and only in the US and FDA-approved ARi for the treatment of patients with mHSPC, in combination with ADT, with or without chemotherapy. Darolutamide, under the brand name Nubeqa®, is approved in over 85 countries for use with ADT and docetaxel in mHSPC, and with ADT alone in non-metastatic castration-resistant prostate cancer (nmCRPC) in patients who are at high risk of developing metastatic disease. Darolutamide is developed jointly by Orion and Bayer. Prostate cancer is the second most common cancer and the fifth most common cause of cancer death in men worldwide. In 2022, an estimated 1.5 million men were diagnosed with prostate cancer, and about 397,000 died from the disease worldwide.1 In Europe, there were almost 474,000 estimated new cases of prostate cancer in 2022 with approximately 115,000 deaths. 2 Prostate cancer diagnoses are projected to increase to 2.9 million by 2040.3 About the ARANOTE trial The ARANOTE trial is a randomized, double-blind, placebo-controlled Phase III study designed to assess the efficacy and safety of darolutamide plus ADT in patients with mHSPC. 669 patients were randomized 2:1 to receive 600mg of darolutamide twice daily or matching placebo in addition to ADT. The primary endpoint of this study is rPFS, measured as time from randomization to date of first documented radiological progressive disease or death due to any cause, whichever occurs first. Secondary endpoints include overall survival (time to death from any cause), time to first castration resistant event, time to initiation of subsequent anti-cancer therapy, time to prostate-specific antigen (PSA) progression, PSA undetectable rates, time to pain progression, and safety assessments. Results from the Phase III ARANOTE trial presented at ESMO 2024 and published in The Journal of Clinical Oncology showed that darolutamide plus ADT significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54; 95% CI 0.41–0.71; P<0.0001), in patients with mHSPC. Consistent benefits in radiological progression-free survival (rPFS) were observed across prespecified subgroups, including patients with high-volume (HR 0.60, 95% CI: 0.44-0.80) and low-volume (HR 0.30, 95% CI: 0.15-0.60) mHSPC. The incidence of adverse events in the treatment group with darolutamide plus ADT in the ARANOTE study was comparable to placebo plus ADT. Darolutamide plus ADT was generally well tolerated and showed lower discontinuation rates due to adverse events compared to placebo plus ADT. About darolutamide Darolutamide is an oral ARi with a unique chemical structure that binds with high affinity to the androgen receptor and exhibits a strong antagonistic effect against the androgen receptor inhibiting the receptor function and the growth of prostate cancer cells. Additionally, preclinical models and neuroimaging data in healthy humans, support darolutamide's low potential for blood-brain barrier penetration. Darolutamide (plus ADT or plus ADT and docetaxel) demonstrated a side effect profile, in both mHSPC registrational studies where the incidences of adverse events were roughly similar to the respective comparator arm. Darolutamide is a treatment option for doctors and patients, considering its tolerability and low risk of drug interaction. A robust clinical development program is underway investigating darolutamide across various stages of prostate cancer. The program includes the Phase III ARASTEP trial evaluating darolutamide plus ADT compared to ADT alone in hormone-sensitive high-risk biochemical recurrence (BCR) prostate cancer, who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline. Furthermore, darolutamide is also being investigated by Bayer in the collaborative Phase III DASL-HiCaP (ANZUP1801) trial led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP). The study evaluates darolutamide as a treatment for localized prostate cancer in combination with radiotherapy. About metastatic hormone-sensitive prostate cancer At the time of diagnosis, most men have localized prostate cancer, meaning their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy. mHSPC is a stage in the disease where the cancer has spread outside of the prostate to other parts of the body. Up to 10% of men will present with mHSPC when first diagnosed.4,5,6 For patients with mHSPC, ADT is the cornerstone of treatment, in combination with chemotherapy docetaxel and/or an androgen receptor inhibitor (ARi). Despite treatment, most men with mHSPC will eventually progress to castration-resistant prostate cancer (CRPC), a condition with limited survival. References Bray F et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21834 Accessed: June 2025.Ferlay J et al. 2024. Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer. Available at: https://gco.iarc.who.int/today. Accessed June 2025..James ND et al. Lancet 2024; 403: 1683–722.Piombino C et al. Cancers (Basel). 2023 Oct 11;15(20):4945.Helgstrand JT et al. Cancer. 2018;124(14):2931-2938.Buzzoni C et al. Eur. Urol. 2015;68:885–890. Publisher:Orion CorporationCommunicationsOrionintie 1A, FI-02200 Espoo, Finlandwww.orionpharma.com Orion is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years. We develop, manufacture and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Orion has an extensive portfolio of proprietary and generic medicines and consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion are used to treat cancer, neurological diseases and respiratory diseases, among others. In 2024 Orion's net sales amounted to EUR 1,542 million and the company employed about 3,700 professionals worldwide, dedicated to building well-being. Orion's A and B shares are listed on Nasdaq Helsinki.

Phase 3Clinical ResultDrug Approval

04 Jun 2025

·www.fiercepharma.com

Bayer gains key FDA expansion for fast-rising prostate cancer drug Nubeqa

The FDA has expanded the use of Bayer's Nubeqa without chemotherapy to patients with metastatic castration-sensitive prostate cancer. It was approved in the indication three years ago in combo with chemo. Bayer has taken another step toward achieving its €3 billion peak sales estimate for androgen receptor inhibitor Nubeqa, scoring an FDA approval to expand its use to all patients with metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC).The label expansion comes three years after the FDA signed off on Nubeqa in combination with androgen deprivation therapy (ADT) and the chemotherapy docetaxel to treat patients with mCSPC. The new nod allows Nubeqa to be used along with ADT by those who can’t tolerate chemo.The FDA endorsement was based on results of a phase 3 trial, ARANOTE, which showed that Nubeqa significantly extended the time before tumor progression or death in patients with mCSPC compared with ADT alone. In the study of 669 patients who were randomized 2 to 1 to receive 600 mg of Nubeqa plus ADT or placebo plus ADT, Nubeqa reduced the risk of radiographic progression or death (rPFS) by 46%, allowing the trial to achieve its primary endpoint.The result demonstrated Nubeqa’s “powerful efficacy,” according to the trial’s principal investigator Dr. Fred Saad, M.D., of the University of Montreal Hospital Center.“Today’s approval further expands physicians’ options for using Nubeqa with and without docetaxel in this setting, providing a potential new choice for patients,” Saad added in a release.Nubeqa was originally approved in 2019 in combination with ADT to treat patients with non-metastatic castration-resistant (nmCRPC) who are at risk of developing metastatic disease. Last year, Nubeqa achieved blockbuster status for the first time with global sales of 1.52 billion euros ($1.65 billion), an increase of 78% from the prior year. With first-quarter sales of 515 million euros ($574 million), Nubeqa is on its way to generating more than $2 billion in 2025.In addition to the two existing tumor settings, Bayer is running the phase 3 trial to evaluate if the addition of Nubeqa could improve upon ADT in non-metastatic hormone-sensitive prostate cancer at high risk of biochemical recurrence. The study has an estimated primary completion date of early 2027.Other androgen receptor inhibitors on the market are Pfizer and Astellas’ powerhouse Xtandi, which was approved 13 years ago and generated sales of $5.4 billion in 2024, as well as Johnson & Johnson’s Erleada, which reached the market in 2018 and achieved $784 million in sales last year. With Nubeqa and kidney disease treatment Kerendia—which achieved an 89% increase in sales to 161 million euros ($179 million) in the first quarter—Bayer has a pair of fast-rising drugs that allowed its pharma sector to post a surprising 4.4% increase in revenue in Q1.“These gains more than offset the declines we’re seeing on Xarelto,” Bayer CEO Bill Anderson said last month of the aging blood thinner, which saw its sales tumble by 31% to 633 million euros ($706 million).

Phase 3Clinical ResultDrug Approval

100 Deals associated with Darolutamide

External Link

KEGG	Wiki	ATC	Drug Bank
D11045	Darolutamide	L02BB06	DB12941

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Castration-sensitive prostate cancer	United States	Bayer HealthCare Pharmaceuticals, Inc.	03 Jun 2025
Hormone-dependent prostate cancer	European Union	Bayer AG	20 Mar 2023
Hormone-dependent prostate cancer	Iceland	Bayer AG	20 Mar 2023
Hormone-dependent prostate cancer	Liechtenstein	Bayer AG	20 Mar 2023
Hormone-dependent prostate cancer	Norway	Bayer AG	20 Mar 2023
Metastatic Prostate Carcinoma	Japan	Bayer AG	24 Feb 2023
Metastatic castration-resistant prostate cancer	United States	Bayer HealthCare Pharmaceuticals, Inc.	05 Aug 2022
Prostatic Cancer	Brazil	Bayer AG	01 Jan 2020
Castration-Resistant Prostatic Cancer	United States	Bayer HealthCare Pharmaceuticals, Inc.	30 Jul 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Localized Prostate Carcinoma	Phase 3	France	Bayer AG	10 Apr 2025
Localized Prostate Carcinoma	Phase 3	Martinique	Bayer AG	10 Apr 2025
Recurrent Prostate Carcinoma	Phase 3	United States	Bayer AG	03 Apr 2023
Recurrent Prostate Carcinoma	Phase 3	China	Bayer AG	03 Apr 2023
Recurrent Prostate Carcinoma	Phase 3	Japan	Bayer AG	03 Apr 2023
Recurrent Prostate Carcinoma	Phase 3	Australia	Bayer AG	03 Apr 2023
Recurrent Prostate Carcinoma	Phase 3	Austria	Bayer AG	03 Apr 2023
Recurrent Prostate Carcinoma	Phase 3	Belgium	Bayer AG	03 Apr 2023
Recurrent Prostate Carcinoma	Phase 3	Brazil	Bayer AG	03 Apr 2023
Recurrent Prostate Carcinoma	Phase 3	Canada	Bayer AG	03 Apr 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05694819 (DISCOVARY, ASCO2025)	Phase 2	AR Positive Salivary Gland Neoplasms androgen receptor (AR)-positive	33	Darolutamide	wcqlpjvhhz(tmsqboqjsg) = sfddanbejf nfhpiuymmt (jdhsectooj ) View more	Positive	30 May 2025
NCT04736199 (ARANOTE, ASCO2025)	Phase 3	Hormone-dependent prostate cancer	-	Darolutamide 600 mg twice daily	dfarissiqg(zswniecmhc): HR = 0.72 (95% CI, 0.54 - 0.96) View more	Positive	30 May 2025
				Placebo
NCT03385655 (PC_BETS, ASCO2025)	Phase 2	Metastatic castration-resistant prostate cancer AR mutation	72	Darolutamide 600mg od	drlsadbizz(gvnnkwsdde) = 11% gwgjutoghz (yhmmdonlqq ) View more	Positive	30 May 2025
ASCO2025	Not Applicable	Hormone-dependent prostate cancer	188	darolutamide (Non-metastatic hormone-sensitive prostate cancer (nmHSPC))	qdovveaerm(beoekndlaa) = Common side effects included fatigue ytnxwsmmka (zksznqeyae ) View more	Positive	30 May 2025
				darolutamide (Metastatic hormone-sensitive prostate cancer (mHSPC))
NCT03383679 (UCBG 3-06 START, Pubmed \| Lancet Oncol)	Phase 2	Advanced Triple-Negative Breast Carcinoma AR positivity	94	Darolutamide 600 mg	flztugleft(osjsdehwln) = toxicoderma (n=1) and headache (n=2) in the darolutamide group, and diarrhoea, general physical deterioration, and hepatic cytolysis in the capecitabine group (n=1 each) atfafkejed (cpanrqlhdi ) View more	Negative	01 Mar 2025
				Capecitabine minimum 1000 mg/m2
NCT06013475 (DEAR-EXT, ASCO_GU2025) Manual	Unknown	Castration-Resistant Prostatic Cancer	1,205	DarolutamideDarolutamide (DARO) (Black pts)	-	Positive	13 Feb 2025
				DarolutamideDarolutamide (DARO) (White pts)
NCT04558866 (ExBAT trial/LACOG 0620, ASCO_GU2025) Manual	Phase 2	Metastatic castration-resistant prostate cancer	48	testosterone cypionatetestosterone cypionate 400 mg on day 1, followed by oral darolutamide 1200 mg/day from day 29 to day 56, followed by a washout period of 7 days, in 63-day cyclesdarolutamide 1200 mg/day from day 29 to day 56, followed by a washout period of 7 days, in 63-day cycles	ntjadzactc(xjztchybsb) = gfzztnrlwu fryifkotzj (vdipxzbfmy, 26.3 - 55.0) View more	Positive	13 Feb 2025
NCT05526248 (ARAMON, ASCO_GU2025) Manual	Phase 2	Castration-sensitive prostate cancer	23	Darolutamide 600 mg twice daily	lzxpcbfddq(ofrvjpsjsp) = hkjpludfam udzbnufwpg (ppooyzgrct, 33 - 76) View more	Positive	13 Feb 2025
NCT02799602 (ARASENS, ASCO_GU2025) Manual	Phase 3	Hormone-dependent prostate cancer	1,305	Darolutamide + ADT + docetaxel (<75 y)	hnpejmyjik(fukvqzjnff) = bbvnowmuve rxeabjgyaa (rhpssbgkss ) View more	Positive	13 Feb 2025
				Placebo + ADT + docetaxel (<75 y)	hnpejmyjik(fukvqzjnff) = qstspkylhs rxeabjgyaa (rhpssbgkss ) View more
NCT04736199 (ARANOTE, ASCO_GU2025) Manual	Phase 3	Hormone-dependent prostate cancer	669	DarolutamideDarolutamide 600 mg twice daily + ADT (High-volume disease)	dybagmpvwg(dlrlepbndz) = sudboyburz xchxceubzf (vpzainocov ) View more	Positive	13 Feb 2025
				DarolutamideDarolutamide 600 mg twice daily + ADT (low-volume disease)	dybagmpvwg(dlrlepbndz) = jxlgkjtqum xchxceubzf (vpzainocov ) View more

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