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Nubeqa (darolutamide)
i
Other names: ODM-201, BAY-1841788 , ODM 201, BAY 1841788
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Company:
Bayer, Orion Corp
Drug class:
Androgen receptor inhibitor
Related drugs:
3d
Adaptive Androgen Deprivation and Docetaxel in Metastatic Castration Sensitive Prostate Cancer (clinicaltrials.gov)
P2, N=25, Recruiting, H. Lee Moffitt Cancer Center and Research Institute
New P2 trial • Metastases
|
docetaxel • Xtandi (enzalutamide) • Nubeqa (darolutamide) • Erleada (apalutamide) • triptorelin • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
6d
Physical Function During ARSI Treatment (clinicaltrials.gov)
P=N/A, N=24, Completed, UNC Lineberger Comprehensive Cancer Center | Recruiting --> Completed
Trial completion • Metastases
|
Xtandi (enzalutamide) • abiraterone acetate • Nubeqa (darolutamide) • Erleada (apalutamide)
9d
Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study (clinicaltrials.gov)
P3, N=27, Active, not recruiting, ECOG-ACRIN Cancer Research Group | Trial primary completion date: May 2028 --> Jun 2025
Trial primary completion date • Surgery
|
Prosigna™ Breast Cancer Prognostic Gene Signature Assay
|
Eligard (leuprolide acetate) • Nubeqa (darolutamide) • triptorelin • goserelin acetate • Viadur (leuprorelin implant)
17d
Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED) (clinicaltrials.gov)
P2, N=33, Recruiting, Atish Choudhury, MD | Not yet recruiting --> Recruiting
Enrollment open
|
Nubeqa (darolutamide) • Orgovyx (relugolix)
23d
PEACE8: Treatment With Darolutamide +/- Radiation Therapy for Patients With a Castration Resistant Cancer and Metastases Detected by Functional Imaging (clinicaltrials.gov)
P3, N=336, Recruiting, UNICANCER | Not yet recruiting --> Recruiting
Enrollment open
|
Nubeqa (darolutamide)
24d
HAYATE: A Study to Learn About How Safe Darolutamide is and How Well it Works in Combination With Androgen Deprivation Therapy and Docetaxel in Routine Medical Care for Japanese Men With Low Volume Metastatic Hormone-Sensitive Prostate Cancer (clinicaltrials.gov)
P=N/A, N=100, Recruiting, Bayer | Not yet recruiting --> Recruiting
Enrollment open • Combination therapy • Metastases
|
docetaxel • Nubeqa (darolutamide)
1m
A Study Using Available Data to Learn to What Extent Patients With Prostate Cancer Who Received Second Generation Androgen Receptor Inhibitors Took Their Medication as Prescribed or Stopped Taking Their Medication Completely (clinicaltrials.gov)
P=N/A, N=13779, Active, not recruiting, Bayer | Trial completion date: Dec 2024 --> Jul 2025 | Trial primary completion date: Dec 2024 --> Jul 2025
Trial completion date • Trial primary completion date • Adherence
|
Xtandi (enzalutamide) • Nubeqa (darolutamide) • Erleada (apalutamide)
1m
Study to Evaluate the Safety, Tolerability,Pharmacokinetics, and Antitumor Activity of a Thorium-227 Labeled Antibody-chelator Conjugate Alone and in Combination With Darolutamide, in Patients With Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov)
P1, N=63, Completed, Bayer | Active, not recruiting --> Completed
Trial completion • Combination therapy • Metastases
|
Nubeqa (darolutamide) • pelgifatamab corixetan (BAY 2315497)
1m
Identification of Oral Bioavailable Coumarin Derivatives as Potential AR Antagonists Targeting Prostate Cancer. (PubMed, J Med Chem)
Especially, 4a showed superior efficacy against ARF876L/T877A and ARW741C mutants compared to darolutamide and enzalutamide. Moreover, 4a exhibited favorable pharmacokinetic profiles (F = 66.24%) in vivo and significant tumor growth inhibition in an LNCaP xenograft mouse model upon oral administration. These results highlight the potential of 4a as a promising oral AR antagonist for overcoming drug resistance in PCa.
Journal
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AR (Androgen receptor)
|
AR F876L • AR T877A • AR W741C
|
Xtandi (enzalutamide) • Nubeqa (darolutamide)
2ms
Evaluating the efficacy of bipolar androgen therapy in extending metastasis-free survival in patients with M0 castrate-resistant prostate cancer with prostate specific antigen progression but not radiological or clinical progression on darolutamide. (ACTRN12624000582550)
P2, N=69, Recruiting, Australian and New Zealand Urogenital and Prostate Cancer Trials Group | Not yet recruiting --> Recruiting
Enrollment open
|
Nubeqa (darolutamide)
2ms
Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer (clinicaltrials.gov)
P1, N=30, Recruiting, AdventHealth | Not yet recruiting --> Recruiting
Enrollment open • Metastases
|
Nubeqa (darolutamide) • Orgovyx (relugolix)
2ms
INTREPId (INTermediate Risk Erection PreservatIon Trial) (clinicaltrials.gov)
P2, N=234, Active, not recruiting, Dana-Farber Cancer Institute | Recruiting --> Active, not recruiting
Enrollment closed
|
Nubeqa (darolutamide) • bicalutamide
2ms
WOMBAT: Working Out M0 Bipolar Androgen Therapy (clinicaltrials.gov)
P2, N=69, Recruiting, Australian and New Zealand Urogenital and Prostate Cancer Trials Group | Not yet recruiting --> Recruiting
Enrollment open
|
Nubeqa (darolutamide)
2ms
HAYATE: A Study to Learn About How Safe Darolutamide is and How Well it Works in Combination With Androgen Deprivation Therapy and Docetaxel in Routine Medical Care for Japanese Men With Low Volume Metastatic Hormone-Sensitive Prostate Cancer (clinicaltrials.gov)
P=N/A, N=100, Not yet recruiting, Bayer
New trial • Combination therapy • Metastases
|
docetaxel • Nubeqa (darolutamide)
2ms
Evaluating Treatment Outcomes Using Darolutamide and Androgen Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer. (clinicaltrials.gov)
P4, N=80, Not yet recruiting, University of Chicago
New P4 trial • Metastases
|
Nubeqa (darolutamide)
2ms
BELBEQA: An Observational Study to Learn More About the Use of Darolutamide as a Part of a Combination Therapy in Belgian Men With Metastatic Hormone-Sensitive Prostate Cancer in Routine Medical Care (clinicaltrials.gov)
P=N/A, N=106, Completed, Bayer | Active, not recruiting --> Completed
Trial completion • Combination therapy • Metastases
|
docetaxel • Nubeqa (darolutamide)
2ms
PSA-DEEP02: PSA Biochemical Response as Prognostic Factor in Metastatic Castration-Sensitive Prostate Cancer (clinicaltrials.gov)
P=N/A, N=152, Not yet recruiting, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
New trial • Metastases
|
docetaxel • Xtandi (enzalutamide) • abiraterone acetate • prednisone • Nubeqa (darolutamide) • Erleada (apalutamide)
2ms
Optimal timing for initiating androgen receptor signaling inhibitor therapy in patients with nonmetastatic castration-resistant prostate cancer: a multicenter collaborative study. (PubMed, Jpn J Clin Oncol)
Patients with rapid PSADT are at increased risk of early disease progression, suggesting that immediate treatment may be warranted. In addition, initiating therapy at a PSA level <5.4 ng/ml may be associated with improved patient outcomes in patients with low PSADT.
Journal • Metastases
|
ARSI (Arylsulfatase Family Member I)
|
Xtandi (enzalutamide) • Nubeqa (darolutamide) • Erleada (apalutamide)
2ms
Androgen receptor pathway inhibitors and drug-drug interactions in prostate cancer. (PubMed, ESMO Open)
These interactions, particularly through pathways like CYP2D6 inhibition by abiraterone and CYP3A4 induction by enzalutamide and apalutamide, necessitate a thorough understanding to optimize therapeutic outcomes and minimize adverse effects. This review aims to delineate the efficacy of ARPIs in prostate cancer management and elucidate their interaction with common medications, highlighting the importance of vigilant drug management to optimize patient care.
Review • Journal
|
CYP3A4 (Cytochrome P450, family 3, subfamily A, polypeptide 4)
|
Xtandi (enzalutamide) • abiraterone acetate • Nubeqa (darolutamide) • Erleada (apalutamide)
2ms
Physical Function During ARSI Treatment (clinicaltrials.gov)
P=N/A, N=24, Recruiting, UNC Lineberger Comprehensive Cancer Center | Active, not recruiting --> Recruiting
Enrollment open • Metastases
|
Xtandi (enzalutamide) • abiraterone acetate • Nubeqa (darolutamide) • Erleada (apalutamide)
2ms
A Study Using Available Data to Learn to What Extent Patients With Prostate Cancer Who Received Second Generation Androgen Receptor Inhibitors Took Their Medication as Prescribed or Stopped Taking Their Medication Completely (clinicaltrials.gov)
P=N/A, N=13779, Active, not recruiting, Bayer | Trial completion date: Sep 2024 --> Dec 2024 | Trial primary completion date: Sep 2024 --> Dec 2024
Trial completion date • Trial primary completion date • Adherence
|
Xtandi (enzalutamide) • Nubeqa (darolutamide) • Erleada (apalutamide)
2ms
An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea (clinicaltrials.gov)
P=N/A, N=600, Recruiting, Bayer | Not yet recruiting --> Recruiting
Enrollment open
|
Nubeqa (darolutamide)
2ms
ASCERTAIN: A Study to Investigate the Biological Effects of Saruparib (AZD5305), Darolutamide, and in Combination in Men With Newly Diagnosed Prostate Cancer. (clinicaltrials.gov)
P1, N=120, Recruiting, AstraZeneca | Trial completion date: Feb 2025 --> Nov 2025 | Trial primary completion date: Feb 2025 --> Nov 2025
Trial completion date • Trial primary completion date
|
Nubeqa (darolutamide) • saruparib (AZD5305)
2ms
A Study of JNJ-78278343 in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
P1, N=200, Recruiting, Janssen Research & Development, LLC | N=345 --> 200
Enrollment change
|
docetaxel • Xtandi (enzalutamide) • abiraterone acetate • prednisone • Nubeqa (darolutamide) • cabazitaxel • Erleada (apalutamide) • cetrelimab (JNJ-63723283) • JNJ-8343
2ms
Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer (clinicaltrials.gov)
P1, N=30, Not yet recruiting, AdventHealth
New P1 trial • Metastases
|
Nubeqa (darolutamide) • Orgovyx (relugolix)
3ms
COACTION Trial - COmbination Androgen bloCkade in inTermediate to hIgh-risk prOstate caNcer (clinicaltrials.gov)
P4, N=144, Not yet recruiting, Brazilian Clinical Research Institute
New P4 trial
|
Nubeqa (darolutamide)
3ms
PEACE 7: Study Evaluating the Efficacy and Safety of Darolutamide and Stereotactic Dose Escalated Radiotherapy in Patients With Localized Prostate Cancer and High-risk Features of Relapse (clinicaltrials.gov)
P3, N=700, Not yet recruiting, UNICANCER
New P3 trial
|
Nubeqa (darolutamide)
3ms
Prospective, multicenter, comparative, randomized placebo-controlled Phase III trial evaluating dAroLutamide Addition to anDrogen Deprivation therapy and radIatioN therapy in newly diagnosed prostate cancer with pelvic lymph nodes metastases. Etude de phase III randomisée multicentrique contrôlée contre placebo évaluant l’ajout du darolutamide à l’hormonothérapie et à la radiothérapie chez des patients atteints d’un cancer de prostate avec des métastases ganglionnaires pelviennes. (clinicaltrialsregister.eu)
P3, N=152, ARTIC - Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie
New P3 trial
|
Nubeqa (darolutamide)
3ms
SAKK 08/23: Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov)
P2, N=162, Recruiting, Swiss Group for Clinical Cancer Research | Not yet recruiting --> Recruiting
Enrollment open • Metastases
|
docetaxel • Nubeqa (darolutamide)
3ms
PEACE6-Unfit: ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Vulnerable) (clinicaltrials.gov)
P3, N=300, Recruiting, UNICANCER | Trial completion date: Sep 2033 --> Sep 2037
Trial completion date • Metastases
|
docetaxel • Nubeqa (darolutamide)
3ms
ORIC-944-01: Study of ORIC-944 in Patients with Metastatic Prostate Cancer (clinicaltrials.gov)
P1, N=250, Recruiting, ORIC Pharmaceuticals | N=42 --> 250 | Trial completion date: Jun 2024 --> Sep 2026 | Trial primary completion date: May 2023 --> Dec 2024
Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
abiraterone acetate • Nubeqa (darolutamide) • Erleada (apalutamide) • ORIC-944
3ms
Darolutamide-mediated phospholipid remodeling induces ferroptosis through the SREBP1-FASN axis in prostate cancer. (PubMed, Int J Biol Sci)
Moreover, the synergistic antitumor effect of combination therapy with darolutamide and ferroptosis inducers (FINs) was confirmed in PCa organoids and a mouse xenografts model. Overall, these findings revealed a novel mechanism of darolutamide mediated ferroptosis in PCa, laying the foundation for the combination of darolutamide and FINs as a new therapeutic strategy for PCa patients.
Journal
|
FASN (Fatty acid synthase)
|
AR mutation
|
Nubeqa (darolutamide)
3ms
Targeting the cancer cells and cancer-associated fibroblasts with next-generation FGFR inhibitors in prostate cancer co-culture models. (PubMed, Cancer Med)
CAFs exert a protective effect on cancer cells and should be included in the in vitro models to make them physiologically more relevant in screening and testing of FGFRis. The FRS2αi was the most potent agent in reducing the viability and proliferation of the 3D organotypic co-cultures, mainly by disrupting the contact between CAFs and cancer cell clusters. The next-generation FGFRi, FRS2αi, may be a better alternative treatment option for overcoming ARi treatment resistance in advanced PCa.
Journal
|
CASP3 (Caspase 3)
|
Xtandi (enzalutamide) • Nubeqa (darolutamide)
3ms
SAKK 08/23: Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov)
P2, N=162, Not yet recruiting, Swiss Group for Clinical Cancer Research | Initiation date: Aug 2024 --> Nov 2024
Trial initiation date • Metastases
|
docetaxel • Nubeqa (darolutamide)
3ms
TRIPLE-SWITCH: Docetaxel to Androgen Receptor Pathway Inhibitors in Metastatic Castration Sensitive Prostate Cancer Without Deep PSA Response (clinicaltrials.gov)
P3, N=830, Not yet recruiting, Canadian Cancer Trials Group
New P3 trial • Metastases
|
docetaxel • Xtandi (enzalutamide) • abiraterone acetate • Nubeqa (darolutamide) • Erleada (apalutamide)
3ms
PEACE8: Treatment With Darolutamide +/- Radiation Therapy for Patients With a Castration Resistant Cancer and Metastases Detected by Functional Imaging (clinicaltrials.gov)
P3, N=336, Not yet recruiting, UNICANCER | Initiation date: Jul 2024 --> Oct 2024 | Trial primary completion date: Jul 2024 --> Oct 2029
Trial initiation date • Trial primary completion date
|
Nubeqa (darolutamide)
3ms
Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED) (clinicaltrials.gov)
P2, N=33, Not yet recruiting, Atish Choudhury, MD | Trial completion date: Aug 2028 --> Nov 2028 | Initiation date: Aug 2024 --> Nov 2024 | Trial primary completion date: Aug 2028 --> Nov 2028
Trial completion date • Trial initiation date • Trial primary completion date
|
Nubeqa (darolutamide) • Orgovyx (relugolix)
3ms
WOMBAT: Working Out M0 Bipolar Androgen Therapy (clinicaltrials.gov)
P2, N=69, Not yet recruiting, Australian and New Zealand Urogenital and Prostate Cancer Trials Group
New P2 trial
|
Nubeqa (darolutamide)
3ms
Inhibition of human UDP-glucuronosyltransferase (UGT) enzymes by darolutamide: prediction of in vivo drug-drug interactions. (PubMed, Chem Biol Interact)
In particular, it also potently inhibited SN-38, the active metabolite of irinotecan, glucuronidation in HLMs with an IC50 value of 3.84 ± 0.46 μM. The prediction results showed that darolutamide may increase the risk of DDIs when administered in combination with substrates of UGT1A1, UGT1A7, or UGT2B15. Therefore, the combined administration of darolutamide and drugs metabolized by the above UGTs should be used with caution to avoid the occurrence of potential DDIs.
Preclinical • Journal
|
UGT1A7 (UDP Glucuronosyltransferase Family 1 Member A7) • UGT2B15 (UDP Glucuronosyltransferase Family 2 Member B15)
|
UGT1A1*1*1
|
irinotecan • Nubeqa (darolutamide)
4ms
Darolutamide + Androgen Deprivation Therapy (ADT) in Chinese Men With High Risk, Nonmetastatic Prostate Cancer (clinicaltrials.gov)
P2, N=78, Active, not recruiting, Bayer | Recruiting --> Active, not recruiting
Enrollment closed
|
Nubeqa (darolutamide)
4ms
Neoadjuvant Therapy of Darolutamide Plus ADT for High Risk Prostate Cancer (clinicaltrials.gov)
P2, N=80, Recruiting, Xijing Hospital
New P2 trial
|
Nubeqa (darolutamide) • goserelin acetate
4ms
Docosahexaenoic acid enhances the treatment efficacy for castration-resistant prostate cancer by inhibiting autophagy through Atg4B inhibition. (PubMed, Arch Biochem Biophys)
Furthermore, we investigated the effect of DHA on resistance to ARSI by establishing darolutamide-resistant prostate cancer 22Rv1 (22Rv1/Dar) cells, which had developed resistance to darolutamide, a novel ARSI...DHA significantly suppressed Dar-induced autophagy and sensitized 22Rv1/Dar cells by inducing apoptotic cell death through mitochondrial dysfunction. These results suggest that DHA supplementation may improve prostate cancer therapy with ARSI.
Journal
|
ATG4B (Autophagy Related 4B Cysteine Peptidase)
|
Nubeqa (darolutamide)
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