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 2026

Sponsor / Collaborator

The University of Chicago

NCT07538843

/ Not yet recruitingNot Applicable

A Multicenter, Real-world Study Evaluating the Effectiveness of Darolutamide Plus ADT in Patients Progressing to nmCRPC After Bicalutamide Plus ADT Treatment During nmHSPC Stage

In this observational study, participants receive darolutamide: a treatment that is already available for doctors to prescribe for non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic hormone-sensitive prostate cancer (mHSPC).
Prostate cancer is a common cancer in men, and the number of cases is rising, especially in China. Many men are diagnosed at a late stage, which makes treatment more difficult. Standard treatment for prostate cancer often includes lowering the levels of male hormones (androgens) in the body, as these hormones can help the cancer grow. This is called androgen deprivation therapy (ADT). Sometimes, medicines like bicalutamide are added to ADT, but over time, the cancer can become resistant to these treatments. When this happens and the cancer has not yet spread to other parts of the body, it is called nmCRPC. Newer agents, such as darolutamide, have demonstrated efficacy in controlling the disease and delaying progression, with a more favorable safety profile and fewer severe adverse events than conventional therapies.
This study wants to observe how effective darolutamide plus ADT is at controlling the cancer in Chinese men with nmCRPC who have already been treated with bicalutamide plus ADT during an earlier stage of their disease, known as non-metastatic hormone-sensitive prostate cancer (nmHSPC), but whose cancer has since progressed despite that treatment.
The study will look at how many participants have their prostate-specific antigen (PSA) levels drop to undetectable levels within 6 months of starting darolutamide (in the main group of 800 participants). PSA is a protein made by the prostate, and high levels can be a sign of prostate cancer. In a smaller group of 100 participants, the study will also look at how many men remain free from PSA progression (a sign that the cancer is not getting worse) after 12 months.
To learn more about the safety of darolutamide, the researchers will study whether the participants have adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The researchers will also learn more about how well darolutamide is working in these participants.

Start Date01 Jun 2026

Sponsor / Collaborator

Bayer AG

NCT07450599

/ RecruitingPhase 2

CHINANEO: A China Phase 2, Open-Label, Randomized, Multicenter Study to Investigate the Efficacy and Safety of Darolutamide + ADT as Neo-Adjuvant Treatment for 12 Weeks vs 24 Weeks in Treatment-Naïve Participants Who Have Planned for Radical Prostatectomy (RP) With High-Risk Localized Prostate Cancer

Researchers are looking for a better way to treat men who have high-risk localized prostate cancer, which refers to a type of prostate cancer that is still confined to the prostate gland but has certain characteristics that make it more likely to grow and spread.
The study treatment darolutamide plus androgen deprivation therapy (ADT) is under development as treatment before surgery for men who have high-risk localized prostate cancer. Darolutamide works by blocking the attachment of androgen hormones to androgen receptors in cancer cells, thereby blocking cancer progression and growth. ADT is an established treatment that is used to lower the amount of androgen hormones (e.g., testosterone) in the body.
The main purpose of this study is to learn how the cancer responds to the two different treatment durations (12 weeks or 24 weeks) of darolutamide combined with ADT used before the men undergo surgery to remove the prostate. For this, the researchers will compare the percentage of participants who either achieve complete response to the treatment (where no cancer cells are found) or with condition of minimal residual disease after the treatment (where only a small amount of cancer cells remains).
The study participants will be randomly (by chance) assigned to one of two treatment groups. Depending on the group, they will receive darolutamide tablets by mouth plus ADT administered under the skin for either 12 weeks or 24 weeks. No more than 30 days after the end of the treatments, study participants will be performed with surgery to remove the prostate.
Each participant will be in the study for approximately 29 to 32 months, including a screening phase of up to 28 days, 12 weeks or 24 weeks of treatment depending on the treatment groups, followed by the surgery no more than 30 days after the treatment, and a follow up phase of up to 2 years after the surgery.
2 visits to the study site are planned during the screening phase, followed by 3 to 6 visits (every 28 days) during treatment. The treatment period ends with a visit within 7 days after the last dose of treatment.
During the study, the doctors and their study team will:
* take blood and urine samples
* check the participants' health parameters
* do physical examinations
* check if the participants' cancer has grown and/or spread using CT (computed tomography) or MRI (magnetic resonance imaging) and, if needed, bone scan
* take tumor samples
* ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.
About 30 days after the last dose of treatment, 5 weeks after the surgery and every 12 weeks thereafter, the study doctors and their team will check the participants' health and any changes in cancer. This follow-up period ends 2 years after the surgery.

Start Date27 Apr 2026

Sponsor / Collaborator

Bayer AG

100 Clinical Results associated with Darolutamide

100 Translational Medicine associated with Darolutamide

100 Patents (Medical) associated with Darolutamide

513

Literatures (Medical) associated with Darolutamide

01 May 2026·UROLOGIC CLINICS OF NORTH AMERICA

Systemic Treatments in Men with De Novo Metastatic Prostate Cancer

Review

Author: Kim, Isaac Yi ; Zhang, Anthony ; Lim, Dong-Hoon

De novo metastatic prostate cancer represents a biologically and clinically distinct subset of metastatic hormone-sensitive prostate cancer characterized by aggressive disease behavior and poor survival outcomes. Although androgen deprivation therapy (ADT) has long been the cornerstone of systemic management, recent advances transformed the treatment paradigm toward intensified combination regimens. The addition of docetaxel or androgen-receptor-pathway inhibitors such as abiraterone, enzalutamide, apalutamide, or darolutamide to ADT has demonstrated significant improvements in survival. More recently, triplet strategies combining ADT, docetaxel, and either abiraterone or darolutamide have produced further survival gains without excess toxicity. Molecular insights have advanced precision-based approaches.

01 Apr 2026·UROLOGIC ONCOLOGY-SEMINARS AND ORIGINAL INVESTIGATIONS

Progression-free survival with darolutamide and docetaxel vs. androgen receptor pathway inhibitors vs. docetaxel in metastatic hormone-sensitive prostate cancer: A real-world multicenter retrospective study

Article

Author: Schlack, Katrin ; Seitz, Anna Katharina ; Kappler, Paula ; Darr, Christopher ; Schnabel, Marco J ; Cathomas, Richard ; Paffenholz, Pia ; Steinestel, Julie ; Müller, Marten ; Unland-Gies, Daniel ; Rinderknecht, Emily ; Burger, Maximilian ; Richter, Julika ; Bielstein, Gloria ; Breyer, Johannes ; Heidegger, Isabel ; Bastian, Julius L D

BACKGROUND AND OBJECTIVE:

In metastatic hormone-sensitive prostate cancer (mHSPC), first-line treatment with either docetaxel + androgen deprivation therapy (ADT) or androgen receptor pathway inhibitors (ARPI) + ADT represented the standard of care. Triplet therapy (docetaxel + ARPI + ADT) has shown superiority over docetaxel + ADT, leading to regulatory approval. However, real-world data directly comparing ARPI + ADT and triplet therapy are lacking. This study evaluates real-world outcomes across 3 treatment regimens using inverse probability of treatment weighting (IPTW).

METHODS:

We retrospectively analyzed data from 13 centers of men with mHSPC treated with docetaxel + ADT, ARPI (apalutamide or enzalutamide) + ADT, or darolutamide + docetaxel + ADT. The primary endpoint was progression-free survival (PFS); secondary endpoints included adverse events. To address baseline imbalances, IPTW was employed. Time-to-event data were analyzed using weighted Cox proportional hazards regression with robust variance estimation.

RESULTS:

After excluding incomplete cases, 346 men were analyzed: 58 (16.8%) received docetaxel + ADT, 203 (58.7%) ARPI + ADT, and 85 (24.6%) triplet therapy. Before weighting, triplet patients demonstrated more adverse baseline features. After achieving covariate balance through IPTW adjustment, no significant differences in PFS were observed, with hazard ratios of 1.60 (95% CI: 0.78-3.28, P = 0.20) for docetaxel + ADT and 0.70 (95% CI: 0.36-1.35, P = 0.29) for ARPI + ADT compared to triplet therapy. Grade ≥3 adverse events occurred in 36.2%, 10.9%, and 31.8% of patients, respectively (P < 0.001).

CONCLUSIONS:

In this IPTW-adjusted real world cohort, triplet therapy was not significantly associated with improved PFS compared to ARPI + ADT or docetaxel + ADT. These findings should be interpreted in the context of limited sample size and follow-up, and further prospective studies are warranted.

01 Mar 2026·Biomaterials advances

PEGylated liposomes co-encapsulating darolutamide and hesperetin for enhanced prostate cancer therapy: 2D, 3D PC3 models and in-vivo evaluation

Article

Author: Khemchandani, Rahul ; Pawar, Avinash ; Pardhi, Ekta ; Mehra, Neelesh Kumar ; Smanthula, Gananadhamu ; Patil, Ruchita

In this study, a darolutamide and hesperetin co-loaded PEGylated liposomal formulation (DHLP) was developed for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC). The formulation was prepared using the ethanol injection method, followed by membrane extrusion through a 100 nm polycarbonate filter to ensure size uniformity. The optimized DHLP liposomal formulation exhibited a clear bluish appearance, with a mean particle size of 106.5 ± 3.2 nm, a polydispersity index of 0.128 ± 0.023, and a zeta potential of -14.10 ± 0.25 mV, indicating colloidal stability and uniformity. Spherical morphology was confirmed through microscopic analysis. High encapsulation efficiencies were achieved for both DA (90.1 ± 3.3 %) and HE (91.3 ± 2.7 %). For both medication, in vitro drug release experiments showed a sustained release profile from the DHLP. Cytotoxicity assessment in PC3 prostate cancer cells revealed a 2.83-fold increase in cytotoxicity compared to free DA solution, a 3.89-fold increase compared to free HE solution, and a 1.47-fold improvement over the combined DA-HE solution. The combination index value of 0.89 confirmed synergistic anticancer activity. DHLPs inhibited cell migration, increased ROS generation, and reduced 3D spheroid size, with enhanced cellular uptake contributing to improved therapeutic efficacy. In-vivo pharmacokinetic studies in BALB/c mice demonstrated a 1.7- and 3.4-fold increase in the plasma half-life of DA and HE, respectively, compared to their free drug solutions. Biodistribution studies revealed reduced accumulation of DHLP in vital organs compared to the free drug solution. Acute toxicity assessment at three dose levels showed no histopathological alterations, indicating a favorable safety profile. These results imply that DHLP is a potential nanocarrier system for the effective management of prostate cancer.

286

News (Medical) associated with Darolutamide

12 May 2026

·www.fiercepharma.com

Bayer's Eylea declines by 24%, bearing the brunt of biosmilar competition

After staving off sales declines for Eylea, Bayer is getting hit with full force by biosimilar competition for the eye disease treatment, which saw a 24% sales decline in the first quarter. Since Roche launched its long-acting eye disease medicine Vabysmo in 2022, Bayer and Regeneron have seen the impact on sales of their rival treatment Eylea, with the U.S. biotech taking a bigger hit.Bayer has managed to keep its annual Eylea sales relatively stable as they have toggled between 3.1 billion euros and 3.3 billion euros in each of the last four years. But that’s coming to an end this year as biosimilar competition is hitting the German company with full force.In the first quarter (PDF), Bayer’s Eylea sales were down 24% year over year to 623 million euros ($731 million). They also declined sequentially by 11%. None of this is a surprise as Bayer has projected Eylea sales to drop 20% to 25% this year.However, it wasn’t all bad news for Bayer’s Eylea franchise, as Chief Financial Officer Wolfgang Nickl cited “continued positive volume development” for Eylea’s longer-acting 8 mg formulation, which now accounts for 46% of the company’s overall Eylea sales.“We continue to see pricing pressure from the market entry of biosimilars and that’s especially on pricing,” Nickl added. While the company expects sales to continue falling this year, Bayer Pharmaceuticals Division President Stefan Oelrich said there is also an expectation of “some sustained Eylea business” from the eventual uptake of the 8 mg option.Bayer held off the Eylea slide longer than Regeneron, which saw sales for the franchise plummet from $6 billion in 2024 to $4.4 billion in 2025. Last month, the New York drugmaker reported that its macular degeneration treatment generated $941 million in Q1, marking the first time in eight years that its sales dipped below $1 billion in a quarter. Last week, Bayer addressed its declining presence in the eye disease market with a potential answer as it acquired San Francisco-based Perfuse and its mid-phase eye disease implant PER-001. Bayer will pay $300 million up front, with $2.15 billion in potential milestones attached to the deal. “You have to see this as not just a commercial play but also as something where we leverage our knowledge in the space. When I talk about knowledge, it’s both on the science side but also in our KOL network and hopefully setting up a good and fast late-stage clinical development for this new medicine,” Oelrich said. “Please also be reminded that we don’t have a commercial infrastructure for ophthalmology in the U.S. so a lot of this needs to be built.”With Bayer also bearing the brunt of a rapid sales decline for blood thinner Xarelto, which was down 43% in the quarter, the company’s pharma division saw overall sales decline by 7%. There was a symbolic passing of the torch for Bayer as its new top-selling product is Nubeqa. The prostate cancer treatment has leapfrogged Eylea and Xarelto, generating 749 million euros ($879 million) in the quarter, for a 45% increase year-over-year. Bayer’s other growth standout, cardiovascular and kidney drug Kerendia, achieved sales of $274 million ($321 million) in Q1 for a 70% increase.Bayer’s other two business divisions—crop science and consumer health—exceeded expectations in the first quarter, with sales flat. As a result, Bayer’s share price ticked up by 4%.

AcquisitionBiosimilar

12 May 2026

·endpoints.news

Bayer to make 'careful but aggressive' return to pharma M&A, CEO says

Bayer is back on the market for drug acquisitions after a half-decade on the sidelines, according to CEO Bill Anderson. “We’re going to be careful, but also aggressive,” Anderson said on a first-quarter earnings call with the media Tuesday. He added that the company has “been on the lookout” for product acquisitions and is “not afraid to try a new therapy area” so long as the science is strong. The push for deals comes as two of Bayer’s top drugs, Eylea and Xarelto, saw sales plummet further in the first three months of the year due to generic competition. Anderson’s comments also came a week after the company announced it would buy ophthalmic biotech Perfuse Therapeutics for $300 million upfront . Perfuse has a mid-stage program targeting the leading causes of blindness. The last time Bayer purchased a drugmaker before Perfuse was about five years ago, when it struck a deal for Vividion Therapeutics that included $1.5 billion upfront . But the Vividion deal was not a typical bolt-on, since the company is an independently operated subsidiary. That acquisition also occurred before Anderson’s appointment in 2023. Since then, Bayer has largely limited itself to smaller licensing pacts and R&D collaborations . In 2025, Vividion bought Tavros Therapeutics for an undisclosed amount. Anderson said Bayer will still refrain from buying “ready-to-launch worldwide medicines, because the price of those relative to the value is just generally out of whack.” The drugmaker is working to resolve thousands of lawsuits related to Monsanto, which has led to a much tighter budget for deals. Anderson’s other main focus since joining Bayer has been restructuring the company to improve efficiency and cut red tape. The process has involved several large rounds of job cuts , mostly impacting middle management. The CEO confirmed on Tuesday that 14,000 roles have been affected to date. The company had just under 88,100 full-time or equivalent employees at the end of 2025, down from 92,815 at the end of 2024, according to its latest annual report . Bayer said in an earnings presentation that it terminated two Phase 1 candidates, known as BAY 2701250 and BAY 3178275. The former was in development for pulmonary hypertension, while the latter was being studied for diabetic neuropathic pain. A company spokesperson said in an email that neither program was dropped for safety reasons. Meanwhile, Bayer’s pharma business generated €4.25 billion ($4.9 billion) in sales during the first three months of 2026, roughly matching the same period in 2025. The medicines that saw the most growth were prostate cancer drug Nubeqa and chronic kidney disease treatment Kerendia. Nubeqa sales rose 57% in Q1 to €749 million ($879 million), while Kerendia sales increased 84% in the same period to €274 million ($321 million). Those figures helped offset declines for eye drug Eylea and anticoagulant Xarelto. Eylea sales were down 20% from the same quarter in 2025 to €623 million ($731 million), while Xarelto sales declined 40% to €364 million ($427 million).

Phase 1AcquisitionLicense out/inExecutive Change

07 May 2026

·www.biospace.com

Celcuity Schedules Release of First Quarter 2026 Financial Results and Webcast/Conference Call

MINNEAPOLIS, May 07, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it will release its financial results for the first quarter 2026 after the market closes on Thursday, May 14, 2026. Management will host a webcast/teleconference the same day at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update. Webcast and Conference Call Information To participate in the teleconference, domestic callers should dial 1-800-717-1738 and international callers should dial 1-646-307-1865. A live webcast presentation can also be accessed using this weblink: . A replay of the webcast will be available on the Celcuity website following the live event. About Celcuity Celcuity is a clinical-stage biotechnology company pursuing the development of targeted therapies for the treatment of multiple solid tumor indications. The company's lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PI3K/AKT/mTOR (“PAM”) pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT, or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant, with or without palbociclib, in patients with HR+/HER2- advanced breast cancer (“ABC”), has reported detailed results for the PIK3CA wild-type cohort and topline results for the PIK3CA mutant cohort. A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib in combination with a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with endocrine resistant HR+/HER2- ABC, is ongoing. A Phase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing. More detailed information about Celcuity’s active clinical trials can be found at ClinicalTrials.gov . Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at . Follow us on LinkedIn and X . Contacts: Celcuity Inc. Brian Sullivan, bsullivan@celcuity.com Vicky Hahne, vhahne@celcuity.com (763) 392-0123 Jodi Sievers, jsievers@celcuity.com (415) 494-9924

Financial StatementPhase 3

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
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
Castration-sensitive prostate cancer	China	Bayer HealthCare Pharmaceuticals, Inc.	16 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

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06013475 (DEAR-EXT, Pubmed \| Prostate Cancer Prostatic Dis)	Not Applicable	Castration-Resistant Prostatic Cancer	1,375	Darolutamide	dhfhenhhgu(tflmlafxib) = pqiuouruvw pbwqmjteyq (lqyfzzdfzn ) View more	Positive	18 Mar 2026
				Enzalutamide	dhfhenhhgu(tflmlafxib) = mgsmrilmqp pbwqmjteyq (lqyfzzdfzn ) View more
NCT02799602 (ARASENS, ASCO_GU2026)	Phase 3	Hormone-dependent prostate cancer	1,305	darolutamide+androgen deprivation therapy+docetaxel	xpvmaaluws(aducmowvqk) = htederrtzw jfmcfvgjsa (piazhzscje ) View more	Positive	26 Feb 2026
				placebo+androgen deprivation therapy+docetaxel	xpvmaaluws(aducmowvqk) = itiydjpeqb jfmcfvgjsa (piazhzscje ) View more
NCT05900973 (Daro-PET, ASCO_GU2026)	Phase 2	Localized Prostate Carcinoma	16	Darolutamide 600 mg	tumfxehvkh(gahfmfsqrv) = No adverse events were reported, and all patients completed treatment. qimlylivij (gaiyhqwkpr )	Positive	26 Feb 2026
NCT06190899 (ASCO_GU2026)	Phase 1/2	Metastatic castration-resistant prostate cancer	56	Gedatolisib 120 mg + Darolutamide	iarqsdwoyj(jvkkmvxusf) = pujmhmunlb stezhkbjnh (tghxbhinlm ) View more	Positive	26 Feb 2026
				Gedatolisib 180 mg + Darolutamide	wfmrapirct(rlhhxublti) = wiqznymehx lgxzophzdv (jxvdysudpj ) View more
NCT04736199 (ARANOTE, ASCO_GU2026)	Phase 3	Hormone-dependent prostate cancer	669	Darolutamide + ADT	cdwmhrngmg(ffjmckwnei) = wbgxrfqzax swpzuipijr (nppgnocxuf ) View more	Positive	26 Feb 2026
				Placebo + ADT	cdwmhrngmg(ffjmckwnei) = mlqenffzuy swpzuipijr (nppgnocxuf ) View more
NCT05526248 (ARAMON, ASCO_GU2026)	Phase 2	Castration-sensitive prostate cancer	23	Darolutamide 600 mg	iijxxoonfd(msfpbettlf) = yzwuwpxxoz yafieiobxp (dtqxgthyvv ) View more	Positive	26 Feb 2026
ASCO_GU2026	Not Applicable	Castration-Resistant Prostatic Cancer	96	enzalutamide	mmbnsaatzv(yjirqlivyy) = ngcbeqhcdc mhmlcpqrav (tshannhpoa ) View more	Positive	26 Feb 2026
				apalutamide	mmbnsaatzv(yjirqlivyy) = krwaxpvhav mhmlcpqrav (tshannhpoa ) View more
ASCO_GU2026	Not Applicable	Prostatic Cancer	195	Abiraterone acetate	axerfpddwq(swtawbyzpf) = ttrccgjpjn ctryixwgrq (arymqrmlcg ) View more	Negative	26 Feb 2026
				Apalutamide	axerfpddwq(swtawbyzpf) = wnmoodomup ctryixwgrq (arymqrmlcg ) View more
NCT05526248 (ARAMON, Pubmed \| Eur Urol Focus)	Phase 2	Castration-sensitive prostate cancer \| Non-metastatic prostate cancer	23	Darolutamide 600 mg	sxcfqpsyrx(lfusefxczp) = Most AEs were grade 1/2, including feminizing AEs, occurring mainly during the first 6 months lqygqcdaye (tknjbrzejj )	Positive	01 Feb 2026
NCT02200614 (ARAMIS, Pubmed \| Cancer Med)	Phase 3	Castration-Resistant Prostatic Cancer	1,509	Darolutamide + ADT	saleztzqmj(kqoohyvhke): HR = 0.36 (95.0% CI, 0.26 - 0.48) View more	Positive	01 Jan 2026
				Placebo + ADT

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