Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for OligoRecurrenT Prostate Cancer (VA STARPORT)

This is a prospective, open-label, multi-center seamless phase II to phase III randomized clinical trial designed to compare SST with or without PET-directed local therapy in improving the castration-resistant prostate cancer-free survival (CRPC-free survival) for Veterans with oligometastatic prostate cancer. Oligometastasis will be defined as 1-10 sites of metastatic disease based on the clinical determination of the LSI which incorporates all imaging, clinical, and pathologic data available.

Start Date01 Jul 2021

Sponsor / Collaborator

VA Office of Research and Development

NCT03678025

/ RecruitingPhase 3IIT

Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer

This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.

Start Date24 Sep 2018

Sponsor / Collaborator

National Cancer Institute

CTRI/2018/01/011386

/ CompletedPhase 1

A randomized, open label, multi-center, two-treatment, two-period, two-sequence, two-waycross-over, multiple dose, steady state Bioequivalence (BE) study of Genus Lifesciences Inc.Nilutamide Tablets 150 mg with NILANDRONÂ® (Nilutamide) Tablets 150 mg from ConcordiaPharmaceuticals Inc. in metastatic prostate cancer patients. - NLM101

Start Date01 Mar 2018

Sponsor / Collaborator

Genus Lifesciences, Inc.

100 Clinical Results associated with Nilutamide

100 Translational Medicine associated with Nilutamide

100 Patents (Medical) associated with Nilutamide

498

Literatures (Medical) associated with Nilutamide

01 Dec 2025·ENVIRONMENTAL RESEARCH

Nanoengineered scheelite-structured SrWO4 decorated on MXene sheets: A novel platform for electrochemical sensing of the anti-cancer drug nilutamide with DFT insights

Article

Author: Liu, Xinke ; Lin, Lu-Yin ; Tung, Ching-Wei ; Gong, Cihun-Siyong ; Chung, Ren-Jei ; Kanke, Vaibhav ; Lin, Yu-Chien ; Katkar, Amar S ; Sakthivel, Rajalakshmi ; Jagtap, Akash Ashokrao

The persistent presence of the pharmaceutical pollutant nilutamide (NLT) in environmental and biological systems poses a serious threat to ecosystems and human health, necessitating efficient and sustainable detection strategies. In this study, we present a nanoengineered SrWO₄@MXene electrocatalyst as a high-performance platform for electrochemical sensing. The hybrid material seamlessly integrates the catalytic activity and electrochemical stability of SrWO₄ with the exceptional conductivity and tunable surface chemistry of MXenes, resulting in a synergistic architecture optimized for rapid and selective NLT detection. Detailed structural and spectroscopic characterizations confirmed the successful fabrication of the electrocatalyst, while electrochemical studies demonstrated an ultra-low detection limit of 0.07 μM, a linear range of 5-115 μM, and a high sensitivity of 5.66 μA μM^-1 cm^-2. Moreover, density functional theory calculations provided insights into the energy level and electron active site of NLT during the electrochemical process. Real-world applications in pond water and human serum demonstrated the electrocatalyst's robustness, selectivity, and real-world applicability. This study establishes SrWO₄@MXene as an innovative, scalable, and environmentally sustainable electrocatalyst for pharmaceutical pollutant monitoring, offering significant advancements in electrochemical sensing for environmental and clinical applications.

01 Aug 2025·CHEMICAL ENGINEERING JOURNAL

Fe atom-substituted molybdenum carbide catalyst for the chemoselective hydrogenation of nitro compounds under mild conditions

Author: Cao, Yueling ; Qu, Ruiyang ; Li, Haoyang ; Bai, Weiwei ; Ge, Huibin ; Zhang, Hepeng ; Wen, Hao

In the quest for sustainable catalytic processes, non-noble metal catalysts offer a promising alternative for the selective hydrogenation of organic compoundsThis work reports the design of a Fe-doped Mo₂C catalyst (Fe-Mo₂C@CN), featuring partial substitution of Mo atoms with Fe atoms, which exhibits remarkable catalytic performance in the chemoselective hydrogenation of nitro compoundsThe Fe-Mo₂C@CN-700 catalyst achieves a turnover frequency (TOF) of 36.6 h^-1 at mild reaction conditions (80 °C and 1 MPa H₂), outperforming most non-noble metal catalysts reported under similar conditions.More notably, at near room temperature (30 °C and 1 bar H₂), it achieves high yields (≥93 %), making it competitive with noble metal catalysts.Studies reveal that Mo₂C serves as the primary active site for hydrogenation, and partial substitution of Mo atoms with atomically dispersed Fe not only modulates the adsorption strength but also induces a tilted adsorption configuration of the nitro group, thereby facilitating more efficient hydrogenation.Fe-Mo₂C@CN-700 delivers excellent yields (86-98 %) in the hydrogenation of a wide variety of functionalized nitroarenes to anilines, including sulfur-containing substrates and several high-value pharmaceutical nitroaroms.The optimal Fe-doped Mo₂C catalyst can also maintain its activity for >18 h in a fixed-bed reactor, implying its promising industrial application.

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.

News (Medical) associated with Nilutamide

06 Nov 2018

·www.biospace.com

AstraZeneca Unloads Three Asthma and Rhinitis Drugs to Covis Pharma for $350 Million

Courtesy of Roland Magnusson/Getty Images AstraZeneca is unloading rights to Alvesco (ciclesonide) to treat persistent asthma, and Omnaris and Zetonna (ciclesonide) to treat nasal symptoms associated with rhinitis. The company indicates that the rights cover markets outside the United States and the U.S. royalties for the drugs. Roland Magnusson / Shutterstock.com As AstraZeneca focuses on its strategy of divesting assets and spending on its own pipeline, the company sold rights to three older drugs to Covis Pharma for $350 million. AstraZeneca is unloading rights to Alvesco (ciclesonide) to treat persistent asthma, and Omnaris and Zetonna (ciclesonide) to treat nasal symptoms associated with rhinitis. The company indicates that the rights cover markets outside the United States and the U.S. royalties for the drugs. Covis already commercializes the three drugs in the U.S., but upon closing, will own them. No AstraZeneca staff or facilities are transferred as part of the deal. “One of our strategic objectives is to divest parts of our portfolio, allowing us to allocate resources to develop innovative new medicines to address unmet patient needs,” stated Mark Fallon, AstraZeneca’s executive vice president, Global Product and Portfolio Strategy. “Covis Pharma has strong capabilities in marketing medicines around the world, and our agreement with them means patients will continue to benefit from Alvesco, Omnaris and Zetonna.” Under the terms of the deal, Covis is paying AstraZeneca $350 million in addition to conditional sales-related payments of up to $21 million over four years from 2019. AstraZeneca notes that because it will “not maintain a significant ongoing interest in the medicines following completion, the payments will be recognized as Other Operating Income in the Company’s financial statements.” In 2017, the three drugs brought in $106 million. Covis was founded by Cerberus Capital Management in 2011, an investment firm with over $30 billion in managed assets. Between 2011 and 2015, Covis bought 17 branded drugs. Then in 2015, it divested 12 products to Concordia Healthcare for $1.2 billion. The drugs sold included branded drugs, injectables and authorized generics in a broad range of therapeutic areas including cardiovascular, central nervous system and acute care. Some of the products were Nilandron for metastatic prostate cancer; Dibenzyline for pheochromocytoma; Lanoxin for mild-to-moderate heart failure and atrial fibrillation; and Plaquenil for lupus and rheumatoid arthritis. Consistent with today’s deal, in July 2017, Covis Pharma acquired several asthma and allergy products from Sunovion Pharmaceuticals . Covis acquired Alvesco (ciclesonide) Inhalation Aerosol; Omnaris (ciclesonide) Nasal Spray; and Zetonna (ciclesonide) Nasal Aerosol. All three drugs were licensed by Sunovion from Takeda GmbH (formerly Nycomed ) in 2008. No financial details were released concerning the Sunovion deal. “With the divestiture of asthma and allergy products, Sunovion is reinforcing its strategic focus on chronic obstructive pulmonary disease (COPD) in the respiratory area,” stated Nobuhiko Tamura, chairman and chief executive officer of Sunovion, at the time. “Sunovion has the broadest COPD portfolio in the U.S., offering both handheld and nebulized treatment options that can be tailored to individual needs.” A year ago, on October 30, 2017, AstraZeneca signed a licensing deal with Mereo BioPharma to out-license the oral inhibitor of neutrophil elastase (AZD9668) to the smaller Mereo. It, like today’s deal, is reverse of the typical deal, where large companies acquire or license products from smaller companies. That deal, like today’s, is an example of AstraZeneca offloading an under-developed or abandoned product that it outside its primary focus. At the time, Kumar Srinivasan , AstraZeneca’s vice president of scientific partnering and alliances, stated, “This transaction reaffirms AstraZeneca’s commitment to patients by repositioning an asset into an orphan indication with a high unmet need. We will continue to divest or out-license deprioritized assets where we believe it will help accelerate the development of new medicines.”

License out/inAcquisitionDrug Approval

16 Nov 2015

·www.biospace.com

Some Pharma Companies Attempt to Keep Shares from Falling in the Hands of Activist Investors Like Ackman and Icahn

November 16, 2015 By Alex Keown , BioSpace.com Breaking News Staff NEW YORK – Some pharmaceutical companies are including activist shareholder protection clauses when striking financing deals with equity firms, Bloomberg reported this morning. Bloomberg cited an October agreement between Concordia Healthcare Corp. and Cinven a private European equity firm for a 14 percent stake in the company that includes clauses preventing Cinven from transferring or reselling shares to 60 activist investors and hedge funds, including those run by Bill Ackman , Carl Icahn , and Dan Loeb . Concordia focuses on legacy pharmaceutical products and orphan drugs. It markets Nilandron for prostate cancer, Lanoxin for mild-to-moderate heart failure, and Zonegran, for partial seizures in epilepsy. Blomberg’s research placed the reason for these protectionist clauses at the feet of Ackman and his company, Pershing Square Capital Management , a major investor in Canadian-based Valeant Pharmaceuticals International Inc. . Ackman, who is the third-largest investor in Valeant , was a major player in Valeant ’s unsuccessful attempt to acquire Allergan Inc. the maker of the Botox anti-wrinkle treatment. As the deal fell apart, Allergen filed a lawsuit against Ackman for breaking insider trading regulations. Loeb, who runs Third Point LLC , was behind a call to break up Amgen , which it had a large stake in, according to the Bloomberg report. The term activist investor is defined as “a person or firm who has started a proxy contest against them, called a meeting of their shareholders, or made a hostile bid for their stock within the past two years,” Bloomberg said. Ackman has been a point of focus as Valeant is facing troubles related to the pricing of recently acquired drugs as well as its relationship with Philidor RX Services , a specialty pharmacy company that has been the subject of scrutiny over its accounting practices. Although he ultimately stood behind J. Michael Pearson , Valeant ’s chief executive officer, Ackman questioned Pearson’s leadership and at one point suggested the CEO should be replaced. Citing the Wall Street Journal , a Business Insider report said Ackman, who has lost approximately $2 billion as Valeant shares have lost more than 75 percent of their value, sent an email to Pearson on Oct. 27 saying the CEO’s reputation was “at grave risk” and that Valeant has become “toxic.” He also indicated that Pearson may have to be replaced as CEO of Valeant , Business Insider said. Ultimately though, Ackman expressed his support in an email to Pearson. “You are one of the most shareholder-oriented CEOs I know. You have assured me that you and the rest of the board are considering any and all alternatives that would benefit shareholders and other stakeholders. That is very comforting to us,” Ackman said in the email posted by CNBC. Additional companies including the protection clauses in financing deals include Israel-based Teva Pharmaceuticals , which “included a ban on resales to activists when it agreed in July to purchase Allergan ’s generic business for almost $41 billion in cash and stock,” Bloomberg reported. Mylan NV also added a no-activist clause in a 204 deal to acquire Abbott Laboratories ’ generics pharmaceutical business. Over the past year, there have been more than $550 billion worth of M&A activity in the pharmaceutical industry.

AcquisitionExecutive ChangeBiosimilar

08 Sep 2015

·www.biospace.com

Concordia Healthcare Snaps Up Rare Disease Drugmaker in $3.5 Billion Deal

September 8, 2015 By Mark Terry , BioSpace.com Breaking News Staff Canadian company Concordia Healthcare , headquartered in Oakville, Ontario, announced today that it is buying Amdipharm Mercury Limited (AMCo) from Cinven for $3.5 billion. Cinven is a European private equity firm. The deal will be a combination of cash, common shares of Concordia , and a performance-based earn-out payable in cash. “This acquisition is a key milestone and pivotal turning point in Concordia ’s strategy, which gives us the platform to take our business to the next level,” said Mark Thompson , Concordia ’s chairman and chief executive officer in a statement. “We are not only acquiring products and commercial infrastructure, but a seasoned management team who has done a fantastic job of building a solid and successful international pharma operation. The combination of our highly complementary yet geographically diverse business is truly transformational.” Amphidarm has a portfolio of more than 190 drugs in the areas of endocrinology, opthalmology and urology. When the deal closes in the fourth quarter of 2015, Cinven will hold 19.9 percent of Concordia ’s shares. Concordia will expand its market to more than 100 countries. Amdipharm , headquartered in London, was the result of a merger between Amdipharm and the Mercury Pharma Group . Cinven originally bought both in 2012 and merged the two companies a year later. It markets niche drugs under the brands Amdipharm , Mercury Pharma , Abcur and Focus . In 2014 it reported revenue of about $446 million. Concordia focuses on legacy pharmaceutical products and orphan drugs. It markets Nilandron for prostate cancer, Lanoxin for mild-to-moderate heart failure, and Zonegran, for partial seizures in epilepsy. The company’s fiscal year ends in March. It reported $122.2 million in revenue for the 2015 fiscal year. Concordia owns Concordia Pharmaceuticals Inc. , U.S.-based Pinnacle Biologics Inc. and Complete Medical Homecare Inc. , which focuses on home delivery of diabetic supplies, diabetic shoes and inserts, insulin pumps and diabetes drugs. In its second quarter financial reporting on Aug. 13, Concordia Healthcare noted it had completed the acquisition of Covis Pharma and Covis Injectables for $1.2 billion. That acquisition included a portfolio of 12 branded products, 5 generic products and a product distributed by a third party in Australia. “We are on track to achieving our targets, and have already exceeded our 2014 EBITDA levels within the first six months of this year,” said Thompson in a statement. “Our newly acquired Covis assets delivered impressive results this quarter, contributing almost $40 million to our top line with approximately ten weeks of consolidated sales. We believe these high-margin, branded pharmaceuticals and authorized generics, which address life threatening and other serious medical conditions, have room for continued growth.” The acquisition of AMCo is being conducted with the assistance of Goldman, Sachs & Co. , Credit Suisse , RBC Capital Markets and Jefferies and Co. . They have agreed to provide credit facilities and bridge commitments up to $4.3 billion (U.S.). The breakdown of the deal is $1.2 billion (U.S.) in total, with 8.49 million shares of Concordia stock worth approximately $0.7 billion (U.S.) and the assumption of about $1.4 billion (U.S.) AmCo net debt. There will be a maximum performance-based earn-out of about $220 million (U.S.) in the fourth quarter of 2016.

Acquisition

100 Deals associated with Nilutamide

External Link

KEGG	Wiki	ATC	Drug Bank
D00965	Nilutamide	L02BB02	DB00665

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Prostatic Cancer	France	-	01 Jan 1987

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00028769 (S0032, CTgov)	Phase 2	Metastatic Prostate Carcinoma	41	etoposide+estramustine+paclitaxel+bicalutamide+flutamide+leuprolide acetate+goserelin acetate+nilutamide	emsddvkixq(dfrkljgqmk) = qygyzelrti zknyqtbaxi (bqxiuusmty, jtkqsewtcf - cjchkokmla) View more	-	16 Jul 2013
NCT00020254 (Pubmed \| Clin Cancer Res)	Phase 2	Castration-Resistant Prostatic Cancer	-	Vaccine	xzjdrqeqbh(wcddkghygx) = akicgnsmbw svbocfpdjk (hvzfyyxqhu )	-	15 Jul 2008
NCT00020254 (Pubmed \| Clin Cancer Res)	Phase 2	Castration-Resistant Prostatic Cancer	-	Nilutamide	xzjdrqeqbh(wcddkghygx) = rhjnmwsnnu svbocfpdjk (hvzfyyxqhu )	-	15 Jul 2008
ASCO2005	Not Applicable	Castration-Resistant Prostatic Cancer	45	Nilutamide	whnxogpktk(appxwtjoof) = The most common reversible adverse effects were mild to moderate visual adaptation alterations (20%) acjlycwxyl (munylsvcdt )	Positive	01 Jun 2005

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