A bioequivalence study comparing Nafithromycin (WCK 4873) Oral Tablet 400 mg of Wockhardt Limited, India and Nafithromycin (WCK 4873) Oral suspension 400 mg of Wockhardt Limited, India in healthy, adult, human subjects under fed condition.

开始日期2021-03-01

申办/合作机构-

CTRI/2019/11/021964

/ Completed临床3期

A Phase III, Randomised, Multicentre, Double-Blind, Comparative Study to Determine the Efficacy and Safety of Oral Nafithromycin Versus Oral Moxifloxacin in the Treatment of Community-Acquired Bacterial Pneumonia (CABP) in Adults

开始日期2019-12-31

申办/合作机构

Wockhardt Bio AG

NCT03981887

/ Completed临床1期

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Intravenous Nafithromycin in Healthy Subjects

This will be a Phase 1, randomized, double-blind, single-center, placebo-controlled study in healthy male and female adult subjects. Subjects will be randomly assigned to receive either nafithromycin or placebo by intravenous (IV) infusion based on a double-blind randomization schedule. The following treatments will be administered:
Nafithromycin 200 mg or placebo administered as IV infusions twice daily (q12h) over a period of 3 hours for 3 days.
Eight subjects (n=8) will receive nafithromycin and 2 subjects (n=2) will receive placebo.

开始日期2019-06-18

申办/合作机构

Wockhardt Ltd.

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100 项与 Nafithromycin 相关的临床结果

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100 项与 Nafithromycin 相关的转化医学

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100 项与 Nafithromycin 相关的专利（医药）

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项与 Nafithromycin 相关的文献（医药）

2024-04-01·Chemistry & biodiversity

Synthesis and Antimicrobial Activity Evaluation of Pyridine Derivatives Containing Imidazo[2,1‐b][1,3,4]Thiadiazole Moiety

Article

作者: Quan, Yan‐Hua ; Huang, Xin‐Yi ; Quan, Ji‐Shan ; Li, Siqi ; Jiao, Yu‐Xin ; Li, Ming‐Yu ; Yang, Liu ; Jin, Jun‐Zheng ; Jin, Cheng‐Hua

Abstract:

Four series of novel pyridine derivatives (17 a–i, 18 a–i, 19 a–e, and 20 a–e) were synthesized and their antimicrobial activities were evaluated. Of all the target compounds, almost half target compounds showed moderate or high antibacterial activity. The 4‐F substituted compound 17 d (MIC=0.5 μg/mL) showed the highest antibacterial activity, its activity was twice the positive control compound gatifloxacin (MIC=1.0 μg/mL). For fungus ATCC 9763, the activities of compounds 17 a and 17 d are equivalent to the positive control compound fluconazole (MIC=8 μg/mL). Furthermore, compounds 17 a and 17 d showed little cytotoxicity to human LO2 cells, and did not show hemolysis even at ultra‐high concentration (200 μM). The results indicate that these compounds are valuable for further development as antibacterial and antifungal agents.

2024-01-08·ChemistrySelect

A New Process for the Synthesis of R‐nosylate a Key Intermediate of Nafithromycin

作者: Pund, Amit ; Ahirrao, Vinod ; Yeole, Ravindra ; Diwan, Furqan ; Rafeeq, Mohammad ; Merwade, Arvind ; Deshpande, Prathmesh ; Rane, Vipul

Abstract:

Present study described the facile and efficient synthesis of R‐nosylate (chemical name: (R)‐1‐(5‐(pyridin‐2‐yl)‐1,3,4‐thiadiazol‐2‐yl)‐ethyl,4‐nitrobenzenesulfonate) as new key intermediate of nafithromycin. The R‐nosylate (3 b) was prepared in six steps, starting from readily available methyl‐D‐lactate. To produce a 3 b with a good yield and remarkable chiral high performance liquid chromatography (CHPLC) purity more than 99 %, a large‐scale practical and environmentally friendly process was generated and optimized. The developed method, which was successfully established at the pilot scale and then used as the base for industrial production, considerably decreased the use of harmful reagents.

2023-07-01·CHEMICAL PAPERS

Design and development of efficient synthetic strategies for the chiral synthesis of novel ketolide antibiotic, nafithromycin (WCK 4873)

作者: Bhavsar, Satish ; Bhagwat, Sachin ; Patel, Mahesh ; Deshpande, Prasad ; Tadiparthi, Ravikumar ; Kayastha, Abhijeet K. ; Gupta, Sunil ; Pawar, Shivaji ; Yeole, Ravindra

In structure activity relationship-driven novel ketolide drug development program at Wockhardt, the reaction between racemic 2-[5-(1-bromoethyl)-1,3,4-thiadiazol-2-yl]pyridine and novel amidoxime ketolide core concluded the synthesis of WCK 4871 as a diastereomeric mixtureThis mixture of compounds, when subjected for initial microbiol. evaluation, exhibited desired activities against resistant Gram-pos. Streptococcus pneumoniae and Streptococcus pyogenes.In order to attain further improvements in microbiol. activities, diastereomeric separation of WCK 4871 was essential.Initially, development of chiral preparative HPLC method helped to achieve the separation of diastereomeric mixture by giving out two compounds, WCK 4872 and WCK 4873.Here, WCK 4873 (nafithromycin) was found potent in preclin. studies and chosen for advance clin. developments as suitable drug candidate.In order to accomplish the chiral synthesis of nafithromycin, in the first attempt, chiral auxiliary, (S)-mandelic acid gave us undesired isomer, (S)-1-(5-(pyridin-2-yl)-1,3,4-thiadiazol-2-yl)ethanol, leading into the synthesis of WCK 4872.Upon altering the chiral auxiliary, (R)-mandelic acid furnished the synthesis of nafithromycin, although associated problems in the recrystallization through chiral auxiliary approach prompted us in finding the alternate routes.Finally, the chiral synthesis of nafithromycin was achieved through the chiral pool approach where the side chain, (R)-1-(5-(pyridin-2-yl)-1,3,4-thiadiazol-2-yl)ethyl 4-nitrobenzenesulfonate, was prepared in 5 steps, starting from Me D-lactate.

项与 Nafithromycin 相关的新闻（医药）

2024-11-27

·Pharmaindustrial

CPHI & PMEC India 2024 Showcases Pharma Industry Innovation and Global Reach

Informa Markets in India has recently hosted the 17th edition of CPHI & PMEC India at the India Expo Centre, Greater Noida, Delhi-NCR, showcasing the robust potential of India’s pharmaceutical industry. With the Indian pharma market projected to grow to USD 130 billion by 2030 and USD 450 billion by 2047, the event highlighted the industry’s vital role in shaping global healthcare. Bringing together over 2,000 exhibitors and 50,000 visitors from more than 150 countries, including the USA, UAE, South Korea, Japan, and the United Kingdom, the expo serves as a dynamic hub for innovation and collaboration. Spanning pharma machinery, packaging, analytical instruments, laboratory technologies, ingredients, and beyond, it offers a comprehensive platform for stakeholders to engage in transformative dialogues and foster strategic partnerships. The grand inauguration of the 17th edition of CPHI &PMEC India, took place, setting the tone for a spectacular showcase of the pharmaceutical and healthcare industries' future. Key dignitaries such as K. Raja Bhanu, Director General, Pharmexcil; Harish K. Jain, President, FOPE (Federation of Pharma Entrepreneurs) ; Namit Joshi, Vice Chairman, Pharmexcil; Mr. AVPS Chakravarthy, Global Ambassador, WPO; Rhonda Duffy, Executive Vice President and COO, Biocon Biologics; Rakesh Kumar, Chairman, India Expo Mart Limited (IEML) & Director General, Export Promotion Council for Handicrafts (EPCH); Mr R.K. Jain, Chairman, CPI; Ranjana Ganguly, Board Member, PCSI; Yogesh Mudras, Managing Director, Informa Markets in India, Wouter Moulman, Chief Commercial Officer, Informa Markets, IMEA, Adam Anderson, Executive Vice President - Pharma, Informa Markets B.V.; and Rahul Deshpande, Sr. Group Director, Informa Markets in India, did the honours, amidst an august industry presence. The event featured a stellar lineup of exhibitors, including leading names like Dr. Reddy's Laboratories Ltd, Biocon Ltd, Glenmark Lifesciences Ltd, Morepen Laboratories Ltd, Hetero Labs Limited, Lupin Ltd, Signet Excipients Pvt. Ltd, Apitoria Pharma Pvt Ltd, Capsugel Healthcare Pvt. Ltd, Supriya Lifescience Ltd, SMS Pharmaceuticals Ltd, MSN Laboratories Pvt. Ltd, Sekhmet Pharmaventures Pvt. Ltd, Tirupati Lifesciences Pvt. Ltd, and Merck Life Science Pvt. Ltd, among others. The PMEC pavilion showcases cutting-edge pharmaceutical manufacturing technologies, with prominent exhibitors like ACG, Accupack Engineering, Ace Technologies, Avish Machines, Bowman & Archer Pharma Machines, Cadmach Machinery, CAM PAK India, Fette India, IMA Industria Macchine, Parle Global Technologies, Snowbell Machines, and Truking Technology, spotlighting the latest advancements in equipment and innovation. This year, the expo garnered strong support from prominent industry associations, including CIPI, FOPE (Federation of Pharma Entrepreneurs), IPEC India, and Pharmexcil, further cementing its status as a leading and highly anticipated event in the pharmaceutical industry. AVPS Chakravarthy, Global Ambassador, WPO, said, "The Indian pharmaceutical industry is demnstrating its innovative potential through advancements like Carticel therapy for cancer treatment and Nafithromycin, a groundbreaking macrolide antibiotic tackling drug-resistant pathogens. These innovations highlight India's dual strengths in affordability and efficacy, reaffirming its role as the 'pharmacy of the world.' Events like CPHI & PMEC India provide vital platforms for collaboration, showcasing progress in AI-driven drug inspection, sustainable packaging, and startup-driven innovations, propelling the industry towards a future of higher value creation and global leadership in both volume and value." Dr. Veeramani, Chairman, Pharmexcil, said, “The Indian pharmaceutical industry stands as a global leader, exporting to over 200 countries and providing comprehensive solutions across APIs, finished dosages, clinical research, and pharmacovigilance. With platforms like CPHI showcasing India's capabilities, the sector is poised for transformative growth—from its current $55 billion to a projected $130 billion by 2030 and $450 billion by 2047. Innovations in biologics, specialty generics, and the impact of policies like the U.S. Biosecure Act underline the industry's potential to redefine healthcare solutions worldwide.” K. Raja Bhanu, Director General, Pharmexcil, said, “The Indian pharmaceutical sector, a key focus area for exports, has demonstrated remarkable growth, with current market size at $55 billion and exports contributing USD 27.85 billion. Projections indicate exports will soar to USD 130 billion by 2030 and USD 450 billion by 2047. CPHI & PMEC India highlights India’s strengths in manufacturing, analytics, AI, and machine learning.” Namit Joshi, Vice Chairman, Pharmexil, said, "The Indian pharmaceutical industry has solidified its global position as the 'Pharmacy of the World' and earned recognition as the 'Healers of the World' through its exceptional contribution to COVID-19 vaccine distribution. With exports nearing $27.84 billion and innovative advancements like nanoparticles and improved drug delivery systems, India continues to lead. Integrating IT with pharmaceuticals will further strengthen its role, paving the way for dominance in biologics and biosimilars. CPHI & PMEC India is instrumental in showcasing this progress and reinforcing India's potential to serve global healthcare needs.” Harish K. Jain, President, FOPE (Federation of Pharma Entrepreneurs), said, “India's pharmaceutical industry, valued at USD 60 billion, plays a vital role in global exports, with USD 30 billion of that in exports. By 2030, we expect our exports to grow significantly, with 70 percent directed to Europe and the US. Our industry’s impact is enormous—Indian pharmaceuticals contribute $8 billion annually to the US healthcare system, saving patients over USD 1.5 trillion. With growing capabilities in AI, machine learning, and biologics, India is poised to become the world's leading pharmaceutical hub, targeting a USD 1 trillion industry by 2047." Highlighting the significance of this year’s CPHI & PMEC India Expo, Yogesh Mudras, Managing Director, Informa Markets in India, said, “The Indian pharmaceutical industry stands as a pillar of manufacturing excellence, scale, and research-led competitiveness. Having evolved into a vibrant sector, it now ranks 3rd globally in pharmaceutical production by volume and 14th by value, contributing approximately 1.72% to the nation’s GDP. India is among the top 12 global biotechnology destinations and the third largest in the Asia-Pacific region. This leadership stems from key advantages such as a low manufacturing cost, which is 30 percent-35 percent lower than in the US and Europe, cost-efficient R&D at 87% less than developed markets, and an abundant pool of skilled labor. These strengths position India as a formidable player in shaping the future of global healthcare. The CPHI & PMEC India expo acts as a catalyst in propelling the pharmaceutical industry’s progress, fostering transformative innovations, strategic collaborations, and impactful global synergies. We are also proud to have a Start Up Pavilion under the aegis of the expo, which showcases emerging pharma disruptors with cutting-edge solutions that challenge traditional approaches. This offers attendees a glimpse into the future of the industry.” Adam Anderson, Executive Vice President - Pharma, Informa Markets B.V, said, “India’s pharmaceutical sector is stronger than ever, not only in raw ingredients but also in machinery and biopharmaceuticals. By 2027, biopharma is projected to account for 35% of the global market, positioning India as a leader. This growth extends across the entire supply chain, including contract manufacturing and packaging, providing India with tremendous opportunities as the industry continues to evolve. CPHI & PMEC India plays a crucial role in showcasing this transformation, bringing together key industry players and fostering innovation.” Day 1 of the event showcased the Pharma Connect Congress, which addressed pivotal themes shaping the pharmaceutical landscape. Sessions included discussions on continuous innovation and agile manufacturing for next-generation therapeutics, moderated by Dr. Mahesh Bhalgat, Group CEO & MD, Veeda Clinical Research Limited, and insights into India’s position as the “Pharmacy of the World” with cost-effective generics and biosimilars, led by Dr. Rhonda Duffy, Executive Vice-President & Chief Operating Officer, Biocon Biologics. Additionally, Day 1 featured the Pharma Leaders Roundtable, a closed-door session for senior leaders to explore transformative trends and challenges. Discussions highlighted leveraging geopolitical shifts, such as the BIOSECURE Act, to enhance India’s CDMO sector, integrating AI and machine learning for efficiency, and addressing regulatory and infrastructure barriers in advanced therapies. The day concluded with the prestigious India Pharma Awards 2024, celebrated outstanding achievements in innovation and excellence within the pharmaceutical industry. This prestigious event highlighted transformative contributions across categories such as R&D, sustainability, and digital innovation, while recognizing individuals with a Lifetime Achievement Award.

疫苗

2024-11-21

·Pharmaindustrial

Dr. Jitendra Singh Announces Soft Launch of Antibiotic Nafithromycin

The Union Minister Dr. Jitendra Singh has unveiled India’s first indigenous antibiotic ‘Nafithromycin’ for resistant infections. The antibiotic ‘Nafithromycin’ has been developed with the support of Biotechnology Industry Research Assistance Council (BIRAC), a unit of the Department of Biotechnology and has been brought to market under the trade name ‘Miqnaf’ by pharma company ‘Wolkardt’. It is the country's first indigenously developed antibiotic aimed at tackling Antimicrobial Resistance (AMR). This innovation is designed to treat Community-Acquired Bacterial Pneumonia (CABP), a severe illness caused by drug-resistant bacteria, which disproportionately affects vulnerable populations, including children and the elderly as well as immune compromised hosts like Patients with Diabetes, Cancers etc. Dr. Jitendra Singh described the three-day treatment regimen of Nafithromycin as a game-changer in addressing drug-resistant pneumonia, a condition responsible for over two million deaths globally each year. India, which bears 23 percent of the world’s community pneumonia burden, faces challenges with existing treatments, including widespread resistance to drugs like azithromycin. The new antibiotic, developed by Wockhardt with support from the Biotechnology Industry Research Assistance Council (BIRAC), is ten times more effective than current options and offers a safer, faster, and more tolerable solution for patients. Nafithromycin’s efficacy stands out as it targets both typical and atypical pathogens, offering a potent solution where no new antibiotic in this class has been developed worldwide for over three decades. Remarkably, it is ten times more effective than azithromycin and achieves comparable outcomes with just a three-day regimen, as validated by clinical trials. Beyond its efficacy, Nafithromycin boasts superior safety and tolerability. The antibiotic has minimal gastrointestinal side effects, no significant drug interactions, and remains unaffected by food, making it a versatile option for patients. Nafithromycin marks a historic breakthrough as the first new antibiotic in its class to be developed globally in over 30 years. This significant milestone comes at a time when antimicrobial resistance (AMR) is a growing global health crisis, with few new drugs entering the pipeline. The development of Nafithromycin is a testament to India’s scientific advancement, offering a much-needed solution to combat multi-drug-resistant pathogens. Its innovative design, targeting both typical and atypical organisms and its ability to overcome existing resistance mechanisms, positions it as a beacon of hope in the fight against AMR, with the potential to save countless lives worldwide. The development of Nafithromycin represents 14 years of dedicated research and an investment of INR 500 crores, with clinical trials spanning the US, Europe, and India. Supported by BIRAC under its Biotechnology Industry Partnership Program (BIPP), the initiative showcases the power of public-private collaboration in advancing healthcare innovation. Dr. Jitendra Singh highlighted that the drug is now awaiting final approval from the Central Drugs Standard Control Organization (CDSCO) for manufacturing and public use, marking a major leap forward in India’s fight against AMR. The Minister underscored the importance of addressing AMR, calling it a global crisis that prolongs illnesses and raises healthcare costs. He pointed to the critical role of innovation and collaboration in tackling this issue, emphasizing that the COVID-19 pandemic had significantly increased public awareness of biotechnology and it’s potential. Dr. Jitendra Singh also urged the scientific community to leverage this momentum to drive further advancements in diagnostics, AMR surveillance, and new antibiotic research. Dr. Jitendra Singh also praised the collaborative efforts between the public and private sectors that made the development of Nafithromycin possible. He noted that this partnership model, which combines government support with private sector innovation, is key to driving India’s leadership in biotechnology and pharmaceuticals. “The success of Nafithromycin is a testament to India’s growing capability to develop homegrown solutions for pressing healthcare challenges,” he stated. The Minister highlighted the importance of sustained investment in research and development, particularly in the field of AMR. He emphasized that the government’s proactive approach to fostering innovation, alongside its focus on strengthening the healthcare infrastructure, will play a crucial role in addressing the global AMR crisis. Dr. Jitendra Singh stressed the need for continued collaboration between research institutions, the pharmaceutical industry, and government bodies to ensure that India remains at the forefront of global efforts to combat drug-resistant infections. “This achievement not only marks a significant milestone in our fight against antimicrobial resistance but also paves the way for future breakthroughs in the development of life-saving medicines. We are committed to improving lives and building a healthier, more resilient future for all,” he said. The soft launch of Nafithromycin serves as a powerful reminder of India’s potential to lead the world in tackling one of the most pressing health threats of our time. The event was attended by prominent leaders in the scientific community, including Dr. Rajesh S. Gokhale, Secretary, DBT and Chairman, BIRAC; Dr. Habil Khorakiwala, Chairman, Wockhardt; Dr. Jitendra Kumar, MD, BIRAC and Dr.Y.K.Gupta, President, AIIMS, Jammu. The launch of Nafithromycin signals India’s determination to combat AMR and contribute meaningfully to global health.

上市批准

2021-08-25

·Pharmaindustrial

Wockhardt arm partners with Jemincare for novel respiratory antibiotic nafithromycin

Wockhardt Bio AG – a subsidiary of Wockhardt Limited, a worldwide leader in discovery of novel antibiotics and Jiangxi Jemincare Group Company Limited, China, have partnered for Wockhardt’s novel patented antibiotic WCK 4873 (nafithromycin) in People’s Republic of China, Hong Kong, Macau and Taiwan for the treatment of community-acquired bacterial pneumonia and other respiratory tract infections. Under the terms of the definitive agreement, Jemincare will be responsible for exclusive development and commercialization of the nafithromycin in the select markets. A joint steering committee is formed to oversee development and regulatory activities. Wockhardt will receive an upfront payment and will be eligible for regulatory-linked milestone payments. Further, Wockhardt would supply the product to Jemincare and will receive royalties on net sales. Wockhardt would transfer the manufacturing technology to Jemincare at mutually agreed time. Dr Habil Khorakiwala, founder chairman of Wockhardt Group said, “Wockhardt has been at the forefront in the fight against anti-microbial resistance (AMR) which has been identified as one of the top threats by WHO. Our novel drug discovery programme of around 20 years has yielded a rich pipeline of products which are at different stages of commercialization. This arrangement upholds our commitment in the fight against AMR.” Wockhardt will continue to develop nafithromycin for other markets including India where phase III clinical study is on-going. “We are happy to partner with a company of repute like Jemincare in China, which is also one of the biggest market. We are confident that Jemincare with its excellent standing in the China market will do full justice to the potential of the product,” noted Dr. Murtaza Khorakiwala, managing director, Wockhardt. Dr Mahesh Patel, chief scientific officer of Wockhardt added, “Bacterial pneumonia and other respiratory tract infections trigger the highest volume of antibiotic prescriptions world over. Prevalence of antimicrobial resistance poses a therapeutic challenge to physicians with extremely limited safer and effective therapeutic options, particularly for most vulnerable group such as pediatric and older age group patients.

引进/卖出临床3期合格传染病产品

100 项与 Nafithromycin 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16246

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
社区获得性细菌性肺炎	临床2期	美国	Wockhardt Ltd.	2016-11-18
社区获得性肺炎	临床2期	拉脱维亚	Wockhardt Ltd.	2016-08-11
嗜血杆菌感染	临床前	印度	Wockhardt Ltd.	2017-05-14

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02903836 (CTgov)	临床2期	社区获得性细菌性肺炎	231	Nafithromycin 800 mg 3 days (Nafithromycin 800 mg 3 Days)	淵築遞獵糧範廠鹹鹹壓 = 衊願構積願製衊醖製築積醖構鬱簾衊醖願選廠 (壓遞鹹顧憲網廠願簾選, 憲製淵醖繭憲鹹簾衊夢 ~ 齋築鹽艱願膚鹽窪顧衊) 更多	-	2019-12-20
				Nafithromycin 800 mg 5 days (Nafithromycin 800 mg 5 Days)	淵築遞獵糧範廠鹹鹹壓 = 築廠艱範壓襯蓋餘遞遞積醖構鬱簾衊醖願選廠 (壓遞鹹顧憲網廠願簾選, 範鏇壓窪壓獵製淵淵網 ~ 顧醖遞獵鹹餘淵選鑰願) 更多