A Multicentre, Open Label, Non-comparative, Phase 4 study to evaluate the safety and efficacy of intravenous Plazomicin for the treatment of complicated urinary tract infection (cUTI), including Acute Pyelonephritis (AP), in adults - NIL

Start Date28 Apr 2025

Sponsor / Collaborator

Cipla Ltd.

NCT04699656

/ CompletedPhase 1

A Phase 1 Open-Label Study to Assess the Pharmacokinetics, Safety, and Tolerability of Intravenous Administration of Plazomicin in Subjects With End Stage Renal Disease (ESRD) Receiving Intermittent Hemodialysis (IHD)

This study is being conducted to directly characterize the pharmacokinetic (PK) profile of plazomicin following administration of a single oral dose before and after IHD in subjects with ESRD. This PK assessment will be used to provide appropriate plazomicin dosing recommendations for patients with ESRD receiving IHD.

Start Date05 Jan 2021

Sponsor / Collaborator

Cipla USA, Inc.

NCT03270553

/ CompletedPhase 1

A Phase 1, Open Label, Randomized, 2-Period, 2-Treatment, Crossover Study to Assess the Effect of Plazomicin on the Pharmacokinetics of Metformin in Healthy Subjects

This is a single-center, Phase 1, open label, randomized, two-sequence, two-period, crossover study to evaluate the drug-drug interaction potential between plazomicin and metformin in healthy subjects.

Start Date31 Aug 2017

Sponsor / Collaborator

Achaogen, Inc.

100 Clinical Results associated with Plazomicin Sulfate

100 Translational Medicine associated with Plazomicin Sulfate

100 Patents (Medical) associated with Plazomicin Sulfate

271

Literatures (Medical) associated with Plazomicin Sulfate

07 May 2025·ANTIMICROBIAL AGENTS AND CHEMOTHERAPY

The newly identified grdA gene confers high-level plazomicin resistance in Salmonella enterica serovars

Article

Author: Foley, Steven ; Zhao, Shaohua ; Khan, Ashraf A. ; Hikal, Ahmed F.

ABSTRACT:

Plazomicin, a next-generation aminoglycoside, was recently approved by the U.S. Food and Drug Administration for the treatment of multidrug-resistant complicated urinary tract infections. It is highly effective against most aminoglycoside-modifying enzymes (AMEs). Here, we report that Salmonella enterica strains containing the newly identified gentamicin resistance gene ( grdA ) are highly resistant to plazomicin. Heterologous expression of grdA in Escherichia coli Δ tolC resulted in plazomicin resistance with minimum inhibitory concentration (MIC) > 256 µg/mL. These findings reveal that GrdA confers significantly higher resistance to plazomicin than the previously known plazomicin-resistant AMEs AA (2)-Ia and APH (2″)-Iva.

01 May 2025·ARCHIVES OF MICROBIOLOGY

Newly developed antibiotics against multidrug-resistant and carbapenem-resistant Gram-negative bacteria: action and resistance mechanisms

Review

Author: Başaran, Sena Nur ; Öksüz, Lütfiye

Antimicrobial resistance stands as one of the most urgent global health concerns in the twenty-first century, with projections suggesting that deaths related to drug-resistant infections could escalate to 10 million by 2050 if proactive measures are not implemented. In intensive care settings, managing infections caused by multidrug-resistant (MDR) Gram-negative bacteria is particularly challenging, posing a significant threat to public health and contributing substantially to both morbidity and mortality. There are numerous studies on the antibiotics responsible for resistance in Gram-negative bacteria, but comprehensive research on resistance mechanisms against new antibiotics is rare. Considering the possibility that antibiotics may no longer be effective in combating diseases, it is crucial to comprehend the problem of emerging resistance to newly developed antibiotics and to implement preventive measures to curb the spread of resistance. Mutations in porins and efflux pumps play a crucial role in antibiotic resistance by altering drug permeability and active efflux. Porin modifications reduce the influx of antibiotics, whereas overexpression of efflux pumps, particularly those in the resistance-nodulation-cell division (RND) family, actively expels antibiotics from bacterial cells, significantly lowering intracellular drug concentrations and leading to treatment failure.This review examines the mechanisms of action, resistance profiles, and pharmacokinetic/pharmacodynamic characteristics of newly developed antibiotics designed to combat infections caused by MDR and carbapenem-resistant Gram-negative pathogens. The antibiotics discussed include ceftazidime-avibactam, imipenem-relebactam, ceftolozane-tazobactam, meropenem-vaborbactam, aztreonam-avibactam, delafloxacin, temocillin, plazomicin, cefiderocol, and eravacycline.

01 Apr 2025·Microbiology Spectrum

Comparative phenotypic and genotypic antimicrobial susceptibility surveillance in Achromobacter spp. through whole genome sequencing

Article

Author: Johnson, J. Kristie ; Flemming, Laurie K. ; Scudder, Chelsea J. ; Ray, Sreejana ; Clark, Andrew E. ; Smith, Richard D. ; Ly, Melissa A. ; Das, Sanchita ; Porterfield, Harry S.

ABSTRACT:

Treatment of Achromobacter infections remains challenging due to intrinsic and acquired resistance to commonly used antimicrobial agents and no established clinical breakpoints. We attempted accurate species-level identification and compared the presence of genotypic resistance markers to phenotypic susceptibility patterns in retrospectively collected clinical isolates of Achromobacter spp. Our study concludes that Achromobacter xylosoxidans is the most prevalent species. Commercial matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) systems cannot accurately identify all Achromobacter species due to the limited inclusion of spectra in the databases. Phenotypic antimicrobial susceptibility testing (AST) confirms resistance to the majority of antibiotics tested. Newer agents like delafloxacin, plazomicin, and omadacycline showed little or no activity, while minimum inhibitory concentrations were low for eravacycline. In general, the species other than A. xylosoxidans showed lower MIC 50 and MIC 90 , especially to carbapenems and β-lactamase inhibitor combinations like piperacillin-tazobactam, meropenem-vaborbactam, and imipenem-relebactam. Genotypic analysis confirmed that A. xylosoxidans carries a high number of resistance genes, including multidrug efflux pump AxyXY-OprZ, several class D (OXA-type), and the Class A ß-lactamase bla AXC , while Achromobacter mucicolens has the lowest number of resistance genes and no efflux pumps. This study concludes that there is significant genotypic and phenotypic diversity within the different species of Achromobacter, which are important for the identification of the species and for appropriate antimicrobial therapy.

IMPORTANCE:

Identification and susceptibility testing of Gram-negative non-fermenting bacteria belonging to the genus Achromobacter is difficult due to the lack of robust databases in commercial identification systems such as matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) and clinical breakpoints for antimicrobial agents. Most clinical laboratories interpret minimum inhibitory concentration data using the “non- Enterobacterales ” breakpoints included in the Clinical and Laboratory Standards Institute (CLSI) M100. These are breakpoints used for a group of organisms for which data is insufficient to provide species-specific interpretation. Our study provides phenotypic data regarding identification and susceptibility testing and correlates this with the genotypic characterization of 109 clinical isolates belonging to Achromobacter spp. This comprehensive study sheds light on the phenotypic and genotypic character of this bacteria, that is of increasing clinical relevance in hospital-acquired infections.

News (Medical) associated with Plazomicin Sulfate

22 May 2025

·pharma.economictimes.indiatimes.com

Cipla launches novel injectable for drug resistant Urinary Tract Infections

Mumbai: Respiratory drugs major Cipla has launched Plazomicin a novel treatment for drug resistant complicated Urinary Tract Infections (cUTI) including pyelonephritis in India. The novel injectable was in-licensed by Cipla from a US-based biopharmaceutical company Achaogen and the Indian drug maker US-arm had acquired the drug worldwide rights in 2019 (excluding Greater China) with its allied assets and limited liabilities. In India the drug has been launched under its global brand name ‘ Zemdri ’. As per the company the novel injectable approval was supported by data from the EPIC (Evaluating Plazomicin In cUTI) clinical trial, which was the first randomized controlled study of once-daily aminoglycoside therapy for the treatment of cUTI, including pyelonephritis. The drug has shown promising activity against Indian multi-drug resistant (MDR) isolates including those expressing PBP-3 inserts and Cipla has generated Indian-specific pathogen data to address this urgent need, it added. “We are proud to be the first pharmaceutical company to launch Zemdri in India and remain committed to developing a robust antimicrobial portfolio , forging partnerships with thought leaders and industry alliances to ensure global access to antimicrobial drugs for a healthier life,” Umang Vohra , Managing Director and Global CEO, Cipla, commented. Plazomicin is a new intravenous (IV) aminoglycoside indicated in patients 18 years of age or older for the treatment of cUTIs including pyelonephritis caused by the susceptible microorganisms such as Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Enterobacter cloacae. The injectable during protein synthesis binds the 30S subunit of bacterial ribosomes and disrupts the misreading of mRNA. The novel antibiotic is stated to be effective against some of the cUTI-causing gram-negative bacteria that are resistant to beta-lactam antibiotics including carbapenems. A cUTIs (complicated UTIs) occur in those with underlying problem in the urinary tract, such as structural or functional abnormality, like kidney stones or diabetes and currently, the condition affects around 150 million patients each year across the globe. By Online Bureau ,

Drug ApprovalClinical ResultPhase 3

14 Jul 2022

·endpts.com

Updated: ContraFect to terminate PhIII MRSA antibiotic trial — stock capsizes

One year after BARDA backed ContraFect’s MRSA treatment, the Yonkers, NY-based biotech said Wednesday it will stop its Phase III trial of the asset early due to futility. The data safety monitoring board reviewed clinical response data from 84 patients, looking at superiority over the control arm at two weeks, and recommended the trial be stopped, the company said in a press release . The Phase III trial was originally designed to test exebacase — a lysin treatment that would dissolve bacteria cell walls — in 350 patients with bacteremia from MRSA, including those with right-sided heart inflammation. “This disappointing news reflects the long history of difficulties in treating life-threatening infections like MRSA bacteremia in patients with heterogeneous co-morbidities, and who are in need of immediate life-saving treatments,” ContraFect president and CEO Roger Pomerantz said in a statement. SVB Securities analysts Roanna Ruiz and Nik Gasic noted the unique trial design: ContraFect had designed its trial for superiority as opposed to non-inferiority in a risky bet to make exebacase an earlier treatment option for MRSA, a difficult-to-treat bacteria infection that led to some 20,000 deaths in 2017, according to the CDC. Why make that ambitious bet? When new antibiotics are approved on non-inferiority, they’re deemed a last resort , resulting in low returns for the developer. In 2019, Achaogen went bankrupt despite winning approval for Zemdri, its antibiotic for complicated urinary tract infections. BARDA had previously backed ContraFect on exebacase with an initial $9.8 million alongside $77 million in future payments. In reaction to the trial stoppage, ContraFect’s stock $CFRX all but collapsed, falling over 80% to around $0.50 this morning. In an email to Endpoints News , ContraFect CFO Michael Messinger said the biotech has not planned any non-inferiority trials for any of its programs, writing that “clinical superiority is critically important for new antibacterial therapies.” He added that ContraFect will “continue to evaluate the medical opportunities for exebacase, whether it remains in bacteremia or in another indication like prosthetic joint infections.” The antibiotic biotech plans to do its own analysis of the exebacase Phase III data before detailing future plans, according to the press release. On the financial end, Messinger noted the biotech was funded through 2022 prior to stopping enrollment in the study and is evaluating how its runway could be extended depending on the results of said analysis. This story was updated to include comment from Michael Messinger.

14 Sep 2021

·www.biospace.com

ELISA to Contribute Maximum Sales in the Calprotrectin Serum Immunoassay Market through 2031

Increasing Calprotrectin Serum Immunoassay Application in Inflammatory Bowel Disorders Diagnosis to Facilitate Growth A recent study conducted by Fact.MR presents a deep-dive assessment of the current dynamics affecting the pace of the calprotectin serum immunoassay market growth. The report also reveals insights into calprotectin serum immunoassay demand outlook in terms of assay type, application, and end user between 2021 and 2031 Fact.MR – A Market Research and Competitive Intelligence Provider: As per a survey by Fact.MR, the global calprotectin serum immunoassay market is poised to witness a steady growth during the forecast period 2021 to 2031. Increasing applications of calprotectin serum as inflammation marker is likely to create growth prospects for the market. Various researches are finding calprotectin serum immunoassay applications in diagnosis of numerous diseases like pulmonary fibrosis, cardio vascular diseases, and others. According to a study published in British Medical Journal (BMJ) and Bentham Science Publishers, a rise in of calprotectin serum was observed in the patients suffering from pulmonary fibrosis, aortic aneurysm, and rheumatoid arthritis diseases. Thus, administering immunoassays for detecting the serum for the diagnosis of these diseases is expected to elevate the market growth. Request a report brochure to gain comprehensive insights at Rising prevalence for inflammatory bowel disorders (IBDs) like Crohn disease and ulcerative colitis are the chief drivers, accelerating the market growth. According to a study report by the Crohn’s and Colitis Foundation of America, around 1.4 million people across the U.S. are affected by Crohn disease every year, with most of the patient diagnosed are under 30 years of age. As calprotectin serum immunoassay finds large applications in IBDs, increasing incidence of these disease will bolster the market growth. “Researchers are studying neutrophils, D-dimers, and fibrinogens extracted from calprotectin serum for determining the severity of the viral infection in coronavirus positive patients. This novel calprotectin serum application as biomarker for COVID19 will favor the market growth,” says the Fact.MR analyst. Key Takeaways from Fact.MR’s Calprotectin Serum Immunoassay Market Survey The U.S. is expected to emerge as the most lucrative market in North America, owing to the presence of leading market players such as Agilent Technologies, Inc. and Thermo-Fisher Scientific. The U.K. is estimated to exhibit steady growth, driven by the increasing number of research and development activities in the calprotectin serum immunoassay domain. Due to the high prevalence of inflammatory bowel disorders such as ulcerative colitis, the China market is forecast to a hold a significant revenue share in Asia Pacific. Based on end user, diagnostic laboratories are anticipated to account for a major share in the segment, supported by the increasing demand for effective diagnostic of rheumatoid arthritis and cardiovascular diseases. Key Drivers Growing awareness regarding the diagnostic testing for cardiovascular disease amongst the European population is expected to drive the market. Increasing applications in prevention and treatment of inflammatory bowel disorders will spur the sales of calprotectin serum immunoassay. Surging research and development activates for understanding the constant mutation of COVID-19 virus is estimated to propel the demand for calprotectin serum immunoassay Key Restraints High cost of equipment required for the calprotectin serum immunoassay is hampering the market growth. Lack of awareness regarding the application of calprotectin serum immunoassay across developing and under developed economies such as Thailand, Bhutan, and others is impeding the growth. To gain in-depth insights on Calprotectin Serum Immunoassay Market, request methodology at Competitive Landscape Companies operating in the market are focusing of adopting strategies such as product launch to expand their product portfolio and strategic merger, acquisition, and partnership to increase their market revenue share. For instance, In December 2018, Thermo Fisher Scientific, an American provisioner of scientific instrumentation, reagents and consumables, announced launching in new product, QMS Plazomicin Immunoassay, the world’s first complementary diagnostics immunoassay that measures the concentration of a new therapeutic antibiotic named Plazomicin. In February 2021, Agilent Technologies Inc., an American analytical instrumentation development and manufacturing company, announced launching the Agilent Dako SARS-CoV-2 IgG Enzyme-Linked Immunosorbent Assay (ELISA) kit. It is capable of qualitative detection of immunoglobulin G (IgG) antibodies to SARS-CoV-2 in human calprotectin serum or plasma. Some of the leading players in the market profiled by Fact.MR are: Eurospital Calpro Thermo-Fisher Scientific Buehlmann Biotec Abbott Laboratories F.Hoffmann-La Roche Siemens AG Danaher Corporation Diasorin SPA Sysmex Corporation Biomerieux SA QIAGEN Agilent Technologies, Inc. More Valuable Insights on Calprotectin Serum Immunoassay Market Fact.MR, in its new report, offers an unbiased analysis of the global calprotectin serum immunoassay market, analyzing forecast statistics through 2021 and beyond. The survey reveals growth projections on in calprotectin serum immunoassay market with detailed segmentation: By Assay Type: ELISA (Enzyme linked Immunosorbent Assay) Enzyme fluoroimmunoassay Quantitative immune-chromatography By Application: Crohn Disease Ulcerative colitis By End User: Hospitals Diagnostic Laboratories Ambulatory Care Centres Research Institutions By Region: North America Latin America Europe South Asia East Asia Oceania Middle East & Africa Key Questions Covered in the Calprotectin Serum Immunoassay Market Report The market survey also highlights projected sales growth for calprotectin serum immunoassay market between 2021 and 2031 The report offers insight into calprotectin serum immunoassay demand outlook for 2021-2031 Calprotectin serum immunoassay market share analysis of the key companies within the industry and coverage of strategies such as mergers & acquisitions, collaborations or partnerships, and others Calprotectin serum immunoassay market analysis identifies key growth drivers, restraints, and other forces impacting prevailing trends and evaluation of current market size and forecast and technological advancements within the industry Explore Fact.MR’s Coverage on the Healthcare Domain – Chemiluminescence Immunoassay (CLIA) Analyzers Market- Antibodies are increasingly being labelled using chemiluminescence immunoassay (CLIA) technology in laboratories all around the world. Chemiluminescent techniques are crucial in biomedical research. The number of clinical tests utilizing CLIA techniques is expected to grow as a result of technical advancements in disease diagnostics and increased need for preventive diagnostics and treatment monitoring. The global chemiluminescence immunoassay market is expected to grow positively as a result of these factors. Immunoassay Market- The database of biomarkers utilized by industry participants to design new assays that detect the onset of a disease or ailment has grown as a result of rapid advances in genomes and proteomics. The global immunoassays market is expected to grow at a rapid pace. With the growing database on genetics and biomarkers of numerous infectious pathogens, key firms are investing in the development of innovative immunoassays in the infectious diseases area. For the diagnosis of infectious disorders, immunoassay analyzers such as enzyme-linked immunosorbent assay (ELISA) and others are preferred. Laboratory Centrifuge Market- Over the last decade, laboratory centrifuges have grown in popularity across a wide range of industries, including pharmaceuticals, biotechnology, and microbiology. They are essential in the study and research of cells, macromolecules, and other disciplines of life science because of their ability to separate mixtures based on density and viscosity. Despite problems during the COVID-19 pandemic, laboratory centrifuge manufacturers are expected to gain traction as end customers like as academic and research institutes, hospitals, and diagnostic sectors continue to recover. About Fact.MR Market research and consulting agency with a difference! That’s why 80% of Fortune 1,000 companies trust us for making their most critical decisions. We have offices in US and Dublin, whereas our global headquarter is in Dubai. While our experienced consultants employ the latest technologies to extract hard-to-find insights, we believe our USP is the trust clients have on our expertise. Spanning a wide range – from automotive & industry 4.0 to healthcare & retail, our coverage is expansive, but we ensure even the most niche categories are analysed. Reach out to us with your goals, and we’ll be an able research partner. Contact: Mahendra Singh US Sales Office 11140 Rockville Pike Suite 400 Rockville, MD 20852 United States Tel: +1 (628) 251-1583 E: sales@factmr.com Source: Fact.MR

AntibodyAcquisitionCollaborate

100 Deals associated with Plazomicin Sulfate

External Link

KEGG	Wiki	ATC	Drug Bank
D10655	Plazomicin Sulfate	J01GB14	DB12615

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Pyelonephritis	United States	Cipla USA, Inc.	25 Jun 2018
Urinary Tract Infections	United States	Cipla USA, Inc.	25 Jun 2018

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Acute pyelonephritis	Phase 3	-	Achaogen, Inc.	11 Jan 2016
Carbapenem Resistant Bacterial Infection	Phase 3	-	Achaogen, Inc.	16 Sep 2014
Complicated urinary tract infection	Phase 3	-	Achaogen, Inc.	16 Sep 2014
Hospital acquired bacterial pneumonia	Phase 3	-	Achaogen, Inc.	16 Sep 2014
Sepsis	Phase 3	-	Achaogen, Inc.	16 Sep 2014
Ventilator associated bacterial pneumonia	Phase 3	-	Achaogen, Inc.	16 Sep 2014
Kidney Failure, Chronic	Phase 1	United States	Cipla USA, Inc.	05 Jan 2021
Renal Insufficiency	Phase 1	-	Achaogen, Inc.	01 Sep 2011

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01514929 (Pubmed)	Phase 1	-	64	Plazomicin	rtjxzeybga(rywycvmkxt) = bhwvvhdxbq augbkswjga (mmlcrxnjtj )	-	01 Nov 2019
NCT02486627 (Pubmed \| Br Dent J \| N Engl J Med) Manual	Phase 3	Urinary Tract Infections	609	Plazomicin	wbrgyehusy(etfgwxogny) = hpsalmmmpd efdfcdxcdf (tpqabyiulq )	Non-superior	21 Feb 2019
				meropenem	wbrgyehusy(etfgwxogny) = fadorfsgxa efdfcdxcdf (tpqabyiulq )
NCT01970371 (CARE, CTgov)	Phase 3	Hospital acquired bacterial pneumonia \| Pneumonia, Ventilator-Associated \| Sepsis ... View more	69	tigecycline+plazomicin+meropenem (Plazomicin in Combination With Meropenem or Tigecycline)	yjrnhzhjas = fwsopfzlyt bawpazfxiy (qnmtzqtpil, yxhrrtduin - swotkpvfkv) View more	-	16 Oct 2018
				tigecycline+colistin+meropenem (Colistin in Combination With Meropenem or Tigecycline)	yjrnhzhjas = nyfdmwsfal bawpazfxiy (qnmtzqtpil, nozcuqtpqy - avalgrfwgm) View more
NCT02486627 (EPIC, CTgov)	Phase 3	Acute pyelonephritis \| Complicated urinary tract infection	609	plazomicin+levofloxacin (Plazomicin)	ncaviityny = kuvvfijxdk drgahteryl (macjoliuci, czrigvwstk - isthvugavp) View more	-	23 Aug 2018
				levofloxacin+meropenem (Meropenem)	ncaviityny = zwwhfvwogl drgahteryl (macjoliuci, rxfeawhznv - zxamztjgqg) View more
NCT01096849 (CTgov)	Phase 2	Acute pyelonephritis \| Complicated urinary tract infection	145	plazomicin+placebo (Plazomicin (10 mg/kg))	wzkvcxuant = pmjnkuxyuo tdsuasxyci (ogineyrhsg, mforiknrgu - zutpuxpwnr) View more	-	22 Aug 2018
				plazomicin+placebo (Plazomicin (15 mg/kg))	wzkvcxuant = grypeblepc tdsuasxyci (ogineyrhsg, scgdeogcxm - aikuiwualo) View more
NCT01096849 (Pubmed \| Antimicrob Agents Chemother)	Phase 2	Acute pyelonephritis \| Complicated urinary tract infection	145	Plazomicin 10 mg/kg	spkizvovyu(nyrkxedxsl) = bchyzmdkym nkqgwchmgv (daldvlgypv, 21.1 - 78.9) View more	-	01 Apr 2018
				Plazomicin 15 mg/kg	spkizvovyu(nyrkxedxsl) = yqsdbtnogn nkqgwchmgv (daldvlgypv, 46.1 - 74.2) View more

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