This study is a single-center, randomized, controlled, open-label clinical trial designed to assess the early bactericidal activity of a single agent, contezolid, in patients with Mycobacterium abscessus infections. Patients were administered contezolid monotherapy for 14 days specifically targeting Mycobacterium abscessus, and were compared to a control group receiving linezolid, a classic anti-Mycobacterium abscessus drug. The comparison was conducted through the analysis of colony forming units counts and Time To Positivity in sputum cultures. By evaluating the impact of contezolid monotherapy on the bacterial load in the sputum of patients with Mycobacterium abscessus infections, this study aimed to assess the early bactericidal activity of contezolid, thereby providing a basis for the selection of new therapeutic options for the treatment of patients with Mycobacterium abscessus infections.

Start Date01 Jan 2026

Sponsor / Collaborator

Beijing Chest Hospital

CTR20251837

/ RecruitingPhase 3

以利奈唑胺静脉输注转口服给药为对照，评估静脉输注 MRX-4 转口服康替唑胺治疗中国成人耐药革兰氏阳性菌感染的有效性和安全性的多中心、随机、双盲双模拟 III 期临床试验

[Translation] A multicenter, randomized, double-blind, double-dummy phase III clinical trial to evaluate the efficacy and safety of intravenous MRX-4 to oral contizolid in the treatment of drug-resistant Gram-positive bacterial infections in Chinese adults, with linezolid intravenous to oral administration as a control

主要目的：评估静脉输注 MRX-4 转口服康替唑胺片治疗耐药革兰氏阳性菌感染[包括急性细菌性皮肤及皮肤结构感染（ABSSSI）、医院获得性细菌性肺炎（HABP）/呼吸机相关细菌性肺炎（VABP）/ 医疗机构相关性肺炎（HCAP）和血流感染（BSI）]患者的临床疗效。次要目的：评估静脉输注 MRX-4 转口服康替唑胺片治疗耐药革兰氏阳性菌感染患者的微生物学疗效；评估静脉输注 MRX-4 转口服康替唑胺片治疗耐药革兰氏阳性菌感染患者的综合疗效；评估 D14 和 D28 时的全因死亡率；评估静脉输注 MRX-4 转口服康替唑胺片的安全性；评估静脉输注 MRX-4 转口服康替唑胺片的药代动力学特征。

[Translation]

Primary objective: To evaluate the clinical efficacy of intravenous MRX-4-to-oral contezolid tablets in the treatment of patients with resistant Gram-positive bacterial infections [including acute bacterial skin and skin structure infections (ABSSSI), hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP)/healthcare-associated pneumonia (HCAP) and bloodstream infection (BSI)]. Secondary objectives: To evaluate the microbiological efficacy of intravenous MRX-4-to-oral contezolid tablets in the treatment of patients with resistant Gram-positive bacterial infections; to evaluate the comprehensive efficacy of intravenous MRX-4-to-oral contezolid tablets in the treatment of patients with resistant Gram-positive bacterial infections; to evaluate the all-cause mortality at D14 and D28; to evaluate the safety of intravenous MRX-4-to-oral contezolid tablets; and to evaluate the pharmacokinetic characteristics of intravenous MRX-4-to-oral contezolid tablets.

Start Date05 Aug 2025

Sponsor / Collaborator

Shanghai MicuRx Pharmaceutical Co., Ltd.

NCT07213765

/ RecruitingPhase 4IIT

Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease

The goal of this clinical trial is to learn if adding contezolid works to shorten the length of treatment in mycobacterium avium pulmonary disease in adults. It will also learn about the safety of extended usage of contezolid. The main questions it aims to answer are:
Does adding contezolid to standard regimen decrease the bacterial load, lesion severity and improve the life quality of patients with mycobacterium avium pulmonary disease? What medical problems do participants have when taking contezolid for an extended length? Researchers will compare standard regimen plus contezolid to standard regimen alone to see if contezolid helps further decrease the bacterial load, lesion severity and improve the life quality of patients with mycobacterium avium pulmonary disease?
Participants will:
Take contezolid and standard regimen (azithromycin, ethambutol, and rifampicin) for 6 months, contezolid is administered every day while other drugs are taken three times a week OR take standard regimen three times a week for 12 months.
Visit the clinic once every 1 month for checkups and tests.

Start Date24 Jul 2025

Sponsor / Collaborator

Capital Medical University

[+4]

100 Clinical Results associated with Contezolid

100 Translational Medicine associated with Contezolid

100 Patents (Medical) associated with Contezolid

107

Literatures (Medical) associated with Contezolid

01 Jun 2026·INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES

Efficacy and safety of contezolid-containing treatment in treating Gram-positive bacterial bloodstream infections following cardiac surgery: A single-center real-world experience

Article

Author: Lei, Jinghan ; Cui, Shunyao ; Wu, Yuanxing ; Ye, Xiaofang ; Chen, Yong ; Wang, Yan ; Li, Fei ; Zhou, Peixi

OBJECTIVES:

This study aimed to evaluate the real-world feasibility of contezolid-containing treatment in patients with Gram-positive bacterial bloodstream infections (GPB-BSIs) following cardiac surgery.

METHODS:

A single-center retrospective analysis was conducted, including 22 patients with post-cardiac surgery GPB-BSIs who received contezolid treatment. The primary outcome was the overall clinical response rate.

RESULTS:

The overall clinical response rate of contezolid-containing treatment was 77.3% (17/22, 95% CI: 54.6-92.2%), with 9 patients achieving cure and 8 achieving improvement. The microbial eradication rate reached 92.6% (25/27, 95% CI: 75.0-99.1%), particularly 95% (19/20, 95% CI: 75.3-99.9%) for coagulase-negative staphylococci (CoNS)-the dominant pathogen. The overall adverse event (AE) incidence was 9.1% (2/22, 95% CI: 1.1-29.2%), involving two Grade II renal injury events with low correlation to contezolid. No cases of new-onset or exacerbated thrombocytopenia were observed, and no patients discontinued treatment due to AEs. The in-hospital mortality was 4.5% (1/22), with median total hospital stay and ICU stay of 31.0 (interquartile range[IQR]: 25.0-45.5) days and 11.0 (IQR: 8.0-16.0) days, respectively.

CONCLUSION:

This study reports the initial clinical experience with contezolid-containing regimens for GPB-BSIs in a complex post-cardiac surgery cohort, supporting its feasibility in this population. These descriptive findings highlight the need for prospective studies to further evaluate its role.

27 Apr 2026·INTERNATIONAL JOURNAL OF TUBERCULOSIS AND LUNG DISEASE

Safety of long-term use of contezolid for TB and non-TB mycobacteria infections

Article

Author: Yang, X. ; Xu, J. ; Nai, J. ; Yan, C. ; Cheng, K. ; Li, X.

07 Apr 2026·Microbiology Spectrum

Evaluation of contezolid’s cerebrospinal fluid concentration and safety in tuberculous meningitis patients

Article

Author: Nie, Wenjuan ; Huang, Mailing ; Lu, Yu ; Chen, Tao ; Wang, Yujin ; Chu, Naihui

ABSTRACT:

Tuberculous meningitis (TBM) is the most severe form of tuberculosis (TB) with high mortality. This study evaluated the cerebrospinal fluid (CSF) concentration and safety of the novel oxazolidinone contezolid compared to linezolid in TBM patients. In this randomized prospective study, 10 TBM patients received either a linezolid-containing ( n = 5) or contezolid-containing ( n = 5) anti-TB regimen. CSF and blood concentrations were measured at 2 and 6 h post-dose. Peak (2 h) and trough (6 h) concentrations, area under the concentration-time curve (AUC), and safety were assessed. Contezolid CSF concentrations exceeded the Mycobacterium tuberculosis (Mtb) MIC (0.5 μg/mL) at 2 h (median: 1.0806 μg/mL, range: 0.9295–1.3165 μg/mL) but declined by 6 h (median: 0.7920 μg/mL, range: 0.1867–1.0194 μg/mL). Linezolid CSF concentrations were significantly higher than contezolid at both 2 h (median: 3.251 μg/mL, range: 1.9545–4.9636 μg/mL; P = 0.008) and 6 h (median: 1.623 μg/mL, range: 0.941–1.765 μg/mL; P = 0.016), remaining above MIC in all samples at 6 h. The mean CSF AUC for contezolid (4.637 μg·h/mL, 95% CI: 3.599–5.675) was significantly lower than that for linezolid (12.537 μg·h/mL, 95% CI: 7.8797–17.277; P = 0.008). Blood concentrations were higher than CSF for both drugs at all time points. No serious drug-related adverse events occurred. Contezolid effectively penetrates the blood-CSF barrier in TBM patients, achieving CSF concentrations above the MIC for Mtb. Although its CSF exposure was significantly lower than linezolid, its demonstrated penetration and safety profile suggest contezolid warrants further investigation as a potential treatment option for drug-resistant TBM.

IMPORTANCE:

Tuberculous meningitis (TBM) is the deadliest form of tuberculosis, especially difficult-to-treat drug-resistant TBM. Finding new, effective, and safe medicines is critical. This study provides evidence in TBM patients that a newer antibiotic, contezolid, successfully reaches the infection site in cerebrospinal fluid (CSF) at levels expected to kill Mycobacterium tuberculosis . While linezolid achieved higher levels in CSF, contezolid still reached concentrations predicted to be effective and caused no serious side effects in our study. This is important because contezolid might offer a safer alternative to linezolid, which can have significant long-term toxicity. These promising results suggest contezolid could become a valuable new weapon against refractory drug-resistant TBM, potentially saving lives where current options are limited or too toxic.

News (Medical) associated with Contezolid

08 Apr 2025

·www.prnewswire.com

MicuRx: 15 Clinical and Preclinical Research Studies to be Presented at ESCMID Global 2025

SHANGHAI, April 8, 2025 /PRNewswire/ -- The 2025 European Congress of Clinical Microbiology and Infectious Diseases (ESCMID Global 2025) will take place in Vienna from April 11 to 15, 2025. As one of the largest, most comprehensive, and influential global academic conferences in the fields of clinical microbiology, infectious diseases, and infection control, ESCMID Global serves as a pivotal platform for scientific exchange. Shanghai MicuRx Pharmaceutical Co., Ltd. ("MicuRx", Stock Code: 688373) will present 15 new clinical and preclinical research datasets related to its pipeline products in poster presentations during the conference. The presentations will focus on two core products: Contezolid and MRX-5. MRX-5: Preclinical and Phase 1 data supporting its potential as a novel treatment for nontuberculous mycobacterial (NTM) pulmonary disease, particularly Mycobacterium abscessus (MAB) infections. Four studies on MRX-5 presented at the conference "We are excited to share our latest clinical and scientific advancements at ESCMID Global 2025," Dr. Zhengyu Yuan, Chairman and CEO of MicuRx, stated，"These data highlighted our ongoing commitment to developing innovative therapies to address urgent unmet needs in infectious and chronic pulmonary diseases." MicuRx invites attendees to visit the poster sessions to engage with the team and learn more about the company's clinical progress and future development plans. SOURCE MicuRx Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1

25 Feb 2025

·www.prnewswire.com

MicuRx Pharmaceutical: Contezolid Global Phase III Clinical Trial Safety and Efficacy Evaluation Endorsed by Data Monitoring Committee, Promising Prospects for Diabetic Foot Infection Treatment

Data Monitoring Committee (DMC) has completed the first safety and efficacy assessment of the global Phase III clinical trial, recommending continued progression as planned MRX-4 Injection followed by Contezolid Tablets demonstrated favorable safety and efficacy profiles in patients with diabetic foot infections (DFI), meeting expectations SHANGHAI, Feb. 25, 2025 /PRNewswire/ -- Recently, Shanghai MicuRx Pharmaceutical Co., Ltd. ("MicuRx", 688373.SH) announced significant progress in its global multicenter Phase III clinical trial evaluating MRX-4 Injection followed by Contezolid Tablets for the treatment of DFI. The DMC has completed its first safety and efficacy assessment, confirming that the drug's safety and efficacy profiles meet favorable expectations and recommending the trial proceed as planned. DMC Endorsement: Safety and Efficacy Meet Favorable Expectations This evaluation was conducted in accordance with the DMC charter, analyzing the safety and efficacy data of the first 33% of enrolled subjects (285 cases) who completed the study. The results showed that MRX-4 Injection followed by Contezolid Tablets demonstrated favorable safety and efficacy profiles in treating moderate-to-severe DFI patients, meeting expectations. Based on this, the DMC unanimously recommended no adjustments to the trial, injecting confidence into subsequent clinical advancement. Addressing Unmet Needs and Targeting Global Markets DFI is one of the severe complications of diabetes. In China, the number of DFI patients was 4.76 million in 2018, growing to 5.2 million by 2024 at a compound annual growth rate (CAGR) of 1.5%. It is projected to reach 5.36 million by 2030 and 5.42 million by 2035. In the United States, 3.65 million patients suffered from DFI in 2018, increasing to 3.76 million by 2024 at a CAGR of 0.5%. The number is expected to rise to 3.84 million by 2030 and 3.89 million by 2035. Antibiotic therapy is the cornerstone of DFI treatment. MRX-4 Injection and Contezolid Tablets, as a new generation of oxazolidinone antibiotics, reduce risks such as myelosuppression—common with traditional therapies—through structural optimization, making them particularly suitable for patients requiring long-term treatment. Contezolid Tablets, approved in China in 2021 for complicated skin and soft tissue infections (cSSTI), have already demonstrated robust clinical safety. MRX-4, a water-soluble prodrug of Contezolid, converts into Contezolid in vivo to exert therapeutic effects. In 2023, both Contezolid Tablets and MRX-4 received U.S. FDA Qualified Infectious Disease Product (QIDP) and Fast Track designations for treating moderate-to-severe DFI without concurrent osteomyelitis. This global Phase III trial is an international multicenter, randomized, double-blind, controlled study comparing MRX-4 Injection followed by Contezolid Tablets with linezolid in treating moderate-to-severe DFI patients. The trial plans to enroll 865 patients, with a treatment duration of 14 to 28 days. Mr. Jerry Li, CFO and President of MicuRx U.S., stated, "The DMC's positive evaluation underscores the promising efficacy and safety of MRX-4 Injection and Contezolid Tablets, marking a critical milestone toward global market entry. We anticipate this therapy will offer DFI patients a safer treatment option while addressing antibiotic resistance challenges." Dr. Zhengyu Yuan, Chairman and CEO of MicuRx, emphasized, "The development of MRX-4 and Contezolid has always focused on unmet clinical needs. DFI patients urgently require better-tolerated innovative therapies suitable for long-term use, and the current data further validate their potential." Forward-Looking Statements This press release contains certain forward-looking statements. These statements are not historical facts but are based on the Company's current predictions or expectations regarding future events based on available data and information. Words such as "anticipate," "believe," "continue," "may," "estimate," "expect," "intend," "plan," "potential," "predict," "project," "should," "will," "would," and similar expressions are intended to identify forward-looking statements, though not all such statements include these specific terms. These forward-looking statements involve known and unknown uncertainties and other significant factors that may cause actual results to differ materially from those expressed or implied due to risks associated with policy, R&D, market conditions, regulatory uncertainties, and other variables. Existing and potential investors are cautioned to carefully evaluate these risks and not to rely unduly on the forward-looking statements herein. Any forward-looking statements contained in this press release are made only as of the date of this press release. Unless required by applicable law, the Company undertakes no obligation to update or revise any forward-looking statements to reflect new information, future events, or circumstances. SOURCE MicuRx Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Fast TrackQualified Infectious Disease ProductDrug ApprovalClinical Result

29 Nov 2024

·www.prnewswire.com

MicuRx: Successfully Completes Phase III Clinical Trial of MRX-4 for Injection in China

SHANGHAI, Nov. 29, 2024 /PRNewswire/ -- Recently, Shanghai MicuRx Pharmaceutical Co., Ltd. ("MicuRx", 688373.SH) announced the successful completion of its Phase III clinical trial of MRX-4 for injection transitioning to oral Contezolid tablets for the treatment of adult patients with complex skin and soft tissue infections (cSSTI) in China. The trial achieved its primary efficacy endpoint, and the company will actively move forward with the New Drug Application (NDA) process of MRX-4 for injection in China. Clinical Trial Results and Key Findings This clinical trial was designed to evaluate MRX-4 for injection transitioning to oral Contezolid tablets in comparison to intravenous Linezolid for treating adult patients with cSSTI (including those caused by methicillin-resistant Staphylococcus aureus (MRSA)). The results of the study showed that the intravenous infusion of MRX-4 at 2000 mg for the first dose, followed by 1000 mg (subsequent oral administration of 800 mg Contezolid tablets, referred to as "MRX-4/Contezolid"), administered every 12 hours for a duration of 7-14 days, demonstrated good clinical and microbiological efficacy. Statistical analysis showed that MRX-4/Contezolid were non-inferior to the Linezolid group in terms of clinical efficacy, achieving the primary endpoint of the study. Regarding safety, the study showed that the MRX-4/Contezolid regimen had good safety and tolerability. No adverse events related to the study drug led to treatment discontinuation or withdrawal from the trial. The clinical adverse events related to the study drug were primarily gastrointestinal reactions, including nausea and vomiting. Laboratory abnormalities related to the study drug were elevations in liver enzymes. Most of them were mild and transient. Additionally, the incidence of platelet reduction and hematological adverse events in the MRX-4/Contezolid group was significantly lower than in the Linezolid group. Impact of the Study and Future Plans The success of this clinical trial is expected to enable MRX-4 for injection to be approved and commercialized in China for the first time. After being launched, it can provide more medication convenience for critically ill patients and patients who are not suitable for oral administration, meeting clinical needs and significantly boosting the company's revenue from the Chinese market. This success lays a solid foundation for the drug's future commercialization, and the company will continue to invest in this project, with plans to complete communications with the CDE, submit the NDA, and undergo technical reviews and site inspections. Additionally, based on the company's lifecycle management plan for oral Contezolid tablets and MRX-4 for injection, MicuRx is planning to conduct a Phase III clinical trial in China for MRX-4/Contezolid tablets in the treatment of infections caused by drug-resistant Gram-positive bacteria at various sites. This trial aims to expand the potential indications and enhance the social and commercial value of the drug. Furthermore, the international multicenter Phase III clinical trial for MRX-4/Contezolid tablets in the treatment of diabetic foot infections will continue, with China being one of the participating countries. About Contezolid Tablets and MRX-4 Contezolid tablets and MRX-4 are novel oxazolidinone-class antibacterial drugs developed by MicuRx, with global intellectual property rights. Contezolid tablets (400 mg) were approved by the NMPA in China on June 1, 2021, for the treatment of cSSTI, marking the first approval worldwide. MRX-4 for injection is a water-soluble prodrug of contezolid, developed by the company based on an in-depth analysis and scientific investigation of contezolid. MRX-4 for injection can be converted into the active ingredient contezolid in the human body, expanding the usage scenarios. SOURCE MicuRx Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Drug ApprovalNDAClinical Result

100 Deals associated with Contezolid

External Link

KEGG	Wiki	ATC	Drug Bank
D11297	-	J01XX	DB12796

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Complicated skin and soft tissue infection	China	MicuRx Pharmaceuticals, Inc.	01 Jun 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Gram-Positive Bacterial Infections	NDA/BLA	China	Shanghai MicuRx Pharmaceutical Co., Ltd.	04 Jan 2020
Gram-Positive Bacterial Infections	NDA/BLA	China	Zhejiang Huahai Pharmaceutical Co., Ltd.	04 Jan 2020
Healthcare-Associated Pneumonia	NDA/BLA	China	Shanghai MicuRx Pharmaceutical Co., Ltd.	04 Jan 2020
Healthcare-Associated Pneumonia	NDA/BLA	China	Zhejiang Huahai Pharmaceutical Co., Ltd.	04 Jan 2020
Skin and skin structure infections	NDA/BLA	China	Zhejiang Huahai Pharmaceutical Co., Ltd.	04 Jan 2020
Soft Tissue Infections	Phase 3	China	Shanghai MicuRx Pharmaceutical Co., Ltd.	04 Aug 2023
Diabetic foot infection	Phase 3	-	MicuRx Pharmaceuticals, Inc. (United States)	30 Jan 2022
Cellulitis	Phase 2	-	MicuRx Pharmaceuticals, Inc.	01 Feb 2015
Erysipelas	Phase 2	-	MicuRx Pharmaceuticals, Inc.	01 Feb 2015
Mycobacterium Avium-Intracellulare Infection	Phase 1	China	MicuRx Pharmaceuticals, Inc.	15 Jul 2025

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EHA2026	Not Applicable	Sepsis	334	Contezolid	jmxhywmcrw(shwpxuoscz) = No contezolid-related adverse events leading to treatment modification were observed. rwfshmtyza (jxobiykwtc ) View more	Positive	12 May 2026
EHA2026	Not Applicable	Sepsis	334	Other antibiotics		Positive	12 May 2026
PRNewswire Manual	Phase 3	Diabetic foot infection	285	Contezolid + MRX-4	qsunznagpi(opvafuerbd) = The results showed that MRX-4 Injection followed by Contezolid Tablets demonstrated favorable safety and efficacy profiles in treating moderate-to-severe DFI patients, meeting expectations. onwoesnesd (bgjjomnmox )	Positive	25 Feb 2025
NCT05369052 (NEWS)	-	Diabetic foot infection	-	康替唑胺+康替唑胺前药-MRX4康替唑胺+康替唑胺前药-MRX4	wsmobjisig(rfcxloqukr) = Clinical results have reached the endpoint mjenljxsig (chqppdnsca )	Positive	28 Nov 2024
NCT02269319 (ABSSSI, CTgov)	Phase 2	Bacterial Infections \| Skin and skin structure infections \| Erysipelas ... View more	120	MRX-I (MRX-I)	ydmdfihvog = ctnypzboxs mqnukhkrwo (rrqjptjwqh, bvooiiltds - ajbagwglzc) View more	-	04 Nov 2024
NCT02269319 (ABSSSI, CTgov)	Phase 2		120	Linezolid (Linezolid)	ydmdfihvog = ykhoxpsuwl mqnukhkrwo (rrqjptjwqh, hrcnpuoboz - znzlsjfzqy) View more	-	04 Nov 2024
CTR20131214 (Pubmed \| Clin Ther)	Phase 1	-	-	MRX-I tablet	kjvvklmkav(rwccrtbjir) = hxhvwbingo zwkznltqtg (vpvfhdeqql ) View more	-	01 Feb 2018

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