Efficacy and Safety of Saccharomyces Boulardii Combined With Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment: A Prospective, Multicenter, Randomized Controlled Trial

This study aims at evaluating efficacy and safety of Saccharomyces boulardii combined with bismuth-containing quadruple Therapy versus bismuth-containing quadruple Therapy(bismuth#esomeprazole#tetracycline and furazolidone) in H. pylori rescue therapy. It is hypothesized that Saccharomyces boulardii combined with bismuth-containing quadruple Therapy is superior to bismuth-containing quadruple Therapy. Patients with confirmed failure of H. pylori eradication will be randomized to one of the treatments described above. At week 6 follow-up visits, a urea breath test#rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.

Start Date01 Sep 2025

Sponsor / Collaborator

Xijing Hospital

NCT07144657

/ Not yet recruitingPhase 2IIT

Prospective Study of Frontline Antibiotics Therapy in the Treatment of Early-stage Helicobacter Pylori-negative Gastric Mucosa-associated Lymphoid Tissue Lymphoma

We hypothesized that a proportion of patients with localized Helicobacter pylori-negative gastric MALT lymphoma may well respond to frontline Helicobacter pylori eradication therapy (HPE) and remain lymphoma-free for the long term. In addition, we hypothesized that for patients with antibiotics-unresponsive HP-negative gastric MALT lymphoma, the administration of a combination of clarithromycin and low-dose cyclophosphamide (CAMC) could result in tumor regression through the direct anti-neoplastic effects and the indirect immune modulatory effect.
Therefore, in this proposal, we will design a prospective phase II study to evaluate the treatment efficacy of frontline HPE, consisting of two weeks of quadruple HPE regimen followed by four weeks of clarithromycin in patients with stage IE/IIE1 HP-negative gastric MALT lymphoma. In addition, we will treat patients who did not respond to HPE using combination regimens of clarithromycin and low-dose cyclophosphamide (CAMC).

Start Date01 Sep 2025

Sponsor / Collaborator

National Taiwan University Hospital

ChiCTR2500110714

/ Not yet recruitingPhase 4IIT

Dose Intensification of Potassium-Competitive Acid Blocker in Optimizing Regimen Duration and Medication for Helicobacter pylori Eradication: A Multicenter, Open-Label, Randomized Controlled Trial

Start Date07 Aug 2025

Sponsor / Collaborator

Qilu Hospital of Shandong University

[+2]

100 Clinical Results associated with Tetracycline Hydrochloride

100 Translational Medicine associated with Tetracycline Hydrochloride

100 Patents (Medical) associated with Tetracycline Hydrochloride

62,741

Literatures (Medical) associated with Tetracycline Hydrochloride

01 Feb 2026·SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY

Cobalt phthalocyanine encapsulation boosts oxidase-like activity of single-atom Co N C nanozyme for fluorescence sensing of tetracycline

Article

Author: Kang, Mingqin ; Dong, Zhongping ; Liu, Siyi ; Liu, Jing ; Xiao, Shuyan

Tetracycline residues in food pose risks to human health and contribute to antibiotic resistance, thereby requiring sensitive detection methods. This study developed a fluorescence sensor using a single-atom CoNC nanozyme, which was synthesized via pyrolysis of a cobalt phthalocyanine-encapsulated zeolitic imidazolate framework-8 precursor (CoPc@ZIF-8). This strategy directly converted the pre-organized CoN₄ macrocyclic structure of CoPc into atomically dispersed CoNC sites, exhibiting exceptional oxidase-like activity with 20-fold higher specific activity than its cobalt nitrate-derived counterpart. Based on this activity, a fluorescence sensing platform was developed in which CoNC catalyzes oxidation of non-fluorescent amplex red to fluorescent resorufin. Tetracycline binds to CoNC via coordination interactions, inhibiting the nanozyme's activity and inducing concentration-dependent fluorescence quenching. Quantitative analysis demonstrated a linear correlation between fluorescence intensity and tetracycline concentration ranging from 0.25 to 2 μg/mL, with a detection limit of 0.058 μg/mL, which is significantly below regulatory thresholds. Furthermore, practical validation in milk samples yielded recovery rates between 101.6 % and 106.8 %, validating its practical applicability for tetracycline residue monitoring.

01 Jan 2026·WATER RESEARCH

Data-driven persistence correction and environmental health prioritization of pharmaceuticals and personal care products in biological wastewater treatment processes

Article

Author: Gong, Sai ; Liu, Qiuju ; Ren, Xinkun ; Zhu, Boyang ; Wang, Jinfeng ; Yin, Ran ; Zhang, Shubo ; Fan, Yingzheng ; Huang, Yizhan

Pharmaceuticals and personal care products (PPCPs) can accumulate during biological wastewater treatment processes (BWWTPs) and are easily released into the environment, posing serious ecological risks. However, current concentration-based persistence assessments of PPCPs in BWWTPs are inaccurate due to nonlinear biotransformation-adsorption interactions. In this study, we analyzed 28 PPCPs in 768 water samples across influent, biological stages, and effluent from 154 BWWTPs in China. Unsupervised learning and variance partitioning analysis (VPA) were applied to evaluate the biotransformation-related variance share and to correct apparent persistence. An environmental health prioritization index (EHPi) was subsequently developed to rank PPCPs for control based on corrected removal rates. Detection frequencies of 21 PPCPs in effluent exceeded those in influent, and 20 PPCPs exhibited negative removal, with oxic-stage removal significantly lower than that in the anoxic and anaerobic stages, indicating widespread desorption and deconjugation. VPA showed that reversible adsorption accounted for an average of 60.33 % of the variance, suggesting that prioritization based on apparent removal rates was biased. Molecular descriptors and fingerprints further demonstrated that structural features have a strong influence on PPCP biotransformation. The EHPi was created based on the adjusted removal rate weighted by the biotransformation-related variance share. The results showed that the priorities of roxithromycin, ketoprofen, clarithromycin, tetracycline, and sulfadimethoxypyrimidine were incorrectly assessed. Finally, diclofenac, ciprofloxacin, ofloxacin, norfloxacin, roxithromycin, amoxicillin, and ketoprofen were identified as high-priority PPCPs. This framework enables persistence correction and informed prioritization for environmental risk management and wastewater treatment for PPCPs.

01 Jan 2026·WATER RESEARCH

Environmental co-exposure to roxarsone and heavy metals drives bacterial antibiotic multidrug resistance via genetic and phenotypic adaptations

Article

Author: Leung, Kenneth Mei Yee ; Liu, Qian-He ; Sheng, Guo-Ping ; Yuan, Li ; Li, Zheng-Hao

Agricultural wastewater, a significant component of the anthropogenic water cycle, often contains complex mixtures of contaminants, including non-antibiotic feed additives, posing largely uncharacterized risks for antimicrobial resistance (AMR) evolution. This study addresses the critical knowledge gap regarding the combined impact of commonly co-occurring roxarsone (ROX) and heavy metals (Zn, Cu) at environmentally relevant concentrations on the de novo evolution and persistence of multidrug resistance in aquatic environments. Using a 90-day laboratory evolution experiment with Escherichia coli, we demonstrate that while ROX alone induced moderate resistance (e.g., 6.2-fold increase in minimum inhibitory concentration (MIC) for chloramphenicol), co-exposure with Zn and Cu synergistically drove multidrug tolerance to nine antibiotics and selected for stable, heritable resistance to chloramphenicol, tetracycline, and kanamycin (up to 8.2-fold MIC increase). This robust resistance persisted even after pollutant removal, highlighting a significant long-term threat to water quality and public health via the dissemination of resilient AMR bacteria from agricultural sources. Co-exposure intensified oxidative stress-induced mutagenesis and selected for key adaptive strategies enhancing bacterial survival and AMR persistence in contaminated water. These include upregulated efflux pumps, increased secretion of extracellular polymeric substances (1.1-3.2-fold), enhanced motility (1.1-1.5-fold), and cell filamentation (lengths 2.4-8.2-fold greater). These findings illuminate a potent, previously underestimated environmental pathway where mixtures of common agricultural pollutants in wastewater synergistically select for persistent multidrug resistance. This research underscores the urgent need to revise water quality criteria and wastewater treatment paradigms to address the co-selection pressures exerted by non-antibiotic chemical mixtures in aquatic ecosystems.

News (Medical) associated with Tetracycline Hydrochloride

17 Oct 2025

·www.globenewswire.com

Paratek Pharmaceuticals to Present New Data on NUZYRA® (omadacycline) at IDWeek 2025 and CHEST 2025

Highlights include clinical data from Phase 3 studies in Community Acquired Pneumonia (CABP) and microbiologic data from a Phase 2 study in nontuberculous mycobacterial pulmonary disease (NTM-PD) caused by Mycobacterium abscessus complex (MABc), as well as additional clinical and non-clinical data from Company- and investigator-sponsored studies KING OF PRUSSIA, Pa. and BOSTON, Oct. 17, 2025 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc., a privately held pharmaceutical company focused on the development and commercialization of specialty therapies for specialists and community care providers that address public health threats and important unmet medical needs, today announced that new data from clinical studies of NUZYRA® (omadacycline) will be presented at IDWeek 2025 in Atlanta, GA, and CHEST 2025 in Chicago, IL, both meetings being held October 19-22. “The upcoming presentations at two major conferences will provide the medical community a broad window into understanding NUZYRA’s potential utility against serious, community-acquired infections,” said Randy Brenner, chief development and regulatory officer of Paratek. “At CHEST, an oral presentation will report quality-of-life outcomes from our Phase 3b OPTIC-2 study, while new microbiological results from the Company’s Phase 2 study assessing NUZYRA in NTM-PD will be featured in an oral presentation at IDWeek. We are also pleased that additional, investigator-sponsored studies will provide research findings for NUZYRA in non-respiratory infections, including the treatment of bone and joint infections.” CHEST 2025 Oral Presentation Abstract title: Health-related quality-of-life outcomes in OPTIC-2: A randomized, controlled, Phase 3b trial of omadacycline vs. moxifloxacin in community-acquired bacterial pneumoniaSession: Lung Infections: Considerations in ManagementPresenter: Holly Mallon, RRT, M.S. (Paratek research)Session Date, Time: Tuesday, Oct. 21; 1:45 p.m. - 2:30 p.m. CTSession Location: Lakeside Center Exhibit Hall Rapid Fire Area 1CSession ID: 4043(The study has been supported in whole or part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) under contract number 75A50120C00001.) CHEST 2025 Poster Session Poster title: Omadacycline outcomes in community-acquired bacterial pneumonia: pooled efficacy and safety from the Phase 3 OPTIC and OPTIC-2 trialsPoster Session Title: Chest Infections Scientific Abstract Posters (F)Presenter: Alex Winans, Pharm.D. (Paratek research)Date, Time: Wednesday, Oct. 22; 10:20 a.m. - 11:05 a.m. CTLocation: Lakeside Center Exhibit Hall Poster Area 1Poster ID: 4101(The study has been supported in whole or part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) under contract number 75A50120C00001.) IDWeek 2025 Oral Presentation Abstract title: Microbiological Outcomes of Oral Omadacycline Treatment in Adults with Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD) Caused by Mycobacterium abscessus complex (MABc): Results from a Phase 2, Double-blind, Randomized, Placebo-controlled, Multi-center TrialSession: TB and Beyond: Innovations in Treatment, Resistance and Real-World ReachPresenter: Reeti Khare, Ph.D., (Paratek research)Session Date, Time: Tuesday, Oct. 21; 10:30 a.m. - 11:45 a.m. ETSession Location: B207-B208Session ID: 119 IDWeek 2025 Poster Sessions Poster title: Omadacycline was Shown to Preserve the Microbiome in a Murine Model of Post-Influenza MRSA PneumoniaPoster session: Basic Science and Translational StudiesPresenter: Jessica V. Pierce, Ph.D. (Paratek research)Date, Time: Wednesday, Oct. 22; 12:15 p.m. - 1:30 p.m. ETLocation: Poster Hall B4-B5Poster ID: P-1535 Poster title: Pooled Microbiological Outcomes from the Phase 3, Randomized OPTIC and OPTIC-2 Trials of Omadacycline vs Moxifloxacin in Community-acquired Bacterial PneumoniaPoster session: Respiratory infections: Viral and BacterialPresenter: Diane M. Anastasiou, B.S. (Paratek research)Date, Time: Monday, Oct. 20; 12:15 p.m. - 1:30 p.m. ETLocation: Poster Hall B4-B5Poster ID: P-618(The study has been supported in whole or part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) under contract number 75A50120C00001.) Poster title: In Vitro Activity of Omadacycline and Comparator Agents Against Periodontal PathogensPoster session: Novel AgentsPresenter: David A. Hufnagel, Ph.D. (Investigator-initiated research)Date, Time: Tuesday, Oct. 21; 12:15 p.m. - 1:30 p.m. ETLocation: Poster Hall B4-B5Poster ID: P-1182 Poster title: Susceptibility of Omadacycline in Bone and Joint Infections: Pathogen Susceptibility and Regimen Decisions from an Ongoing Randomized Controlled TrialPoster session: Bone and JointPresenter: Amy Y. Kang, Pharm.D., BCIDP (Investigator-initiated research)Date, Time: Monday, Oct. 20; 12:15 p.m. - 1:30 p.m. ETLocation: Poster Hall B4-B5Poster ID: P-78 About Paratek Pharmaceuticals, Inc. Paratek Pharmaceuticals, Inc. is a privately held pharmaceutical company providing innovative specialty therapies for specialists and community care providers, addressing public health threats and important unmet medical needs. NUZYRA (omadacycline) is a once-daily oral and intravenous antibiotic indicated for adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). XHANCE (fluticasone propionate) is a drug-device combination product indicated for chronic rhinosinusitis (CRS) with or without polyps, targeting the site of inflammation using the proprietary Exhalation Delivery System™ (EDS®). Paratek continues to diversify its portfolio to address unmet patient needs. Paratek was acquired in 2023 by B-FLEXION and Novo Holdings. In December 2019, BARDA awarded Paratek a contract (75A50120C00001) that is now valued at up to approximately $304 million. In addition to supporting the development of NUZYRA for both the treatment and prophylaxis of pulmonary anthrax, this contract supports the U.S. onshoring of NUZYRA and manufacturing security requirements; FDA post-marketing requirements associated with the initial NUZYRA approval; and the procurement of up to 10,000 treatment courses of NUZYRA for the treatment of anthrax. For more information, visit https://www.paratekpharma.com/ or follow us on LinkedIn and X. About NUZYRANUZYRA (omadacycline) is an antibiotic with both once-daily oral and intravenous (IV) formulations indicated for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible microorganisms. A next-generation tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypical, and other drug-resistant strains. IMPORTANT SAFETY INFORMATIONCONTRAINDICATIONS NUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline class antibacterial drugs, or to any of the excipients. WARNINGS AND PRECAUTIONS Mortality imbalance was observed in the CABP clinical trial, with eight deaths (2%) occurring in patients treated with NUZYRA compared to four deaths (1%) in patients treated with moxifloxacin. The cause of the mortality imbalance has not been established. All deaths, in both treatment arms, occurred in patients >65 years of age; most patients had multiple comorbidities. The causes of death varied and included worsening and/or complications of infection and underlying conditions. Closely monitor clinical response to therapy in CABP patients, particularly in those at higher risk for mortality. The use of NUZYRA during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia. The use of NUZYRA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth. Hypersensitivity reactions have been reported with NUZYRA. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with other tetracycline class antibacterial drugs. NUZYRA is structurally similar to other tetracycline class antibacterial drugs and is contraindicated in patients with known hypersensitivity to tetracycline class antibacterial drugs. Discontinue NUZYRA if an allergic reaction occurs. Clostridioides difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs. NUZYRA is structurally similar to tetracycline class antibacterial drugs and may have similar adverse reactions. Adverse reactions, including photosensitivity, fixed drug eruption, pseudotumor cerebri, and anti-anabolic action (which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests), have been reported for other tetracycline class antibacterial drugs, and may occur with NUZYRA. Discontinue NUZYRA if any of these adverse reactions are suspected. Prescribing NUZYRA in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. ADVERSE REACTIONS The most common adverse reactions (incidence ≥2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, insomnia, and constipation. DRUG INTERACTIONS Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while taking NUZYRA. Absorption of tetracyclines, including NUZYRA, is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate, and iron-containing preparations. USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding is not recommended during treatment with NUZYRA. See full prescribing information here. About XHANCEXHANCE is a drug-device combination product that uses the Exhalation Delivery System™ (also known as the EDS®) designed to deliver a topical steroid to the high and deep regions of the nasal cavity where sinuses ventilate and drain. XHANCE is approved by the U.S. Food and Drug Administration for both the treatment of chronic rhinosinusitis without nasal polyps (also called chronic sinusitis) and chronic rhinosinusitis with nasal polyps (also called nasal polyps) in patients 18 years of age or older. IMPORTANT SAFETY INFORMATIONCONTRAINDICATIONS: Hypersensitivity to any ingredient in XHANCE.WARNINGS AND PRECAUTIONS: Local nasal adverse reactions, including epistaxis, erosion, ulceration, septal perforation, Candida albicans infection, and impaired wound healing, can occur. Monitor patients periodically for signs of possible changes on the nasal mucosa. Avoid use in patients with recent nasal ulcerations, nasal surgery, or nasal trauma until healing has occurred.Glaucoma and cataracts may occur with long-term use. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use XHANCE long-term.Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, contact dermatitis, rash, hypotension, and bronchospasm) have been reported after administration of fluticasone propionate. Discontinue XHANCE if such reactions occur.Immunosuppression and infections can occur, including potential increased susceptibility to or worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infection; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue XHANCE slowly.Assess for decrease in bone mineral density initially and periodically thereafter. ADVERSE REACTIONS: Chronic rhinosinusitis without nasal polyps: The most common adverse reactions (incidence 3%) are epistaxis, headache, and nasopharyngitis.Chronic rhinosinusitis with nasal polyps: The most common adverse reactions (incidence 3%) are epistaxis, nasal septal ulceration, nasopharyngitis, nasal mucosal erythema, nasal mucosal ulcerations, nasal congestion, acute sinusitis, nasal septal erythema, headache, and pharyngitis. DRUG INTERACTIONS: Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of systemic corticosteroid effects. USE IN SPECIFIC POPULATIONS: Hepatic impairment. Monitor patients for signs of increased drug exposure. See full prescribing information here. MEDIA CONTACT: Adam Silversteinadam@scientpr.com

Phase 3Phase 2Clinical ResultDrug ApprovalAcquisition

21 May 2025

·www.globenewswire.com

Paratek Pharmaceuticals Completes Acquisition of Optinose, Creating an Expanded Portfolio of Specialty Therapies

BOSTON, May 21, 2025 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc., a privately held pharmaceutical company focused on the development and commercialization of specialty therapies for specialists and community care providers, that address important medical and public health threats, today announced that the Company has completed its acquisition of Optinose, Inc. (NASDAQ:OPTN). This acquisition broadens Paratek’s commercial portfolio which now includes both its flagship antibiotic, NUZYRA® (omadacycline), and Optinose’s product XHANCE® (fluticasone propionate). “Adding XHANCE to our portfolio is a pivotal first step in achieving our long-term vision to become a multi‑product specialty therapeutics company, focused on addressing significant unmet medical needs,” said Evan Loh, MD, Chief Executive Officer of Paratek. “Our medical and commercial teams are deeply experienced with capabilities focused on bringing innovative treatments to specialists and primary care providers that address the needs of their patients. This transaction establishes a strong platform for us to continue to leverage these capabilities as we move forward to explore opportunities to expand our portfolio through future product acquisitions.” Under the terms of the merger agreement, Paratek acquired all outstanding shares of Optinose for approximately $330 million, including the assumption of debt and assuming full payment of the contingent value rights (CVRs), and Optinose shareholders were paid $9 per share in cash and received CVRs for up to $5 per share in cash payable in the event that certain net revenue milestones are achieved by XHANCE. Paratek will pay $1 per share if XHANCE achieves $150M in net sales in any calendar year prior to December 31, 2028, and $4 per share if XHANCE achieves $225M in net sales in any calendar year prior to December 31, 2029. Optinose shareholders approved the merger proposal at Optinose’s special meeting of shareholders held on May 16, 2025, and following completion of the merger Optinose's common stock will be delisted from the Nasdaq Global Select Market. The transaction was financed with capital from Paratek, B-FLEXION Life Sciences, and Novo Holdings, and debt financing from funds managed by Oaktree Capital Management, L.P. ("Oaktree"). Lazard acted as the exclusive financial advisor to Paratek Pharmaceuticals, and Skadden, Arps, Slate, Meagher & Flom LLP served as its legal advisor. Evercore acted as the exclusive financial advisor to Optinose, and Hogan Lovells US LLP served as its legal advisor. About Paratek Pharmaceuticals, Inc.Paratek Pharmaceuticals, Inc. is a privately held pharmaceutical company providing innovative specialty therapies for specialists and community care providers, addressing important medical and public health threats. Paratek's lead product, NUZYRA (omadacycline), is a once-daily oral and intravenous antibiotic indicated for adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Paratek continues to diversify its portfolio to address unmet patient needs. Paratek was acquired in 2023 by B-FLEXION and Novo Holdings. For more information, visit https://www.paratekpharma.com/ or follow us on LinkedIn and X. About B-FLEXION Life SciencesB-FLEXION Life Sciences is part of the B-FLEXION group, a private, entrepreneurial investment firm with offices in Europe and the United States. B-FLEXION seeds, acquires and builds investment partnerships across a number of focused fields and makes principal investments into operating businesses in transformative industries. Through B-FLEXION Life Sciences there is also targeted investment across biopharma, diagnostics and a broad spectrum of innovative healthcare services. It is an active owner, applying the experience and skills of its investment and operationally experienced team to work closely with management to build its portfolio companies. www.bflexion.com About Novo Holdings A/SNovo Holdings is a holding and investment company that is responsible for managing the assets and the wealth of the Novo Nordisk Foundation. The purpose of Novo Holdings is to improve people’s health and the sustainability of society and the planet by generating attractive long-term returns on the assets of the Novo Nordisk Foundation. Wholly owned by the Novo Nordisk Foundation, Novo Holdings is the controlling shareholder of Novo Nordisk and Novonesis and manages an investment portfolio with a long-term return perspective. In addition to managing a broad portfolio of equities, bonds, real estate, infrastructure and private equity assets, Novo Holdings is a world-leading life sciences investor. Through its Seed, Venture, Growth, Planetary Health Investments and Principal Investments teams, Novo Holdings invests in life science companies at all stages of development. As of year-end 2024, Novo Holdings had total assets of EUR 142 billion. www.novoholdings.dk About OaktreeOaktree is a leader among global investment managers specializing in alternative investments, with $203 billion in assets under management as of March 31, 2025. The firm emphasizes an opportunistic, value-oriented, and risk-controlled approach to investments in credit, equity, and real estate. The firm has more than 1,200 employees and offices in 25 cities worldwide. For additional information, please visit Oaktree’s website at http://www.oaktreecapital.com/. About NUZYRANUZYRA (omadacycline) is an antibiotic with both once-daily oral and intravenous (IV) formulations indicated for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible microorganisms. A next-generation tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypical, and other drug-resistant strains. IMPORTANT SAFETY INFORMATIONCONTRAINDICATIONSNUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline-class antibacterial drugs or to any of the excipients. WARNINGS AND PRECAUTIONSMortality imbalance was observed in the CABP clinical trial with eight deaths (2%) occurring in patients treated with NUZYRA compared to four deaths (1%) in patients treated with moxifloxacin. The cause of the mortality imbalance has not been established. All deaths, in both treatment arms, occurred in patients > 65 years of age; most patients had multiple comorbidities. The causes of death varied and included worsening and/or complications of infection and underlying conditions. Closely monitor clinical response to therapy in CABP patients, particularly in those at higher risk for mortality. The use of NUZYRA during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.The use of NUZYRA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth. Hypersensitivity reactions have been reported with NUZYRA. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with other tetracycline-class antibacterial drugs. NUZYRA is structurally similar to other tetracycline-class antibacterial drugs and is contraindicated in patients with known hypersensitivity to tetracycline-class antibacterial drugs. Discontinue NUZYRA if an allergic reaction occurs. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs. NUZYRA is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse reactions. Adverse reactions, including photosensitivity, fixed drug eruption, pseudotumor cerebri, and anti-anabolic action (which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests), have been reported for other tetracycline-class antibacterial drugs, and may occur with NUZYRA. Discontinue NUZYRA if any of these adverse reactions are suspected. Prescribing NUZYRA in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. ADVERSE REACTIONSThe most common adverse reactions (incidence 2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, insomnia, and constipation. DRUG INTERACTIONSPatients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while taking NUZYRA. Absorption of tetracyclines, including NUZYRA is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron containing preparations. USE IN SPECIFIC POPULATIONSLactation: Breastfeeding is not recommended during treatment with NUZYRA. See full prescribing information here. About XHANCEXHANCE is a drug-device combination product that uses the Exhalation Delivery System™ (also known as the EDS®) designed to deliver a topical steroid to the high and deep regions of the nasal cavity where sinuses ventilate and drain. XHANCE is approved by the U.S. Food and Drug Administration for both the treatment of chronic rhinosinusitis without nasal polyps (also called chronic sinusitis) and chronic rhinosinusitis with nasal polyps (also called nasal polyps) in patients 18 years of age or older. IMPORTANT SAFETY INFORMATIONCONTRAINDICATIONS: Hypersensitivity to any ingredient in XHANCE.WARNINGS AND PRECAUTIONS: Local nasal adverse reactions, including epistaxis, erosion, ulceration, septal perforation, Candida albicans infection, and impaired wound healing, can occur. Monitor patients periodically for signs of possible changes on the nasal mucosa. Avoid use in patients with recent nasal ulcerations, nasal surgery, or nasal trauma until healing has occurred.Glaucoma and cataracts may occur with long-term use. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use XHANCE long-term.Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, contact dermatitis, rash, hypotension, and bronchospasm) have been reported after administration of fluticasone propionate. Discontinue XHANCE if such reactions occur.Immunosuppression and infections can occur, including potential increased susceptibility to or worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infection; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue XHANCE slowly.Assess for decrease in bone mineral density initially and periodically thereafter. ADVERSE REACTIONS: Chronic rhinosinusitis without nasal polyps: The most common adverse reactions (incidence 3%) are epistaxis, headache, and nasopharyngitis.Chronic rhinosinusitis with nasal polyps: The most common adverse reactions (incidence 3%) are epistaxis, nasal septal ulceration, nasopharyngitis, nasal mucosal erythema, nasal mucosal ulcerations, nasal congestion, acute sinusitis, nasal septal erythema, headache, and pharyngitis. DRUG INTERACTIONS: Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of systemic corticosteroid effects. USE IN SPECIFIC POPULATIONS: Hepatic impairment. Monitor patients for signs of increased drug exposure. See full prescribing information here. MEDIA CONTACT: Adam Silversteinadam@scientpr.com

AcquisitionDrug ApprovalClinical Result

19 Dec 2024

·pharma.economictimes.indiatimes.com

J&J drug helps delay multiple myeloma in high-risk patients

By Nancy Lapid Bengaluru: The Johnson & Johnson drug Darzalex showed promise in helping keep a precancerous condition from progressing to the blood cancer multiple myeloma for those at high risk, according to results from a trial presented at the American Society of Hematology meeting in San Diego. Darzalex, a monoclonal antibody that targets a protein found on the surface of myeloma cells known as CD38, significantly reduced patients' risk of developing the blood cancer and improved their survival in an international late-stage trial. "These results are a major advancement in the treatment of high-risk smoldering multiple myeloma," study leader Dr. S. Vincent Rajkumar of the Mayo Clinic Comprehensive Cancer Center in Rochester, Minnesota said in a statement. In smoldering multiple myeloma, abnormal plasma cells accumulate in the bone marrow. As the abnormal cells and certain proteins accumulate, a patient's risk for cancer increases. In the trial of 390 patients with high-risk SMM, participants received either Darzalex, known chemically as daratumumab , or active monitoring. After a median follow-up of 65.2 months, researchers saw a 51% reduction in the risk of disease progression or death in patients receiving daratumumab, according to a report published in The New England Journal of Medicine. At five years, 63% of patients in the daratumumab group remained progression-free, compared to 41% in the active monitoring group. Survival at five years was 93% in the daratumumab group versus 87% for monitoring. "For the first time, we have a treatment option that can significantly delay or prevent the progression to active disease, improving the lives of patients and offering them a chance at a longer, healthier future," Rajkumar said. Pill for type 2 diabetes may control diabetic eye disease Boehringer Ingelheim and Eli Lilly 's oral diabetes drug Jardiance may keep diabetic eye disease from worsening in patients with type 2 diabetes, according to a report in JAMA Ophthalmology. Researchers analyzed U.S. health insurance claims data on more than 80,000 patients with type 2 diabetes, including 7,831 closely-matched pairs with diabetic eye disease and another 34,239 pairs without the eye disease. In each pair, one patient had received Jardiance, a pill from a class of drugs known as SGLT2 inhibitors, and the other received a DPP4 inhibitor such as Merck's Januvia or Boehringer Ingelheim's Tradjenta. On average, they were tracked for eight months after starting treatment. The risk of developing a new case of diabetic eye disease was the same regardless of which drug patients were taking. But the risk that existing diabetic eye disease would worsen was 22% lower in patients who started taking Jardiance, the researchers found. The study was not a randomized trial and cannot prove that Jardiance actually slowed progression of the so-called diabetic retinopathy. Still, the authors concluded, "these findings may be helpful when weighing the risks and benefits of various glucose-lowering agents in adults with type 2 diabetes." Highly drug-resistant cholera strain is spreading A highly drug-resistant strain of cholera is now spreading over long distances, researchers warned in a letter to the editor of The New England Journal of Medicine. From September 2018 to March 2019, a cholera outbreak with more than 10,000 suspected cases caused by a highly drug-resistant AFR13 7PET strain occurred in Zimbabwe. This strain had been introduced into East Africa from South Asia during 2013-2014. By 2022, the AFR13 7PET strain was identified in cholera cases in southern and eastern Lebanon. AFR13 7PET has probably contributed to a major cholera outbreak in Kenya between October 2022 and October 2023, with 12,120 cases, and to outbreaks in Tanzania and Comoros, where the number of cholera cases has been increasing since early 2024, researchers said. In 2023, the highly drug-resistant strain was isolated from three European travelers returning from Kenya at different times of the year. In March 2024, it was isolated in Mayotte, a French island off the coast of southeastern Africa, initially from patients coming from Tanzania or Comoros, and subsequently from patients infected locally. From 2019 onward, isolates have been resistant to the antibiotics azithromycin, ciprofloxacin, and third-generation cephalosporins. These data demonstrate the need to "strengthen global surveillance of the cholera agent, and especially to determine how it reacts to antibiotics in real time," study leader Dr. Francois-Xavier Weill of Institut Pasteur in Paris said in a statement. "If the new strain that is currently circulating acquires additional resistance to tetracycline, this would compromise all possible oral antibiotic treatment." (Reporting by Nancy Lapid; editing by Bill Berkrot)

Clinical Result

100 Deals associated with Tetracycline Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D02122	Tetracycline Hydrochloride	J01AA07 S02AA08 S03AA02	DB00759

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Infectious Diseases	China	Tianjin Jinyao Pharmaceutical Co., Ltd.	01 Jan 1981
Acute Bronchitis	Japan	Sun Pharma Japan Ltd.	01 Dec 1964
Anthrax	Japan	Sun Pharma Japan Ltd.	01 Dec 1964
Brain Abscess	Japan	Sun Pharma Japan Ltd.	01 Dec 1964
Brucellosis	Japan	Sun Pharma Japan Ltd.	01 Dec 1964
Cystitis	Japan	Sun Pharma Japan Ltd.	01 Dec 1964
Gas Gangrene	Japan	Sun Pharma Japan Ltd.	01 Dec 1964
Gonorrhea	Japan	Sun Pharma Japan Ltd.	01 Dec 1964
Granuloma	Japan	Sun Pharma Japan Ltd.	01 Dec 1964
Intrauterine infection	Japan	Sun Pharma Japan Ltd.	01 Dec 1964
Laryngitis	Japan	Sun Pharma Japan Ltd.	01 Dec 1964
Lung Abscess	Japan	Sun Pharma Japan Ltd.	01 Dec 1964
Lymphadenitis	Japan	Sun Pharma Japan Ltd.	01 Dec 1964
Mastitis	Japan	Sun Pharma Japan Ltd.	01 Dec 1964
Osteomyelitis	Japan	Sun Pharma Japan Ltd.	01 Dec 1964
Periodontitis	Japan	Sun Pharma Japan Ltd.	01 Dec 1964
Pharyngitis	Japan	Sun Pharma Japan Ltd.	01 Dec 1964
Pneumonia	Japan	Sun Pharma Japan Ltd.	01 Dec 1964
Pyelonephritis	Japan	Sun Pharma Japan Ltd.	01 Dec 1964
Pyoderma	Japan	Sun Pharma Japan Ltd.	01 Dec 1964

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06351891 (Pubmed \| Helicobacter)	Phase 4	Helicobacter pylori infection penicillin allergy	248	Cefuroxime-Tetracycline‐containing Bismuth Quadruple Therapy (Cef‐Tet BQT)	wfwcgcaktx(qfbmmwrznc) = ctlfelqoni gtjdsfrsen (xkvwltqekk, 85.12% - 95.52) View more	Positive	01 Mar 2025
				Cefuroxime-Levofloxacin‐containing Bismuth Quadruple Therapy (Cef‐Lev BQT)	wfwcgcaktx(qfbmmwrznc) = bquhhubgbj gtjdsfrsen (xkvwltqekk, 74.61% - 88.29) View more
NCT03658733 (Pubmed \| Clin Transl Gastroenterol)	Phase 4	Helicobacter pylori infection	65	Esomeprazole 40 mg or rabeprazole 20 mg	psvuyentzm(zddhdbzake) = 23.4% (15/64) of patients experienced drug-related TEAEs stzwycqljc (kuabgqnwqn )	-	01 Aug 2021
				Amoxicillin 1,000 mg
NCT04716426 (CTgov)	Not Applicable	COVID-19	100	Tetracycline hydrochloride 3% (Tetracycline Hydrochloride 3%)	cmsmajkvtt = urtkftolug zbqdawahil (buqqrocqka, bfksmnbajx - vfsxpnjquf) View more	-	08 Apr 2021
				Placebo (Placebo)	cmsmajkvtt = iqxlbtoifi zbqdawahil (buqqrocqka, wiuassxqad - gkjqoalioh) View more
UEGW2020	Not Applicable	Infectious Diseases	-	Tetracycline-containing bismuth quadruple therapy	tjafictjob(gthkcjpvlb) = aymocmpblv rawhshhisa (abdabpsxid, 67 - 86) View more	-	01 Oct 2020
				Doxycycline-containing bismuth quadruple therapy	tjafictjob(gthkcjpvlb) = bhvczavtty rawhshhisa (abdabpsxid, 55 - 77) View more
NCT03708848 (Pubmed \| Helicobacter)	Phase 4	Helicobacter pylori infection First line	112	Triple therapy based on susceptibility to clarithromycin, levofloxacin, and metronidazole	dgtrvlzyrk(dtvfikepuc) = liwuqntgfy hwrncjggkz (oahimkmxjz, 88.1% - 97.7%)	-	01 Aug 2020
				Quadruple therapy based on susceptibility to clarithromycin, levofloxacin, and metronidazole	dgtrvlzyrk(dtvfikepuc) = polbzfxsap hwrncjggkz (oahimkmxjz, 97.1% - 100%)
NCT02547038 (CTgov)	Not Applicable	Helicobacter pylori infection	352	pantoprazole+tetracycline+metronidazole+bismuth subcitrate (Pantoprazole+Bismuth+Tetra+Metro)	zijspgbzeq = ynoruujwva dmlxfrgiss (pnlyawsogk, trybnyfedc - ykgtucuikc) View more	-	10 Jun 2019
				pantoprazole+amoxicillin+metronidazole+clarithromycin ((Panto+Amox+Clar+Metr)+(Panto+Amox))	zijspgbzeq = djngxoovvw dmlxfrgiss (pnlyawsogk, dykqcsosho - duxyvfdhqn) View more
NCT02547012 (CTgov)	Not Applicable	Helicobacter pylori infection	51	levofloxacin+amoxicillin +tetracycline+esomeprazole (Esomeprazole+Amox+Levo+Tetra)	snlxokqcxy = fgsrpptele imsdrfdrab (mqbxvhkahx, putcpzdfaa - xrvyrpbblv) View more	-	14 Mar 2019
				amox+esomeprazole (Esomeprazole+Amox+Levo)	snlxokqcxy = idriwmbhcq imsdrfdrab (mqbxvhkahx, nchenzdywt - zuhwxkooht) View more
NCT00347776 (STAR \| STAR trial, CTgov)	Phase 4	Trichiasis	1,452	topical tetracycline	bpaypjqahw = nxrykalxlt hnppdeuigw (ivqubwznny, cezhtwurtf - nqgsmeeypm) View more	-	07 Aug 2017
NCT01880515 (CTgov)	Phase 2	Non-small cell lung cancer stage IIIB \| Non-Small Cell Lung Cancer \| Exanthema	107	Tetracycline (Tetracycline)	cucrrwytky = bxeybrwwcq ydogvglmxc (kgsqkacozl, fvodsszltp - apqpdrgpfc) View more	-	12 Apr 2017
				tetracycline (No Tetracycline)	cucrrwytky = eerlwxibfs ydogvglmxc (kgsqkacozl, xhsskvelwi - mxfpohnbgu) View more
NCT02349685 (CTgov)	Not Applicable	Helicobacter Infections	219	H. pylori culture and antimicrobial susceptibility test	czksinduka = ljauuzozdl ipyzniziex (wqikatutpb, gocppfrepa - fqynhuuebh) View more	-	04 Oct 2016

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