Delving into the Latest Updates on Azithromycin with Synapse

Overview

Basic Info

SummaryAzithromycin, a small molecule drug, works by targeting the 50S subunit of the bacterial ribosome and disrupting protein synthesis, ultimately leading to bacterial death. This drug falls under the class of macrolide antibiotics and is commonly used to treat a diverse range of bacterial infections, such as respiratory tract infections, skin and soft tissue infections, and sexually transmitted infections. It is also used as a prophylactic treatment for certain opportunistic infections in HIV patients. Azithromycin gained FDA approval in 1991, representing a significant breakthrough in the field of antibiotic development. With its broad-spectrum activity against a wide range of bacterial species, Azithromycin is a valuable tool for healthcare providers in managing bacterial infections. However, the overuse or misuse of antibiotics such as Azithromycin can lead to the emergence of antibiotic-resistant bacteria. Therefore, healthcare providers must exercise caution and prudence when prescribing Azithromycin to prevent the development of antibiotic resistance. Overall, Azithromycin is a potent antibiotic that plays a crucial role in the treatment of bacterial infections.

Drug Type

Small molecule drug

Synonyms

Azithromycin (INN), Azithromycin Dihydrate, Azithromycin Hydrate

+ [29]

Target

50S subunit

Action

inhibitors

Mechanism

50S subunit inhibitors(50S ribosomal subunit inhibitors)

Therapeutic Areas

Infectious DiseasesEye DiseasesHemic and Lymphatic Diseases+ [6]

Active Indication

Genital infectionLower Respiratory Tract InfectionsOtitis Media+ [34]

Inactive Indication

Acne VulgarisAcquired Immunodeficiency Syndromeacute bacterial conjunctivitis+ [21]

Originator Organization

Pfizer Inc.

Active Organization

Shinpoong Pharmaceutical Co., Ltd.

Pfizer Japan, Inc.Thea Pharma, Inc.

+ [6]

Inactive Organization

PF Prism CV

Laboratoires Théa SASTeva Pharmaceuticals USA, Inc.

+ [4]

Drug Highest PhaseApproved

First Approval Date

United States (01 Nov 1991),

Infectious Diseases

RegulationOrphan Drug (United States), Priority Review (China), Orphan Drug (Japan)

Login to view timeline

Structure/Sequence

Molecular FormulaC38H72N2O12

InChIKeyMQTOSJVFKKJCRP-BICOPXKESA-N

CAS Registry83905-01-5

考察健康受试者在空腹及餐后条件下，单次口服1片浙江贝得药业有限公司生产的阿奇霉素分散片（受试制剂T，规格：0.25g）与相同条件下单次口服1片由Teva Nederland B.V.持证的阿奇霉素片（参比制剂R，商品名：Azitromycin 250mg TEVA，规格：0.25g）的药动学特征，评价两制剂间的生物等效性及安全性。

[Translation]

To investigate the pharmacokinetic characteristics of a single oral administration of azithromycin dispersible tablets produced by Zhejiang Beide Pharmaceutical Co., Ltd. (test preparation T, specification: 0.25 g) and a single oral administration of azithromycin tablets certified by Teva Nederland B.V. (reference preparation R, trade name: Azitromycin 250 mg TEVA, specification: 0.25 g) in healthy subjects under fasting and postprandial conditions, and to evaluate the bioequivalence and safety of the two preparations.

Start Date24 Feb 2025

Sponsor / Collaborator

Zhejiang Better Pharmaceuticals Co. Ltd.

NCT06461429

/ Not yet recruitingNot ApplicableIIT

Platform for Adaptive Trials in Perinatal Units (Core Protocol)

PLATIPUS is an adaptive platform trial aimed at improving the health of infants born preterm (before 37 weeks' gestation). PLATIPUS will compare how different treatments and care provided to pregnant women and people at risk of preterm birth and infants born preterm affect infant health.
The main questions PLATIPUS aims to answer are:
1. What effect/s do different treatments/care provided to pregnant women and people at risk of preterm birth have on the health of their infants? (Pregnancy domains)
2. What effect/s do different treatments/care given to infants born preterm have on their health ? (Neonatal domains).
This registration record relates to the PLATIPUS Core (or 'master') protocol which provides guidance for the overall running of the trial. Additional appendices will outline the aims, questions, treatments, and activities for each separate research question (domain). Each Domain-Specific Appendix will be registered separately on ClinicalTrials.gov and will link to this record.

Start Date01 Feb 2025

Sponsor / Collaborator

University of Melbourne

[+10]

NCT06325293

/ RecruitingNot ApplicableIIT

A Randomized Controlled Non-inferiority Trial of Placebo Versus Macrolide Antibiotics for Mycoplasma Pneumoniae Infection in Children with Community-acquired Pneumonia - the MYTHIC Study

The goal of this clinical trial is to compare a placebo (a look-alike substance that contains no active drug) with a commonly used antibiotic in children with Mycoplasma pneumoniae (a specific bacterium) induced community-acquired pneumonia. The main question it aims to answer is:
Is antibiotic treatment needed in Mycoplasma pneumoniae (a specific bacterium) induced pneumonia?
Participants will receive either a placebo or a antibiotic treatment and track their symptoms and vital signs until they are healthy.
Researchers will then compare the length of symptoms between the placebo and the antibiotic group.

Start Date28 Jan 2025

Sponsor / Collaborator

Swiss Clinical Trial Organization

100 Clinical Results associated with Azithromycin

Login to view more data

100 Translational Medicine associated with Azithromycin

Login to view more data

100 Patents (Medical) associated with Azithromycin

Login to view more data

24,392

Literatures (Medical) associated with Azithromycin

31 Dec 2025·Emerging Microbes & Infections

Construction and validation of a predictive model for meningoencephalitis in pediatric scrub typhus based on machine learning algorithms

Article

Author: Yang, Xiaotao ; Zou, Xiu ; Wang, Yanchun ; Ding, Wenrui ; Bai, Houxi ; Zhang, Ting ; Jiao, Feng ; Luo, Yonghan ; Guo, Yan

To retrospectively analyze the clinical characteristics of pediatric scrub typhus (ST) with meningoencephalitis (STME) and to construct and validate predictive models using machine learning.Clinical data were collected from 100 cases of pediatric STME and matched with data from 100 ST cases without meningitis using propensity-score matching. Risk factors for STME in pediatrics were identified through the least absolute shrinkage and selection operator (LASSO) regression analysis. Six predictive models-Logistic Regression, K-Nearest Neighbors, Naive Bayes, Multi-layer Perceptron(MLP), Random Forest, and XGBoost-were constructed using the training set and evaluated for performance, with validation conducted on the test set. The Shapley Additive Explanations (SHAP) method was applied to rank the importance of each variable.All children improved and were discharged following treatment with azithromycin/doxycycline (1/99). Twelve variable features were identified through the LASSO regression. Of the six predictive models developed, the XGBoost model demonstrated the highest performance in the training set (AUC = 0.926), though its performance in the test set was moderate (AUC = 0.740). The MLP model exhibited robust predictive performance in both training and test sets, with AUCs of 0.897 and 0.817, respectively. Clinical decision curve analysis indicated that the MLP and XGBoost models provide significant clinical utility. SHAP analysis identified the most important predictors for STME as ferritin, white blood cell count, edema, prothrombin time, fibrinogen, duration of pre-admission fever, eschar, activated partial thromboplastin time, splenomegaly, and headache. The MLP and XGBoost models showed strong predictive capability for pediatric STME, with favorable outcomes following doxycycline-based therapy.

01 Dec 2025·JOURNAL OF CLINICAL IMMUNOLOGY

Restitutio ad integrum: Rescuing the Alveolar Macrophage Function with HSCT in Pulmonary Alveolar Proteinosis Due to CSF2Rα Deficiency

Article

Author: Pandrowala, Ambreen ; Mishra-Sopori, Varsha ; Khan, Sanaa ; Bodhanwala, Minnie ; Hiwarkar, Prashant ; Chandane, Parmarth ; Khosla, Indu ; Kataria, Darshan ; Sehgal, Kunal ; Prabhudesai, Pralhad

Hereditary pulmonary alveolar proteinosis (hPAP) is a rare lung-related primary immunodeficiency. In hPAP, variants of genes encoding the heterodimeric GM-CSF receptor alpha or beta-chains (CSF2Rα, CSF2Rβ) lead to perturbations in GM-CSF signalling. These perturbations impair the scavenging function of pulmonary alveolar macrophages leading to accumulation of surfactant proteins and lipids within the alveoli. The replacement of defective pulmonary alveolar macrophages can be achieved with allogeneic hematopoietic stem cell transplantation. However, previous reports highlight undesirable pulmonary outcomes associated with this therapeutic approach. We report a 4-year-old developmentally normal girl born of second-degree consanguineous marriage diagnosed with severe form of CSFRα-deficient PAP. She required recurrent whole lung lavage and hence was treated with allogeneic hematopoietic stem cell transplantation. A reduced toxicity treosulfan-based myeloablative regimen with alemtuzumab serotherapy was used for conditioning. Ciclosporin, mycophenolate mofetil and FAM (fluticasone inhaler, azithromycin, montelukast) were used to prevent graft-versus-host disease and immune-related complications of lung. Her post-transplant course was uneventful with full donor chimerism and complete resolution of symptoms. We demonstrate for the first time in a case of severe CSF2Rα-deficient PAP, the successful use of hematopoietic stem cell transplantation as a primary curative treatment, restoring normal lungs both anatomically and functionally. The case report provides evidence for considering allogeneic hematopoietic stem cell transplant in severe forms of CSF2R-deficient PAP.

01 Aug 2025·COMPUTATIONAL BIOLOGY AND CHEMISTRY

Modulating Acinetobacter baumannii BfmR (RstA) drug target: Daniellia oliveri compounds as RstA quorum sensing inhibitors

Article

Author: Dweba, Yamkela ; Aruwa, Christiana E ; Sabiu, Saheed ; Ayodele, Oladunni M

Plant products have been integral to the derivation of interventive therapies to mitigate the current scourge of antimicrobial resistance (AMR). The South African plant, Daniellia oliveri, may yet hold promise against WHO-listed critical priority pathogens like Acinetobacter baumannii and its quorum sensing (QS) system, BfmR (RstA). Hence, we bio-prospected D. oliveri compounds in a bid to provide alternative antimicrobial therapeutics, specifically, potential quorum sensing inhibitors (QSIs). This study utilized a range of in silico validated tools for the cheminformatic analysis of RstA modulating properties of D. oliveri-associated compounds. The two (2) lead compounds identified (β-carotene, β-amyrin) had docking scores of -6.8 kcal/mol, relative to -6.7 kcal/mol observed for the azithromycin reference. Only cis-Calamenene and β-amyrin had pharmacokinetic features conformed to the rule of 5 (Ro5) for selection as potential oral drug candidates. β-carotene and rutin had the best quantum reactivity attributes (lowest energy gap, and highest electronegativity and global electrophilicity). Molecular dynamics (MD) simulation revealed that all lead ligands bound to RstA stabilized system compactness and thermodynamics. Although the azithromycin-RstA system had the least ∆G_bind (-40.48 kcal/mol), rutin had the next highest ∆G_bind (-31.53 kcal/mol) of all D. oliveri compounds. Overall, these lead Daniellia oliveri metabolites may yet have potential RstA inhibitory/modulatory action upon further structural modification, and in vitro and in vivo validation tests prior to formulation into oral, interventive QSIs targeting A. baumannii RstA modulation.

42

News (Medical) associated with Azithromycin

26 Mar 2025

·pipelinereview.com

Blujepa (gepotidacin) Approved by US FDA for Treatment of Uncomplicated Urinary Tract Infections (uUTIs) in Female Adults and Pediatric Patients 12 Years of Age and Older

PHILADELPHIA, PA, USA I March 25, 2025 I GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Blujepa (gepotidacin) for the treatment of female adults (≥40 kg) and pediatric patients (≥12 years, ≥40 kg) with uncomplicated urinary tract infections (uUTIs) caused by the following susceptible microorganisms: Escherichia coli , Klebsiella pneumoniae , Citrobacter freundii complex, Staphylococcus saprophyticus and Enterococcus faecalis . Discovered by GSK scientists, Blujepa is a first-in-class oral antibiotic with a novel mechanism of action that is part of GSK’s infectious diseases portfolio. Tony Wood, Chief Scientific Officer, GSK, said : “The approval of Blujepa is a crucial milestone with uUTIs among the most common infections in women. We are proud to have developed Blujepa , the first in a new class of oral antibiotics for uUTIs in nearly three decades, and to bring another option to patients given recurrent infections and rising rates of resistance to existing treatments.” uUTIs are the most common infection in women, impacting up to 16 million women in the US annually. 1-4 Over half of all women are affected by uUTI in their lifetime, 5 with approximately 30% suffering from at least one recurrent episode which can cause significant patient burden, including discomfort and restriction of daily activities. 6 New treatments are needed as the number of uUTIs caused by drug-resistant bacteria is increasing which can result in higher treatment failure rates. 7 Thomas Hooton, MD, Professor of Clinical Medicine, University of Miami School of Medicine said: “For many, uUTIs can be a burden that severely impacts daily life. With an increasing number of patients experiencing recurrent infections, there remains a clear need for continued research of antimicrobials to help address ongoing patient challenges and the strain on healthcare systems.” The approval is based on positive results from the pivotal phase III EAGLE-2 and EAGLE-3 trials which demonstrated non-inferiority to nitrofurantoin, one of the leading current standard of care options for uUTI, in female adults (≥40 kg) and pediatric patients (≥12 years, ≥40 kg) with a confirmed uUTI. In EAGLE-2, Blujepa demonstrated non-inferiority in therapeutic success which occurred in 50.6% (162/320) of participants compared to 47.0% (135/287) for nitrofurantoin (covariate-adjusted treatment difference 4.3%, 95% CI (-3.6, 12.1)). In EAGLE-3, Blujepa demonstrated statistically significant superiority versus nitrofurantoin (one-sided p-value 0.0003). Therapeutic success occurred in 58.5% (162/277) of participants compared to 43.6% (115/264) for nitrofurantoin (covariate-adjusted treatment difference 14.6%, 95% CI (6.4, 22.8)). The safety and tolerability profile of Blujepa in the EAGLE-2 and EAGLE-3 phase III trials was consistent with previous trials. The most commonly reported adverse events (AEs) in Blujepa participants were gastrointestinal (GI). Diarrhea was the most common (16% of participants), followed by nausea (9%). Of the participants who reported GI AEs in the Blujepa group, the most common maximum severity was mild (69% Grade 1) and moderate (28% Grade 2). Participants with Grade 3 GI events accounted for 3% of all patients with GI events and occurred in <1% of all participants. There was one drug-related serious adverse event in each treatment arm ( Blujepa and nitrofurantoin) across the two trials. US commercial launch is planned in 2H 2025. The development of Blujepa (gepotidacin) has been funded in part with federal funds from the US Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction Agreement number HHSO100201300011C and with federal funds awarded by the Defense Threat Reduction Agency under agreement number HDTRA1-07-9-0002. About Blujepa (gepotidacin) Blujepa , discovered by GSK scientists, is a bactericidal, first-in-class triazaacenaphthylene antibiotic that inhibits bacterial DNA replication by a distinct binding site, a novel mechanism of action and for most pathogens, provides well-balanced inhibition of two different Type II topoisomerase enzymes. This provides activity against most target uropathogens (such as Escherichia coli and Staphylococcus saprophyticus ), and Neisseria gonorrhoeae , including isolates resistant to current antibiotics. Due to the well-balanced inhibition for most pathogens, Blujepa target-specific mutations in both enzymes are needed to significantly affect susceptibility to Blujepa . Therefore, a lower potential for resistance development is expected. Efficacy and safety in patients have been demonstrated in uUTI and gonorrhea phase III clinical trials, including in patients with drug-resistant pathogens. Please see full Prescribing Information including Medication Guide, available here . About the EAGLE (Efficacy of Antibacterial Gepotidacin Evaluated) phase III program The global phase III clinical program for Blujepa (gepotidacin) in adults and pediatric patients consists of three trials: EAGLE-2 and EAGLE-3 (non-inferiority uUTI trials) compared the efficacy and safety of Blujepa (1,500mg administered orally twice daily for five days) to nitrofurantoin (100mg administered orally twice daily for five days) with 1531 and 1605 female adults and pediatric patients with uUTIs, respectively. Across both trials, the planned duration of follow-up for participants was approximately 28 days, and the primary endpoint, a stringent composite measure of efficacy, was the combined clinical and microbiological response at the Test-of-Cure (ToC) visit (days 10-13) in patients with qualifying uropathogens susceptible to nitrofurantoin. EAGLE-1 (non-inferiority uncomplicated urogenital gonorrhea trial) compared the efficacy and safety of Blujepa to ceftriaxone plus azithromycin in 628 patients with uncomplicated urogenital gonorrhea caused by N. gonorrhoeae . GSK in infectious diseases GSK has pioneered innovation in infectious diseases for over 70 years, and the Company’s pipeline of medicines and vaccines is one of the largest and most diverse in the industry, with a goal of developing preventive and therapeutic treatments for multiple disease areas or diseases with high unmet needs globally. Our expertise and capabilities in infectious disease strongly position us to help prevent disease and mitigate the challenge of antimicrobial resistance (AMR). In antimicrobials, in addition to gepotidacin, GSK entered into an exclusive license agreement with Spero Therapeutics, Inc. in September 2022 to add tebipenem HBr, a late-stage antibiotic and potential treatment for complicated urinary tract infections (cUTIs), to the pipeline and are currently enrolling for PIVOT-PO, a phase III trial. In March 2023, GSK announced an exclusive license agreement with Scynexis for Brexafemme (ibrexafungerp tablets), a first-in-class antifungal for the treatment of vulvovaginal candidiasis (VVC) and reduction in the incidence of recurrent VVC. BLUJEPA (gepotidacin) tablets, for oral use Indication(s) and Important Safety Information (ISI) INDICATION BLUJEPA is indicated for the treatment of female adult and pediatric patients 12 years of age and older weighing at least 40 kilograms (kg) with uncomplicated urinary tract infections (uUTI) caused by the following susceptible microorganisms: Escherichia coli , Klebsiella pneumoniae , Citrobacter freundii complex, Staphylococcus saprophyticus , and Enterococcus faecalis . Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of BLUJEPA and other antibacterial drugs, BLUJEPA should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com . References 1 Advani SD, et al. Poster presented at: ISPOR 2024; May 5-8, 2024. Presentation EPH17. 2 Foxman B, et al. Urinary tract infection: self-reported incidence and associated costs. Ann Epidemiol . 2000;10(8):509-15. 3 Foxman B. Urinary Tract Infection Syndromes: Occurrence, Recurrence, Bacteriology, Risk Factors, and Disease Burden. Infect Dis Clin North Am . 2014 28(1):1-13. 4 United States Census Bureau. Age and Sex Composition: 2020. [Available from: https://www2.census.gov/library/publications/decennial/2020/census-briefs/c2020br-06.pdf Last accessed March 2025]. 5 Czajkowski, K, et al. Urinary tract infection in women. Prz Menopauzalny . 2021;20(1):40-7. 6 Little P, et al. Presentation, pattern, and natural course of severe symptoms, and role of antibiotics and antibiotic resistance among patients presenting with suspected uncomplicated urinary tract infection in primary care: observational study. BMJ . 2010;340:b5633. 7 Kaye KS, et al. Antimicrobial resistance trends in urine Escherichia coli isolates from adult and adolescent females in the United States from 2011 to 2019: rising ESBL strains and impact on patient management. Clin Infect Dis 2021;73:1992–1999. SOURCE: GlaxoSmithKline

Phase 3Clinical ResultLicense out/inDrug Approval

15 Nov 2024

·www.echemi.com

Pfizer Plans to Sell Hospital Drug Division, 35% of Chinese Market to Change Hands

On November 12, Reuters reported that US pharmaceutical giant Pfizer plans to sell its hospital drugs unit and is currently working with Goldman Sachs to evaluate it. The move means that the products, including antibiotics, steroids and immunoglobulins, will change owners, including the original drug Supraxen, which has a 35 percent market share in China. Pfizer's hospital drugs unit is an asset it acquired after acquiring Hospira for $17 billion in 2015. Less than a decade later, however, Pfizer was willing to put it up for sale, and it is interesting why. It is speculated that the pressure behind this decision may come from investment institutions. The Starboard Value fund made a strategic investment in Pfizer this year, and according to data from the Wall Street Journal, it now holds a $1 billion stake in the company, enough to influence Pfizer's management decisions. Starboard's chief financial officer has repeatedly called on Pfizer to optimize internal capital allocation, liquidate some of its assets and put more money into areas with more potential. Pfizer's hospital pharmaceuticals division includes anti-infective drugs and sterile injections, including well-known antibiotics Supraxen, Sfortol and Zithromax, steroids Medrol and immunoglobulin product Panzyga, and is currently part of its specialty pharmaceuticals business. In 2023, the division contributed billions of dollars in revenue to Pfizer and maintained a 15% growth rate. However, from the perspective of the capital market, such a growth rate still seems to fall short of expectations. Pfizer is widely expected to make further changes to its business segments in the future. Under the significant impact of the Starboard Value fund on Pfizer's strategic layout, Pfizer's core business may also face significant changes, which adds a considerable degree of uncertainty to the company's future development. On November 13, Pfizer's share price was slightly affected, falling nearly 3% at one point.

Acquisition

12 Aug 2024

·www.drugs.com

Some Cases of Recurrent Wheeze in Kids May Need New Treatment

MONDAY, Aug. 12, 2024 -- Does your kid suffer from wheezing that returns again and again? They might be suffering from a “silent” viral lung infection that would be better treated by changing up their medications, a new study finds. Nearly a quarter of children and teens with severe wheezing have undetected lung infections, researchers reported recently in the Journal of Allergy and Clinical Immunology . Unfortunately, these infections won’t respond to corticosteroids commonly used to treat wheezing, researchers said. In fact, higher doses of steroids might put children at higher risk of lingering lung inflammation, as well as other known side effects of those drugs. “While steroids can help some children with wheeze, many children in the study showed no patterns of inflammation that would improve with steroids,” said lead researcher Dr. Gerald Teague , a pediatric pulmonologist with the University of Virginia School of Medicine. Instead, these kids should be treated with medications that target viruses and symptoms of viral infection, Teague said. “I advise the parents of my patients that have wheeze episodes that are triggered by colds should be treated with anti-inflammatory medications that build immunity to viruses, such as azithromycin ,” Teague said in a university news release. "They look surprised that we would use an antibiotic for a viral infection, but, in fact, azithromycin bolsters the immune response to viruses in a positive way,” Teague added. For the study, researchers screened more than 800 children and teens with severe and persistent wheezing -- a whistling or rattling sound that occurs while breathing. Rhinoviruses -- the main cause of the common cold -- can trigger wheezing episodes, but wheezing more often is treated the same as asthma, researchers said. In asthma , inhaled corticosteroids are used to reduce airway inflammation. But the results showed that 22% of children with recurrent wheezing were indeed suffering from silent viral infections. Researchers aren’t sure why these kids can’t shake off these infections, which also can involve other types of viruses. They suspect something may be going awry in the immune cells of the children’s lungs, so that they are unable to fight off these viruses. Notably, the problem seems to primarily affect very young children, researchers said. By the time they reach school age, viral-associated wheezing becomes less common. Doctors should rethink how they treat recurrent wheezing and explore potential causes before prescribing powerful corticosteroids, Teague said. “Viral infections are the most important trigger of acute wheeze episodes in children and, in some cases, lead to respiratory distress and hospital care,” Teague said. “We hope this discovery will stimulate further work in the treatment of recurrent wheeze and viral infections in children,” Teague added. “The field has to get to away from overuse of potentially toxic steroids for the treatment of acute wheeze to include novel therapies which target specific patterns of inflammation.” Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical Result

100 Deals associated with Azithromycin

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
D07486	Azithromycin	J01FA10 S01AA26	DB00207

R&D Status

Approved

10 top approved records.

Login

to view more data

Indication	Country/Location	Organization	Date
Genital infection	South Korea	Shinpoong Pharmaceutical Co., Ltd.	28 Jun 2024
Lower Respiratory Tract Infections	South Korea	Shinpoong Pharmaceutical Co., Ltd.	28 Jun 2024
Otitis Media	South Korea	Shinpoong Pharmaceutical Co., Ltd.	28 Jun 2024
Skin structures and soft tissue infections	South Korea	Shinpoong Pharmaceutical Co., Ltd.	28 Jun 2024
Blepharitis	Japan	Senju Pharmaceutical Co., Ltd.	18 Jun 2019
Dacryocystitis	Japan	Senju Pharmaceutical Co., Ltd.	18 Jun 2019
Hordeolum	Japan	Senju Pharmaceutical Co., Ltd.	18 Jun 2019
Conjunctivitis, Bacterial	United States	Thea Pharma, Inc.	27 Apr 2007
Acute bacterial sinusitis	United States	PF Prism CV	10 Jun 2005
Acute Bronchitis	Japan	Pfizer Japan, Inc.	10 Mar 2000
Laryngitis	Japan	Pfizer Japan, Inc.	10 Mar 2000
Lung Abscess	Japan	Pfizer Japan, Inc.	10 Mar 2000
Lymphadenitis	Japan	Pfizer Japan, Inc.	10 Mar 2000
Pericoronitis	Japan	Pfizer Japan, Inc.	10 Mar 2000
Periodontitis	Japan	Pfizer Japan, Inc.	10 Mar 2000
Pharyngitis	Japan	Pfizer Japan, Inc.	10 Mar 2000
Respiratory Tract Infections	Japan	Pfizer Japan, Inc.	10 Mar 2000
Sinusitis	Japan	Pfizer Japan, Inc.	10 Mar 2000
Skin and skin structure infections	Japan	Pfizer Japan, Inc.	10 Mar 2000
Tonsillitis	Japan	Pfizer Japan, Inc.	10 Mar 2000

Developing

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Inflammation	Phase 3	Mali	Pfizer Inc.	15 Oct 2020
Malaria	Phase 3	Mali	Pfizer Inc.	15 Oct 2020
COVID-19	Phase 3	United States	Pfizer Inc.	22 May 2020
acute bacterial conjunctivitis	Phase 3	China	Shandong Bestcomm Pharmaceutical Co., Ltd.	03 Sep 2014
Acne Vulgaris	Phase 3	Italy	Pfizer Inc.	01 Oct 2007
Chronic disease of respiratory system	Phase 3	Japan	Pfizer Inc.	01 Oct 2006
Asthma	Phase 3	United States	Pfizer Inc.	01 Jan 2006
Acute maxillary sinusitis	Phase 3	United States	Pfizer Inc.	01 Jan 2003
Acute maxillary sinusitis	Phase 3	Argentina	Pfizer Inc.	01 Jan 2003
Acute maxillary sinusitis	Phase 3	Chile	Pfizer Inc.	01 Jan 2003

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01235546 (Pubmed \| J Matern Fetal Neonatal Med)	Phase 3	Obstetric Labor, Premature	-	Adjunctive Azithromycin Prophylaxis	jaqsfuxgtm(kkpreejkcn): OR = 1.06 (95% CI, 0.77 - 1.46), P-Value = 0.42	Positive	01 Dec 2024
				Placebo
NCT03871491 (A-PLUS, CTgov)	Phase 3	Pregnancy Complications, Infectious \| Maternal Death \| Neonatal Sepsis	58,747	Azithromycin (Intervention)	isrwaeqdbo = ycipgkceaw avmbbsjesy (haszrriwxm, tzxrbegrhk - wuhzalckti)	-	24 Oct 2024
				Placebo (Placebo)	isrwaeqdbo = irbiorkmox avmbbsjesy (haszrriwxm, ygzlmqmghu - wrvetzocnx)
NCT05027516 (ResistAZM, CTgov)	Phase 4	Gonorrhea	42	Rocephin (Rocephine®)	hiwuuextkq(ifdwbkggpc) = wgjrqoblcy dmhflggant (cvhrtsnenu, wfeshwslso - ccjbrlrrva) View more	-	02 Aug 2024
				Azithromycin+Rocephin (Rocephine® + Azithromycin)	oyslpkqavr = eezyowtprb mscoqtzccx (ocvgrsqtnc, zeqmlanflc - tethjkyvvq) View more
NCT04677543 (ARISE, CTgov)	Phase 3	Mycobacterium Infections, Nontuberculous	99	Ethambutol+Azithromycin+ALIS (ALIS + Background Regimen (Azithromycin + Ethambutol))	lidunblqxq(ielpdzwqpm) = xwipaywigs qhpiqorkel (mtwksprjwd, 0.82) View more	-	28 Jun 2024
				ELC+Ethambutol+Azithromycin (ELC + Background Regimen (Azithromycin + Ethambutol))	lidunblqxq(ielpdzwqpm) = dssxdwowgo qhpiqorkel (mtwksprjwd, 0.90) View more
NCT03060473 (TREAT, CTgov)	Phase 3	Preterm Premature Rupture of the Membranes	21	Amoxicillin+Azithromycin+Ampicillin (Azithromycin)	amikoknmxo(fxgwzusdwu) = vhyaxcnoke jrmzklspgx (lbenwkqarc, dgwgtnkgsw - wxxvftaigu) View more	-	25 Jun 2024
				Amoxicillin+Ampicillin+Erythromycin (Erythromycin)	amikoknmxo(fxgwzusdwu) = faklncdfze jrmzklspgx (lbenwkqarc, ppjoksifjp - xnlmaxxylc) View more
ATS2024	Not Applicable	Bronchiectasis	-	Azithromycin 250mg	tvyhfvldlr(ilflwdxtav) = dxydkxfumw pznqpvvubz (vflilhrszc ) View more	-	19 May 2024
NCT04341727 (WU352, CTgov)	Phase 3	COVID-19 \| Severe Acute Respiratory Syndrome	30	Hydroxychloroquine Sulfate (Hydroxychloroquine Alone)	cwbulhhlro(whsucbqjbc) = owzkhakhed sfqwimmjym (lkcxtluqnf, cztxzoxvym - zeoefdatvj) View more	-	25 Apr 2024
				Hydroxychloroquine Sulfate+Azithromycin (Hydroxychloroquine Plus Azithromycin)	cwbulhhlro(whsucbqjbc) = bcoybheacs sfqwimmjym (lkcxtluqnf, edyamubuyy - dxcnikyuue) View more
NCT03130114 (ABCD, Pubmed \| J Infect Dis) Manual	Phase 3	Diarrhea	6,692	Azithromycin	fuorabsfbq(gavyhraoik) = tbzvlxavop goiofjdlrg (xphxnwolix )	Positive	12 Apr 2024
				Placebo	fuorabsfbq(gavyhraoik) = punewcvoiw goiofjdlrg (xphxnwolix )
NCT04321278 \| NCT04322123 (COALITION II, Pubmed \| Am J Cardiol) Manual	Phase 3	COVID-19	1,114	Hydroxychloroquine	qkgfxamqny(sbyulrqllw) = snpacyvmzn oblmqzfjts (mmxjpurkln ) View more	Positive	01 Mar 2024
				Hydroxychloroquine pAzithromycinycin	qkgfxamqny(sbyulrqllw) = ayodzlwxgd oblmqzfjts (mmxjpurkln ) View more
APAO2024	Not Applicable	Uveitis TNF-α	-	Azithromycin (Sham)	yfijhwmkyi(fpxhrctxel) = zceefiwkrz euvmszklul (jbxicmrxnr )	Positive	22 Feb 2024
				Topical AZM 1.5%	yfijhwmkyi(fpxhrctxel) = wxvrdewspo euvmszklul (jbxicmrxnr )