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Last update 23 Jul 2025

Azithromycin

Last update 23 Jul 2025

Overview

R&D Status

Clinical Result

Translational Medicine

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+ [27]

Originator Organization

Pfizer Inc.

Active Organization

Shinpoong Pharmaceutical Co., Ltd.Jiangxi Yiyou Pharmaceutical Co., Ltd.

Beijing Taiyang Pharmaceutical Co. Ltd.

+ [8]

Inactive Organization

PF Prism CVTeva Parenteral Medicines, Inc.

Laboratoires Théa SAS

+ [5]

License Organization

Laboratoires Théa SAS

Akorn, Inc.

InSite Vision, Inc.

+ [2]

Drug Highest PhaseApproved

First Approval Date

United States (01 Nov 1991),

Infectious Diseases

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

Structure/Sequence

Molecular FormulaC38H72N2O12

InChIKeyMQTOSJVFKKJCRP-BICOPXKESA-N

CAS Registry83905-01-5

898

Clinical Trials associated with Azithromycin

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 Nov 2025

Sponsor / Collaborator

University of Melbourne

[+10]

NCT06906757

/ Not yet recruitingNot ApplicableIIT

Preterm Rupture of Membranes Optimising Antibiotics Trial (PROMOAT). A Pregnancy Domain Within PLATIPUS.

The goal of this clinical trial is to learn which antibiotic regimen works best to prevent infection in pregnant women whose waters break early (preterm, pre-labour rupture of membranes, or PPROM) and assess the health outcomes of babies born to pregnant women who have received these antibiotics.
PROMOAT aims to answer the question: Which antibiotic or combined antibiotic regimen most effectively prevents infection in pregnant women with PPROM < 37+0 weeks' gestation.
Researchers will compare three antibiotic regimens already used in clinical practice to prevent infection in pregnant women with PPROM.
Participants will be randomly allocated to the antibiotic regimen they will follow for seven days, or until birth (whichever is earlier). All antibiotics will be taken orally.
Neonatal health outcomes will be collected at 42 weeks postmenstrual age and maternal birth and postpartum care outcomes assessed at 42 days postpartum.
Questionnaires will capture maternal mood at time of consent and at 42 days postpartum. Antibiotic tolerance will be assessed at the time antibiotic treatment is ceased.
This trial will be undertaken as part of the PLATIPUS trial (NCT06461429).

Start Date01 Sep 2025

Sponsor / Collaborator

University of Melbourne

NCT05763693

/ Not yet recruitingPhase 4IIT

Vitality in Infants Via Azithromycin for Neonates Trial

Nearly half of child deaths occur during the neonatal period, and 80% of those occur in babies with low birthweight. Although tremendous progress has been made towards reducing under-five mortality globally, declines in neonatal mortality lag behind those observed in older children. Low birthweight babies are at increased risk of poor outcomes compared to those who are term-appropriate for gestational age, including mortality, stunting, and growth failure. Recent evidence has demonstrated that the incidence of wasting and linear growth failure is highest between birth and 3 months of age, substantially earlier than previously thought. Interventions are urgently needed to improve outcomes in low birthweight babies; however, these interventions must not interfere with breastfeeding and thus some well-established interventions used to treat or prevent malnutrition in older children cannot be considered. The investigators recently demonstrated that biannual mass azithromycin distribution reduces all-cause childhood mortality by approximately 25% in infants aged 1-5 months, with stronger effects seen in underweight infants. This study did not include neonates due to the risk of infantile hypertrophic pyloric stenosis (IHPS) that has been hypothesized to be associated with macrolide use during early infancy. However, our study team documented only a single case of IHPS among 21,833 neonates enrolled in a trial of azithromycin versus placebo administered to neonates aged 8-27 days for prevention of infant mortality, documenting no major risk of IHPS associated with azithromycin. Here, the investigators propose an individually randomized trial where participants will receive a single oral dose of azithromycin (administered either during the neontal period or 21 days after enrollment), two does of oral azithromycin spaced 21 days apart, or two doses of placebo to evalute if azithromycin improves nutritional outcome and reduces infectious burden among neonates aged 1-27 days who are either low birthweight (<2500 g at birth) or underweight (weight-for-age Z-score < -2 at enrollment). The primary outcome will be weight-for-age Z-score at 6 months of age compared between arms. The investigators anticipate that the results of this study will provide definitive evidence on azithromycin as an early intervention for low birthweight/underweight neonates, who are at the highest risk of adverse outcomes.

Start Date31 Jul 2025

Sponsor / Collaborator

The University of California, San Francisco

100 Clinical Results associated with Azithromycin

100 Translational Medicine associated with Azithromycin

100 Patents (Medical) associated with Azithromycin

24,931

Literatures (Medical) associated with Azithromycin

31 Dec 2025·RENAL FAILURE

Acute kidney injury in hospitalized children with diphtheria in northwestern Nigeria: incidence and hospitalization outcomes

Article

Author: Ibrahim, Olayinka Rasheed ; Adedoyin, Olanrewaju Timothy ; Alege, Abdurrazzaq ; Alao, Michael Abel

BACKGROUND:

Despite the kidney being affected by diphtheria exotoxin, the extent of acute kidney injury (AKI) and its possible impact on outcomes remain unknown. This study examined the incidence, risk factors, and outcomes of AKI in children with diphtheria.

METHODS:

This was a prospective cohort study of confirmed diphtheria managed from July 1, 2023, to April 30, 2024, at a health facility in Nigeria. We obtained data on clinical and laboratory features and treatments received. AKI was defined using Kidney Disease: Improving Global Outcomes (KDIGO) criteria.

RESULTS:

We included 237 children with a median [interquartile range] age of 7.0 [4-10] years. Using KDIGO, 139 (58.6%) had AKI [stage 1:88 (37.1%); stage 2: 18 (7.6%); and stage 3: 33 (13.9%)]. Variables associated with AKI included age, sore throat, inability to swallow, difficulty breathing, nasal blockade, hypoxemia, nasal discharge, pallor, abnormal chest findings, hospitalization duration, vaccination status, white blood cells, lymphocytes, platelets, serum bicarbonate, sodium and potassium, and treatments received, p < 0.05. On multivariable logistic regression, predictors of AKI included age ≤ 60 months [AOR 2.75, 95% CI 1.27-5.95], dexamethasone [AOR 2.57, 95% CI 1.11-4.60], oxygen therapy [4.85, 95% CI 1.24-18.99], and ibuprofen [AOR 2.74, 95 CI% 1.16-6.44]. Mortality rate was 24.5% (58/237) and 33.1% (46/139) in AKI. The odds of deaths with AKI were 3.56 (95% CI 1.76-7.14).

CONCLUSION:

There is a high incidence of AKI among children with diphtheria and increased odds of death. Factors that predicted AKI included younger age, oxygen therapy, and medications (ibuprofen and dexamethasone).

31 Dec 2025·ANNALS OF MEDICINE

Influential predictors of azithromycin pharmacokinetics: a systematic review of population pharmacokinetics

Review

Author: Jirasomprasert, Totsapol ; AlEjielat, Rowan ; Methaneethorn, Janthima ; Jiao, Zheng

INTRODUCTION:

Azithromycin exhibits significant pharmacokinetic variability. Thus, dosage optimization is crucial for optimal therapeutic outcomes. This systematic review aims to analyze the population pharmacokinetics (PopPK) of azithromycin and identify key covariates influencing its pharmacokinetics.

METHODS:

A systematic search was conducted in PubMed, Scopus, and ScienceDirect databases. Azithromycin PopPK studies conducted using a nonlinear mixed-effects approach in humans were included. Studies published in non-English or non-Thai languages were excluded. Moreover, studies with insufficient information, review articles, or registered protocols were also excluded. The reporting quality of the included studies was assessed using adapted guidelines from a previously published framework. Data on study designs, population characteristics, pharmacokinetic parameters, and influential predictors were summarized. Forest plots were used to determine the influence of covariates on azithromycin pharmacokinetics.

RESULTS:

Fifteen studies were included. The volume of distribution (V_d) and the clearance in preterm newborns were approximately 68%-94% and 87%-100% lower than those of adults and children. Pregnant women had approximately 85% higher V_d. Patients with alanine aminotransferase >40 U/L had about 24% lower clearance. Azithromycin clearance slightly decreased with advancing age. There is limited data on the relationship between azithromycin exposure and safety outcomes. Finally, most models were not externally evaluated.

CONCLUSIONS:

Significant predictors for azithromycin pharmacokinetics were identified in this review. However, the limited external validation of most models restricts their clinical utility. Further research is necessary to confirm the models' external validity.

PROSPERO REGISTRATION:

CRD42024609484.

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 ; Bai, Houxi ; Wang, Yanchun ; Ding, Wenrui ; 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.

News (Medical) associated with Azithromycin

19 Jul 2025

·pharma.economictimes.indiatimes.com

185 drugs fail CDSCO quality Test; 4 samples flagged as Spurious

New Delhi: India’s drug regulator, the Central Drugs Standard Control Organization (CDSCO), identified 185 drug samples as ‘ Not of Standard Quality ’ (NSQ) and flagged four others as ‘spurious’ during its monthly quality review for June. Of the total NSQ samples, 55 were flagged by Central Drugs Laboratories , while the remaining 130 were reported by State Drugs Testing Laboratories. In addition, the CDSCO drug alert identified four spurious drug samples, including a Cefixime Tablet from Bihar, an ointment of Heparin Sodium and Benzyl Nicotinate from Delhi, and two samples of Rosuvastatin and Fenofibrate Tablets — Rosuvas F 10 and Rosuvas F 20—collected from Telangana. A drug is deemed spurious if it qualifies certain conditions detailed under Section 17-B of the Drugs and Cosmetics Act, 1940. Of the 55 samples flagged as NSQ by central testing laboratories includes Dextrose Injection manufactured by Tam-Bran Pharmaceuticals; Azithromycin Tablet by Apple Formulations; Paracetamol Intravenous Infusion by D.J. Laboratories Telmisartan Tablets by Healers Lab and 51 other samples. The 130 samples flagged by state laboratories includes several common medicines and supplements such as Paracetamol, Pantoprazole, Calcium , Vitamin D3 tablets and several other common drugs. The identification of drug samples as NSQ is done based on failure of the drug sample in one or the other specified quality parameters and the term NSQ has been defined under Section 16(1)(a) of the Drugs and Cosmetics Act, 1940. However, according to the Health Ministry, “identification of drug samples as 'NSQ' does not warrant any concerns on the other drug products available in the market. The CDSCO routinely notifies ‘'NSQ ' and spurious medicines based on a monthly review undertaken by the central and state drug regulatory bodies to ensure that these drugs are removed from the market and enforce quality norms. By Abhijeet Singh ,

12 Jun 2025

·pipelinereview.com

FDA Grants Priority Review for Zoliflodacin New Drug Application for the Treatment of Uncomplicated Gonorrhea and Assigns Target PDUFA Date of December 15, 2025

FDA is expected to notify Innoviva Specialty Therapeutics regarding its decision to conduct an Advisory Committee Meeting in the Day 74 letter If approved, zoliflodacin would be the first new antibiotic for treating gonorrhea in decades WALTHAM, MA, USA & GENEVA, Switzerland I June 12, 2025 I Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. (NASDAQ: INVA), in collaboration with the Global Antibiotic Research & Development Partnership (GARDP), today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for zoliflodacin, an investigational first-in-class, single dose, spiropyrimidinetrione oral antibiotic for the treatment of uncomplicated gonorrhea in adults and pediatric patients 12 years and older. The FDA assigned a target action date of December 15, 2025 under the Prescription Drug User-Fee Act (PDUFA). It is expected the FDA will notify Innoviva Specialty Therapeutics regarding the FDA’s decision to conduct an Advisory Committee Meeting in the Day 74 letter. If approved, zoliflodacin would be the first new antibiotic for treating gonorrhea in decades. The U.S. FDA has granted zoliflodacin a Qualified Infectious Disease Product (QIDP) designation. This designation allows it to benefit from FDA Priority Review, and Extended Market Exclusivity. Entasis Therapeutics, Inc., the legal NDA holder and affiliate of Innoviva Specialty Therapeutics, Inc., retains the commercial rights for zoliflodacin in the major markets in North America, Europe, and Asia-Pacific. GARDP retains the right to register and commercialize the product in more than three-quarters of the world’s countries, including all low-income countries, most middle-income countries, and several high-income countries. GARDP is committed to working with its partners and local health authorities in markets where zoliflodacin receives regulatory approval to help remove access barriers to ensure treatment is available to address unmet medical needs while ensuring appropriate and sustainable use. About Uncomplicated Gonorrhea With more than 82 million new gonorrhea infections occurring globally each year, gonorrhea is the second most common bacterial sexually transmitted infection (STI), affecting both men and women, which, if left untreated, can result in serious and permanent health consequences. With the rise and spread of drug-resistant infections, the World Health Organization (WHO) has identified antimicrobial resistance (AMR) as one of the ten most critical global threats to public health. The bacterium Neisseria gonorrhoeae, which causes gonorrhea, has progressively developed resistance to most classes of antibiotics used to treat these infections, including ceftriaxone, a widely used intramuscular injection that was first made available in 1984. About Zoliflodacin Zoliflodacin is an investigational first-in-class antibacterial that is administered in a single oral dose for the treatment of uncomplicated gonorrhea. The oral route of administration simplifies treatment by providing a convenient option for patients unable to receive an intramuscular injection. Zoliflodacin has a unique mechanism of action, inhibiting a crucial bacterial enzyme called type II topoisomerase, which is essential for bacterial function and reproduction. In in vitro studies, zoliflodacin demonstrated activity against multidrug-resistant strains of Neisseria gonorrhoeae , including those resistant to ceftriaxone and azithromycin, with no cross-resistance to other antibiotics. In a pivotal Phase 3 clinical trial, zoliflodacin demonstrated non-inferiority in achieving microbiological cure at the urogenital site of infection with a single oral dose of zoliflodacin compared to a treatment regimen of a single intramuscular injection of 500mg ceftriaxone followed by 1g of oral azithromycin. The Phase 3 study found that zoliflodacin was generally well-tolerated, with no serious adverse events or deaths reported during the trial. About GARDP The Global Antibiotic Research & Development Partnership (GARDP) is a not-for-profit global health organization driven to protect people from the rise and spread of drug-resistant infections, one of the biggest threats to us all. By forging the public and private partnerships that matter, we develop and make accessible antibiotic treatments for people who need them. Vital support for our work comes from the governments of Canada, Germany, Japan, Monaco, the Netherlands, Switzerland, the United Kingdom, the Canton of Geneva, the European Union, as well as the Gates Foundation, Global Health EDCTP3, GSK, the RIGHT Foundation, the South African Medical Research Council (SAMRC) and Wellcome. About Innoviva Innoviva is a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (“GSK”). Innoviva is entitled to receive royalties from GSK on sales of RELVAR ® /BREO ® ELLIPTA ® and ANORO ® ELLIPTA ® . Innoviva’s other innovative healthcare assets include infectious disease and critical care assets stemming from acquisitions of Entasis Therapeutics, including XACDURO ® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex and the investigational zoliflodacin currently being developed for the treatment of uncomplicated gonorrhea, and La Jolla Pharmaceutical Company, including GIAPREZA ® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock and XERAVA ® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. Innoviva also markets ZEVTERA® (ceftobiprole), an advanced-generation cephalosporin antibiotic, in the U.S. through an exclusive license from Basilea Pharmaceutica International Ltd, Allschwil. For more information about Innoviva, go to www.innoviva.com . For information about Innoviva Specialty Therapeutics, go to www.innovivaSpecialtytherapeutics.com . SOURCE: Innoviva

Phase 3Priority ReviewDrug ApprovalLicense out/inClinical Result

10 Jun 2025

·pipelinereview.com

Innoviva Specialty Therapeutics Receives FDA New Drug Application Acceptance for Zoliflodacin, a First-in-Class Oral Antibiotic for Uncomplicated Gonorrhea in Adults

WALTHAM, MA, USA & GENEVA, Switzerland I June 10, 2025 I Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. (NASDAQ: INVA), in collaboration with the Global Antibiotic Research & Development Partnership (GARDP), today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for zoliflodacin, the investigational first-in-class, single dose, spiropyrimidinetrione oral antibiotic for the treatment of uncomplicated gonorrhea in adults and pediatric patients 12 years and older. If approved, zoliflodacin would be the first new antibiotic for treating gonorrhea in decades. With more than 82 million new gonorrhea infections occurring globally each year, gonorrhea is the second most common bacterial sexually transmitted infection (STI), affecting both men and women, which, if left untreated, can result in serious and permanent health consequences. With the rise and spread of drug-resistant infections and the World Health Organization (WHO) identifying antimicrobial resistance (AMR) as one of the ten most critical global threats to public health, the bacterium Neisseria gonorrhoeae has progressively developed resistance to many classes of antibiotics used to treat these infections, including ceftriaxone, a widely used intramuscular injection that was first made available in 1984. “Today’s acceptance of the zoliflodacin NDA marks significant progress toward delivering health care providers with a potential new oral treatment option for uncomplicated gonorrhea, including infections caused by drug-resistant strains,” said David Altarac, M.D., Chief Medical Officer, Innoviva Specialty Therapeutics. “We look forward to working closely with the FDA during its review and, if approved, we are committed to expediting the availability of zoliflodacin to patients in the U.S.” Recent reports ( The Lancet Infectious Diseases ) of emergent ceftriaxone-resistant infections have heightened the urgency for new antibiotics. Effective treatment options are essential to reducing the burden of disease for individuals and preventing the spread of highly drug-resistant gonorrhea globally. If left untreated, gonorrhea can also cause infertility in women, life-threatening ectopic pregnancies, and pelvic inflammatory disease. 2 The FDA’s acceptance of the zoliflodacin NDA is based on the totality of data collected from several clinical trials as part of an innovative public-private partnership with GARDP. These trials include a pivotal Phase 3 clinical trial which demonstrated non-inferiority in achieving microbiological cure at the urogenital site of infection of a single oral dose of zoliflodacin compared to a treatment regimen of a single intramuscular injection of ceftriaxone followed by 1 week of oral azithromycin. The Phase 3 study found that zoliflodacin was generally well-tolerated, with no serious adverse events or deaths reported during the trial. “This important milestone demonstrates the crucial role that public-private partnerships can play in tackling the escalating global antimicrobial resistance crisis,” said Dr. Manica Balasegaram, Executive Director, Global Antibiotic Research Development Partnership (GARDP). “If zoliflodacin is approved, this collaboration paves the way for millions of people across the world to get access to a potentially powerful new drug to treat multidrug-resistant gonorrhea.” Zoliflodacin has a unique mechanism of action, inhibiting a crucial bacterial enzyme called type II topoisomerase, which is essential for bacterial function and reproduction. In vitro studies have demonstrated its activity against multidrug-resistant strains of Neisseria gonorrhoeae , including those resistant to ceftriaxone and azithromycin, with no cross-resistance to other antibiotics. This investigational antibacterial is administered in a single, oral dose, simplifying treatment by providing a convenient option for patients unable to receive an intramuscular injection. The U.S. FDA has granted zoliflodacin a Qualified Infectious Disease Product (QIDP) designation. This designation allows it to benefit from FDA Priority Review, and Extended Market Exclusivity. Innoviva Specialty Therapeutics, Inc., anticipates that the NDA review will proceed according to the standard process for drugs with this designation. Entasis Therapeutics, Inc., the legal NDA holder and affiliate of Innoviva Specialty Therapeutics, Inc., retains the commercial rights for zoliflodacin in the major markets in North America, Europe, and Asia-Pacific. GARDP retains the right to register and commercialize the product in more than three-quarters of the world’s countries, including all low-income countries, most middle-income countries, and several high-income countries. GARDP is committed to working with its partners and local health authorities in markets where zoliflodacin receives regulatory approval to help remove access barriers to ensure treatment is available to address unmet medical needs while ensuring appropriate and sustainable use. About GARDP The Global Antibiotic Research & Development Partnership (GARDP) is a not-for-profit global health organization driven to protect people from the rise and spread of drug-resistant infections, one of the biggest threats to us all. By forging the public and private partnerships that matter, we develop and make accessible antibiotic treatments for people who need them. Vital support for our work comes from the governments of Canada, Germany, Japan, Monaco, the Netherlands, Switzerland, the United Kingdom, the Canton of Geneva, the European Union, as well as the Gates Foundation, Global Health EDCTP3, GSK, the RIGHT Foundation, the South African Medical Research Council (SAMRC) and Wellcome. About Innoviva Innoviva is a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (“GSK”). Innoviva is entitled to receive royalties from GSK on sales of RELVAR ® /BREO ® ELLIPTA ® and ANORO ® ELLIPTA ® . Innoviva’s other innovative healthcare assets include infectious disease and critical care assets stemming from acquisitions of Entasis Therapeutics, including XACDURO ® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex and the investigational zoliflodacin currently being developed for the treatment of uncomplicated gonorrhea, and La Jolla Pharmaceutical Company, including GIAPREZA ® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock and XERAVA ® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. On December 14, 2024, Innoviva entered into an exclusive distribution and license agreement with Basilea Pharmaceutica Ltd, Allschwil for the commercialization of ZEVTERA ® (ceftobiprole), an advanced-generation cephalosporin antibiotic, in the U.S. For more information about Innoviva, go to www.innoviva.com . For information about Innoviva Specialty Therapeutics, go to www.innovivaSpecialtytherapeutics.com . SOURCE: Innoviva

Phase 3Drug ApprovalPriority ReviewLicense out/inNDA

100 Deals associated with Azithromycin

External Link

KEGG	Wiki	ATC	Drug Bank
D07486	Azithromycin	J01FA10 S01AA26	DB00207

R&D Status

Approved

10 top approved records.

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.

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
Acne Vulgaris	Phase 3	Italy	Pfizer Inc.	01 Oct 2007
Pharyngolaryngitis	Phase 3	Japan	Pfizer Inc.	01 Nov 2006
Chronic disease of respiratory system	Phase 3	Japan	Pfizer Inc.	01 Oct 2006
Asthma	Phase 3	United States	Pfizer Inc.	01 Jan 2006
acute bacterial conjunctivitis	Phase 3	United States	Merck Sharp & Dohme Corp.	01 Jul 2004
Scarlet Fever	Phase 3	United States	Pfizer Inc.	01 May 2003
Scarlet Fever	Phase 3	Canada	Pfizer Inc.	01 May 2003

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04224987 (AVENIR, CTgov)	Phase 4	Bacterial Infections	864,493	Placebo+Azithromycin (Azithro 1-11)	ziiaskyqse = hxisqigjej hbbuqxsauf (envpqwustp, meprkffzlc - dtgmjkhzaw) View more	-	14 May 2025
				Azithromycin (Azithro 1-59)	ziiaskyqse = ikbbnjbeid hbbuqxsauf (envpqwustp, eudvdnamcg - govwejhxfw) View more
NCT06272370 (iTREAT-PC, CTgov)	Phase 4	Asthma \| Respiratory Tract Infections	103	Asthma Symptom Monitoring online tools (Enhanced Usual Care)	swmzompjrr(jqcqmipukw) = xdmjvhcmst kdapwiinwd (fbdhraewhm, 3.82) View more	-	20 Apr 2025
				Inhaled Steroids (Rescue Inhaled Corticosteroids)	swmzompjrr(jqcqmipukw) = xtzzrsemwq kdapwiinwd (fbdhraewhm, 3.72) View more
NCT05473234 (CTgov)	Phase 3	Malnutrition	310	Amoxicillin (Amoxicillin)	cluwrozuch(huuaxratot) = uwshyrapgi esqgtiwpii (ktjdazmvzj, 17.11) View more	-	25 Feb 2025
				Azithromycin (Azithromycin)	cluwrozuch(huuaxratot) = ggqprcpdfy esqgtiwpii (ktjdazmvzj, 18.82) View more
NCT03676764 (CHAT \| The CHAT Randomized Clinical Trial, CTgov)	Phase 4	-	77,664	Azithromycin (Biannual Mass Oral Azithromycin)	ulufvtkmvy = zdwgdvhdik ezsrieddes (ntdrvsxkak, kiasrrfsjr - fqlcawpbik) View more	-	24 Feb 2025
				Placebos+Azithromycin (Biannual Mass Oral Placebo)	ulufvtkmvy = dhbmsgebxv ezsrieddes (ntdrvsxkak, vhskaszlam - plcutnivgy) View more
NCT04294641 (CTgov)	Phase 2	Chronic graft-versus-host disease	10	Ibrutinib	bpzqucpduh = pombespwfe yotqsukyse (vtajkufvlz, rrfwmjnojy - dqtqhubump) View more	-	22 Jan 2025
NCT01235546 (Pubmed \| J Matern Fetal Neonatal Med)	Phase 3	Obstetric Labor, Premature	-	Adjunctive Azithromycin Prophylaxis	abudmyjagj(znwevfawrq): OR = 1.06 (95% CI, 0.77 - 1.46), P-Value = 0.42	Positive	01 Dec 2024
				Placebo
ISRCTN49726849 (TABS-PKPD, Pubmed \| BMC Med)	Phase 2	Malaria C-reactive protein (CRP)	-	Azithromycin 10 mg/kg	wtvlqatnvw(riznljckef) = xmychzafmj ysgizsriiw (fgtavohkpj, 57.1 - 74.5)	Negative	06 Nov 2024
				Azithromycin 15 mg/kg	wtvlqatnvw(riznljckef) = srhtglqqiy ysgizsriiw (fgtavohkpj, 42.9 - 59.5)
NCT03871491 (A-PLUS, CTgov)	Phase 3	Pregnancy Complications, Infectious \| Maternal Death \| Neonatal Sepsis	58,747	Azithromycin (Intervention)	jnnthoefee = pgtcfqglsz graxtxprxk (yxejkhpuvf, lzplfuohei - cmehdzgbxj)	-	24 Oct 2024
				Placebo (Placebo)	jnnthoefee = rfyhyhaogr graxtxprxk (yxejkhpuvf, vsehhktkrh - ndbuyximex)
NCT05027516 (ResistAZM, CTgov)	Phase 4	Gonorrhea	42	Rocephin (Rocephine®)	sqotghegwf(ivwqiuvuvv) = pczxihnbro latxbpbxjp (ixtjdscdfz, xingfuzquk - belclezwuj) View more	-	02 Aug 2024
				Azithromycin+Rocephin (Rocephine® + Azithromycin)	hobsqlaslh = duplpbagsx aewlnhvjzi (ewqgldgyse, wawyivvkpz - qzarjcladq) View more
NCT04617626 (Pubmed)	Not Applicable	Trachoma azithromycin	-	1-5 month-olds receiving azithromycin	truqpqrcjp(ejxcvwuiym) = cqpmrdywuj zetfzoogpa (gzhdwjzrai ) View more	Positive	10 Jul 2024

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