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AZ

azithromycin (Azimac)

✓ Approved

Beijing Holley-Cotec Pharma · Small Molecule · Small Molecule

What is azithromycin?

azithromycin is a small molecule developed by Beijing Holley-Cotec Pharma. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand NamesAzimac
CompanyBeijing Holley-Cotec Pharma
Drug ClassSmall Molecule
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, Beijing Holley-Cotec Pharma

Therapeutic Indications

azithromycin is developed for 8 unique indications across 3 therapeutic areas.

Therapeutic AreaConditionPhase
Infections and infestationsLower respiratory tract infection✓ Approved
Infections and infestationsOtitis media✓ Approved
Infections and infestationsSinusitis✓ Approved
Infections and infestationsTonsillitis✓ Approved
Infections and infestationsUrinary tract infection✓ Approved

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Related Research Articles

PubMedMicrobiology spectrum2026-11-11

A dual-action combination therapy targeting bacteria and host immunity against bacterial infections.

Liu Yanjun Y, Zheng Anni A, Zhang Hongfang H, Lu Xingyue X et al.

The escalating crisis of antimicrobial resistance, coupled with a stagnant novel antibiotic discovery pipeline, underscores the urgent need for innovative strategies to combat bacterial infections. The development of antibiotic adjuvants that increase the efficacy of existing drugs represents a critical approach for addressing this challenge. We demonstrate that combining the conventional antibiotic azithromycin with the quorum-sensing inhibitor norharmane exerts potent antibacterial effects through both direct bactericidal activity and host immune activation. This combination not only disrupts bacterial structural integrity but also promotes macrophage polarization toward the M1-type phenotype and upregulates the expression of the important mediator, Muc5b, through activation of the IL-17 signaling pathway, ultimately enhancing mucosal immune defense and tissue repair functions. This regimen shows potent antibacterial efficacy against a range of pathogens in vitro and in vivo, along with a favorable safety profile. These findings highlight a promising combinatorial therapeutic strategy against the growing threat of antibiotic resistance. Antibiotic resistance has become one of the most urgent threats to global public health, yet the development of new antibiotics has slowed dramatically. In this study, we propose a promising alternative strategy that combines azithromycin with a small-molecule compound capable of inhibiting bacterial quorum sensing. This combination not only kills bacteria more effectively than the antibiotic alone but also harnesses the body's own immune system to fight infection. Its mechanisms of action include disrupting bacterial structure, promoting the polarization of macrophages toward the M1-type phenotype, and enhancing bactericidal capacity by activating the IL-17 signaling pathway to stimulate the production of the Muc5b protein. Our findings suggest that this dual-pronged approach could help revitalize existing antibiotics, offering a practical pathway to combat drug-resistant infections.

PMID 43012424
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PubMedEuropean journal of case reports in internal medicine2026-11-11

Granulomatous Hepatitis Due to Bartonella Henselae Mimicking Stage IV Malignancy.

Eliard Marine M, Sansen Pierre-Yves PY, Benoit Martin M, Krug Bruno B et al.

Hepatosplenic cat-scratch disease (HS-CSD) is a rare manifestation of Bartonella henselae infection in immunocompetent adults and may closely mimic haematological malignancy. A 62-year-old woman with a history of breast cancer presented with an eight-week history of fever, night sweats and weight loss. A fluorodeoxyglucose positron emission tomography-computed tomography (FDG PET/CT) revealed hypermetabolic hepatosplenic lesions, retroperitoneal lymphadenopathy and a focal acetabular bone lesion, strongly suggesting stage IV lymphoma or metastatic disease. Bone marrow biopsy showed no evidence of malignancy; liver biopsy revealed caseous necrotising granulomas. Mycobacterial polymerase chain reaction (PCR) and cultures were negative. Bartonella serology demonstrated a high IgG titre (>1:1.280), while tissue PCR was borderline positive. Treatment with azithromycin and rifampicin for four weeks resulted in clinical improvement and resolution of constitutional symptoms. HS-CSD can closely mimic advanced malignancy. In patients with prolonged fever, visceral lesions and feline exposure, B. henselae infection should be considered early in the diagnostic workup. HS-CSD may closely mimic advanced malignancy.Feline exposure should prompt consideration of Bartonella henselae infection in patients with prolonged fever and visceral lesions, to avoid unnecessary investigations or inappropriate treatments.

PMID 43011688
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PubMedJournal of pediatric gastroenterology and nutrition2026-11-11

Low-risk paediatric Crohn's disease: A narrative review of current evidence and unmet research needs.

Pochesci Saverio S, Scarallo Luca L, Gianolio Laura L, Russell Richard K RK

While current paediatric management increasingly favours early intensive treatment for children and adolescents with Crohn's disease (CD) at high risk of disease progression, a smaller subset of patients presents with a potentially 'low-risk' disease phenotype. Identifying these children is clinically challenging, as overtreatment may expose them to unnecessary risks and costs, whereas undertreatment may allow irreversible bowel damage and complications to develop. This narrative review summarises the current evidence on the definition, assessment, treatment, and monitoring of low-risk paediatric CD, highlighting existing knowledge gaps and future research priorities. At present, no consensus definition of low-risk paediatric CD exists, and disease classification relies largely on the absence of recognised high-risk features rather than validated criteria. Similarly, unlike adult practice, no paediatric prognostic model is available to identify children likely to follow a persistently mild disease course. Current assessment requires integration of clinical indices, inflammatory biomarkers, endoscopy, cross-sectional imaging, and evaluation of growth and nutritional status. Dietary treatment (Exclusive Enteral Nutrition and emerging dietary strategies, including the CD Exclusion Diet [CDED] and the Tasty & Healthy [T&H]] remains the commonest induction therapy. Budesonide or antibiotics (azithromycin and metronidazole) represent an appropriate alternative for selected children. CDED and the T&H diet may also represent attractive medium term treatment options, although robust maintenance data are still awaited. Prospective studies are needed to establish a consensus definition, develop paediatric-specific prediction models, optimise risk stratification, and determine the most effective long-term therapeutic and monitoring approaches for the 'low-risk' population.

PMID 43010643
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PubMedOral diseases2026-11-10

Adjunctive Use of Azithromycin to Non-Surgical Periodontal Therapy: Rationale and Evidence for Its Use in Periodontitis-A Scoping Review.

Ramachandra Srinivas Sulugodu SS, Woodford Valerie V, Lee Ryan S B RSB, Arora Shelly S et al.

Antimicrobials are added as adjuncts to non-surgical periodontal therapy in certain cases to achieve improved outcomes. Among the adjunct antimicrobials that have gained renewed interest is azithromycin, owing to its additional anti-inflammatory and host-modulating properties. This review aims to summarise the pharmacology, adverse effects, and the current evidence for the adjunct use of azithromycin in different forms of periodontitis. In vitro studies, randomized controlled trials, and longitudinal studies published in English were searched in MEDLINE, Scopus, Web of Science and Google Scholar (https://osf.io/m8enj/overview). Following screening of 677 articles, 70 articles were subjected to full-text review and ultimately 57 articles were included. In vitro studies demonstrated anti-bacterial, host-modulating, and anti-inflammatory properties of azithromycin with drug concentrating in inflamed tissues. The additional benefits of adjunctive azithromycin are moderate and inconsistent, although deep periodontal pockets may show enhanced improvements. Local delivery of azithromycin demonstrated additional benefits in single-rooted teeth. Azithromycin may provide clinical and microbiological benefits, especially in deep periodontal pockets. However, the World Health Organization categorizes azithromycin as a critically important antimicrobial for human medicine. Due to inconsistent results and owing to the importance of azithromycin, the adjunctive use of azithromycin with non-surgical periodontal therapy is currently not recommended.

PMID 43006139
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PubMedThe American journal of tropical medicine and hygiene2026-11-10

A Single Dose of Azithromycin and Inflammation in Infants: A Cluster-Randomized Placebo-Controlled Trial.

Ihamuotila Rikhard R, Haidara Fadima F, Samaké Oumar O, Luoma Juho J et al.

Azithromycin mass drug administration (MDA) reduces under-5 mortality in some African settings. The biomechanisms behind the mortality reduction are unknown. The aim of this study was to test the hypothesis that a dose of azithromycin reduces inflammation in infants in a West African setting. This cluster-randomized, double-blind, placebo-controlled trial was part of a large-scale trial in Mali conducted to test the effect of azithromycin MDA on infant mortality (LAKANA trial, ClinicalTrials.gov NCT04424511). In the LAKANA trial, villages were randomly assigned to placebo or azithromycin groups. All participants, investigators, and study personnel were masked. Whole-blood C-reactive protein (CRP) concentration was measured in 4- to 11-month-old infants in a subset of villages right before and 2 weeks after receiving either placebo or azithromycin. CRP values were log-transformed, and mixed-effects regression with random intercepts for clusters and identity link was used to compare the groups. Among 1,615 infants in 72 villages, the baseline geometric mean CRP level was 1.76 mg/L in the placebo group (n = 696) and 1.81 mg/L in the azithromycin group (n = 919). On day 14, the mean CRP level was 1.67 mg/L in the placebo group and 1.47 mg/L in the azithromycin group, accounting for an average 14% lower CRP with azithromycin (95% CI: 1%-26%; P = 0.048). There was no statistically significant difference in prevalence of elevated CRP levels (>5 mg/L). Those with two or more morbidities seemed to benefit most, with 42% lower CRP levels on average with azithromycin treatment (95% CI: 1%-67%; P = 0.047). These findings support the hypothesis that a single dose of azithromycin reduces inflammation in Malian infants.

PMID 43008298
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PubMedReproductive toxicology (Elmsford, N.Y.)2026-11-10

Effects of azithromycin exposure during pregnancy at different gestational stages, doses, and dosing regimens on articular cartilage development in the mouse fetus.

Du Hongrui H, Xu Junmiao J, Zhang Qi Q, Jiang Tao T et al.

Azithromycin is a macrolide antibiotic commonly used during pregnancy, but the effects of prenatal azithromycin exposure (PAzE) on fetal articular cartilage remain unclear. Pregnant Kunming mice received azithromycin at 50, 100, or 200mg/kg·d during GD15-17, at 200mg/kg·d during GD10-12 or GD15-17, or as a single 200mg/kg dose on GD17. On GD18, fetal articular cartilage was assessed histologically and molecularly. PAzE reduced chondrocyte density, Safranin O staining intensity, and COL2A1 protein expression; suppressed Acan and Col2a1 expression; and altered expression of genes associated with matrix turnover, proliferation, and apoptosis. Across 28 direct interaction tests with Benjamini-Hochberg correction, treatment effects differed between gestational windows for Mmp13 expression, chondrocyte density, and relative COL2A1 immunohistochemical mean optical density, and between dosing regimens for Mmp13 expression, TGFβR1 immunofluorescence intensity, and total SMAD3 immunofluorescence intensity. These joint tests evaluated female- and male-specific treatment-effect differences simultaneously and do not imply significance within each sex separately. The window comparisons were limited by different intervals between the final dose and GD18 collection, whereas the total administered dose was 600mg/kg in the repeated-dose regimen, compared with 200mg/kg in the single-dose regimen. Total SMAD3 immunofluorescence intensity was reduced under all three high-dose conditions. Overall, changes were generally more pronounced at the high dose, while alterations were observed across a broader range of endpoints in the repeated-dose group, with no consistent monotonic dose-response pattern evident. These findings identify a potential developmental toxicology signal warranting further mechanistic, pharmacokinetic, and translational investigation.

PMID 43008902
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