Drug Database
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

PubMedCurrent drug delivery2026-10-14

Optimization, In vitro and In vivo Evaluation of an Azithromycin Nanosuspension-Based Nanogel for Enhanced Dermal Delivery.

Salih Omar Saeb OS, Toma Nawar Mikhael NM, Tamer Manar Adnan MA, Aljubouri Sajad Moneim SM et al.

Azithromycin is a BCS class II macrolide antibiotic characterized by poor aqueous solubility, a limited dissolution rate, and relatively low oral bioavailability (37%), limiting its therapeutic effectiveness for the treatment of skin infections. This study aimed to design and optimize an azithromycin nanosuspension-based nanogel using a Box-Behnken design. Azithromycin nanosuspension was prepared by the antisolvent precipitation method followed by probe sonication. The effects of formulation-variable concentrations on particle size, polydispersity index, and zeta potential were optimized using a Box-Behnken design. The optimized formulation was incorporated into a Carbopol-based gel and subsequently evaluated. In vitro release, ex vivo skin permeation, in vivo dermal irritation, antimicrobial activity, and stability studies were performed. The optimized formulation contained PVP K30 (0.1% w/v), Tween 80 (0.2% w/v), and HPMC E5 (0.02% w/v), yielding a particle size of 30.65 ± 1.7 nm, polydispersity index of 0.13 ± 0.01, and zeta potential of -0.53 ± 0.13 mV. The nanogel significantly enhanced ex vivo permeation across rat skin (flux 16.8 ± 0.45 μg/cm²·min) compared with the plain hydroalcoholic gel (6.0 ± 0.2 μg/cm²·min). The optimized nanogel exhibited appreciable dermal safety and enhanced antibacterial efficacy against Staphylococcus aureus and Escherichia coli. The improved performance of the selected nanogel was attributed to the nanosuspended particles, which enhanced azithromycin dissolution, localization at the application site, and permeation across the dermal layers. The optimized nanogel exhibited enhanced dissolution, controlled drug release, improved skin permeation, local antimicrobial efficacy, and good dermal tolerability.

PMID 42872455
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PubMedAME case reports2026-10-14

Cat scratch disease with fever and lymphadenopathy without definite cat exposure diagnosed via tissue metagenomic next-generation sequencing technology: a case report.

Yang Shuang S, Zhu Minghui M, Cheng Zhenshun Z

Cat scratch disease (CSD), a disease caused by Bartonella henselae (B. henselae), is often associated with exposure to cats. However, in rare cases, a history of cat exposure is absent, and thus achieving a definitive diagnosis may be challenging. Metagenomic next-generation sequencing (mNGS) is a relatively new technology that can analyze pathogens without introducing inherent biases. In this report, we describe a case of CSD diagnosed via mNGS, which supports the use of mNGS in identifying rare types of pathogenic infection. A 54-year-old male exhibited fever and headache of unknown cause, with a history of working at a chicken farm and no clear cat exposure. Routine antibiotic treatment for infection was ineffective. Lymph node biopsy demonstrated granulomas accompanied by chronic suppurative inflammation and abscess formation. A biopsy sample from the parotid lymph node was subjected to mNGS, which revealed the presence of B. henselae and led to a subsequent diagnosis of CSD. After treatment with azithromycin, the patient recovered and was discharged. At the 3-month telephone follow-up, the patient was asymptomatic. CSD in patients with prolonged fever plus culture-negative granulomatous lymphadenopathy or similar compatible findings, even when the exposure history is atypical，and mNGS, as an effective examination method, can aid in arriving at a definitive diagnosis.

PMID 42871255
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PubMedPLOS global public health2026-10-13

Mass azithromycin distribution and nutritional status among children aged 1-59 months: A secondary analysis of a cluster randomized trial.

Ouattara Mamadou M, Hu Huiyu H, Bountogo Mamadou M, Coulibaly Boubacar B et al.

Twice yearly distribution of azithromycin has been shown to reduce all-cause child mortality in several contexts. Azithromycin likely reduces mortality via reduction in clinical or subclinical infections. Treating infections may improve child nutritional status to further reduce mortality risk. Here, we used data from a placebo-controlled cluster randomized trial of azithromycin for prevention of child mortality in Burkina Faso to evaluate the effects of twice-yearly azithromycin on mid-upper arm circumference (MUAC) in children aged 1-59 months and weight-for-age Z-score (WAZ) in infants aged 1-11 months. The Child Health with Azithromycin Trial (CHAT) was a 1:1 cluster randomized trial of twice-yearly azithromycin compared to matching placebo for prevention of all-cause mortality in children aged 1-59 months. Measurements were collected every 6 months, including MUAC measurements in all children and weight measurements in infants aged 1-11 months to calculate weight-based dosing. We evaluated MUAC and WAZ at the community level and longitudinally at the individual child level, accounting for the cluster randomized design of the trial. 80,282 children aged 1-59 months, of whom 26,983 were infants aged 1-11 months, in 284 communities were included in analyses. At the community level, we found no evidence of a difference in mean MUAC or WAZ after 36 months or over time. There was no evidence of a difference in change over time in MUAC (P-value for interaction = 0.94) or WAZ (P = 0.18) at the individual level. We found no evidence to support an effect of twice-yearly mass azithromycin distribution on measures of undernutrition in children in this setting in Burkina Faso. ClinicalTrials.gov NCT03676764.

PMID 42868154
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PubMedJournal of tropical medicine2026-10-13

Scrub Typhus in Pregnancy: A Retrospective Observational Study From Primary Hospital of Southwest China.

Zhang Mengji M, Pan Su S, Lan Xi X, Li Yueming Y et al.

Scrub typhus is an acute zoonotic disease caused by Orientia tsutsugamushi. There are limited reports on scrub typhus in pregnancy, and the misdiagnosis rate is relatively high, potentially leading to adverse maternal and fetal outcomes. This retrospective observational study analyzed 19 pregnant patients with scrub typhus admitted to the People's Hospital of Ximeng Wa Autonomous County, Southwest China, from August 2023 to November 2025. Epidemiological, clinical, test, treatment, and outcome data were collected and descriptively analyzed. All patients were farmers, with 73.68% reporting a history of outdoor activities. Common symptoms included fever (100%), myalgia (78.94%), headache (57.89%), and eschar (94.74%). Laboratory findings revealed elevated transaminases (ALT or AST 94.74%) and decreased eosinophil percentages (89.47%). Initial misdiagnosis occurred in 10.53% (upper respiratory infection). Among the 18 patients treated with azithromycin, fever resolution occurred within 1 to 5 days. No maternal deaths occurred. However, adverse fetal outcomes included spontaneous miscarriage (n = 1), embryonic arrest (n = 1), and embryo demise (n = 3). Among 19 cases, 14 resulted in live births; 2 premature infants required pediatric care, and all live-born newborns showed normal development at six-month follow-up. Scrub typhus in pregnancy poses serious maternal-fetal risks. Early clinical recognition and prompt azithromycin therapy are crucial for improving maternal and perinatal outcomes, especially in resource-limited settings.

PMID 42865820
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PubMedJournal of pharmacy practice2026-10-13

Therapeutic and Pharmacokinetic Challenges With Treatment of Nontuberculous Mycobacteria Infection in Two Lung Transplant Recipients: Case Report.

Jung Regina R, Ali Alicia A, Royer Tricia T, Tucker Mollie M et al.

Lung transplant (LTx) recipients are susceptible to pulmonary nontuberculous mycobacteria (NTM) infections due to pre-transplant colonization and post-transplant immunosuppression. This presents a challenge when managing immunosuppression and infection prophylaxis post-LTx due to drug-drug interactions (DDIs) with antimycobacterial agents. We present two cases of LTx recipients requiring concomitant rifabutin and isavuconazole. A 62-year-old male receiving rifabutin for pre-LTx pulmonary Mycobacterium avium complex (MAC) infection was initiated on isavuconazole for post-LTx fungal prophylaxis. A rifabutin peak level on post-operative day (POD) 6 was 0.43 mcg/mL (range 0.3-0.9 mcg/mL) and an isavuconazole trough was 1.96 mcg/mL (range ≥1 mcg/mL). Acid fast bacilli (AFB) stains and cultures were followed serially with no growth and NTM therapy was continued for 3 months post-LTx. The patient developed leukopenia that was managed conservatively without changes to the antimycobacterial regimen. A 45 year-old female was similarly diagnosed with MAC pre-LTx and required a triple-drug regimen including rifabutin. The rifabutin peak levels were 0.33 mcg/mL and 0.22 mcg/mL on POD 7 and 14, respectively. Isavuconazole trough levels were 1.33 mcg/mL and 1.04 mcg/mL on POD 7 and 18, respectively. This patient experienced severe, prolonged leukopenia, prompting discontinuation of rifabutin. She remained on dual therapy with ethambutol and azithromycin. Despite this adverse reaction, neither patient required antimicrobial dose adjustments due to DDIs. Therapeutic drug monitoring of rifabutin and isavuconazole may be necessary to confirm therapeutic serum concentrations when used concomitantly. The effect of this drug interaction on the incidence or severity of rifabutin-associated leukopenia needs further evaluation.

PMID 42863248
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PubMedCureus2026-10-13

Quantifying Diagnostic Misclassification and Inpatient Mortality Determinants in Scrub Typhus: A Systematic Review and Interaction Meta-Analysis of Acute Undifferentiated Febrile Illness (AUFI) Cohorts in India.

C A Jayashankar J, Kandi Venkataramana V, Harikrishna Ganaraja V GV, Sam Koshy T KT et al.

Scrub typhus (ST), caused by Orientia tsutsugamushi, is an underrecognized but major etiology of acute undifferentiated febrile illness (AUFI) across India. Prior national syntheses were limited by selection biases arising from heterogeneous screening denominators. To establish an unbiased epidemiological baseline, we conducted a Preferred Reporting Items for Systematic Reviews and Meta‑Analyses‑compliant systematic review and meta‑analysis (registered with the International Prospective Register of Systematic Reviews) of observational studies published between January 2015 and June 2026, enforcing strict AUFI syndromic gatekeeping. Sixteen institutional cohorts comprising 27,892 screened AUFI patients met inclusion criteria. DerSimonian-Laird random‑effects modeling was applied to estimate pooled prevalence and heterogeneity. The pooled prevalence of ST was 14.60% (95% confidence interval (CI): 11.27-18.71; I2 = 97.40%, p < 0.001), with marked regional disparities: East/Central India 22.70% (95% CI: 16.80-29.80), South India 16.70% (95% CI: 10.20-25.90), North India 13.80% (95% CI: 8.40-21.50), and West India 2.50% (95% CI: 0.80-7.20; p < 0.001). The nationwide 95% prediction interval (3.30-45.20) captured extreme localized microfocal transmission dynamics. Multivariable meta‑regression explained 68.90% of between‑study variance (R2 = 68.90%; residual I2 = 34.20%), identifying a significant interaction between diagnostic assay stringency and regional transmission intensity (β = 0.485, p = 0.041). Cohorts employing high‑rigor composite criteria, including immunoglobulin M (IgM) enzyme‑linked immunosorbent assay (ELISA), polymerase chain reaction (PCR), indirect immunofluorescence assay, or eschar confirmation, reported a pooled prevalence of 17.40% (95% CI: 12.80-23.10), compared with 11.90% (95% CI: 7.60-18.00) in cohorts using single‑modality rapid immunochromatographic tests (ICTs) or legacy Weil-Felix assays (p = 0.024). Fever was universal (100.00%), while pathognomonic eschars were documented in only 21.40% (95% CI: 15.10-29.20). Pooled inpatient mortality was 4.92% (95% CI: 2.98-7.95), driven primarily by multiorgan dysfunction syndrome (pooled odds ratio (pOR) = 5.18, 95% CI: 3.20-8.38, p < 0.001), acute respiratory distress syndrome (pOR = 4.12, 95% CI: 2.45-6.93, p < 0.001), therapeutic delay beyond seven days (pOR = 3.42, 95% CI: 2.15-5.44, p < 0.001), and acute kidney injury (AKI) (pOR = 3.25, 95% CI: 1.98-5.33, p < 0.001). O. tsutsugamushi accounts for approximately one in seven AUFI hospital admissions in India. These findings mandate decommissioning low‑sensitivity rapid and legacy assays, expanding decentralized IgM ELISA/PCR platforms, and immediately initiating protocol‑driven empiric doxycycline or azithromycin when clinically suspected.

PMID 42866668
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