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artesunate (artesunate, Amivas)

✓ Approved

Amivas · Small Molecule · Small Molecule

What is artesunate?

artesunate is a small molecule developed by Amivas. It is approved for therapeutic indications via injectable (others) or intravenous (iv).

Drug Profile

Brand Namesartesunate, Amivas
CompanyAmivas
Drug ClassSmall Molecule
RouteInjectable (Others), Intravenous (IV)
StatusApproved
Sources: ClinicalTrials.gov, Amivas

Therapeutic Indications

artesunate is developed for 2 unique indications across 1 therapeutic area.

Therapeutic AreaConditionPhase
Infections and infestationsPlasmodium malariae infection✓ Approved
Infections and infestationsCytomegalovirus infectionPreclinical

Related Research Articles

PubMedMatrix biology : journal of the International Society for Matrix Biology2026-10-14

Clitocine for Translational Readthrough in Junctional Epidermolysis Bullosa.

Zhang Rui R, Mabrouk Haifa El HE, Has Cristina C, Sayar Saliha Beyza SB

Junctional epidermolysis bullosa (JEB) caused by laminin-332 deficiency (JEB-LAM332) is a severe inherited skin disorder characterized by impaired dermal-epidermal adhesion, chronic wounds, and increased cancer susceptibility. The management of JEB-LAM332 is primarily symptomatic, focusing on wound care and general supportive measures; however, many therapeutic needs remain unmet. While gene and stem cell therapy has been effective in JEB-LAM332, it is not yet broadly available owing to its complexity and cost. Translational readthrough-inducing drugs (TRIDs) represent an alternative strategy for treating JEB-LAM332, given that most patients carry nonsense mutations in at least one allele of their LAMA3, LAMB3, or LAMC2 genes, with LAMB3 c.1903C>T, p.R635* (p.Arg635Ter) being the most common variant. To determine promising TRID candidates for developing readthrough therapy for JEB-LAM332 patients with LAMB3 mutations, we evaluated different classes of TRIDs and compared their efficacy against gentamicin. Erythromycin, TRID-C5 (aminoglycoside-based cocktail), artesunate and atazanavir (non-aminoglycosides, ribosomal protein RpL35 ligand) and clitocine (nucleoside analog) were tested in patient-derived keratinocytes carrying the LAMB3 nonsense variants, homozygous c.1903C>T (p.R635*) or compound heterozygous c.124C>T;c.1903C>T (p.R42*;p.R635*). We used a previously established screening platform for systematic testing of TRIDs, including immunoblotting, cell functional assays, and transcriptomics. We identified clitocine as the most potent compound for promoting translational readthrough, restoring laminin β3 chain expression and improving keratinocyte adhesion in JEB models. Clitocine treatment elicited dose- and mutation-dependent responses, while toxicity was observed at higher concentrations, particularly in normal keratinocytes. Although normal keratinocytes are not the intended therapeutic target, these findings highlight the importance of defining a therapeutic window and optimizing mutation-specific dosing. Overall, clitocine represents a potential candidate for the topical therapy of JEB-LAM332.

PMID 42874790
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PubMedActa tropica2026-10-13

Dendrimer-Based Nano Artesunate/β-Glucan as a Promising Antimalarial Candidate: Insights from in Vivo Evaluations.

Noorzaei Mahla M, Khanabadi Faride F, Alimardan Zahra Z, Akbariqomi Mostafa M et al.

Malaria remains a major global health burden, with increasing concerns regarding resistance to conventional antimalarial therapies, including artemisinin derivatives. This study aimed to develop and evaluate a second-generation dendrimer-based nano artesunate/β-glucan formulation designed to combine antiplasmodial activity with potential immunomodulatory effects against malaria. A nano artesunate/β-glucan nanocomposite was synthesized using a G2 dendrimer platform and characterized by dynamic light scattering (DLS), scanning electron microscopy (SEM), Fourier-transform infrared spectroscopy (FTIR), drug loading analysis, solubility assessment, and release kinetics. Antimalarial efficacy was evaluated in a murine Plasmodium berghei model using parasitemia monitoring, lactate dehydrogenase (LDH) assays, and survival analysis. Immunomodulatory effects were assessed through macrophage nitric oxide (NO) production and serum interferon-gamma (IFN-γ) levels. Toxicological evaluation included body weight monitoring, erythrocyte morphology and hemolysis assays, liver enzyme analysis, and histopathological examination of hepatic tissues. The synthesized nanocomposite showed a mean particle size of 157.5 nm, acceptable size distribution (PDI = 0.284), and spherical morphology. Loading into the dendrimer-based nanocomposite improved the aqueous solubility of artesunate and β-glucan by 83% and 27%, respectively, and enabled sustained drug release over 48 hours. In vivo, the nano artesunate/β-glucan formulation at 100 mg/kg and 80 mg/kg, respectively, achieved complete parasite clearance within 4 days, with no recrudescence during the 21 days of follow-up. This effect was accompanied by increased NO and IFN-gamma levels, suggesting possible immune involvement. Compared with free artesunate and chloroquine, the nanocomposite showed lower hepatotoxicity, minimal hemolysis, preserved erythrocyte morphology, and only minor liver histopathological changes. The dendrimer-based nano artesunate/β-glucan formulation showed potent antiplasmodial activity, improved solubility, sustained release, and a favorable acute safety profile in a murine malaria model. It may represent a promising antimalarial nano formulation, although further mechanistic and long-term safety studies are needed.

PMID 42869154
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PubMedInternational medical case reports journal2026-10-08

Blackwater Fever Complicated by Severe Acute Kidney Injury and a Therapeutic Dilemma: A Case Report from Niger.

Adamou Bara Abdoul-Aziz AA, Abdou Maman Ibrahim I II, Mahaman Moustapha Lamine L, Souleymane Adoum Fils F et al.

Blackwater fever (BWF) is a rare complication of antimalarial treatment characterized by acute intravascular hemolysis. Its diagnosis is mainly clinical, particularly based on the presence of dark-colored urine. We report the case of a 50-year-old woman admitted to the Infectious and Tropical Diseases Department of the National Hospital of Zinder for fever, jaundice, and acute kidney injury in the context of persistent Plasmodium falciparum infection and repeated antimalarial treatments, including artesunate. Clinical and laboratory findings were suggestive of severe intravascular hemolysis, with severe acute kidney injury (serum creatinine: 1104.1 µmol/L). After renal replacement therapy was initiated and urine output resumed, the patient developed dark 'Coca-Cola'-colored urine, suggestive of hemoglobinuria. Blackwater fever was strongly suspected based on the overall clinical context. The patient underwent eight sessions of hemodialysis and received alternative antimalarial therapy. The outcome was favorable, with progressive recovery of renal function. This case highlights the diagnostic and therapeutic challenges of suspected blackwater fever in a patient with persistent Plasmodium falciparum infection and repeated antimalarial exposure. Although repeated artesunate exposure raises the possibility of a drug-related contribution, causality cannot be established. Early recognition of hemolysis and acute kidney injury, together with appropriate antimalarial and supportive treatment, is essential.

PMID 42846951
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PubMedMolecular neurobiology2026-10-06

Intranasal Artesunate Ameliorates Hippocampal LFP Abnormalities and Cellular Apoptosis in APP/PS1 Mice via a Mechanism Involving GHRH/PI3K/AKT Signaling.

Jin Yue Y, Gong Xuewu X, Shen Lei L, Zhang Meng M et al.

Alzheimer's disease (AD) is characterized by progressive neurodegeneration and aberrant neural network activity. Artesunate (ART) has shown neuroprotective potential, but its effects on macroscopic hippocampal network dynamics and the underlying molecular mechanisms remain unclear. This study investigated the therapeutic efficacy and mechanisms of intranasal ART in APP/PS1 transgenic mice and Aβ1-42-treated HT22 hippocampal neurons, integrating behavioral assays, multi-channel local field potential (LFP) recordings, ultrastructural analyses, and transcriptomics. In vivo, ART administration ameliorated cognitive deficits and mitigated macroscopic hippocampal LFP disruptions, manifested as an attenuation of the spectral power shift toward lower frequencies, reduced aberrant theta-gamma phase-amplitude coupling (PAC), and improved sharp-wave ripple (SWR) properties during resting states. Concurrently, ART reduced the number of TUNEL-positive cells and quantitatively preserved postsynaptic density (PSD) thickness and synaptic cleft width, alongside qualitative improvements in myelin sheath and mitochondrial morphology. Mechanistically, RNA-sequencing identified the neuroactive ligand-receptor interaction pathway as a prominent ART-responsive target, with growth hormone-releasing hormone (GHRH) emerging as a key candidate. In vitro pharmacological blockade revealed that ART's anti-apoptotic effects against Aβ toxicity depend on GHRH-R and subsequent PI3K/AKT cascade activation. This was accompanied by the inhibitory phosphorylation of GSK-3β, increased NF-κB p65 nuclear translocation, Bcl-2 upregulation, and caspase-3 inhibition. Collectively, these findings demonstrate that intranasal ART exerts sustained neuroprotective effects that preserve synaptic ultrastructure and ameliorate macroscopic network dysfunction in AD models. While the precise in vivo causality requires further validation, our in vitro data suggest that these cellular benefits are strongly associated with GHRH/PI3K/AKT signaling, highlighting ART as a promising therapeutic candidate for early AD.

PMID 42834252
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PubMedFrontiers in cellular and infection microbiology2026-10-06

Epidemiological and clinical characteristics of imported malaria patients admitted to a specialized hospital: a retrospective study (2021- June 2026).

Peng Kun K, Gong Wenjing W, Dong Xuan X, Zhao Yunjing Y et al.

China was certified malaria-free by the World Health Organization in 2021; however, imported malaria remains a significant challenge to maintaining malaria elimination due to increasing international travel and overseas population mobility. Imported malaria cases have been continuously reported in Shandong Province, but detailed clinical characteristics, parasite species distribution, travel history, and treatment patterns among hospitalised malaria patients following elimination remain insufficiently characterised. We conducted a retrospective hospital-based observational study of malaria patients admitted to our hospital in Shandong Province, China, from January 2021 to June 2026. Demographic information, travel history, clinical manifestations, laboratory findings, Plasmodium species identification, and antimalarial treatments were analysed. The associations between travel regions and Plasmodium species distribution were evaluated using chi-square tests. A total of 120 hospitalised malaria patients were included in the analysis. The number of malaria admissions increased from two cases in 2021 to 45 cases in 2025, with seasonal clustering during the second and third quarters of the year. All patients were male, and 98.3% were aged 30-59 years. Most patients had a travel history to Africa (95.8%), particularly West Africa (54.2%) and Central Africa (28.3%). Among the 120 patients with confirmed parasite identification, Plasmodium falciparum (P. falciparum) was the predominant species (67.5%), followed by Plasmodium ovale (P. ovale) (20.0%), Plasmodium vivax (P. vivax) (7.5%), and Plasmodium malariae (P. malariae) (5.0%). Fever was observed in all patients. The distribution of Plasmodium species differed significantly according to travel regions (Monte Carlo simulated P < 0.001). Further analysis within Africa revealed a significant difference among West, Central, and East Africa (Monte Carlo simulated P = 0.016). All patients received antimalarial treatment. Artemisinin-based therapies were the main treatment strategies, with dihydroartemisinin-piperaquine used in 90.0% of patients and intravenous artesunate administered in 41.7% of cases. Imported malaria remains a significant clinical and public health challenge following malaria elimination in Shandong Province. Cases are predominantly identified among working-age males returning from sub-Saharan Africa, with P. falciparum as the dominant parasite species. Therefore, strengthening surveillance of overseas travellers, improving early diagnosis, and maintaining standardised treatment protocols are essential to prevent the re-establishment of malaria.

PMID 42835030
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PubMedPhytomedicine : international journal of phytotherapy and phytopharmacology2026-10-04

Artesunate reverses alveolar macrophage immunometabolic collapse and prevents breast cancer lung metastasis via the SREBP1- and FATP4-dependent fatty acid axis.

Li Yanping Y, Yu Fengling F, Zou Xiaofeng X, Wu Ziqiang Z et al.

Alveolar macrophages (AMs) are critical sentinels of the lung microenvironment, however, the metabolic mechanisms driving their functional reprogramming within the breast cancer pulmonary pre-metastatic niche (PMN) remain poorly defined. This study aimed to elucidate the metabolic-immune crosstalk governing AM dysfunction during breast cancer lung metastasis and evaluate the therapeutic potential of artesunate (AS) as a fatty acid metabolic remodeler. Utilizing 4T1-based spontaneous lung metastasis and post-surgical recurrence models, we integrated single-cell RNA sequencing (scRNA-seq) and flow cytometry (FCM) to delineate the functional and lipid metabolic landscape of AMs in the breast cancer pulmonary PMN. Bulk RNA-seq, metabolomics, immunofluorescence, and FCM were subsequently employed to elucidate how AS remodels fatty acid metabolism in AMs. The underlying mechanisms were elucidated through in vitro and in vivo functional rescue assays and further valuated by publicly available clinical datasets and human clinical tissue samples. We identified a disruption of fatty acid metabolism in AMs resident within the breast cancer pulmonary PMN, characterized by coordinated impairment of both fatty acid uptake and lipid accumulation. This metabolic defect correlated with reduced phagocytic capacity and an immunosuppressive phenotype. Notably, AS treatment effectively restored fatty acid uptake and lipid accumulation in AMs, reestablished immunological surveillance within breast cancer pulmonary PMN, and effectively suppressed primary tumor growth and lung metastasis. Subsequent in vitro study confirmed that AS-remodeled AMs reboot anti-tumor immunity by enhancing phagocytosis and promoting T-cell activation. Functional intervention experiments further demonstrated that AS-induced immunometabolic reprogramming of AMs depends, at least in part, on SREBP1 driven lipogenesis and FATP4 mediated fatty acid uptake. Notably, these two metabolic pathways also serve as conserved prognostic signatures in human lung cancer cohorts. Our findings define the disruption of fatty acid homeostasis as a hallmark of AM dysfunction in the breast cancer pulmonary PMN and establish artesunate as a promising candidate for intercepting breast cancer lung metastasis by targeting metabolic fitness in AMs.

PMID 42828849
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