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artemisinin (artemisinin, Mateon / ArtiShield / ARTIVeda)

✓ Approved

Oncotelic Therapeutics, Inc. · therapeutic agent

What is artemisinin?

artemisinin is a therapeutic agent developed by Oncotelic Therapeutics, Inc.. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand Namesartemisinin, Mateon, ArtiShield, ARTIVeda
CompanyOncotelic Therapeutics, Inc.
RouteOral (PO)
StatusApproved

Therapeutic Indications

artemisinin is developed for 6 unique indications across 6 therapeutic areas.

Therapeutic AreaConditionPhase
InvestigationsBody temperature increased✓ Approved
Hepatobiliary disordersHepatitis✓ Approved
General disorders and administration site conditionsPyrexia✓ Approved
Infections and infestationsCOVID-19Phase I
Respiratory, thoracic and mediastinal disordersAcute respiratory distress syndromePhase I

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Related Research Articles

PubMedMalaria journal2026-06-09

Exploring the antimalarial potential of (+)-2,2'-epicytoskyrin A: in vitro and in vivo studies of a bioactive metabolite from endophytic fungus Diaporthe sp. GNBP-10.

Novita Risqa R, Fathoni Ahmad A, Waluyo Danang D, Suprayogi Agik A et al.

Malaria remains a major global parasitic disease, increasingly complicated by resistance to frontline antimalarial drugs such as chloroquine and artemisinin. This challenge underscores the urgent need for novel antimalarial agents with alternative mechanisms of action. Endophytic fungi constitute a promising yet underexplored source of structurally diverse bioactive metabolites. This study investigated the antimalarial potential of ( +)-2,2'-epicytoskyrin A (Epi-A), a bisanthraquinone isolated from Diaporthe sp. GNBP-10, an endophyte of Uncaria gambir (Hunter) Roxb., was utilized in both in vitro and in vivo models. In vitro antimalarial activity was assessed against chloroquine-sensitive Plasmodium falciparum 3D7 using microscopic examination of Giemsa-stained thin blood smears. At the same time, cytotoxicity was evaluated in MCF-7 cells by measuring absorbance at 450 nm and calculating CC₅₀ values using GraphPad Prism. In vivo efficacy was evaluated in Plasmodium berghei-infected Swiss Webster mice. Animals were assigned to five groups: oral Epi-A (12.5, 25, and 50 mg/kg BW), artemisinin (20 mg/kg BW), and an untreated infected group. Treatment was administered for four consecutive days after the mean parasitaemia reached 10%. Histopathological analysis of the liver, spleen, kidney, and intestine was performed on day 8 pi using one mouse per group, while the remaining mice were monitored until day 15 pi for parasitaemia, survival, clinical manifestations, and body weight changes. Epi-A demonstrated potent in vitro activity, with an IC₅₀ of 0.24 µM, a CC₅₀ of 4.4 µM, and a selectivity index of 18.33. In vivo, on day 8 pi, histopathology revealed haemozoin deposition with mild tissue alterations in the liver, spleen, kidney, and intestine. Parasitaemia did not differ among Epi-A-treated groups but was significantly lower than in the negative control. Epi-A achieved > 50% inhibition (63.6%, 77.4%, and 50% at 12.5, 25, and 50 mg/kg BW, respectively), classifying it as a very good antimalarial activity. No post-treatment weight loss was observed, and only mild clinical signs were noted, compared with the severe manifestations observed in the negative control. Epi-A demonstrates potent in vitro and very good in vivo antimalarial activity, with low toxicity and potential organ-protective effects, supporting its promise as a candidate for further mechanistic studies.

PubMedFolia microbiologica2026-06-09

Virtual screening and molecular dynamics analysis of Plasmodium falciparum dihydroorotate dehydrogenase (DHODH) inhibitors targeting pyrimidine biosynthesis pathway.

Alzahrani Abdullah R AR, Alhuthali Hayaa M HM, Alzahrani Shatha S, Hawsawi Nahed Mohammed NM et al.

Malaria caused by Plasmodium falciparum remains a major global health challenge, exacerbated by the emergence of resistance to artemisinin-based combination therapies. Dihydroorotate dehydrogenase (PfDHODH), an essential enzyme in parasite pyrimidine biosynthesis, represents a validated and selective antimalarial drug target. In this study, an integrated multilevel computational strategy was employed to identify novel PfDHODH inhibitors from a structurally diverse chemical library. Structure-based virtual screening yielded 1,500 initial hits, from which three top-ranking compounds (17507474, 24348860, and 17433008) were shortlisted based on binding affinity and active-site complementarity. Density functional theory analyses indicated favorable HOMO-LUMO energy gaps, suggesting chemical stability and reactivity conducive to biological activity. Redocking confirmed stable accommodation of optimized ligands within the PfDHODH catalytic pocket. Long-timescale molecular dynamics simulations (500 ns) demonstrated persistent binding stability of all complexes, with compound 24348860 exhibiting minimal structural deviation and compound 17433008 forming adaptive hydrogen-bonding networks. Principal component and free energy landscape analyses revealed well-defined low-energy conformational basins. MM/GBSA binding free energy calculations identified compounds 17433008 (- 86.46 kcal/mol) and 17507474 (- 85.91 kcal/mol) as the most thermodynamically favorable. Overall, these findings highlight the druggability of PfDHODH and propose compounds 17433008 and 17507474 as promising lead candidates for further experimental validation and antimalarial drug development.

PubMedThe Lancet. Microbe2026-06-09

Evaluation of the effectiveness of artemether-lumefantrine and artesunate-pyronaridine each combined with single low-dose primaquine in adults with Plasmodium falciparum infection in Ethiopia: a phase 2/3, observer-masked, randomised, parallel-group trial.

Bezabih Migbaru Keffale MK, Misganaw Tadesse T, Ejigu Legesse Alamerie LA, Rosillo Stefano S et al.

Plasmodium falciparum parasites carrying the pfkelch13 R622I variant, associated with artemisinin resistance, are prevalent in the Horn of Africa. These parasites can also harbour histidine rich protein 2/3 (pfhrp2/3) gene deletions that are associated with false-negative rapid diagnostic tests. This study assessed the efficacy of artemisinin-based combination therapies artemether-lumefantrine plus primaquine or pyronaridine-artesunate plus primaquine in an area with high levels of pfkelch13 mutations and pfhrp2/3 gene deletions. We conducted a phase 2/3, observer-masked, randomised, parallel-group trial at the Maksegnit and Enfranz health centres (primary health-care units) in Ethiopia. Individuals with fever (measured or history of fever in the past 24 h) with uncomplicated P falciparum-caused malaria were randomly assigned (1:1 per health centre) to receive artemether-lumefantrine plus primaquine or pyronaridine-artesunate plus primaquine. Patients with severe anaemia, chronic diseases, or who were pregnant or breastfeeding were excluded from enrolment. Outcome assessors, but not participants or clinicians, were masked to treatment allocation. Primary outcomes were PCR-corrected adequate clinical and parasitological response (ACPR) on day 28 for artemether-lumefantrine plus primaquine and on days 28 and 42 for pyronaridine-artesunate plus primaquine, analysed per protocol, and safety profile and tolerability monitored at each visit (on days 0-3 and weekly from days 7-42) through clinical assessments and self-reports. The study was powered to assess ACPR per group and not for a comparison between the groups. The study was registered with the Pan African Clinical Trials Registry (PACTR202110520435408) and is now completed. Between Dec 17, 2021, and May 20, 2022, 199 individuals (136 [68%] male and 63 [32%] female; median age 25 years [IQR 19-36]) with microscopy-confirmed P falciparum were enrolled into the artemether-lumefantrine plus primaquine (n=101) and pyronaridine-artesunate plus primaquine (n=98) groups. Day 28 PCR-corrected ACPR was 96·8% (95% CI 90·9-99·3) for the artemether-lumefantrine plus primaquine group and 98·9% (93·9-99·9) for the pyronaridine-artesunate plus primaquine group; day 42 ACPR in the pyronaridine-artesunate plus primaquine group was 96·5% (90·0-99·3). No early treatment failures were observed. The most commonly detected mild adverse events were headache, weakness, and body ache. Headaches were recorded in 46 (45%) of 101 participants in the artemether-lumefantrine plus primaquine group vs 43 (44%) of 98 participants in the pyronaridine-artesunate plus primaquine group on day 1, declining to eight (8%) of 96 vs 18 (19%) of 95 on day 7. Weakness was reported in 27 (27%) of 101 participants in the artemether-lumefantrine plus primaquine group vs 24 (24%) of 98 in the pyronaridine-artesunate plus primaquine group on day 1, declining to five (5%) of 96 vs six (6%) of 95 on day 7. Body ache was reported in 24 (24%) of 101 participants in the artemether-lumefantrine plus primaquine group vs 24 (24%) of 98 participants in the pyronaridine-artesunate plus primaquine group on day 1, declining to three (3%) of 96 vs seven (7%) of 95 on day 7. No serious adverse events were reported. Our findings reinforce the continued use of artemether-lumefantrine plus primaquine for treating uncomplicated P falciparum malaria. Pyronaridine-artesunate plus primaquine also shows promise as an alternative regimen. Continued surveillance remains essential to safeguarding both therapeutic effectiveness and diagnostic accuracy. FGT was supported by grants from the US President's Malaria Initiative, Gates Foundation, and the Wellcome Trust.

PubMedThe Lancet. Microbe2026-06-09

Efficacy of chloroquine plus low-dose primaquine and pyronaridine-artesunate plus low-dose primaquine against Plasmodium vivax malaria in adults and transmission to mosquitoes in Ethiopia: a phase 2/3, observer-masked, randomised, parallel-group trial.

Bezabih Migbaru Keffale MK, Sisay Solomon S, Behaksera Sinknesh Wolde SW, Ramjith Jordache J et al.

In areas co-endemic for Plasmodium vivax and Plasmodium falciparum, artemisinin-based combination therapy is being considered as unified treatment strategy. The clinical and transmission-reducing efficacy of antimalarials remain understudied for P vivax, particularly in Africa. In this study, we aimed to evaluate the in-vivo efficacy, safety, and tolerability of pyronaridine-artesunate and chloroquine, each combined with a 14-day low-dose primaquine regimen, to treat uncomplicated P vivax malaria in Ethiopia and to assess the gametocytocidal and transmission-blocking effects of pyronaridine-artesunate and chloroquine, with or without low-dose primaquine, through direct mosquito feeding assays. Two parallel-group, observer-masked, randomised, phase 2/3 trials were conducted at two health centres (primary health-care units) in Maksegnit and Enfranz, Ethiopia, to evaluate the efficacy of chloroquine and pyronaridine-artesunate, each combined with low-dose primaquine, in adult febrile participants aged 18 years or older with microscopy-confirmed asexual P vivax malaria. Participants were randomly assigned 1:1 to receive either chloroquine plus low-dose primaquine or pyronaridine-artesunate plus low-dose primaquine using simple randomisation. Microscopists assessing outcomes were masked to treatment allocation. Clinical assessments and fingerprick blood collection for microscopy and molecular analysis were conducted on days 0-3 and weekly on days 7-42. The primary outcomes were adequate clinical and parasitological response (ACPR), assessed at day 28 in both chloroquine plus low-dose primaquine and pyronaridine-artesunate plus low-dose primaquine groups and at day 42 in the pyronaridine-artesunate plus low-dose primaquine group, analysed per protocol. Safety and tolerability were monitored in the intention-to-treat population throughout the 42-day follow-up period via clinician assessments and participant self-reports. In the transmission substudy, individuals carrying gametocytes, per microscopy detection, were recruited and randomly assigned to receive chloroquine or pyronaridine-artesunate, with immediate or delayed (day 3) low-dose primaquine administration. Mosquito infectivity was assessed before and on days 1-3 after treatment. The completed trial is registered at the Pan African Clinical Trials Registry (PACTR202110520435408). Between Jan 3, and June 17, 2022, 176 participants (122 [69%] male and 54 [31%] female) were enrolled (88 per group), and 79 in the chloroquine group and 83 in the pyronaridine-artesunate group were included in primary outcome analyses. Day-28 ACPR was 98·7% (78 of 79; 95% CI 91·3-99·8) for the chloroquine plus low-dose primaquine group and 98·8% (82 of 83; 95% CI 91·7-99·8) for the pyronaridine-artesunate plus low-dose primaquine group; day-42 ACPR in the pyronaridine-artesunate plus low-dose primaquine group was 96·4% (80 of 83; 95% CI 89·2-98·8). The most common adverse events were mild and included headache (45 [51%] of 88 in the chloroquine group vs 49 [56%] in the pyronaridine-artesunate group), weakness (28 [32%] vs 25 [28%]), body pain (27 [31%] vs 25 [28%]), and chills (20 [23%] vs 23 [26%]). No serious adverse events or treatment-related deaths occurred. Both treatment regimens were well tolerated. 60 participants were enrolled in the transmission substudy during the same time period as the main treatment efficacy study; 55 (92%) participants were infectious to mosquitoes at baseline. By day 1, infectivity was completely blocked in 15 (100%) of 15 participants in the pyronaridine-artesunate plus low-dose primaquine group, but residual transmission was observed in the chloroquine (seven [47%] of 15), pyronaridine-artesunate (two [13%] of 15), and chloroquine plus low-dose primaquine groups (four [27%] of 15). No mosquito infections occurred on day 2 or day 3 in any group. Both regimens treated P vivax malaria with high efficacy. Pyronaridine-artesunate plus low-dose primaquine rapidly interrupted transmission. The findings support further evaluation of pyronaridine-artesunate plus low-dose primaquine as a unified treatment strategy in co-endemic settings to improve malaria control and support malaria elimination efforts. US President's Malaria Initiative and Wellcome Trust.

PubMedActa crystallographica. Section E, Crystallographic communications2026-06-08

Crystal structure of (3R,5aS,6R,9R,12R,12aR)-3,6,9-tri-methyl-deca-hydro-12H-3,12-ep-oxy[1,2]dioxepino[4,3-i]isochromen-10-yl 5-((3aS,4S,6aR)-2-oxohexa-hydro-1H-thieno[3,4-d]imidazol-4-yl)penta-noate.

Yang Xiaomei X, Chen Siyu S, Liu Wenxin W, Cui Mengjie M et al.

In the title biotin-conjugated di-hydro-artemisinin (DHA) derivative, C25H38N2O7S, the mol-ecule retains the essential endoperoxide bridge and links the C-10 position of DHA to the penta-noate chain of biotin via an ester bond. In the solid state, the tetra-hydro-pyran ring of DHA adopts a chair conformation, the fused peroxide seven-membered ring exhibits a twist conformation, the imidazolidone ring of biotin shows an envelope conformation and the tetra-hydro-thio-phene ring adopts a twisted conformation. Supra-molecularly, adjacent mol-ecules are linked through a classical N-H⋯O double hydrogen-bonding motif between the urea groups of biotin, forming anti-parallel cyclic dimers. These strong dimers are further supported by weaker C-H⋯O inter-actions. The SQUEEZE [Spek (2015 ▸). Acta Cryst. C71, 9-18] routine in PLATON was used to remove electron density corresponding to disordered solvent mol-ecules. This structure determination provides a valuable blueprint for the rational design of hybrid anti-malarial and anti-cancer therapies based on DHA-biotin conjugates.

PubMedAutoimmunity2026-06-08

Multi-cohort transcriptomic analysis with machine learning identifies interferon-related candidate genes in systemic lupus erythematosus.

Apaer Aishanjiang A, Aobulitalifu Alimijiang A, Keyoumu Jumahong J, Alifu Adilijiang A et al.

Systemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease with complex molecular mechanisms. Although transcriptomic studies have revealed prominent interferon signatures in SLE, robust prioritization of candidate genes across independent cohorts remains challenging. In this study, we performed a multi-cohort transcriptomic analysis using publicly available GEO datasets. Differential expression analysis was conducted independently within each cohort to minimize cross-study confounding. Machine learning models, including LASSO, support vector machine, and random forest, were applied for feature prioritization in a designated training cohort, followed by independent validation in separate datasets. Model interpretability was assessed using SHAP analysis. Immune cell composition was estimated descriptively using CIBERSORT. In addition, molecular docking and molecular dynamics simulations were performed as exploratory in silico analyses to evaluate potential protein-compound interactions. A set of consistently dysregulated genes across cohorts was identified, many of which are associated with interferon signaling. Among these, RSAD2 showed robust prioritization across multiple machine learning models. The predictive performance of the models was stable in independent validation datasets. SHAP analysis highlighted the contribution of interferon-stimulated genes to model predictions. Immune deconvolution suggested altered immune cell composition in SLE samples, consistent with previously reported immune activation patterns. Exploratory in silico analyses suggested a potential interaction between artemisinin and RSAD2. This study provides a robust, multi-cohort computational framework for prioritizing candidate genes associated with SLE. The findings highlight interferon-associated transcriptional features as reproducible molecular signatures of SLE and generate testable hypotheses for future experimental and clinical investigation.

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