Drug Database
AG

AGP-103 (Esapent / Eskim / EPA + DHA)

✓ Approved

Pronova BioPharma ASA · therapeutic agent

What is AGP-103?

AGP-103 is a therapeutic agent developed by Pronova BioPharma ASA. It is approved for therapeutic indications.

Drug Profile

Brand NamesEsapent, Eskim, EPA + DHA
CompanyPronova BioPharma ASA
StatusApproved
Sources: ClinicalTrials.gov, Pronova BioPharma ASA

Therapeutic Indications

AGP-103 is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Metabolism and nutrition disordersHypertriglyceridaemia✓ Approved

Related Research Articles

PubMedZhonghua zhong liu za zhi [Chinese journal of oncology]2026-11-11

[Comparison of efficacy and safety between TAE combined with FOLFOX-HAIC or RALOX-HAIC in the treatment of hepatocellular carcinoma].

Zhang M M, Chang X J XJ, Gao X D XD, Kong H F HF et al.

Objective: To compare the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) using the FOLFOX regimen, consisting of oxaliplatin, leucovorin, and 5-fluorouracil, with those of HAIC using the RALOX regimen in patients with intermediate-advanced hepatocellular carcinoma. Methods: A total of 239 patients with primary hepatocellular carcinoma who received transarterial embolization (TAE) combined with FOLFOX-HAIC or RALOX-HAIC at the Fifth Medical Center of Chinese PLA General Hospital between January 2022 and October 2024 were retrospectively enrolled. Patients in the FOLFOX-HAIC and RALOX-HAIC groups were matched at a ratio of 2∶1 using propensity score matching (PSM), resulting in 103 patients in the FOLFOX-HAIC group and 68 patients in the RALOX-HAIC group. The objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and adverse events were compared between the two groups. Results: After PSM, there were no statistically significant differences in baseline characteristics between the FOLFOX-HAIC and RALOX-HAIC groups, with all P values greater than 0.05. According to Response Evaluation Criteria in Solid Tumors version 1.1, the ORR was 37.9% (39/103) in the FOLFOX-HAIC group and 33.8% (23/68) in the RALOX-HAIC group, while the DCR was 84.5% (87/103) and 76.5% (52/68), respectively. No significant differences were observed between the two groups, with P values of 0.707 and 0.266, respectively. According to modified Response Evaluation Criteria in Solid Tumors, the ORR was 49.5% (51/103) in the FOLFOX-HAIC group and 45.6% (31/68) in the RALOX-HAIC group, while the DCR was 84.5% (87/103) and 76.5% (52/68), respectively. The differences were also not statistically significant, with P values of 0.729 and 0.266, respectively. The median PFS was 11.9 months in the FOLFOX-HAIC group and 10.0 months in the RALOX-HAIC group, while the median OS was 23.1 months and 17.2 months, respectively, with no statistically significant differences between the two groups, both P=0.400. The incidences of grade 1-2 adverse events were 62.1% and 66.2% in the FOLFOX-HAIC and RALOX-HAIC groups, respectively, while the incidences of grade 3-4 adverse events were 36.9% and 29.4%, respectively. No significant differences were observed between the two groups, with all P values greater than 0.05. The most common grade 3-4 adverse events in both groups were increased aspartate aminotransferase levels (29.1% and 19.1%), increased alanine aminotransferase levels (20.4% and 20.6%), and thrombocytopenia (16.5% and 25.0%). Conclusions: In patients with intermediate-advanced hepatocellular carcinoma receiving TAE combined with HAIC, FOLFOX-HAIC and RALOX-HAIC showed comparable efficacy and safety. RALOX-HAIC may serve as a potential alternative to FOLFOX-HAIC.

PMID 43010747
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PubMedFrontiers in public health2026-11-11

A narrative review of HIV surveillance strategies used in selected sub-Saharan African countries.

Nliwasa Marriott M, Tippett Barr Beth A BA, Chigawa Fumbani F, Chipeta Michael G MG et al.

Over the last two decades, new HIV infections and AIDS-related deaths have declined significantly through expansion of access to HIV testing, treatment, and prevention services. Data to monitor epidemic trends and program coverage have been central to driving progress. We describe HIV surveillance indicators and methods that countries use to monitor the HIV epidemic and impact of programs in selected African countries. We conducted a review of global and national HIV surveillance guidelines. We extracted information on (1) indicators used to monitor HIV epidemic changes, and (2) activities countries conduct to measure these. We conducted an in-depth document analysis for five selected African countries: Ghana, Kenya, Lesotho, Malawi, and Zimbabwe. We identified 66 documents that inform HIV surveillance plans at national or global levels. Documents from the five selected countries reflected a range of 80 to 103 HIV indicators per country compared to 128 from a consolidated list of indicators in global guidance documents. The largest proportion of reported national indicators was for integrated services and non-biomedical measures such as HIV stigma and knowledge, with these accounting for a range of 22.8% (21/92) in Ghana to 64.1% (66/103) in Lesotho. Measuring incidence and mortality relied predominantly on mathematical modeling. Activities such as community and facility-based mortality surveillance, HIV drug resistance surveys and bio-behavioral surveys were specified in strategic plans but were partially implemented or not documented. HIV surveillance among selected African countries primarily used mathematical models for estimating HIV incidence and mortality and heavily depended on infrequent household surveys for quantifying epidemic burden. Strategy documents named many HIV indicators and surveillance activities, which were inconsistently implemented. Countries could reassess suitability of current indicators and activities and streamline these for efficient estimation of HIV burden.

PMID 43011257
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PubMedOrphanet journal of rare diseases2026-11-11

Development and clinical application of CAPAH: a long-read sequencing approach for accurate second-tier screening of phenylketonuria in newborns.

Xue Shuyuan S, Feng Ziyi Z, Zhu Jingying J, Chen Xi X et al.

Phenylketonuria (PKU) is a common inherited metabolic disorder in newborns. Early diagnosis and timely intervention are essential to prevent neurodevelopmental impairment. Traditional newborn screening primarily relies on measuring blood phenylalanine (Phe) levels, which can lead to both false-positive and false-negative results. Long-read sequencing (LRS) offers high coverage and long-fragment resolution, enabling comprehensive detection of PAH gene variants and potentially improving PKU screening and diagnosis. We developed a comprehensive PAH gene sequencing technology (CAPAH) based on the HiFi LRS platform, and applied it to the second-tier screening for PKU in newborns. First, CAPAH was validated for consistency with traditional NGS, MLPA, and Sanger sequencing in 20 samples with known genotypes. Subsequently, a retrospective analysis of 200 newborns with positive or borderline primary screening results was performed to assess the impact of CAPAH on variant detection, genotype-phenotype associations, and second-tier screening performance. CAPAH achieved complete consistency (100%) with traditional methods in the 20 validation samples. It enabled direct determination of cis-trans configurations and precise localization of large deletion breakpoints. Among 200 newborns, CAPAH identified 103 newborns with biallelic variants, 47 carriers, and 50 negative individuals, reducing the recall rate from primary screening by 48.5% (97/200). Among 131 newborns with negative or excluded PKU based on rescreening blood Phe levels, CAPAH detected 40 newborns carrying compound heterozygous variants, preventing approximately 20% of potential missed detections. In the 103 newborns with biallelic variants, CAPAH identified 64 PAH variants, including 47 missense, eight splice-site, four nonsense, and five deletion variants. Genotype-phenotype analysis revealed that the proportion of severe biallelic PKU-related variants (classic and mild PKU) was significantly higher in the rescreen-positive group than in the rescreen-negative group (25.00% vs. 14.29%). Homozygosity for c.158G > A or its combination with PKU- or mild hyperphenylalaninemia (MHP)-related variants was associated with blood Phe levels within the MHP range (2-6 mg/dL). When c.158G > A was combined with PKU-related variants, rescreening Phe levels were significantly elevated (p < 0.01). CAPAH enables comprehensive detection of the PAH gene, including complex variants and cis-trans configurations, thereby improving the accuracy of second-tier PKU screening in newborns and reducing unnecessary recalls. This approach provides an efficient and practical molecular diagnostic tool for newborn screening of inherited metabolic disease.

PMID 43009993
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PubMedJournal of ovarian research2026-11-11

Considerations on external validation, potential data leakage, and model selection in a PET/CT-based radiomics model predicting residual disease in ovarian cancer.

Wang Lu L, Sun Xiaohu X

Ye et al. recently reported that a PET/CT-based radiomics model incorporating clinical variables and using a support vector machine classifier outperformed conventional scoring systems in predicting complete cytoreduction in ovarian cancer (J Ovarian Res 2026). We appreciate this valuable contribution and wish to raise three points for consideration. First, although the validation cohort was held out from model development, it shares institution and scanner platform with part of the training set. The Siemens platform, which contributed 103 of 153 training patients, was not represented in the validation cohort. The results may therefore primarily reflect reproducibility on the GE platform, and broader cross-center or cross-scanner generalizability may warrant further evaluation. Second, SMOTE oversampling and mRMR feature selection are described as applied to the entire training cohort before nested cross-validation; if this reflects the actual workflow, fold-level data leakage could be a consideration. Third, selecting the SVM from seven models using identical cross-validation estimates and reporting the maximum could, in principle, introduce some optimistic selection bias. These points are offered in the hope of further strengthening the evidence base for broader multicenter use.

PMID 43010073
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PubMedThe New phytologist2026-11-11

The evolutionary history of brackish specialization from marine ancestry in the seagrass Ruppia sinensis.

Zou Yang Y, Huang Lei L, Zhao Haocun H, Wang Ya Y et al.

Ruppia sinensis, a unique seagrass species that originated in the marine environment yet successfully colonized extreme inland habitats, offers a rare window onto how plants cope with major habitat shifts and clarifies the mechanisms of adaptive evolution during marine-to-brackish transitions. We assembled a chromosome-level genome, conducted comparative phylogenomic analyses, assessed salinity tolerance through physiological experiments, and analyzed whole-genome resequencing data from 103 individuals representing 19 coastal and inland populations. R. sinensis falls in the core seagrass PRC (Posidoniaceae, Ruppiaceae, and Cymodoceaceae) clade with a Ruppiaceae-specific whole-genome duplication yet has lost tolerance to full-strength seawater and is an obligate brackish specialist. Coastal and inland lineages diverged c. 25 000 yr ago; dramatic sea-level fluctuations since the Last Glacial Period repeatedly displaced coastal populations, causing reductions in effective population size, loss of genetic diversity, and elevated genetic load. Inland populations persisted in saline-lake refugia and retain nearly twice the genetic diversity. The marine-to-brackish shift is an evolutionary trade-off rather than passive habitat tracking, with inland saline lakes serving as refugia that preserved diversity. Such shifts may be a recurrent adaptive strategy in seagrass evolution, and these diverse inland populations warrant conservation priority under climate change.

PMID 43009456
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PubMedMikrochimica acta2026-11-11

A phage-displayed nanobody-based colorimetric-fluorescent dual-readout immunoassay using Eu-micelles for detecting Bacillus cereus in food.

Ge Guangsheng G, Wang Mengnan M, Zheng Kai K, Fan Xueyi X et al.

Bacillus cereus (B. cereus) is a common foodborne pathogen that contaminates agricultural products and induces emetic or diarrheal food poisoning. We report an europium(Eu)-micelle-mediated colorimetric-fluorescent dual-readout nanobody-based immunoassay for B. cereus detection. Four novel B. cereus-specific nanobodies were isolated for the first time from an immune Bactrian camel phage-displayed nanobody library. A sandwich immunoassay was established using a purified soluble nanobody (Nb23) for target capture and a phage-displayed Nb (phage-Nb23) for detection, leveraging an HRP-conjugated anti-M13 antibody to achieve phage-mediated primary signal amplification. Self-assembled Eu-micelles were introduced post-reaction as an independent fluorescent module. HRP-catalyzed oxidation of TMB generated a 652 nm colorimetric signal while concurrently quenching Eu-micelle red emission at 616 nm through a combination of inner filter effects and interfacial excited-state deactivation. Under optimized conditions, the limits of detection were 3.84 × 104 CFU/mL for the colorimetric channel and 8.57 × 103 CFU/mL for the fluorescent channel, demonstrating a 4.5-fold sensitivity enhancement. Spiked recoveries across diverse food matrices (rice, pork, bean sprouts, and juice) ranged from 92.48% to 116.42%, with relative standard deviations ≤ 5.54%. This dual-readout strategy offers mutual validation and broad applicability for food safety monitoring.

PMID 43009655
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