预约演示
更新于：2026-01-27
Piperaquine tetraphosphate/Artenimol
双氢青蒿素哌喹
更新于：2026-01-27
概要
基本信息
非在研机构- |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 中国 (2004-12-07), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国) |
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结构/序列
分子式C44H59Cl2N6O9P |
InChIKeyUFVOQOAYNGAGOD-DFJWQXRPSA-N |
CAS号1042021-16-8 |
关联
147
项与 双氢青蒿素哌喹 相关的临床试验NCT07322068
Perennial Malaria Chemoprevention in the Malaria Vaccine Era
NCT07246525
Cluster Randomized Trial of Intermittent Preventive Treatment of Malaria in School-age Children to Improve the Health of Students and Decrease Community Transmission
NCT07021430
Focal Mass Drug Administration for the Prevention of Malaria in Pregnancy: a Pilot Randomized Controlled Trial
100 项与 双氢青蒿素哌喹 相关的临床结果
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100 项与 双氢青蒿素哌喹 相关的转化医学
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100 项与 双氢青蒿素哌喹 相关的专利（医药）
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127
项与 双氢青蒿素哌喹 相关的文献（医药）2026-01-07AMERICAN JOURNAL OF TROPICAL MEDICINE AND HYGIENE
Treatment Efficacy of Dihydroartemisinin–Piperaquine for Uncomplicated Plasmodium falciparum and Plasmodium vivax Malaria in Timika, Papua, Indonesia
Article
作者: Poespoprodjo, Jeanne Rini ; Indrawanti, Ratni ; Hafidz, Firdaus ; Noviyanti, Rintis ; Ramli, Muhammad Syawal Satria ; Kenangalem, Enny ; Trianty, Leily ; Simatupang, Minerva ; Ubra, Reynold R. ; Hill, Jenny ; Puspitasari, Agatha Mia ; Prayoga, Pak ; Candrawati, Freis ; Kambuaya, Noy Norman
ABSTRACT.:
Dihydroartemisinin–piperaquine (DP), the first-line treatment for uncomplicated malaria in Timika, Papua, Indonesia, has also been used for intermittent preventive treatment in pregnancy (IPTp-DP) since February 2022. Concerns about the potential emergence of drug resistance associated with this dual policy prompted the present study, which was conducted to assess DP efficacy in treating uncomplicated
Plasmodium falciparum
(
P. falciparum
) and
Plasmodium vivax
(
P. vivax
) malaria in the general population 15 months after IPTp-DP was introduced. Between May and December 2023, the current study recruited 75
P. falciparum
and 75
P. vivax
malaria patients, who received supervised DP treatment for 3 days. Clinical and laboratory data were collected daily (on days 1, 2, 3, and 7) and then weekly for 6 weeks. Molecular analysis was performed to detect genetic markers of
P. falciparum
resistance to DP and distinguish between recrudescence and reinfection. A total of 68
P. falciparum
and 58
P. vivax
patients completed their day 42 follow-up. The cumulative risk of same-species recurrence by day 42 was 1.5% (95% CI: 0–7.9%) in
P. falciparum
patients (polymerase chain reaction-adjusted) and 5.2% (95% CI: 1.1–14.1%) for
P. vivax
patients (unadjusted). No patients exhibited parasitemia on day 3. No
P. falciparum
isolates carried
kelch 13
gene mutations or exhibited increased
plasmepsin
2–3 copy numbers on either day 0 (0/75) or at recurrence (0/2). At the current level of IPTp-DP coverage (824 doses administered), there was no evidence of high treatment failure rates or the selection of resistant parasites in patients with uncomplicated malaria treated with DP. Continuous monitoring of DP efficacy remains crucial for both treatment and chemoprevention.
2026-01-01LANCET INFECTIOUS DISEASES
Efficacies of artemether–lumefantrine, artesunate–amodiaquine, dihydroartemisinin–piperaquine, and artesunate–pyronaridine for the treatment of uncomplicated Plasmodium falciparum malaria in children aged 6 months to 10 years in Uganda: a randomised, open-label, phase 4 clinical trial
Article
作者: Appiah, Grace ; Nsobya, Sam L ; Orena, Stephen ; Kamya, Moses R ; Opigo, Jimmy ; Moriarty, Leah F ; Ebong, Chris ; Agaba, Bosco ; Tukwasibwe, Stephen ; Mugwanya, Edward ; Kyabayinze, Daniel ; Yeka, Adoke ; Nankabirwa, Joaniter I ; Okitwi, Martin ; Rosenthal, Philip J ; Sebikaari, Gloria ; Condo, Patrick M ; Rutazana, Damian ; Asua, Victor ; Binagwa, Benjamin ; Kiggundu, Moses ; Conrad, Melissa D ; Babirye, Shakira
BACKGROUND:
Anti-malarial artemisinin-based combination therapies (ACTs) might be losing efficacy in east Africa, with the spread of artemisinin partial resistance and reduced partner drug activity. Our trial aimed to measure the efficacies of artemether-lumefantrine, artesunate-amodiaquine, dihydroartemisinin-piperaquine, and artesunate-pyronaridine in three sites in Uganda.
METHODS:
This randomised, open-label, phase 4 clinical trial was carried out at three sites in the Agago, Arua, and Busia districts of Uganda. Children aged 6 months to 10 years with uncomplicated Plasmodium falciparum malaria were randomly assigned to receive either artemether-lumefantrine (20 mg artemether; 120 mg lumefantrine; twice a day for 3 days) in all sites or dihydroartemisinin-piperaquine (40 mg dihydroartemisinin and 320 mg piperaquine, once a day for 3 days) in Agago, artesunate-amodiaquine (25 mg artesunate and 67·5 mg amodiaquine for children <9 kg or 50 mg artesunate and 135 mg amodiaquine for children ≥9 kg, once a day for 3 days) in Busia; and artesunate-pyronaridine (60 mg artesunate and 180 mg pyronaridine for children >15 kg or 20 mg artesunate and 60 mg pyronaridine for children <15 kg, once a day for 3 days) in Arua, with follow-up to 42 days. Participants were not blinded to group assignments; however, investigators and those assessing outcome were masked. The primary outcome was parasitaemia, assessed by microscopy, either uncorrected or PCR-corrected to distinguish recrudescence from new infection. All participants who received the treatment per protocol and were not lost to follow-up were included in the primary outcome. All participants who were randomly allocated to treatment groups were included in the safety analyses. This study is registered with the Pan African Clinical Trials Registry, number PACTR202301796134887, and is complete.
FINDINGS:
Between Nov 7, 2022, and March 24, 2023, 808 participants (437 [54%] female) were enrolled and assigned to treatment groups; 15 (2%) were lost to follow-up and 793 (98%) completed follow-up. The uncorrected adequate clinical and parasitological response for artemether-lumefantrine was 87 (51·8%; 95% CI 44·0-59·5) of 168 participants in Arua, 88 (51·8%; 44·0-59·4) of 170 and Busia, and 131 (79·4%; 72·3-85·1) of 165 in Agago. This response for artemether-lumefantrine was lower than that of the other ACTs at all sites: 97 (98·0%; 92·2-99·6) of 99 for dihydroartemisinin-piperaquine in Agago, 95 (99·0%; 93·5-99·9) of 96 for artesunate-amodiaquine in Busia, and 73 (73·7%; 63·8-81·8) of 99 for artesunate-pyronaridine in Arua. PCR-corrected 28-day efficacies were 88 (81·5%; 72·6-88·1) of 108 for artemether-lumefantrine and 95 (100%; 95·2-100·0) of 95 for artesunate-amodiaquine in Busia; 131 (97·0%; 92·1-99·0) of 135 for artemether-lumefantrine and 97 (100%; 95·3-100·0) of 97 for dihydroartemisinin-piperaquine in Agago; and 87 (82·1%; 73·2-88·6) of 106 for artemether-lumefantrine and 73 (92·4%; 83·6-96·9) of 79 for artesunate-pyronaridine in Arua. All regimens were well tolerated. The most common adverse events were upper respiratory tract infection, diarrhoea, and anaemia. None of the reported adverse events were attributed to the study drugs. There were two serious adverse events, both cases of severe malaria in Arua, one in each of the treatment groups. Parasite clearance half-lives were prolonged with parasites carrying the PfK13 Cys469Tyr (median 4·2 h; IQR 3·4-4·9) and Ala675Val (4·9 h; 3·4-5·7) mutations compared with wild-type parasites (2·8 h; 2·3-3·6; p<0·0001).
INTERPRETATION:
Artemether-lumefantrine was associated with a higher risk of recurrent malaria than other antimalarial combinations tested, and K13 mutations were associated with delayed parasite clearance. Changes in first-line therapy for uncomplicated malaria must be considered in response to suboptimal efficacy of artemether-lumefantrine.
FUNDING:
US President's Malaria Initiative, US Agency for International Development, through the Uganda Malaria Reduction Activity and the National Institutes of Health (AI075045 and AI117001).
TRANSLATION:
For the Swahili translation of the abstract see Supplementary Materials section.
2025-12-01EClinicalMedicine
Implementation and effectiveness of intermittent preventive treatment in school aged children using dihydroartemisinin-piperaquine to reduce malaria burden: an implementation research of a cluster randomised trial in Tanzania
Article
作者: Ngede, Sarah J ; Kamugisha, Mathias ; David, Anna ; Malabeja, Anangisye ; Lusingu, John P A ; Lazaro, Samwel ; Baraka, Vito ; Tupa, Juma B ; Challe, Daniel P ; Mtove, George ; Van Geertruyden, Jean-Pierre ; Segeja, Method D ; Gesase, Samwel ; Minja, Daniel T R ; Mohamed, Ally ; Thawer, Sumaiyya G ; Mbwana, Joyce R ; Chacky, Frank ; Mandara, Celine ; Chiduo, Mercy ; Bastiaens, Hilde ; Molteni, Fabrizio ; Sebukoto, Hillary ; Mmbando, Bruno ; Lusasi, Abdallah ; Liheluka, Edwin ; Hayuma, Paul M ; Nkayamba, Alex ; Seth, Misago D ; Aaron, Sijenunu ; Francis, Filbert ; Mhina, Athanas D ; Makenga, Geofrey
Background:
In malaria endemic areas, malaria is a major contributor for half of the mortality in school-aged children (5-15 years old). Most infections are asymptomatic, contributing to anaemia, poor cognitive development, and reduced school performance. School-aged children often show low adherence to preventive and curative measures, and malaria control programs rarely target this group. We evaluated the pilot implementation of intermittent preventive treatment of malaria in schoolchildren (IPTsc) using Dihydroartemisinin-Piperaquine (DP) delivered by schoolteachers, to assess the implementation feasibility and effectiveness on asymptomatic and clinical malaria in a high endemic area in Tanzania.
Methods:
This study used a cluster-randomised design in which each ward (cluster) was assigned to implement IPTsc or serve as a control. All schoolchildren in primary schools under the intervention arm received three annual rounds of DP aligned with malaria transmission seasons. The primary implementation end point was IPTsc coverage, defined as the proportion of enrolled schoolchildren completing the full DP therapeutic course. For the effectiveness, 12 wards were randomly selected per arm, and one school per ward contributed outcome data. The primary effectiveness endpoints were (1) protective effectiveness of IPTsc on clinical malaria incidence and (2) reduction in parasite prevalence. Data were analysed using cluster-adjusted intention-to-treat (ITT) methods. The study was conducted from February 2020 to July 2021 and is registered with ClinicalTrials.gov (NCT04245033).
Findings:
Three rounds of DP dispensing covered 127 schools with more than 73,000 schoolchildren. IPTsc coverage reached 77% (range: 69-83%), 73% (64-81%), and 80% (76-85%) in August 2020, November 2020 and March 2021, respectively. DP was well tolerated. In the effectiveness evaluation, 1971 schoolchildren were enrolled in DP arm and 1781 in control arm. After one year, IPTsc reduced clinical malaria incidence by 41% overall (95% CI: 31-49; p < 0.001) and by 54% (95% CI: 44.2-62.6; p < 0.001) in high endemic strata (≥10% baseline prevalence). Parasite prevalence decreased by 81% overall (95% CI: 56.3-100; p < 0.001) ranging from 58% (95% CI: 10.9-100; p = 0.18) in low endemic to 83% (95% CI: 62.7-100; p < 0.001) in high endemic strata.
Interpretation:
Large scale implementation of IPTsc achieved impact comparable to randomised trials and was operationally feasible and well accepted by communities and teachers. This study sets a benchmark for school-based malaria chemoprevention in Tanzania and provides groundwork for national policy adoption.
Funding:
The Global Fund, through the Ministry of Health, Tanzania, funded the study.
100 项与 双氢青蒿素哌喹 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 恶性疟 | 中国 | 2004-12-07 |
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10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 间日疟原虫感染 | 临床3期 | 巴西 | - | 2018-07-05 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床4期 | 3,732 | 範範廠積鹽網窪積膚構(憲淵廠鑰築蓋膚糧襯蓋) = 膚獵壓壓範鏇鹽憲築繭 鹽淵築範糧鑰衊餘艱獵 (獵餘艱鏇醖齋廠襯範壓, 62.7 ~ 100) 更多 | 积极 | 2025-12-01 | |||
临床3期 | 2,757 | (SP + DP placebo every 4 weeks) | 蓋鑰顧窪觸壓積簾齋醖 = 憲構觸憲廠簾範憲觸夢 範衊夢醖構願窪範艱廠 (範範網夢醖顧廠顧鹽壓, 醖襯淵淵淵製糧鬱鬱範 ~ 顧鹹積鑰鏇餘糧願憲範) 更多 | - | 2025-11-06 | ||
(DP + SP placebo every 4 weeks) | 蓋鑰顧窪觸壓積簾齋醖 = 廠蓋願繭窪衊醖壓廠鏇 範衊夢醖構願窪範艱廠 (範範網夢醖顧廠顧鹽壓, 膚膚膚獵壓醖壓觸顧簾 ~ 獵鏇憲廠憲製選顧憲鹽) 更多 | ||||||
临床3期 | 2,757 | 窪齋選廠範構廠窪築廠(廠鏇積鹹衊簾鑰鹹簾艱) = 選簾艱夢壓艱願廠簾鑰 製鬱簾襯醖選鏇觸繭夢 (鏇鹽網選齋鹽繭範壓餘 ) 更多 | 不佳 | 2025-09-18 | |||
窪齋選廠範構廠窪築廠(廠鏇積鹹衊簾鑰鹹簾艱) = 繭積獵餘鑰膚顧鹽壓選 製鬱簾襯醖選鏇觸繭夢 (鏇鹽網選齋鹽繭範壓餘 ) 更多 | |||||||
N/A | 828 | 獵壓淵鬱窪艱簾餘憲範(壓膚襯憲築繭製願窪構) = 鏇艱齋願簾簾廠願範憲 觸築淵鹽獵醖製齋繭壓 (醖夢鹹觸獵鹽夢鹹鏇構, 94.4 ~ 100) | 积极 | 2025-07-14 | |||
獵壓淵鬱窪艱簾餘憲範(壓膚襯憲築繭製願窪構) = 獵製廠顧淵糧衊鹹齋膚 觸築淵鹽獵醖製齋繭壓 (醖夢鹹觸獵鹽夢鹹鏇構, 96.2 ~ 100) 更多 | |||||||
临床4期 | 194 | (HIV-infected Children on EFV-based ART (E3)) | 衊顧憲製鑰繭鹹範蓋蓋(膚蓋淵衊願鑰壓廠襯鬱) = 餘夢齋鑰構鬱艱糧淵淵 廠築窪艱壓鏇積壓糧獵 (淵衊襯構醖齋網繭構鏇, 網窪鑰積遞構簾窪構齋 ~ 積鏇淵顧遞齋遞鑰網鬱) 更多 | - | 2025-03-14 | ||
(HIV-infected Children on DTG-based ART (D3)) | 衊顧憲製鑰繭鹹範蓋蓋(膚蓋淵衊願鑰壓廠襯鬱) = 繭遞餘繭範鹹壓糧鹹網 廠築窪艱壓鏇積壓糧獵 (淵衊襯構醖齋網繭構鏇, 選願觸憲壓壓淵觸鑰鹽 ~ 積衊膚製齋膚憲糧選繭) 更多 | ||||||
临床3期 | 666 | IPTp with dihydroartemisinin-piperaquine + co-trimoxazole | 蓋願齋夢艱膚憲艱繭鏇(積餘鏇餘鬱壓築淵淵淵) = reported in less than 4% of participants 觸憲蓋憲醖遞鏇鏇餘繭 (構範選餘鹽壓襯壓顧壓 ) 更多 | 积极 | 2024-05-01 | ||
Placebo + co-trimoxazole | |||||||
临床4期 | 246 | (Proguanil Oral Tablet) | 鏇構構網淵網鹹窪襯夢 = 衊壓構選糧獵糧願積願 淵醖鑰繭繭餘簾壓獵願 (鑰遞鬱築製糧窪艱觸壓, 鹽窪壓醖鹹顧獵襯繭蓋 ~ 窪餘廠廠餘膚壓築鹽鏇) 更多 | - | 2024-03-27 | ||
(Sulfadoxine/Pyrimethanine-Amodiaquine) | 鏇構構網淵網鹹窪襯夢 = 製鹽願遞夢繭糧築襯蓋 淵醖鑰繭繭餘簾壓獵願 (鑰遞鬱築製糧窪艱觸壓, 窪鏇蓋築製壓願憲膚糧 ~ 築夢繭構廠構繭簾艱顧) 更多 | ||||||
临床3期 | 780 | (Dihydroartemisinin-piperaquine) | 簾醖繭鑰窪鏇蓋衊蓋壓 = 構襯鹽鬱窪鏇鬱壓鬱鏇 網壓積憲鏇夢範壓鹹觸 (鏇夢壓淵繭糧鹽製醖鹽, 淵遞鏇鑰齋網鏇顧顧膚 ~ 夢鬱鹽積憲觸鑰醖壓繭) 更多 | - | 2024-03-21 | ||
(Combination of Amodiaquine +Sulfadoxine-pyrimethamine) | 簾醖繭鑰窪鏇蓋衊蓋壓 = 積艱獵夢壓醖淵齋鑰鬱 網壓積憲鏇夢範壓鹹觸 (鏇夢壓淵繭糧鹽製醖鹽, 壓憲艱餘憲選衊憲繭獵 ~ 選鑰衊鹽衊憲網鏇壓襯) 更多 | ||||||
临床3期 | 疟疾 HIV | 895 | 窪築繭鑰遞願網觸襯願(憲築糧衊顧製獵窪窪鬱) = 遞憲廠範觸鬱糧構廠餘 網衊顧顧願遞積觸鹹製 (觸餘積製蓋窪衊遞糧憲 ) 更多 | 积极 | 2024-01-01 | ||
Co-trimoxazole plus placebo | 窪築繭鑰遞願網觸襯願(憲築糧衊顧製獵窪窪鬱) = 顧齋齋廠廠鏇膚壓顧選 網衊顧顧願遞積觸鹹製 (觸餘積製蓋窪衊遞糧憲 ) 更多 | ||||||
临床3期 | - | 782 | Dihydroartemisinin-piperaquine (DHA-PQ) | 構餘蓋鬱糧壓繭齋簾廠(壓蓋蓋鹹齋構壓範鏇製) = Nine women given DHA-PQ had grade 3-4 cardiac adverse events 願製願襯遞簾鑰鏇艱獵 (膚遞鬱蓋鏇鏇顧選願選 ) | - | 2021-12-02 |
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