A Multicenter, Prospective, Randomized, Open-label Phase 2b Study, with Blinded Evaluation, Comparing the Combination of Amodiaquine and Potassium Canrenoate with Either Exenatide or Glibenclamide Versus Best Medical Therapy, in Patients with Acute Ischemic Stroke

Start Date01 Dec 2025

Sponsor / Collaborator-

NCT06173206

/ CompletedPhase 3IIT

Effect of Single-course Malaria Chemoprevention on Clearance of and Protection from Plasmodium Falciparum Infection in the Presence of Resistance-associated Genotypes in Cameroon

The Cameroon PCPI study will measure the effect of the parasite genotypes associated with SP resistance on parasite clearance and protection from infection when exposed to SP. The total number of participants is expected to be 900 healthy between 3 to 5 years old who have no symptoms of malaria infection of which 450 children will be assigned to the SP group, 250 to the SPAQ group, and 200 to the AS group. The results of this study will allow to measure the effect of the parasite genotypes associated with SP resistance on parasite clearance and protection from infection when exposed to SP.

Start Date10 Jun 2024

Sponsor / Collaborator

London School of Hygiene & Tropical Medicine

NCT06337253

/ Not yet recruitingPhase 4IIT

Seasonal Malaria Chemoprevention Rapid Assessment Study Mozambique

Seasonal malaria chemoprevention (SMC) is a highly effective community-based intervention to prevent malaria infections caused by Plasmodium falciparum in areas where the burden of malaria is high and malaria transmission is seasonal. SMC is commonly seen as a success story in the Sahel region, however, there are regions in east and southern Africa where malaria transmission is seasonal, and the burden is high. However, the same decision-making frameworks that was used in the Sahel are unlikely to be applicable to east and southern Africa due to higher pre-existing resistance to the drugs used, seasonality heterogeneity, contextual difference, and unknown cost-effectiveness, amongst others. This study aims to estimate the chemoprevention efficacy, potential upscale impact, acceptability, and feasibility of SMC with sulfadoxine-pyrimenthamine + amodiaquine (SP+AQ) medicines in Niassa Province in Mozambique.
The study is divided into two separate components with different objectives which outputs feed into each other: a non-randomized controlled trial to estimate the chemoprevention efficacy of SP+AQ; and a qualitative study that will evaluate the feasibility and acceptability of the intervention.
These will be the first studies analysing the chemoprevention efficacy, feasibility, acceptability, and potential scale-up impact of SMC in Niassa Province, Mozambique The outcomes of these studies aim to guide future policy changes at local, national, and international levels and potentially allow for a historically successful program to expand in a sustained and cost-effective way beyond the Sahel region.

Start Date26 Mar 2024

Sponsor / Collaborator

Malaria Consortium

100 Clinical Results associated with Amodiaquine Hydrochloride

100 Translational Medicine associated with Amodiaquine Hydrochloride

100 Patents (Medical) associated with Amodiaquine Hydrochloride

2,260

Literatures (Medical) associated with Amodiaquine Hydrochloride

03 Feb 2026·AMERICAN JOURNAL OF TROPICAL MEDICINE AND HYGIENE

Efficacy and Safety of Artesunate + Amodiaquine and Artemether + Lumefantrine for the Treatment of Uncomplicated Plasmodium falciparum Malaria in Madagascar, 2020

Article

Author: Randriamiarinjatovo, Dina Ny Aina Liantsoa ; Randrianarivelojosia, Milijaona ; Svigel, Samaly Souza ; Irinantenaina, Judickaelle ; Patel, Dhruviben ; Rakotomanga, Tovonanahary Angelo ; Andriamananjara, Mauricette Nambinisoa ; Razanatsiorimalala, Seheno ; Razafindrakoto, Jocelyn ; Harimanana, Aina ; Abdallah, Rispah A. ; Moriarty, Leah F. ; Laird, Veronica ; Razafinjato, Celestin ; Zhiyong, Zhou ; Kapesa, Laurent ; Rason, Marie Ange ; Ralinoro, Fanomezantsoa

ABSTRACT.:

The efficacy of artesunate + amodiaquine (ASAQ) and artemether + lumefantrine (AL) for treating malaria was investigated in Madagascar in 2020. A randomized parallel-group study was conducted at four health centers (Antsenavolo, Vohitromby, and Matanga in the southeastern region and Ankazomborona in the northwestern region). The therapeutic efficacy and safety of ASAQ and AL were assessed using the WHO protocol, with a 28-day follow-up period. Children aged 6 months to 14 years with uncomplicated Plasmodium falciparum ( P. falciparum ) malaria were randomly assigned to receive either ASAQ or AL. Genotyping assays for the pfK13 gene were conducted on P. falciparum isolates obtained from dry blood samples collected on Day 0. Of 765 enrolled patients, 709 (92.7%) reached the study endpoint. Among the per-protocol population, crude adequate clinical and parasitological response (ACPR) rates were 99%, 99%, 100%, and 100% for Antsenavolo, Vohitromby, Matanga, and Ankazomborona, respectively, in the ASAQ group and 98%, 91%, 90%, and 100% for the same locations, respectively, in the AL group. Polymerase chain reaction-corrected ACPR rates were 100% for the ASAQ group at all study sites, whereas for the AL group, they were 98.8% in Antsenavolo, 97.6% in Vohitromby, 100% in Matanga, and 100% in Ankazomborona. Day 3 slide positivity rates were 0%, 1%, 1%, and 0% for Antsenavolo, Vohitromby, Matanga, and Ankazomborona, respectively. During follow-up, mild and moderate adverse events, including gastrointestinal issues (abdominal pain and vomiting) and headache, were reported in 10.2% (72/709) of patients. Of 727 samples successfully analyzed for pfK13 , no mutation associated with artemisinin resistance was observed. The study results reveal that ASAQ and AL remain safe and efficacious for treating uncomplicated P. falciparum malaria in Madagascar.

01 Feb 2026·BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Population pharmacokinetics of artemether–lumefantrine plus amodiaquine in patients with uncomplicated Plasmodium falciparum malaria

Article

Author: Joel Tarning ; Thomas J. Peto ; Chanaki Amaratunga ; Sukanta Das ; Mayfong Mayxay ; Marie A. Onyamboko ; Junjie Ding ; Nicholas P. J. Day ; Anupkumar R. Anvikar ; James J. Callery ; Nguyễn Hoàng Châu ; M. Abul Faiz ; Caterina Fanello ; Rupam Tripura ; Richard M. Hoglund ; Cholrawee Promnarate ; Nicholas J. White ; Frank Smithuis ; Arjen M. Dondorp ; Mavuto Mukaka ; Lek Dysoley ; Lorenz von Seidlein ; Mehul Dhorda ; Rob W. van der Pluijm ; Ho Dang Trung Nghia

Aims:

Resistance to the artemisinins and the artemisinin‐based combination therapy (ACT) partner drugs has developed in Southeast Asia, and artemisinin resistance has also emerged in eastern Africa. Triple ACTs (triple artemisinin‐based combination therapies, TACT), consisting of two partner drugs with different mechanisms of action and similar pharmacokinetic profiles, combined with an artemisinin derivative can help to delay or prevent artemisinin resistance and prolong the useful lifetime of the partner drugs. This study aims to characterize the pharmacokinetic properties of a recommended TACT, artemether‐lumefantrine plus amodiaquine, using data from two large clinical trials.

Methods:

We analysed data from two randomized, controlled intervention trials conducted between 2015 and 2020 in one African country and two Southeast Asian countries, in which artemether‐lumefantrine was administered alone ( n = 443) or together with amodiaquine ( n = 442) to patients with uncomplicated P . falciparum malaria. Both studies included a sub‐cohort with dense pharmacokinetic sampling, combined with sparse data in the other patients. Concentration–time data of artemether, dihydroartemisinin, lumefantrine, desbutyllumefantrine, amodiaquine and desethylamodiaquine were analysed using nonlinear mixed‐effects modelling.

Results:

Pharmacokinetic models were developed for all drugs and demonstrated good predictive performance and goodness‐of‐fit diagnostics. Coadministered amodiaquine was not a significant covariate on pharmacokinetic properties of artemether‐lumefantrine. Model‐predicted Cmax and AUC (median [95% confidence interval, CI]) for artemether were 256 (159–407) ng/mL and 2850 (1820‐4920) h·ng/mL for artemether‐lumefantrine alone, and 230 (123–391) ng/mL and 2800 (1570‐4570) h·ng/mL for artemether‐lumefantrine‐amodiaquine. For dihydroartemisinin, values were 135 (54.5–214) ng/mL and 1870 (813–3015) h·ng/mL for artemether‐lumefantrine alone, and 116 (40.8–186) ng/mL and 1580 (547–2680) h·ng/mL for artemether‐lumefantrine‐amodiaquine. For lumefantrine, values were 15.2 (2.90–31.3) μg/mL and 600 (275–1230) h·μg/mL for artemether‐lumefantrine alone, and 14.1 (2.72–31.4) μg/mL and 586 (269–1070) h·μg/mL for artemether‐lumefantrine‐amodiaquine. Day 7 concentrations of lumefantrine were 452 (215–1240) and 438 (204–1030) μg/mL for artemether‐lumefantrine alone and artemether‐lumefantrine‐amodiaquine, respectively. All geometric mean ratios (GMRs) for the drug–drug interaction (DDI) effect on key pharmacokinetic parameters of artemether, dihydroartemisinin and lumefantrine fell within the 0.80–1.25 range, with the majority of the corresponding 90% CI also contained within this range. This indicates no clinically relevant DDIs between artemether‐lumefantrine and amodiaquine.

Conclusions:

The DDI effect of amodiaquine on the pharmacokinetics of artemether‐lumefantrine is expected to be minimal, the based on the current analysis. However, further large‐scale clinical trials are needed to confirm this finding.

01 Feb 2026·YAKUGAKU ZASSHI-JOURNAL OF THE PHARMACEUTICAL SOCIETY OF JAPAN

Elucidation of a Novel Protective Function of AADAC Against Drug-induced Liver Injury through Ferroptosis Suppression

Review

Author: Fukami, Tatsuki

Drug-induced liver injury (DILI) remains a major cause of drug withdrawal from the market, and safety concerns in clinical settings. Reactive metabolites, primarily produced by cytochrome P450 enzymes, are known to induce oxidative stress and hepatotoxicity through covalent binding to macromolecules and the generation of reactive oxygen species. Recent evidence suggests that ferroptosis, an iron-dependent form of lipid peroxidation-mediated cell death, is involved in DILI triggered by compounds such as carbon tetrachloride (CCl₄) and acetaminophen (APAP). Arylacetamide deacetylase (AADAC), a hepatic hydrolase previously recognized for its role in drug metabolism, has recently been implicated in tumor suppression and ROS regulation in cancer cells. In this study, our group explored whether AADAC exerts a protective effect against ferroptosis-associated liver injury. Using Aadac knockout (KO) mice, we demonstrated that CCl₄, APAP, and amodiaquine induced more severe liver damage in the absence of Aadac, with elevated ferrous (Fe²⁺) levels, lipid peroxidation, and oxidative stress. We identified that Aadac interacts with ceruloplasmin, a ferroxidase that converts Fe²⁺ to ferric (Fe³⁺), thereby limiting ferroptosis. Notably, this function of Aadac was independent of its enzymatic activity. Furthermore, human AADAC overexpression in Huh-7 cells similarly reduced intracellular Fe²⁺ levels and conferred protection against CCl₄-induced cytotoxicity in a ceruloplasmin-dependent manner. These findings reveal a novel, non-catalytic role for AADAC in iron homeostasis and ferroptosis suppression, suggesting its clinical significance in DILI susceptibility and therapy.

News (Medical) associated with Amodiaquine Hydrochloride

26 Apr 2024

·www.prnewswire.com

Fosun Pharma's Self-developed Artemisinin Medicines Inject New Impetus to Malaria Prevention and Treatment in Africa

SHANGHAI, April 26, 2024 /PRNewswire/ -- World Malaria Day is marked each year on April 25. World Health Organization (WHO) gave as the theme for World Malaria Day 2024 Accelerating the fight against malaria for a more equitable world. WHO stated that malaria not only continues to directly endanger health and cost lives, but it also perpetuates a vicious cycle of inequity. People living in the most vulnerable situations including pregnant women and children under 5 years of age continue to be disproportionately impacted. Artemisinin medicines developed with China's scientific research efforts have become a ticket for China's innovative medicines to go global. According to the WHO World Malaria Report 2023, globally in 2022, there were an estimated 249 million malaria cases and 608,000 malaria deaths. Sub-Saharan Africa accounted for more than 95% of the global malaria cases and deaths. Globally, an estimated 11.7 million malaria deaths were averted in the period 2000-2022. Among them, the average malaria mortality rate (number of deaths per 100,000 population at risk) in Africa decreased from 0.14% per 100,000 population to 0.055%, from 142.6 per 100,000 population in 2020 to 55.5 in 2022. The widespread use of artemisinin medicines is one of the key success factors. Several global multi-center phase III clinical studies and real-world data have shown that artesunate injection is effective in reducing malaria mortality rate. Self-developed Artemisinin medicines covering from prevention to severe disease treatment As a leading global R&D and production enterprise of anti-malaria drugs, anti-malaria drugs produced under the R&D and innovation of Fosun Pharma cover malaria prevention, general malaria treatment and severe malaria treatment. A total of 33 products in the anti-malaria series were approved by WHO pre-qualification (WHO PQ), which have made significant contribution to malaria prevention and treatment in countries and regions such as Africa. In 2010, Artesun®, an artesunate for injection independently developed and manufactured by Fosun Pharma, was approved by WHO PQ. Since 2011, it has been recommended by WHO as a first-line drug for the treatment of severe malaria in children and adults. At the same time, Fosun Pharma is also a supplier of anti-malaria drugs of the Global Fund, UNICEF, WHO and African governments. By the end of 2023, Fosun Pharma has supplied over 340 million doses of artesunate for injection across the world, treating more than 68 million severe malaria patients worldwide. Meanwhile, Fosun Pharma went deep into the remote areas of African villages and meet the needs of clinicians through continuous innovation. Through process optimization, it has independently developed and launched the second generation of artesunate injection (trade name: Argesun®), which is the first one-step preparation passing the WHO PQ in the world. The preparation time of the drug was reduced from 3 minutes to 1 minute, which can save the time for treating patients with severe malaria. Meanwhile, the concentration of Argesun® was standardized for intravenous and intramuscular injections, which makes it more convenient and safer for clinical purposes. Artemisinin-based combination therapies (ACTs) are recognized by WHO as the best available treatment. However, in recent years, drug resistance to these therapies has also begun to emerge in Plasmodium falciparum, which is becoming a major threat to malaria control. The global multicenter Phase III clinical trial project led by Fosun Pharma for a triple artemisinin combination drug (Artemether-Lumefantrine-Amodiaquine fixed-dose formulation) against malaria in Africa and Southeast Asia has also received attention from all parties, and the Japan-based Global Health Innovative Technology Fund (GHIT Fund) announced in December 2023 that it will invest approximately US$3.3 million (approximately 500 million yen[1]), to accelerate the development and commercialization of this new drug. This drug candidate should have a significant public health benefit as it is expected to play an important role in the fight against artemisinin partial resistance (ART-R) which is now observed widely in the Greater Mekong Subregion (GMS) of Southeast Asia[2] and to some extent in several African countries, including Rwanda and Uganda. Further improving the accessibility of second generation of Artesunate for injection to benefit remote areas of Africa From April 21 to 27, the 8th Multilateral Initiative on Malaria (MIM) Pan-African Malaria Conference was held in Kigali-Rwanda. As one of the main sponsors of the conference, Fosun Pharma showcased its full range of antimalarial products and successfully hosted the academic symposium "Improving antimalarial treatment for severe P. falciparum malaria" on April 23. The symposium introduced the recent trends in the global and particularly African burden of severe malaria and the latest treatment and clinical management strategies to over 300 malaria researchers, clinicians, malaria control officials, and NGO representatives from Africa and around the world. The session was co-chaired by Professor Olugbenga A Mokuolu from Nigeria (Co-Chair of RBM Case Management Working Group; Strategic Adviser on Malaria Elimination to the Honorable Minister of Health Nigeria) and Professor Marielle Bouyou Akotet from the Université des Sciences de la Santé Gabon. Professor Arjen Dondorp and Professor Joel Tarning from the University of Oxford, and Dr. Samwel Gesase from the National Institute for Medical Research in Tanzania, respectively, presented the important contributions of injectable artesunate in the treatment of severe malaria patients from the epidemiological, clinical pharmacological, and pharmacoeconomic perspectives. They also highlighted the clinical advantages of Fosun Pharma's second-generation of artesunate injection with one-step preparation in the management of severe malaria. The 1.5 hours scientific session was ended by an introduction of the post-discharge malaria chemoprevention, PDMC by Professor Kamija Phiri from Kamuzu University of Health Sciences Malawi. The attendees highly appreciated the academic professionalism of Fosun Pharma's symposium on severe malaria and recognized Fosun Pharma's commitment to affordable innovation in bringing a new generation of artesunate injection with one-step preparation to Africa. The experts agreed that " artesunate injection is currently the most effective drug for the treatment of severe malaria. The new generation of artesunate injection with one-step preparation will further enhance the convenience of clinical use and reduce the clinical cost of severe malaria treatment, benefiting critically ill children with malaria in remote areas of Africa where medical conditions are poor." From treatment to prevention, effectively reducing the incidence of severe malaria in children According to the WHO, children under 5 years old are still the most vulnerable population to malaria infection. in 2022, an estimated 4 out of 5 malaria-related deaths in the African Region were among children under 5 years of age. Inequities in access to education and financial resources further exacerbates risk: children under 5 years of age from the poorest households in sub-Saharan Africa are 5 times more likely to be infected with malaria than those from the wealthiest households. To improve this situation, Fosun Pharma, in collaboration with the National Malaria Control Program in Africa, continued to carry out the "Promoting Malaria Prevention Knowledge among Children Program" in 14 malaria-prone countries in Africa, targeting at the community level, in order to raise the awareness of malaria prevention among the local population in Africa, and to help reduce the incidence rate of malaria and interrupt the transmission of malaria in the community. In August 2018, Fosun Pharma's SPAQ-CO® Disp (co-packed sulfadoxine-pyrimethamine dispersible tablets and amodiaquine dispersible tablets), for the prevention of malaria in children, was approved by WHO PQ . By the end of 2023, more than 258 million children in Africa had benefited from the "Seasonal Malaria Chemoprevention Program", for which SPAQ-CO® Disp is used as the core drug, effectively reducing the incidence of malaria in children under five years old in Africa. Promoting the localization of pharmaceutical production and helping to enhance the healthcare capacity of developing countries Based in China and with a global presence, Fosun Pharma has always been committed to providing high-quality medical solutions to patients worldwide. It actively expands its business in emerging markets, including Africa, India and Southeast Asia, to improve the accessibility of medicines in developing countries. By the end of 2023, Fosun Pharma had established five regional distribution centers in emerging markets. The overseas commercialization team consists of approximately 1,000 people, dedicated to enhancing the accessibility of pharmaceutical products. To achieve localized pharmaceutical manufacturing and supply in Africa and to enhance the accessibility and affordability of pharmaceutical and healthcare products in the African region, Fosun Pharma's Cote d'Ivoire park project was initiated in November 2022. The project is planned to be carried out in three phases, with the first phase expected to be completed in 2024. Upon completion of the project, the production capacity of the park will be expanded to 5 billion tablets per year and include a warehouse with a storage capacity of 10,000 pallets, which is expected to bring nearly 1,000 job opportunities to the Greater Bassam area and effectively promote the development of the pharmaceutical industry in Cote d'Ivoire. About Fosun Pharma Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* ("Fosun Pharma"; stock code: 600196. SH, 02196. HK) is a global innovation-driven pharmaceutical and healthcare industry group. Fosun Pharma directly operates businesses including pharmaceuticals, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business. Fosun Pharma is patient-centered and clinical needs-oriented. The company continuously enriches its innovative product pipeline through independent research and development, cooperative development, license-in, and in-depth incubation. Fosun Pharma improves the research and clinical development capabilities of FIC (First-in-class) and BIC (Best-in-class) new drugs as well as accelerates the R&D and launch of innovative technologies and products. Fosun Pharma's innovative products mainly covered core therapeutic areas such as tumors (solid tumors and hematologic tumors), immunology, central nervous system, and chronic diseases (liver disease/metabolism/kidney disease). Guided by the 4IN strategy (Innovation, Internationalization, Intelligentization, and Integration), Fosun Pharma will uphold the development model of "Innovation Transformation, Integrated Operation and Steady Growth", with the mission of creating shareholder values through strengthening its independent R&D and external cooperation and enriching its product pipelines, as well as promoting the global networks and enhancing operational efficiency. Fosun Pharma will actively promote the digital and physical business layout in the pharmaceutical and healthcare industry and is committed to becoming a first-class enterprise in the global pharmaceutical and healthcare markets. For more information, please visit our official website: SOURCE Fosun Pharma

Phase 3Drug Approval

14 Dec 2023

·www.prnewswire.com

Fosun Pharma's Global Multi-Center Phase III Clinical Trial Project for A New Antimalarial Drug Receives 500 Million Japanese Yen Investment from GHIT Fund to Jointly Improve the Global Accessibility of Antimalarial Drugs

SHANGHAI, Dec. 14, 2023 /PRNewswire/ -- The Japan-based Global Health Innovative Technology Fund (GHIT Fund) announced today that it will invest approximately US$3.3 million (approximately 500 million yen[1]) in a global multicenter Phase III clinical trial project (the "Program") led by Fosun Pharma for a triple artemisinin combination drug (Artemether-Lumefantrine-Amodiaquine fixed-dose formulation) against malaria in Africa and Southeast Asia, to accelerate the development and commercialization of this new drug. The Project will be jointly conducted by Fosun Pharma, a major Chinese pharmaceutical and healthcare company, Marubeni, a leading Japanese integrated trading and investment business conglomerate, a Thailand-based research collaboration of universities, Mahidol-Oxford Tropical Medicine Research Unit (MORU), and the product development partnership Medicines for Malaria Venture (MMV), which provides technical support and market access expertise. This is the first time GHIT Fund has invested in a research project led by a Chinese pharmaceutical company. This drug candidate should have a significant public health benefit as it is expected to play an important role in the fight against artemisinin partial resistance (ART-R) which is now observed widely in the Greater Mekong Subregion (GMS) of Southeast Asia[2] and to some extent in several African countries, including Rwanda and Uganda. Importantly, the project includes the development of a co-formulated child-friendly version, given that most malaria cases are in children[3]. Malaria is an infectious parasitic disease transmitted by mosquitos that affects approximately 250 million people annually and was responsible for approximately 620,000 deaths in 20213. Infection in the African region constitutes 95% of the total global malaria cases, and children under the age of 5 account for 80% of all malaria deaths in this region. The GHIT Fund invests in innovative drug development with the aim of contributing to global health through facilitating collaboration between Japanese and global institutions' technology and innovation to address these neglected infectious diseases. Wen Deyong, CEO of Fosun Pharma, said, "We are very pleased to work with GHIT Fund to promote the clinical research on this antimalarial innovator drug. The collaboration will accelerate the launch of this new drug so as to actively respond to the threat of artemisinin partial resistance and partner drug resistance of Plasmodium falciparum parasites and save more lives from malaria. Fosun Pharma is committed to further improving the accessibility and affordability of antimalarial drugs through continuous innovation and our global operational capabilities, so as to continuously strive for a malaria-free world." Dr. Osamu Kunii, CEO of the GHIT Fund, said "We are very excited to have Marubeni and FOSUN PHARMA as our new product development partners. It is an important step forward to invest in the development of antimalarial drugs in late-phase clinical trials to advance commercialization. The number of malaria cases and deaths in children under 5 years old is an urgent issue. This investment will make a significant contribution to reducing the burden of malaria globally, especially among young children." The antimalarial drug independently developed by Fosun Pharma has been used to treat more than 60 million patients with severe malaria worldwide The artemisinin based antimalaria medicines originated from China have made significant contributions to global malaria prevention and control. In Sub-Saharan Africa alone, about 240 million people benefit from artemisinin-based combination therapies every year. The artesunate for injection (Artesun®) independently developed by Fosun Pharma is the first-line treatment of severe malaria for both adults and children recommended by the WHO since 2011. It has become a well-known Chinese innovator drug in Africa and the world. So far, Artesun® has been used to treat more than 60 million patients with severe malaria worldwide, most of whom were African children under five years old. In June 2023, the second-generation artesunate for injection (Argesun®) independently developed by Fosun Pharma was prequalified by the WHO (WHO-PQ), becoming the first injectable artesunate presented with a single solvent system approved by WHO-PQ. It greatly improves the convenience of clinical use and is particularly practicable for remote areas in Africa with backward medical conditions to save more lives. Up to now, the product has been registered and marketed in 18 countries. The deployment of Fosun Pharma's new generation Argesun® has further improved the accessibility of high-quality antimalarial innovator drugs in Africa, providing a convenient solution for primary medical institutions to treat sever malaria patients and save lives. Fosun Pharma was therefore recognized on Fortune 2023 China's Most Admired Company List. Effectively reduce the incidence rate of severe malaria in children from treatment to prevention As an innovation-driven global pharmaceutical and health industry group, Fosun Pharma has independently developed innovative antimalarial products covering malaria prevention and treatment, as well as the rescue of critically ill patients. From "treatment" to "prevention", Fosun Pharma continues to provide more prevention and treatment solutions for malaria patients, especially children. In August 2018, Fosun Pharma's SPAQ-CO® Disp (co-packed sulfadoxine-pyrimethamine dispersible tablets and amodiaquine dispersible tablets), for the prevention of malaria in children, was prequalified by WHO. Fosun Pharma has actively carried out community-oriented "Child Malaria Prevention Knowledge Popularization Projects" in 14 malaria-endemic countries in Africa. These projects aim to enhance local awareness of malaria prevention among African populations, thus helping to reduce the incidence of malaria and interrupt community transmission of the disease. By the end of June 2023, more than 245 million children in Africa had benefited from the "Seasonal Malaria Chemoprevention Program", for which SPAQ-CO® Disp is used as the core drug, effectively reducing the incidence of malaria in children under five years old in Africa. About GHIT Fund The GHIT Fund is a Japan-based international public-private partnership (PPP) fund that was formed between the Government of Japan, multiple pharmaceutical companies, the Bill & Melinda Gates Foundation, Wellcome, and the United Nations Development Programme (UNDP). The GHIT Fund invests in and manages an R&D portfolio of development partnerships aimed at addressing neglected diseases, such as malaria, tuberculosis, and neglected tropical diseases, which afflict the world's vulnerable and underserved populations. In collaboration with global partners, the GHIT Fund mobilizes Japanese industry, academia, and research institutes to create new drugs, vaccines, and diagnostics for malaria, tuberculosis, and neglected tropical diseases. About Fosun Pharma Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* ("Fosun Pharma"; stock code: 600196. SH, 02196. HK) is a global innovation-driven pharmaceutical and healthcare industry group. Fosun Pharma directly operates businesses including pharmaceuticals, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business. Fosun Pharma is patient-centered and clinical needs-oriented. The company continuously enriches its innovative product pipeline through independent research and development, cooperative development, license-in, and in-depth incubation. Fosun Pharma improves the research and clinical development capabilities of FIC (First-in-class) and BIC (Best-in-class) new drugs as well as accelerates the R&D and launch of innovative technologies and products. Guided by the 4IN strategy (Innovation, Internationalization, Intelligentization, and Integration), Fosun Pharma will uphold the development model of "Innovation Transformation, Integrated Operation and Steady Growth", with the mission of creating shareholder values through strengthening its independent R&D and external cooperation and enriching its product pipelines, as well as promoting the global networks and enhancing operational efficiency. Fosun Pharma will actively promote the digital and physical business layout in the pharmaceutical and healthcare industry and is committed to becoming a first-class enterprise in the global pharmaceutical and healthcare markets. For more information, please visit our official website: . SOURCE Fosun Pharma

Phase 3Drug Approval

08 Nov 2023

·www.fiercepharma.com

Strides African unit nabs WHO first with nod to produce malaria treatment

Global malaria cases have been on the rise in recent years, according to the World Health Organization. Universal Corporation Limited, a unit of Strides Pharma Science, became the first African drug manufacturer to snare a World Health Organization (WHO) pre-qualification (PDF) to produce the anti-malarial drug sulfadoxine-pyrimethamine and amodiaquine (SPAQ). The treatment is a combination regimen used to prevent malaria in children living in areas with seasonal malaria transmission. The WHO's pre-qualification program is designed to set standards of quality, safety and efficacy in manufacturing medicines. With the designation, Kenya-based UCL will look to boost regional production and access to essential medicines on the African continent, where about 95% of all malaria cases and 96% of deaths from malaria occur, the company said in a Nov. 6 press release. “Universal Corporation is committed to advancing the fight against malaria and improving the health and well-being of communities across Africa,” Perviz Dhanani, founder and managing director of UCL, said in the release. “The WHO prequalification of our SPAQ production is a significant step forward in achieving these goals.” In 2022, WHO began to recommend SPAQ for any child at high risk of severe malaria in areas with seasonal malaria transmission. This recommendation resulted in more than 48 million children being protected from malaria, significantly reducing the burden of this deadly disease, the organization said. According to WHO, the reported cases of malaria hit 247 million in 2021, compared with 245 million in 2020 and 232 million in 2019. In an unrelated but recent move, Strides in September said it planned to spin off its CDMO and soft gelatin businesses into a single entity that will be known as OneSource. The goal of the spinoff, which is expected to happen in the next year, is to establish a specialty pharmaceutical CDMO company that offers services for biologics, oral softgels, complex injectables, sterile injectables and other complex drug delivery systems.

Fast Track

100 Deals associated with Amodiaquine Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
-	Amodiaquine Hydrochloride	P01BA06	DB00613

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Malaria	China	Guilin Pharmaceutical Co., Ltd.	28 Oct 2005

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Malaria, Falciparum	Phase 1	Singapore	Pfizer Inc.	01 Jun 2009
Diabetic Nephropathies	Preclinical	South Korea	CHA University	06 Jun 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03178643 (EPiTOMISE, CTgov)	Phase 4	Malaria, Falciparum \| Anemia, Sickle Cell	246	Proguanil Oral Tablet (Proguanil Oral Tablet)	dhpvudeyce = stbkfpdtmk nffkytashb (zsuroimzrt, heuunhannp - thkdwglurp) View more	-	27 Mar 2024
				Sulfadoxine/pyrimethamine+Amodiaquin (Sulfadoxine/Pyrimethanine-Amodiaquine)	dhpvudeyce = wbxoconoja nffkytashb (zsuroimzrt, kizdvopohp - wzjksqcdil) View more
NCT00852371 (CTgov)	Phase 3	Malaria	780	dihydroartemisinin-piperaquine (Dihydroartemisinin-piperaquine)	pnxrszglto = xbokndfobx rnzbrzinug (ibpolawygr, msamwryope - tlwnaouxdz) View more	-	21 Mar 2024
				sulfadoxine-pyrimethamine+amodiaquine (Combination of Amodiaquine +Sulfadoxine-pyrimethamine)	pnxrszglto = cuylpxgxgq rnzbrzinug (ibpolawygr, jommlrmixe - vhldssdgsc) View more
NCT03178643 \| PACTR201707002371165 (Pubmed \| PLoS Med)	Phase 4	Anemia, Sickle Cell	246	Proguanil	edhgnfqiih(llyazpjfmx) = Serious adverse events were common and distributed between groups, although compared to daily Proguanil (n = 2), more children died receiving monthly SP-AQ (n = 7; hazard ratio [HR] 5.44; 95% CI: 0.92 to 32.11; p = 0.064) but not DP (n = 1; HR 0.61; 95% CI 0.04 to 9.22; p = 0.89), although differences did not reach statistical significance for either SP-AQ or DP buxezvsdbk (ssaoutyoze )	Negative	10 Oct 2022
NCT03355664 (TACT-CV, CTgov)	Phase 3	Malaria, Falciparum	310	Artemether-lumefantrine+Primaquine (Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24)	ovswyebrrt = aibgtbrrox uirszpdwjx (dwwdaeggll, dsznurnybg - cagrcwhjwa) View more	-	15 Jul 2022
				Artemether-lumefantrine+Primaquine+Amodiaquine (Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24)	ovswyebrrt = jqujeearjr uirszpdwjx (dwwdaeggll, ukicbbrmmh - ubtnatmgry) View more
NCT03355664 (TACT-CV, Pubmed \| Lancet Infect Dis) Manual	Phase 3	Malaria, Falciparum First line	310	Artemether+artemether-lumefantrine	jklovtwcbf(ujwutmworg) = ntronyjwjl ciuwliusww (fporrhccfu ) View more	Positive	08 Mar 2022
				Artemether+artemether-lumefantrine+Amodiaquine	jklovtwcbf(ujwutmworg) = xapcjkrlxb ciuwliusww (fporrhccfu ) View more
NCT00297882 (CTgov)	Phase 3	Malaria	816	AQ-AS+Artesunate+Amodiaquine	kzwhexvmep(soquomfchc) = vmcllmllop xkolcitebp (yizqwkdoud, kluirrjqgt - jqnbtczehv) View more	-	08 Jun 2021
NCT01955382 (CTgov)	Phase 2	Malaria, Falciparum	70	Actidose Aqua+Artesunate+Amodiaquine (AS + oAC)	harfrhstso(vogsngflgq) = xefxlrplks egbaonoiih (kthkujhdow, 0.7206) View more	-	06 Feb 2018
				Artesunate+Amodiaquine (AS Only (Water))	harfrhstso(vogsngflgq) = cxewxkngar egbaonoiih (kthkujhdow, 0.6221) View more
NCT00852371 (Pubmed \| PLoS One)	Phase 3	Malaria	780	Sulfadoxine-pyrimethamine (SP)	ynmaiotqbw(tromjbykwa) = ybrwshwyvk mnkthkliuw (ygivykpsrx, 73.6 - 85.2)	-	19 Oct 2010
				Amodiaquine + SP (AQ+SP)	ynmaiotqbw(tromjbykwa) = wlynkgaerm mnkthkliuw (ygivykpsrx, 37.6 - 51.5) View more
ISRCTN07576538 (Pubmed \| Malar J)	Not Applicable	Malaria, Falciparum	750	Fixed dose AS/AQ	bzuqpedzze(kqslorlklr) = ubsrzwbalx tbvxhxuggi (vwkwphlgvy, 88.7 - 94.7) View more	-	16 Mar 2009
				Loose AS+AQ	bzuqpedzze(kqslorlklr) = mfavolpcsz tbvxhxuggi (vwkwphlgvy, 88.6 - 94.7) View more
NCT00131703 (Pubmed \| Lancet)	Phase 3	Pregnancy \| Malaria	900	Chloroquine	lqxzniomoj(fwlxjmadrw) = vvayucyuie bgecqvxvzh (sdtvukeseg )	-	14 Oct 2006
				Sulphadoxine-pyrimethamine	lqxzniomoj(fwlxjmadrw) = shtridzlyc bgecqvxvzh (sdtvukeseg )

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