A Phase 2, Open-Label Study of Intravenous Pevonedistat in Combination With Oral Decitabine and Cedazuridine in Adult Patients With Higher-Risk Myelodysplastic Syndromes

The main aim of the study is to see if signs and symptoms of myelodysplastic syndromes disappear when treated with pevonedistat combined with decitabine and cedazuridine.
Participants will receive an infusion of pevonedistat 3 times during a 28-day cycle. They will also take decitabine and cedazuridine tablets once a day for the first 5 days of the same cycle. A minimum of 6 28-day cycles is recommended, but participants can stop treatment at any time.
A bone marrow biopsy, bone marrow aspirates, and blood samples will be collected during the study.
Participants will attend a follow-up visit 30 days after their last dose of pevonedistat. Once treatment has ended, participants will be followed up with either monthly clinic visits or will be contacted every 3 months.

Start Date01 Oct 2021

Sponsor / Collaborator

Takeda Pharmaceutical Co., Ltd.

JPRN-jRCT2031210181

/ SuspendedPhase 2IIT

Phase II study of pevonedistat plus niraparib in patient with recurrent ovarian cancer

Start Date28 Sep 2021

Sponsor / Collaborator-

NCT04800627

/ TerminatedPhase 1/2IIT

A Phase I/II Trial of Pevonedistat in Combination With Pembrolizumab in Patients With dMMR/MSI-H Cancers

This phase I/II trial identifies the side effects and best dose of pevonedistat when given together with pembrolizumab in treating mismatch repair deficiency (dMMR)/high-frequency microsatellite instability (MSI-H) solid tumor that has spread to other places in the body (metastatic) or has spread to nearby tissue or lymph nodes (locally advanced) and cannot removed by surgery (unresectable). Pevonedistat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pevonedistat and pembrolizumab may kill more tumor cells.

Start Date29 Mar 2021

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

100 Clinical Results associated with Pevonedistat

100 Translational Medicine associated with Pevonedistat

100 Patents (Medical) associated with Pevonedistat

640

Literatures (Medical) associated with Pevonedistat

01 Jan 2026·ACTA BIOCHIMICA ET BIOPHYSICA SINICA

MLN4924 promotes the transcriptional activation of BTG2 via the ROS/EGR1-mediated signaling axis to suppress acute myeloid leukemia progression

Article

Author: Liu, Bei ; Zhao, Long ; Guo, Yuancheng ; An, Shujuan ; Jian, Jinli ; Tang, Xiao

Acute myeloid leukemia (AML) is a highly heterogeneous hematological malignancy characterized by a high relapse rate and a low survival rate. Although chemotherapy and allogeneic hematopoietic stem cell transplantation (allo-HSCT) have improved the prognosis for AML patients, the overall survival rate remains suboptimal. MLN4924 is a neddylation inhibitor and is considered a promising treatment approach for AML. However, the exact molecular mechanism remains elusive and requires further investigation. This study aims to investigate the molecular mechanisms of MLN4924 and novel molecular pathways in AML. RNA sequencing (RNA-seq) reveals that the transcription factor (TF) EGR1 serves as a core regulator of MLN4924 and is upregulated by MLN4924 in AML. Mechanistic studies demonstrate that MLN4924 induces apoptosis by generating reactive oxygen species (ROS) and facilitates the nuclear translocation of EGR1. This translocated EGR1 interacts with the promoter region of BTG2, promoting its transcription and inhibiting the progression of AML. Notably, the ROS generated by MLN4924 influences the expression of both EGR1 and BTG2 and establishes a positive feedback loop between EGR1 and ROS. In vivo, we confirm that MLN4924 reduces the leukemic burden in AML cell-derived xenograft models by increasing the expression of both EGR1 and BTG2. In conclusion, these findings suggest that MLN4924 exerts an anti-tumor effect on AML by inducing apoptosis through the ROS-EGR1-BTG2 signaling axis. Our research provides a novel theoretical basis for the clinical potential of MLN4924 in improving the treatment of AML patients, offers novel strategies for AML treatment, and thereby advances the implementation of precision medicine.

31 Dec 2025·Hematology

Integrated transcriptome profiling and in vitro analysis reveals MLN4924’s role in inducing ferroptosis in acute myeloid leukemia

Article

Author: Zhao, Long ; Liu, Bei ; Guo, Yuancheng ; Jian, Jinli ; Tang, Xiao

OBJECTIVES:

While ferroptosis induction emerges as a therapeutic strategy for solid tumors, its role in acute myeloid leukemia (AML) remains unexplored. This study aimed to investigate the role of MLN4924 in modulating ferroptosis and its molecular targets in AML.

METHODS:

Transcriptome sequencing and bioinformatics analyses were performed to identify MLN4924 potential targets in ferroptosis. First, ferroptosis-related phenotypic assays were conducted, including assays of reactive oxygen species (ROS), glutathione (GSH), malondialdehyde (MDA), and Fe²⁺ levels. Second, cell viability assays were carried out with the combination of MLN4924 and ferroptosis inducers (Erastin, Sorafenib). Third, rescue experiments were used the ferroptosis inhibitor Ferrostatin-1 after MLN4924 treatment. In vivo efficacy was evaluated in NOD/SCID mice bearing AML xenografts treated with MLN4924, followed by tumor tissue analysis of GSH and Fe²⁺ levels, immunohistochemistry (IHC), and Western blotting for SLC7A11/GPX4 axis components.

RESULTS:

Transcriptome sequencing and bioinformatics analyses identified SLC7A11 and GPX4 as key MLN4924 target genes, both of which are glutathione-related proteins. MLN4924 significantly suppressed SLC7A11 and GPX4 expression, decreased GSH activity, and increased ROS, Fe²⁺, and MDA levels. Ferroptosis inducers (Erastin, Sorafenib) further enhanced the antileukemic activity of MLN4924, and ferroptosis inhibitor Ferrostatin-1 partially reversed this toxicity. In vivo, MLN4924 reduced tumor burden, accompanied by SLC7A11/GPX4 downregulation and Fe²⁺ accumulation in xenografts.

CONCLUSION:

This study provides the first evidence that MLN4924 triggers ferroptosis in AML by inhibiting the SLC7A11/GPX4 axis. These findings establish MLN4924 as a ferroptosis sensitizer through synergistic effects with ferroptosis inducers, supporting its therapeutic potential in AML.

01 Dec 2025·EXPERIMENTAL AND MOLECULAR PATHOLOGY

SUMOylation and NEDDylation in kidney diseases

Review

Author: Li, Ping ; Li, Dan ; Zhao, Hai-Ling ; Chen, Dan-Qian ; Wei, Bo-Yu ; Chen, Zi-Han ; Zhang, Jian-Yu

Kidney disease poses a serious threat to human health and life, while the lack of specific therapeutic targets hinders the treatment of kidney disease. Emerging evidence shows that post-translational modifications (PTMs), particularly SUMOylation and NEDDylation, two ubiquitin-like modifications, are potential therapeutic targets for kidney disease. SUMOylation and NEDDylation participate in the treatment of kidney diseases by regulating different substrate proteins and signaling pathways. In renal ischemia-reperfusion injury, the promotion of LKB1 SUMOylation and the inhibition of NEDDylation modification facilitate renal fibrosis, and the increase of HIF-1α deSUMOylation contributes to attenuating apoptosis and oxidative stress in the kidneys. In diabetic kidney disease (DKD), the suppression of IKKγ SUMOylation attenuates NF-κB inflammatory signaling, while the inhibition of STAT1 SUMOylation and RBMX SUMOylation alleviates renal fibrosis. Additionally, inhibiting Notch1 signaling SUMOylation reduces podocyte apoptosis and glomerular endothelial cell injury, while the suppression of RhoA NEDDylation decreases inflammation and fibrosis in DKD. Accumulated studies display the therapeutic effect of the activators and inhibitors of SUMOylation and NEDDylation against kidney diseases, such as TAK-981 and MLN4924. Therefore, SUMOylation and NEDDylation function as promising therapeutic targets for kidney diseases, and their activators and inhibitors may serve as novel candidates.

News (Medical) associated with Pevonedistat

30 Jan 2023

·www.prnewswire.com

Acute Myeloid Leukemia Pipeline Experiences Momentum: DelveInsight Estimates a Diverse Pipeline Comprising 200+ Companies Working in the Domain

The incidence of AML has gradually increased around the globe. Males and older people had a higher possibility to develop AML. Developed countries tended to have higher age-standardized incidence rates and death rates than developing regions. Novel therapies for AML, including refinements of conventional cytotoxic chemotherapies, genetic and epigenetic targeted drugs, as well as immunotherapies, have significantly improved patient outcomes in recent years. LAS VEGAS, Jan. 30, 2023 /PRNewswire/ -- DelveInsight's ' Acute Myeloid Leukemia Pipeline Insight – 2023 ' report provides comprehensive global coverage of available, marketed, and pipeline acute myeloid leukemia therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the acute myeloid leukemia pipeline domain. Key Takeaways from the Acute Myeloid Leukemia Pipeline Report DelveInsight's acute myeloid leukemia pipeline report depicts a robust space with 200+ active players working to develop 260+ pipeline therapies for acute myeloid leukemia treatment. Key acute myeloid leukemia companies such as GlycoMimetics, CSPC ZhongQi Pharmaceutical Technology Co., Ltd., Takeda Oncology, Orca Bio, Gilead Sciences, Actinium Pharmaceuticals, Kronos Bio, Bristol-Myers Squibb, ImmunityBio, Bellicum Pharmaceuticals, Syros Pharmaceuticals, Armaceutica, Teva Pharmaceutical Industries, New Epsilon Innovation Limited, MediGene, TC Biopharm, PersonGen BioTherapeutics, Oncoceutics, Janssen Research & Development, LLC, Immune-Onc Therapeutics, Novartis, Jasper Therapeutics, Agastiya Biotech, Poseida Therapeutics, Molecular Partners, Allogene Therapeutics, and others are evaluating new acute myeloid leukemia drugs to improve the treatment landscape. Promising acute myeloid leukemia pipeline therapies in various stages of development include Uproleselan, SKLB1028, Pevonedistat, Orca T, Magrolimab, Iomab-B, Entospletinib, Nivolumab, ALT 803, BPX-501, TCB008, Tamibarotene, Pyronaridine, Trisenox (Arsenic Trioxide), NEI-01, MDG1011, OmnImmune, anti-FLT3 CAR-T, JNJ 63709178, IO 202, IDH 305, JSP 191, AB001, P-ckit-ALLO1, MP-0533, ALLO-316, ALL0-819, and others. In January 2023, Innate Pharma SA announced the publication in Nature Biotechnology of preclinical data showing the control of acute myeloid leukemia (AML) cells by a trifunctional NKp46-CD16a-NK cell engager (NKCE) targeting CD123. In January 2023, the FDA granted JBI-802 orphan drug designation for patients diagnosed with small cell lung cancer (SCLC) and acute myeloid leukemia (AML), according to a press release from Jubilant Therapeutics. In January 2022, Astex Pharmaceuticals, Inc. announced that the European Commission (EC) had granted orphan-drug designation (ODD) to the oral fixed-dose combination of decitabine and cedazuridine (ASTX727) for the treatment of Acute Myeloid Leukemia (AML). Request a sample and discover the recent advances in acute myeloid leukemia drug treatment @ Acute Myeloid Leukemia Pipeline Report The acute myeloid leukemia pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage acute myeloid leukemia drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the acute myeloid leukemia clinical trial landscape. Acute Myeloid Leukemia Overview Acute myeloid leukemia (AML) is the most common type of leukemia in adults, accounting for roughly 80% of all cases. Clonal expansion of immature "blast cells" in the peripheral blood and bone marrow results in ineffective erythropoiesis and bone marrow failure. There are various types of AML. Each affects a different type of blood cell. The acute myeloid leukemia symptoms you experience are determined by the type of blood cell that is affected. The common acute myeloid leukemia symptoms include tiredness, weakness, pale skin, irregular heartbeat, dizziness, and others. Many tests are used for acute myeloid leukemia diagnosis. Doctors will also perform tests to determine the subtype of AML. Chemotherapy is the primary treatment for most AML types, sometimes in conjunction with a targeted therapy drug. A stem cell transplant could follow this. Other drugs (aside from standard chemotherapy drugs) may be used to treat people with acute promyelocytic leukemia (APL). Find out more about drugs for acute myeloid leukemia @ New Acute Myeloid Leukemia Drugs A snapshot of the Acute Myeloid Leukemia Pipeline Drugs mentioned in the report: Learn more about the emerging acute myeloid leukemia pipeline therapies @ Acute Myeloid Leukemia Clinical Trials Acute Myeloid Leukemia Therapeutics Assessment The acute myeloid leukemia pipeline report proffers an integral view of acute myeloid leukemia emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Acute Myeloid Leukemia Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous Therapeutics Assessment By Molecule Type: Small molecule, Cell therapy, Peptides, Polymer, Small molecule, Gene therapy Therapeutics Assessment By Mechanism of Action: Cell replacements, E-selectin inhibitors, Interleukin-15 receptor agonists, Immunologic cytotoxicity, T lymphocyte replacements, Bcr-abl tyrosine kinase inhibitors, Epidermal growth factor receptor antagonists, Fms-like tyrosine kinase 3 inhibitors, Lyn protein-tyrosine kinase inhibitors, NEDD 8 activating enzyme inhibitors Key Acute Myeloid Leukemia Companies: GlycoMimetics, CSPC ZhongQi Pharmaceutical Technology Co., Ltd., Takeda Oncology, Orca Bio, Gilead Sciences, Actinium Pharmaceuticals, Kronos Bio, Bristol-Myers Squibb, ImmunityBio, Bellicum Pharmaceuticals, Syros Pharmaceuticals, Armaceutica, Teva Pharmaceutical Industries, New Epsilon Innovation Limited, MediGene, TC Biopharm, PersonGen BioTherapeutics, Oncoceutics, Janssen Research & Development, LLC, Immune-Onc Therapeutics, Novartis, Jasper Therapeutics, Agastiya Biotech, Poseida Therapeutics, Molecular Partners, Allogene Therapeutics, and others. Key Acute Myeloid Leukemia Pipeline Therapies: Uproleselan, SKLB1028, Pevonedistat, Orca T, Magrolimab, Iomab-B, Entospletinib, Nivolumab, ALT 803, BPX-501, TCB008, Tamibarotene, Pyronaridine, Trisenox (Arsenic Trioxide), NEI-01, MDG1011, OmnImmune, anti-FLT3 CAR-T, JNJ 63709178, IO 202, IDH 305, JSP 191, AB001, P-ckit-ALLO1, MP-0533, ALLO-316, ALL0-819, and others. Dive deep into rich insights for new drugs for acute myeloid leukemia treatment; visit @ Acute Myeloid Leukemia Medications Table of Contents For further information on the acute myeloid leukemia pipeline therapeutics, reach out @ Acute Myeloid Leukemia Drug Treatment Related Reports Acute Myeloid Leukemia Market Acute Myeloid Leukemia Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key acute myeloid leukemia companies, including Takeda Oncology, Immunity Bio, Teva Pharmaceuticals, among others. Relapsed/Refractory Acute Myeloid Leukemia Epidemiology Relapsed/Refractory Acute Myeloid Leukemia Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted relapsed/refractory acute myeloid leukemia epidemiology in the 7MM. Acute Lymphocytic Leukemia Pipeline Acute Lymphocytic Leukemia Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key acute lymphocytic leukemia companies, including AbbVie, Novartis, Jazz Pharmaceutical, among others. Chronic Lymphocytic Leukemia Pipeline Chronic Lymphocytic Leukemia Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key chronic lymphocytic leukemia companies, including Celgene, Loxo Oncology, Octapharma, among others. Chronic Myeloid Leukemia Pipeline Chronic Myeloid Leukemia Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key chronic myeloid leukemia companies, including Kartos Therapeutics, Novartis, Incyte Corporation, among others. Other Trending Reports Tay-sachs Disease Or Gm2 Gangliosidosis Market | Onycholysis Market | Diagnostic Imaging Equipment Market | Chemotherapy-induced Peripheral Neuropathy Market | Global Electrophysiology Devices Market | Anaphylaxis Market | Atherectomy Devices Market | Helicobacter Pylori Infections Market | Ophthalmic Imaging Equipment Market | Androgenetic Alopecia Market | Allergic Rhinitis Market | Chronic Inflammatory Demyelinating Polyneuropathy Market | Chronic Inflammtory Demyelinating Polyneuropathy Market | Colorectal Cancer Crc Market | Opioid Induced Constipation Market | Vertigo Market | Bone Anchored Hearing Systems Market | Wound Closure Devices Market | Hip Replacement Devices Market | Hemodynamic Monitoring Systems Market | Egfr Non-small Cell Lung Cancer Market | Helicobacter Pylori Infection Market | Hyperkalemia Market | Polycythemia Market Neurostimulation Devices Market | Carpal Tunnel Syndrome Market | Ventilator Market | Cerebral Aneurysm Market | Alpha Antitrypsin Market | Binge Eating Disorder Market | Bunion Market | Concussions Market Size | Exocrine Pancreatic Insufficiency Market | Healthcare Due Diligence Services | Minimal Residual Disease Market | Hypertrophic Scar Market | Lung Fibrosis Market | Anterior Uveitis Market | 22q11.2 deletion syndrome Market | X-Linked Retinitis Pigmentosa (XLRP) Market | Acute Radiation Syndrome Market | Alpha-1 Protease Inhibitor Deficiency Market | Androgenetic Alopecia Market | Hyperlipidemia Market | Cardiotoxicity Market | Hypertrophic Cardiomyopathy Market | Fatty Acid Oxidation Disorders (FAODs) Market | Androgen Insensitivity Syndrome Market | Emphysema Market | Canaloplasty Market | Dravet Syndrome Market | Celiac Disease Market | Chlamydia Infections Market | Syphilis Market | Renal Tubular Acidosis Market | Palmoplantar Pustulosis (PPP) Market | Aplastic Anemia Market | Bacterial Pneumonia Market | B cell Chronic Lymphocytic Leukemia Market | B cell Lymphomas Market | Behcets Disease Market Neoantigen-based Personalized Cancer therapeutic Vaccines Competitive Landscape and Market Forecast—by 2035 | Glioblastoma Market Related Healthcare Blogs Upcoming Oncology Drugs Oncology Market Outlook Future of Oncology Market Related Cases Studies Competitive Intelligence Market Assessment Product Assessment Epidemiology Assessment Related Healthcare Services Healthcare Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect with us on LinkedIn |Facebook|Twitter Additionally, get in touch with our business executive to explore @ Healthcare Due Diligence Services Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

ImmunotherapyOrphan DrugASCO

14 Sep 2021

·www.biospace.com

Best Known for Therapeutics, Takeda Sees Growing Value in Vaccines

Tokyo-based Takeda Pharmaceutical announced that the company plans to grow its vaccines business. CEO Christophe Weber discussed this today in an interview at Reuters Events’ Pharma Japan 2021 conference. Takeda distributes Moderna’s COVID-19 vaccine in Japan but the company is better known for its cancer and gastrointestinal therapeutics than its vaccines. Vaccine production, “when established,” Weber said, “has a very long life. There is no generic of vaccines, for example. So, it’s a different type of lifecycle, but it can be a very good business if you bring innovation.” In May, the company presented long-term safety and efficacy data from its ongoing pivotal Phase III Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial for its TAK-003, a vaccine against dengue. The data has also been included in a submission to the European Medicines Agency (EMA). The data showed the vaccine provided 83.6% protection against hospitalization and 62% overall efficacy against dengue. Dengue is the fastest spreading mosquito-borne viral disease. It affects about 390 million people worldwide, with 500,000 hospitalizations. In addition to the Moderna COVID-19 vaccine, the company has a license to manufacture Novavax’s COVID-19 vaccine, which is still being evaluated in clinical trials. The Japanese government had entered a contract to acquire another 50 million Moderna doses to be delivered in 2022, as well as 150 million Novavax doses. The Novavax vaccine, TAK-019, is known outside Japan as NVX-CoV2373. As part of an earlier announcement, Takeda is developing manufacturing capabilities for TAK-109 in Japan with a goal of being distributed in early 2022. The licensing deal allows Takeda to manufacture the vaccine antigen, and Novavax is supplying the Matrix-M adjuvant to Takeda that is used in the vaccine. Takeda will handle Japanese clinical trial and regulatory submission to the Pharmaceuticals and Medical Devices Agency (PMDA) and distribute TAK-019 in Japan if it is approved by Japan’s Ministry of Health, Labour and Welfare (MHLW). In July 2021, Takeda and Frazier Healthcare Partners partnered to launch HilleVax, a biopharma company designed to develop and commercialize Takeda’s norovirus vaccine candidate. HilleVax received a license from Takeda for exclusive development and commercialization rights to the vaccine candidate, HIL-214, worldwide outside Japan, in exchange for an upfront fee, future cash milestones and royalties on net sales. Takeda will keep commercialization rights in Japan and HilleVax, will integrate some of the Japan development activities into its global development plan. Takeda also has vaccine programs for pandemic influenza and Zika. “Takeda and Frazier have a history of successfully partnering together, and we are confident in HilleVax’s capabilities to progress HIL-214, the most advanced norovirus vaccine candidate in development with the potential to address the huge global burden of norovirus-associated acute gastroenteritis,” said Rajeev Venkayya, President of the Global Vaccine Business Unit, Takeda. “This will allow Takeda to focus its efforts and resources on our dengue vaccine, which we have begun filing for licensure around the world, our pandemic programs, and our partnership with the U.S. Government to develop a Zika vaccine.” Weber was quick to note that the company has 40 clinical-stage compounds, with more than 10 in late-stage development. There was some concern when its Pevonedistat for blood cancer had poor clinical trial data. Weber said, “We don’t rely on one product in our pipeline, or two, when we have 40 in clinical stage.”

VaccineLicense out/inCollaborate

14 Sep 2021

·www.biospace.com

Best Known for Therapeutics, Takeda Sees Growing Value in Vaccines

Takeda announced that the company plans to grow its vaccines business. CEO Christophe Weber discussed this today in an interview at Reuters Events’ Pharma Japan 2021 conference. Tokyo-based Takeda Pharmaceutical announced that the company plans to grow its vaccines business. CEO Christophe Weber discussed this today in an interview at Reuters Events’ Pharma Japan 2021 conference. Takeda distributes Moderna’s COVID-19 vaccine in Japan but the company is better known for its cancer and gastrointestinal therapeutics than its vaccines. Vaccine production, “when established,” Weber said, “has a very long life. There is no generic of vaccines, for example. So, it’s a different type of lifecycle, but it can be a very good business if you bring innovation.” In May, the company presented long-term safety and efficacy data from its ongoing pivotal Phase III Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial for its TAK-003, a vaccine against dengue. The data has also been included in a submission to the European Medicines Agency (EMA). The data showed the vaccine provided 83.6% protection against hospitalization and 62% overall efficacy against dengue. Dengue is the fastest spreading mosquito-borne viral disease. It affects about 390 million people worldwide, with 500,000 hospitalizations. In addition to the Moderna COVID-19 vaccine, the company has a license to manufacture Novavax’s COVID-19 vaccine, which is still being evaluated in clinical trials. The Japanese government had entered a contract to acquire another 50 million Moderna doses to be delivered in 2022, as well as 150 million Novavax doses. The Novavax vaccine, TAK-019, is known outside Japan as NVX-CoV2373. As part of an earlier announcement, Takeda is developing manufacturing capabilities for TAK-109 in Japan with a goal of being distributed in early 2022. The licensing deal allows Takeda to manufacture the vaccine antigen, and Novavax is supplying the Matrix-M adjuvant to Takeda that is used in the vaccine. Takeda will handle Japanese clinical trial and regulatory submission to the Pharmaceuticals and Medical Devices Agency (PMDA) and distribute TAK-019 in Japan if it is approved by Japan’s Ministry of Health, Labour and Welfare (MHLW). In July 2021, Takeda and Frazier Healthcare Partners partnered to launch HilleVax, a biopharma company designed to develop and commercialize Takeda’s norovirus vaccine candidate. HilleVax received a license from Takeda for exclusive development and commercialization rights to the vaccine candidate, HIL-214, worldwide outside Japan, in exchange for an upfront fee, future cash milestones and royalties on net sales. Takeda will keep commercialization rights in Japan and HilleVax, will integrate some of the Japan development activities into its global development plan. Takeda also has vaccine programs for pandemic influenza and Zika. “Takeda and Frazier have a history of successfully partnering together, and we are confident in HilleVax’s capabilities to progress HIL-214, the most advanced norovirus vaccine candidate in development with the potential to address the huge global burden of norovirus-associated acute gastroenteritis,” said Rajeev Venkayya, President of the Global Vaccine Business Unit, Takeda. “This will allow Takeda to focus its efforts and resources on our dengue vaccine, which we have begun filing for licensure around the world, our pandemic programs, and our partnership with the U.S. Government to develop a Zika vaccine.” Weber was quick to note that the company has 40 clinical-stage compounds, with more than 10 in late-stage development. There was some concern when its Pevonedistat for blood cancer had poor clinical trial data. Weber said, “We don’t rely on one product in our pipeline, or two, when we have 40 in clinical stage.”

VaccinePhase 3License out/inClinical Result

100 Deals associated with Pevonedistat

External Link

KEGG	Wiki	ATC	Drug Bank
D10413	Pevonedistat	-	DB11759

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Myeloid Leukemia	Phase 3	United States	Takeda Pharmaceutical Co., Ltd.	28 Nov 2017
Acute Myeloid Leukemia	Phase 3	China	Takeda Pharmaceutical Co., Ltd.	28 Nov 2017
Acute Myeloid Leukemia	Phase 3	Japan	Takeda Pharmaceutical Co., Ltd.	28 Nov 2017
Acute Myeloid Leukemia	Phase 3	Australia	Takeda Pharmaceutical Co., Ltd.	28 Nov 2017
Acute Myeloid Leukemia	Phase 3	Belgium	Takeda Pharmaceutical Co., Ltd.	28 Nov 2017
Acute Myeloid Leukemia	Phase 3	Brazil	Takeda Pharmaceutical Co., Ltd.	28 Nov 2017
Acute Myeloid Leukemia	Phase 3	Canada	Takeda Pharmaceutical Co., Ltd.	28 Nov 2017
Acute Myeloid Leukemia	Phase 3	Czechia	Takeda Pharmaceutical Co., Ltd.	28 Nov 2017
Acute Myeloid Leukemia	Phase 3	France	Takeda Pharmaceutical Co., Ltd.	28 Nov 2017
Acute Myeloid Leukemia	Phase 3	Germany	Takeda Pharmaceutical Co., Ltd.	28 Nov 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04175912 (EA2187, ASCO2025)	Phase 2	Intrahepatic Cholangiocarcinoma First line gemcitabine-based therapy	40	Pevonedistat monotherapy	bmtlsjrqol(olarsdnupz) = One patient on Arm B achieved stable disease lasting ≥24 weeks, corresponding to a CBR of 5.9% (95% CI: 0.1%-28.7%) fpdaiqfpto (bhuuntxfam ) View more	Negative	30 May 2025
				Pevonedistat + Carboplatin + Paclitaxel
PB2774 (EHA2025)	Phase 1/2	Myelodysplastic Syndromes	770	Rigosertib	rlfplislyc(lbufsehspu) = lathvrgdzf wnytcmiudc (slofdcyoug, 0.012 - 0.039) View more	Positive	14 May 2025
NCT04266795 (Pubmed \| Leuk Lymphoma)	Phase 2	Acute Myeloid Leukemia	-	Pevonedistat + Azacitidine + Venetoclax	zecieylstd(vdjycxgffd) = jyveroroyn egrpwzvjaz (pduyzlddcx ) View more	Negative	28 Nov 2024
				Azacitidine + Venetoclax	zecieylstd(vdjycxgffd) = fstzkluaff egrpwzvjaz (pduyzlddcx ) View more
NCT03319537 (CTgov)	Phase 1/2	Mesothelioma, Malignant \| Malignant Mesothelioma of Peritoneum \| Malignant Pleural Mesothelioma	9	pevonedistat (Pevonedistat)	xoerikcyro = rcbwitneqv rhtlkxinju (zmbmhcmrlh, gypzavkztl - naakylfemw) View more	-	23 May 2024
				cisplatin+pevonedistat+pemetrexed (Pevonedistat in Combination With Pemetrexed and Cisplatin)	fwohelkyzz(bdqghuqcls) = wdxegwobbp fkobpahvcd (cnbuezwcks, xchaprcbuu - czyzngsdic) View more
NCT04090736 (PETHEMA PEVOLAM, EHA2024)	Phase 3	Acute Myeloid Leukemia	310	Pevonedistat (PEVO) + Azacitidine (AZA)	imsgvrcinm(eiyrxxicfw) = znzszoxtlj gmxwkovqbc (tdjfaufjan ) View more	Negative	14 May 2024
				Azacitidine (AZA)	imsgvrcinm(eiyrxxicfw) = hfizhppsyt gmxwkovqbc (tdjfaufjan ) View more
NCT04172844 (Pubmed) Manual	Phase 1	Acute Myeloid Leukemia Second line MCL1	16	azacitidinet 1venetoclaxpevonedistat	inllrifzcp(fgymxtovmg) = qgnuiyvdee oxsmpiifpr (psqctljtgw ) View more	Positive	04 Apr 2024
NCT04266795 (pevenaza, AACR2024) Manual	Phase 2	Acute Myeloid Leukemia First line FLT3 \| IDH2 Mutation \| ASXL1 \| ... View more	120	Venetoclax anAzacitidinene	assdsznrat(asgaeblcyl) = atkzcyddlc cdbgvqlrty (dgtxeypaqx ) View more	Positive	22 Mar 2024
				Venetoclax, AAzacitidine anPevonedistatat	pgdllwvcfm(dxyrnnnacq) = lbfkkrcwzr ynjbynhetu (kuposaycyb )
NCT03330821 (ASH2023)	Phase 1/2	Acute Myeloid Leukemia	28	Pevonedistat	foydbegtnv(erkctyhqcw) = wlljeylsqu jblwpcqaqc (eltbadpjnk ) View more	Positive	11 Dec 2023
NCT03238248 (CTgov)	Phase 2	Myeloproliferative Disorders \| Myelodysplastic Syndromes	71	Bone Marrow Biopsy & Aspirate+Pevonedistat Infusion+Azacitidine Subcutaneous Injection or Intravenous Infusion	taefayahyz(eqmdrljjai) = nhaqkohhyr bxbqwzeamj (pgkoyejrrk, fvzwholvrj - mrqepmcyxn) View more	-	21 Nov 2023
NCT02782468 (CTgov)	Phase 1	Acute Myeloid Leukemia \| Myelodysplastic Syndromes	23	Pevonedistat (Single Agent Arm: Pevonedistat 25 mg/m^2)	peeigxbsgz = ibnjncvfya nixdarxgpv (avjbkvzjhj, djyuyrndsd - fywnmcmuav) View more	-	03 Nov 2023
				Pevonedistat (Single Agent Arm: Pevonedistat 44 mg/m^2)	peeigxbsgz = ifrlkmpfun nixdarxgpv (avjbkvzjhj, mozruqwvmw - tobvfsswhr) View more

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