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Peony

(Pevonedistat)

Phase 3Small molecule

Pevonedistat is used to treat certain types of blood cancers, particularly myelodysplastic syndromes. It works by helping the body's immune system destroy cancer cells that have become resistant to other treatments.[1] Peony is currently being investigated across 15 indications[3], with its most advanced program in Phase 3.[1]

Peony is one of 415 small molecule programs targeting Nasopharyngeal Carcinoma. It is currently in Phase 3.

15

Indications

32

Total Trials

8

Active Trials

414

Competitors

Pipeline

Status by Indication[3][1]

Indication

Nasopharyngeal CarcinomaActive, not recruiting

LymphomaActive, not recruiting

LeukemiaActive, not recruiting

MesotheliomaActive, not recruiting

Metastatic MelanomaActive, not recruiting

MyelofibrosisActive, not recruiting

Chronic Myelomonocytic LeukemiaActive, not recruiting

Myelodysplastic SyndromeActive, not recruiting

Non-Small Cell Lung CancerActive, not recruiting

Multiple MyelomaActive, not recruiting

Nasopharyngeal CarcinomaPreclinical

Active, not recruiting

LymphomaPhase 1

Active, not recruiting

LeukemiaPhase 1

Active, not recruiting

MesotheliomaPhase 1/Phase 2

Active, not recruiting

Metastatic MelanomaPhase 1

Active, not recruiting

MyelofibrosisPhase 1

Active, not recruiting

Chronic Myelomonocytic LeukemiaPhase 3

Active, not recruiting

Myelodysplastic SyndromePhase 3

Active, not recruiting

Non-Small Cell Lung CancerPhase 2

Active, not recruiting

Multiple MyelomaPhase 1

Active, not recruiting

Showing 10 of 15 indications

Competition

Competitive Landscape

1774 competitors in Lymphoma

#DrugCompanyPhaseTrials

Peony

Blenoxane

SSequus Pharmaceuticals

Velban

EEastern Cooperative Oncology Group

Oncaspar

Zofran

Tafasitamab

Nuvigil

NNuvo Research GmbH

Systemic Therapy

Bristol-Myers Squibb

PEG-Intron

Decadron

QQuince Therapeutics S.p.A.

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 3Active, not recruiting

Leukemia, Myeloid, Acute

NCT04090736

Q4 2026

Phase 2Active, not recruiting

Metastatic Cholangiocarcinoma

NCT04175912

Phase 1Active, not recruiting

Lymphoma

NCT03479268

Phase 1/2Active, not recruiting

Acute Myeloid Leukemia

NCT03330821

Q1 2027

Phase 1/2Active, not recruiting

Acute Myeloid Leukemia

NCT03862157

Q4 2028

Phase 1/2Recruiting

Acute Myeloid Leukemia

NCT03013998

Clinical

Trials by Indication[1]

Acute Myeloid Leukemia6 trials

Pevonedistat, Cytarabine, and Idarubicin in Treating Patients With Acute Myeloid Leukemia

Active, not recruiting·UUniversity of Southern California·Phase 1/2·NCT03330821·53 enrolled

Pevonedistat and Decitabine in Treating Patients With High Risk Acute Myeloid Leukemia

Active, not recruiting·—·Phase 1·NCT03009240·30 enrolled

Pevonedistat With Azacitidine Versus Azacitidine Alone in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Withdrawn·NNational Cancer Institute (NCI)·Phase 2·NCT03745352

Show 3 more trials

Azacitidine, Venetoclax, and Pevonedistat in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT03862157·40 enrolled

A Study of Pevonedistat and Venetoclax Combined With Azacitidine to Treat Acute Myeloid Leukemia (AML) in Adults Unable to Receive Intensive Chemotherapy

Completed· Takeda logo

Takeda·Phase 2·NCT04266795·164 enrolled

Study of Biomarker-Based Treatment of Acute Myeloid Leukemia

Recruiting·BBeat AML, LLC·Phase 1/2·NCT03013998·3,000 enrolled

Advanced Solid Tumors3 trials

A Study of [14 C]-Pevonedistat in Participants With Advanced Solid Tumors

Completed· Takeda logo

Takeda·Phase 1·NCT03057366·8 enrolled

A Study to Evaluate the Effects of Rifampin on Pharmacokinetics (PK) of Pevonedistat in Participants With Advanced Solid Tumors

Completed· Takeda logo

Takeda·Phase 1·NCT03486314·20 enrolled

A Study to Evaluate the Effects of Pevonedistat on the Corrected QT (QTc) Interval in Participants With Advanced Solid Tumors

Completed· Takeda logo

Takeda·Phase 1·NCT03330106·68 enrolled

Non-Small Cell Lung Cancer2 trials

Trial of Pevonedistat Plus Docetaxel in Patients With Previously Treated Advanced Non-Small Cell Lung Cancer

Terminated·UUniversity of Michigan Rogel Cancer Center·Phase 2·NCT03228186·40 enrolled

Testing the Combination of MLN4924 (Pevonedistat), Carboplatin, and Paclitaxel in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Who Have Previously Been Treated With Immunotherapy

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03965689·27 enrolled

Lymphoma2 trials

Pevonedistat, Irinotecan, and Temozolomide in Treating Patients With Recurrent or Refractory Solid Tumors or Lymphoma

Completed·CChildren's Oncology Group·Phase 1·NCT03323034·30 enrolled

Pevonedistat and Ibrutinib in Treating Participants With Relapsed or Refractory CLL or Non-Hodgkin Lymphoma

Active, not recruiting·—·Phase 1·NCT03479268·18 enrolled

Chronic Myelomonocytic Leukemia2 trials

Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML)

Completed· Takeda logo

Takeda·Phase 3·NCT03268954·454 enrolled

An Efficacy and Safety Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML) and Low-Blast Acute Myelogenous Leukemia (AML)

Completed· Takeda logo

Takeda·Phase 2·NCT02610777·120 enrolled

15 more indications

Myelodysplastic Syndromes2 trials

Expanded Access Program With Pevonedistat (Given With Azacitidine) for Adults With Higher-risk Myelodysplastic Syndromes

No longer available· Takeda logo

Takeda··NCT04484363

A Study of Pevonedistat Combined With Decitabine and Cedazuridine in Adults With Higher-risk Myelodysplastic Syndromes

Withdrawn· Takeda logo

Takeda·Phase 2·NCT04985656

Myelodysplastic Syndrome2 trials

Pevonedistat and Belinostat in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Terminated·NNational Cancer Institute (NCI)·Phase 1·NCT03772925·18 enrolled

Pevonedistat, Azacitidine, Fludarabine Phosphate, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT03813147·12 enrolled

Treatment1 trial

Treatment of MDS/AML Patients With an Impending Hematological Relapse With AZA or ATA and Pevonedistat

Completed·UUniversity of Leipzig·Phase 2·NCT04712942·14 enrolled

Myelofibrosis1 trial

Pevonedistat in Combination With Ruxolitinib for Treatment of Patients With Myelofibrosis

Terminated·WWashington University School of Medicine·Phase 1·NCT03386214·8 enrolled

Solid Tumors1 trial

A Study of Pevonedistat in People With Blood Cancers or Solid Tumors With Kidney or Liver Problems

Completed· Takeda logo

Takeda·Phase 1·NCT03814005·17 enrolled

Leukemia1 trial

Pevonedistat, Azacitidine (or Decitabine), and Venetoclax for the Treatment of Patients With Acute Myelogenous Leukemia

Terminated·MMedical College of Wisconsin·Phase 1·NCT04172844·16 enrolled

Adult1 trial

Pevonedistat and Low Dose Cytarabine in Adult Patients With AML and MDS

Completed·—·Phase 1·NCT03459859·12 enrolled

Mesothelioma1 trial

Pevonedistat Alone and in Combination With Chemotherapy in Patients With Mesothelioma

Terminated·MMemorial Sloan Kettering Cancer Center·Phase 1/2·NCT03319537·9 enrolled

Unresectable Solid Tumor1 trial

Pevonedistat and Pembrolizumab for the Treatment of dMMR/MSI-H Metastatic or Locally Advanced Unresectable Solid Tumor

Terminated·MM.D. Anderson Cancer Center·Phase 1/2·NCT04800627·2 enrolled

Multiple Myeloma1 trial

Ixazomib and Pevonedistat in Treating Patients With Multiple Myeloma That Has Come Back or Does Not Respond to Treatment

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT03770260·8 enrolled

Relapsed/Refractory1 trial

Pevonedistat With VXLD Chemotherapy for Adolescent/Young Adults With Relapsed/Refractory ALL or Lymphoblastic NHL

Completed·—·Phase 1·NCT03349281·6 enrolled

Allogeneic Stem Cell Transplantation1 trial

Pevonedistat and Azacitidine as Maintenance Therapy After Allogeneic Stem Cell Transplantation for Non-Remission AML

Terminated·MMilton S. Hershey Medical Center·Phase 2·NCT03709576·3 enrolled

MDS/MPN1 trial

Pevonedistat and Azacitidine in MDS or MDS/MPN Patients Who Fail Primary Therapy With DNA Methyl Transferase Inhibitors

Completed·VVanderbilt-Ingram Cancer Center·Phase 2·NCT03238248·71 enrolled

Metastatic Cholangiocarcinoma1 trial

A Phase 2 Study of Pevonedistat in Combination With Carboplatin and Paclitaxel in Advanced Intrahepatic Cholangiocarcinoma

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04175912·40 enrolled

Leukemia, Myeloid, Acute1 trial

A Randomized Phase III, Multicentre, Open Label Clinical Trial Comparing Azacitidine Plus Pevonedistat Versus Azacitidine in Older/Unfit Patients With Newly Diagnosed Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Chemotherapy

Active, not recruiting·PPETHEMA Foundation·Phase 3·NCT04090736·302 enrolled

Sources

References

[1]
ClinicalTrials.gov — 32 trial records for Pevonedistat. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Pevonedistat compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Pevonedistat. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Takeda company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: NEDD8 Activating Enzyme Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Takeda

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