Peposertib

Phase 1Small molecule

Peposertib is one of 179 small molecule programs targeting Metastatic Castration-Resistant Prostate Carcinoma. It is currently in Phase 1.

Indications

Total Trials

Active Trials

178

Competitors

Pipeline

Status by Indication[3][1]

Indication

Metastatic Castration-Resistant Prostate CarcinomaRecruiting

Metastatic Dedifferentiated LiposarcomaRecruiting

Endometrioid AdenocarcinomaActive, not recruiting

Locally Advanced Pancreatic AdenocarcinomaRecruiting

Pediatric CancerRecruiting

Locally Advanced Malignant Solid NeoplasmActive, not recruiting

Advanced Malignant Solid NeoplasmRecruiting

Advanced Head and Neck CancerActive, not recruiting

Pancreatic Neuroendocrine TumorActive, not recruiting

GlioblastomaActive, not recruiting

Metastatic Castration-Resistant Prostate CarcinomaPreclinical

Recruiting

Metastatic Dedifferentiated LiposarcomaPhase 1

Recruiting

Endometrioid AdenocarcinomaPhase 1

Active, not recruiting

Locally Advanced Pancreatic AdenocarcinomaPreclinical

Recruiting

Pediatric CancerPreclinical

Recruiting

Locally Advanced Malignant Solid NeoplasmPreclinical

Active, not recruiting

Advanced Malignant Solid NeoplasmPhase 1

Recruiting

Advanced Head and Neck CancerPhase 1

Active, not recruiting

Pancreatic Neuroendocrine TumorPhase 1

Active, not recruiting

GlioblastomaPhase 1

Active, not recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

255 competitors in Acute Myeloid Leukemia

#DrugCompanyPhaseTrials

Novantrone

Pfizer

Phase 3

34 2

Xospata

Astellas

Phase 3

24 3

Fludara

Sanofi

Phase 3

17 4

Mylotarg

WWyeth-Lederle Vaccines

Phase 3

38 5

Cerubidine

EEastern Cooperative Oncology Group

Phase 3

42 6

Vanflyta

Daiichi Sankyo

Phase 3

14 7

Neupogen

EEastern Cooperative Oncology Group

Phase 3

31 8

Cerubidine

HHikma Pharmaceuticals LLC

Phase 3

30 9

Nexavar

Cellcept

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

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Metastatic Dedifferentiated Liposarcoma

NCT05711615

Phase 1Active, not recruiting

Advanced Head and Neck Cancer

NCT04533750

Q2 2027

Phase 1Active, not recruiting

Endometrioid Adenocarcinoma

NCT04092270

Q3 2027

PreclinicalActive, not recruiting

Locally Advanced Malignant Solid Neoplasm

NCT04068194

PreclinicalRecruiting

Locally Advanced Pancreatic Adenocarcinoma

NCT04172532

Phase 1Recruiting

Advanced Malignant Solid Neoplasm

NCT05687136

Clinical

Trials by Indication[1]

Rectal Cancer1 trial

Study of Peposertib in Combination With Capecitabine and RT in Rectal Cancer

Completed· EMD Serono Research & Development Institute, Inc. logo

EMD Serono Research & Development Institute, Inc.·Phase 1/2·NCT03770689·19 enrolled

Pancreatic Neuroendocrine Tumor1 trial

Testing the Addition of An Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiation-Based Treatment (Lutetium Lu 177 Dotatate) for Pancreatic Neuroendocrine Tumors

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT04750954·29 enrolled

Advanced Head and Neck Cancer1 trial

Testing the Addition of M3814 (Peposertib) to Radiation Therapy for Patients With Advanced Head and Neck Cancer Who Cannot Take Cisplatin

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT04533750·21 enrolled

Acute Myeloid Leukemia1 trial

Testing the Addition of an Anti-cancer Drug, M3814, to the Usual Treatment (Mitoxantrone, Etoposide, and Cytarabine) for Relapsed or Refractory Acute Myeloid Leukemia

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT03983824·48 enrolled

Metastatic Castration-Resistant Prostate Carcinoma1 trial

A Phase I and Randomized Phase II Trial of Radium-223 Dichloride, M3814, &Amp; Avelumab in Advanced Metastatic Castrate-Resistant Prostate Cancer (mCRPC)

Suspended·NNational Cancer Institute (NCI)·Preclinical·NCT04071236·90 enrolled

8 more indications

Metastatic Dedifferentiated Liposarcoma1 trial

A Phase 1 Study of Peposertib (M3814) and Low-Dose Liposomal Doxorubicin in Patients With Metastatic Leiomyosarcoma and Other Soft Tissue Sarcomas

Recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT05711615·30 enrolled

Locally Advanced Pancreatic Adenocarcinoma1 trial

A Phase 1/2 Study of M3814 (Peposertib) in Combination With Hypofractionated Radiotherapy for the Treatment of Locally Advanced Pancreatic Adenocarcinoma

Recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT04172532·92 enrolled

Advanced Malignant Solid Neoplasm1 trial

A Molecularly Driven Phase 1b Dose Escalation and Dose Expansion Study of the DNA-PK Inhibitor Peposertib (M3814) in Combination With the ATR Inhibitor Tuvusertib (M1774)

Recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT05687136·66 enrolled

Locally Advanced Malignant Solid Neoplasm1 trial

A Phase I/II Study of M3814 and Avelumab in Combination With Hypofractionated Radiation in Patients With Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies

Active, not recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT04068194·103 enrolled

Glioblastoma1 trial

Phase I Trial of DNA-PK Inhibitor (PEPOSERTIB ) in Combination With Radiation and Adjuvant Temozolomide in Newly Diagnosed MGMT Unmethylated and Recurrent Glioblastoma

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT04555577·29 enrolled

Endometrioid Adenocarcinoma1 trial

A Phase I/Ib Dose Escalation Study of Pegylated Liposomal Doxorubicin (PLD) With Peposertib (M3814) in Platinum - Resistant or Ineligible Ovarian and Related Cancers With Planned Expansions in High Grade Serous (HGSOC) and Low Grade Serous Ovarian Cancer (LGSOC)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT04092270·55 enrolled

Pediatric Cancer1 trial

European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors

Recruiting·GGustave Roussy, Cancer Campus, Grand Paris·Preclinical·NCT02813135·472 enrolled

Unspecified1 trial

Effect of Food on Peposertib PK

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT04702698·12 enrolled

Sources

References

[1]
ClinicalTrials.gov — 13 trial records for Peposertib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Peposertib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Peposertib. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Merck & Co. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 1[1]
Company: Merck & Co.

Peposertib

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q3 2027

Trials by Indication[1]

Rectal Cancer1 trial

Pancreatic Neuroendocrine Tumor1 trial

Advanced Head and Neck Cancer1 trial

Acute Myeloid Leukemia1 trial

Metastatic Castration-Resistant Prostate Carcinoma1 trial

Metastatic Dedifferentiated Liposarcoma1 trial

Locally Advanced Pancreatic Adenocarcinoma1 trial

Advanced Malignant Solid Neoplasm1 trial

Locally Advanced Malignant Solid Neoplasm1 trial

Glioblastoma1 trial

Endometrioid Adenocarcinoma1 trial

Pediatric Cancer1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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