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Devimistat

Alternative Names: devimistat, cpi-613, cpi613, cpi 613
Latest Update: 2024-09-11
Latest Update Note: Clinical Trial Update

Product Description

RafaelÕs lead compound, CPI-613¨Ê(devimistat), is designed to target the mitochondria of cancer cells in order to disrupt their energy production, cutting off the fuel for disease growth. (Sourced from: https://rafaelpharma.com/research-and-development/cpi-613-drug)

Mechanisms of Action: Pyruvate Dehydrogenase Inhibitor

Novel Mechanism: No

Modality: Small Molecule

Route of Administration: Intravenous

FDA Designation:
Fast Track - Acute Leukemia|Acute Myeloid Leukemia|Leukemia|Myeloid Leukemia
Fast Track - Pancreatic Cancer
Orphan Drug - Biliary Tract Cancer
Orphan Drug - Lymphoma|Burkitt Lymphoma
Orphan Drug - Sarcoma *

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Known Adverse Events: None

Company: Rafael Pharmaceuticals
Company Location:
Company CEO:
Additonal Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Devimistat

Countries in Clinic: United States

Active Clinical Trial Count: 2

Highest Development Phases

Phase 3: Adenocarcinoma|Pancreatic Cancer

Phase 2: Clear Cell Sarcoma

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success
CCS618

P2

Completed

Clear Cell Sarcoma

2023-03-09

PANC003 (also known as “AVENGER 500”)

P3

Active, not recruiting

Pancreatic Cancer|Adenocarcinoma

2022-05-07

Recent News Events

Date

Type

Title

07/01/2024

PubMed

 Inhibition of pyruvate dehydrogenase accelerates anaerobic glycolysis under postmortem simulating conditions.

03/14/2024

PubMed

 OGDH and Bcl-xL loss causes synthetic lethality in glioblastoma.

02/04/2024

PubMed

 Inducing Melanoma Cell Apoptosis by ERp57/PDIA3 Antibody in the Presence of CPI-613 and Hydroxychloroquine.

09/28/2022

News Article

 Cornerstone Pharmaceuticals Initiates Phase 1 Trial of CPI-613® (devimistat) in Combination with Chemoradiation for the Treatment of Advanced Pancreatic Cancer

08/03/2022

News Article

 Cornerstone Pharmaceuticals Announces Successful Completion of Phase 1b Clinical Trial for CPI-613® (Devimistat) in Combination with Gemcitabine and Cisplatin in Patients with Biliary Tract Cancer

07/06/2022

News Article

 Cornerstone Pharmaceuticals Strengthens Scientific Advisory Board with the Appointment of Distinguished Scholar Jason Locasale, Ph.D.

06/27/2022

News Article

 Cornerstone Pharmaceuticals to Present Pancreatic Cancer Data on CPI-613® (Devimistat) From Its Open-Label Phase 1 Study at the European Society of Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer 2022

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