Drugs / CPI-613
last change Aug 2026 re-read 2 minutes ago

CPI-613

Small molecule targets OGDH, PDHA1 via inhibition

Developed for
pancreatic adenocarcinoma · pancreatic ductal adenocarcinoma · acute myeloid leukemia · myelodysplastic syndrome · biliary tract cancer · granulocytic sarcoma · lymphoma · mycosis fungoides and variants
+56 more · pancreatic acinar cell carcinoma · acute myeloid leukemia with 11q23 abnormalities · acute myeloid leukemia with abnormal bone marrow eosinophils inv(16)(p13q22) or t(16;16)(p13;q22) · acute myeloid leukemia with t(8;21)(q22;q22) translocation · acute myeloid leukemia, del(5q31-q32) · acute myeloid leukemia, t(16;16)(p13.1;q22) · acute promyelocytic leukemia · adult T-cell leukemia/lymphoma · anaplastic large cell lymphoma · angioimmunoblastic T-cell lymphoma · B-cell adult acute lymphocytic leukemia · Burkitt lymphoma · cancer · cholangiocarcinoma · chronic lymphocytic leukemia/small lymphocytic lymphoma · clear cell sarcoma · colon mucinous adenocarcinoma · colon signet ring cell adenocarcinoma · colorectal carcinoma · exocrine pancreatic carcinoma · extranodal nasal NK/T cell lymphoma · gallbladder carcinoma · gastroesophageal junction adenocarcinoma · grade III lymphomatoid granulomatosis · hematopoietic and lymphoid cell neoplasm · hepatosplenic T-cell lymphoma · Hodgkin's lymphoma, lymphocytic depletion · Hodgkin's lymphoma, mixed cellularity · intraocular lymphoma · large-cell immunoblastic lymphoma · leukemia · lung adenocarcinoma · malignant pancreatic neoplasm · MALT lymphoma · mantle cell lymphoma · metastatic malignant neoplasm · nodal marginal zone B-cell lymphoma · nodular lymphocyte predominant Hodgkin lymphoma · nodular sclerosis classical Hodgkin lymphoma · non-small cell lung carcinoma · ovarian carcinoma · pancreatic neoplasm · peripheral T-cell lymphoma, not otherwise specified · primary cutaneous B-cell lymphoma · rectal signet ring cell adenocarcinoma · rectum mucinous adenocarcinoma · refractory hairy cell leukemia · small cell lung carcinoma · small intestine lymphoma · splenic marginal zone lymphoma · T-cell adult acute lymphocytic leukemia · T-cell large granular lymphocyte leukemia · T-cell non-Hodgkin lymphoma · testicular lymphoma · urothelial carcinoma · Waldenstrom macroglobulinemia
Investigated by
National Cancer Institute (NCI) · Wake Forest University Health Sciences · Cornerstone Pharmaceuticals · University of Michigan Rogel Cancer Center · Atlantic Health System · Barbara Ann Karmanos Cancer Institute
+9 more · City of Hope Medical Center · David Bajor, MD · George Washington University · M.D. Anderson Cancer Center · Massachusetts General Hospital · Medical College of Wisconsin · Memorial Sloan Kettering Cancer Center · Northwestern University · Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Trials 34 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 113 trials
Phase 1 NCT05070104 Mar 2023 → Mar 2024 Cornerstone Pharmaceuticals Withdrawn No outcome recorded
Phase 1 NCT05325281 Oct 2022 → Jul 2025 pancreatic adenocarcinoma Medical College of Wisconsin Terminated No outcome recorded
Phase 1 NCT03435289 Oct 2017 → Nov 2018 malignant pancreatic neoplasm Atlantic Health System Unknown No outcome recorded
Phase 1 NCT02484391 Sep 2015 → Oct 2018 granulocytic sarcoma Wake Forest University Health Sciences Completed No outcome recorded
Phase 1 NCT02232152 Jan 2015 → Feb 2019 colon mucinous adenocarcinoma, colon signet ring cell adenocarcinoma, rectal signet ring cell adenocarcinoma, rectum mucinous adenocarcinoma Wake Forest University Health Sciences Completed No outcome recorded
Phase 1 NCT02168907 Dec 2014 → Feb 2015 B-cell adult acute lymphocytic leukemia, Burkitt lymphoma, MALT lymphoma, Waldenstrom macroglobulinemia +12 Wake Forest University Health Sciences Terminated No outcome recorded
Phase 1 NCT02168140 Sep 2014 → Apr 2019 Hodgkin's lymphoma, lymphocytic depletion, Hodgkin's lymphoma, mixed cellularity, T-cell adult acute lymphocytic leukemia, T-cell large granular lymphocyte leukemia +9 Wake Forest University Health Sciences Completed No outcome recorded
Phase 1 NCT01931787 Oct 2013 → Dec 2015 small cell lung carcinoma Wake Forest University Health Sciences Completed No outcome recorded
Phase 1 NCT01839981 Jul 2013 → Oct 2015 pancreatic acinar cell carcinoma, pancreatic ductal adenocarcinoma Wake Forest University Health Sciences Completed No outcome recorded
Phase 1 NCT01835041 Apr 2013 → Feb 2017 pancreatic acinar cell carcinoma, pancreatic ductal adenocarcinoma Wake Forest University Health Sciences Completed No outcome recorded
Phase 1/29 trials
Phase 1/2 NCT05926206 Jul 2023 → Jan 2027 pancreatic adenocarcinoma University of Michigan Rogel Cancer Center Withdrawn No outcome recorded
Phase 1/2 NCT04593758 Sep 2021 → Mar 2023 clear cell sarcoma Cornerstone Pharmaceuticals Completed No outcome recorded
Phase 1/2 NCT03929211 May 2021 → Sep 2022 myelodysplastic syndrome Wake Forest University Health Sciences Withdrawn No outcome recorded
Phase 1/2 NCT04203160 Jun 2020 → Apr 2024 biliary tract cancer University of Michigan Rogel Cancer Center Terminated No outcome recorded
Phase 1/2 NCT03699319 Dec 2018 → Sep 2024 pancreatic ductal adenocarcinoma David Bajor, MD Completed No outcome recorded
Phase 1/2 NCT03370159 Jun 2018 → Mar 2019 non-small cell lung carcinoma Wake Forest University Health Sciences Withdrawn No outcome recorded
Phase 1/2 NCT02472626 Dec 2015 → Jul 2016 acute myeloid leukemia Wake Forest University Health Sciences Withdrawn No outcome recorded
Phase 1/2 NCT01766219 May 2013 → Apr 2018 cholangiocarcinoma, gallbladder carcinoma Wake Forest University Health Sciences Completed No outcome recorded
Phase 1/2 NCT00907166 May 2009 → Dec 2017 exocrine pancreatic carcinoma Cornerstone Pharmaceuticals Terminated No outcome recorded
Phase 210 trials
Phase 2 NCT05854966 Dec 2024 → Apr 2025 granulocytic sarcoma Wake Forest University Health Sciences Withdrawn No outcome recorded
Phase 2 NCT06518538 Aug 2024 → Aug 2026 pancreatic neoplasm Cornerstone Pharmaceuticals Withdrawn No outcome recorded
Phase 2 NCT05733000 Mar 2023 → Jan 2028 expected biliary tract cancer, colorectal carcinoma, gastroesophageal junction adenocarcinoma, lung adenocarcinoma +3 Northwestern University Recruiting No outcome recorded
Phase 2 NCT04217317 Sep 2020 → Apr 2023 T-cell non-Hodgkin lymphoma Wake Forest University Health Sciences Terminated No outcome recorded
Phase 2 NCT03793140 Dec 2018 → Dec 2026 expected leukemia, lymphoma Memorial Sloan Kettering Cancer Center Active not recruiting No outcome recorded
Phase 2 NCT03374852 Aug 2018 → Oct 2019 pancreatic ductal adenocarcinoma Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University Withdrawn No outcome recorded
Phase 2 NCT01520805 Jan 2016 → Dec 2018 acute myeloid leukemia, myelodysplastic syndrome Cornerstone Pharmaceuticals Withdrawn No outcome recorded
Phase 2 NCT01830322 Jan 2014 → Dec 2018 pancreatic adenocarcinoma Cornerstone Pharmaceuticals Withdrawn No outcome recorded
Phase 2 NCT01902381 Aug 2013 → Nov 2018 myelodysplastic syndrome Wake Forest University Health Sciences Terminated No outcome recorded
Phase 2 NCT01832857 Jun 2013 → Dec 2016 cancer Cornerstone Pharmaceuticals Terminated No outcome recorded
Phase 32 trials
Phase 3 NCT03504410 Nov 2018 → Oct 2021 acute myeloid leukemia Cornerstone Pharmaceuticals Terminated No outcome recorded
Phase 3 NCT03504423 Nov 2018 → Aug 2021 pancreatic adenocarcinoma Cornerstone Pharmaceuticals Completed No outcome recorded

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 37 sources stand behind the page.

FieldValueCited text
Known as CPI-613 “Day 1,15 CPI-613: IV infusion at a rate of 4 mL/min via a central venous catheter starting at 500 mg/m2 (with concurrent D5W infusing at a rate of 125-150 cc/hr” NCT03435289
18

NCT03435289

NCT01830322

NCT01832857

NCT00741403

NCT03504410

NCT05070104

NCT05325281

NCT04203160

NCT00907166

NCT04217317

NCT03699319

NCT03929211

NCT01768897

NCT04593758

NCT03374852

NCT01034475

NCT01520805

NCT03793140

Known as 6,8-bis(benzylthio)octanoic acid ClinicalTrials.gov intervention name — accepted as the source's own label NCT01835041
9

NCT01902381

NCT01931787

NCT02168140

NCT02232152

NCT01766219

NCT02168907

NCT03370159

NCT01839981

NCT02472626

Known as devimistat “CPI-613® (devimistat) targets the altered energy metabolism and processes for production of ATP and essential bio-intermediates unique to and characteristic of most cancer cell types.” NCT03504410
8

Devimistat (CPI-613®) is a novel lipoate analog that inhibits the tricarboxcylic acid cycle at two key carbon entry points.” PMID 31512497 Sep 2019

“For INDUCTION therapy (14 day cycles): Devimistat (CPI-613) 2,500mg/m2, days 1-5, 14-day cycles for cycles 1 and 2 only.” NCT05854966

“Novel devimistat results in complete remissions in heavily pretreated Burkitt lymphoma in a phase 2 trial.” PMID 40674734 Nov 2025

Devimistat is a TCA cycle inhibitor.” PMID 35354808 Mar 2022

“CPI-613® (Devimistat)” NCT04593758

“* CPI-613, devimistatNCT06518538

NCT05733000

NCT05926206

Action Inhibit Inhibition of PDHA1 and OGDH by either shRNA or pharmacological inhibitor by CPI613 dramatically attenuated melanoma progression as well as improved the therapeutic efficacy of...” PMID 37678921 Sep 2023
Modality Small molecule “The lipoate derivative CPI-613 is a first-in-class agent that targets mitochondrial metabolism.” PMID 25165100 Aug 2014
Route Intravenous “following intravenous (IV) administration” NCT00741403
Target OGDH “Inhibition of PDHA1 and OGDH by either shRNA or pharmacological inhibitor by CPI613 dramatically attenuated melanoma progression as well as improved the therapeutic efficacy of...” PMID 37678921 Sep 2023
Target PDHA1 “Inhibition of PDHA1 and OGDH by either shRNA or pharmacological inhibitor by CPI613 dramatically attenuated melanoma progression as well as improved the therapeutic efficacy of...” PMID 37678921 Sep 2023