Drugs / DICHLOROACETIC ACID
DICHLOROACETIC ACID
also known as
Dichloroacetate · DCA · Bichloracetic acid · Bichloroacetic acid · Dichloracetic acid · Dichlorethanoic acid · Dichloroethanoic acid · NSC-2654
Small molecule targets GSTZ1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Rejected (CRL) | US (FDA) | — | pyruvate dehydrogenase deficiency | 2025-09-08 | “FDA has issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for SL1009, Sodium Dichloroacetate Oral Solution (DCA)” saolrx.com ↗ |
Trials 16
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT02690285 | Mar 2016 → May 2017 | — | University of Florida | Completed | No outcome recorded |
| Phase 1 | NCT01807702 | Mar → Jul 2013 | — | University of Florida | Completed | No outcome recorded |
| Phase 1 | NCT01123005 | Dec 2010 → Aug 2015 | neoplasm | Stanford University | Terminated | No outcome recorded |
| Phase 1 | NCT01163487 | Aug 2010 → Feb 2015 | head and neck cancer | Daniel T. Chang | Completed | No outcome recorded |
| Phase 1 | NCT00703859 | Jul 2008 → Jan 2010 | glioblastoma | AHS Cancer Control Alberta | Withdrawn | No outcome recorded |
| Phase 1 | NCT00566410 | Dec 2007 → Mar 2013 | neoplasm | AHS Cancer Control Alberta | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01128270 | Apr 2010 → Oct 2012 | — | University of Florida | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT01029925 | Dec 2009 → Aug 2011 | breast cancer, lung cancer | Jonsson Comprehensive Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT00540176 | Oct 2007 → Aug 2009 | malignant glioma | University of Alberta | Completed | No outcome recorded |
| Phase 2 | NCT00068913 | Mar 2000 → ? | MELAS syndrome | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Unknown | No outcome recorded |
| Phase not applicable4 trials · 1 met primary | ||||||
| — | NCT04046081 | Nov 2019 → Sep 2021 | endometriosis | University of Edinburgh | Completed | No outcome recorded |
| — | NCT00865514 | Aug 2011 → Jan 2012 | — | University of Florida | Terminated | No outcome recorded Stop: Business |
| — | NCT00874276 | Aug 2009 → Nov 2012 | lactic acidosis | University of Florida | Completed | Met primary |
| — | NCT00031161 | Sep 2001 → Sep 2005 | lactic acidosis | University of Florida | Completed | No outcome recorded |
| Phase not stated2 trials | ||||||
| — | NCT06931262 | — | pyruvate dehydrogenase deficiency | Saol Therapeutics Inc | Available | No outcome recorded |
| — | NCT01797276 | — | inborn mitochondrial metabolism disorder | University of Florida | No longer available | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 0 | NCT05317455 Comparator | May 2025 → May 2027 expected | type 1 diabetes mellitus | Yale University | Recruiting | No outcome recorded |
| Phase 0 | NCT03356457 Comparator | Nov 2017 → Mar 2019 | hyperglycemia | Yale University | Completed | No outcome recorded |
| Phase 1 | NCT01111097 Comparator | Apr 2010 → Mar 2014 | brain neoplasm, glioblastoma | University of Florida | Completed | No outcome recorded |
| Phase 2 | NCT05120284 Comparator | Jul 2022 → Jul 2026 overdue | glioblastoma | University of Florida | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02616484 Comparator | Jul 2020 → Aug 2025 overdue | pyruvate dehydrogenase deficiency | Saol Therapeutics Inc | Active not recruiting | No outcome recorded |
| Phase 4 | NCT02469337 Comparator | May 2012 → Jun 2017 | — | University of Nottingham | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2026-07-28 | Saol Therapeutics Inc | Regulatory Saol Therapeutics Announces the Acceptance of Resubmission of SL1009 (DCA) by the FDA with PDUFA Date of Dec. 30, 2026 saolrx.com ↗
The FDA acknowledged the resubmission as complete, classified it as Class 2, and set a Prescription Drug User Fee Act (PDUFA) target action date of Dec. 30, 2026. |
| 2026-07-07 | Saol Therapeutics Inc | Regulatory Saol Therapeutics Resubmits the New Drug Application for SL1009 (DCA) for the Treatment of Pyruvate Dehydrogenase Complex Deficiency (PDCD), an Ultra-Rare Disease saolrx.com ↗
The resubmission follows a Type A meeting in December and a Type C meeting in March, during which the FDA provided guidance recommending additional survival analyses to support the application. |
| 2025-09-08 | Saol Therapeutics Inc | Regulatory Saol Therapeutics Has Been Granted a Type A Meeting with the FDA to Determine the Path Forward for SL1009 in Pyruvate Dehydrogenase Complex Deficiency (PDCD) saolrx.com ↗
The FDA provided specific observations within the CRL that Saol will need to address to clarify the path forward. |
| 2025-06-19 | Saol Therapeutics Inc | Results Saol Therapeutics Announces Poster Presentation at the UMDF Mitochondrial Medicine 2025 Conference saolrx.com ↗
The primary efficacy endpoint, the Observer Reported Outcome (ObsRO) survey, did not demonstrate statistical significance in the double-blind portion of the trial. |
| 2025-04-17 | Saol Therapeutics Inc | Regulatory Saol Therapeutics Announces Major Clinical Milestones Across Multiple Development Programs saolrx.com ↗
The FDA recently notified Saol of a 90-day extension to the NDA review, moving the PDUFA date from May 27, 2025, to August 27, 2025. |
| 2025-01-28 | Saol Therapeutics Inc | Regulatory Saol Therapeutics announces FDA acceptance of New Drug Application for SL1009 for treatment of Pyruvate Dehydrogenase Complex Deficiency saolrx.com ↗
Saol Therapeutics, a privately held, clinical-stage pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for SL1009, Sodium Dichloroacetate Oral Solution (DCA). |
| 2024-12-03 | Saol Therapeutics Inc | Regulatory Saol Therapeutics Announces Submission of New Drug Application (NDA) to the U.S. FDA for SL1009 saolrx.com ↗ |
| 2024-02-12 | Saol Therapeutics Inc | Regulatory Saol Therapeutics Receives Fast Track Designation for Treatment of Rare Mitochondrial Disease – Pyruvate Dehydrogenase Complex Deficiency (PDCD) saolrx.com ↗
Saol Therapeutics, a privately held, clinical-stage pharmaceutical company, announced today that the FDA has granted Fast Track Designation for Dichloroacetate (DCA, SL-1009) for the treatment of an orphan pediatric mitochondrial disease, Pyruvate Dehydrogenase Complex Deficiency (PDCD)1. |
All press releases naming this drug 9 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | DICHLOROACETIC ACID | ChEMBL registry synonym — accepted as the source's own label CHEMBL13960 ↗ |
| Known as | Bichloracetic acid | ChEMBL registry synonym — accepted as the source's own label CHEMBL13960 ↗ |
| Known as | Bichloroacetic acid | ChEMBL registry synonym — accepted as the source's own label CHEMBL13960 ↗ |
| Known as | DCA | “Dichloroacetate (DCA) is a highly bioavailable small molecule that inhibits pyruvate dehydrogenase kinase, promoting glucose oxidation and reversing the glycolytic phenotype in...” PMID 24442098 ↗ Jan 20148“At least one week following the first admission subjects will return to repeat the above procedure and receive 25mg of dichloroacetate (DCA) one hour before receiving the pyruvate.” NCT01807702 ↗ “Dichloroacetate (DCA) is a small molecule that has been used for years to treat lactic acidosis and rare metabolic disorders in humans.” NCT00566410 ↗ “Dichloroacetate (DCA, an inhibitor of the mitochondrial pyruvate dehydrogenase kinase)” NCT00540176 ↗ “Dichloroacetate (DCA) 25 mg/kg oral solution will be administered daily for 5 days.” NCT02690285 ↗ “Dichloroacetate (DCA)” NCT00874276 ↗ “Dichloroacetate (DCA)” NCT02616484 ↗ “Dichloroacetate (DCA)” NCT00703859 ↗ “Dichloroacetate (DCA)” NCT06931262 ↗ |
| Known as | Dichloracetic acid | ChEMBL registry synonym — accepted as the source's own label CHEMBL13960 ↗ |
| Known as | Dichlorethanoic acid | ChEMBL registry synonym — accepted as the source's own label CHEMBL13960 ↗ |
| Known as | Dichloroacetate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02690285 ↗ |
| Known as | Dichloroethanoic acid | ChEMBL registry synonym — accepted as the source's own label CHEMBL13960 ↗ |
| Known as | NSC-2654 | ChEMBL registry synonym — accepted as the source's own label CHEMBL13960 ↗ |
| Action | Inhibit | “inhibition of PDHK by DCA” NCT00566410 ↗ |
| Modality | Small molecule | “DCA is also a very small molecule” NCT00540176 ↗ |
| Route | Oral | “DCA will be given orally” NCT00540176 ↗ |
| Target | GSTZ1 | “DCA is a mechanism-based inhibitor of GSTZ1” NCT02690285 ↗ |