Conduct a multicenter, open label Phase IIA trial of oral DCA in 40 surgical patients with recurrent GBM who have clinically indicated debulking surgery planned. No patients will be recruited at UF. Patients will be genotyped to establish safe dosing regimens and will be randomized to receive DCA (N=20) or no DCA (N=20) for one week prior to surgery. Deidentified blood and tumor tissue obtained at surgery will be assessed at UF for biochemical markers of DCA dynamics.

Start Date01 Jul 2022

Sponsor / Collaborator

University of Florida

NCT02616484

/ Active, not recruitingPhase 3

Phase 3 Trial of Dichloroacetate in Pyruvate Dehydrogenase Complex Deficiency:

The objective of this research study is to conduct a pivotal phase 3 trial of treatment with the investigational drug dichloroacetate (DCA) in young children with deficiency of the pyruvate dehydrogenase complex (PDC). PDC deficiency (PDCD) is the most common cause of congenital lactic acidosis and is a frequently fatal metabolic disease of childhood for which no proven treatment exists. The investigators predict that DCA represents targeted potential therapy for PDCD because of its ability to increase both the catalytic activity and stability of the enzyme complex. The conclusions of numerous laboratory and clinical investigations are consistent with this postulate and have led to the designation of DCA as an Orphan Product for congenital lactic acidosis by the Food and Drug Administration.
A novel Observer reported outcome (ObsRO) survey that is completed by study participant's parent/caregiver, is the efficacy outcome measure.
Funding Source - FDA OOPD

Start Date14 Jul 2020

Sponsor / Collaborator

Saol Therapeutics, Inc.

[+1]

NCT04046081

/ CompletedNot ApplicableIIT

A Single-arm Open Label Exploratory Clinical Trial to Evaluate Dichloroacetate (DCA) as a Possible Treatment for Endometriosis-associated Pain

This is a single-arm open label exploratory clinical trial to evaluate dichloroacetate (DCA) as a possible treatment for treatment of endometriosis-associated pain

Start Date19 Nov 2019

Sponsor / Collaborator

The University of Edinburgh

[+3]

100 Clinical Results associated with Sodium Dichloroacetate

100 Translational Medicine associated with Sodium Dichloroacetate

100 Patents (Medical) associated with Sodium Dichloroacetate

4,737

Literatures (Medical) associated with Sodium Dichloroacetate

31 Dec 2026·RENAL FAILURE

Explainable machine learning integrating bioelectrical impedance for 6-month cardiovascular risk in peritoneal dialysis

Article

Author: Wu, Chia Lin ; Tsai, Yi Liang ; Chiang, Jung Hsien

Peritoneal dialysis (PD) is a common treatment for end-stage renal disease, yet cardiovascular disease (CVD) remains a major cause of morbidity. Inadequate fluid management can elevate CVD risk, and bioelectrical impedance spectroscopy (BIS) is increasingly used to assess fluid status. This study aimed to develop an artificial intelligence model integrating BIS measurements and medical history to predict major adverse cardiovascular events (MACEs) within six months in clinically stable PD patients. Data were stratified by MACE occurrence and subject, with 80% assigned to training and 20% to testing. Class imbalance was addressed using the synthetic minority over-sampling technique. Four algorithms - logistic regression, random forest, XGBoost, and deep neural networks - were trained using fivefold cross-validation and grid search for optimal hyperparameters. Model performance was evaluated with area under the ROC curve (AUC), calibration plots, and decision curve analysis (DCA). Feature ablation experiments compared models using all 15 features, only 11 BIS-recorded features, and only 4 medical history features. The random forest model achieved the highest performance (AUC = 0.88), with CVD history as the most influential predictor. Isotonic regression calibration improved probability alignment (brier score = 0.0451). DCA suggested potential clinical benefit. While the model relied on four medical history features, its initial sensitivity was modest (0.68). Integrating BIS features significantly enhanced diagnostic sensitivity (0.84). The random forest model, based on 15 clinically accessible features, accurately predicts the risk of MACE within six months in clinically stable PD patients, demonstrating strong discriminatory ability with a performance reaching 88%.

01 Nov 2026·JOURNAL OF COLLOID AND INTERFACE SCIENCE

Development of novel polyacrylate-based adsorbents for precise fluoride removal: role of polar skeleton and chelating groups

Article

Author: Sun, Yue ; Gu, Yingpeng

Conventional polystyrene-based adsorbents for fluoride (F^-) often suffer from slow adsorption kinetics and low uptake capacity. To overcome these limitations, two novel Al³⁺-immobilized adsorbents were developed using a high-polar polyacrylate matrix functionalized with carboxylic or phosphonic groups, denoted as DCA and DPA, respectively, for precise F^- removal. Compared with the conventional polystyrene-based adsorbent (D860A), both DCA and DPA showed higher adsorption capacity and nearly twofold faster kinetics. Both adsorbents also demonstrated superior F^- selectivity in the presence of common coexisting substances and could be efficiently regenerated because of their polar frameworks. Among the two adsorbents, DPA exhibited stronger Al³⁺ immobilization, resulting in higher adsorption capacity and selectivity, while DCA showed faster kinetics and more efficient utilization of immobilized Al³⁺. Detailed characterization confirmed that F^- adsorption occurred through inner-sphere complexation with immobilized Al³⁺ sites. Further analysis indicated that Al³⁺ chelated with carboxylic and phosphonic groups at stoichiometric ratios of 1:2 and 1:1, respectively. The lower steric hindrance of carboxylic groups improved the accessibility of Al³⁺ sites in DCA, whereas the stronger electronegativity of phosphonic groups promoted Al³⁺ coordination in DPA. In column experiments using actual F^--containing wastewater, the treatment capacities of DCA and DPA were 1.5-2.0 times higher than that of D860A. This work offers two effective adsorbents for precise F^- removal and highlights the role of the metal-chelated microenvironment in governing their structure-activity relationship.

01 Aug 2026·JOURNAL OF ETHNOPHARMACOLOGY

Dabupi decoction mitigates fluorouracil-induced intestinal mucositis via farnesoid X receptor activation and dihydropyrimidine dehydrogenase upregulation

Article

Author: Li, JunJie ; Li, Yaling ; Liu, YongQi ; Wa, XiaoXia ; Zhou, YuCen ; Huang, Dan ; Ma, Jing ; Wang, ShunZhi

ETHNOPHARMACOLOGICAL RELEVANCE:

5-Fluorouracil (5-FU) is a widely utilized antimetabolite in colorectal cancer chemotherapy, primarily exerting its cytotoxic effects by irreversibly inhibiting thymidylate synthase (TS). This inhibition leads to a reduction in deoxythymidine monophosphate (dTMP), which disrupts DNA synthesis and repair. A major challenge in 5-FU treatment is the dose-limiting toxicity of chemotherapeutic-induced intestinal mucositis. Da-Bu-Pi Decoction (DBPD), a well-established formula in traditional Chinese medicine for treating spleen-stomach deficiency, is often used to enhance spleen qi and balance the middle jiao. While growing clinical evidence points to the therapeutic benefits of DBPD in alleviating 5-FU-induced mucositis, the underlying molecular mechanisms remain largely undefined.

AIM OF THE STUDY:

To elucidate the molecular mechanisms underlying chemotherapy-induced intestinal mucositis (CIM) induced by 5-FU, with a focus on the disruption of bile acid metabolism and the downregulation of the key detoxifying enzyme DPYD expression.

MATERIALS AND METHODS:

DBPD was administered orally to C57BL/6 mice with 5-FU-induced intestinal mucositis over a seven-day period. The evaluation of intestinal damage included assessments of diarrhea, morphology, intestinal barrier function and inflammatory factors, alongside techniques such as immunofluorescence, immunohistochemistry, transmission electron microscopy and Western blot. Transcriptome analysis of mouse ileal tissue was applied to reveal differentially expressed genes (DEGs) in different treated mice, and bile acid metabolism-related genes (UDP-glucuronosyltransferase 1A1 (UGT1A1), UGT1A9, Farnesoid x receptor (FXR), TGR5) and DPYD, a key detoxification enzyme for 5-FU, were confirmed by qRT-PCR. Additionally, changes of DCA and LCA were measured using ELISA. Bioinformatics helped delineate the association of these genes with pan-cancer versus normal tissues. Meanwhile, 5-FU-induced intestinal epithelial cells (HIEC) were treated with serum containing DBPD. It was further explored how DBPD modulates the UGT1A1/TGR5/FXR signaling pathway and enhances DPYD activity to reduce apoptosis and intestinal barrier damage in 5-FU induced HIEC. AlphaFold3 and further bioinformatics analysis predicted the binding interactions and expression correlations among UGT1A1, UGT1A9 and FXR.

RESULTS:

DBPD is protective by reducing inflammation and intestinal barrier dysfunction in 5-FU-induced intestinal mucositis. Transcriptome analysis and in vivo validation highlighted the crucial function of bile acid metabolism-related pathways and DPYD in 5-FU-induced CIM. 5-FU increased the levels of deoxycholic acid (DCA) and lithocholic acid (LCA) in the mouse ileum. DBPD activated the UGT1A1/TGR5/FXR pathway and up-regulated DPYD to suppress the pathological accumulation of these specific cytotoxic bile acids within the local intestinal microenvironment and ameliorate 5-FU-induced CIM. It was indicated by the analysis of bioinformatics that low levels of UGT1A1, UGT1A9, and FXR exhibited a connection with poor prognosis within colorectal cancer. In vitro studies confirmed that DBPD significantly improved the UGT1A1/TGR5/FXR pathway and increased the expression of DPYD in 5-FU treated HIEC, thereby improving intestinal barrier integrity and alleviating apoptosis. Further validation using the FXR inhibitor (Gly-β-MCA) showed that DBPD ameliorated Gly-β-MCA induced HIEC apoptosis and barrier attenuation. Finally, AlphaFold3 and bioinformatics predictions suggested potential binding interactions between UGT1A1, UGT1A9 and FXR with positively correlated expression.

News (Medical) associated with Sodium Dichloroacetate

14 Jul 2026

·www.biospace.com

Saol boards FDA’s resubmission boat, armed with new survival data

iStock, monkeybusinessimages Saol Therapeutics is the latest biotech to resubmit for approval of a drug rejected under former FDA Commissioner Marty Makary, following REGENXBIO and Replimune. Ten months ago, Saol Therapeutics was in a bind after the FDA rejected the application for its ultra-rare disease drug. To address the agency’s concerns would take “several years” and require “significant financial resources,” the Georgia and Bermuda–based biotech said in September 2025. Now, Saol’s fortunes appear to have changed, as the company resubmitted the candidate on Tuesday. The filing follows Type A and Type C meetings with the FDA. During the Type A meeting in December, Saol—pronounced “Sail”—asked to “directly” resubmit the application for SL1009, but the FDA advised that it would be quicker to first participate in a Type C meeting so both parties could agree on the content of the submission package, CEO Dave Penake recalled. “We’re hoping that that leads to a faster review,” he told BioSpace . SL1009, also known as DCA, is being developed for pyruvate dehydrogenase complex deficiency, a life-threatening mitochondrial disease for which there are no FDA-approved treatments. During the meetings, “the FDA provided guidance recommending additional survival analyses to support the application,” according to Saol’s announcement. Because the company’s resubmission includes additional data—such as information from its emergency Investigational New Drug (IND) programs—Penake said the review period is supposed to be six months—“if they go by the book.” However, he said, “I think the agency has not always been bound by the standard timeframes lately, which I think is a good thing.” It wouldn’t be the first time the agency has expedited a review of a previously rejected therapy. Saol’s candidate was among a spate of rare disease rejections by the FDA in the second half of 2025. Other biotechs caught off-guard by rejections were Capricor Therapeutics, Biohaven and Replimune. Capricor’s Duchenne muscular dystrophy cardiomyopathy cell therapy deramiocel and Replimune’s advanced melanoma drug RP1 have both been resubmitted and now have new target action dates this summer. In Replimune’s case, the decision date will arrive less than two months after the agency accepted the application. Saol submitted its application on June 30 and expects the FDA to set a target action date prior to July 30, Penake said. If the agency does accept Saol’s new filing, SL1009 will be the latest therapy to benefit from the FDA’s newfound flexibility after the spring departures of former Commissioner Marty Makary and Center for Biologics Research and Evaluation (CBER) director Vinay Prasad. In addition to Capricor and Replimune, uniQure has also rebounded from a regulatory rebuff delivered under Makary, announcing plans last month to submit for approval of its Huntington’s disease gene therapy in the third quarter after the FDA reversed course on requiring a sham surgery–controlled Phase 3 trial. UniQure was quickly followed by REGENXBIO, which revealed it would re approval of a recently rejected Hunter syndrome gene therapy, also in Q3, after the FDA deemed the company’s existing data sufficient to support an accelerated filing. Huntington’s disease UniQure plans Q3 submission for Huntington’s gene therapy after FDA reverses course—again After a regulatory odyssey that delayed a filing for what would be the first genetic medicine for Huntington’s disease, the FDA has agreed that three-year data from uniQure’s Phase 1/2 trial are sufficient to support an accelerated biologics license application. June 17, 2026 · 4 min read · Heather McKenzie Read more “What I would assume is that the vast majority of the other products that have gone through this have really tried to deal head on with the issues,” Penake said of the recent rush of seeming regulatory reversals. “The agency may have been more receptive under different folks who were operating it, or maybe it was the same, the issues just needed to be addressed.” Penake believes Saol has addressed the FDA’s concerns, which the company did not reveal at the time of the complete response letter. The new survival data includes 36 natural history–matched pairs—compared to around 28 in the initial submission—and an additional 18 months of data demonstrating a 91% reduction in the risk of death with SL1009, he said. The United Mitochondrial Disease Foundation at the time of the September CRL issued a dire warning. The FDA’s rejection of SL1009, according to the group, could delay access to life-saving therapies, in turn leading to “irreversible damage—or even death.” Regarding the resubmission, Penake said, “We’re just excited to be working with the agency and helping these kids.”

Phase 3Gene TherapyCell Therapy

10 Jul 2026

·www.prnewswire.com

Saol Therapeutics Resubmits the New Drug Application for SL1009 (DCA) for the Treatment of Pyruvate Dehydrogenase Complex Deficiency (PDCD), an Ultra-Rare Disease

Existing data supports direct path to resubmission following constructive FDA engagement July 7, 2026 -- Saol Therapeutics, a privately held, clinical-stage pharmaceutical company, today announced the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for SL1009, sodium dichloroacetate (DCA), for the treatment of pyruvate dehydrogenase complex deficiency (PDCD), a rare, life-threatening mitochondrial disease with no FDA-approved therapies. 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. This guidance enabled Saol to proceed directly to resubmission without conducting an additional trial, an outcome Saol believes reflects the FDA's commitment to working constructively with sponsors to identify viable regulatory paths for programs serving patients with serious unmet needs. Saol's resubmission follows the receipt of a Complete Response Letter (CRL) in August 2025, which did not identify concerns related to safety or manufacturing, but requested additional evidence to support approval. In response Saol conducted further analyses of existing data, including functional outcomes, survival, mechanistic evidence, and long-term safety data. "We are encouraged by the clarity and alignment achieved with the FDA during our recent interactions," said Dave Penake, chief executive officer of Saol Therapeutics. "This resubmission reflects the totality of evidence supporting SL1009. We are committed to continuing to work collaboratively with the Agency and are encouraged by the FDA's demonstrated willingness to apply regulatory flexibility." Penake added, "We are grateful for the continued engagement of the PDCD community and experts, whose efforts have helped communicate the impact of this disease on affected individuals and families. We remain focused on advancing our NDA resubmission while continuing to support the need for timely evaluation of therapies for rare, life-threatening conditions." SL1009 has been studied across multiple clinical trials, including two Phase 3 studies, and long-term open-label extension data, supporting a well-characterized safety profile. Saol believes the totality of evidence supports the potential for meaningful clinical benefit in patients with PDCD. The FDA will assign a new action (PDUFA) date upon acceptance of the file. SL1009 has received Priority Review, Orphan Drug Designation, and Rare Pediatric Disease Designation and Saol anticipates receiving a Priority Review Voucher (PRV) under the Rare, Pediatric Disease Statute. SL1009 is an investigational product that, if approved, will be used with a proprietary dose-determining genetic test to treat an orphan pediatric-onset mitochondrial disease, Pyruvate Dehydrogenase Complex Deficiency (PDCD). PDCD is a rare and life-threatening genetic disorder that can cause chronic energy deficit leading to lactic acidosis, profound developmental problems, and early childhood death. There are currently no FDA-approved therapies for PDCD. SL1009 has received Priority Review, Orphan Drug Designation, and Rare Pediatric Disease Designation. Saol, in collaboration with Medosome Biotec, also filed the Humanitarian Device Exemption (HDE) application for the dose-determining genetic test that will serve as a required companion diagnostic for patients treated with SL1009. Saol Therapeutics (pronounced "Sail") is a privately held, clinical-stage, pharmaceutical company with operations in Roswell, GA, Dublin, Ireland, and Hamilton, Bermuda. Saol is focused on development activity in CNS disorders such as spasticity and pain management, and orphan diseases. Saol is committed to providing and advancing therapeutic options for patients and the physicians treating these populations. The content above comes from the network. if any infringement, please contact us to modify.

08 Jul 2026

·www.biopharmadive.com

Prime wins gene editing dispute; Saol claims latest post-Makary FDA reversal

Today, a brief rundown of news involving Prime Medicine and Saol Therapeutics, as well as updates from Revolution Medicines and Cyllene Therapeutics that you may have missed.Prime Medicine has won a legal dispute with Beam Therapeutics surrounding rival therapies the two companies are developing for the rare disease alpha-1 antitrypsin deficiency, or AATD. Beam and Prime both sprang from the labs of gene editing specialist David Liu and, in 2019, the two companies formed a broad collaboration that, among other things, appeared to potentially forfeit Prime's rights to develop an AATD treatment. Since then, though, Prime has brought a potential therapy forward, leading Beam to claim the deal was breached and Prime to counter that the treatment was within its rights to develop. An arbitration panel ruled Wednesday in favor of Prime, meaning the company won't owe Beam any monetary damages. Beam's AATD treatment, built on “base editing“ technology, is in advanced clinical development. Prime's “prime editing“ rival is in preclinical testing, and could produce initial human data next year. In an emailed statement, Beam said it respectfully disagree[s] with aspects of the ruling but is pleased that the decision doesnt affect broader, exclusive rights it has to use certain prime editing tools.Privately held Saol Therapeutics is the latest drugmaker to announce progress resuscitating a medicine the Food and Drug Administration previously rejected. Saol on Tuesday said it resubmitted an application for SL1009, a potential treatment for the rare disease pyruvate dehydrogenase complex deficiency that the FDA turned back last August. Upon rejecting SL1009, U.S. regulators asked Saol for additional evidence to support approval. Saol provided more analyses of existing data and, after an FDA meeting in March, was advised to proceed with a new application instead of running another trial. Saol joins others, including Replimune and UniQure, that have seen their fortunes change following recent FDA meetings. Saol is “encouraged by the FDAs demonstrated willingness to apply regulatory flexibility,“ CEO Dave Penake said in a statement.European drug regulators are speeding the review of a drug that's been heralded as a breakthrough against pancreatic cancer. In a Tuesday statement, the European Medicines Agency said it's started a “phased review“ of Revolution Medicines' daraxonrasib, as data becomes available and ahead of a full approval submission. According to the EMA, daraxonrasib has been recognized as a “high priority“ and its expedited evaluation will be used as an “example“ for expected EU legislation that could strengthen the use of phased reviews. Daraxonrasib nearly doubled survival compared to chemotherapy in a Phase 3 study earlier this year.Cyllene Therapeutics has raised $33 million in Series C funding to support a gene therapy its developing for a kind of bladder malfunction associated with neurological damage. Cyllenes gene therapies use a non-replicating version of an HSV-1 virus to deliver therapeutic DNA into cells. Its top treatment, EG110A, is designed to effectively subdue the uncontrollable spasms and resulting incontinence in people with neurogenic detrusor overactivity. Cyellene plans to start a late-stage trial next year. '

Gene TherapyPhase 3

100 Deals associated with Sodium Dichloroacetate

External Link

KEGG	Wiki	ATC	Drug Bank
D05857	Sodium Dichloroacetate	-	DB08809

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pyruvate Dehydrogenase Complex Deficiency Disease	NDA/BLA	United States	Saol Therapeutics, Inc.	03 Dec 2024
Congenital lactic acidosis	Phase 3	-	University of Florida	01 Oct 1998
Acidosis, Lactic	Phase 3	-	The Valens Co., Inc.	-
Acidosis, Lactic	Phase 3	-	Keenova Therapeutics Plc	-
Brain Injuries, Traumatic	Phase 3	-	Keenova Therapeutics Plc	-
Brain Injuries, Traumatic	Phase 3	-	The Valens Co., Inc.	-
Myocardial Ischemia	Phase 3	-	Keenova Therapeutics Plc	-
Myocardial Ischemia	Phase 3	-	The Valens Co., Inc.	-
Glioblastoma Multiforme	Phase 2	United States	Saol Therapeutics, Inc.	01 Jul 2022
Glioblastoma Multiforme	Phase 2	United States	University of Florida	01 Jul 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01386632 (Pubmed) Manual	Phase 2	Locally Advanced Head and Neck Squamous Cell Carcinoma	45	Chemoradiotherapy+dichloroacetate	vmeompmrju(kgzyfjjjcd) = However, there were no significant differences in grade 3/4 AE rates. usonvyjinp (xeqrlxfkvl ) View more	Positive	21 Mar 2022
				Placebo
NCT01386632 (CTgov)	Phase 2	Advanced Head and Neck Carcinoma \| Squamous Cell Carcinoma of Head and Neck	50	dichloroacetate (DCA (Dichloroacetate) Treatment)	biixsnofil = yhztscsvwd mcqfmvdkoc (aegfwvqirc, woqjfhivjf - hpgylxsmqk) View more	-	14 Jun 2017
				Placebo (Placebo)	biixsnofil = qwlvsfbvuz mcqfmvdkoc (aegfwvqirc, crbpgucset - upewvffuzu) View more
NCT01029925 (CTgov)	Phase 2	Metastatic breast cancer	7	Dichloroacetate (DCA)	zgwkwofqet = fwazjeltra obfwdmsyuv (cwsvvjtdfe, sdwxtgrvrm - ejfdwltogx) View more	-	12 Feb 2016
NCT01386632 (ASCO2015)	Phase 2	Locally Advanced Head and Neck Squamous Cell Carcinoma	50	Dichloroacetate (DCA)	vuwnvyhokm(zirhjokqxa) = not significantly different (16% DCA vs 4% P; p = 0.35) ckkhhwyutc (vgmrlhiijk ) View more	-	20 May 2015
				Placebo
NCT01128270 (CTgov)	Phase 1/2	-	27	Chloral Hydrate+DCA (2A) (Therapeutic Chloral Hydrate and DCA (2A))	xiwfjwgjes(pevqnlcyun) = ussvbqpjwz gghuwbgoet (cynvsmkaez, 0.40) View more	-	07 May 2014
				Chloral Hydrate (Therapeutic Chloral Hydrate (2B))	xijrhrpcse(dlhpneczcr) = ciikcqrlpa bzhoeuuiiw (kixjivyxlh, 1403) View more
NCT01029925 (Pubmed \| J Cancer Res Clin Oncol)	Phase 2	Hypoxia \| Advanced Lung Non-Small Cell Carcinoma	7	Dichloroacetate	fwbmjbidla(vkigdsbpfy) = two patients had disease progression prior to the first scheduled scans yadpoangjs (bqsniuzids ) View more	-	01 Mar 2014
NCT00865514 (CTgov)	Not Applicable	-	2	tyrosine+Dichloroacetate	gkcuppsueo(ggbzpopboj) = tmkqtaaend wlpmmutcir (doetydjyzt, euuxcqxujq - jboalgobwg) View more	-	20 Jun 2013

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