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- Scemblix (asciminib) / Novartis
ASCIMINIB IN CHRONIC-PHASE CML AFTER PRIOR TKI INTOLERANCE OR RESISTANCE: REAL-WORLD OUTCOMES FROM A SINGLE-CENTER COHORT () - May 12, 2026 - Abstract #EHA2026EHA_2580;
ASC showed favorable tolerability and meaningful molecular responses in this heavily pretreated CP-CML cohort with significant comorbidities. Discontinuation due to newly emergent or recurring toxicity was at low rates, supporting ASC as an effective and safe option in patients requiring therapy change due to standard TKI intolerance or resistance.
- | denifanstat (TVB-2640) / Sagimet Biosci
Journal, IO biomarker: Epigenetically silenced KAT2B suppresses de novo lipogenesis through destroying HDAC5/LSD1 complex assembly in renal cell carcinoma. (Pubmed Central) - Apr 24, 2026
Discontinuation due to newly emergent or recurring toxicity was at low rates, supporting ASC as an effective and safe option in patients requiring therapy change due to standard TKI intolerance or resistance. Our findings reveal that KAT2B suppresses de novo lipogenesis by interfering with HDAC5-LSD1 complex assembly, and highlight the potential of FASN inhibitors as a therapeutic strategy for RCC patients with low KAT2B expression.
- denifanstat (TVB-2640) / Sagimet Biosci
A phase 2 multi-center pharmacodynamic study of the fatty acid synthase (FASN) inhibitor TVB-2640 in advanced KRAS-mutant non (Hall A - Posters and Exhibits; Poster Bd #: 216) - Apr 21, 2026 - Abstract #ASCO2026ASCO_1185;
P2
Our findings reveal that KAT2B suppresses de novo lipogenesis by interfering with HDAC5-LSD1 complex assembly, and highlight the potential of FASN inhibitors as a therapeutic strategy for RCC patients with low KAT2B expression. Funded by Gateway Foundation for funding the clinical trial Sagimet for provision of product/material Clinical Trial Registration Number: NCT03808558 The full, final text of this abstract will be available on May 21 at 05:00 PM EST.
- denifanstat (TVB-2640) / Sagimet Biosci, Rezdiffra (resmetirom) / Madrigal Pharma
Denifanstat and resmetirom combination therapy rapidly decreased atherogenic lipids in healthy adults in Phase 1 open-label trial (Poster Area - Hall 7) - Apr 19, 2026 - Abstract #EASL2026EASL_3045;
The combination significantly reduced atherogenic lipids, suggesting cardiovascular benefits. Together with prior fibrosis improvement data, the safety, PD/biomarker and PK results support further clinical evaluation of Deni/Res combination for MASH and fibrosis.
- Rezdiffra (resmetirom) / Madrigal Pharma
Transcriptomic analysis revealed distinct mechanisms underlying the synergistic effect of a fatty acid synthase inhibitor and resmetirom combination in LDL receptor knockout MASH mice (Poster Area - Hall 7) - Mar 18, 2026 - Abstract #EASL2026EASL_2786;
Transcriptomic analysis confirmed that combination of a FASN inhibitor and resmetirom increased the anti-inflammatory and anti-fibrotic effects, and enhanced metabolic correction associated with lipid and cholesterol synthesis in a mouse model of MASH and dyslipidemia. These findings support future clinical evaluation of this combination therapy in MASH.
- denifanstat (TVB-2640) / Sagimet Biosci
Designing a novel 3D co-culture model incorporating patient T-cells to study lipid metabolism as a metabolic vulnerability in KRAS driven non-small cell lung cancer (Section 23) - Mar 17, 2026 - Abstract #AACR2026AACR_6985;
P
Fatty acid synthase (FASN) inhibitor, TVB-2640, showed the greatest efficacy in KL cells...Moreover, we have developed a novel 3D co-culture model using NSCLC cells and patient T-cells. Further analysis, supported by our 3D co-culture model, aims to analyse the consequences of targeting fatty acid synthesis in combination with immunotherapy in the KL genotype of NSCLC.
- | telaglenastat (CB-839) / Synhale Therapeutics, denifanstat (TVB-2640) / Sagimet Biosci
Review, Journal: Metabolic reprogramming in cancer: dysregulation of glucose, lipid, and amino acid pathways and therapeutic opportunities. (Pubmed Central) - Mar 10, 2026
We recognize that adverse effects on normal tissues and drug resistance driven by metabolic plasticity represent major challenges for metabolism-targeted therapies. Accordingly, we systematically summarize innovative strategies that offer new therapeutic possibilities, including targeting multiple metabolic pathways through combination therapy to enhance efficacy, combining metabolic inhibitors to overcome resistance to conventional anticancer agents, leveraging metabolic reprogramming for early cancer detection, and exploring emerging approaches such as immunometabolism and metabolomics.
- | ASC30 / Ascletis, denifanstat (TVB-2640) / Sagimet Biosci
Journal: Investigating the Shelf-Life Extension of Shrimp Surimi Using a Polysaccharide-Based Film from Alpinia oxyphylla. (Pubmed Central) - Feb 13, 2026
It is superior to single/individual chemical preservatives in terms of film-forming ability, functionality, and safety, providing a natural, effective, and environmentally friendly preservation approach for shrimp surimi and other aquatic products. It also offers a theoretical foundation and practical reference for the development of natural preservation technologies in the food industry.
- | Review, Journal: Genomic alterations and their correlation with metabolic-related genes in lung cancer. (Pubmed Central) - Feb 11, 2026
Rational combination strategies that pair genomic-targeted agents (sotorasib and adagrasib) with metabolic inhibitors (CB-839 and TVB-2640) show promise in overcoming adaptive resistance. Integrating genomic and metabolic profiling may enhance precision oncology approaches and improve clinical outcomes.
- | Lynparza (olaparib) / Merck (MSD), AstraZeneca, denifanstat (TVB-2640) / Sagimet Biosci, irinotecan / Generic mfg.
Journal, BRCA Biomarker, PARP Biomarker: FASN Inhibition Enhances the Efficacy of Chemotherapy in Colorectal Cancer by Inhibiting the DNA Damage Response. (Pubmed Central) - Feb 9, 2026
Importantly, combining FASN inhibition with the chemotherapeutic drug irinotecan synergistically decreased xenograft tumor growth and delayed tumor relapse, which was potentiated by the PARP inhibitor olaparib as maintenance treatment. Taken together, this study describes a therapeutic strategy in which FASN inhibitors can be utilized to delay tumor recurrence after chemotherapy, which is a major challenge in patients with CRC.
- | omeprazole / Generic mfg., denifanstat (TVB-2640) / Sagimet Biosci
Retrospective data, Review, Journal: Targeting fatty acid synthase for cancer drug discovery: Retrospective analyses and outlook. (Pubmed Central) - Jan 28, 2026
Despite progress with novel and repurposed inhibitors, none have gained approval. This review critically examines past efforts, current challenges, and offers insights to guide future development of effective fatty acid synthase-targeting cancer therapeutics.
- | denifanstat (TVB-2640) / Sagimet Biosci
Journal: Neutrophil Extracellular Trap Reprograms Cancer Metabolism to Form a Metastatic Niche Promoting Non-Small Cell Lung Cancer Brain Metastasis. (Pubmed Central) - Jan 27, 2026
Using an AI-driven prediction model and in vitro/in vivo assays, fatty acid synthase inhibitor TVB-2640 is identified as a potential therapeutic agent for disrupting metabolic vulnerability and suppressing NSCLC BMs. These findings provide novel insights into NET-dependent cellular interactions that sustain the pro-metastatic microenvironment underlying NSCLC BMs, offering robust development of novel metabolism-based therapeutic strategies to combat this lethal complication.
- Scemblix (asciminib) / Novartis
Real-world data comparison of asciminib 40 mg twice daily vs. 80 mg once daily in chronic myeloid leukemia patients () - Dec 5, 2025 - Abstract #ASH2025ASH_9267;
Overall efficacy was well maintained. The QD regimen was associated with fewer dose escalations and discontinuation rate, supporting its convenience and potentially advantageous dosing strategy in clinical practice.
- || denifanstat (TVB-2640) / Sagimet Biosci
Clinical, P2 data, Journal: Denifanstat for moderate-to-severe acne: A Phase 2, randomized, double-blind, placebo-controlled trial. (Pubmed Central) - Nov 4, 2025
P2
Denifanstat 50?mg once daily for 12?weeks was generally well tolerated and showed potential to reduce total lesion counts in moderate-to-severe acne vulgaris. Larger and longer term studies are needed to confirm efficacy and safety.
- Cotellic (cobimetinib) / Exelixis, Roche, denifanstat (TVB-2640) / Sagimet Biosci
MAPK pathway-driven metabolic-inflammatory axis in AL amyloidosis (OCCC - West Halls B3-B4) - Nov 4, 2025 - Abstract #ASH2025ASH_7729;
This axissustains a pro-inflammatory environment that may contribute to disease pathogenesis. Thus, FASN andMAPK may represent promising metabolic-immunologic targets for therapeutic intervention in ALamyloidosis.
- Scemblix (asciminib) / Novartis
Asciminib and pregnancy in CML: Preliminary human data and clinical implications from 47 reported outcomes (OCCC - West Halls B3-B4) - Nov 4, 2025 - Abstract #ASH2025ASH_7648;
In the paternal exposure group, 8 men were receiving ASC asmonotherapy at the time of conception, while 5 were treated with ASC in combination with nilotinib orimatinib...In most cases, ASC hadbeen discontinued during the first trimester, often between 4 and 9W, with daily doses ranging from 20to 120 mg, and one ASC 40 QD+imatinib 400 mg...However, contraception is advised for women on ASC, especially if previouslyfailing other treatments; no contraception is needed for men. The presentation will provide updatedclinical details, including CML management during gestation and reproductive outcomes, offeringinsights to improve patient counseling, support informed reproductive choices, and guide personalizedtreatment.
- Scemblix (asciminib) / Novartis
High rates of deep molecular response (DMR) in patients (pts) with chronic myeloid leukemia in chronic Phase (CML-CP) who have not achieved dmr after ?1 year of prior imatinib (IMA) in the asciminib (ASC) monotherapy arm of the Phase 2 ASC4MORE study (OCCC - West Halls B3-B4) - Nov 4, 2025 - Abstract #ASH2025ASH_7634;
P2
No new or worsening safety signalswere observed compared with prior ASC studies and overall QOL improved or remained stable in mostpts. Results support early switching to ASC as an effective strategy to achieve DMR while maintainingfavorable safety/tolerability and QOL.
- Herceptin (trastuzumab) / Roche, denifanstat (TVB-2640) / Sagimet Biosci
Phase II Trial of the FASN Inhibitor, Denifanstat (TVB-2640), Plus Trastuzumab in Combination with Paclitaxel or Endocrine Therapy (ET) in Patients with HER2+ Metastatic Breast Cancer (MBC) Resistant to Trastuzumab (Exhibit Hall) - Oct 30, 2025 - Abstract #SABCS2025SABCS_1957;
Expected paclitaxel-associated AEs were observed. Nearly half of pts experienced a grade 3 or 4 AE attributed to the combination therapy, and 20% stopped treatment due to AE.
- || denifanstat (TVB-2640) / Sagimet Biosci
New P1 trial: A Drug-Drug Interaction Study of Denifanstat and Resmetirom in Healthy Adult Participants (clinicaltrials.gov) - Oct 16, 2025
P1, N=40, Active, not recruiting, Sponsor: Sagimet Biosciences Inc.
- denifanstat (TVB-2640) / Sagimet Biosci
DENIFANSTAT ELICITED A SIGNIFICANT ?2-STAGE IMPROVEMENT IN FIBROSIS IN F3 MASH PATIENTS, AND IMPROVED LIVER FIBROSIS AND BIOMARKERS IN QFIBROSIS STAGE 4 MASH PATIENTS: SECONDARY ANALYSIS OF PHASE 2B FASCINATE-2 STUDY (Convention Center: Hall DE 4001-4103 Posters) - Oct 7, 2025 - Abstract #AASLD2025AASLD_3017;
Digital pathology identified a subpopulation of MASH patients with advanced baseline fibrosis (qF4), and denifanstat reduced fibrosis and multiple NIT biomarkers that indicate improvements in steatosis, inflammation and fibrosis in this subgroup. These findings support further clinical evaluation of denifanstat in MASH patients with advanced fibrosis, including compensated liver cirrhosis.
- denifanstat (TVB-2640) / Sagimet Biosci
Spatial Computational Histology Stratified Denifanstat Fibrosis Responders in the Phase 2b FASCINATE-2 MASH Study (Convention Center: Hall DE 2001-2158 Posters) - Oct 7, 2025 - Abstract #AASLD2025AASLD_1765;
These findings support further clinical evaluation of denifanstat in MASH patients with advanced fibrosis, including compensated liver cirrhosis. Quantitative single-fiber traits and clustering revealed fibrosis phenotypes that predict denifanstat response, supporting that computational pathology could be leveraged for response stratification.
- | omeprazole / Generic mfg., denifanstat (TVB-2640) / Sagimet Biosci
Review, Journal: Fatty acid synthase in chemoresistance: mechanisms and therapeutic opportunities. (Pubmed Central) - Sep 29, 2025
While by far, several FAS inhibitors, including denifanstat and omeprazole, have demonstrated beneficial effects in clinical trials, no candidate has been approved by the FDA. We concluded here that targeting FAS is a feasible strategy to overcome chemoresistance, although more interdisciplinary efforts are needed to identify a potent, specific, and bioavailable FAS inhibitor for clinical applications.
- | Review, Journal, IO biomarker: Present and Future Perspectives in the Treatment of Liver Fibrosis. (Pubmed Central) - Sep 27, 2025
Novel modalities such as immunotherapy, gene editing, and multi-targeted therapies hold additional potential for fibrosis reversal. Continued translational efforts are critical to establish safe, effective, and accessible treatments for patients with liver fibrosis.
- | denifanstat (TVB-2640) / Sagimet Biosci
Review, Journal: Targeting Cancer Metabolism: Therapeutic Potential of the Fatty Acid Synthase (FASN) inhibitors. (Pubmed Central) - Sep 20, 2025
Clinical evidence suggests that FASN blockade not only impairs tumor growth but also potentiates the efficacy of existing treatments, including chemotherapy and targeted agents, thereby supporting its integration into combination regimens. Future clinical optimization will require the identification of predictive biomarkers to guide patient selection and treatment stratification.
- denifanstat (TVB-2640) / Sagimet Biosci
First-in-Class FASN Inhibitor Denifanstat Achieved All Endpoints in the Treatment of Acne Vulgaris: Results from a Phase ? Randomised Placebo Controlled Trial (Paris Nord) - Sep 8, 2025 - Abstract #EADV2025EADV_6145;
P2, P3
Conclusion Once daily 50 mg denifanstat achieved highly statistically significant and clinically meaningful improvements across all efficacy endpoints. The exceptional efficacy of denifanstat coupled with its favorable safety and tolerability profile represents a potential major break-through for the treatment of acne vulgaris.
- | denifanstat (TVB-2640) / Sagimet Biosci
Journal: Laboratory Investigation of Lipid Metabolic Reprogramming in Pulpitis: The Linolenic Acid-FASN-NR4A1 Axis in Modulating Dental Pulp Inflammation. (Pubmed Central) - Sep 4, 2025
Dual targeting of fatty acid synthesis and lipid depletion-through FASN inhibition and LA supplementation-attenuates inflammation via NR4A1-dependent mechanisms. These findings lay the groundwork for metabolic approaches to modulate inflammation in endodontics.
- denifanstat (TVB-2640) / Sagimet Biosci, etomoxir (MIQ-001) / Numiera Therapeutics
Hypoxia-Driven Fatty Acid Metabolism Regulates Angiogenesis in Gastrointestinal Cancers (Poster and Exhibition Hall; Poster Board No EACR25-2085) - Jun 29, 2025 - Abstract #EACR2025EACR_1596;
The inverse correlation between secreted FA levels and vessel formation highlights a potential mechanism for aberrant tumor vascularization. Interestingly, gastric cancer cells appear to follow a distinct metabolic pattern, warranting further investigation.
- ||||||| denifanstat (TVB-2640) / Sagimet Biosci
Trial completion: A Study to Evaluate the Safety and Efficacy of ASC40 (Denifanstat) Tablets in the Treatment of Patients With Moderate to Severe Acne Vulgaris (clinicaltrials.gov) - Jun 19, 2025
P3, N=480, Completed, Sponsor: Ascletis Pharmaceuticals Co., Ltd.
Interestingly, gastric cancer cells appear to follow a distinct metabolic pattern, warranting further investigation. Active, not recruiting --> Completed
- Scemblix (asciminib) / Novartis
ASC4OPT STUDY: HIGH EFFICACY AND FAVORABLE TOLERABILITY OF ASCIMINIB ONCE OR TWICE DAILY IN CML PATIENTS WITH SUBOPTIMAL RESPONSE, RESISTANCE OR INTOLERANCE OF 2 OR MORE TYROSINE KINASE INHIBITORS (Poster Hall) - May 15, 2025 - Abstract #EHA2025EHA_2852;
P3
The ASC4OPT findings strengthen those of the ASCEMBL study, supporting ASC as a standard of care for pts with CML-CP pretreated with ?2 TKIs; the more convenient 80 mg QD regimen may enhance treatment adherence and ultimately improve patient outcomes. Pts who discontinued previous TKIs due to intolerance were able to maintain or deepen responses on ASC regardless of dosing schedule.
- || denifanstat (TVB-2640) / Sagimet Biosci
Enrollment change, Trial withdrawal: FASCINIT: A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASLD and MASH (clinicaltrials.gov) - May 15, 2025
P3, N=0, Withdrawn, Sponsor: Sagimet Biosciences Inc.
Pts who discontinued previous TKIs due to intolerance were able to maintain or deepen responses on ASC regardless of dosing schedule. N=2000 --> 0 | Not yet recruiting --> Withdrawn
- || denifanstat (TVB-2640) / Sagimet Biosci
Enrollment change, Trial withdrawal: FASCINATE-3: A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASH and F2/F3 Fibrosis (clinicaltrials.gov) - May 15, 2025
P3, N=0, Withdrawn, Sponsor: Sagimet Biosciences Inc.
N=2000 --> 0 | Not yet recruiting --> Withdrawn N=1260 --> 0 | Not yet recruiting --> Withdrawn
- | cisplatin / Generic mfg., denifanstat (TVB-2640) / Sagimet Biosci
Journal: Targeting FASN enhances cisplatin sensitivity via SLC7A11-mediated ferroptosis in cervical cancer. (Pubmed Central) - Apr 16, 2025
Targeting FASN enhances cisplatin sensitivity in CC by promoting SLC7A11-mediated ferroptosis. TVB-2640 combined with cisplatin had superior synergistic antitumor effects in cisplatin-resistant CC models.
- | denifanstat (TVB-2640) / Sagimet Biosci
Journal: Pharmacologically targeting fatty acid synthase-mediated de novo lipogenesis alleviates osteolytic bone loss by directly inhibiting osteoclastogenesis through suppression of STAT3 palmitoylation and ROS signaling. (Pubmed Central) - Apr 5, 2025
The results show that ASC40 significantly attenuates bone loss and osteoclastogenesis in both models. In conclusion, our results demonstrate that Fasn-mediated DNL is a novel positive regulator of osteoclastogenesis and may serve as a promising therapeutic target for the treatment of osteoclast-driven osteolytic bone diseases.
- denifanstat (TVB-2640) / Sagimet Biosci
Structure, dynamics and therapeutic potential of fatty acid synthase (Section 26; Poster Board No: 5) - Mar 25, 2025 - Abstract #AACR2025AACR_6378;
The modifying region of hFASN was determined at near-atomic resolution using a recombinant expression system bound to the first-in-class inhibitor Denifanstat, enabling structure-based small molecule discovery...These modifications may play a role in protein stabilization or regulation under stress conditions, highlighting a potential mechanism for hFASN activity modulation. Together, these findings provide critical structural and regulatory insights, paving the way for targeted therapeutic development.
- | Journal: Fatty acid synthase (FASN) inhibition cooperates with BH3 mimetic drugs to overcome resistance to mitochondrial apoptosis in pancreatic cancer. (Pubmed Central) - Mar 16, 2025
Computational studies with TVB-3166 and TVB-3664, two analogues of the clinical-grade FASNi TVB-2640 (denifanstat), confirmed their uncompetitive behavior towards NADPH when bound to the FASN ketoacyl reductase domain...Experiments in PDAC PDXs in vivo confirmed the synergistic antitumor activity of TVB-3664 with navitoclax and venetoclax, independent of the nature of the replication stress signature of patient-derived PDAC cells. The discovery that targeted inhibition of FASN is a metabolic perturbation that sensitizes PDAC cells to BH3 mimetics warrants further investigation to overcome resistance to mitochondrial apoptosis in PDAC patients.
- ||||| denifanstat (TVB-2640) / Sagimet Biosci
Enrollment closed: A Study to Evaluate Safety of ASC40 Tablets in Patients with Moderate to Severe Acne Vulgaris (clinicaltrials.gov) - Mar 12, 2025
P3, N=240, Active, not recruiting, Sponsor: Ascletis Pharmaceuticals Co., Ltd.
The discovery that targeted inhibition of FASN is a metabolic perturbation that sensitizes PDAC cells to BH3 mimetics warrants further investigation to overcome resistance to mitochondrial apoptosis in PDAC patients. Recruiting --> Active, not recruiting
- | tamoxifen / Generic mfg., fulvestrant / Generic mfg., denifanstat (TVB-2640) / Sagimet Biosci
Journal: Lipid metabolic reprogramming drives triglyceride storage and variable sensitivity to FASN inhibition in endocrine-resistant breast cancer cells. (Pubmed Central) - Mar 9, 2025
While TVB-2640 reduced lipid storage in most conditions, it had limited effects on the growth of endocrine resistant breast cancer cells. Targeting specific lipid metabolic dependencies, particularly pathways that produce PUFAs, represents a potential therapeutic strategy in endocrine resistant breast cancer.
- denifanstat (TVB-2640) / Sagimet Biosci
Denifanstat improves multiple qFibrosis-based collagen features linked to major adverse liver outcomes in patients with metabolic dysfunction-associated steatohepatitis patients and high polygenic risk (Poster Area) - Mar 8, 2025 - Abstract #EASL2025EASL_2183;
- denifanstat (TVB-2640) / Sagimet Biosci
Denifanstat-mediated reduction of plasma glycine- and taurine-conjugated bile acids correlates with histological improvements in denifanstat-treated metabolic dysfunction-associated steatohepatitis patients in phase 2b FASCINATE-2 study (Poster Area) - Mar 8, 2025 - Abstract #EASL2025EASL_872;
- denifanstat (TVB-2640) / Sagimet Biosci
Assessment of the metabolic dysfunction-associated steatohepatitis resolution index and component biomarkers in prediction of histology response to denifanstat in the FASCINATE-2 trial (Poster Area) - Mar 8, 2025 - Abstract #EASL2025EASL_835;
- | Retrospective data, Journal: Comparison of pharmacological therapies in metabolic dysfunction-associated steatohepatitis for fibrosis regression and MASH resolution: Systematic review and network meta-analysis. (Pubmed Central) - Feb 4, 2025
This study provides updated rank-order efficacy of MASH pharmacological therapies for fibrosis regression and MASH resolution. These data are helpful to inform practice and clinical trial design.
- ||||| denifanstat (TVB-2640) / Sagimet Biosci
Trial initiation date: FASCINATE-3: A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASH and F2/F3 Fibrosis (clinicaltrials.gov) - Jan 29, 2025
P3, N=1260, Not yet recruiting, Sponsor: Sagimet Biosciences Inc.
These data are helpful to inform practice and clinical trial design. Initiation date: Dec 2024 --> Mar 2025
- | Xtandi (enzalutamide) / Pfizer, Astellas, denifanstat (TVB-2640) / Sagimet Biosci
Trial completion date: Study of TVB-2640 in Men With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - Dec 27, 2024
P1, N=30, Recruiting, Sponsor: Weill Medical College of Cornell University
Initiation date: Dec 2024 --> Mar 2025 Trial completion date: Nov 2027 --> Nov 2026
- | denifanstat (TVB-2640) / Sagimet Biosci
Trial primary completion date: Phase 2 Study of TVB-2640 in KRAS Non-Small Cell Lung Carcinomas (clinicaltrials.gov) - Dec 20, 2024
P2, N=18, Active, not recruiting, Sponsor: David E Gerber
Trial completion date: Nov 2027 --> Nov 2026 Trial primary completion date: Dec 2024 --> Apr 2025
- ||||| denifanstat (TVB-2640) / Sagimet Biosci
Enrollment closed, Trial primary completion date: A Study to Evaluate the Safety and Efficacy of ASC40 (Denifanstat) Tablets in the Treatment of Patients With Moderate to Severe Acne Vulgaris (clinicaltrials.gov) - Nov 22, 2024
P3, N=480, Active, not recruiting, Sponsor: Ascletis Pharmaceuticals Co., Ltd.
Trial primary completion date: Dec 2024 --> Apr 2025 Trial primary completion date: Dec 2024 --> May 2025 | Recruiting --> Active, not recruiting
- |||||||||| denifanstat (TVB-2640) / Sagimet Biosci
New P3 trial: FASCINIT: A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASLD and MASH (clinicaltrials.gov) - Nov 18, 2024
P3, N=2000, Not yet recruiting, Sponsor: Sagimet Biosciences Inc.
- || denifanstat (TVB-2640) / Sagimet Biosci
P2b data, Journal: Denifanstat for the treatment of metabolic dysfunction-associated steatohepatitis: a multicentre, double-blind, randomised, placebo-controlled, phase 2b trial. (Pubmed Central) - Nov 13, 2024
P2
Treatment with denifanstat resulted in statistically significant and clinically meaningful improvements in disease activity, MASH resolution, and fibrosis. The results of this phase 2b trial support the advancement of denifanstat to phase 3 development.
- denifanstat (TVB-2640) / Sagimet Biosci, Truqap (capivasertib) / Otsuka, AstraZeneca
Targeting the PI3K/AKT Pathway and Fatty Acid Synthase in AL Amyloidosis: Mechanistic Insights and Therapeutic Implications (Halls G-H (San Diego Convention Center)) - Nov 6, 2024 - Abstract #ASH2024ASH_5392;
Conclusions : Our findings highlight the significant upregulation of FASN in AL amyloidosis and its regulation by the PI3K/AKT pathway. The observed effects of Capivasertib on FASN expression and cell proliferation, along with the upregulation of inflammatory cytokines, underscore the potential for targeting the PI3K/AKT signaling pathway and FASN in developing more specific therapeutic strategies for AL amyloidosis.
- |||||| denifanstat (TVB-2640) / Sagimet Biosci
Enrollment open: A Study to Evaluate Safety of ASC40 Tablets in Patients with Moderate to Severe Acne Vulgaris (clinicaltrials.gov) - Nov 4, 2024
P3, N=240, Recruiting, Sponsor: Ascletis Pharmaceuticals Co., Ltd.
The observed effects of Capivasertib on FASN expression and cell proliferation, along with the upregulation of inflammatory cytokines, underscore the potential for targeting the PI3K/AKT signaling pathway and FASN in developing more specific therapeutic strategies for AL amyloidosis. Not yet recruiting --> Recruiting
- Inhibition of FASN and ACC1 as a Potential Treatment for Advanced Endocrine Therapy-Resistant Breast Cancer (Halls 2-3) - Nov 1, 2024 - Abstract #SABCS2024SABCS_1183;