RegulationOrphan Drug (United States), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Special Review Project (China)

Structure/Sequence

Molecular FormulaC22H19FN4O2

InChIKeySZMJVTADHFNAIS-BJMVGYQFSA-N

CAS Registry1616493-44-7

271

Clinical Trials associated with Chidamide

NCT06556862

/ Not yet recruitingPhase 2IIT

Exploration of Dalpiciclib Plus HDACi in HR+/HER2- Advanced Breast Cancer After Failure of CDK4/6 Inhibitor: a Phase II Study

A phase II study to explore the efficacy and safety of dalpiciclib plus HDACi in HR+/HER2- advanced breast cancer after the failure of CDK4/6 inhibitor therapy.

Start Date01 Oct 2025

Sponsor / Collaborator

302 Military Hospital of China

NCT07133763

/ Not yet recruitingPhase 1/2IIT

A Multicenter, Single-Arm, Prospective Study to Evaluate the Efficacy and Safety of PD-1 Inhibitor Combined With Tenofovir, Chidamide, and Lenalidomide in the Treatment of Relapsed or Refractory EBV-Associated Lymphoproliferative Disorders.

This study is a prospective, multicenter, single-arm clinical trial designed to evaluate the efficacy and safety of PD-1 inhibitor combined with tenofovir, chidamide, and lenalidomide in the treatment of relapsed or refractory Epstein-Barr virus (EBV)-associated lymphoproliferative disorders (LPDs). The primary endpoint is the overall response rate (ORR) at 3 months, including complete response (CR) and partial response (PR). Secondary endpoints include overall survival (OS), progression-free survival (PFS), as well as safety and tolerability assessments. Eligible patients must have histologically confirmed EBV-positive B-cell or T/NK-cell LPDs with measurable lesions. This combination regimen targets multiple mechanisms, including inhibition of EBV replication, activation of the immune system, and enhancement of antitumor effects, aiming to provide an innovative therapeutic strategy for this challenging disease.

Start Date01 Sep 2025

Sponsor / Collaborator

Affiliated Hospital of Xuzhou Medical University

NCT07133776

/ Not yet recruitingPhase 1/2IIT

A Multicenter, Single-Arm, Prospective Clinical Study to Evaluate the Efficacy and Safety of PD-1 Inhibitor Combined With Tenofovir, Chidamide, and Lenalidomide in the Treatment of EBV-Associated Diseases

Currently, treatment options for Epstein-Barr virus (EBV) infection are limited, with unsatisfactory efficacy and no established standard therapy. Therefore, our center is conducting a prospective, multicenter, single-arm clinical trial to evaluate the efficacy and safety of PD-1 inhibitor in combination with tenofovir, chidamide, and lenalidomide in patients with EBV infectious diseases, aiming to provide a more effective and safer therapeutic option for EBV infectious diseases.

Start Date01 Sep 2025

Sponsor / Collaborator

Affiliated Hospital of Xuzhou Medical University

100 Clinical Results associated with Chidamide

100 Translational Medicine associated with Chidamide

100 Patents (Medical) associated with Chidamide

2,481

Literatures (Medical) associated with Chidamide

01 Dec 2025·BIOORGANIC & MEDICINAL CHEMISTRY LETTERS

Recent progress in synthetic strategies to develop potent, HDAC8-selective, small-molecule inhibitors

Review

Author: Fletcher, Steven ; Lowe, Brandon D

Key players in epigenetic control, the 11 zinc-dependent histone deacetylase (HDAC) enzymes have been affirmed as therapeutic targets, particularly in the discovery of new chemotherapy drugs: currently there are 3 FDA-approved pan-HDAC inhibitors (HDACi's), although these are not without their side effects. It has been rationalized that achieving HDAC isoform-selective inhibitors may yield safer drugs. HDAC8 has recently been validated as a novel target for the treatment of (pediatric) neuroblastoma, and its overexpression has been implicated in a range of other diseases. Herein, we discuss the topology of the HDAC8 active site in the context of inhibitor design, and we present recent progress in the discovery of potent, HDAC8-selective small-molecule inhibitors, with a discussion on the particular structural criteria required. HDACi's largely conform to a canonical pharmacophore model of a capping group connected via a linker to a zinc binding group (ZBG), which is typically a (potentially mutagenic) hydroxamic acid. In particular, for HDAC8-selectivity, the small-molecule should adopt a geometric "L"-shape, which may be accomplished by the linker itself, or the linker and capping group. More recently, HDAC isoform selectivity has been realized with hydroxamic acid surrogates, such as ortho-aminoanilides that yield potent and HDAC1-3-selective (but HDAC8-inactive) inhibitors. Hydrazides have long been utilized as bioisosteres of hydroxamic acids in HDAC inhibitor design, but a recent re-visiting explored the attachment of alkyl groups, and an n-hexyl substituent on the distal, non-acylated nitrogen affords potent and selective HDAC8 inhibitors probably through targeting the foot pocket of the active site; this discovery was observed across three different HDACi scaffolds, and thus appears quite general. α-Aminoketo ZBGs have also demonstrated HDAC8-selectivity, with associated benzylic moieties likewise engaging the foot pocket. We speculate that a re-imagining of the ortho-aminoanilide ZBG through a careful and methodical survey of related moieties, may lead to the discovery of additional HDAC8-selective ZBGs towards the realization of safe, pre-clinical inhibitors. 2025 Elsevier Ltd. All rights reserved.

01 Nov 2025·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Targeting histone deacetylase 1: Inhibition and activation as promising therapeutic strategies for diverse disorders

Review

Author: Cosentino, Giuseppe ; Reale, Carlo ; Rescifina, Antonio ; Marrazzo, Agostino ; Pasquinucci, Lorella ; Buccheri, Rocco ; Amata, Emanuele ; Costanzo, Giuliana ; Zuccalà, Sara

Epigenetic regulation plays a crucial role in several pathological conditions. Dysregulation of histone deacetylase (HDAC) enzymes has been implicated in the onset and progression of numerous diseases, including cancer, inflammatory disorders, and neurodegenerative conditions. Most known HDAC inhibitors (HDACi) are classified as "pan-inhibitors", targeting multiple HDAC isoforms indiscriminately. However, the growing demand for isoform-selective ligands has emphasized the need for more targeted therapeutic strategies. Among HDAC isoforms, HDAC1 has emerged as a particularly promising target for pharmacological intervention. This review provides a comprehensive overview of current HDAC1-selective ligands, including inhibitors and activators, highlighting their potential as useful therapeutic tools. The most promising class I of HDACi currently in clinical trials is discussed.

01 Oct 2025·BIOCHEMICAL PHARMACOLOGY

Therapeutic potential of HDAC inhibitors in a xenograft model of cancers: A special focus on breast cancer

Review

Author: Vora, Lalitkumar K ; Sinha, Suman ; Babu, Raja ; Pancholi, Bhaskaranand ; Khatri, Dharmendra Kumar ; Garabadu, Debapriya ; Manhar, Nirmal

Histone deacetylase inhibitors (HDACi) have emerged as promising agents in cancer therapy, particularly in breast cancer treatment. In this context, it is postulated that HDACi exhibits strong antiproliferative effects on breast cancer cells, regulating the cell cycle, modulating the immune response, triggering apoptosis, suppressing tumour growth, and reducing angiogenesis. Their ability to modify the acetylation status of histone proteins and other nonhistone targets has shown significant anticancer activity. However, there is less information on their application in clinical breast cancer treatment. Moreover, the ability of patient-derived xenograft (PDX) models of breast cancer to replicate the genetic and histological heterogeneity of human tumours has made them practical tools in preclinical research. This review focuses on the fate of the anticancer activity of HDACi in a PDX model of breast cancer, which serves as an essential experimental tool to evaluate the efficacy and safety of these molecules in vivo. The results highlight the promise of HDACi in treating breast cancer in PDX models, providing information on their mechanisms of action and encouraging further investigations in clinical studies. The present study also highlights the importance of personalized treatment strategies for controlling the progression of breast cancer.

News (Medical) associated with Chidamide

20 Aug 2025

·www.prnewswire.com

HDAC Inhibitors Market Sees Upward Trajectory Across the 7MM During the Forecast Period (2025-2034) Driven by Innovation in Cancer Therapies | DelveInsight

The HDAC inhibitor pipeline remains active, with several next-generation agents advancing in clinical trials. Abexinostat (Xynomic Pharmaceuticals) is in Phase III development for renal cell carcinoma, representing a potential expansion into solid tumors. Quisinostat (Viriom) is in Phase II for uveal melanoma, and Entinostat, partnered between EOC Pharma and Syndax, is being explored in Hodgkin lymphoma. LAS VEGAS, Aug. 20, 2025 /PRNewswire/ -- DelveInsight's HDAC Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, addressable patient population, which includes top indications such as Multiple Myeloma, Peripheral T-cell Lymphoma (PTCL), Cutaneous T-cell Lymphoma (CTCL), Amyotrophic Lateral Sclerosis (ALS), and others. The selected indications are based on approved therapies and ongoing pipeline activity. The report also provides insights into the emerging HDAC inhibitors, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM. Key Takeaways from the HDAC Inhibitors Market Report As per DelveInsight's analysis, the total market size of HDAC inhibitors in the 7MM is expected to surge significantly by 2034. The report provides the total potential number of patients in the indications, such as Multiple Myeloma, Peripheral T-cell Lymphoma (PTCL), Cutaneous T-cell Lymphoma (CTCL), Amyotrophic Lateral Sclerosis (ALS), and others. Leading HDAC inhibitor companies, such as Xynomic Pharmaceuticals, Viriom, EOC Pharma, Syndax Pharmaceuticals, Jubilant Therapeutics, and others, are developing novel HDAC inhibitors that can be available in the HDAC inhibitors market in the coming years. Some of the key HDAC inhibitors in the pipeline include Abexinostat, Quisinostat, Entinostat, JBI-802, and others. Discover which indication is expected to grab the major HDAC inhibitors market share @ HDAC Inhibitors Market Report HDAC Inhibitors Overview Histone deacetylases (HDACs) remove acetyl groups from both histone and non-histone proteins. Because acetylation of histones is linked to an open chromatin structure and active gene transcription, HDAC activity leads to histone deacetylation and epigenetic suppression of gene expression. Since HDACs influence many pathways involved in cancer development, HDAC inhibitors (HDACis) show clinical effects through several mechanisms, including changes in gene expression of cell cycle and apoptotic proteins, acetylation of other proteins involved in cell growth and survival, effects on angiogenesis, aggresome formation, and DNA repair. There are 18 known HDACs, divided into two major groups and four classes based on their cellular location, homology, enzyme mechanism, sequence of discovery, and histone substrate specificity. The first group includes zinc-dependent HDACs, which all share a similar catalytic core for deacetylating acetyl-lysine residues. These comprise Class I (HDAC1, -2, -3, -8), Class II (IIa: HDAC4, -5, -7, -9; IIb: HDAC6, -10), and Class IV (HDAC11). The second group includes Class III HDACs (sirtuins, SIRT1–7), which rely on NAD+ for their enzymatic activity. HDAC Inhibitors Epidemiology Segmentation The HDAC inhibitors market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Cases of Selected Indications for HDAC Inhibitor Total Eligible Patient Pool of Selected Indications for HDAC Inhibitor Total Treated Cases of Selected Indications for HDAC Inhibitor HDAC Inhibitors Treatment Market Several HDAC inhibitors are currently available on the market. Recent entrants include DUVYZAT (givinostat), while earlier approved drugs include BELEODAQ (belinostat), HIYASTA (tucidinostat), among others. DUVYZAT is a histone deacetylase inhibitor approved for treating Duchenne muscular dystrophy (DMD) in patients aged 6 and above. While it is categorized as an HDAC inhibitor, its exact mechanism of action in DMD is not fully understood. In April 2025, Italfarmaco announced that the CHMP of the European Medicines Agency (EMA) issued a positive opinion on DUVYZAT. The drug is also being evaluated in other indications: Phase III trial in Becker muscular dystrophy (BMD) and Phase II trial in polycythemia vera. HIYASTA (HBI-8000) is an epigenetic immunomodulator approved for several indications, including use as monotherapy for certain subtypes of relapsed or refractory T-cell non-Hodgkin's lymphoma, specifically adult T-cell leukemia-lymphoma (ATLL) and peripheral T-cell lymphoma (PTCL) in Japan. HUYABIO International is conducting a multinational Phase III trial evaluating HIYASTA in combination with nivolumab for previously untreated metastatic or unresectable malignant melanoma. HIYASTA is an oral HDAC Class I inhibitor that induces cell cycle arrest and apoptosis in tumor cells, which underlies its efficacy in lymphoma. In September 2020, the Japanese Ministry of Health, Labour and Welfare (MHLW) granted orphan drug designation (ODD) to HIYASTA for relapsed/refractory ATL, and in December 2015 for PTCL. In June 2021, HUYABIO also received regulatory approval in Japan for HBI-8000 as monotherapy for relapsed/refractory ATL. Key Emerging HDAC Inhibitors and Companies Xynomic Pharmaceuticals (Abexinostat), Viriom (Quisinostat), EOC Pharma/Syndax Pharmaceuticals (Entinostat), Jubilant Therapeutics (JBI-802), and several other companies are currently engaged in the development and production of HDAC inhibitors, which have the potential to significantly impact and enhance the HDAC inhibitors market. Abexinostat, an oral, broad-spectrum HDAC inhibitor originally developed by Pharmacyclics and later licensed by Xynomic Pharmaceuticals in 2017, has demonstrated encouraging activity in both blood cancers and solid tumors. The drug is currently being studied in several Phase I to III clinical trials worldwide. In September 2019, Xynomic announced that the FDA had granted Fast Track Designation (FTD) to abexinostat as a monotherapy for fourth-line treatment of relapsed or refractory follicular lymphoma. The FDA had previously granted FTD for abexinostat in combination with pazopanib for first- or second-line therapy in renal cell carcinoma. Additional Phase II trials are underway in indications such as Diffuse Large B-cell Lymphoma (DLBCL) and Follicular Lymphoma. Quisinostat is another potent, selective oral pan-HDAC inhibitor, initially developed by Janssen Pharmaceuticals. HDAC inhibitors work by inducing cell cycle arrest, promoting differentiation, and triggering apoptosis in various human cancer cell lines. By inhibiting histone deacetylase, they increase acetylation of histone proteins, resulting in a more transcriptionally active chromatin state and altered gene expression involved in proliferation, apoptosis, and differentiation. Multiple preclinical studies and Phase I/II trials have evaluated quisinostat's safety and effectiveness, showing promising anti-tumor effects in several advanced and treatment-resistant cancers — including platinum-resistant ovarian cancer (in combination with paclitaxel and carboplatin), uveal melanoma, and synovial sarcoma. The anticipated launch of these emerging therapies are poised to transform the HDAC inhibitors market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the HDAC inhibitors market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about HDAC inhibitors clinical trials, visit @ HDAC Inhibitors Treatment Recent Developments in the HDAC Inhibitors Space In May 2025, Amylyx Pharmaceuticals announced positive Week 48 data from the Phase II open-label HELIOS clinical trial of AMX0035 in adults living with Wolfram syndrome. In May 2025, the University of Miami, in collaboration with Viriom, initiated a Phase II clinical trial in the US (NCT06932757) to evaluate an oral therapy for patients with uveal melanoma who have undergone at least one prior line of treatment. In April 2025, Xynomic Pharmaceuticals concluded a Phase I/II clinical trial in the United States (NCT03939182), evaluating a combination oral therapy for patients with Diffuse Large B-cell Lymphoma and Mantle Cell Lymphoma who had received at least one prior line of treatment. Discover more about HDAC inhibitors in development @ HDAC Inhibitors Clinical Trials HDAC Inhibitors Market Dynamics HDAC inhibitors are a class of epigenetic drugs that modify gene expression by altering chromatin structure. Initially developed as anticancer agents, they have shown significant therapeutic potential in various malignancies, especially hematologic cancers like T-cell lymphoma and multiple myeloma. The market initially gained traction with FDA approvals of drugs such as Vorinostat, Romidepsin, and Panobinostat. Their unique mechanism of action targeting epigenetic regulation drew interest as precision medicine and oncology research grew, driving pharmaceutical investment in this segment. The HDAC inhibitors market continues to expand largely due to the rising prevalence of cancer worldwide and the need for more targeted therapies with better safety profiles. Additionally, ongoing clinical trials are exploring HDAC inhibitors in combination with other therapies, such as immune checkpoint inhibitors, proteasome inhibitors, and traditional chemotherapeutics. These combination approaches aim to overcome resistance and enhance efficacy, creating more opportunities for market growth. As more data emerges demonstrating synergistic benefits, partnerships between biotech startups and large pharmaceutical firms are accelerating further development. Despite this positive outlook, the market faces several challenges. Many HDAC inhibitors are associated with toxicity issues such as fatigue, gastrointestinal disturbances, and thrombocytopenia, which limit broader adoption. Competition from newer targeted therapies and immuno-oncology drugs also puts pressure on the HDAC inhibitor segment. Moreover, several compounds failed in late-stage trials due to a lack of efficacy, leading to cautious investor sentiment and prioritization of combination rather than monotherapy approaches. Looking ahead, the market dynamics are expected to be shaped increasingly by precision oncology trends and biomarker-driven patient selection, allowing more effective targeting of responders. If safety profiles can be improved and combination regimens continue to show strong results, HDAC inhibitors will retain a meaningful role in the evolving oncology landscape. Novel formulations, selective HDAC isoform inhibitors, and expansion into non-oncology indications such as neurodegenerative or inflammatory diseases may further diversify the market and drive its next phase of growth. Learn more about the HDAC inhibitors @ HDAC Inhibitors Analysis Scope of the HDAC Inhibitors Market Report HDAC Inhibitors Therapeutic Assessment: HDAC Inhibitors' current marketed and emerging therapies HDAC Inhibitors Market Dynamics: Conjoint Analysis of Emerging HDAC Inhibitor Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, HDAC Inhibitors Market Access and Reimbursement Table of Contents Related Reports Multiple Myeloma Market Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key multiple myeloma companies, including Sanofi, Karyopharm Therapeutics, Takeda Pharmaceutical, Celgene, Bristol-Myers Squibb, RAPA Therapeutics, Pfizer, Array Biopharma, Cellectar Biosciences, BioLineRx, Celgene, Aduro Biotech, ExCellThera, Janssen Pharmaceutical, Precision BioSciences, Takeda, Glenmark (Ichnos Sciences SA), Poseida Therapeutics, Molecular Partners AG, Chipscreen Biosciences, AbbVie, Genentech (Roche), Janssen Biotech, Nanjing Legend Biotech, Merck Sharp & Dohme Corp., among others. Amyotrophic Lateral Sclerosis Market Amyotrophic Lateral Sclerosis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key ALS companies, including AB Science, Alector, GSK, Brainstorm Cell Therapeutics, Ionis Pharmaceuticals, Medicinova, Denali Therapeutics, AbbVie, Calico Life Sciences, Clene Nanomedicine Biosciences, Seelos Therapeutics, Prilenia Therapeutics, Rapa Therapeutics, Neurosense Therapeutics, Helixmith, Transposon Therapeutics, Revalesio Corporation, Annexon Biosciences, Corcept Therapeutics, AL-S Pharma, Sanofi, Denali Therapeutics, Orphai Therapeutics, among others. Peripheral T-cell Lymphoma Market Peripheral T-cell Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key PTCL companies, including Secura Bio, Shanghai YingLi Pharmaceutical, Dizal Pharmaceuticals, Viracta Therapeutics, Innate Pharma, CStone Pharmaceuticals, Affimed, Otsuka Pharmaceutical, Astex Pharmaceuticals, Autolus, Myeloid Therapeutics, Merck Sharp & Dohme, Bristol Myers Squibb, among others. Cutaneous T-cell Lymphoma Market Cutaneous T-cell Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key CTCL companies, including Pfizer, Helsinn Therapeutics, Kyowa Hakko Kirin, Citius Pharmaceuticals, Soligenix, Prescient Therapeutics, Innate Pharma, Bristol-Myers Squibb, BioInvent International AB, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Phase 3Fast TrackOrphan DrugImmunotherapy

01 Jul 2025

·cerenoscientific.com

Cereno Scientific is included in Nasdaq’s First North 25™ Index

01 Jul 2025 06:00 Cereno Scientific (Nasdaq First North: CRNO B), an innovative biotech pioneering treatments to enhance and extend life for people with rare cardiovascular and pulmonary diseases, today announced that the company is added to the First North 25™ Index (FN25 Index). The Index gathers a selection of the largest and most traded securities on the Nasdaq Nordic First North Growth Markets. The inclusion is effective at market open on Tuesday, July 1, 2025. "Being included in the First North 25 Index is a proud milestone for Cereno Scientific and a reflection of the progress we have made in building a strong and credible biotech company. It also represents the trust and long-term belief placed in us by our shareholders, who continue to support our mission to develop pioneering treatments for patients with rare cardiovascular and pulmonary diseases. We remain focused on delivering scientific, clinical, and strategic value for patients and shareholders as we move forward,” said Sten R. Sörensen, CEO at Cereno Scientific. The First North 25 Index measures the performance of a selection of the largest and most traded securities listed on the Nasdaq Nordic First North Growth Markets (First North Denmark, First North Finland, First North Iceland and First North Sweden). Further information is available on https://indexes.nasdaqomx.com/Index/Overview/FN25 For further information, please contact: Tove Bergenholt, Head of IR & Communications Email: tove.bergenholt@cerenoscientific.com Phone: +46 73- 236 62 46 About Cereno Scientific AB Cereno Scientific is pioneering treatments to enhance and extend life. Our innovative pipeline offers disease-modifying drug candidates to empower people suffering from rare cardiovascular and pulmonary diseases to live life to the full. Lead candidate CS1 is an HDACi that works through epigenetic modulation, being developed as an effective and disease modifying treatment with a favorable safety and tolerability profile for rare disease Pulmonary Arterial Hypertension (PAH). A Phase IIa trial evaluating CS1’s safety, tolerability, and exploratory efficacy in patients with PAH demonstrated that CS1 has a favorable safety profile, is well-tolerated and showed a positive impact on exploratory clinical efficacy parameters. An Expanded Access Program enables patients that have completed the Phase IIa trial to gain access to CS1. CS014, in Phase I development, is a new chemical entity with disease-modifying potential. CS014 is a HDAC inhibitor with a multimodal mechanism of action as an epigenetic modulator having the potential to address the underlying pathophysiology of rare cardiovascular and pulmonary diseases with high unmet needs such as idiopathic pulmonary fibrosis (IPF). Cereno Scientific is also pursuing a preclinical program with CS585, an oral, highly potent and selective prostacyclin (IP) receptor agonist that has demonstrated the potential to significantly improve disease mechanisms relevant to cardiovascular diseases. While CS585 has not yet been assigned a specific indication for clinical development, preclinical data indicates that it could potentially be used in indications like Thrombosis prevention without increased risk of bleeding and Pulmonary Hypertension. The Company is headquartered in GoCo Health Innovation City, in Gothenburg, Sweden, and has a US subsidiary; Cereno Scientific Inc. based in Kendall Square, Boston, Massachusetts, US. Cereno Scientific is listed on the Nasdaq First North (CRNO B). The Company’s Certified Adviser is DNB Carnegie Investment Bank AB, certifiedadviser@carnegie.se. More information can be found on www.cerenoscientific.com. Read PDF Share

Phase 1Phase 2

30 Jun 2025

·cerenoscientific.com

Cereno Scientific shares that the top-line results of the CS014 Phase I trial will be communicated in mid-July

Cereno Scientific (Nasdaq First North: CRNO B), an innovative biotech pioneering treatments to enhance and extend life for people with rare cardiovascular and pulmonary diseases, today announced that the top-line results of CS014’s Phase I trial will be announced mid-July 2025. The previously communicated timeline was June 2025. The Phase I trial is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending oral doses of CS014 in healthy volunteers. "The first-in-human Phase I trial of CS014 was successfully conducted and concluded in April. Since then, the contract research organization (CRO) has followed standard procedures in collating, verifying and analyzing data to prepare the study report. We look very much forward to the top-line results in mid-July and the next stage of the development program for CS014 to start this fall,” said Sten R. Sörensen, CEO at Cereno Scientific. CS014 is a new chemical entity and HDAC inhibitor with a multimodal mechanism of action. Being an epigenetic modulator, CS014 has the potential to target the underlying pathophysiology of several rare cardiovascular and pulmonary diseases with high unmet medical needs. The initial target indication is idiopathic pulmonary fibrosis (IPF). The Phase I trial evaluated safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending oral doses of CS014 in healthy volunteers. The trial was conducted in two parts: part one explored safety, tolerability and PK of single ascending oral doses (SAD) of CS014; part two explored safety, tolerability, PK, and PD following multiple ascending doses (MAD) of CS014, dosed for seven days. In total, 48 subjects were included in the trial, 30 in the SAD and 18 in the MAD part. The trial was conducted in Sweden. For further information, please contact: Tove Bergenholt, Head of IR & Communications Email: tove.bergenholt@cerenoscientific.com Phone: +46 73- 236 62 46 About Cereno Scientific AB Cereno Scientific is pioneering treatments to enhance and extend life. Our innovative pipeline offers disease-modifying drug candidates to empower people suffering from rare cardiovascular and pulmonary diseases to live life to the full. Lead candidate CS1 is an HDACi that works through epigenetic modulation, being developed as an effective and disease modifying treatment with a favorable safety and tolerability profile for rare disease Pulmonary Arterial Hypertension (PAH). A Phase IIa trial evaluating CS1’s safety, tolerability, and exploratory efficacy in patients with PAH demonstrated that CS1 has a favorable safety profile, is well-tolerated and showed a positive impact on exploratory clinical efficacy parameters. An Expanded Access Program enables patients that have completed the Phase IIa trial to gain access to CS1. CS014, in Phase I development, is a new chemical entity with disease-modifying potential. CS014 is a HDAC inhibitor with a multimodal mechanism of action as an epigenetic modulator having the potential to address the underlying pathophysiology of rare cardiovascular and pulmonary diseases with high unmet needs such as idiopathic pulmonary fibrosis (IPF). Cereno Scientific is also pursuing a preclinical program with CS585, an oral, highly potent and selective prostacyclin (IP) receptor agonist that has demonstrated the potential to significantly improve disease mechanisms relevant to cardiovascular diseases. While CS585 has not yet been assigned a specific indication for clinical development, preclinical data indicates that it could potentially be used in indications like Thrombosis prevention without increased risk of bleeding and Pulmonary Hypertension. The Company is headquartered in GoCo Health Innovation City, in Gothenburg, Sweden, and has a US subsidiary; Cereno Scientific Inc. based in Kendall Square, Boston, Massachusetts, US. Cereno Scientific is listed on the Nasdaq First North (CRNO B). The Company’s Certified Adviser is DNB Carnegie Investment Bank AB, certifiedadviser@carnegie.se. More information can be found on www.cerenoscientific.com. Read PDF Share

Phase 1Phase 2Clinical Result

100 Deals associated with Chidamide

External Link

KEGG	Wiki	ATC	Drug Bank
-	Chidamide	L01XX	DB06334

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Diffuse Large B-Cell Lymphoma	China	Shenzhen Chipscreen Biosciences Co., Ltd.	24 Apr 2024
Adult T-Cell Leukemia-Lymphoma	Japan	Meiji Seika Pharma Co., Ltd.	23 Jun 2021
Breast Cancer	China	Shenzhen Chipscreen Biosciences Co., Ltd.	20 Nov 2019
Peripheral T-Cell Lymphoma	China	Shenzhen Chipscreen Biosciences Co., Ltd.	23 Dec 2014

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Unresectable Colorectal Carcinoma	Phase 3	China	Shenzhen Chipscreen Biosciences Co., Ltd.	27 Nov 2024
Metastatic Microsatellite Stable Colorectal Carcinoma	Phase 3	China	Sun Yat-Sen University	01 Mar 2023
Microsatellite Stable Colorectal Carcinoma	Phase 3	China	Sun Yat-Sen University	01 Mar 2023
Brain metastases	Phase 3	United States	Huyabio International LLC	12 Aug 2021
Brain metastases	Phase 3	United States	Bristol Myers Squibb Co.	12 Aug 2021
Brain metastases	Phase 3	Japan	Huyabio International LLC	12 Aug 2021
Brain metastases	Phase 3	Japan	Bristol Myers Squibb Co.	12 Aug 2021
Brain metastases	Phase 3	Australia	Huyabio International LLC	12 Aug 2021
Brain metastases	Phase 3	Australia	Bristol Myers Squibb Co.	12 Aug 2021
Brain metastases	Phase 3	Austria	Bristol Myers Squibb Co.	12 Aug 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04231448 (DEB, NEWS) Manual	Phase 3	Diffuse Large B-Cell Lymphoma First line	-	西达本胺+R-CHOP	ezqpprixvj(ifatwhtjwd) = 试验组无事件生存期（EFS）显著优于对照组，达成研究主要终点。 kcydroacxt (afxidkdgyt ) Met View more	Positive	16 Jul 2025
NCT04994210 (SCENT-2, ASCO2025) Manual	Phase 2	Extranodal NK-T-Cell Lymphoma \| T-Cell Lymphoma First line	47	Sintilimab + Chidamide (part A)	iuaioxvkzh(qhicwdlbmf) = oibukhnzlx qzbacyqkic (gijjhpprbv ) View more	Positive	30 May 2025
NCT04994210 (SCENT-2, ASCO2025) Manual	Phase 2	Extranodal NK-T-Cell Lymphoma \| T-Cell Lymphoma First line	47	Sintilimab + Chidamide + P-GemOx (part A+part B)	iuaioxvkzh(qhicwdlbmf) = vdpnrnoktn qzbacyqkic (gijjhpprbv ) View more	Positive	30 May 2025
NCT04025931 (ASCO2025) Manual	Phase 2	Soft Tissue Sarcoma	69	Chidamide + toripalimab	btdtrmwgrj(cjsohabnwa) = cgmkvibdvo jjqvjdgwoq (xgvqiwcnui ) View more	Positive	30 May 2025
NCT04562311 (ASCO2025) Manual	Phase 2	Advanced Urothelial Carcinoma	45	Chidamide + tislelizumab	huyflnokuv(gxxflroemf) = oiffwfqflr vabpxvcmas (usgwihtujl, 29.6 - 60.0) View more	Positive	30 May 2025
NCT05586841 (ASCO2025) Manual	Phase 1	Hormone receptor positive HER2 negative breast cancer HER2 Negative \| HR Positive	22	dalpiciclib + chidamide	upwjmrzzkb(goyrtlcihg) = the MTD was established as Group C (dalpiciclib 100 mg/d, chidamide 25 mg BIW). avrbxoalgs (axeljvrron )	Positive	30 May 2025
NCT05586841 (ASCO2025) Manual	Phase 1		22	dalpicicldalpiciclibchidamide (Group C: dalpiciclib 100 mg/d, chidamide 25 mg BIW)		Positive	30 May 2025
ChiCTR2400080783 (B-Enefits/SCOG-B001, ASCO2025) Manual	Phase 2	Biliary Tract Neoplasms First line	35	Envafolimab + Chidamide + GEMOX	yislocjzmi(cnesifvynw) = rphjbokwvo fcgkhwzcbh (qvfjtddbmb ) View more	Positive	30 May 2025
NCT06584227 (ADEPT, ASCO2025) Manual	Phase 2	Pancreatic Cancer First line	13	Adebrelimab + Chidamide + Gemcitabine + S-1	sddrtubgvk(ncwnqiqrbi) = qmudfmequx wcapkxbhtt (iwtbxmdztv, 7.0–13.3) View more	Positive	30 May 2025
NCT05958719 (IIT2023003, EHA2025) Manual	Phase 2	Peripheral T-Cell Lymphoma First line	13	chidamidechidamide in combination with azacitidine, mitoxantrone liposomesazacitidine, mitoxantrone liposomes and prednisone	lworwggtku(ngrfhelihn) = djafyjgphz cpmihmhtcd (tikrubnsyh ) View more	Positive	14 May 2025
PS1888 (EHA2025)	Phase 2	B-Cell Lymphoma EZH2 \| KMT2C \| KMT2D ... View more	33	Chidamide + anti-CD20 mAb + CHOP	fygbwnhhqa(vhwlfayznu) = exvpzctppt cpnyayldhy (kuchlammgf ) View more	Positive	14 May 2025
PB2532 (EHA2025)	Phase 2	Acute Myeloid Leukemia First line ELN 2022 adverse-risk	28	Chidamide	bqyoofljff(rqinkbmefa) = 3.6% kfjelecbym (esebnfyuke ) View more	Positive	14 May 2025
PB2532 (EHA2025)	Phase 2	Acute Myeloid Leukemia First line ELN 2022 adverse-risk	28	Cytarabine, Aclarubicin, Granulocyte colony-stimulating factor, Venetoclax-Azacitidine		Positive	14 May 2025

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