Randomized, Open-label, Multicenter Phase 3 Study to Assess the Efficacy and Safety of GIVinostat Versus Hydroxyurea IN JAK2V617F-positive High-risk Polycythemia Vera Patients: the GIV-IN PV TRIAL

The goal of this clinical trial is to compare the efficacy and safety of givinostat to hydroxyurea in Jak2V617F-positive high risk polycythemia vera patients.

Start Date26 Mar 2024

Sponsor / Collaborator

Italfarmaco SpA

NCT05933057 / RecruitingPhase 3

Randomised, Double-blind, Placebo-controlled, Multicentre Study to Evaluate the Efficacy, Safety and Tolerability of Givinostat in Non-ambulant Patients With Duchenne Muscular Dystrophy

This is a randomised, double-blind, placebo-controlled, multicentre study to evaluate the efficacy, safety, and tolerability of givinostat in non-ambulant male paediatric (aged 9 to <18 years) patients with DMD. 138 patients will be randomised 2:1 to givinostat or placebo and will be treated for 18 months.
* Planned screening duration: approximately 4 weeks (±14 days)
* Planned treatment duration: 18 months (approximately 72 weeks)
* Planned follow-up duration: 4 weeks (±7 days) (for patients not participating in the long-term safety study)
* Total duration of study participation: up to 83 weeks (ie, 20-21 months)

Start Date19 Feb 2024

Sponsor / Collaborator

Italfarmaco SpA

[+1]

NCT05860114 / CompletedPhase 1

An Open-label, Single-center, Study in Healthy Subjects to Evaluate the Plasma and Urine Pharmacokinetics of Givinostat and Its Metabolites Following Single and Multiple Oral Doses of Givinostat (Part 3).

Primary objective:
To evaluate the plasma and urine PK of givinostat following multiple oral doses of givinostat.
Secondary objective:
To assess the safety and tolerability multiple oral doses of givinostat.

Start Date21 Mar 2022

Sponsor / Collaborator

Italfarmaco SpA

100 Clinical Results associated with Givinostat Hydrochloride

100 Translational Medicine associated with Givinostat Hydrochloride

100 Patents (Medical) associated with Givinostat Hydrochloride

144

Literatures (Medical) associated with Givinostat Hydrochloride

18 Sep 2024·British Journal of Dermatology

Histone deacetylase inhibition mitigates fibrosis-driven disease progression in recessive dystrophic epidermolysis bullosa

Article

Author: Floriddia, Giovanna ; Reinoso Sánchez, Jonathan Fernando ; Teson, Massimo ; Castiglia, Daniele ; Primerano, Alessia ; Roubaty, Carole ; Cardarelli, Silvia ; De Luca, Naomi ; Nyström, Alexander ; Mastroeni, Simona ; Cristofoletti, Cristina ; Dengjel, Jörn ; Baldini, Enke ; Cangelosi, Davide ; Ulisse, Salvatore ; Scaglione, Giovanni Luca ; Odorisio, Teresa ; De Domenico, Emanuela ; Uva, Paolo ; Cianfarani, Francesca

AbstractBackgroundRecessive dystrophic epidermolysis bullosa (RDEB) is a blistering disease caused by mutations in the gene encoding type VII collagen (C7). RDEB is associated with fibrosis, which is responsible for severe complications. The phenotypic variability observed in siblings with RDEB suggests that epigenetic modifications contribute to disease severity. Identifying epigenetic changes may help to uncover molecular mechanisms underlying RDEB pathogenesis and new therapeutic targets.ObjectivesTo investigate histone acetylation in RDEB skin and to explore histone deacetylase inhibitors (HDACi) as therapeutic molecules capable of counteracting fibrosis and disease progression in RDEB mice.MethodsAcetylated histone levels were detected in human skin by immunofluorescence and in RDEB fibroblasts by enzyme-linked immunosorbent assay (ELISA). The effects of givinostat and valproic acid (VPA) on RDEB fibroblast fibrotic behaviour were assessed by a collagen–gel contraction assay, Western blot and immunocytofluorescence for α-smooth muscle actin, and ELISA for released transforming growth factor (TGF)-β1. RNA sequencing was performed in HDACi- and vehicle-treated RDEB fibroblasts. VPA was systemically administered to RDEB mice and effects on overt phenotype were monitored. Fibrosis was investigated in the skin using histological and immunofluorescence analyses. Eye and tongue defects were examined microscopically. Mass spectrometry proteomics was performed on skin protein extracts from VPA-treated RDEB and control mice.ResultsHistone acetylation decreases in RDEB skin and primary fibroblasts. RDEB fibroblasts treated with HDACi lowered fibrotic traits, including contractility, TGF-β1 release and proliferation. VPA administration to RDEB mice mitigated severe manifestations affecting the eyes and paws. These effects were associated with fibrosis inhibition. Proteomic analysis of mouse skin revealed that VPA almost normalized protein sets involved in protein synthesis and immune response, processes linked to the increased susceptibility to cancer and bacterial infections seen in people with RDEB.ConclusionsDysregulated histone acetylation contributes to RDEB pathogenesis by facilitating the progression of fibrosis. Repurposing of HDACi could be considered for disease-modifying treatments in RDEB.

12 Aug 2024·American Journal of Health-System Pharmacy

Givinostat Hydrochloride

Article

01 Jul 2024·Heliyon

Synergistic drug interactions of the histone deacetylase inhibitor givinostat (ITF2357) in CRLF2-rearranged pediatric B-cell precursor acute lymphoblastic leukemia identified by high-throughput drug screening

Article

Author: Bardini, Michela ; Biondi, Andrea ; Watrin, Titus ; Fazio, Grazia ; Schliehe-Diecks, Julian ; Bhatia, Sanil ; Savino, Angela Maria ; Palmi, Chiara ; Borkhardt, Arndt ; Scharov, Katerina ; Valsecchi, Luigia ; Bresolin, Silvia ; Cazzaniga, Giovanni ; Oikonomou, Athanasios

Combining multiple drugs broadens the window of therapeutic opportunities and is crucial for diseases that are currently lacking fully curative treatments. A powerful emerging tool for selecting effective drugs and combinations is the high-throughput drug screening (HTP). The histone deacetylase inhibitor (HDACi) givinostat (ITF2357) has been shown to act effectively against CRLF2-rearranged pediatric B-cell precursor acute lymphoblastic leukemia (BCP-ALL), a subtype characterized by poor outcome and enriched in children with Down Syndrome, very fragile patients with a high susceptibility to treatment-related toxicity. The aim of this study is to investigate possible synergies with givinostat for these difficult-to-treat patients by performing HTP screening with a library of 174 drugs, either approved or in preclinical studies. By applying this approach to the CRLF2-r MHH-CALL-4 cell line, we identified 19 compounds with higher sensitivity in combination with givinostat compared to the single treatments. Next, the synergy between givinostat and the promising candidates was further validated in CRLF2r cell lines with a broad matrix of concentrations. The combinations with trametinib (MEKi) or venetoclax (BCL2i) were found to be the most effective and with the greatest synergy across three metrics (ZIP, HAS, Bliss). Their efficacy was confirmed in primary blasts treated ex vivo at concentration ranges with a safe profile on healthy cells. Finally, we described givinostat-induced modifications in gene expression of MAPK and BCL-2 family members, supporting the observed synergistic interactions. Overall, our study represents a model of drug repurposing strategy using HTP screening for identifying synergistic, efficient, and safe drug combinations.

News (Medical) associated with Givinostat Hydrochloride

25 Jul 2024

·www.prnewswire.com

PANTHERx®Rare Partnering with ITF Therapeutics LLC for U.S. Distribution of DUVYZAT™

PITTSBURGH, Pa., July 25, 2024 /PRNewswire/ -- PANTHERx® Rare, a leader in rare disease product patient access and support services in the United States, is pleased to announce it is partnering with ITF Therapeutics LLC for the U.S. distribution of DUVYZAT™ (givinostat), the first nonsteroidal drug approved to treat patients with all genetic variants of Duchenne muscular dystrophy (DMD) aged six years and older. DUVYZAT, a twice daily oral suspension, is a histone deacetylase (HDAC) inhibitor that reduces inflammation and loss of muscle observed in DMD. DMD is a rare and serious muscle disorder affecting approximately 1 in 5,000 male births worldwide and is caused by a variant in the DMD gene located on the X chromosome. This gene is responsible for regulating the production of dystrophin, which is a protein located in skeletal and cardiac muscle cells. Disease onset in DMD is typically observed between three and five years of age and progression is characterized by muscle wasting and weakness in the voluntary muscles of the body. The disease typically affects muscles closest to the trunk (e.g., upper legs, upper arms, shoulders, and pelvic muscles) first and then progresses outward toward the extremities. By late teenage years, many patients develop additional potentially life-threatening complications including cardiomyopathy and respiratory failure. "We are looking forward to serving the needs of people living with Duchenne muscular dystrophy and their families and caregivers by streamlining the process associated with getting rare medications from the people who create them to the people who need them most. We appreciate ITF Therapeutics' commitment to making a difference in the lives of patients with this disease," said Rob Snyder, CEO of PANTHERx® Rare Pharmacy. About PANTHERx Rare PANTHERx Rare is a dual-accredited specialty pharmacy focused on rare and orphan disease, distributing several orphan products and providing access and support services to those needing them most. PANTHERx transforms lives by delivering medicine breakthroughs, clinical excellence, and access solutions to people living with rare and devastating conditions. While each rare condition affects few people, together all rare diseases impact an estimated 25 to 30 million Americans. Currently over 7,000 rare diseases have been identified and more than 90% of rare diseases are still without an FDA-approved treatment. Changes in federal policy and advances in science have led to a surge in FDA orphan drug approvals, providing tremendous hope to the rare disease community. PANTHERx is a dual-accredited specialty pharmacy, holding distinctions in rare disease including the Accreditation Commission for Health Care (ACHC) Distinction in Orphan Drugs and Utilization Review Accreditation Commission (URAC) Rare Disease Center of Excellence. As a pharmacy focused on patient satisfaction, PANTHERx is now a six-time winner of the prestigious MMIT Patient Choice Award, including the 2023 honor. PANTHERx is headquartered in Pittsburgh, Pennsylvania and is licensed in all 50 states and US territories. About DUVYZAT™ (givinostat) DUVYZAT is a U.S. FDA approved therapy indicated for the treatment of patients six years of age and older with Duchenne muscular dystrophy (DMD) that was discovered through the research and development efforts of Italfarmaco in collaboration with Telethon and Duchenne Parent Project (Italy). DUVYZAT is a histone deacetylase (HDAC) inhibitor that modulates the deregulated activity of HDACs in the dystrophic muscle, which is a major consequence of the lack of dystrophin associated with DMD. Though the exact mechanism of action of DUVYZAT is unknown, it is believed to inhibit HDAC pathological overactivity to address the cascade of events leading to muscle damage, thereby counteracting the disease pathology and slowing down muscle deterioration. References: Duvyzat. Package Insert. ITF Therapeutics, LLC; 2024. FDA Approves Nonsteroidal Treatment for Duchenne Muscular Dystrophy. FDA; March 21, 2024; Duchenne Muscular Dystrophy. NORD; (accessed April 2, 2024) For more information, please contact [email protected] SOURCE PANTHERx Rare Pharmacy

Drug ApprovalOrphan Drug

27 Jun 2024

·www.biospace.com

KAZIA ANNOUNCES UPCOMING DIPG DATA PRESENTATIONS AT ISPNO AND PUBLICATION IN EUROPEAN JOURNAL OF CANCER

SYDNEY, June 27, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), a biotechnology company specialising in oncology, is pleased to announce the presentation of new data from its lead program, paxalisib, at the upcoming 21st International Symposium on Pediatric Neuro-Oncology (ISPNO 2024) June 29 – July 2, 2024, in Philadelphia, PA. Kazia concurrently announces publication of an article in European Journal of Cancer highlighting the need for evaluating mutation-specific, CNS penetrant, inhibitors to treat pediatric patients with Diffuse Midline Glioma (DMG). There will be three paxalisib-related presentations in total at ISPNO, including data from the Phase 2 PNOC DMG-ACT (DMG-Adaptive Combination Trial, PNOC022) study evaluating the efficacy and safety of paxalisib in combination with ONC201. As a follow up to data presented last year at the Society for NeuroOncology, 28th Annual Meeting, lead researchers will discuss survival, pharmacokinetics, and tumor biomarkers from 132 diffuse midline glioma (DMG) patients enrolled in the Phase 2 study. Highlights of the abstract include median overall survival of 13.2 months in Cohort 1 (newly diagnosed, enrolled pre-radiation n=33), 15.8 months in Cohort 2 (newly diagnosed, enrolled post-radiation n=69) and 8.8 months in Cohort 3 (relapsed patients, enrolled after progression n=30). The second presentation is based on novel preclinical data utilizing the addition of a novel HDAC inhibitor to the backbone therapy of paxalisib in DMG models. The third presentation will highlight preclinical data results of the combination therapy of paxalisib and gemcitabine for patients with relapsed/recurrent atypical teratoid/rhabdoid tumors AT/RT by Johns Hopkins University researchers. Based on these findings, the Pacific Pediatric Neuro-Oncology Consortium is planning to include this combination therapy in its next AT/RT international clinical trial. Summary of Abstracts ( ) Clinical Trials; July 2, 2024; 8:15am TRLS-14: PNOC022 report: a combination therapy trial using an adaptive platform design for patients with diffuse midline glioma at initial diagnosis, post-radiation therapy, or progression Cassie Kline, Andrea Franson, Anuradha Banerjee, Alyssa T Reddy, et al Poster Session I; June 30, 2024; 5pm ATRT-15 Combining the PI3K inhibitor paxalisib with nucleoside analog gemcitabine to improve survival of atypical teratoid/rhabdoid tumors Tyler Findlay, Kristen Malebranche, Anupa Geethadevi, Charles Eberhart, Jeffrey Rubens, Eric Raabe DIPG-21 Preclinical assessment of a multimodal treatment approach with Givinostat, Paxalisib, and radiotherapy for Diffuse Midline Glioma (DMG) Aimée du Chatinier, Michaël H Meel, Piotr Waranecki, Dennis S Metselaar, Esther The European Journal of Cancer publication titled Paediatric Strategy Forum for Medicinal Product Development of PI3-K, mTOR, AKT and GSK3β Inhibitors in Children and Adolescents with Cancer is the output from a two-day forum in April 2023 at Dana Farber Cancer Institute. Consisting of patient advocates, regulators, researchers and pediatric clinicians, the publication concludes "Evaluation of mutation-specific, CNS-penetrant PI3-K inhibitors in children with DMG should be prioritised and innovative regulatory approaches are needed in view of the rarity of the population." The paper can be accessed at the following website: (24)00801-3/fulltext About Kazia Therapeutics Limited Kazia Therapeutics Limited (NASDAQ: KZIA) is an oncology-focused drug development company, based in Sydney, Australia. Our lead program is paxalisib, an investigational brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat multiple forms of brain cancer. Licensed from Genentech in late 2016, paxalisib is or has been the subject of ten clinical trials in this disease. A completed Phase 2 study in glioblastoma reported early signals of clinical activity in 2021, and a pivotal study in glioblastoma, GBM AGILE, has completed enrollment, with final data expected imminently. Other clinical trials are ongoing in brain metastases, diffuse midline gliomas, and primary CNS lymphoma, with several of these having reported encouraging interim data. Paxalisib was granted Rare Pediatric Disease Designation and Orphan Drug Designation by the FDA for diffuse intrinsic pontine glioma in August 2020, and for atypical teratoid / rhabdoid tumours in June 2022 and July 2022, respectively. For more information, please visit or follow us on Twitter @KaziaTx. Forward-Looking Statements This announcement may contain forward-looking statements, which can generally be identified as such by the use of words such as "may," "will," "estimate," "future," "forward," "anticipate," or other similar words. Any statement describing Kazia's future plans, strategies, intentions, expectations, objectives, goals or prospects, and other statements that are not historical facts, are also forward-looking statements, including, but not limited to, statements regarding: the timing for results and data related to Kazia's clinical and preclinical trials and investigator-initiated trials of Kazia's product candidates, and Kazia's strategy and plans with respect to its programs, including paxalisib and EVT801. Such statements are based on Kazia's current expectations and projections about future events and future trends affecting its business and are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements, including risks and uncertainties: associated with clinical and preclinical trials and product development, related to regulatory approvals, and related to the impact of global economic conditions. These and other risks and uncertainties are described more fully in Kazia's Annual Report, filed on form 20-F with the United States Securities and Exchange Commission (SEC), and in subsequent filings with the SEC. Kazia undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required under applicable law. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this announcement. This announcement was authorized for release by Dr John Friend, CEO. Company Codes: NASDAQ-SMALL:KZIA

Phase 2Orphan DrugRadiation TherapyASCO

24 Jun 2024

·www.prnewswire.com

Parent Project Muscular Dystrophy Hosts 30th Annual Conference in Orlando, Florida

Milestone event brings together record-breaking 1,300 plus families, physicians, researchers, caregivers, industry partners, and those living with Duchenne and Becker in person and virtually to connect, share information, and learn the latest progress in the fight for every future. ORLANDO, Fla., June 24, 2024 /PRNewswire/ -- Parent Project Muscular Dystrophy (PPMD), a nonprofit organization leading the fight to end Duchenne muscular dystrophy (Duchenne), will host its 30th Annual Conference in Orlando, Florida, June 27–29. Each year, the Duchenne and Becker community gathers to learn about the latest progress in the fight to end Duchenne and connect with leading experts. Now in its 30th year, PPMD's Annual Conference returns to Orlando, the location of the organization's very first Annual Conference in 1994, to engage more of the Duchenne and Becker community than ever before. PPMD expects a record-breaking 1,300 plus families, researchers, clinicians, and industry partners from all over the world for three days of informative and interactive sessions featuring the latest news in research, clinical trials, approved and emerging therapies, care initiatives, quality of life issues, and more. Before the Conference officially kicks off, PPMD will host a Becker Care Professional Meeting, June 26–27, aimed at initiating discussions within the healthcare professional community regarding the creation of consensus-based standards of care for Becker muscular dystrophy. Founded in 1994 by a group of parents and grandparents, and led by Founding President and CEO Pat Furlong, PPMD is the largest, most comprehensive nonprofit organization in the United States focused on ending Duchenne. Since its first meeting 30 years ago, PPMD has convened families with researchers, clinicians, industry partners, advocacy organizations, and most importantly, people with Duchenne and Becker and their families at the largest Duchenne-specific conference held in the U.S. Furlong is excited about this year's milestone Conference and looks forward to bringing the Duchenne and Becker community together: "From PPMD's first Annual Conference 30 years ago to our momentous return to Orlando this week, this community's unwavering commitment, passion, and resilience have been the driving force behind our fight for every future. We have faced challenges and celebrated victories and we have motivation to keep progressing. PPMD's 30th Annual Conference will be filled with a variety of interactive experiences to spark conversation, foster new and familiar relationships, learn from one another, and continue to drive change in the fight to end Duchenne." PPMD is grateful to all of our industry sponsors, whose support helps make the Annual Conference possible, especially our 30th Anniversary Star sponsor Sarepta Therapeutics, our Platinum sponsors Catalyst Pharmaceuticals and Pfizer, Inc., and our Gold sponsors Avidity Biosciences, Dyne Therapeutics, Edgewise Therapeutics, ITF Therapeutics, NS Pharma, Inc., Upsher-Smith Laboratories, and Wave Life Sciences. For sponsorship opportunities, please click here. PPMD's 30th Annual Conference agenda will feature stories from multiple keynote speakers, and interactive discussion panels addressing comprehensive, multi-dimensional approaches to care for Duchenne and Becker. Unique topics to this year's conference include: Approved therapies in Duchenne, including presentations on the recently expanded label for ELEVIDYS and newly-approved therapies AGAMREE and DUVYZAT, as well as a clinician panel discussion on the eight currently approved therapies. Becker-specific breakout sessions, including discussions on neuromuscular care, cardiology, genetic counseling, and physical therapy, as well as industry updates about emerging therapies for Becker. What we have learned over time about outcome measures, including Functional Reach, Stride Velocity, Dynamic Visual Acuity (DVA), and Northstar and Performance of Upper Limb (PUL). Cardiac, neuromuscular, and adolescent care for carriers, as well as physical therapy implications and research in progress in the field of Duchenne carriers. Unique experiences and perspectives on life, living, and hope, as well as daily life care such as sleep and behavior; decision making around steroids, weight, and nutrition; pain; exercise; social connection; and more. This year's Conference will also feature dedicated updates from more than 20 partners currently in clinical trials, with panels including: Strategies to restore dystrophin The current and evolving landscape of gene therapy Approaches to alter disease progression PPMD's role in moving the needle in clinical research A variety of breakout sessions and social gatherings will also be offered during PPMD's 30th Annual Conference, encouraging attendees to create their own, unique experiences, in-person or virtually, by participating in: Special programming for Newly Diagnosed Families A dedicated track for Teens and Adults with Duchenne/Becker Expanded Sibs Track sessions, offering a safe place for siblings to be together, talk, and open up about topics that they face Breakout sessions according to age, covering multiple aspects of care One-on-one private appointments with Physical Therapists, Genetic Counselors, and behavior, speech, and language experts to help provide guidance on every family's unique needs Small group Lighthouse Mini-Sessions focused on self-care, effective communication, asking for help, and staying connected and finding belonging A Build Your Own Care Binder station for families to create personalized binders filled with important information regarding Duchenne/Becker care to help navigate routine care and emergencies A robust Resource Fair enabling resource providers and the community to connect about practical services, research and more A meet and greet for diverse families in Duchenne to share their unique experiences and foster connection Social activities for moms, dads, grandparents, siblings, and, of course, tweens, teens, and adults with Duchenne and Becker Fun and interactive sessions for kids Ahead of the Conference, all registered attendees were given access to PPMD's online Conference Hub & App to stream sessions and personalize their agenda and Conference experience. This year's Hub & App offers an enhanced experience for both in-person and virtual attendees, allowing for engagement with exhibitors and increased interaction during live sessions. AI-powered live translation will also be available for main sessions in dozens of languages. It is not too late to attend this year's meeting, in-person or virtually. To register for PPMD's 30th Annual Conference, click here. To learn more about PPMD, please visit our website. SOURCE Parent Project Muscular Dystrophy (PPMD)

100 Deals associated with Givinostat Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
-	Givinostat Hydrochloride	-	DB12645

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Muscular Dystrophy, Duchenne	US	Italfarmaco SpA	21 Mar 2024

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Muscular Dystrophy, Duchenne	NDA/BLA	EU	Italfarmaco SpA	-
Polycythemia Vera	Phase 3	HU	Italfarmaco SpA	26 Mar 2024
Polycythemia Vera	Phase 3	FR	Italfarmaco SpA	26 Mar 2024
Polycythemia Vera	Phase 3	NL	Italfarmaco SpA	26 Mar 2024
Polycythemia Vera	Phase 3	IE	Italfarmaco SpA	26 Mar 2024
Polycythemia Vera	Phase 3	DE	Italfarmaco SpA	26 Mar 2024
Polycythemia Vera	Phase 3	IL	Italfarmaco SpA	26 Mar 2024
Polycythemia Vera	Phase 3	AT	Italfarmaco SpA	26 Mar 2024
Polycythemia Vera	Phase 3	PL	Italfarmaco SpA	26 Mar 2024
Polycythemia Vera	Phase 3	HR	Italfarmaco SpA	26 Mar 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02851797 (EPIDYS, Literature) Manual	Phase 3	Muscular Dystrophy, Duchenne	120	givinostat	(nsstkbevrp) = tjfklnudhd ldxeggdbpa (envffxvxgq, 1.17 - 1.37)	Positive	01 Apr 2024
				Placebo	(nsstkbevrp) = qtigpifmni ldxeggdbpa (envffxvxgq, 1.17 - 1.37)
NCT02851797 (FDA_CDER) Manual	Phase 3	Muscular Dystrophy, Duchenne	179	DUVYZAT	(xyieesahgn) = fuuzzmgetf vekhtvaxoq (nuukkgtgpr )	Positive	21 Mar 2024
NCT05845567 (CTgov)	Phase 1	Medication interactions	20	Givinostat (Givinostat Alone (Day 1))	ixoendqrsg(eypzcnojmj) = blekjatmdo abzldjzwuh (wpqbmxafxy, lrokgczorl - twzzaydquf) View more	-	09 Feb 2024
				Givinostat+Clarithromycin (Givinostat Co-Administered With Clarithromycin)	-
NCT00792740 (CD, CTgov)	Phase 1/2	Crohn Disease	51	Placebo (Placebo)	jepojpsdmv(khvsewzikl) = zocjtuehdn ziyxgirnfh (zywuwetszv, uebipwlyih - norjbyjapi) View more	-	19 Jul 2023
				ITF2357 (ITF2357)	jepojpsdmv(khvsewzikl) = pjexknbrwc ziyxgirnfh (zywuwetszv, srugmsvbwc - ivmlrvkcqw) View more
NCT02851797 (Epidys Study, MDA2023)	Phase 3	Muscular Dystrophy, Duchenne	179	Givinostat	(zfbnhfeiwj) = reversible and manageable tapgurethd (zbljamsoeh ) View more	Positive	19 Mar 2023
NCT02851797 (Epidys, MDA2023)	Phase 3	Muscular Dystrophy, Duchenne fat fraction of the vastus lateralis (VL)	179	Givinostat	(jxkucvyamr) = mfoxlkpusr gicynekimq (ezdlsfvqdx )	Positive	19 Mar 2023
				Placebo	(jxkucvyamr) = qevminpegw gicynekimq (ezdlsfvqdx )
NCT02851797 (Study 1 \| Epidys Study \| EPIDYS, CTgov)	Phase 3	Muscular Dystrophy, Duchenne	179	givinostat (Givinostat)	mhatimkxhh(dwibouzxnv) = hqaxdfhzpq fnpozflmjh (gmqsqdxgej, komuvenbuw - hlcxsksgoq) View more	-	02 Feb 2023
				placebo (Placebo)	mhatimkxhh(dwibouzxnv) = tactnvkkym fnpozflmjh (gmqsqdxgej, bbfjxrshjn - vglyciutyy) View more
NCT02851797 (EPIDYS, PipelineReview) Manual	Phase 3	Muscular Dystrophy, Duchenne	179	Givinostat	(ofgmlcirxe): difference = 1.78, P-Value = 0.0345 View more	Positive	26 Jun 2022
				Placebo
NCT03238235 (BusinessWire) Manual	Phase 2	Becker Muscular Dystrophy	47	Givinostat	(jbbwtzxzrd) = No serious Adverse Events (AE) occurred during the course of the trial. uvujnfkbya (kmvacvjgmj ) View more	Positive	26 Jun 2021
				Placebo
NCT00792467 (CTgov)	Phase 1/2	Hodgkin's Lymphoma	24	ITF2357	bfoxsofcna(zyhcxvfxoe) = oilyphkyzw ugsmrbfehp (kbdnwqjpmk, fzkjzsmidp - basjkegfjg) View more	-	19 Apr 2021

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