A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Enzastaurin for the Prevention of Arterial Events in Patients With Vascular Ehlers-Danlos Syndrome (vEDS) Confirmed With COL3A1 Mutations, Followed by an Open Label Extension (OLE)

The purpose of this study is to investigate the efficacy of enzastaurin compared to placebo in preventing arterial events (rupture, dissection, pseudoaneurysm, carotid-cavernous sinus fistula, or aneurysm, fatal or not) leading to intervention or mortality attributable to an arterial event in patients with vEDS confirmed with pathogenic heterozygous COL3A1 gene mutations predicted to derive a mutant protein.

Start Date01 Jan 2025

Sponsor / Collaborator

Aytu Biopharma, Inc.

[+1]

EUCTR2021-006574-23-BE

/ Not yet recruitingPhase 3

A multicenter, randomized, double-blind, placebo-controlled study of enzastaurin for the prevention of arterial events in patients with vascular Ehlers-Danlos Syndrome (vEDS) confirmed with COL3A1 mutations, followed by an open label extension (OLE) - PREVEnt (Prevention of Rupture with Enzastaurin in Vascular Ehlers-Danlos Syndrome Trial)

Start Date20 Jun 2022

Sponsor / Collaborator

Aytu Biopharma, Inc.

CTR20210055

/ CompletedPhase 3

在新诊断为胶质母细胞瘤并且全新生物标记物DGM1 阳性患者中评估Enzastaurin联合替莫唑胺同步放化疗加辅助化疗方案的随机双盲安慰剂对照III期临床试验

[Translation] A randomized, double-blind, placebo-controlled phase III trial evaluating Enzastaurin combined with temozolomide concurrent chemoradiotherapy plus adjuvant chemotherapy in patients with newly diagnosed glioblastoma and positive for the novel biomarker DGM1

主要目的：在新诊断为胶质母细胞瘤的Denovo基因标记物1（DGM1）阳性患者中，与安慰剂对照，评估enzastaurin联合替莫唑胺同步放化疗加辅助化疗方案在患者总生存期（OS）方面的优效性。次要目的： 1. 在DGM1生物标记物阳性患者中比较治疗组间的无进展生存期（PFS）。 2. 在DGM1生物标记物阳性患者中比较治疗组间的客观缓解率（ORR）。 3. 进一步评估enzastaurin加入替莫唑胺同步放化疗加辅助化疗方案后的安全性特征。探索性目的： 1. 在DGM1生物标记物阴性患者中评估总生存期（OS）。 2. 确定色素尿的存在（尿液呈橙色/红色）是否与服用enzastaurin的患者生存期改善存在关联。 3. 分析尿液中是否存在enzastaurin和enzastaurin代谢产物（尿液药代动力学[PK]）。 4. 评估其它胚系或肿瘤生物标记物的存在是否与服用enzastaurin的患者的疗效改善存在关联。 5. 确定enzastaurin和enzastaurin代谢产物的浓度，以便纳入后续的群体PK分析中。

[Translation]

Primary Objectives: To evaluate the superiority of enzastaurin in combination with concurrent chemoradiotherapy plus adjuvant chemotherapy with temozolomide compared with placebo in terms of overall survival (OS) in patients with newly diagnosed glioblastoma who are Denovo Genetic Signature 1 (DGM1) positive. Secondary Objectives: 1. To compare progression-free survival (PFS) between treatment arms in patients who are DGM1 biomarker positive. 2. To compare objective response rate (ORR) between treatment arms in patients who are DGM1 biomarker positive. 3. To further evaluate the safety profile of enzastaurin added to concurrent chemoradiotherapy plus adjuvant chemotherapy with temozolomide. Exploratory Objectives: 1. To evaluate overall survival (OS) in patients who are DGM1 biomarker negative. 2. To determine if the presence of pigmenturia (orange/red urine) is associated with improved survival in patients taking enzastaurin. 3. To analyze the presence of enzastaurin and enzastaurin metabolites in urine (urine pharmacokinetics [PK]). 4. Evaluate whether the presence of other germline or tumor biomarkers is associated with improved efficacy in patients taking enzastaurin. 5. Determine the concentrations of enzastaurin and enzastaurin metabolites for inclusion in subsequent population PK analyses.

Start Date13 Jul 2021

Sponsor / Collaborator

Denovo Biopharma LLC

[+2]

100 Clinical Results associated with Enzastaurin Hydrochloride

100 Translational Medicine associated with Enzastaurin Hydrochloride

100 Patents (Medical) associated with Enzastaurin Hydrochloride

436

Literatures (Medical) associated with Enzastaurin Hydrochloride

23 Dec 2024·Journal of Chemical Information and Modeling

SDDSynergy: Learning Important Molecular Substructures for Explainable Anticancer Drug Synergy Prediction

Article

Author: Che, Chao ; Zhang, Peiliang ; Wei, Ziqi ; Liu, Yunjiong

Drug combination therapies are well-established strategies for the treatment of cancer with low toxicity and fewer adverse effects. Computational drug synergy prediction approaches can accelerate the discovery of novel combination therapies, but the existing methods do not explicitly consider the key role of important substructures in producing synergistic effects. To this end, we propose a significant substructure-aware anticancer drug synergy prediction method, named SDDSynergy, to adaptively identify critical functional groups in drug synergy. SDDSynergy splits the task of predicting drug synergy into predicting the effect of individual substructures on cancer cell lines and highlights the impact of important substructures through a novel drug-cell line attention mechanism. And a substructure pair attention mechanism is incorporated to capture the information on internal substructure pairs interaction in drug combinations, which aids in predicting synergy. The substructures of different sizes and shapes are directly obtained from the molecular graph of the drugs by multilayer substructure information passing networks. Extensive experiments on three real-world data sets demonstrate that SDDSynergy outperforms other state-of-the-art methods. We also verify that many of the novel drug combinations predicted by SDDSynergy are supported by previous studies or clinical trials through an in-depth literature survey.

13 Dec 2024·ACS Pharmacology & Translational Science

Repurposing Drugs and Synergistic Combinations as Potential Therapies for Inhibiting SARS-CoV-2 and Coronavirus Replication

Article

Author: Iddir, Mustapha ; Boulon, Richard ; Chatel-Chaix, Laurent ; Charpentier, Tania ; Mazeaud, Clément ; Anton, Anaïs ; Ayotte, Yann ; Lamarre, Alain ; Broquière, Mathilde ; Woo, Simon ; Farahani, Majid D. ; LaPlante, Steven R.

Drug repurposing can serve an important role in rapidly discovering medicament options for emerging microbial pandemics. In this study, a pragmatic approach is demonstrated for screening and testing drug combinations as potential broad-spectrum therapies against SARS-CoV-2 and other betacoronaviruses. Rapid cell-based phenotypic small molecule screens were executed using related common-cold-causing HCoV-OC43 betacoronavirus to identify replication inhibitors from a library of drugs approved by regulatory agencies for other indications. Given the best inhibitors, an expedient checkerboard strategy then served to identify synergistic drug combinations. These combinations were then validated using more challenging assays involving SARS-CoV-2 and variants. Promising drug combinations against multiple viral variants were discovered and involved Tilorone with Nelfinavir or Molnupiravir.

01 Dec 2024·BIOCHEMICAL PHARMACOLOGY

Epoxytiglianes induce keratinocyte wound healing responses via classical protein kinase C activation to promote skin re-epithelialization

Article

Author: Johns, Jenny P. ; Dally, Jordanna ; Steadman, Robert ; Moses, Rachael L. ; Gordon, Victoria ; Boyle, Glen M. ; Johns, Jenny P ; Boyle, Glen M ; Knäuper, Vera ; Reddell, Paul ; Moseley, Ryan ; Woods, Emma L ; Woods, Emma L. ; Moses, Rachael L

Epoxytiglianes are a novel class of diterpene esters. The prototype epoxytigliane, EBC-46 (tigilanol tiglate), is a potent anti-cancer agent in clinical development for local treatment of a range of human and animal tumors. EBC-46 also consistently promotes wound re-epithelialization at the treatment sites, mediated via activation of classical protein kinase C (PKC) isoforms. We have previously shown that epoxytiglianes stimulate proliferative and wound repopulation responses in immortalized human skin keratinocytes (HaCaTs) in vitro, abrogated by pan-PKC inhibitor, bisindolylmaleimide-1. In this study, we further investigate the specific PKC isoforms responsible for inducing such wound healing responses, following HaCaT treatment with 1.51 nM-15.1 µM EBC-46 or analogue, EBC-211. Classical PKC inhibition by GӦ6976 (1 μM), significantly attenuated epoxytigliane induced, HaCaT proliferation and wound repopulation at all epoxytigliane concentrations. PKC-βI/-βII isoform inhibition by enzastaurin (1 μM), significantly inhibited HaCaT proliferation and wound repopulation responses induced by both epoxytiglianes, especially at 1.51-151 nM. PKC-α inhibitor, Ro 31-8220 mesylate (10 nM), exerted lesser inhibitory effects on HaCaT responses. Epoxytigliane changes in key keratin (KRT17) and cell cycle (cyclin B1, CDKN1A) protein levels were partly attenuated by GӦ6976 and enzastaurin. GӦ6976 also inhibited increases in matrix metalloproteinase (MMP-1, MMP-7, MMP-10) activities. Phospho-PKC (p-PKC) studies confirmed that epoxytiglianes transiently activated classical PKC isoforms (p-PKCα, p-PKC-βI/-βII, p-PKCγ) in a dose- and time-dependent manner. By identifying how epoxytiglianes stimulate classical PKCs to facilitate keratinocyte healing responses and re-epithelialization, these findings support further epoxytigliane development as topical therapeutics for clinical situations involving impaired re-epithelialization, such as non-healing wounds in skin.

News (Medical) associated with Enzastaurin Hydrochloride

21 Nov 2023

·www.prnewswire.com

KAZIA PROVIDES OVERVIEW OF PAXALISIB RELATED PRESENTATIONS FROM THE SOCIETY OF NEURO-ONCOLOGY 2023 ANNUAL MEETING

SYDNEY, Nov. 21, 2023 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, is pleased to provide key highlights of the clinical and preclinical paxalisib related presentations given by key thought leaders at the Society of Neuro-Oncology 2023 Annual Meeting. "The 2023 SNO Annual Meeting was another successful event with the latest advances in clinical trials, diagnosis and treatment of pediatric and adult patients with CNS malignancies," stated Dr. John Friend, CEO Kazia. "We are highly encouraged with the preliminary overall survival data from the PNOC022 clinical study that we believe will provide an alternative to the current therapies considered as standard of care." Key paxalisib highlights from the meeting: Friday, November 17th Combining ONC201 and paxalisib for the treatment of diffuse midline glioma (DMG); the preclinical results underpinning the international Phase II clinical trial (NCT05009992). Presenter: Evangeline R. Jackson; University of Newcastle, NSW, Australia The mechanism of action of both paxalisib and ONC201 were reviewed as well as the synergistic effects of their combination in DMG preclinical models Specifically, the authors observed how ONC201 over activates the PI3K-AKT pathway, which is the target pathway for paxalisib Consistent and statistically significant improvements were observed with the combination of paxalisb and ONC201 in DMG preclinical mouse models Two patient case studies were discussed; each receiving the combination of paxalisib and ONC201 through compassionate access 16-year old female with advanced and relapsed diffuse intrinsic pontine glioma (DIPG) who demonstrated significant neurological improvements as well as rapid tumour regression after receiving the combination Six-year old female with DIPG who received the combination of paxalisib and ONC201 after upfront radiation therapy. Tumor regression has been maintained for more than two years on paxalisib and ONC201 Exploiting the genetic dependency on PI3K/mTOR signaling for the treatment of H3-altered Diffuse Midline Glioma Presenter: Ryan Duchatel, PhD; University of Newcastle, NSW, Australia PI3K pathway activation is observed in >80% of all DMGs and was shown to be required for DMG cell growth The authors stated that the success of a monotherapy in DMG is highly unlikely; therefore they explored several combinations [of other therapies] with paxalisib with the aim of optimizing tolerability and efficacy of such combinations in preclinical mouse studies Adding metformin to paxalisib was observed to improve hyperglycemia (elevated blood glucose) as well as extend the overall survival rate The combination of paxalisib and enzastaurin (PKC inhibitor) was observed to further extend the overall survival when combined to radiation treatment Authors concluded the triple combination of paxalisib, enzastaurin and metformin warranted further investigation in clinical trials Phase I study of paxalisib and radiotherapy for CNS disease harboring PI3K pathway mutations: pilot analysis of circulating tumor DNA for patient eligibility confirmation and post-treatment response Presenter: Brandon Imber, MD, Memorial Sloan Kettering Cancer Center, NYC, USA This is a multi-institutional, Phase I trial of concurrent paxalisib and radiation therapy in patients with brain metastases with documented PI3K pathway mutations Study has expanded after data from the initial stage identified the maximal tolerated dose (45mg once daily) along with observed signals of clinical activity (100% response rate) The authors observed that plasma circulating tumor DNA (ctDNA) was able to accurately confirm the tumor's genetic mutations at baseline and can potentially be used as a biomarker to assess patient treatment response The authors presented a representative case from the ongoing Phase I study: 70-year-old woman with metastatic breast cancer with tumor harboring PIK3CA mutation received radiation therapy in combination with paxalisib for brain metastases Her baseline plasma ctDNA test before starting treatment detected the same PIK3CA mutation as her tumor MRI scan three months after treatment demonstrated radiographic response. In addition, a 99% reduction in the amount of ctDNA with PIK3CA mutation compared to baseline was detected, indicating ctDNA can potentially be used as an accurate method to monitor response after radiation therapy in combination with paxalisib This is the first time in this patient population to demonstrate a link between MRI findings and a blood-based measure of tumor burden (ctDNA) Sunday, November 19 PNOC022: a combination therapy trial using an adaptive platform design for patients with diffuse midline gliomas (DMGs) at initial diagnosis, post-radiation therapy and at time of therapy Presenter: Sabine Mueller, MD, UCSF, San Francisco, USA 30 sites open to enrollment in North America, Europe and Australia Total enrollment to date: 137 patients Cohort 1 (newly diagnosed) = 37 patients Cohort 2 (post radiation therapy) = 69 patients (one patient was replaced due to physician preference) Cohort 3 (at the time of recurrence) = 31 patients Cohort 2 preliminary analyses (median follow-up time was approximately 9 months) Median Overall Survival rate was 16.5 months Median Progression Free Survival (PFS) was 9.9 months (central review is ongoing) Analysis of preliminary data from all cohorts is still ongoing and the protocol is subject to amendment to refine dosing with the aim of improving tolerability and efficacy at which time the enrollment of new patients will start Additional data includes ctDNA, microbiome and quality of life measures This announcement was authorized for release by Dr. John Friend, CEO. 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, a 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 II study in glioblastoma reported promising signals of clinical activity in 2021, and a pivotal study, GBM AGILE, is ongoing, with final data expected in CY2023. Other clinical trials are ongoing in brain metastases, DMGs, and primary CNS lymphoma, with several of these having reported encouraging interim data. Paxalisib was granted Orphan Drug Designation for glioblastoma by the US Food and Drug Administration (US FDA) in February 2018, and Fast Track Designation for glioblastoma by the US FDA in August 2020. In addition, paxalisib was granted Rare Pediatric Disease Designation and Orphan Designation by the US FDA for DIPG in August 2020, and for atypical teratoid / rhabdoid tumors in June 2022 and July 2022, respectively. Kazia is also developing EVT801, a small-molecule inhibitor of VEGFR3, which was licensed from Evotec SE in April 2021. Preclinical data has shown EVT801 to be active against a broad range of tumor types and has provided evidence of synergy with immuno-oncology agents. A Phase I study in advanced solid tumors commenced recruitment in November 2021. 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 Kazia's strategy and plans with respect to its programs, including paxalisib and EVT801, as well as any potential future indications and timing for the release of interim or final data for such programs. 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, including the risk that preliminary or interim data may not reflect final results, 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. SOURCE Kazia Therapeutics Limited

Clinical ResultPhase 1Fast TrackOrphan DrugPhase 2

09 Dec 2022

·www.prnewswire.com

Global Molecular Oncology Diagnostics Market to Reach $12.13 Billion by 2032 - Exclusive DeepTech M-A-P™ Analysis by BIS Research

Emerging technologies such as microarray are also expected to be integrated more into molecular oncology diagnostics soon, which is expected to further boost the market growth. FREMONT, Calif., Dec. 9, 2022 /PRNewswire/ -- BIS Research, the global leader in providing market intelligence on deep technologies, has released its latest study titled Molecular Oncology Diagnostics Market - A Global and Regional Analysis. According to this study, the market for global molecular oncology diagnostics was valued at $3.62 billion in 2021 and is projected to reach $12.13 billion by 2032. The following factors are responsible for the increase in demand for molecular oncology diagnostics: Rising incidence of cancer cases Launch of innovative products in the molecular oncology diagnostics ecosystem Growth in biomarker identification and transformations in molecular techniques The detailed study is a compilation of 3 market data tables and 206 figures spread through 264 pages. Check out the detailed table of content here Analyst's Take on the Market Projection According to Nitish Kumar, Principal Consultant, Healthcare, BIS Research, "Although there have been significant innovations for the enhancement of all the important areas of diagnostics, molecular diagnostics, particularly, has harbored phenomenal attention in recent years owing to the in-depth insights they bring to diagnosis and treatment. As the next frontier of precision medicine, the global molecular oncology diagnostics market is expected to showcase enormous potential to completely revolutionize patient care and overall wellness in general." Request a FREE sample of this report here Existing Competitive Landscape The companies that are profiled have been selected based on input gathered from primary experts and analyzing company coverage, product portfolio, and market penetration. Some of the established names in the market are Agilent Technologies, Inc., Abbott, Biocartis NV, Bio-Rad Laboratories, Inc., F. Hoffmann-La Roche Ltd., QIAGEN N.V., Thermo Fisher Scientific, Inc., Danaher, Guardant Health, HTG Molecular Diagnostics, Inc., Illumina, Inc., Invivoscribe, Inc., Myriad Genetics, Inc., Sysmex Corporation, and more. Recent Developments in the Global Molecular Oncology Diagnostics Market In August 2022, Guardant Health expanded its Guardant Reveal usage, a liquid biopsy test for residual disease detection and recurrence monitoring, to include early-stage breast and lung cancers. It is the only tissue-free test used for colorectal cancer (CRC) and is now available for patients with breast and lung cancer. In December 2021, QIAGEN partnered with Denovo Biopharma to develop a companion diagnostic test for the treatment of diffuse large B-cell lymphoma. This test identified patients expressing Denovo genomic marker 1 (DGM1), which responded to Denovo's investigational cancer drug DB102. In September 2021, Illumina partnered with Merck to develop and commercialize research tests for use in identifying specific cancer genetic mutations used in the assessment of homologous recombination deficiency (HRD). In August 2021, Agilent Technologies, Inc. expanded its CE-IVD marked PD-L1 IHC 22C3 pharmDx assay usage in Europe. This assay was used as an aid in identifying esophageal cancer patients for treatments with KEYTRUDA using a combined positive score. Polymerase Chain Reaction Technology Type to Witness the Highest Market Growth The global market for molecular oncology diagnostics (by technology) has been divided into six categories, i.e., next-generation sequencing (NGS), polymerase chain reaction (PCR), fluorescence in-situ hybridization (FISH), immunohistochemistry (IHC), flow cytometry, and others. These rapidly evolving technologies have the potential to transform medical diagnoses and treatment for the better. Not only are developing diagnostic tools becoming more useful in a wider range of clinical scenarios, but they are also assisting in a more exploratory outlook in order to cater to a holistic approach to cancer treatment. According to this study from BIS Research, the PCR segment dominated the technology market in 2021 with a cumulative value of $1.20 billion, and the trend is expected to continue during the forecast period 2022-2032. Want to learn more about the latest trends in precision medicine? Speak to our analysts Exclusive DeepTechTM MAP Analysis for Healthcare by BIS Research: Molecular Diagnostics Market About BIS Research: BIS Research is a global B2B market intelligence and advisory firm focusing on deep technology and related emerging trends which can disrupt the market dynamics in the near future. We publish more than 200 market in telligence studies annually that focus on several deep technology verticals. Our strategic market analysis emphasizes on market estimations, technology analysis, emerging high-growth applications, deeply segmented granular country-level market data, and other important market parameters useful in the strategic decision-making for senior management. BIS Research offers syndicate as well as custom studies and expert consultations to firms, providing them with specific and actionable insights on novel technology markets, business models, and competitive landscapes. Contact: Bhavya Banga Email: [email protected] Ph no: 1-510-404-8135 BIS Research Inc. 39111 PASEO PADRE PKWY STE 313, FREMONT CA 94538-1686 Visit our Blog @ Get Expert Insights @ Connect with us on LinkedIn @ Connect with us on [email protected] Logo: SOURCE BIS Research

Diagnostic Reagents

13 Oct 2022

·endpts.com

A Colorado biotech ends clinical work to focus on marketing ADHD drug, consumer health products

A biopharma that markets an ADHD medication, and sells a portfolio of over-the-counter consumer health products on Amazon and elsewhere, has decided to scrap all work on clinical-stage assets. The Englewood, CO-based biotech will do away with a global Phase III trial that had begun just three months ago. The goal was to test enzastaurin, or AR101, as a treatment for patients with a certain type of Vascular Ehlers-Danlos syndrome, which can weaken the aorta and other arteries. Aytu BioPharma said it will also suspend, indefinitely, the clinical development of its endotracheal light catheter, an ultraviolet-A light, that it had hoped to use as an antimicrobial treatment for the virus behind Covid-19, as well as pneumonia associated with ventilators. The penny stock company markets central nervous system stimulants for people with attention deficit hyperactivity disorder, as well as medications for allergic rhinitis and fluoride deficiency for children. About $20 million will be saved, based on projections of what the studies would have cost, Aytu said Thursday. The company had raised $10 million in an offering in August to support the Phase III trial, among other capital purposes. The goal is to get in the black in the first half of next year as the company saw its first profitable quarter for prescriptions at the end of June. “In today’s economic environment, we believe strongly it is in the best interest of all stakeholders for us to focus our efforts on accelerating the growth of the commercial businesses and generating positive cash flow,” CEO Josh Disbrow said in prepared remarks. The move doesn’t mark a complete end to the VEDS asset, Disbrow said. The biotech plans to “revisit the program at the appropriate time,” with future clinical work requiring either the help of partners or internal profits to kick back into gear. At the end of June, the conclusion of Aytu’s fiscal year, the company reported $42.9 million in full-year net revenue from its ADHD products, following the acquisition of Neos Therapeutics, and $16.1 million in net revenue from its pediatric prescriptions. Consumer health — including allergy nasal spray, hair loss foam, heartburn relief and dietary supplements — brought in $35.5 million over a 12-month stretch. Amid concerns of a medication shortage for ADHD, namely limited supplies of Adderall, Aytu reassured patients last week that it has experienced “no supply disruptions to date” for its ADHD med, an oral, extended-release tablet formulation of amphetamine. In addition to Neos, Aytu also acquired Innovus Pharmaceuticals in recent years. Aytu is led by co-founder Disbrow, who previously served as COO of Ampio Pharmaceuticals; chief commercial officer Greg Pyszczymuka, who joined via the Neos buy; and CFO Mark Oki, who previously held the same post at Vivus, a bankrupt weight loss pillmaker that went through a Chapter 11 in late 2020.

Acquisition

100 Deals associated with Enzastaurin Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D04014	Enzastaurin Hydrochloride	-	DB06486

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Ehlers-Danlos Syndrome	Phase 3	US	Aytu Biopharma, Inc.	01 Jan 2023
Diffuse Large B-Cell Lymphoma	Phase 3	US	Eli Lilly & Co.	01 Jun 2006
Diffuse Large B-Cell Lymphoma	Phase 3	CN	Eli Lilly & Co.	01 Jun 2006
Diffuse Large B-Cell Lymphoma	Phase 3	JP	Eli Lilly & Co.	01 Jun 2006
Diffuse Large B-Cell Lymphoma	Phase 3	AU	Eli Lilly & Co.	01 Jun 2006
Diffuse Large B-Cell Lymphoma	Phase 3	BE	Eli Lilly & Co.	01 Jun 2006
Diffuse Large B-Cell Lymphoma	Phase 3	BR	Eli Lilly & Co.	01 Jun 2006
Diffuse Large B-Cell Lymphoma	Phase 3	CA	Eli Lilly & Co.	01 Jun 2006
Diffuse Large B-Cell Lymphoma	Phase 3	CZ	Eli Lilly & Co.	01 Jun 2006
Diffuse Large B-Cell Lymphoma	Phase 3	DK	Eli Lilly & Co.	01 Jun 2006

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03263026 (ENGINE, CTgov)	Phase 3	Diffuse Large B-Cell Lymphoma	256	Enzastaurin Hydrochloride (R-CHOP + Enzastaurin)	eashnzbgke(lwikndkjva) = fzptznsrlx onkvazgkuq (novlfidaqf, wkshqujnvl - tpddshcpds) View more	-	23 Jan 2025
				Cyclophosphamide+Prednisone+Doxorubicin+Rituximab+Vincristine (R-CHOP + Placebo)	aywthzuugk(mfptzslxxr) = ypnrgkdprp shtxhkhxsv (olwpwhgvfj, vmwewaoxmb - poifzgzhfk) View more
NCT00402116 (CTNI-25, SNO2021)	Phase 1/2	Recurrent Glioblastoma Adjuvant DGM1 positive	1	Enzastaurin + Temozolomide	dnukjyhggw(qnlptumpgw) = mvmbrsvysr mayddjacwq (fmmzmicrtt )	Positive	12 Nov 2021
NCT00308750 (CTgov)	Phase 2	Non-Small Cell Lung Cancer	218	carboplatin+enzastaurin+pemetrexed (Enzastaurin/Pemetrexed/Carboplatin)	oeuonchmro(ychckboqzt) = dhjudfgrav yasnjjqpyz (pkonroffkr, oitinwphdc - boirgeqvnd) View more	-	13 May 2021
				carboplatin+pemetrexed (Pemetrexed/Carboplatin)	oeuonchmro(ychckboqzt) = zcivydsvcx yasnjjqpyz (pkonroffkr, cxvytuiazw - nnqxsjxzuk) View more
NCT00452413 (CTgov)	Phase 1/2	Advanced Malignant Solid Neoplasm \| Non-Small Cell Lung Cancer	65	Erlotinib+Enzastaurin (Phase 1, Dose 1 and 2 (Enzastaurin and Erlotinib))	wygxtqbeur(reeegdqiux) = ynsnqobsvf mmcbrphawi (blihwcvhyn, oknpdepxkq - bvlnviwlkf) View more	-	13 May 2021
				Erlotinib+Enzastaurin (Phase 2 (Enzastaurin 500 mg, Erlotinib 150 mg))	vkzlmyfkcg(fqkjdkxehc) = yzjarjipyw hvqpzazubf (mgrjryffwm, shjlzjkiff - rkzcxfyxqd) View more
NCT00533429 (H6Q-MC-S034, CTgov)	Phase 2	Non-Small Cell Lung Cancer \| Advanced Lung Non-Small Cell Carcinoma	40	Carboplatin+Enzastaurin+Bevacizumab+Pemetrexed (Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin)	pwnamrueee(iabzkskqls) = qaslvgcvbs kgtnsfeopm (jxuqraxail, tlbltoixyj - tourbggdhk) View more	-	13 May 2021
				Placebo+Carboplatin+Bevacizumab+Pemetrexed (Pemetrexed + Carboplatin + Bevacizumab + Placebo)	pwnamrueee(iabzkskqls) = uqyikxmaky kgtnsfeopm (jxuqraxail, jcmvylzrqg - mdfltomfqg) View more
NCT00420381 (CTgov)	Phase 2	Ovarian Cancer \| Recurrent ovarian cancer \| Recurrent Primary Peritoneal Carcinoma ... View more	28	Enzastaurin	qnlqvhviro(knusnaefag) = rccazygyqa tkziwgyywj (gaakbvpltl, jypcimjirb - wodpatnxqs) View more	-	19 Dec 2020
NCT00428714 (CTgov)	Phase 2	Prostatic Cancer \| Castration-Resistant Prostatic Cancer \| Metastatic Prostate Carcinoma	73	enzastaurin (Enzastaurin-Cohort 1)	eyyyesysdc(reyqayzdtm) = pydjqzmotc sczbahcqpy (cidjxiqxqp, suyddlcgmr - vtxivunkvf) View more	-	25 Nov 2020
				enzastaurin (Enzastaurin-Cohort 2)	tqdvwtiaqp(sgrgqgvylp) = ctnfelmrcx qoybtqkuue (fodiltbjyp, voaoeuifgz - pxxlqjxnet) View more
NCT00466440 (CTgov)	Phase 2	Metastatic castration-resistant prostate cancer	108	Prednisone+Enzastaurin+Docetaxel (Part 2: Docetaxel + Prednisone + Enzastaurin)	ysvwtgubmk(bjtazayggo) = levtbldtrc oiiyadrnbz (gxqhhsskpq, paehmxcuiu - hmiblvogyb) View more	-	06 Nov 2020
				Placebo+Prednisone+Docetaxel (Part 2: Docetaxel + Prednisone + Placebo)	ysvwtgubmk(bjtazayggo) = fpxnciesud oiiyadrnbz (gxqhhsskpq, myuktaknoj - qkwrocatbo) View more
NCT00415363 (CTgov)	Phase 2	Small Cell Lung Cancer \| Non-Small Cell Lung Cancer \| Lung Cancer with Brain Metastasis	109	Enzastaurin (Enzastaurin)	sngqwcrema(ojdcayjueo) = mbdruxbfqy qydgexaljz (itvaclevqq, lciozuudyh - zescejjhqm) View more	-	05 Nov 2020
				Placebo (Placebo)	sngqwcrema(ojdcayjueo) = sgcnfgtbmc qydgexaljz (itvaclevqq, imnqswumob - ugalbhtddv) View more
NCT00538681 (CTgov)	Phase 2	Metastatic Lung Cancer	35	enzastaurin+cisplatin+pemetrexed (Part 1- Cohort 1)	lwcfxdjlix(bltxvvtcfl) = rkpvwqqwhq xzoqglotqr (xhzvekyabm, uvbpwlnalp - ibgvvuntee) View more	-	05 Nov 2020
				enzastaurin+cisplatin+pemetrexed (Part 1- Cohort 2)	lwcfxdjlix(bltxvvtcfl) = mioiqfkbky xzoqglotqr (xhzvekyabm, guscafkyau - kbnplevvym) View more

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