A Phase I/II, Open-label Study to Evaluate the Abscopal Response and Safety of Manganese and Standard-of-care Radiotherapy/ SBRT in Subjects With Metastatic Solid Tumors or Lymphoma

Radiotherapy is a regular care for metastatic solid tumors or lymphoma, and it can induce immunogenic death of tumor cells and a stronger immune response. Sometimes, tumor regression would be observed at sites distant to an irradiated field because of the radiotherapy-induced anticancer immune responses, so-called abscopal response. Manganese has been confirmed to activate innate immune and function as anticancer immunoadjuvant in pre-clinical studies. This study is designed to assess the abscopal response and safety of combined therapy of manganese and radiotherapy in patients with metastatic solid tumors or lymphoma.

Start Date06 May 2021

Sponsor / Collaborator

Chinese People's Liberation Army General Hospital

NCT03989336 / CompletedPhase 2IIT

A Phase I/II, Open-label, Two-arm, Single-center Study to Evaluate the Safety and Efficacy of the Pan-immunotherapy in Subjects With Relapsed/Refractory Ovarian Cancer

Ovarian cancer is the most lethal gynecological cancer and the 5th leading cause of cancer death in women. Platinum chemotherapy has been widely adopted as a standard treatment for advanced ovarian cancer, the response rates in patients with relapsed/refractory ovarian cancer is unacceptably low. PD-1 blockade has been developed to a new class of cancer immunotherapy that could restore an adequate immunosurveillance against the neoplasm and enhance T-cell-mediated anticancer immune responses. Manganese has been confirmed to activate antigen-presenting cells and function as mucosal immunoadjuvants in pre-clinical studies. This two-arm, phase I/II study is designed to assess the safety and efficacy of combined therapy of anti-PD-1 antibody and chemotherapy with or without Manganese priming.

Start Date23 Dec 2020

Sponsor / Collaborator

Chinese People's Liberation Army General Hospital

NCT04119843 / CompletedPhase 3

A Multicenter, Open-label Study to Evaluate the Safety and Diagnostic Efficacy of Mangoral in Patients With Known or Suspected Focal Liver Lesions and Severe Renal Impairment

The overall objective of this study is to evaluate the safety and diagnostic efficacy of Mangoral in liver MRI in participants with known or suspected focal liver lesions and severe renal impairment. The diagnostic efficacy of Mangoral will be assessed in terms of visualization of detected focal liver lesions in combined MRI (CMRI: combined Mangoral-enhanced and unenhanced MRI) compared to unenhanced MRI.

Start Date19 Feb 2020

Sponsor / Collaborator

Ascelia Pharma AB

100 Clinical Results associated with Manganese Chloride

100 Translational Medicine associated with Manganese Chloride

100 Patents (Medical) associated with Manganese Chloride

341

Literatures (Medical) associated with Manganese Chloride

01 Dec 2024·Applied microbiology and biotechnology

Transcriptomic profiling of adding cobalt chloride to improve dendrobine-type total alkaloid production

Article

Author: Qian, Xu ; Chen, Jishuang ; Qin, Yitong ; Sarasiya, Surendra

Trichoderma longibrachiatum UN32 is known for its efficient production of dendrobine-type total alkaloids (DTTAs). This study aimed to determine the optimal medium composition for the UN32 strain using response surface methodology. Key factors, including glucose, beef extract, and CoCl₂, were selected through the Plackett-Burman design. Subsequently, a factorial optimization approach was employed using the steepest ascent design, and 17 trial sets were completed via the Box-Behnken design. The optimal medium composition was found to consist of 29.4 g/L of glucose, 17.3 g/L of beef extract, and 0.28 mmol/L of CoCl₂. This optimized medium resulted in an impressive 80.8% increase in mycelial dry weight (reaching 12.303 g/L) and a substantial 76.4% boost in DTTA production (reaching 541.63 ± 46.95 μg). Furthermore, the fermentation process was scaled up to a 5-L bioreactor, leading to a DTTA production approximately 1.95 times than the control. Transcriptome analysis of strain UN32 in response to CoCl₂ supplementation revealed significant changes in the expression of critical genes associated with the TCA cycle and L-valine, L-leucine, and L-isoleucine biosynthesis changed. These alterations resulted in a heightened influx of acetyl-CoA into DTTA production. Additionally, the expression of genes related to antioxidant enzymes was modified to maintain homeostasis of reactive oxygen species (ROS). A potential mechanism for the accumulation of DTTAs based on ROS as a signal transduction was proposed. These findings provide valuable insights into the regulatory mechanisms of DTTA biosynthesis, potentially offering a method to enhance the production of secondary metabolites in the UN32 strain. KEY POINTS: • After the RSM optimization, there is a substantial increase of 80.8% in biomass production and a significant 76.4% rise in DTTA production. • Transcriptome analysis revealed that the inclusion of CoCl₂ supplements resulted in an enhanced influx of acetyl-CoA. • Proposed a mechanism for the accumulation of DTTAs for the role of ROS as a signal transduction pathway.

01 Feb 2024·Redox biology

Enhancing HIF-1α–P2X2 signaling in dorsal raphe serotonergic neurons promotes psychological resilience

Article

Author: Pan, Yi-da ; Qian, Yu ; Mechawar, Naguib ; Turecki, Gustavo ; Zhang, Yuan ; Ou Yang, Wen-Jie ; Zhu, Min-Zhen ; Li, Huan-Yu ; Zhu, Xin-Hong ; Zheng, Wen-Ying

Major depressive disorder (MDD) is a devastating condition. Although progress has been made in the past seven decades, patients with MDD continue to receive an inadequate treatment, primarily due to the late onset of first-line antidepressant drugs and to their acute withdrawal symptoms. Resilience is the ability to rebound from adversity in a healthy manner and many people have psychological resilience. Revealing the mechanisms and identifying methods promoting resilience will hopefully lead to more effective prevention strategies and treatments for depression. In this study, we found that intermittent hypobaric hypoxia training (IHHT), a method for training pilots and mountaineers, enhanced psychological resilience in adult mice. IHHT produced a sustained antidepressant-like effect in mouse models of depression by inducing long-term (up to 3 months after this treatment) overexpression of hypoxia-inducible factor (HIF)-1α in the dorsal raphe nucleus (DRN) of adult mice. Moreover, DRN-infusion of cobalt chloride, which mimics hypoxia increasing HIF-1α expression, triggered a rapid and long-lasting antidepressant-like effect. Down-regulation of HIF-1α in the DRN serotonergic (DRN^5-HT) neurons attenuated the effects of IHHT. HIF-1α translationally regulated the expression of P2X2, and conditionally knocking out P2rx2 (encodes P2X2 receptors) in DRN^5-HT neurons, in turn, attenuated the sustained antidepressant-like effect of IHHT, but not its acute effect. In line with these results, a single sub-anesthetic dose of ketamine enhanced HIF-1α-P2X2 signaling, which is essential for its rapid and long-lasting antidepressant-like effect. Notably, we found that P2X2 protein levels were significantly lower in the DRN of patients with MDD than that of control subjects. Together, these findings elucidate the molecular mechanism underlying IHHT promoting psychological resilience and highlight enhancing HIF-1α-P2X2 signaling in DRN^5-HT neurons as a potential avenue for screening novel therapeutic treatments for MDD.

01 Feb 2024·Investigative radiology

Oral Manganese Chloride Tetrahydrate: A Novel Magnetic Resonance Liver Imaging Agent for Patients With Renal Impairment

Review

Author: Madrazo, Beatrice L ; Persson Hedman, Hanna ; Brismar, Torkel B ; Geisel, Dominik ; Norlin, Andreas ; Kartalis, Nikolaos

Abstract:

Manganese-based contrast agents (MBCAs) show promise to complement gadolinium-based contrast agents (GBCAs) in magnetic resonance imaging (MRI) of the liver. Management of patients with focal liver lesions and severely impaired renal function uses unenhanced liver MRI or GBCA-enhanced MRI. However, unenhanced MRI risks reducing patient's survival.Gadolinium-based contrast agents, which help to detect and visualize liver lesions, are associated with increased risk of nephrogenic systemic fibrosis in renally impaired patients, a severe adverse event (AE) with potentially fatal outcome. Therefore, use of GBCA in patients with impaired renal function requires careful consideration. Other concerns are related to tissue deposition in the brain and other organs due to lack of gadolinium clearance, which could lead to concerns also for other patient populations, for example, those exposed to multiple procedures with GBCA. Of particular concern are the linear chelates that remain available for liver MRI, where there is no replacement technology. This has highlighted the urgency for safer alternatives.An alternative may be the drug candidate Ascelia-MBCA (ACE-MBCA, Orviglance), oral manganese chloride tetrahydrate. This candidate effectively visualizes and detects focal liver lesions, as demonstrated in 8 clinical studies on 201 adults (healthy or with known or suspected focal liver lesions). ACE-MBCA has a low and transient systemic exposure, which is likely the reason for its beneficial safety profile. The AEs were primarily mild and transient, and related to the gastrointestinal tract. This new, orally administered product may offer a simple imaging approach, allowing appropriate patient management in renally impaired patients when use of GBCA requires careful consideration.In this review, we highlight the clinical development of ACE-MBCA—a novel, liver-specific contrast agent. We begin with a brief overview of manganese properties, addressing the need for MBCAs and describing their optimal properties. We then review key findings on the novel agent and how this allows high-quality MRIs that are comparable to GBCA and superior to unenhanced MRI. Lastly, we provide our view of future perspectives that could advance the field of liver imaging, addressing the medical needs of patients with focal liver lesions and severe renal impairment.Our review suggests that ACE-MBCA is a promising, effective, and well-tolerated new tool in the radiologist's toolbox.

News (Medical) associated with Manganese Chloride

02 May 2024

·www.biospace.com

Ascelia Pharma Successfully Meets Primary Endpoint with Strong Headline Results in Orviglance Phase 3 Study

Ascelia Pharma AB (publ) (ticker: ACE), a biotech focused on improving the life of people living with rare cancer conditions, today announced that liver imaging drug candidate, Orviglance®, significantly improved visualization of focal liver lesions, successfully meeting the primary endpoint in the pivotal Phase 3 study SPARKLE. Investors and analysts are invited to the virtual Investor Update: “Bringing Orviglance to Patients”, on Tuesday, 7 May at 14:00 CEST The Phase 3 study demonstrated strong superiority in visualization of focal liver lesions with Orviglance (CMRI) vs. unenhanced MRI with statistical significance for all three readers (<0.001) Orviglance is in development as a first-in-class contrast agent for use in liver MRI in patients with severely impaired kidney function and has been granted FDA Orphan Drug Designation Orviglance addresses a global USD 800 million market annually The Phase 3 data marks the completion of Orviglance clinical development with nine studies in 286 patients and healthy volunteers Submission of the New Drug Application (NDA) the US Food and Drug Administration (FDA) is expected by mid-2025 Investors, analysts and media are invited to the virtual Investor Update and live Q&A on next steps: “Bringing Orviglance to Patients”, on Tuesday, 7 May 2024 at 14:00 CES The pivotal Phase 3 study, SPARKLE, successfully met the primary endpoint and demonstrated that the company’s magnetic resonance imaging (MRI) contrast agent, Orviglance significantly improved the visualization of focal liver lesions compared to unenhanced MRI. The results for all three readers were highly statistically significant (P values <0.001). The reliability of the data is strong and conclusive for all readers – this includes an acceptable level of variability. Common adverse events in this vulnerable patient population were in line with previous studies with Orviglance, such as mild- to moderate nausea. No serious adverse drug reactions were observed “We are thrilled to announce these strong and convincing Phase 3 results for Orviglance. This is the most significant milestone achievement for Ascelia Pharma so far”, said Magnus Corfitzen, CEO of Ascelia Pharma. “Following considerable challenges during the SPARKLE study, we are very excited to complete the Orviglance clinical development with these strong results in Phase 3. We now look forward to advancing Orviglance through the registration process and make it available for patients.” The Company will now focus on bringing Orviglance through the regulatory submission and approval process. In parallel, we will continue to advance launch readiness and dialogue with potential commercialization partners to make Orviglance available to patients who need high-quality liver imaging without gadolinium-related safety risk. “On behalf of the entire Ascelia Pharma team, I would like to thank patients and investigators involved in the SPARKLE study as well as other partners instrumental in completing the successful data read-out. We look forward to discussing the results with the medical community and regulatory authorities”, said Magnus Corfitzen. The Company expects to submit the New Drug Application (NDA) the US Food and Drug Administration (FDA) by mid-2025 to obtain regulatory approval. Investors, analysts, and media are invited to the virtual Investor Update: “Bringing Orviglance to Patients”, on Tuesday, 7 May 2024 at 14:00 CEST. In this update and live Q&A, executive management will further explain the strong headline results and share plans for the upcoming regulatory and commercialization activities. A link to the event will be available on the company’s website ( com). Clinical development of Orviglance has now been completed with consistent positive efficacy and safety data from 286 patients and healthy volunteers in nine studies, of which the SPARKLE is the last and pivotal study. Patient enrollment in the global multi-center SPARKLE study was completed early 2023, with MRI data from 85 patients with known or suspected focal liver lesions and severely impaired kidney function. In accordance with regulatory requirements, the improvement of visualization of lesions was evaluated by three independent radiologist readers. In mid-2023, the unexpected discovery of high intra-reader variability in the study image scoring by the readers prevented the Company from evaluating the efficacy data from SPARKLE. Therefore, a new evaluation of the images with new readers was required. The company successfully completed the re-evaluation according to the planned timeline with the announcement today. Orviglance has been granted an Orphan Drug Designation by the US Food and Drug Administration (FDA) for liver MRI in patients with severely impaired kidney function. These patients have the highest risk of developing the serious and potentially fatal condition Nephrogenic Systemic Fibrosis (NSF) after exposure to the currently available gadolinium-based contrast agents. Regulatory bodies have issued warnings for the use of these agents in this vulnerable patient population. Therefore, there is a need for an alternative solution to detect and visualize focal liver lesions in patients with impaired kidney function, who today typically receive inferior unenhanced MRI. Liver MRI is a cornerstone in cancer care, as liver metastases are common in many cancer types and often the cause of mortality. Orviglance aims to give patients with impaired kidney function access to safe and effective liver imaging to live longer and healthier lives. The unmet need for these patients represents an addressable market potential of USD 800 million globally. *The Company considers mid-2025 to be the period from the second half of Q2 to the first half Q3. Contacts Magnus Corfitzen, CEO Email: moc@ascelia.com Tel: +46 735 179 118 Julie Waras Brogren, Deputy CEO (Finance, Investor Relations & Commercial) Email: jwb@ascelia.com Tel: +46 735 179 116 This information was submitted for publication, through the agency of the contact persons set out above. About Us Ascelia Pharma is a biotech company focused on orphan oncology treatments. We develop and commercialize novel drugs that address unmet medical needs and have a clear development and market pathway. The company has two drug candidates – Orviglance and Oncoral – in clinical development. Ascelia Pharma has global headquarters in Malmö, Sweden, and is listed on Nasdaq Stockholm (ticker: ACE). For more information, please visit About Orviglance Orviglance (manganese chloride tetrahydrate) is a novel oral contrast agent for MR-imaging developed to improve the detection and visualization of focal liver lesions (including liver metastases and primary tumors) in patients with reduced kidney function. These patients are at risk of serious side effects from the currently available class of gadolinium-based contrast agents. Orviglance, has been granted an Orphan Drug Designation by the US Food and Drug Administration (FDA). A clinical program of nine studies, including the pivotal global Phase 3 study SPARKLE, has successfully been completed with strong and consistent efficacy and safety results. About Oncoral Oncoral is a novel irinotecan chemotherapy tablet developed initially for the treatment of gastric cancer. Irinotecan chemotherapy has an established potent anti-tumor effect. Oncoral is a daily tablet with the potential to offer better patient outcomes with improved safety following the daily dosing at home compared to intravenous high-dose infusions at the hospital. Following successful Phase 1 results, Oncoral is now prepared for Phase 2 clinical development. This information is information that Ascelia Pharma is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2024-05-02 11:12 CEST. Attachments Ascelia Pharma Successfully Meets Primary Endpoint with Strong Headline Results in Orviglance Phase 3 Study

Phase 3Orphan DrugClinical ResultPhase 2

28 Feb 2023

·www.biospace.com

Ascelia Pharma meets major milestone with patient enrollment completion of Phase 3 Study for Orviglance, novel MRI contrast agent for patients with kidney impairment

Ascelia Pharma AB (publ) (ticker: ACE), a biotech focused on improving the life of people living with rare cancer conditions, today announced the successful completion of patient enrollment in the company’s pivotal phase 3 clinical study, SPARKLE, with the lead candidate drug Orviglance®. “We are very pleased to have reached our enrollment target of 80 patients. This is a major milestone in the history of Ascelia Pharma and a key step on the journey to making Orviglance available to patients around the world. The focus will now switch to the evaluation of MRI images by independent radiologists, as required by regulatory standards, and the headline results from this pivotal study are expected in mid-2023”, said Magnus Corfitzen, CEO of Ascelia Pharma. Orviglance, which has been granted an Orphan Drug Designation by the US Food and Drug Administration (FDA), is the first contrast agent in development for use in liver magnetic resonance imaging (MRI) in patients with severely impaired kidney function. Cancer can be difficult to diagnose and treat because of its ability to metastasize - spread beyond the location of the primary tumor. The liver is the second most likely organ for metastases to develop, playing a significant role in the demise of patients diagnosed with breast or colorectal cancer. MRI is usually the preferred imaging modality for both initial cancer disease staging and monitoring of liver metastases and relies on contrast agents to improve the quality of the obtained scan. However, the standard MRI contrast agents currently available contain the heavy metal gadolinium, which when used in patients with impaired kidney function can increase the risk of the serious and potentially fatal condition, Nephrogenic Systemic Fibrosis (NSF). For this reason, regulatory bodies have issued warnings for their use in this patient population and patients with severe kidney impairment typically have an MRI without contrast enhancement, which reduces image quality and ability to detect and localize cancer tumors or metastases. Ascelia Pharma’s SPARKLE study aims to demonstrate that Orviglance improves the detection and visualization of focal liver lesions, including liver metastases and primary tumors, in patients with severe kidney impairment. The SPARKLE study is the last of nine studies in the extensive clinical development program for Orviglance, which will enable Ascelia Pharma to complete a New Drug Application (NDA) submission to the FDA. Orviglance aims to give cancer patients with poor kidney function access to safe and effective liver imaging to live longer and healthier lives. The unmet need for these patients represents an addressable market potential of USD 500-600 million in the US, Europe and Japan. “On behalf of the entire Ascelia Pharma team, I would like to thank patients, investigators, and other collaborators who have been involved in SPARKLE. We have succeeded in enrolling 80 patients in a rare disease clinical study under highly challenging circumstances, including a global pandemic and the invasion of Ukraine. Based on strong results in earlier clinical studies, we are optimistic of a positive outcome of SPARKLE and look forward to the next steps in bringing Orviglance through the regulatory process and making it available to patients for whom the use of gadolinium-based products may be medically inadvisable”, said Magnus Corfitzen. Contacts Media contact: Hannah Steele Email: hls@scottpr.com Tel: +44 1477 539 539 Magnus Corfitzen, CEO Email: moc@ascelia.com Tel: +46 735 179 118 About Us Ascelia Pharma is a biotech company focused on orphan oncology treatments. We develop and commercialize novel drugs that address unmet medical needs and have a clear development and market pathway. The company has two drug candidates – Orviglance (previously referred to as Mangoral) and Oncoral – in clinical development. Ascelia Pharma has global headquarters in Malmö, Sweden, and is listed on Nasdaq Stockholm (ticker: ACE). For more information, please visit About Orviglance (previously referred to as Mangoral) Orviglance (manganese chloride tetrahydrate) is a novel oral contrast agent for MR-imaging developed to improve the detection and visualization of focal liver lesions (including liver metastases and primary tumors) in patients with reduced kidney function. These patients are at risk of serious side effects from the currently available class of gadolinium-based contrast agents. Orviglance has been granted an Orphan Drug Designation by the US Food and Drug Administration (FDA). A clinical program of nine studies, including the global Phase 3 study SPARKLE, have been completed.

Phase 3Orphan Drug

28 Nov 2022

·www.biospace.com

Ascelia Pharma Presents Results of Orviglance Food Effect Study at RSNA 2022 Showing Strong Liver Enhancement Both With Light Meal And In Fasting Condition

XX November 2022: Ascelia Pharma AB (publ) – a biopharmaceutical company focused on improving the life of people living with rare cancer conditions – is presenting results from its Orviglance* Food Effect study at the RSNA conference 2022 (Radiological Society of North America – 27 November – 1 December Chicago, Illinois). The study evaluates the effect of food intake on the absorption and signal intensity of Orviglance, a manganese-based MRI contrast agent, and successfully concludes that image enhancement is not impacted by a light meal The Food Effect Study evaluates the effect of food intake on absorption and signal intensity of Orviglance, Ascelia Pharma’s investigational magnetic resonance-imaging (MRI) agent used in the visualization and detection of cancer in the liver in patients with reduced kidney function. The results show that intake of a light meal within 30 min prior to Orviglance administration provides similar image MRI enhancement of the liver compared to a fasting condition. In line with previous studies, the data also confirms strong image enhancement of the liver after Orviglance administration compared to an MRI image without a contrast agent. In clinical practice, the results demonstrate the possibility of being administered Orviglance both after fasting or after consumption of a light meal. In this crossover study, Orviglance was administered to 24 healthy volunteers in fasting condition and in one of two conditions with food intake (either a light or full meal). The image enhancement effect was measured by the change in the MR signal intensity before and after (1, 4, 8 and 24 hours) administration of Orviglance. The results showed that a light meal prior to Orviglance administration provided similar image enhancement when compared to a fasting condition, whereas the image enhancement was less pronounced for the group receiving a full meal. Ascelia Pharma has filed a patent application based on the results of the study. The reporting of these final results for the Food Effect Study completes two of the three studies in Ascelia Pharma’s ongoing Phase 3 clinical program for registration of Orviglance. A Hepatic Impairment Study successfully concluded that Orviglance is well tolerated in patients with liver (hepatic) impairment, with only mild to moderate transient, gastrointestinal adverse events reported, such as nausea. No new safety concerns were identified. The data confirmed there was no renal excretion of Orviglance, and that excretion is primarily occurring via the liver also in this subgroup of patients. The plan for the ongoing Phase 3 study, SPARKLE, required for a subsequent regulatory submission, is to complete patient enrolment by the end of this year. Data from all three studies will be included in the marketing authorization application to health authorities, including FDA and EMA. Magnus Corfitzen, CEO at Ascelia Pharma, said: “We are very pleased to be presenting the study as an oral presentation at the RSNA. The possibility for omitting a fasting condition improves the convenience for patients and eases the administration of Orviglance in clinical practice. The study provides robust evidence of the diagnostic value that Orviglance can offer once it is available to patients and physicians. Orviglance is being developed to address the unmet medical need of patients with poor kidney function who require liver imaging, and it is very encouraging that the study results support previous findings on the ability of Orviglance to provide strong image enhancement to liver MRI scans.” Orviglance is a novel manganese-based oral contrast agent for MRI developed to improve the detection and visualization of focal liver lesions (including liver metastases and primary tumors) in patients with reduced kidney function. These patients are at risk of serious, and potentially fatal, side effects from the currently available class of gadolinium-based contrast agents, which all carry black box warnings issued by regulatory authorities, such as the US Food and Drug Administration (FDA) because of this risk. Orviglance, which has been granted an Orphan Drug Designation by the FDA, is currently in Phase 3 development. SPARKLE is a global multicenter study of Orviglance in up to 200 patients with severe renal impairment and known or suspected focal liver lesions. Primary efficacy, in terms of lesion visualization compared to unenhanced MRI (MRI without a contrast agent), will be evaluated by three independent blinded readers. The Orviglance Food Effect study will be presented by Dr. Kohkan Shamsi at the RSNA on Wednesday, 30 November 2022 at 3,00pm ET. RSNA is the annual meeting of the radiologists, where new technologies and key research studies are presented. Visitors can attend in person, or virtually. For more information, visit . ENDS Notes to editor: About Ascelia Pharma Ascelia Pharma is a biotech company focused on orphan oncology treatments. It develops and commercializes novel drugs that address unmet medical needs and has a clear development and market pathway. The company has two drug candidates – Orviglance (previously referred to as Mangoral) and Oncoral – in clinical development. Ascelia Pharma has global headquarters in Malmö, Sweden, and is listed on Nasdaq Stockholm (ticker: ACE). For more information, please visit About Orviglance (previously referred to as Mangoral) Orviglance (manganese chloride tetrahydrate) is a novel oral contrast agent for MR-imaging developed to improve the detection and visualization of focal liver lesions (including liver metastases and primary tumors) in patients with reduced kidney function. These patients are at risk of serious side effects from the currently available class of gadolinium-based contrast agents. Orviglance, which has been granted an Orphan Drug Designation by the US Food and Drug Administration (FDA), is currently in Phase 3 development, including the global multi-center SPARKLE study.

Clinical ResultPhase 3Orphan Drug

100 Deals associated with Manganese Chloride

External Link

KEGG	Wiki	ATC	Drug Bank
D04852	-	-	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Contrast agents	JP	Meiji Seika Pharma Co., Ltd.	20 Apr 2006
Nutrition Disorders	US	Hospira, Inc.	26 Jun 1986

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Solid tumor	Phase 2	CN	Chinese People's Liberation Army General Hospital	06 May 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03989336 (ASCO2020) Manual	Phase 2	Ovarian Cancer Last line	27	nab-paclitaxel+ cisplatin+MnCl2+Sintilimab	mjxyfdbtoc(mqtopoesho) = The most common AEs are hematological toxicity (87%), nausea (56%) and vomiting (47%) in both two cohorts. enfclmvzgi (neyklzztsn )	Positive	25 May 2020
				cisplatin+nab-paclitaxel+Sintilimab

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis