Drugs / Manganese Chloride
Manganese Chloride
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | MANGANESE CHLORIDE IN PLASTIC CONTAINER | — | 1986-06-26 | fda.gov ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT05451654 | Feb → Oct 2022 | COVID-19 | Medesis Pharma SA | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT04873440 | May 2021 → May 2022 | lymphoma | Chinese PLA General Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT03989310 | Mar 2019 → May 2021 | malignant pancreatic neoplasm | Chinese PLA General Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT04004234 | Mar 2019 → Aug 2020 | biliary tract cancer | Chinese PLA General Hospital | Unknown | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT03989336 | Dec 2020 → May 2022 | ovarian cancer | Chinese PLA General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT00963131 | Dec 2004 → Dec 2008 | central serous chorioretinopathy | Prince of Songkla University | Completed | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT07822646 | Oct 2026 → Apr 2029 expected | ovarian cancer | Chinese PLA General Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT04119843 | Feb 2020 → Feb 2023 | liver and intrahepatic bile duct neoplasm | Ascelia Pharma AB | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT03991559 Comparator | Nov 2018 → Dec 2019 | cancer, lymphoma | Chinese PLA General Hospital | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2026-03-27 | Ascelia Pharma AB | Results ASCELIA PHARMA ANNOUNCES ACCEPTANCE OF ORVIGLANCE DATA FOR ORAL PRESENTATION AT THE ANNUAL RADIOLOGY CONGRESS ESGAR 2026 ascelia.com ↗
The abstract titled “Diagnostic Value of Manganese-Based Contrast Agent (ACE-MBCA) vs Unenhanced MRI in Liver Lesion Detection: Re-analysis of STAR Study Images from Two Phase II Clinical Trials”, demonstrated that Orviglance significantly improves the detection of focal liver lesions compared to unenhanced MRI. |
| 2025-04-08 | Ascelia Pharma AB | Results Ascelia Pharma Announces Publication of Orviglance Study in Investigative Radiology ascelia.com ↗
In this 20-patient study, Orviglance enhanced MRI resulted in statistically significant superior visualization and a greater number of detected focal liver lesions than unenhanced. |
| 2024-12-17 | Ascelia Pharma AB | Results Ascelia Pharma Announces Acceptance of SPARKLE Phase 3 Data for Presentation at the Society of Abdominal Radiology Congress 2025 ascelia.com ↗
The two abstracts highlight the positive outcomes of the SPARKLE Phase 3 study. |
| 2024-05-02 | Ascelia Pharma AB | Results Ascelia Pharma Successfully Meets Primary Endpoint with Strong Headline Results in Orviglance Phase 3 Study ascelia.com ↗
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. |
| 2023-06-16 | Ascelia Pharma AB | Results Ascelia Pharma presented Orviglance Hepatic Impairment Data and hosted a Q&A with liver imaging experts at the 2023 ESGAR Annual Meeting ascelia.com ↗
As previously communicated, the results of the Hepatic Impairment Study showed that Orviglance is well tolerated in patients with liver (hepatic) impairment, with only mild to moderate transient, gastrointestinal adverse events reported, such as nausea. |
| 2022-11-30 | Ascelia Pharma AB | Results ASCELIA PHARMA PRESENTS RESULTS OF ORVIGLANCE FOOD EFFECT STUDY AT RSNA 2022 SHOWING STRONG LIVER ENHANCEMENT BOTH WITH LIGHT MEAL AND IN FASTING CONDITION ascelia.com ↗
The Food Effect Study 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. |
| 2021-12-01 | Ascelia Pharma AB | Results Results from Orviglance comparison study to gadolinium presented at RSNA 2021 ascelia.com ↗
The results showed that a higher number of liver lesions was detected by all three independent readers for Orviglance compared to gadolinium. |
| 2021-08-10 | Ascelia Pharma AB | Regulatory Ascelia Pharma receives conditional FDA acceptance for brand name Orviglance ascelia.com ↗
Ascelia Pharma AB (publ) (ticker: ACE) today announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted Orviglance® as the proposed brand name for manganese chloride tetrahydrate (Mangoral), the company's novel first-in-class MRI contrast agent for use in liver MR imaging in adults with severely impaired kidney function. |
| 2020-12-02 | Ascelia Pharma AB | Results New study shows Mangoral’s lesion visualization as effective as gadolinium contrast agent ascelia.com ↗
The results showed that Mangoral was as effective as the gadolinium-based contrast agent gadobenate dimeglumine for visualization of focal liver lesions. |
| 2020-11-03 | Ascelia Pharma AB | Regulatory EMA confirms Mangoral eligible for the centralized regulatory procedure in the EU ascelia.com ↗
Ascelia Pharma AB (publ) (ticker: ACE) today announced that it has received confirmation from the European Medicines Agency (EMA) that a Marketing Authorization Application (MAA) for Mangoral is eligible to be submitted in the European Union (EU) under the Agency’s centralized procedure. |
All press releases naming this drug 27 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Manganese Chloride | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03989310 ↗ |
| Known as | manganese | “manganese 4 mg” NCT00963131 ↗ |
| Known as | Manganese sulfate monohydrate | “Manganese sulfate monohydrate, MnSO4, H2O (NanoManganese®) will be administered using the microemulsion AONYS® technology.” NCT05451654 ↗ |
| Known as | Mangoral | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04119843 ↗ |
| Known as | MnSO4, H2O | “Manganese sulfate monohydrate, MnSO4, H2O (NanoManganese®) will be administered using the microemulsion AONYS® technology.” NCT05451654 ↗ |
| Known as | NanoManganese | “Manganese sulfate monohydrate, MnSO4, H2O (NanoManganese®) will be administered using the microemulsion AONYS® technology.” NCT05451654 ↗ |
| Action | Activate | “Manganese has been confirmed to activate antigen-presenting cells” NCT04004234 ↗ |
| Modality | Other / unclassified | “function as mucosal immunoadjuvants” NCT04004234 ↗ |
| Route | Inhaled | “Administered by inhalation” NCT03989310 ↗ |