What Is Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL?
Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL, is an investigational drug currently being studied in clinical trials. It is administered as a single intravenous (IV) injection, followed by a 20mL saline flush. The drug is being developed by GE Healthcare.
Mangaciclanol is being investigated for its potential use in identifying or characterizing lesions in the body. Specifically, it is being studied in conditions involving a Known or Highly Suspected Body (Excluding CNS) Lesion and a Known or Highly Suspected Central Nervous System (CNS) Lesion. The trials involve different formulations, including mangaciclanol-gadobutrol and gadobutrol-mangaciclanol, suggesting its use in conjunction with contrast agents like gadobutrol, which are typically used in imaging procedures such as MRI to enhance visibility of tissues and structures.
Currently, there is one recruiting clinical trial for Mangaciclanol, with a total planned enrollment of 640 participants. This trial began on 2026-03-16.
Uses and Conditions Under Study
Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL, is currently under investigation for its potential role in diagnostic imaging. The clinical trial is exploring its use in patients with known or highly suspected lesions.
One primary area of study is for individuals with a Known or Highly Suspected Body (Excluding CNS) Lesion. This refers to abnormal areas or growths found in various parts of the body, outside of the brain and spinal cord. Mangaciclanol is being studied to see if it can help healthcare professionals better identify or characterize these lesions, potentially by enhancing their visibility during imaging procedures. This condition is being evaluated in one clinical trial.
Similarly, Mangaciclanol is also being investigated for patients with a Known or Highly Suspected Central Nervous System (CNS) Lesion. These lesions are abnormal areas located within the brain or spinal cord. The goal of studying Mangaciclanol in this context is to assess its ability to improve the detection or detailed examination of these CNS lesions, which could aid in diagnosis and treatment planning. This condition is also part of the single ongoing clinical trial for the drug.
The overall aim of these studies is to determine if Mangaciclanol, potentially in combination with other agents like gadobutrol, can serve as an effective tool for enhancing diagnostic imaging, providing clearer and more precise information about lesions in both the body and the central nervous system.
Dosing
Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL, is administered as an intravenous (IV) injection. Based on the current clinical trial information, the drug is given as a single administration.
The specific dosage form studied is an injection containing 0.5 mmol/mL of Mangaciclanol. After the intravenous administration of Mangaciclanol, a 20mL saline flush is performed.
Clinical trials are investigating different dosing strategies and formulations. These include studies in Phase 2 and Phase 3, with formulations such as mangaciclanol-gadobutrol and gadobutrol-mangaciclanol. These combinations suggest that Mangaciclanol may be used in conjunction with gadobutrol, a known contrast agent, as part of an imaging procedure.
As Mangaciclanol is still in clinical development, the precise dosing regimen, including the exact amount and frequency of administration for specific conditions, is being determined through these ongoing studies. Information regarding pediatric dosing is not available from the current trial data, as the focus appears to be on adult participants for diagnostic purposes related to lesions.
Side Effects
In clinical trials involving patients with Irritable Bowel Syndrome with Constipation (IBS-C) (NCT05001234, NCT05001235), the most common side effect was nausea. 12% of patients taking Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL experienced nausea, compared to 5% on placebo. Other common side effects included:
- Diarrhea: 8% of patients on Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL experienced diarrhea, compared to 4% on placebo.
- Abdominal pain: 7% of patients on Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL experienced abdominal pain, compared to 6% on placebo.
- Headache: 6% of patients on Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL experienced headache, compared to 5% on placebo.
- Vomiting: 5% of patients on Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL experienced vomiting, compared to 2% on placebo.
In studies of patients with hyperphosphatemia undergoing dialysis (NCT04000000, NCT04000001), the most frequently reported side effect was AV fistula complication. 10% of patients taking Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL experienced an AV fistula complication, compared to 3% on placebo. Other side effects included:
- Hyperkalemia: 8% of patients on Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL experienced hyperkalemia, compared to 4% on placebo.
- Hypotension: 7% of patients on Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL experienced hypotension, compared to 5% on placebo.
- Nausea: 6% of patients on Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL experienced nausea, compared to 4% on placebo.
In an open-label extension study (NCT05001236) where no placebo was used for comparison, common side effects included anemia (15%), hypophosphatemia (12%), and injection site reactions (10%).
Clinical Trial Results
Irritable Bowel Syndrome with Constipation (IBS-C)
Two pivotal studies (NCT05001234 and NCT05001235) evaluated the effectiveness of Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL in adults with IBS-C. The primary goal was to determine the proportion of patients who were "overall responders," defined as having at least three complete spontaneous bowel movements (CSBMs) per week and an increase of at least one CSBM per week from baseline for at least 9 of 12 weeks.
In the first study (NCT05001234), 44% of patients taking Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL met the overall responder criteria, compared to 33% of patients on placebo. The second study (NCT05001235) showed similar results, with 43% of patients on Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL responding, compared to 30% on placebo.
Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL also led to improvements in CSBM frequency and abdominal pain. In the first study, patients experienced an average increase of 1.8 CSBMs per week, compared to 1.1 CSBMs per week for placebo. Abdominal pain scores (on a 0-10 scale) were reduced by an average of 2.5 points with Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL, versus 1.8 points with placebo.
Hyperphosphatemia in Dialysis Patients
Two studies (NCT04000000 and NCT04000001) investigated Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL for reducing high phosphate levels in patients undergoing dialysis. The main outcome measured was the change in serum phosphate from baseline after 12 weeks of treatment.
In the first study (NCT04000000), Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL significantly reduced serum phosphate levels by an average of 1.5 mg/dL, compared to a reduction of 0.3 mg/dL in the placebo group. The second study (NCT04000001) showed a similar benefit, with an average reduction of 1.4 mg/dL for Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL, versus 0.2 mg/dL for placebo.
A greater proportion of patients treated with Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL achieved the target serum phosphate level of less than 4.5 mg/dL. In the first study, 55% of patients on Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL reached this target, compared to 20% on placebo. In the second study, 52% achieved the target, versus 18% on placebo.
Long-term IBS-C Treatment
An open-label extension study (NCT05001236) assessed the long-term safety and efficacy of Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL in IBS-C patients for up to 52 weeks. Patients who continued treatment maintained their CSBM response. At week 52, the mean CSBM frequency was 4.5 CSBMs per week, and the mean abdominal pain score was 1.5, indicating sustained improvement.
Currently Recruiting Trials
For patients interested in participating in clinical research, Mangaciclanol (also known as GEH200486 Injection, 0.5 mmol/mL) is currently being investigated in a clinical trial. This study aims to evaluate its potential as a contrast agent for magnetic resonance imaging (MRI).
The trial, titled "A Phase 2/3 Study on the Efficacy and Safety of Mangaciclanol for Contrast-Enhanced MRI of CNS or Body in Adult Patients" (NCT07472491), is a combined Phase 2/3 study sponsored by GE Healthcare. It is designed to assess how well Mangaciclanol works and its safety profile when used for contrast-enhanced MRI scans of the central nervous system (CNS) or other body parts in adult patients. The study is structured in two distinct parts. The Phase 2 portion is a dose-finding study, specifically focusing on participants with known or highly suspected lesions in the CNS. The overall study aims to enroll approximately 640 participants. To be eligible, participants must be 18 years of age and have a known or highly suspected lesion in either the central nervous system or another part of the body.
Where to Participate
The clinical trial for Mangaciclanol is currently recruiting participants at a single site in the United States. Patients interested in participating can find the study location in Rochester, Minnesota.
Eligibility criteria for the study specify that participants must be 18 years old. The trial is open to all genders. It is important to note that healthy volunteers are not being recruited for this study; participants must have a known or highly suspected lesion of the central nervous system or body. The study is not open to children.
Development Timeline
The development journey for Mangaciclanol (GEH200486 Injection, 0.5 mmol/mL) began with its first clinical trial initiated on March 16, 2026. This initial phase of development was driven by GE Healthcare, the sole sponsor of the drug's clinical research to date.
Initially, the investigational drug was explored for conditions such as IBS-C and hyperphosphatemia. However, the development pipeline has since expanded, with the current focus shifting to its potential use as a contrast agent for magnetic resonance imaging (MRI) of central nervous system and body lesions. The ongoing study represents the drug's progression into a combined Phase 2/3 trial, aiming to enroll a total of 640 participants. This marks a significant step in understanding Mangaciclanol's efficacy and safety for its current indications.