Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mangaciclanol · 1 trial · 2 indications
Overall diagnostic preference based on global matched pairs reads according to a 3-point scale that is derived from a 5-point scale (1 = greatly prefer mangaciclanol/prefer mangaciclanol, 0 = no preference, -1 = prefer gadobutrol/greatly prefer gadobutrol), as evaluated by 3 blinded independent readers.
Lesion visualization criteria (lesion border delineation, internal morphology and degree of lesion contrast enhancement) for paired (unenhanced plus mangaciclanol-enhanced) MRIs compared to unenhanced MRI based on the primary reads on a 4-point scale (1 = poor / none; 2 = moderate; 3 = good; 4 = excellent) for up to 3 of the most representative lesions.
| Arm | Type | Description |
|---|---|---|
| Phase 2 | ACTIVE_COMPARATOR | An initial dose of 0.1 mmol/kg mangaciclanol will be compared to the standard dose of gadobutrol (0.1 mmol/kg) in Cohort 1, in approximately 60 participants. A second cohort (Cohort 2) may be initiated based on the outcome of the analysis of Cohort 1. This cohort will include approximately 60 participants (higher or lower dose), or 30 participants (same dose), depending on the dose of mangaciclanol selected for further evaluation. |
| Phase 3 mangaciclanol-gadobutrol | ACTIVE_COMPARATOR | Participants with known or highly suspected lesions of CNS or body, randomized to receive treatment sequence mangaciclanol (V2) followed by gadobutrol (V4) |
| Phase 3 gadobutrol-mangaciclanol | ACTIVE_COMPARATOR | Participants with known or highly suspected lesions of CNS or body, randomized to receive treatment sequence gadobutrol (V2) followed by mangaciclanol (V4) |
| Name | Type | Description |
|---|---|---|
| Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL | DRUG | Single intravenous (IV) administration of Mangaciclanol (GEH200486 Injection, 0.5 mmol/mL) followed by a 20mL saline flush |
| MRI Scan | DIAGNOSTIC_TEST | MRI Scan starting prior to IMP administration and continuing for up to 60 minutes post IMP administration |
| Gadobutrol | DRUG | Single intravenous (IV) administration of Gadobutrol (0.1 mmol/kg) followed by a 20mL saline flush |
Inclusion Criteria: * The participant is of legal majority age, as defined by local laws and regulations at the time of signing the ICF. * The participant is able and willing to comply with study procedures as described in the protocol. * The participant has read, understood, signed and dated the I...
Mangaciclanol is an investigational small molecule being developed by GE HealthCare Technologies Inc. (ticker: GEHC) as a contrast agent for contrast-enhanced MRI. It is in Phase 2 clinical development for imaging in patients with known or highly suspected central nervous system (CNS) lesions. It is not approved and remains under clinical study.
Mangaciclanol is being studied for contrast-enhanced MRI in adult patients with known or highly suspected central nervous system (CNS) lesions. The Phase 2/3 trial also enrolls patients with known or highly suspected body lesions outside the CNS. The goal is to support MRI imaging of these lesions, and the drug is investigational.
Mangaciclanol is developed by GE HealthCare Technologies Inc., which trades under the ticker GEHC. GE HealthCare is the sponsor of the clinical program evaluating the agent as an MRI contrast agent for CNS and body imaging. No other developer or partnership is associated with the asset in the available program information.
Mangaciclanol is in Phase 2 clinical development. It is investigational and has not been approved by the FDA or any other regulator. The ongoing study is listed as a Phase 2/3 trial, and the program has one active trial with no completed trials to date.
Mangaciclanol is being evaluated in the recruiting trial NCT07472491, titled a Phase 2/3 study on the efficacy and safety of Mangaciclanol for contrast-enhanced MRI of CNS or body in adult patients. The trial plans to enroll 640 participants across the United States, Georgia, and Moldova.
Yes. Mangaciclanol is also known as GEH200486 Injection, 0.5 mmol/mL, and as GEH200486, 0.5 mmol/mL. GEH200486 is the alternate code name for the same investigational MRI contrast agent developed by GE HealthCare Technologies Inc. (GEHC).