Gadobenate dimeglumine

also known as MultiHance

Investigated by: Bracco Diagnostics, Inc · National Cancer Institute (NCI) · Guerbet · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · University of Colorado, Denver · University of Southern California

Regulatory milestones approvals, filings & regulatory actions · 4 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Label expansions (2)	US (FDA)	MULTIHANCE MULTIPACK	—	2012-07-06 – 2018-01-19	fda.gov ↗
Label expansion	US (FDA)	MULTIHANCE	—	2010-03-17	fda.gov ↗
Approved	US (FDA)	MULTIHANCE	—	2004-11-23	fda.gov ↗

Trials 12

today

US approved 2004

NCT04973007 · Ph 4 NCT02633501 · Ph 2 NCT02070380 · Ph 4 NCT02967380 · not/applicable NCT01260636 · Ph 3 NCT00539253 · not/applicable NCT00486473 · Ph 3 NCT00415805 · Ph 3 NCT00408083 · Ph 3 NCT00411931 · Ph 1 NCT00323102 · Ph 4 NCT00323310 · Ph 3

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 11 trial
Phase 1	NCT00411931	Sep 2006 → Dec 2007	central nervous system disorder	Bracco Diagnostics, Inc	Completed	No outcome recorded
Phase 21 trial · 1 met primary
Phase 2	NCT02633501	Jun 2016 → Jan 2018	—	Guerbet	Completed	Met primary
Phase 35 trials · 3 met primary
Phase 3	NCT01260636	Sep 2009 → Dec 2011	arterial disorder	Bracco Diagnostics, Inc	Completed	Met primary
Phase 3	NCT00486473	Jul 2007 → Dec 2009	breast cancer	Bracco Diagnostics, Inc	Completed	Met primary
Phase 3	NCT00415805	Dec 2006 → Dec 2008	arterial disorder	Bracco Diagnostics, Inc	Completed	No outcome recorded
Phase 3	NCT00408083	Dec 2006 → Nov 2008	peripheral vascular disease	Bracco Diagnostics, Inc	Completed	No outcome recorded
Phase 3	NCT00323310	Apr 2006 → Sep 2008	central nervous system disorder	Bracco Diagnostics, Inc	Terminated	Met primary
Phase 43 trials
Phase 4	NCT04973007	Jun 2021 → May 2025	metastasis from malignant tumor of colon	University of Colorado, Denver	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT02070380	Feb 2014 → Mar 2015	brain disorder	Bracco Diagnostics, Inc	Completed	Mixed
Phase 4	NCT00323102	May 2006 → Mar 2007	brain disorder	Bracco Diagnostics, Inc	Completed	No outcome recorded
Phase not applicable2 trials
—	NCT02967380	Dec 2011 → Oct 2014	adult anaplastic ependymoma, adult brain ependymoma, adult brainstem glioma, adult choroid plexus neoplasm +19	University of Southern California	Terminated	No outcome recorded Stop: Enrollment
—	NCT00539253	Sep 2007 → Mar 2013	hepatocellular carcinoma	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Completed	No outcome recorded
Comparator or background therapy8 trials
Phase 2	NCT04910425 Background	Jun 2023 → Jun 2026	prostate carcinoma	Northwestern University	Withdrawn	No outcome recorded
Phase 2	NCT03703492 Background	Jan 2019 → Jan 2024	ductal breast carcinoma in situ	University of Wisconsin, Madison	Completed	No outcome recorded
Phase 2	NCT01710254 Background	Jan 2013 → Oct 2016	atrial fibrillation, coronary artery disorder	University of Utah	Completed	No outcome recorded
Phase 3	NCT06406517 Comparator	May 2024 → Jun 2025	congenital heart disease	University of California, San Diego	Unknown	No outcome recorded
Phase 4	NCT04373564 Background	Mar 2021 → Dec 2028 expected	cognitive disorder	Guerbet	Recruiting	No outcome recorded
Phase 4	NCT00907530 Comparator	Sep 2009 → Mar 2011	—	Bracco Diagnostics, Inc	Completed	No outcome recorded
Phase 4	NCT00395863 Comparator	Nov 2006 → Feb 2008	brain neoplasm	Bracco Diagnostics, Inc	Completed	No outcome recorded
—	NCT04132843 Background	Jan 2020 → Sep 2022	lymphoma, metastatic malignant neoplasm in the brain	M.D. Anderson Cancer Center	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 2

Date	Issuer	Release
2021-12-01	Ascelia Pharma AB	Results Results from Orviglance comparison study to gadolinium presented at RSNA 2021 ascelia.com ↗ All three readers were also able to see smaller lesions with Orviglance compared to gadolinium.
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.

All press releases naming this drug 2 releases

Date	Issuer	Release
2021-12-01	Ascelia Pharma AB	Results from Orviglance comparison study to gadolinium presented at RSNA 2021 ascelia.com ↗
2020-12-02	Ascelia Pharma AB	New study shows Mangoral’s lesion visualization as effective as gadolinium contrast agent ascelia.com ↗

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 20 sources stand behind the page.

Field	Value	Cited text
Known as	Gadobenate dimeglumine	ClinicalTrials.gov intervention name — accepted as the source's own label NCT03703492 ↗ 11 NCT04910425 ↗ NCT06406517 ↗ NCT02967380 ↗ NCT01260636 ↗ NCT00539253 ↗ NCT04973007 ↗ NCT04373564 ↗ NCT01710254 ↗ NCT04132843 ↗ NCT00323310 ↗ Show 1 more source
Known as	MultiHance	“Phase IV, Double-Blind, Multi-Center, Randomized, Cross-Over Study to Compare 0.10 Mmol/kg of MultiHance With 0.10 Omniscan in Magnetic Resonance Imaging (MRI) of the Brain” NCT00323102 ↗ 8 NCT02070380 ↗ NCT00907530 ↗ NCT00411931 ↗ NCT00395863 ↗ NCT00323102 ↗ NCT00408083 ↗ NCT00486473 ↗ NCT00415805 ↗
Modality	Diagnostic / imaging agent	“magnetic resonance imaging (MRI) contrast agent MultiHance” NCT00323310 ↗
Route	Intravenous	“was injected intravenously” NCT00323310 ↗