diatrazoate meglumine

Trade name: Renografin

Small moleculeapproved

Approved

Nov 26, 1954

This compound belongs to the class of organic compounds known as aminobenzoic acids. These are benzoic acids containing an amine group attached to the benzene moiety. A commonly used x-ray contrast medium. Used, alone or in combination, for a wide variety of diagnostic imaging methods, including angiography, urography, cholangiography, computed tomography, hysterosalpingography, and retrograde pyelography. It can be used for imaging the gastrointestinal tract in patients allergic to barium. Radiopaque agents are drugs used to help diagnose certain medical problems. They contain iodine, which blocks x-rays. Depending on how the radiopaque agent is given, it localizes or builds up in certain areas of the body. The resulting high level of iodine allows the x-rays to make a "picture" of the area. The areas of the body in which the radiopaque agent localizes will appear white on the x-ray film. This creates the needed distinction, or contrast, between one organ and other tissues. — NCATS

Clinical trial activity

4 trials · 5 clinical orgs · 10 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Aug 1, 2007 (NCT00478556)

Timeline

1950s

Nov 26, 1954
General Electric — Earliest FDA Approval
Nov 26, 1954
General Electric — NDA Secondary Org
Nov 26, 1954
General Electric — NDA Organization
Aug 2, 1955
Bracco — NDA Secondary Org

1980s

Jul 2, 1980
General Electric — Marketing Organization
Sep 2, 1981
Liebel-Flarsheim — Marketing Organization
Sep 23, 1982
Bayer — Marketing Organization
Nov 15, 1984
Mallinckrodt — Marketing Organization
Nov 15, 1984
Avon Products — Marketing Organization
Jun 1, 1988
Bracco — Marketing Organization
Sep 29, 1989
Liebel-Flarsheim — NDA Secondary Org

2010s

Jan 1, 2015
Earliest Phase 3 Sponsor(trial)
Jan 1, 2018
Earliest Phase 2 Sponsor(trial)

2020s

Jun 27, 2022
Guardian Drug — Marketing Organization
Jun 27, 2022
ANDA Repository — Marketing Organization
Nov 17, 2023
Annora Pharma — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Unspecified targetOTHER
Diagnostic agent
contrast mediumRadiopaque
contrast medium radiopaque

Combination products

sinografin
with iodipamide meglumine

Approval history

approvedPriority reviewNov 26, 1954

Chemistry & pharmacology

Loading structure…

SMILES

CC(=O)NC1=C(I)C(C(O)=O)=C(I)C(NC(C)=O)=C1I

Mol. weight: 613.9136 g/mol
Lipinski Ro5: 1 violation(s)
Rule of 3: No
Chirality: Achiral Molecule
Inorganic: No
Polymer: No
Delivery: Oral, Parenteral, Topical
Availability: Prescription Only

Oral

Yes

Parenteral

Yes

Topical

Yes

Sources

Also known as

2,4,6-triiodo-3,5-diacetamidobenzoic acid
2,4,6-triiodo-3,5-diacetamidobenzoic acid
3,5-bis(acetylamino)-2,4,6-triiodobenzoic acid
3,5-bis(acetylamino)-2,4,6-triiodobenzoic acid
3,5-diacetamido-2,4,6-triiodobenzoic acid
3,5-diacetamido-2,4,6-triiodobenzoic acid
acide amidotrizoique
acide amidotrizoique
acidum amidotrizoicum
acidum amidotrizoicum
acidum diacetylaminotrijodbenzoicum
acidum diacetylaminotrijodbenzoicum
amidotrizoate
amidotrizoate
amidotrizoic acid
amidotrizoic acid
amidotrizoic acid
amidotrizoic acid
amidotrizoic acid
amidotrizoic acid
amidotrizoic acid (anhydrous)
amidotrizoic acid (anhydrous)
amidotrizoic acid methylglucamine salt
angiografin
angiovist 282
angiovist 282
cardiografin
cystografin
cystografin
cystografin dilute
diatrazoate
diatrizoate
diatrizoate
diatrizoate
diatrizoate
diatrizoate
diatrizoate meglumine
diatrizoate meglumine
diatrizoate meglumine
diatrizoate meglumine
diatrizoate meglumine
diatrizoate methylglucamine
diatrizoate methylglucamine
diatrizoate methylglucamine
diatrizoate sodium
diatrizoate sodium
diatrizoate sodium
diatrizoate sodium
diatrizoesaure
diatrizoesaure
diatrizoic acid
diatrizoic acid
diatrizoic acid
diatrizoic acid
diatrizoic acid
diatrizoic acid (anhydrous)
diatrizoic acid (anhydrous)
diatrizoic acid dihydrate
diiodomethanesulfonic acid, disodium salt
hypaque
hypaque
hypaque
hypaque
hypaque
hypaque-cysto
hypaque-cysto
hypaque sodium
hypaque sodium
md
md
md-50
md-50
meglumine amidotrizoate
meglumine amidotrizoate
meglumine amidotrizoate
meglumine amidotrizoate
meglumine amidotrizoate
meglumine amidotrizoate injection
meglumine amidotrizoate injection
meglumine diatrizoate
meglumine diatrizoate
meglumine sodium amidotrizoate injection
meglumine sodium amidotrizoate injection
methalamic acid
methalamic acid
methalamic acid
methylglucamine diatrizoate
methylglucamine diatrizoate
reno
reno
reno-30
reno-30
reno-60
reno-60
reno-dip
renografin
renografin
renografin
renografin
sodium amidotrizoate
sodium amidotrizoate
sodium diatrizoate
sodium diatrizoate
sodium diatrizoate
triombrin
triombrin
urografin acid
urografin acid
urogranoic acid
urogranoic acid
urogranoic acid
urothrast
urotrast
urovist cysto
urovist cysto pediatric
urovist meglumine diu/ct
urovist meglumine diu/ct
urovist sodium
urovist sodium
urovist sodium 300
urovist sodium 300

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT03573921	Phase 2/Phase 3 (Phase 3)	Sep 1, 2018	University of Western Ontario
NCT02542046	Phase 3	Jan 1, 2015	General Electric, University of California, San Francisco
NCT00460837	Phase 4	Nov 1, 2007	University of London
NCT00478556	Phase 4	Aug 1, 2007	General Electric, University of Alabama, Birmingham

Showing 4 of 4 trials

Page 1 / 1

Organizations

Research & Development (5)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
General Electric	For profit	2	0	2	2007
University of Alabama, Birmingham	Academic/Hospital	1	1	1	2007
University of California, San Francisco	Academic/Hospital	1	1	1	2015
University of London	Academic/Hospital	1	1	1	2007
University of Western Ontario	Academic/Hospital	1	1	1	2018

5 organizations

Page 1 / 1

Marketing (14)

Organization	Org type	Relationship	Date
ANDA Repository	For profit	MKTG	Jun 27, 2022
Annora Pharma	For profit	MKTG	Nov 17, 2023
Avon Products	For profit	MKTG	Nov 15, 1984
Bayer	For profit	MKTG	Sep 23, 1982
Bracco	For profit	NDA2	Aug 2, 1955
Bracco	For profit	MKTG	Jun 1, 1988
General Electric	For profit	NDA2	Nov 26, 1954
General Electric	For profit	MKTG	Jul 2, 1980
General Electric	For profit	NDA	Nov 26, 1954
Guardian Drug	For profit	MKTG	Jun 27, 2022
International Medication	For profit	MKTG	—
Liebel-Flarsheim	For profit	MKTG	Sep 2, 1981
Liebel-Flarsheim	For profit	NDA2	Sep 29, 1989
Mallinckrodt	For profit	MKTG	Nov 15, 1984