meglumine
Small moleculeapprovedImaging agent
Approved
Apr 30, 1974
Meglumine (N-methyl-D-glucamine) is a poorly metabolized derivative of sorbitol that has regulatory acceptance as a benign excipient for drug formulation to increase aqueous solubility of lipophilic drugs and improve their absorption. In conjugated form meglumine is used as a contrast agent. — NCATS
Clinical trial activity
16 trials · 25 clinical orgs · 1 marketing orgs
Phase 1
2
Phase 2
7
Phase 3
7
Phase 4
3
Earliest trial started Feb 1, 2004 (NCT00973128)
Timeline
1970s
- Apr 30, 1974
General Electric — Earliest FDA Approval
- Apr 30, 1974
General Electric — NDA Secondary Org
- Apr 30, 1974
General Electric — NDA Organization
2010s
- Jan 1, 2019
Earliest Phase 1 Sponsor(trial)
Indications
Approved for
Mechanism of action
- contrast mediumRadiopaque
contrast medium radiopaque
Combination products
isopaque
with calcium, metrizoic acid
Approval history
- approvedApr 30, 1974
Chemistry & pharmacology
Loading structure…
SMILES
CNC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO- Mol. weight
- 195.2136 g/mol
- Lipinski Ro5
- 1 violation(s)
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Discontinued
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaMeglumine ↗
- NCATS6HG8UB2MUY ↗
- ChEMBLCHEMBL1200570 ↗
Also known as
- meglumine
- meglumine
- meglumine
- meglumine
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06955416 | Phase 2/Phase 3 (Phase 3) | May 1, 2025 | Polysan, Ltd. |
| NCT06433791 | Phase 1 | Sep 9, 2024 | Duke University, LadeRx LLC |
| NCT06183229 | Phase 3 | Sep 15, 2023 | Polysan, Ltd. |
| NCT05147051 | Phase 2 | Jun 16, 2021 | Atlant Clinical Ltd., GBUZ Arkhangelsk region "First GKB named after E.E. Volosevich", Polysan, Ltd. |
| NCT03927625 | Phase 1 | Aug 1, 2019 | Duke University, LadeRx LLC |
| NCT02530697 | Phase 2 | Aug 1, 2015 | University of Brasilia |
| NCT01953744 | Phase 3 | Feb 1, 2014 | Conselho Nacional de Desenvolvimento Científico e Tecnológico, Federal University of Bahia, University of Bahia |
| NCT01301937 | Phase 2/Phase 3 (Phase 3) | Oct 1, 2008 | Conselho Nacional de Desenvolvimento Científico e Tecnológico, Instituto Nacional de Infectologia, Brazil, Oswaldo Cruz Foundation, Rio de Janeiro State University |
| NCT01301924 | Phase 2/Phase 3 (Phase 3) | Oct 1, 2008 | Conselho Nacional de Desenvolvimento Científico e Tecnológico, Instituto Nacional de Infectologia, Brazil, Oswaldo Cruz Foundation, Rio de Janeiro State University |
| NCT00818818 | Phase 4 | Aug 1, 2008 | University of Brasilia |
| NCT00480883 | N/A | Jan 1, 2008 | Pakistan Army |
| NCT01032187 | Phase 4 | Oct 1, 2007 | Federal University of Tocantins, Government of Brazil, University of Brasilia |
| NCT00487253 | Phase 3 | Jul 1, 2007 | Centro Internacional de Entrenamiento e Investigaciones Médicas |
| NCT00317629 | Phase 3 | May 1, 2006 | Akron University, Cardiovascular Foundation of Colombia, Fundación Cardiovascular de Colombia, Secretaria de Salud de Santander, Secretaria de Salud de Tolima, Universidad de Antioquia, Universidad de Santander, Universidad Industrial de Santander, University of Akron |
| NCT00317980 | Phase 4 | Feb 1, 2006 | Government of Brazil, University of Brasilia |
| NCT00973128 | Phase 2 | Feb 1, 2004 | Federal University of Bahia |
Showing 16 of 16 trials
Page 1 / 1
Organizations
Research & Development (25)
25 organizations
Page 1 / 2
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| General Electric | For profit | NDA2 | Apr 30, 1974 |
| General Electric | For profit | NDA | Apr 30, 1974 |