Drugs / Gadodiamide
Gadodiamide
also known as
Gadodiamide Injection · OMNISCAN · Gadodiamida · Gadodiamide anhydrous · GDDTPA-BMA · S-041
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | OMNISCAN | — | 1996-02-05 | fda.gov ↗ |
| Approved | US (FDA) | OMNISCAN | — | 1993-01-08 | fda.gov ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 31 trial | ||||||
| Phase 3 | NCT00209391 | Sep 2003 → Aug 2005 | renal artery disease | GE Healthcare | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT00908310 | May 2009 → Jun 2013 | chronic kidney disease, impaired renal function disease | GE Healthcare | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 4 | NCT04373564 Background | Mar 2021 → Dec 2028 expected | cognitive disorder | Guerbet | Recruiting | No outcome recorded |
| Phase 4 | NCT04776187 Comparator | Mar → Dec 2021 | nephrogenic systemic fibrosis | The Central Hospital of Lishui City | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2009-06-05 | InnoPharmax Inc. | Regulatory InnoPharmax announced the ANDA approvals of Immurin® 100 mg and Gadoscan® I.V. Injection innopharmax.com ↗
InnoPharmax, Inc. announced that the Department of Health (DOH) has granted approvals for the Company's Abbreviated New Drug Applications (ANDA) for Immurin® Soft Gelatin Capsule 100 mg (cyclosporine) and Gadoscan® I.V. Injection (gadodiamide). |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2009-06-05 | InnoPharmax Inc. | InnoPharmax announced the ANDA approvals of Immurin® 100 mg and Gadoscan® I.V. Injection innopharmax.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Gadodiamide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04373564 ↗ |
| Known as | Gadodiamida | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200346 ↗ |
| Known as | Gadodiamide anhydrous | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200346 ↗ |
| Known as | Gadodiamide Injection | “Generic name: Gadodiamide Injection; Product name: OMNISCAN; Sample specifications: 15ml: 4.305g (a sterile solution containing 287mg/ml gadodiamide).” NCT04776187 ↗1“Drug: Gadodiamide Injection” NCT00209391 ↗ |
| Known as | GDDTPA-BMA | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200346 ↗ |
| Known as | OMNISCAN | “Generic name: Gadodiamide Injection; Product name: OMNISCAN; Sample specifications: 15ml: 4.305g (a sterile solution containing 287mg/ml gadodiamide).” NCT04776187 ↗ |
| Known as | S-041 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200346 ↗ |
| Modality | Diagnostic / imaging agent | “OMNISCAN (Gadodiamide Injection) for Contrast-enhanced Magnetic Resonance Imaging” NCT00908310 ↗ |
| Route | Intravenous | “single intravenous bolus injection” NCT00209391 ↗ |