kit for iodinated I-125 albumin
Trade name: Jeanatope
Biologicalapproved
Approved
Feb 23, 1976
Iodine (125I) human albumin is human serum albumin iodinated with iodine-125, typically injected to aid in the determination of total blood and plasma volume. — Wikipedia
Clinical trial activity
1 trials · 2 clinical orgs · 3 marketing orgs
Phase 1
0
Phase 2
0
Phase 3
0
Phase 4
0
Earliest trial started Jan 1, 2012 (NCT01049087)
Timeline
1970s
- Feb 23, 1976
IsoTex — Earliest FDA Approval
- Feb 23, 1976
IsoTex — NDA Secondary Org
- Feb 23, 1976
Mallinckrodt — NDA Secondary Org
- Feb 23, 1976
IsoTex — NDA Organization
Indications
Approved for
Mechanism of action
- Unspecified targetOTHER
Diagnostic agent
Diagnostic agent
- DNARadiodepletion
DNA radiodepletion
Approval history
- approvedFeb 23, 1976
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Payload
- 125-iodine
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaIodine (125I) human albumin ↗
- ChEMBLCHEMBL1201452 ↗
- WikipediaJeanatope ↗
Also known as
- 125i-albumin
- albumin iodinated (125i) serum
- albumin iodinated i-125 serum
- albumin iodinated i-125 serum
- albumin, iodinated i 125 serum
- albumin, iodinated serum (125i)
- albumotope 1-125
- ihsa i-l25
- iodinated (125i) human serum albumin
- iodine (125i) human albumin
- jeanatope
- jeanatope
- radio-iodinated (125i) serum albumin (human)
- radioiodinated serum albumin (human) ihsa (125i)
- risa-125
- serum albumin, iodinated (125i) human
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT01049087 | N/A | Jan 1, 2012 | University Hospital Koge, University of Copenhagen |
Showing 1 of 1 trials
Page 1 / 1
Organizations
Research & Development (2)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| University Hospital Koge | Academic/Hospital | 1 | 0 | 1 | 2012 |
| University of Copenhagen | Academic/Hospital | 1 | 1 | 1 | 2012 |
2 organizations
Page 1 / 1
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Bayer | For profit | NDA2 | — |
| IsoTex | For profit | NDA2 | Feb 23, 1976 |
| IsoTex | For profit | NDA | Feb 23, 1976 |
| Mallinckrodt | For profit | NDA2 | Feb 23, 1976 |