albumin iodinated i-131 serum

Trade name: Megatope

BiologicalapprovedImaging agent

Approved

Jul 1, 1950

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

3 trials · 3 clinical orgs · 1 marketing orgs

Phase 1
0
Phase 2
1
Phase 3
0
Phase 4
0

Earliest trial started May 1, 2014 (NCT02148809)

Timeline

1950s

  1. Jul 1, 1950

    Earliest FDA Approval

1970s

  1. Feb 23, 1976

    IsoTex — First NDA Organization

  2. Feb 23, 1976

    IsoTex — NDA Secondary Org

  3. Feb 23, 1976

    IsoTex — NDA Organization

2010s

  1. Jan 1, 2017

    Earliest Phase 2 Sponsor(trial)

Indications

Mechanism of action

  • Unspecified targetOTHER

    Diagnostic agent

Approval history

  • approvedJul 1, 1950

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Imaging
131-iodine

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • albumin, iodinated (131i) human serum
  • albumin, iodinated (131i) human serum, injection
  • albumin iodinated i-131 serum
  • albumin iodinated i-131 serum
  • albumin iodinated i-131 serum
  • albumin, iodinated i 131 serum
  • albumin, iodinated serum (131i)
  • albumotope 1-131
  • i-131 human serum albumin
  • ihsa 1-131
  • iodinated (131i) human serum albumin
  • iodinated (131i) human serum albumin injection
  • iodine-131 human serum albumin (risa)
  • iodine (131i) human albumin
  • megatope
  • megatope
  • risa-131

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT03990376N/AJun 19, 2019Emory University
NCT03292653Phase 2Dec 4, 2017Sanofi
NCT02148809N/AMay 1, 2014Rockefeller University
Showing 3 of 3 trials
Page 1 / 1

Organizations

Research & Development (3)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Emory UniversityAcademic/Hospital1112019
Rockefeller UniversityAcademic/Hospital1112014
SanofiFor profit1112017
3 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
IsoTexFor profitNDA2Feb 23, 1976
IsoTexFor profitNDAFeb 23, 1976