iothalamate sodium i-125

Trade name: GloFil

Small moleculeapproved

Approved

Aug 16, 1962

Iothalamic acid is a Radiographic Contrast Agent. The mechanism of action of iothalamic acid is as a X-Ray Contrast Activity. GLOFIL-125 (Sodium Iothalamate I-125 Injection) is a sterile, nonpyrogenic aqueous injection containing approximately 1 mg sodium iothalamate per mL, and 0.9 percent benzyl alcohol as a preservative. The radioactive concentration of the material is 250-300 µCi/mL as of the calibration date. Sodium bicarbonate and hydrochloric acid are present for pH adjustment. GLOFIL-125 (Sodium Iothalamate I-125 Injection) is indicated for evaluation of glomerular filtration in the diagnosis or monitoring of patients with renal disease. The renal clearance of sodium iothalamate in man closely approximates that of inulin. The compound is cleared by glomerular filtration without tubular secretion or reabsorption. Following infusion administration of I-125 iothalamate, the effective half-life is about 0.07 days. — NCATS

Clinical trial activity

0 trials · 0 clinical orgs · 4 marketing orgs

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

Timeline

1960s

  1. Aug 16, 1962

    Liebel-Flarsheim — Earliest FDA Approval

  2. Aug 16, 1962

    Liebel-Flarsheim — NDA Secondary Org

  3. Aug 16, 1962

    Liebel-Flarsheim — NDA Organization

  4. Sep 30, 1963

    Mallinckrodt — NDA Secondary Org

1970s

  1. Feb 12, 1974

    IsoTex — NDA Secondary Org

1990s

  1. Apr 26, 1996

    International Minerals and Chemical Corporation — NDA Secondary Org

Indications

Mechanism of action

  • Unspecified targetOTHER

    Diagnostic agent

  • contrast mediumRadiopaque

    contrast medium radiopaque

Approval history

  • approvedPriority reviewAug 16, 1962

Chemistry & pharmacology

Loading structure…

SMILES

CNC(=O)C1=C([125I])C(C(O)=O)=C([125I])C(NC(C)=O)=C1[125I]
Mol. weight
607.914 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Discontinued
Payload
125-iodine

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • angio-conray
  • angio-conray
  • conray
  • conray
  • conray
  • conray 30
  • conray 30
  • conray 325
  • conray 325
  • conray 400
  • conray 400
  • conray 43
  • conray 43
  • cysto-conray ii
  • glofil-125
  • glofil-125
  • glofil-125
  • iothalamate
  • iothalamate
  • iothalamate meglumine
  • iothalamate meglumine
  • iothalamate meglumine
  • iothalamate meglumine
  • iothalamate sodium
  • iothalamate sodium
  • iothalamate sodium
  • iothalamate sodium
  • iothalamate sodium (125i)
  • iothalamate sodium (125i)
  • iothalamate sodium i 125
  • iothalamate sodium i 125
  • iothalamate sodium i-125
  • iothalamate sodium i-125
  • iothalamate sodium i-125
  • meglumine iotalamate injection
  • meglumine iotalamate injection
  • sodium iotalamate (125i)
  • sodium iotalamate (125i)
  • sodium iotalamate injection
  • sodium iotalamate injection
  • sodium iothalamate
  • sodium iothalamate
  • sodium iothalamate (125i)
  • sodium iothalamate (125i)

Organizations

Marketing (5)

OrganizationOrg typeRelationshipDate
International Minerals and Chemical CorporationFor profitNDA2Apr 26, 1996
IsoTexFor profitNDA2Feb 12, 1974
Liebel-FlarsheimFor profitNDA2Aug 16, 1962
Liebel-FlarsheimFor profitNDAAug 16, 1962
MallinckrodtFor profitNDA2Sep 30, 1963