capromab pendetide
Trade name: Prostascint
Approved
Oct 28, 1996
Indium (111In) capromab pendetide is used to image the extent of prostate cancer. Capromab is a mouse monoclonal antibody which recognizes a protein found on both prostate cancer cells and normal prostate tissue. It is linked to pendetide, a derivative of DTPA. Pendetide acts as a chelating agent for the radionuclide indium-111. Following an intravenous injection of Prostascint, imaging is performed using single-photon emission computed tomography (SPECT). — Wikipedia
Clinical trial activity
2 trials · 10 clinical orgs · 2 marketing orgs
Earliest trial started Oct 1, 2007 (NCT00562315)
Timeline
1990s
- Oct 28, 1996
AYTU BioScience — Earliest FDA Approval
- Oct 28, 1996
Cytogen — Marketing Organization
- Oct 28, 1996
AYTU BioScience — NDA Secondary Org
- Oct 28, 1996
AYTU BioScience — NDA Organization
Indications
Approved for
Studied for
Mechanism of action
- Glutamate carboxypeptidase IIINHIBITOR
FOLH1 inhibitor
- Unspecified targetOTHER
Diagnostic agent
- TAG72Immunity, passive
TAG72 immunity, passive
Approval history
- approvedOct 28, 1996
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
- Imaging
- 111-indium
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaIndium (111In) capromab pendetide ↗
- NCATSBDO5072GRX ↗
- ChEMBLCHEMBL2108800 ↗
- ChEMBLCHEMBL1201579 ↗
Also known as
- (111in)-capromab pendetide
- 111in-capromab pendetide
- 7e11-c5.3
- capromab pendetide
- capromab pendetide
- capromab pendetide
- capromab pendetide
- capromab pendetide
- cc49 antibody
- cyt-351
- cyt 356
- cyt-356
- cyt-356
- cytogen 356
- (iii)in-cyt-356
- indium 111 capromab pendetide
- indium-111-cyt-356
- indium (111in) capromab pendetide
- indium (111in) capromab pendetide
- indium in 111 capromab pendetide
- indium in 111 capromab pendetide
- prostascinct
- prostascint
- prostascint
- prostascint
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT00992745 | Phase 1 | Oct 1, 2009 | Cornell University, Duke University, Molecular Insight Pharmaceuticals, Pacific Coast Imaging, University of California, San Francisco, University of Maryland, Vanguard Urologic Research Foundation, West Coast Radiology Centerse |
| NCT00562315 | Phase 2 | Oct 1, 2007 | Emory University, National Cancer Institute (NCI) |
Organizations
Research & Development (10)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Cornell University | Academic/Hospital | 1 | 0 | 1 | 2009 |
| Duke University | Academic/Hospital | 1 | 0 | 1 | 2009 |
| Emory University | Academic/Hospital | 1 | 1 | 1 | 2007 |
| Molecular Insight Pharmaceuticals | For profit | 1 | 1 | 1 | 2009 |
| National Cancer Institute (NCI) | Government | 1 | 0 | 1 | 2007 |
| Pacific Coast Imaging | Academic/Hospital | 1 | 0 | 1 | 2009 |
| University of California, San Francisco | Academic/Hospital | 1 | 0 | 1 | 2009 |
| University of Maryland | Academic/Hospital | 1 | 0 | 1 | 2009 |
| Vanguard Urologic Research Foundation | Academic/Hospital | 1 | 0 | 1 | 2009 |
| West Coast Radiology Centerse | Academic/Hospital | 1 | 0 | 1 | 2009 |
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| AYTU BioScience | For profit | NDA2 | Oct 28, 1996 |
| AYTU BioScience | For profit | NDA | Oct 28, 1996 |
| Cytogen | For profit | MKTG | Oct 28, 1996 |