Coccidioides immitis Spherule - Derived Skin Test Antigen
Trade name: Spherusol
BiologicalapprovedOrphan Drug FDA
Approved
Jul 29, 2011
Coccidioides immitis is a pathogenic fungus that resides in the soil in certain parts of the southwestern United States, northern Mexico, and a few other areas in the Western Hemisphere. — Wikipedia
Clinical trial activity
1 trials · 4 clinical orgs · 3 marketing orgs
Phase 1
0
Phase 2
1
Phase 3
1
Phase 4
0
Earliest trial started May 1, 2005 (NCT00690092)
Timeline
2000s
- Jan 1, 2005
Nielsen BioSciences, Inc. — Earliest Phase 3 Sponsor(trial)
- Dec 19, 2007
Orphan Drug Designation
2010s
- Jul 27, 2011
Allermed Laboratories — First NDA Organization
- Jul 27, 2011
Allermed Laboratories — NDA Organization
- Jul 27, 2011
Rare Disease Therapeutics — Marketing Organization
- Jul 29, 2011
Earliest FDA Approval
- Jul 29, 2011
Nielsen BioSciences, Inc. — NDA Secondary Org
Indications
Approved for
Studied for
Mechanism of action
- Coccidioides immitisImmunity, passive
Coccidioides immitis immunity, passive
Approval history
- approvedJul 29, 2011
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaCoccidioides immitis ↗
- NCATSITY7G7Q744 ↗
Also known as
- coccidioides immitis spherule-derived skin test antigen
- coccidioidin
- spherusol
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT00690092 | Phase 3 | May 1, 2005 | Nielsen BioSciences, Inc., Sr Consultants Inc., University of Arizona, University of California, Los Angeles |
Showing 1 of 1 trials
Page 1 / 1
Organizations
Research & Development (4)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Nielsen BioSciences, Inc. | For profit | 1 | 1 | 1 | 2005 |
| Sr Consultants Inc. | For profit | 1 | 0 | 1 | 2005 |
| University of Arizona | Academic/Hospital | 1 | 0 | 1 | 2005 |
| University of California, Los Angeles | Academic/Hospital | 1 | 0 | 1 | 2005 |
4 organizations
Page 1 / 1
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Allermed Laboratories | For profit | NDA | Jul 27, 2011 |
| Nielsen BioSciences, Inc. | For profit | NDA2 | Jul 29, 2011 |
| Rare Disease Therapeutics | For profit | MKTG | Jul 27, 2011 |