pegademase-bovine
Trade name: Adagen
Animal productapprovedOrphan Drug FDA
Approved
Mar 21, 1990
Clinical trial activity
2 trials · 4 clinical orgs · 1 marketing orgs
Phase 1
0
Phase 2
2
Phase 3
1
Phase 4
0
Earliest trial started Nov 1, 2008 (NCT00794508)
Timeline
1980s
- May 29, 1984
Orphan Drug Designation
1990s
- Mar 21, 1990
Leadiant Biosciences, Inc. — Earliest FDA Approval
- Mar 21, 1990
Leadiant Biosciences, Inc. — NDA Secondary Org
- Mar 21, 1990
Leadiant Biosciences, Inc. — NDA Organization
2000s
- Jan 1, 2008
Earliest Phase 2 Sponsor(trial)
2010s
- Jan 1, 2013
Leadiant Biosciences, Inc. — Earliest Phase 3 Sponsor(trial)
Indications
Approved for
Mechanism of action
- Adenosine deaminaseAGONIST
ADA agonist
- AdenosineHYDROLYTIC ENZYME
Adenosine hydrolytic enzyme
Replaces the ada enzyme in case of deficiency, and hydrolyses purine substrates
- 2'-deoxyadenosineHYDROLYTIC ENZYME
2'-deoxyadenosine hydrolytic enzyme
Replaces the ada enzyme in case of deficiency, and hydrolyses purine substrates
Approval history
- approvedMar 21, 1990
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Discontinued
Oral
No
Parenteral
Yes
Topical
No
Sources
- NCATSHW3H7D91F6 ↗
- ChEMBLCHEMBL1201514 ↗
Also known as
- adagen
- adagen
- adagen
- adenosine aminohydrolase
- adenosine deaminase
- pegada
- peg-ada
- pegademase
- pegademase bovine
- pegademase bovine
- pegademase bovine
- pegademase bovine
- pegademase-bovine
- polyethylene glycol-modified adenosine deaminase
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT01420627 | Phase 3 | Dec 1, 2013 | Leadiant Biosciences, Inc. |
| NCT00794508 | Phase 2 | Nov 1, 2008 | Food and Drug Administration, National Institutes of Health (NIH), University of California, Los Angeles |
Showing 2 of 2 trials
Page 1 / 1
Organizations
Research & Development (4)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Food and Drug Administration | Government | 1 | 0 | 1 | 2008 |
| Leadiant Biosciences, Inc. | For profit | 1 | 1 | 1 | 2013 |
| National Institutes of Health (NIH) | Government | 1 | 0 | 1 | 2008 |
| University of California, Los Angeles | Academic/Hospital | 1 | 1 | 1 | 2008 |
4 organizations
Page 1 / 1
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Leadiant Biosciences, Inc. | For profit | NDA2 | Mar 21, 1990 |
| Leadiant Biosciences, Inc. | For profit | NDA | Mar 21, 1990 |