alefacept
Trade name: Amevive
Approved
Jan 30, 2003
Alefacept is a genetically engineered immunosuppressive drug. It was sold under the brand name Amevive in Canada, the United States, Israel, Switzerland and Australia. In 2011, the manufacturers made a decision to cease promotion, manufacturing, distribution and sales of Amevive during a supply disruption. According to Astellas Pharma US, Inc., the decision to cease Amevive sales was neither the result of any specific safety concern nor the result of any FDA-mandated or voluntary product recall. On the other hand, usage of Amevive was associated with a certain risk of development systemic diseases such as malignancies. This drug was never approved for the European drug market. — Wikipedia
Clinical trial activity
35 trials · 33 clinical orgs · 2 marketing orgs
Earliest trial started Dec 1, 2001 (NCT00692172)
Timeline
Indications
Approved for
Studied for
- Anemia, Aplastic · Phase 1
- Arthritis, Psoriatic · Phase 2
- Dermatitis, Atopic · Phase 4
- Diabetes Mellitus, Type 1 · Phase 2
- Graft vs Host Disease · Phase 3
- Kidney Failure, Chronic · Phase 1
- Kidney Transplantation · Phase 2
- Lichen Planus · Phase 2
- Lymphoma · Phase 1
- Pharmacokinetics · Phase 1
- Pityriasis Rubra Pilaris · Phase 4
- Psoriasis · Phase 4
Mechanism of action
- Lymphocyte function-associated antigen 3, CD58BINDING AGENT
CD58 binding agent
- T-cell surface antigen CD2INHIBITOR
CD2 inhibitor
Approval history
- approvedJan 30, 2003
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaAlefacept ↗
- NCATSELK3V90G6C ↗
- ChEMBLCHEMBL1201571 ↗
Also known as
- alefacept
- alefacept
- alefacept
- alefacept
- alefacept
- alefacept
- alefacept
- alefacept
- amevive
- amevive
- amevive
- amevive
- asp0485
- bg9273
- bg-9273
- bg9712
- bg-9712
- lfa-3 igg(1) fusion protein
- lfa-3 igg1 fusion protein
- lfa3tip
- lfa3tip
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT01433770 | N/A | Oct 1, 2011 | Astellas, Case Western Reserve University |
| NCT01267643 | Phase 1 | May 1, 2011 | Astellas, University of Rochester |
| NCT00965458 | Phase 2 | Mar 1, 2011 | Immune Tolerance Network, Indiana University, Juvenile Diabetes Research Foundation, National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| NCT01226420 | Phase 2 | Oct 1, 2010 | Astellas, Harvard University |
| NCT01319851 | N/A | Sep 1, 2010 | Emory University |
| NCT01163799 | Phase 1 | Jul 1, 2010 | Astellas, Northwestern University |
| NCT00808223 | Phase 2 | Apr 1, 2009 | Astellas |
| NCT00815633 | Phase 4 | Dec 1, 2008 | Astellas, Icahn School of Medicine at Mount Sinai |
| NCT00655564 | Phase 4 | May 1, 2008 | Wake Forest University |
| NCT00653822 | Phase 1 | Mar 1, 2008 | Astellas |
| NCT00543569 | Phase 2 | Feb 1, 2008 | Astellas, University of Michigan |
| NCT00953329 | Phase 4 | Feb 1, 2008 | Astellas, Duke University |
| NCT00832585 | Phase 4 | Jan 1, 2008 | Astellas, Rush University |
| NCT00617604 | Phase 2 | Dec 1, 2007 | Astellas |
| NCT00658606 | Phase 4 | Oct 1, 2007 | Astellas |
| NCT00678470 | N/A | Sep 1, 2007 | University of California, San Francisco |
| NCT00493324 | Phase 4 | Jul 1, 2007 | Astellas |
| NCT00397332 | Phase 1/Phase 2 (Phase 2) | Oct 1, 2006 | Hebrew University |
| NCT00361413 | Phase 3 | Jun 1, 2006 | Hebrew University |
| NCT00438802 | Phase 1 | Mar 1, 2006 | Mayo Clinic, National Cancer Institute (NCI) |
Organizations
Research & Development (33)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Astellas | For profit | 18 | 11 | 5 | 2001 |
| Biogen | For profit | 12 | 1 | 4 | 2001 |
| Harvard University | Academic/Hospital | 2 | 2 | 1 | 2004 |
| Hebrew University | Academic/Hospital | 2 | 2 | 2 | 2006 |
| Rutgers University | Academic/Hospital | 2 | 0 | 1 | 2003 |
| University of Medicine and Dentistry of New Jersey | Academic/Hospital | 2 | 2 | 1 | 2003 |
| Case Western Reserve University | Academic/Hospital | 1 | 1 | 1 | 2011 |
| Dermatological Clinic Berne | Academic/Hospital | 1 | 0 | 1 | 2006 |
| Duke University | Academic/Hospital | 1 | 1 | 1 | 2008 |
| Emory University | Academic/Hospital | 1 | 1 | 1 | 2010 |
| GoldSkin Care | Academic/Hospital | 1 | 0 | 1 | 2004 |
| Humboldt University | Academic/Hospital | 1 | 1 | 1 | 2004 |
| Icahn School of Medicine at Mount Sinai | Academic/Hospital | 1 | 1 | 1 | 2008 |
| Immune Tolerance Network | Academic/Hospital | 1 | 0 | 1 | 2011 |
| Indiana University | Academic/Hospital | 1 | 0 | 1 | 2011 |
| Juvenile Diabetes Research Foundation | Academic/Hospital | 1 | 0 | 1 | 2011 |
| Loyola University | Academic/Hospital | 1 | 0 | 1 | 2002 |
| Mayo Clinic | Academic/Hospital | 1 | 1 | 1 | 2006 |
| Medical University of Graz | Academic/Hospital | 1 | 1 | 1 | 2004 |
| National Cancer Institute (NCI) | Government | 1 | 0 | 1 | 2006 |