becaplermin
Trade name: regranex
Recombinant proteinapproved
Approved
Dec 16, 1997
Becaplermin, sold under the brand name Regranex, is a cicatrizant, available as a topical gel. Regranex is a human platelet-derived growth factor indicated along with good wound care for the treatment of lower extremity diabetic neuropathic ulcers. It is also known as "platelet-derived growth factor BB". — Wikipedia
Clinical trial activity
12 trials · 22 clinical orgs · 2 marketing orgs
Phase 1
2
Phase 2
8
Phase 3
5
Phase 4
0
Earliest trial started Jan 1, 2000 (NCT01530126)
Timeline
1990s
- Dec 16, 1997
Smith & Nephew — Earliest FDA Approval
- Dec 16, 1997
Smith & Nephew — Marketing Organization
- Dec 16, 1997
Johnson and Johnson — Marketing Organization
- Dec 16, 1997
Smith & Nephew — NDA Organization
2000s
- Jan 1, 2000
Johnson and Johnson — Earliest Phase 3 Sponsor(trial)
Indications
Approved for
Mechanism of action
Platelet-derived growth factor receptor agonist
- Platelet-derived growth factor subunit ASupplementation
PDGFA supplementation
Approval history
- approvedDec 16, 1997
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral, Topical
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
Yes
Sources
- WikipediaBecaplermin ↗
- NCATS1B56C968OA ↗
- ChEMBLCHEMBL1201556 ↗
Also known as
- becaplermin
- becaplermin
- becaplermin
- becaplermin
- becaplermin
- becaplermin
- becaplermin
- becaplermin
- becaplermin
- becaplermin
- c-sis
- pdgf-2
- pdgfb
- pdgf-bb
- pdgf-bb
- pdgf-bb
- pdgf b-chain
- platelet-derived growth factor bb
- platelet-derived growth factor bb, recombinant
- platelet-derived growth factor b chain precursor
- platelet-derived growth factor beta polypeptide
- recombinant platelet-derived growth factor bb
- regranex
- regranex
- regranex
- regranex
- rhpdgf-bb
- rhpdgf-bb
- rpdgf-bb
- rwj 60235
- rwj-60235
- rwj-60235
- sh-polypeptide-59
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT03037970 | Phase 2 | Jan 30, 2017 | Centro Medico Militar, Guatemala, Lynch Biologics LLC, Medelis Inc. |
| NCT02845466 | Phase 3 | Oct 1, 2016 | Canadian Institutes of Health Research (CIHR), McMaster University |
| NCT02236793 | Phase 3 | Dec 1, 2014 | Adocia, SL Raheja Hospital, Virchow Group |
| NCT01353937 | Phase 1 | Apr 1, 2014 | Genzyme, National Institutes of Health (NIH), New York University |
| NCT01746420 | Phase 2 | Dec 1, 2012 | BioMimetic Therapeutics, Brown University |
| NCT01098357 | Phase 1/Phase 2 (Phase 2) | Jun 1, 2010 | Adocia, Virchow Group |
| NCT00496847 | Phase 3 | Aug 1, 2007 | Sri Sai College of Dental Surgery and Research Centre, Virchow Group |
| NCT00446472 | N/A | Apr 1, 2007 | Department of Veteran Affairs, Heritage Medical Research Institute |
| NCT00389636 | N/A | Sep 1, 2006 | Northwestern University, Solsys Medical |
| NCT00970697 | Phase 3 | Jan 1, 2004 | Dermatology, Charles Foix, University of Paris |
| NCT00034788 | Phase 3 | Dec 1, 2000 | Johnson and Johnson |
| NCT01530126 | N/A | Jan 1, 2000 | University of Michigan |
Showing 12 of 12 trials
Page 1 / 1
Organizations
Research & Development (22)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Virchow Group | For profit | 3 | 2 | 2 | 2007 |
| Adocia | For profit | 2 | 1 | 2 | 2010 |
| BioMimetic Therapeutics | For profit | 1 | 1 | 1 | 2012 |
| Brown University | Academic/Hospital | 1 | 0 | 1 | 2012 |
| Canadian Institutes of Health Research (CIHR) | Academic/Hospital | 1 | 0 | 1 | 2016 |
| Centro Medico Militar, Guatemala | Academic/Hospital | 1 | 0 | 1 | 2017 |
| Department of Veteran Affairs | Government | 1 | 1 | 1 | 2007 |
| Dermatology, Charles Foix | Academic/Hospital | 1 | 0 | 1 | 2004 |
| Genzyme | For profit | 1 | 0 | 1 | 2014 |
| Heritage Medical Research Institute | Academic/Hospital | 1 | 0 | 1 | 2007 |
| Johnson and Johnson | For profit | 1 | 1 | 1 | 2000 |
| Lynch Biologics LLC | For profit | 1 | 1 | 1 | 2017 |
| McMaster University | Academic/Hospital | 1 | 1 | 1 | 2016 |
| Medelis Inc. | For profit | 1 | 0 | 1 | 2017 |
| National Institutes of Health (NIH) | Government | 1 | 0 | 1 | 2014 |
| New York University | Academic/Hospital | 1 | 1 | 1 | 2014 |
| Northwestern University | Academic/Hospital | 1 | 0 | 1 | 2006 |
| SL Raheja Hospital | Academic/Hospital | 1 | 0 | 1 | 2014 |
| Solsys Medical | For profit | 1 | 1 | 1 | 2006 |
| Sri Sai College of Dental Surgery and Research Centre | Academic/Hospital | 1 | 0 | 1 | 2007 |
22 organizations
Page 1 / 2
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Johnson and Johnson | For profit | MKTG | Dec 16, 1997 |
| Smith & Nephew | For profit | MKTG | Dec 16, 1997 |
| Smith & Nephew | For profit | NDA | Dec 16, 1997 |