Drugs / Becaplermin
Becaplermin
also known as
Regranex · Regranex Gel · becaplermin gel · Becaplermina · Becaplermine · Bf-platelet derived growth factor .beta. polypeptide · GEM21S · Gemesis · +9 more
Protein / enzyme biologic targets PDGFB
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | REGRANEX | — | 2005-05-13 – 2018-11-28 | fda.gov ↗ |
| Withdrawn | EU (EMA) | Regranex | — | 2012-07-16 | europa.eu ↗ |
| Refused (EMA) | EU (EMA) | Gemesis | — | 2010-01-29 | europa.eu ↗ |
| Approved | EU (EMA) | Regranex | — | 1999-03-29 | europa.eu ↗ |
| Approved | US (FDA) | REGRANEX | — | 1997-12-16 | fda.gov ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00000431 | Jan 2005 → Jul 2008 | ulcer of lower limbs | University of Pennsylvania | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT04786327 | Jan 2018 → Oct 2019 | periodontitis, aggressive | Tanta University | Completed | No outcome recorded |
| Phase 34 trials · 2 missed | ||||||
| Phase 3 | NCT02845466 | Aug 2018 → Sep 2020 | ulcer of lower limbs | McMaster University | Unknown | No outcome recorded |
| Phase 3 | NCT02236793 | Dec 2014 → Aug 2016 | ulcer of lower limbs | Adocia | Completed | Missed primary |
| Phase 3 | NCT00970697 | Jan 2004 → May 2009 | ulcer of lower limbs | Assistance Publique - Hôpitaux de Paris | Completed | Missed primary |
| Phase 3 | NCT00034788 | Dec 2000 → Feb 2004 | diabetic neuropathy, ulcer of lower limbs | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Terminated | No outcome recorded Stop: Enrollment |
| Phase not applicable1 trial | ||||||
| — | NCT00446472 | Apr 2007 → Sep 2010 | ulcer of lower limbs | Southern California Institute for Research and Education | Unknown | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 1 | NCT01353937 Comparator | Apr 2014 → Mar 2016 | ulcer of lower limbs | NYU Langone Health | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT01098357 Comparator | Jun 2010 → Feb 2011 | ulcer of lower limbs | Virchow Group | Completed | No outcome recorded |
| — | NCT00389636 Comparator | Sep 2006 → Jul 2008 | ulcer of lower limbs | Solsys Medical LLC | Unknown | No outcome recorded |
Evidence & citations 21 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | becaplermin | “It is further hypothesized that this material will enhance the action of Regranex (becaplermin) gel by providing an optimal environment for this growth factor to function.” NCT00389636 ↗ |
| Known as | becaplermin gel | “becaplermin gel (Regranex Gel®)” NCT00970697 ↗ |
| Known as | Becaplermina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201556 ↗ |
| Known as | Becaplermine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201556 ↗ |
| Known as | Bf-platelet derived growth factor .beta. polypeptide | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201556 ↗ |
| Known as | GEM21S | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04786327 ↗ |
| Known as | Gemesis | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201556 ↗ |
| Known as | Pdgf-2 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201556 ↗ |
| Known as | PDGF-B/Ad5 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00000431 ↗ |
| Known as | PDGF-BB | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02236793 ↗ |
| Known as | Pdgfb | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201556 ↗ |
| Known as | Platelet derived growth factor-bb | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201556 ↗ |
| Known as | Platelet-derived growth factor becaplermin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201556 ↗ |
| Known as | Regranex | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00446472 ↗ |
| Known as | Regranex Gel | “becaplermin gel (Regranex Gel®)” NCT00970697 ↗1“topical PDGF/Regranex® Gel” NCT01353937 ↗ |
| Known as | rhPDGF-BB (Becaplermin) | “rhPDGF-BB (Becaplermin)” NCT01353937 ↗ |
| Known as | RWJ 60235 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201556 ↗ |
| Known as | Sh-polypeptide-59 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201556 ↗ |
| Modality | Protein / enzyme biologic | “It is further hypothesized that this material will enhance the action of Regranex (becaplermin) gel by providing an optimal environment for this growth factor to function.” NCT00389636 ↗ |
| Route | Other | “a single intra-ulcer injection of PDGF-B/Ad5” NCT00000431 ↗ |
| Target | PDGFB | “adenovirus vector designed to overexpress PDGF-B” NCT00000431 ↗ |