Drugs / Beremagene Geperpavec
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Vyjuvek | — | 2025-04-23 | europa.eu ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial · 1 met primary | ||||||
| Phase 1/2 | NCT03536143 | May 2018 → Nov 2019 | epidermolysis bullosa dystrophica | Krystal Biotech, Inc. | Completed | Met primary |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT04917874 | May 2021 → Jul 2023 | generalized dominant dystrophic epidermolysis bullosa, recessive dystrophic epidermolysis bullosa | Krystal Biotech, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT04491604 | Aug 2020 → Oct 2021 | generalized dominant dystrophic epidermolysis bullosa, recessive dystrophic epidermolysis bullosa | Krystal Biotech, Inc. | Completed | Met primary |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Beremagene Geperpavec | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04491604 ↗ |
| Known as | B-VEC | “Here, we evaluated beremagene geperpavec (B-VEC), an engineered, non-replicating COL7A1 containing herpes simplex virus type 1 (HSV-1) vector, to treat RDEB skin.” PMID 35347281 ↗ Mar 20222“Beremagene Geperpavec (B-VEC, Previously "KB103") for the Treatment of Dystrophic Epidermolysis Bullosa (DEB)” NCT04491604 ↗ “Open Label Topical Beremagene Geperpavec (B-VEC)” NCT04917874 ↗ |
| Known as | Beremagene geperpavec-svdt | “Beremagene geperpavec-svdt (B-VEC) is a modified, herpes simplex virus type 1-based gene therapy vector that topically delivers COL7A1 to dystrophic epidermolysis bullosa wounds.” PMID 40220208 ↗ Apr 2025 |
| Known as | KB103 | “Beremagene Geperpavec (B-VEC, Previously "KB103") for the Treatment of Dystrophic Epidermolysis Bullosa (DEB)” NCT04491604 ↗ |
| Known as | Vyjuvek | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594328 ↗ |
| Action | Restore | “B-VEC restored C7 expression in RDEB keratinocytes, fibroblasts, RDEB mice and human RDEB xenografts.” PMID 35347281 ↗ Mar 2022 |
| Route | Topical | “Topical gel of non-integrating, replication-incompetent HSV-1 expressing the human collagen VII protein” NCT03536143 ↗ |
| Target | COL7A1 | “an engineered, non-replicating COL7A1 containing herpes simplex virus type 1 (HSV-1) vector” PMID 35347281 ↗ Mar 2022 |