Drugs / Engensis
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05361031 | Sep 2020 → Sep 2021 | Charcot-Marie-Tooth disease type 1 | Helixmith Co., Ltd. | Completed | No outcome recorded |
| Phase 34 trials · 1 missed | ||||||
| Phase 3 | NCT04873232 | May 2021 → Sep 2023 | diabetic polyneuropathy | Helixmith Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT04469270 | Nov 2020 → Mar 2023 | diabetic polyneuropathy | Helixmith Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT04055090 | Feb → Jul 2019 | diabetic polyneuropathy | Helixmith Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT02427464 | Apr 2016 → Apr 2019 | diabetic polyneuropathy | Helixmith Co., Ltd. | Completed | Missed primary |
| Comparator or background therapy4 trials | ||||||
| Phase 2 | NCT05176093 Comparator | Nov 2021 → Dec 2022 | amyotrophic lateral sclerosis | Helixmith Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT04632225 Comparator | Mar 2021 → Jul 2022 | amyotrophic lateral sclerosis | Helixmith Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT01475786 Comparator | Aug 2012 → Mar 2014 | diabetic polyneuropathy | Helixmith Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT02563522 Comparator | Jun 2017 → Sep 2019 | chronic ulcer of skin | Helixmith Co., Ltd. | Terminated | No outcome recorded Stop: Enrollment |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Engensis | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05361031 ↗ |
| Known as | VM202 | “A phase III, randomized, double-blind, placebo-controlled, multicenter, 7-month study designed to assess the safety and efficacy of intramuscular (IM) injections in the calf of...” NCT02563522 ↗3“This study will use Engensis (VM202), which is a DNA plasmid that contains novel genomic cDNA hybrid human HGF coding sequence (HGF-X7) expressing two isoforms of HGF” NCT05361031 ↗ “The purpose of this study is to explore the overall safety profile and durability of efficacy of Engensis (VM202) in painful diabetic peripheral neuropathy.” NCT04055090 ↗ “Treatments - Engensis (VM202) - 336 Engensis of 318 planned participants” NCT02427464 ↗ |
| Modality | Other / unclassified | “which is a DNA plasmid” NCT05361031 ↗ |
| Route | Intramuscular | “given by intramuscular injections” PMID 26000320 ↗ Mar 2015 |
| Target | HGF | “human HGF coding sequence (HGF-X7) expressing two isoforms of HGF” NCT05361031 ↗ |