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Engensis (VM202)
VM202 is a plasmid DNA therapeutic that encodes hepatocyte growth factor (HGF) to promote angiogenesis and tissue repair in ischemic tissues.
VM202 is a plasmid DNA therapeutic that encodes hepatocyte growth factor (HGF) to promote angiogenesis and tissue repair in ischemic tissues. Used for Critical limb ischemia (CLI) / peripheral arterial disease, Diabetic foot ulcers.
At a glance
| Generic name | Engensis (VM202) |
|---|---|
| Sponsor | Helixmith Co., Ltd. |
| Drug class | Plasmid DNA therapeutic; angiogenic agent |
| Target | Hepatocyte growth factor (HGF) pathway; c-Met receptor |
| Modality | Biologic |
| Therapeutic area | Cardiovascular; Regenerative Medicine |
| Phase | Phase 3 |
Mechanism of action
VM202 delivers a HGF-encoding plasmid via intramuscular injection, which is taken up by muscle cells and produces HGF protein locally. HGF stimulates new blood vessel formation (angiogenesis) and promotes tissue regeneration, improving blood flow and function in ischemic tissues. This approach aims to restore perfusion and reduce symptoms in conditions characterized by inadequate blood supply.
Approved indications
- Critical limb ischemia (CLI) / peripheral arterial disease
- Diabetic foot ulcers
Common side effects
- Injection site reactions (pain, swelling, erythema)
- Muscle pain or myalgia
- Transient elevation in liver enzymes
Key clinical trials
- Phase 3 Gene Therapy for Painful Diabetic Neuropathy (PHASE3)
- Extension of Phase 3 Gene Therapy for Painful Diabetic Neuropathy (PHASE3)
- Safety and Efficacy Study of Engensis (VM202) in the Treatment of Chronic Non-Healing Foot Ulcers (PHASE3)
- Safety and Efficacy Study for the Treatment of Painful Diabetic Neuropathy (PHASE2)
- Safety Study of Gene Therapy in Treating Critical Leg Ischemia (PHASE1)
- The Safety and Tolerability of Engensis (VM202) in Patients With Charcot-Marie-Tooth Disease Subtype 1A (CMT1A) (PHASE1, PHASE2)
- Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia (PHASE2)
- Gene Therapy for Painful Diabetic Neuropathy (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Engensis (VM202) CI brief — competitive landscape report
- Engensis (VM202) updates RSS · CI watch RSS
- Helixmith Co., Ltd. portfolio CI