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Engensis
Engensis is a Biologic drug developed by Helixmith Co., Ltd.. It is currently in Phase 3 development.
Engensis, also known as VM202, is a gene therapy being studied for various conditions, including Painful Diabetic Neuropathy, Diabetic Neuropathy, Critical Limb Ischemia, Amyotrophic Lateral Sclerosis, Foot Ulcer, and Diabetic conditions. It is being tested in a Phase 3 clinical trial as a potential treatment for Painful Diabetic Neuropathy.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Engensis |
|---|---|
| Sponsor | Helixmith Co., Ltd. |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
- COVID-19
- Influenza
- Pain in extremity
- Injection site pain
- Cough
- Skin ulcer
- Injection site bruising
- Arthralgia
- Hypertension
- Pyrexia
- Dysphagia
- Skin abrasion
Key clinical trials
- A 6-Month Extension Study of VMDN-003-2 to Assess Engensis in Participants With Painful Diabetic Peripheral Neuropathy (PHASE3)
- Study to Assess Safety and Efficacy of Engensis in Painful Diabetic Peripheral Neuropathy (PHASE3)
- 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 of Engensis in Participants With Amyotrophic Lateral Sclerosis (PHASE2)
- Safety Study of Gene Therapy in Treating Critical Leg Ischemia (PHASE1)
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 CI brief — competitive landscape report
- Engensis updates RSS · CI watch RSS
- Helixmith Co., Ltd. portfolio CI
Frequently asked questions about Engensis
What is Engensis?
Who makes Engensis?
What development phase is Engensis in?
What are the side effects of Engensis?
Related
- Manufacturer: Helixmith Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing