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Neucardin
Neucardin is a Small molecule drug developed by Zensun Sci. & Tech. Co., Ltd.. It is currently in Phase 3 development. Also known as: Recombinant human Neuregulin-1 for Injection.
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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 | Neucardin |
|---|---|
| Also known as | Recombinant human Neuregulin-1 for Injection |
| Sponsor | Zensun Sci. & Tech. Co., Ltd. |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Efficacy and Safety of Human Neuregulin-1 to Treat Stable Chronic Heart Failure (PHASE2)
- Evaluation of the Effect of Injectable Neucardin on Cardiac Function and Reversal Ventricular Remodeling in Patients With Chronic Systolic Heart Failure (PHASE3)
- Evaluate the Effect of Injectable Neucardin on the Cardiac Function of Subjects With Chronic Systolic Heart Failure (PHASE3)
- Survival Study of the Recombinant Human Neuregulin-1β in Subjects With Chronic Heart Failure. (PHASE3)
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:
- Neucardin CI brief — competitive landscape report
- Neucardin updates RSS · CI watch RSS
- Zensun Sci. & Tech. Co., Ltd. portfolio CI
Frequently asked questions about Neucardin
What is Neucardin?
Who makes Neucardin?
Is Neucardin also known as anything else?
What development phase is Neucardin in?
Related
- Manufacturer: Zensun Sci. & Tech. Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Recombinant human Neuregulin-1 for Injection
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing