Drugs / HUMAN NEUREGULIN-1 RECOMBINANT (177-237)
HUMAN NEUREGULIN-1 RECOMBINANT (177-237)
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | congestive heart failure | 2012-01-13 | “Co., Ltd. submitted NDA of rhNRG-1 to SFDA. Zensun are expected to obtain New Drug Certification and apply rhNRG-1 to clinical treatment of CHF.” zensun.com ↗ “Based on these clinical trial data, Zensun has filed a New Drug Application (NDA) in China to obtain accelerated market approval” zensun.com ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT01251406 | Jan → Dec 2012 | heart failure | Zensun Sci. & Tech. Co., Ltd. | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT05949801 | Apr 2023 → Aug 2024 | systolic heart failure | Zensun Sci. & Tech. Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT03388593 | Jul 2018 → Feb 2026 | heart failure | Zensun Sci. & Tech. Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT01541202 | Feb 2012 → Aug 2017 | heart failure | Zensun Sci. & Tech. Co., Ltd. | Terminated | No outcome recorded |
| Phase 3 | NCT01214096 | Jul 2010 → Jan 2011 | heart failure | Zensun Sci. & Tech. Co., Ltd. | Terminated | No outcome recorded |
| Phase 3 | NCT01131637 | Apr 2010 → Jun 2012 | heart failure | Zensun Sci. & Tech. Co., Ltd. | Terminated | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 3 | NCT01439789 Comparator | Jun 2011 → Jun 2012 | heart failure | Zensun Sci. & Tech. Co., Ltd. | Terminated | No outcome recorded |
| Phase 3 | NCT01439893 Comparator | Jun 2011 → Jun 2012 | systolic heart failure | Zensun Sci. & Tech. Co., Ltd. | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2019-09-04 | Zensun Sci. & Tech. Co., Ltd. | Regulatory ZENSUN ANNOUNCES THE INVESTIGATION OF NEUCARDIN FOR CHRONIC HEART FAILURE RECEIVES FAST TRACK DESIGNATION FROM THE US FDA zensun.com ↗ |
| 2017-12-27 | Zensun Sci. & Tech. Co., Ltd. | Regulatory ISS&ISE Reports Have Been Submitted to the FDA zensun.com ↗
Zensun has achieved a major corporate milestone for Neucardin clinical development by submitting the Integrated Summary of Safety (ISS) and Integrated Summary of Effectiveness (ISE) to the FDA on Dec. 18, 2017 as planned. |
| 2017-02-07 | Zensun Sci. & Tech. Co., Ltd. | Results Exciting results from the Neucardin™ Phase III clinical trial (Interim Analysis) zensun.com ↗
The results reveal that based on the clinical standard therapy, Neucardin™ reduced one-year all-cause mortality (the primary endpoint) by 17% compared with placebo in mild to moderate CHF patients. |
| 2014-01-04 | Zensun Sci. & Tech. Co., Ltd. | Regulatory Zensun Announces Successful End of Phase 2 Meeting for Neucardin™ zensun.com ↗ |
| 2013-03-29 | Zensun Sci. & Tech. Co., Ltd. | Results Zensun Announces Positive Results for Neucardin™ to Improve Heart Function and Reduce Mortality zensun.com ↗
The data demonstrates that Neucardin™ reduced all-cause mortality, improved heart function, reduced heart volumes, improved exercise capacity and quality of life on top of current standard of care in patients with chronic heart failure (CHF). |
| 2013-02-21 | Zensun Sci. & Tech. Co., Ltd. | Results Zensun Obtained the Exciting Results of US Phase II Clinical Trial zensun.com ↗
On Feb 20th, Zensun unblinded the clinical data which showed an excellent consistency with Chinese Phase II clinical results. |
| 2012-01-13 | Zensun Sci. & Tech. Co., Ltd. | Regulatory Zensun has Submitted NDA of rhNRG-1 to SFDA zensun.com ↗
In Jan 12, 2012, Zensun (Shanghai) Sci. &Tech. Co., Ltd. submitted NDA of rhNRG-1 to SFDA. |
| 2010-03-30 | Zensun Sci. & Tech. Co., Ltd. | Results The Survival Study of rhNRG-1 Obtained Satisfying Result zensun.com ↗
This study showed: 21 patients died in placebo treated group and only 11 patients died in rhNRG-1 treated group; mortality rate dropped by 47.62%. |
| 2010-03-05 | Zensun Sci. & Tech. Co., Ltd. | Regulatory rhNRG-1 Obtained SFDA Approval for Phase III Clinical Trial zensun.com ↗
rhNRG-1 was approved by SFDA to take phase III clinical trial (2010L00444). |
| 2009-11-20 | Zensun Sci. & Tech. Co., Ltd. | Results rhNRG-1 Phase II Clinical study Showed a Significant Decrease of Rehospitalization zensun.com ↗
The results showed that the rehospitalization rate of rhNRG-1 group is only 0.17 per person. |
| 2009-07-28 | Zensun Sci. & Tech. Co., Ltd. | Results An Article Published in Cell Demonstrated the Similar Mechanism as Zensun Discovered In July 24th zensun.com ↗
In this article, injecting NRG1 in adult mice induces cardiomyocyte cell-cycle activity and promotes myocardial regeneration, leading to improved function after myocardial infarction. |
| 2009-06-26 | Zensun Sci. & Tech. Co., Ltd. | Regulatory rhNRG-1 was Approved to Take Phase II Clinical Trial in US zensun.com ↗
After a critical review of Zensun’s data, FDA approved US phase II clinical trial of rhNRG-1 by skipping phase I study recently. |
| 2009-05-06 | Zensun Sci. & Tech. Co., Ltd. | Results Zensun Completed Chinese Phase II Clinical Study of rhNRG-1 zensun.com ↗
The initial statistics show that the heart function was improved effectively with rhNRG-1 treatment. |
| 2008-10-23 | Zensun Sci. & Tech. Co., Ltd. | Results Zensun Achieved Important Progress in Australian Phase II clinical Trial zensun.com ↗
The results demonstrated that all these dosage groups could improve heart function. |
| 2008-05-07 | Zensun Sci. & Tech. Co., Ltd. | Results Zensun Obtained Initial Results of Australian Clinical Study zensun.com ↗
It showed that the systolic function of patients with medium and high dosages improved significantly, comparing to the patients with the low dosage. |
All press releases naming this drug 30 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HUMAN NEUREGULIN-1 RECOMBINANT (177-237) | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594600 ↗ |
| Known as | Neucardin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05949801 ↗ |
| Known as | recombinant human neuregulin-1 | “RhNRG-1(recombinant human neuregulin-1)directly works on the cardiomyocytes and restored the normal structure and function of it.” NCT01439789 ↗3“RhNRG-1(recombinant human neuregulin-1)directly works on the cardiomyocytes and restored the normal structure and function of it.” NCT01439893 ↗ “RhNRG-1(recombinant human neuregulin-1)directly work on the cardiomyocyte and restored the normal structure and function of it.” NCT01131637 ↗ “RhNRG-1(recombinant human neuregulin-1)directly work on the cardiomyocyte and restored the normal structure and function of it.” NCT01541202 ↗ |
| Known as | RhNRG-1 | “RhNRG-1(recombinant human neuregulin-1)directly works on the cardiomyocytes and restored the normal structure and function of it.” NCT01439893 ↗8“RhNRG-1(recombinant human neuregulin-1)directly work on the cardiomyocyte and restored the normal structure and function of it.” NCT01131637 ↗ |
| Action | Restore | “acts directly on damaged heart muscle cells to restore their structure and function” NCT01251406 ↗ |
| Modality | Protein / enzyme biologic | “recombinant human neuregulin-1” NCT01131637 ↗ |
| Route | Intravenous | “for vein infusion” NCT01131637 ↗ |