Drugs / ND0612
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Rejected (CRL) | US (FDA) | — | Parkinson disease | 2025-10-23 | “Drug Administration (FDA) has issued a complete response letter* for the New Drug Application (NDA) of investigational ND0612” tanabe-pharma.com ↗ |
| Filed | US (FDA) | — | Parkinson disease | 2025-05-29 | “Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) resubmission for investigational ND0612” tanabe-pharma.com ↗ “Regarding the development of ND0612 in the United States, the NDA was initially submitted to the FDA in 2023” tanabe-pharma.com ↗ |
| Filed | EU (EMA) | — | Parkinson disease | 2025-02-20 | “EMA has accepted for review the marketing authorization application (MAA) for ND0612” tanabe-pharma.com ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02604914 | May 2015 → Jun 2016 | Parkinson disease | NeuroDerm Ltd. | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT02726386 | May 2016 → Sep 2019 overdue | Parkinson disease | NeuroDerm Ltd. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01883505 | Jan 2014 → Apr 2015 | Parkinson disease | NeuroDerm Ltd. | Completed | No outcome recorded |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT04006210 | Sep 2019 → Nov 2022 overdue | Parkinson disease | NeuroDerm Ltd. | Active not recruiting | Met primary |
| Phase 3 | NCT03462043 | Apr → Nov 2018 | Parkinson disease | NeuroDerm Ltd. | Withdrawn | No outcome recorded |
| Phase 3 | NCT02782481 | Aug 2016 → Oct 2018 | Parkinson disease | NeuroDerm Ltd. | Withdrawn | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-04-30 | Tanabe Pharma Corporation | Regulatory European Commission Grants Marketing Authorization for Onerji® for the Treatment of Parkinson’s Disease tanabe-pharma.com ↗
European Commission Grants Marketing Authorization for Onerji® for the Treatment of Parkinson’s Disease |
| 2025-10-23 | Tanabe Pharma Corporation | Regulatory Receipt of Complete Response Letter from U.S. FDA for investigational ND0612 tanabe-pharma.com ↗ |
| 2025-05-29 | Tanabe Pharma Corporation | Regulatory U.S. FDA Accepts Resubmission for ND0612, an Investigational Treatment for Motor Fluctuations in Parkinson’s Disease tanabe-pharma.com ↗
U.S. FDA Accepts Resubmission for ND0612, an Investigational Treatment for Motor Fluctuations in Parkinson’s Disease |
| 2025-02-21 | Tanabe Pharma Corporation | Regulatory EMA Accepts Marketing Authorization Application for ND0612, an Investigational Treatment for Motor Fluctuations in Parkinson’s Disease tanabe-pharma.com ↗ |
| 2024-06-11 | Tanabe Pharma Corporation | Regulatory Receipt of Complete Response Letter from U.S. FDA for ND0612 tanabe-pharma.com ↗
the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (hereinafter "CRL") for the New Drug Application (NDA) of investigational ND0612 |
| 2024-03-19 | Tanabe Pharma Corporation | Results Announcement of Publication in The Lancet Neurology from the Clinical Study of Investigational ND0612 for Parkinson's Disease tanabe-pharma.com ↗
Treatment with ND0612 demonstrated favorable efficacy with a statistically significant addition (p<0.0001) of 1.72 hours in “ON” time without troublesome dyskinesia over oral IR-LD/CD, thus meeting the trial’s primary endpoint. |
All press releases naming this drug 7 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ND0612 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02726386 ↗ |
| Route | Subcutaneous | “Subcutaneous infusion via CRONO ND pump” NCT01883505 ↗ |