FDA · United States
cisplatin — FDA regulatory status
cisplatin (CISPLATIN ACCORD) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- CISPLATIN ACCORD
- Originator
- Accord Healthcare Pty.
- Mechanism
- DNA inhibitor
- Target
- DNA
- Structured fields
- 8
Sponsor / originator context: Accord Healthcare Pty.. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: DNA inhibitor. Target: DNA. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 216 published clinical programs and 7 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| 1407-GUCG | Phase 3 | Ningbo Cancer Hospital | 2024-513509-30-00 |
| 1479-0008 | Phase 3 | Boehringer Ingelheim | 2023-504308-27-00 |
| 17000139BLC3001 | Phase 3 | Janssen-Cilag International N.V | 2023-507188-21-00 |
| 2019/2894 | Phase 3 | George Institute for | 2024-514917-36-00 |
| 20200041 | Phase 3 | Amgen | 2023-505989-29-00 |
| 2020HXFH037 | Phase 3 | Chinese Academy of | NCT04414566 |
| 22615 | Phase 3 | Bayer | 2024-511319-91-00 |
| 61186372HNC3001 | Phase 3 | Janssen-Cilag International N.V | 2025-521917-24-00 |
| Abraxane /ml powder for dispersion for infusion. for metastatic NSCLC patients | Phase 3 | Telethon Foundation | 2025-522084-15-00 |
| BNT327-03 | Phase 3 | BioNTech SE | 2024-515765-34-00 |
| BO40336 | Phase 3 | HOFFMANN-LA ROCHE | 2023-506861-76-00 |
| BO42864 | Phase 3 | HOFFMANN-LA ROCHE | 2023-505035-12-00 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 11013740 | Histone deacetylase 6 selective inhibitors for the treatment of cisplatin-induced peripheral neuropathy | US |
| 10272084 | Histone deacetylase 6 selective inhibitors for the treatment of cisplatin-induced peripheral neuropathy | US |
| 8703756 | Synthetic procedure and cancer treatment with cisplatin derivatives | US |
| 2678011 | ANTITUMORIGENE KOMBINATON, DIE CABAZITAXEL UND CISPLATIN UMFASST | EP |
| 2620148 | Antitumorkombination mit Cabazitaxel und Cisplatin | EP |
| 2491925 | Antitumorigene Kombinaton, die Cabazitaxel und Cisplatin umfasst | EP |
| 7700134 | Prevention of cisplatin induced deafness | US |
Related hubs
FAQ
What is the FDA approval status of cisplatin?
cisplatin currently shows FDA approved in our United States regulatory index. Confirm on the official FDA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get cisplatin regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to cisplatin?
This spoke lists 216 published programs associated with cisplatin in our pipeline index.