Drugs / FCN-437c
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | — | — | “has been accepted by the NMPA in January 2025” fosunpharma.com ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials · 1 met primary | ||||||
| Phase 1 | NCT06620731 | Sep 2023 | liver disorder | Ahon Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT06290466 | Nov 2022 → Feb 2023 | breast cancer | Ahon Pharmaceutical Co., Ltd. | Completed | Met primary |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04488107 | Feb 2019 → Dec 2021 | breast neoplasm | Ahon Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05004142 | Jun 2020 → Dec 2021 | breast cancer | Ahon Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT05438810 | Jan 2022 → Feb 2024 | female breast carcinoma | Ahon Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2018-01-25 | Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Regulatory Fosun Pharma Receives CFDA Approval for Clinical Trials of New Innovative Medicine to Treat Solid Tumors fosunpharma.com ↗
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma" SH.600196) announces that it receives CFDA approval for clinical trials of the innovative drug FCN-437c capsule and its APIs ("New Medicine") , which is intended to treat solid tumors. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2018-01-25 | Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Fosun Pharma Receives CFDA Approval for Clinical Trials of New Innovative Medicine to Treat Solid Tumors fosunpharma.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | FCN-437c | “FCN-437c is an oral, second-generation, potent, and selective CDK4/6 inhibitor for the treatment of patients with HR+/HER2- metastatic breast cancer.” PMID 39188943 ↗ Aug 2024 |
| Action | Inhibit | “a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor” PMID 34109484 ↗ Jun 2021 |
| Route | Oral | “available in 25mg and 100mg capsules for oral administration on an empty stomach.” NCT05438810 ↗ |
| Target | CDK4 | “a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor” PMID 34109484 ↗ Jun 2021 |