Drugs / OCIFISERTIB
OCIFISERTIB
also known as
CFI-400945 · AK173721 · AKOS025396133 · CFI-400945 (FREE BASE) · CFI-400945 FUMARATE · Ocifisertib fumarate · OCIFISERTIB(CFI-400945 FREE BASE)
Small molecule targets PLK4 via inhibition
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT03187288 | May 2018 → Jun 2021 | acute myeloid leukemia, myelodysplastic syndrome, refractory malignant neoplasm | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 1 | NCT01954316 | Mar 2014 → Jul 2021 | cancer of unknown primary site | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04730258 | Apr 2021 → Jan 2026 overdue | acute myeloid leukemia, chronic myelomonocytic leukemia, myelodysplastic syndrome | Treadwell Therapeutics, Inc | Active not recruiting | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT05601440 | Jun 2023 → Dec 2027 expected | female breast carcinoma | Canadian Cancer Trials Group | Recruiting | No outcome recorded |
| Phase 2 | NCT04176848 | Aug 2020 → Sep 2022 overdue | breast cancer | Canadian Cancer Trials Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03624543 | Feb 2019 → Nov 2026 expected | breast cancer | Canadian Cancer Trials Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03385655 | Aug 2018 → Oct 2024 overdue | prostate cancer | Canadian Cancer Trials Group | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2024-02-20 | Treadwell Therapeutics, Inc | Regulatory Treadwell Announces Ocifisertib, a First-in-Class PLK4 Inhibitor, has Received Orphan Designation from U.S. FDA for the Treatment of Acute Myeloid Leukemia treadwelltx.com ↗
Treadwell Therapeutics, a privately held clinical-stage biotechnology company pioneering and advancing novel first-in-class medicines for unmet needs in cancer, today announced the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to ocifisertib (CFI-400945), a first-in-class, investigational PLK4 inhibitor for the treatment of acute myeloid leukemia (AML). |
| 2023-12-18 | Treadwell Therapeutics, Inc | Results Treadwell Therapeutics Announces a Presentation at the 2023 ASH Annual Meeting and Advisory Board Meeting treadwelltx.com ↗
CFI-400945 is demonstrating complete remissions as a single agent and in combination with azacitadine in relapsed, adverse risk AML, including those with TP53 mutant disease. |
| 2022-12-13 | Treadwell Therapeutics, Inc | Results Treadwell Therapeutics Announces A Presentation at the 2022 ASH Annual Meeting Featuring a Clinical Trial Update on CFI-400945, an oral PLK4 inhibitor treadwelltx.com ↗
The poster presentation described the preliminary results from the monotherapy dose optimization portion of the TWT-202 in advanced leukemias. |
| 2022-04-26 | Treadwell Therapeutics, Inc | Regulatory Treadwell Therapeutics Announces Fast Track Designation Granted by the FDA to CFI-400945 for the Treatment of Acute Myeloid Leukemia treadwelltx.com ↗
Treadwell Therapeutics, a clinical-stage biotechnology company developing novel medicines for unmet needs in cancer, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to CFI-400945, a first in class inhibitor of Polo-like kinase 4 (PLK4), for the treatment of adult patients with relapsed or refractory Acute Myeloid Leukemia (AML). |
All press releases naming this drug 5 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | OCIFISERTIB | ChEMBL registry synonym — accepted as the source's own label CHEMBL3408947 ↗ |
| Known as | AK173721 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3408947 ↗ |
| Known as | AKOS025396133 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3408947 ↗ |
| Known as | CFI-400945 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03624543 ↗ |
| Known as | CFI-400945 (FREE BASE) | ChEMBL registry synonym — accepted as the source's own label CHEMBL3408947 ↗ |
| Known as | CFI-400945 FUMARATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3408947 ↗ |
| Known as | Ocifisertib fumarate | ChEMBL registry synonym — accepted as the source's own label CHEMBL3408947 ↗ |
| Known as | OCIFISERTIB(CFI-400945 FREE BASE) | ChEMBL registry synonym — accepted as the source's own label CHEMBL3408947 ↗ |
| Action | Inhibit | “blocking polo-like kinase 4 (PLK4) from working” NCT01954316 ↗ |
| Modality | Small molecule | — CHEMBL3408947 ↗ |
| Route | Oral | “CFI-400945 is an oral (taken by mouth) drug” NCT01954316 ↗ |
| Target | PLK4 | “blocking polo-like kinase 4 (PLK4) from working” NCT01954316 ↗ |