CX-5461

also known as Pidnarulex

Developed for: metastatic malignant neoplasm · Burkitt lymphoma · cancer · castration-resistant prostate carcinoma · colorectal adenocarcinoma · diffuse large B-cell lymphoma · female breast carcinoma · HER2 positive breast carcinoma
+6 more
· high grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangement · hormone receptor-positive breast cancer · invasive breast carcinoma · neoplasm · refractory malignant neoplasm · triple-negative breast carcinoma
Investigated by: National Cancer Institute (NCI) · Senhwa Biosciences, Inc. · Canadian Cancer Trials Group · Peter MacCallum Cancer Centre, Australia · Stand Up To Cancer

20172018201920202021202220232024202520262027202820292030

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 15 trials
Phase 1	NCT07137416	Oct 2026 → Jan 2028 expected	HER2 positive breast carcinoma, female breast carcinoma, hormone receptor-positive breast cancer, invasive breast carcinoma +3	National Cancer Institute (NCI)	Recruiting	No outcome recorded
Phase 1	NCT06606990	Jul 2025 → Dec 2026 expected	metastatic malignant neoplasm	National Cancer Institute (NCI)	Recruiting	No outcome recorded
Phase 1	NCT05425862	Oct 2022 → Jul 2024	castration-resistant prostate carcinoma	Peter MacCallum Cancer Centre, Australia	Suspended	No outcome recorded
Phase 1	NCT04890613	Sep 2021 → Mar 2027 expected	neoplasm	Senhwa Biosciences, Inc.	Recruiting	No outcome recorded
Phase 1	NCT02719977	Jun 2016 → Jan 2020	cancer	Canadian Cancer Trials Group	Completed	No outcome recorded
Phase 1/22 trials
Phase 1/2	NCT07069699	Oct 2026 → Jan 2030 expected	Burkitt lymphoma, diffuse large B-cell lymphoma, high grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangement	National Cancer Institute (NCI)	Recruiting	No outcome recorded
Phase 1/2	NCT07147231	Aug 2026 → Sep 2027 expected	colorectal adenocarcinoma	National Cancer Institute (NCI)	Recruiting	No outcome recorded

Every value below carries the sentence it was read from. 9 sources stand behind the page.

Field	Value	Cited text
Known as	CX-5461	“CX-5461 is a G-quadruplex stabilizer that exhibits synthetic lethality in homologous recombination-deficient models.” PMID 35750695 ↗ Jun 2022 2 NCT04890613 ↗ NCT02719977 ↗
Known as	Pidnarulex	ClinicalTrials.gov intervention name — accepted as the source's own label NCT07147231 ↗ 4 NCT06606990 ↗ NCT05425862 ↗ NCT07069699 ↗ NCT07137416 ↗
Action	Inhibit	“designed to stop the action of a particular protein in the body called Polymerase I” NCT05425862 ↗
Modality	Small molecule	“synthetically-derived small molecule” NCT04890613 ↗ 1 CHEMBL4303309 ↗
Route	Intravenous	“CX5461 as intravenous infusion on day 1 and day 8 every 4 weeks.” NCT02719977 ↗