Drugs / RALANITEN ACETATE
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT02606123 | Oct 2015 → Dec 2017 | male reproductive system neoplasm, prostate neoplasm | ESSA Pharmaceuticals | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2017-09-11 | ESSA Pharmaceuticals | Results ESSA Pharma Announces Results from the Phase 1 Clinical Trial of EPI-506 for Treatment of mCRPC and Updates Clinical and Strategic Plans essapharma.com ↗
Long-term stable disease and PSA reductions at higher dose levels in some patients indicate signs of efficacy and suggest the need for a more potent agent |
| 2017-06-05 | ESSA Pharmaceuticals | Results ESSA Pharma Presents Data From Phase 1 Trial of EPI-506 at 2017 ASCO Annual Meeting essapharma.com ↗ |
| 2017-05-17 | ESSA Pharmaceuticals | Results ESSA Pharma Announces Data from Phase 1 Trial of EPI-506 to be Presented During 2017 ASCO Annual Meeting essapharma.com ↗
At the time of the abstract submission, minor PSA declines in 3/18 patients had been observed at doses from 80 to 1280 mg. |
| 2017-05-15 | ESSA Pharmaceuticals | Results ESSA Pharma Provides Business Update and Announces Financial Results for the Second Quarter Ended March 31, 2017 essapharma.com ↗
We are pleased that EPI-506 continues to be well-tolerated, and that recent patient cohorts have achieved drug exposures within the targeted therapeutic range. |
| 2017-04-03 | ESSA Pharmaceuticals | Results ESSA Pharma Provides Clinical Study Update and Announces Presentations at the American Association for Cancer Research Annual Meeting essapharma.com ↗
EPI-506 continues to be very well-tolerated through six patient cohorts at escalating doses in the Phase 1 dose trial. |
| 2015-11-05 | ESSA Pharmaceuticals | Regulatory ESSA Pharma Inc. Receives Health Canada Approval to Commence Clinical Development for EPI-506 essapharma.com ↗
The HPB letter will allow ESSA to include Canadian sites in its ongoing Phase 1/2 clinical study of its novel agent, EPI-506, for the treatment of metastatic castration-resistant prostate cancer ("CRPC") in patients who have failed current therapies. |
| 2015-09-23 | ESSA Pharmaceuticals | Regulatory ESSA Pharma Inc. Receives FDA Approval to Commence Clinical Development essapharma.com ↗ |
| 2015-05-04 | ESSA Pharmaceuticals | Regulatory ESSA Pharma Inc. Receives FDA Response on IND Application essapharma.com ↗
the Company's IND application, filed March 31, 2015, has been placed on clinical hold pending receipt by the FDA of additional chemistry and pharmaceutical data |
| 2015-03-31 | ESSA Pharmaceuticals | Regulatory ESSA Pharma Inc. Announces Filing of Investigational New Drug Application for EPI-506 essapharma.com ↗
ESSA Pharma Inc. ("ESSA" or the "Company") (TSX-V: EPI) announced today that it has filed with the Food and Drug Administration ("FDA") in the US an Investigation New Drug ("IND") application related to the Company's proposed clinical trial of EPI-506 in prostate cancer patients. |
All press releases naming this drug 10 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | RALANITEN ACETATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297675 ↗ |
| Known as | EPI-506 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02606123 ↗ |
| Modality | Small molecule | — CHEMBL4297675 ↗ |
| Route | Oral | “administered orally” NCT02606123 ↗ |