Drugs / masofaniten
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05295927 | Mar → Sep 2022 | prostate neoplasm | Janssen Research & Development, LLC | Terminated | No outcome recorded |
| Phase 1 | NCT04421222 | Jun 2020 → Oct 2024 | prostate cancer | ESSA Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1/21 trial · 1 missed | ||||||
| Phase 1/2 | NCT05075577 | Dec 2021 → Oct 2024 | prostate cancer | ESSA Pharmaceuticals | Terminated | Missed primary |
| Phase 21 trial | ||||||
| Phase 2 | NCT06312670 | May 2024 → Jan 2025 | metastatic prostate carcinoma, prostate adenocarcinoma | Pedro Barata, MD, MSc | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 20
| Date | Issuer | Release |
|---|---|---|
| 2024-10-31 | ESSA Pharmaceuticals | Results ESSA Pharma Announces Termination of Phase 2 Study Evaluating Masofaniten Combined with Enzalutamide in Patients with Metastatic Castration-Resistant Prostate Cancer essapharma.com ↗
Efficacy signals observed will not achieve ESSA's target product profile in patients with metastatic castration-resistant prostate cancer naïve to second-generation antiandrogens |
| 2024-09-13 | ESSA Pharmaceuticals | Results ESSA Pharma Presents Updated Phase 1/2 Masofaniten (EPI-7386) Clinical Data at the 2024 ESMO Congress essapharma.com ↗
Across all dosing cohorts, 88% of patients achieved PSA90, 69% of patients achieved PSA90 in less than 90 days, and 63% of patients achieved PSA <0.2ng/mL. |
| 2024-01-25 | ESSA Pharmaceuticals | Results ESSA Pharma Presents Updated Phase 1 Masofaniten (EPI-7386) Clinical Data at the 2024 ASCO Genitourinary Cancers Symposium essapharma.com ↗
Combination of masofaniten plus enzalutamide continues to be well tolerated with deep and durable reductions in PSA in patients with mCRPC |
| 2023-10-26 | ESSA Pharmaceuticals | Results ESSA Pharma Presents Updated Phase 1 Masofaniten (EPI-7386) Clinical Data at the 30th Annual Prostate Cancer Foundation Scientific Retreat essapharma.com ↗
Across all cohorts of patients including those recently enrolled into cohort four, 81% of patients achieved PSA90, 69% of patients achieved PSA90 in less than 90 days, and 56% of patients achieved PSA <0.2ng/mL |
| 2023-10-21 | ESSA Pharmaceuticals | Results ESSA Pharma Presents Updated Phase 1 Masofaniten (EPI-7386) Clinical Data at the European Society of Medical Oncology 2023 Congress essapharma.com ↗
Combination of masofaniten plus enzalutamide continues to be well tolerated with deep and durable reductions in PSA in patients with mCRPC |
| 2023-02-13 | ESSA Pharmaceuticals | Results ESSA Pharma Announces Presentations at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) essapharma.com ↗
We are encouraged that EPI-7386 has continued to be well-tolerated and safe as well as demonstrate initial anti-tumor activity both as a monotherapy and in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer, |
| 2022-10-31 | ESSA Pharmaceuticals | Results ESSA Provides an Update on its Clinical Collaboration with Janssen essapharma.com ↗
Initial clinical activity was observed in some patients, with two of the three patients achieving a prostate-specific antigen ("PSA") reduction of 90% ("PSA90") within 12 weeks. |
| 2022-10-26 | ESSA Pharmaceuticals | Results Updated Results from the Phase 1/2 Study of ESSA's Lead Candidate EPI-7386 in Combination with Enzalutamide Highlighted at the 29th Annual Prostate Cancer Foundation Scientific Retreat essapharma.com ↗
EPI-7386 in combination with enzalutamide was safe and well-tolerated at the doses tested with clinically relevant drug exposures and deep and durable prostate specific antigen ("PSA") reductions observed in five of six patients |
| 2022-06-27 | ESSA Pharmaceuticals | Results ESSA Pharma Presents Clinical Update on EPI-7386 Monotherapy and Combination Therapy Clinical Development essapharma.com ↗
The initial data from 36 patients demonstrate that EPI-7386 was well-tolerated, exhibited a favorable pharmacokinetic profile, and demonstrated initial anti-tumor activity in a heavily pretreated group of patients. |
| 2021-10-28 | ESSA Pharmaceuticals | Results ESSA Pharma Presents at 28th Annual Prostate Cancer Foundation Scientific Retreat essapharma.com ↗
The data include the results of nuclear magnetic resonance (NMR) studies which confirm the binding of the compound to the N-terminal domain (NTD) of the androgen receptor (AR), a region not currently targeted by other antiandrogen therapies. |
| 2021-10-07 | ESSA Pharmaceuticals | Results ESSA Pharma Announces the Presentation of Preclinical Data Characterizing the Mechanism of Action of EPI-7386 essapharma.com ↗
The preclinical data confirm EPI-7386's target engagement with the NTD of the AR through multiple studies: |
| 2021-04-10 | ESSA Pharmaceuticals | Results ESSA Pharma Presents Preclinical Data Supporting the Therapeutic Potential of EPI-7386 at the 2021 American Association of Cancer Research (AACR) Annual Meeting essapharma.com ↗
In an in vitro cellular thermal shift assay (CETSA), EPI-7386 was shown to physically interact with both the full-length and the splice variant (AR-V7) form of AR. |
| 2021-02-11 | ESSA Pharmaceuticals | Results ESSA Pharma Presents Favorable Initial Phase 1 Clinical Pharmacology Data of EPI-7386 for Advanced Forms of Prostate Cancer at the 2021 ASCO Genitourinary Cancers Symposium essapharma.com ↗
In this initial cohort of patients receiving the 200 mg once-daily dose, EPI-7386 was well-tolerated with no SAEs observed. |
| 2020-10-24 | ESSA Pharmaceuticals | Results ESSA Pharma Presents Therapeutic Potential of EPI-7386 at 32nd EORTC-NCI-AACR Symposium essapharma.com ↗
EPI-7386 exhibits superior activity to enzalutamide in the AR-V7-driven cellular models LNCaP95 and 22Rv1 by modulating AR-driven gene expression with or without the addition of an external androgen. |
| 2020-09-17 | ESSA Pharmaceuticals | Results ESSA Pharma Announces the Presentation of Additional Preclinical Data for EPI-7386 at the ESMO Virtual Congress 2020 essapharma.com ↗
ESSA Pharma Inc. (Nasdaq: EPIX) (TSX-V: EPI), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, today announced the presentation of data of ESSA's clinical candidate, EPI-7386, at the ESMO Virtual Congress 2020. |
| 2020-09-14 | ESSA Pharmaceuticals | Regulatory ESSA Pharma Announces Fast Track Designation Granted by the FDA to EPI-7386 for the Treatment of Metastatic Castration-Resistant Prostate Cancer essapharma.com ↗
the U.S. Food and Drug Administration ("FDA") granted Fast Track Designation to EPI-7386, its oral and highly-selective N-terminal domain inhibitor of the androgen receptor, for the treatment of adult male patients with metastatic castration-resistant prostate cancer ("mCRPC") resistant to standard-of-care treatment. |
| 2020-06-22 | ESSA Pharmaceuticals | Results ESSA Pharma Presents Therapeutic Potential of EPI-7386 at the 2020 American Association for Cancer Research Virtual Annual Meeting II essapharma.com ↗
In the same cellular model, combination treatment of EPI-7386 with enzalutamide displays broader and deeper inhibition of AR-associated transcriptional activity than higher doses of each single agent alone. |
| 2020-04-30 | ESSA Pharmaceuticals | Regulatory ESSA Pharma Announces FDA Allowance of the Clinical Investigation of EPI-7386 in Prostate Cancer essapharma.com ↗
ESSA Pharma Inc. ("ESSA", or the "Company") (Nasdaq: EPIX, TSX-V: EPI), a pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, today announced that the U.S. Food and Drug Administration ("FDA") has notified the Company that it may proceed with its proposed clinical investigation of EPI-7386 for the treatment of metastatic castration-resistant prostate cancer ("mCRPC"). |
| 2020-03-31 | ESSA Pharmaceuticals | Regulatory ESSA Pharma Submits IND for EPI-7386 for Prostate Cancer and Provides Business Update essapharma.com ↗
VANCOUVER and HOUSTON, March 31, 2020 /CNW/ - ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX, TSX-V: EPI), a pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to evaluate its lead clinical candidate, EPI-7386, in a Phase 1 clinical study for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). |
| 2019-09-28 | ESSA Pharmaceuticals | Results ESSA Pharma Presents New Data on EPI-7386 at the European Society of Medical Oncology (ESMO) 2019 Congress essapharma.com ↗
The poster shows that, in preclinical studies, EPI-7386 demonstrates: Activity in multiple in vitro full length androgen receptor (AR) and AR-V7 splice variant driven cellular models. |
All press releases naming this drug 31 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | masofaniten | “Masofaniten (EPI-7386) is a next-generation aniten with promising activity and safety in patients with metastatic castrate-resistant prostate cancer (mCRPC).” PMID 41467749 ↗ Jan 2026 |
| Known as | EPI-7386 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05295927 ↗ |
| Known as | Masofanitene | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095106 ↗ |
| Action | Inhibit | “Anitens are a family of oral N-terminal domain inhibitors of the androgen receptor (AR).” PMID 41467749 ↗ Jan 2026 |
| Modality | Small molecule | — CHEMBL5095106 ↗ |
| Route | Oral | “Once daily oral dose of EPI-7386” NCT04421222 ↗ |
| Target | AR | “Anitens are a family of oral N-terminal domain inhibitors of the androgen receptor (AR).” PMID 41467749 ↗ Jan 2026 |