FDA grants fast track designation to Enolen for localized prostate cancer

The FDA has granted fast track designation to Enolen, a platform that utilizes novel anti-androgen eluting implants to deliver enzalutamide (Xtandi) directly into prostate tissue for patients with low- to intermediate-risk localized prostate cancer.¹

Fast track designation is awarded to novel agents that are intended to treat or prevent serious or life-threatening conditions and have the potential to address an unmet medical need. With this designation, the development process for Enolen can benefit from more frequent engagement with the FDA as well as eligibility for accelerated approval and priority review.

“Receiving fast track designation for Enolen is further evidence of the urgent need for new treatment options for early-stage prostate cancer. Patients living with prostate cancer deserve an alternative to active surveillance or being faced with the considerable negative side effects common with the more aggressive treatment options available today,” said Cam Gallagher, president and CEO of Alessa Therapeutics, in the news release from the company.¹ “We will continue to collaborate closely with the FDA to advance a new treatment option for men suffering not only from the disease itself, but who often face a heavy burden in deciding between not treating their cancer or pursuing therapies with significant health and lifestyle consequences.”

Alessa’s drug-eluting implants are designed to provide 2 or more years of continuous drug elution directly to diseased tissue. Preclinical data has suggested that the implant technology can provide high local drug concentrations without systemic exposure.

According to the company, “This localized delivery can help eliminate the potential [adverse] effects of systemic anti-androgen and testosterone-lowering drugs, including sexual dysfunction, muscle mass loss, cognitive issues, metabolic syndrome, and cardiovascular events.”

Enolen is currently under investigation in a phase 1 trial in the US.² Overall, the study is assessing whether Enolen is safe and effective in delivering enzalutamide locally into the prostate. The trial plans to enroll up to 20 patients who are planning for radical prostatectomy.

Participants in the study will receive the drug eluting Enolen implants. They will undergo a repeat MRI at 6 to 12 weeks following implantation, followed by standard of care radical prostatectomy.

The primary end points for the trial are the incidence of adverse events and measurement of pharmacokinetics. The investigators will also assess MRI changes and changes in testosterone at 6 to 12 weeks following implantation, as well as changes in prostate-specific antigen levels at 6 to 12 weeks following radical prostatectomy.

The company plans to share initial findings from the trial in 2026.

REFERENCE

1. Alessa Therapeutics Announces FDA Fast Track Designation for Enolen, A First-Of-Its-Kind Treatment for Localized Prostate Cancer. News release. Alessa Therapeutics. January 8, 2026. Accessed January 8, 2026. https://alessatherapeutics.com/news/alessa-therapeutics-announces-fda-fast-track-designation-for-enolen-a-first-of-its-kind-treatment-for-localized-prostate-cancer/

2. Enzalutamide Implants (Enolen) in Patients With Prostate Cancer. ClinicalTrials.gov. Last updated June 28, 2024. Accessed January 8, 2026. https://clinicaltrials.gov/study/NCT06257693