# Enabling the repurposing of niclosamide for castrate-resistant prostate cancer using a novel formulation technology platform

> **NIH NIH R41** · VIA THERAPEUTICS, LLC · 2020 · $263,895

## Abstract

Prostate cancer is the most common diagnosed cancer developing in men, developing in around 160,000 men
in the United States. While many men are successfully treated of the disease, nearly 30,000 continue to die
each year to do an advanced cancer which continues to grow despite castration levels of androgen present. A
new generation of androgen receptor signal inhibitors has come to the market and successfully improved the
survival of patients. However, resistance to the new agents is inevitable and occurs in the first few years after
beginning treatment. The resistance has been shown to be linked to splice variants in the androgen receptor.
Niclosamide has recently been discovered to inhibit at least splice variant expression AR-V7, which in
combination with next generation androgen receptor signal inhibitors has shown a synergistic effect. In a
recent phase I feasibility study however, niclosamide failed as a therapeutic due to bioavailability limitations.
Niclosamide is poorly water-soluble drugs who would benefit from our formulation design and processing
technology platform which improves upon current amorphous solid dispersions, the technique currently used in
19 FDA approved products. Preliminary evidence presence promising results for improvements in the drugs
bioavailability with this formulation technique. We propose to optimize the formulation through a quality by
design approach to maximize the performance of the drug in the formulation platform. After validating the
performance of niclosamide with our formulation platform with a pharmacokinetic study we will perform an
efficacy study in a subcutaneous xenograft mouse model of castration-resistant prostate cancer to support the
efficacy of the drug in feasible doses for future clinical testing.

## Key facts

- **NIH application ID:** 10010726
- **Project number:** 1R41CA243931-01A1
- **Recipient organization:** VIA THERAPEUTICS, LLC
- **Principal Investigator:** Robert O. Williams
- **Activity code:** R41 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $263,895
- **Award type:** 1
- **Project period:** 2020-08-01 → 2023-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10010726

## Citation

> US National Institutes of Health, RePORTER application 10010726, Enabling the repurposing of niclosamide for castrate-resistant prostate cancer using a novel formulation technology platform (1R41CA243931-01A1). Retrieved via AI Analytics 2026-05-29 from https://api.ai-analytics.org/grant/nih/10010726. Licensed CC0.

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