# Optimizing Dual Therapy for Chronic Prostatitis/Chronic Pelvic Pain Syndrome

> **NIH NIH R41** · DOLOR THERAPEUTICS, LLC · 2024 · $318,488

## Abstract

SUMMARY
Chronic prostatitis/Chronic pelvic pain syndrome (CP/CPPS) is the most common urological condition affecting
men under the age of 50. With an estimated prevalence of 6-12% of the male population, the average direct and
indirect cost totals $10,000 per patient/per year in the U.S. There are currently no FDA approved therapeutics
for CPPS. Research on CPPS has shown that mast cell dysfunction can lead to symptoms of CPPS and that a
combination of a mast cell stabilizer and histamine receptor antagonist is uniquely synergistic. These
observations have been validated in a recent pilot study in humans with CP/CPPS where this combination was
shown to be efficacious. However, the medications utilized have poor absorption from the GI tract, necessitating
high doses and a cumbersome treatment protocol, contributing to lower patient adherence to treatment. We
therefore proposed to develop an optimized formulation that can be delivered orally, once or twice daily, in a
soft-gel capsule. Working with a formulation company, initial proof of concept studies in dogs showed that
enhancing intestinal permeability can increase absorption, providing a means to achieve our developmental
goals. In this application, we propose to develop and test two unique formulations with permeation enhancers
in dogs to select the formulation with the most desirable pharmacokinetic parameters. In addition, we will work
with our academic partner, Northwestern University, to define the exposure-response relationship of these
therapeutic agents in a murine model of CP/CPPS. These feasibility studies proposed in two separate Aims will
set the stage for a phase II STTR which will focus on optimization and stability of the lead formulation, inclusion
in a proprietary enteric-coated soft-gel capsule and small batch manufacturing.

## Key facts

- **NIH application ID:** 10918611
- **Project number:** 1R41DK139835-01
- **Recipient organization:** DOLOR THERAPEUTICS, LLC
- **Principal Investigator:** William Q Sargent
- **Activity code:** R41 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $318,488
- **Award type:** 1
- **Project period:** 2024-09-01 → 2026-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10918611

## Citation

> US National Institutes of Health, RePORTER application 10918611, Optimizing Dual Therapy for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (1R41DK139835-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10918611. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*