Dual Cromolyn-Cetirizine oral capsule to help men with chronic pelvic pain
Official title: From Formulation to IND: Optimization of a Dual Cromolyn-Cetirizine Enteric Softgel for Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Funded at Dolor Therapeutics, LLC · NIH-11407121 · Data updated 2026-11-12
A new oral medicine combining cromolyn sodium and cetirizine is being developed to help adults with chronic prostatitis/chronic pelvic pain by targeting immune and nerve-related pathways.
Quick facts
| Grant type | Sbir 2 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Dolor Therapeutics, LLC NIH-funded |
| Lab location | 1 site (Chicago, United States) |
| Project start | September 1, 2024 |
| Project end | April 30, 2028 |
| Funding year | 2026 |
| Award (this year) | $1,124,999 |
| NIH project number | 2R44DK139835-02 |
| Project ID | NIH-11407121 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adult men with CP/CPPS who may benefit from a mechanism-based, oral therapy.
✕Less likely to help
Patients seeking non-pharmacologic treatments or those not affected by CP/CPPS may not benefit.
What this research studies
This grant supports optimizing an oral softgel formulation (DT101) to improve absorption and deliver a first-in-class treatment for CP/CPPS. Researchers will conduct formulation work and large-animal pharmacokinetic and toxicology studies to prepare for FDA approval via the 505(b)(2) pathway. The goal is to move a mechanism-based therapy from dogs and early studies toward a potential human treatment for a condition with limited approved options. If successful, the work could lead to a new option that addresses underlying neuroimmune processes in CP/CPPS.
Why it matters
Potential benefit: If successful, patients with CP/CPPS could gain an effective, first-in-class oral treatment targeting mast cell and neuroimmune pathways.
How similar studies have gone: Previous early studies showed improved cromolyn bioavailability in animals with targeted formulations, supporting progression toward human testing.
Where this research is happening
-
Dolor Therapeutics, LLC
Chicago, United States Active
Researchers
- Principal investigator: Sargent, William Q — Dolor Therapeutics, LLC
- Study coordinator: Sargent, William Q
Related research
Other NIH-funded projects on the same topics.
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Exploring allergy-based triggers to prevent UCPPS flare-ups
A short, patient-friendly study will look at whether allergy-related antibodies can help predict and prevent flare-ups in people with urologic chronic pelvic pain syndrome.
-
A brief behavioral treatment for chronic pelvic pain
This project is testing a short behavioral therapy to help people manage chronic pelvic pain and related conditions like irritable bowel syndrome.
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Chemical Clues in Chronic Pelvic Pain
This project looks for unique chemical patterns in the body that could help us better understand and treat chronic pelvic pain in men and women.
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Using glial cells to reduce visceral pain in bladder conditions
This study is looking at how certain cells in the nervous system can be activated to help reduce the pain that comes with chronic pelvic pain syndrome, especially for those dealing with bladder issues, and it aims to find new treatment options that could eventually help people like you.
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Improving treatment for chronic pelvic pain in men
This study is looking to create a new oral medication to help men under 50 who suffer from chronic prostatitis/chronic pelvic pain syndrome, by combining two types of medicine that have shown promise, and it will first test these new formulas in dogs to find the best one before trying it in people.
-
Investigating the role of food-specific antibodies in chronic pelvic pain conditions.
This study is looking at how certain foods might affect people with chronic pelvic pain, like interstitial cystitis and chronic prostatitis, to find out if changing what you eat can help ease your symptoms.
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.