TSRL, Inc., a preclinical contract research organization (CRO) specializing in formulation development, bioanalysis, exploratory toxicology, and pharmacokinetic strategies to guide human dosing schedules, today announced that it has received its second-year Notice of Award from the National Institutes of Health (NIH) to continue advancing its microneedle patch for the treatment of overactive bladder.
The award, issued last month, provides nearly $1.1 million in continued support under Grant Number 5R44DK143799-03. The project, titled “Microneedle delivery of Trospium Chloride optimized for improved tolerance and patient outcomes in overactive bladder disease,” is led by Principal Investigator Dr. Elke Lipka, President and CEO of TSRL.
The funding continues TSRL’s work to develop a self-administered microneedle patch designed to deliver Trospium Chloride, a clinically established therapy for overactive bladder, in a more consistent and patient-friendly way. Trospium Chloride is known for its limited ability to cross the blood-brain barrier, making it an important candidate for patients who may be concerned about cognitive side effects associated with some anticholinergic therapies.
“This continued NIH support is especially meaningful at a time when many research funding awards have faced uncertainty,” said Dr. Lipka. “For our team, it is also continued validation of the scientific rationale behind our microneedle delivery platform and its potential to address real patient challenges in overactive bladder.”
Overactive bladder affects millions of people in the United States and is particularly common among older adults. While anticholinergic therapies remain a standard treatment option, adherence can be limited by inconsistent oral bioavailability, peak-related adverse events, and tolerability concerns.
TSRL’s microneedle patch-based approach is designed to deliver Trospium Chloride at a steady therapeutic rate through a weekly, self-administered system. The goal is to improve tolerability, support more consistent exposure, and create a delivery format that is easier for patients to use.
The continued NIH funding will support preclinical development activities tied to pharmacokinetics, efficacy, safety, formulation optimization, and preparation for future regulatory milestones.
“Trospium Chloride is an established therapy, but delivery matters,” said Dr. Lipka. “By developing a weekly, self-administered microneedle patch, our goal is to create a more consistent and patient-friendly option that can improve tolerability, support adherence, and generate the data needed to move this program toward future regulatory milestones.”
The second-year award builds on TSRL’s original Phase II SBIR grant from the National Institute of Diabetes and Digestive and Kidney Diseases, NIH, which supported the advancement of the company’s hydrogel-based microneedle system for overactive bladder therapy.
TSRL has a long-standing commitment to preclinical innovation and has become one of Michigan’s leading recipients of NIH contract and grant funding. The company operates from a 7,500-square-foot facility in Ann Arbor, Michigan that includes advanced formulation and bioanalytical laboratories, along with an experienced scientific team supporting drug development programs across multiple therapeutic areas.
For more information, visit: https://www.tsrlinc.com/.
The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Health.
Founded in 1986, TSRL, Inc. is a preclinical contract research organization (CRO) specializing in oral drug delivery, formulation development, and drug absorption strategies. Based in Michigan, TSRL supports pharmaceutical, biotechnology, and government partners with a science-first approach that goes beyond standard testing. With expertise spanning in vitro and in vivo models, solubility enhancement, and strategic consulting, TSRL helps advance complex drug candidates from early discovery through IND-enabling studies. Learn more at www.tsrlinc.com.
